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NIST SP 1800-24: Securing Picture Archiving and Communication System (PACS): Cybersecurity for the Healthcare Sector

Jennifer Cawthra (NIST); Bronwyn Hodges (MITRE); Jason Kuruvilla (MITRE); Kevin Littlefield (MITRE); Robert Niemeyer (MITRE); Chris Peloquin (MITRE); Sue Wang (MITRE); Ryan Williams (MITRE); Kangmin Zheng (MITRE) · National Institute of Standards and Technology (NIST)
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NIST SPECIAL PUBLICATION 1800-24

Securing Picture Archiving and Communication System (PACS): Cybersecurity for the Healthcare Sector Includes Executive Summary (A); Approach, Architecture, and Security Characteristics (B); and How-To Guides (C)

Jennifer Cawthra Bronwyn Hodges Jason Kuruvilla* Kevin Littlefield Bob Niemeyer Chris Peloquin Sue Wang Ryan Williams Kangmin Zheng *Former employee; all work for this publication done while at employer.

FINAL

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24 The first draft of this publication is available free of charge from: https://www.nccoe.nist.gov/library/securing-picture-archiving-and-communication-system-nist-sp-180024-practice-guide

NIST SPECIAL PUBLICATION 1800-24

Securing Picture Archiving and Communication System (PACS): Cybersecurity for the Healthcare Sector Includes Executive Summary (A); Approach, Architecture, and Security Characteristics (B); and How-To Guides (C)

Jennifer Cawthra National Cybersecurity Center of Excellence National Institute of Standards and Technology Bronwyn Hodges Jason Kuruvilla* Kevin Littlefield Bob Niemeyer Chris Peloquin Sue Wang Ryan Williams Kangmin Zheng The MITRE Corporation McLean, Virginia *Former employee; all work for this publication done while at employer. FINAL

December 2020

U.S. Department of Commerce Wilbur Ross, Secretary National Institute of Standards and Technology Walter Copan, NIST Director and Undersecretary of Commerce for Standards and Technology

NIST SPECIAL PUBLICATION 1800-24A

Securing Picture Archiving and Communication System (PACS): Cybersecurity for the Healthcare Sector Volume A: Executive Summary

Jennifer Cawthra National Cybersecurity Center of Excellence National Institute of Standards and Technology

Jason Kuruvilla* Kevin Littlefield Bob Niemeyer Sue Wang Ryan Williams Kangmin Zheng The MITRE Corporation McLean, Virginia *Former employee; all work for this publication done while at employer.

December 2020 FINAL This publication is available free of charge from https://doi.org/10.6028/NIST.SP.1800-24 The first draft of this publication is available free of charge from https://www.nccoe.nist.gov/library/securing-picture-archiving-and-communication-system-nist-sp-180024-practice-guide

Executive Summary

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The National Cybersecurity Center of Excellence (NCCoE) at the National Institute of Standards and Technology (NIST) built a laboratory environment to emulate a medical imaging environment, performed a risk assessment, and identified controls from the NIST Cybersecurity Framework to secure a medical imaging ecosystem. This project used picture archiving and communication system (PACS) and a vendor neutral archive (VNA) and implemented controls to safeguard medical images from cybersecurity and privacy threats. PACS and a VNA, hereafter referred to as PACS, comprise the systems to centrally manage medical imaging data. This effort resulted in a NIST Special Publication 1800 series Cybersecurity Practice Guide, based on the following considerations relative to PACS: 

PACS allows for the acceptance, transfer, display, storage, and digital processing of medical images. PACS centralizes functions surrounding medical imaging workflows and serves as an authoritative repository of medical image information. Medical imaging is a critical component in rendering patient care. PACS serves as the repository to manage these images and accompanying clinical information within a healthcare delivery organization (HDO).

PACS fits within a highly complex HDO environment that includes back-office systems, electronic health record systems, and pharmacy and laboratory systems, as well as an array of electronic medical devices. This environment may include cloud storage for medical images. In managing these systems, HDOs work with a diverse group of individuals who interact with the enterprise information technology (IT) infrastructure and may include IT operations staff, internal support teams, and biomedical engineers, as well as vendors and manufacturers.

Securing PACS presents several challenges. Various departments operating in the HDO have unique medical imaging needs and may operate their own PACS or other medical imaging archiving systems. Further, HDOs may use external medical imaging specialists when reviewing patient medical data. The PACS ecosystem, therefore, may include multiple systems for managing medical imaging data, along with a diverse clinical user community, accessing PACS from different locations. This complexity leads to cybersecurity challenges.

PACS may have vulnerabilities that, given its central nature, may impact an HDO’s ability to render patient care or to preserve patient privacy. These vulnerabilities could impede patients’ timely diagnosis and treatment if medical images are altered or misdirected. These vulnerabilities could also expose an HDO to risks of significant data loss, malware and ransomware attacks, and unauthorized access to other parts of an HDO enterprise network.

This NIST Cybersecurity Practice Guide demonstrates how organizations can securely configure and deploy PACS. This guide presents an example solution that helps HDOs improve medical imaging ecosystem privacy and cybersecurity.

CHALLENGE PACS, by its nature, is a system that cannot operate in isolation. The overall PACS ecosystem consists of diverse technologies that include medical imaging devices, patient registry systems, and worklist management systems. PACS also relies on systems to manage and maintain medical image archives, which may include cloud storage capabilities. The primary role of PACS is interaction with disparate medical imaging devices, interconnectivity with other clinical systems, and allowing a geographically and organizationally diverse team of healthcare professionals to review medical images to provide quality

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and timely patient care. Therefore, the threat landscape is broad, and allows for a large attack surface. The PACS environment may include vulnerabilities. Unauthorized individuals may leverage vulnerabilities and compromise or corrupt stored information. Also, unauthorized individuals may use components found in the PACS ecosystem as pivot points to further compromise components in an integrated healthcare information system.

SOLUTION This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

This practice guide demonstrates how an organization may implement a solution to mitigate identified cybersecurity and privacy risks. The reference architecture features technical and process controls to implement: 

a defense-in-depth solution, including network zoning that allows more granular control of network traffic flows and limits communications capabilities to the minimum necessary to support business function

access control mechanisms that include multifactor authentication for care providers, certificate-based authentication for imaging devices and clinical systems, and mechanisms that limit vendor remote support to medical imaging components

a holistic risk management approach that includes medical device asset management, augmenting enterprise security controls, and leveraging behavioral analytic tools for near realtime threat and vulnerability management in conjunction with managed security solution providers

The NCCoE sought existing technologies that provided the following capabilities: 

role-based access control

microsegmentation

behavioral analytics

data security

cloud storage

While the NCCoE used a suite of commercial products to address this challenge, this guide does not endorse these particular products, nor does it guarantee compliance with any regulatory initiatives. Your organization’s information security experts should identify the products that will best integrate with your existing tools and IT system infrastructure. Your organization can adopt this solution or one that adheres to these guidelines in whole, or you can use this guide as a starting point for tailoring and implementing parts of a solution.

BENEFITS The NCCoE’s practice guide, Securing Picture Archiving and Communication Systems, can help your organization: 

improve resilience in the network infrastructure, including limiting a threat actor’s ability to leverage components as pivot points to attack other parts of the HDO’s environment

limit unauthorized movement within the HDO environment by authorized system users to address the “insider threat” as well as limit unauthorized actors once they gain network access

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analyze behavior and detect malware throughout the ecosystem to enable HDOs to determine when components evidence compromise and to enable those organizations to limit the effects of a potential advanced persistent threat such as ransomware

secure sensitive data (e.g., personally identifiable information or protected health information) at rest, in transit, and in cloud environments; enhancing patient privacy by limiting malicious actors’ ability to exfiltrate or expose that data

consider and address risks that may be identified as HDOs examine cloud storage solutions as part of managing their medical imaging infrastructure

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

SHARE YOUR FEEDBACK You can view or download the guide at https://www.nccoe.nist.gov/projects/use-cases/health-it/pacs. If you adopt this solution for your own organization, please share your experience and advice with us. We recognize that technical solutions alone will not fully enable the benefits of our solution, so we encourage organizations to share lessons learned and best practices for transforming the processes associated with implementing this guide. To provide comments or to learn more by arranging a demonstration of this example implementation, contact the NCCoE at hit_nccoe@nist.gov.

COLLABORATORS Collaborators participating in this project submitted their capabilities in response to an open call in the Federal Register for all sources of relevant security capabilities from academia and industry (vendors and integrators). Those respondents with relevant capabilities or product components signed a Cooperative Research and Development Agreement (CRADA) to collaborate with NIST in a consortium to build this example solution.

Certain commercial entities, equipment, products, or materials may be identified by name or company logo or other insignia in order to acknowledge their participation in this collaboration or to describe an experimental procedure or concept adequately. Such identification is not intended to imply special status or relationship with NIST or recommendation or endorsement by NIST or NCCoE; neither is it intended to imply that the entities, equipment, products, or materials are necessarily the best available for the purpose.

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The NCCoE, a part of NIST, is a collaborative hub where industry organizations, government agencies, and academic institutions work together to address businesses’ most pressing cybersecurity challenges. Through this collaboration, the NCCoE develops modular, adaptable example cybersecurity solutions demonstrating how to apply standards and best practices by using commercially available technology.

LEARN MORE Visit https://www.nccoe.nist.gov nccoe@nist.gov 301-975-0200

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24. NIST SP 1800-24A: Securing Picture Archiving and Communication System (PACS)

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NIST SPECIAL PUBLICATION 1800-24B

Securing Picture Archiving and Communication System (PACS): Cybersecurity for the Healthcare Sector Volume B: Approach, Architecture, and Security Characteristics

Jennifer Cawthra National Cybersecurity Center of Excellence National Institute of Standards and Technology

Bronwyn Hodges Jason Kuruvilla* Kevin Littlefield Bob Niemeyer Chris Peloquin Sue Wang Ryan Williams Kangmin Zheng The MITRE Corporation McLean, Virginia *Former employee; all work for this publication done while at employer.

December 2020 FINAL This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24 The first draft of this publication is available free of charge from: https://www.nccoe.nist.gov/library/securing-picture-archiving-and-communication-system-nist-sp-180024-practice-guide

DISCLAIMER Certain commercial entities, equipment, products, or materials may be identified by name of company logo or other insignia in order to acknowledge their participation in this collaboration or to describe an experimental procedure or concept adequately. Such identification is not intended to imply special status or relationship with NIST or recommendation or endorsement by NIST or NCCoE; neither is it intended to imply that the entities, equipment, products, or materials are necessarily the best available for the purpose. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

National Institute of Standards and Technology Special Publication 1800-24B, Natl. Inst. Stand. Technol. Spec. Publ. 1800-24B, 102 pages, (December 2020), CODEN: NSPUE2

FEEDBACK As a private-public partnership, we are always seeking feedback on our practice guides. We are particularly interested in seeing how businesses apply NCCoE reference designs in the real world. If you have implemented the reference design, or have questions about applying it in your environment, please email us at hit_nccoe@nist.gov. All comments are subject to release under the Freedom of Information Act.

National Cybersecurity Center of Excellence National Institute of Standards and Technology 100 Bureau Drive Mailstop 2002 Gaithersburg, MD 20899 Email: nccoe@nist.gov

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NATIONAL CYBERSECURITY CENTER OF EXCELLENCE

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The National Cybersecurity Center of Excellence (NCCoE), a part of the National Institute of Standards and Technology (NIST), is a collaborative hub where industry organizations, government agencies, and academic institutions work together to address businesses’ most pressing cybersecurity issues. This public-private partnership enables the creation of practical cybersecurity solutions for specific industries, as well as for broad, cross-sector technology challenges. Through consortia under Cooperative Research and Development Agreements (CRADAs), including technology partners—from Fortune 50 market leaders to smaller companies specializing in information technology security—the NCCoE applies standards and best practices to develop modular, adaptable example cybersecurity solutions using commercially available technology. The NCCoE documents these example solutions in the NIST Special Publication 1800 series, which maps capabilities to the NIST Cybersecurity Framework and details the steps needed for another entity to re-create the example solution. The NCCoE was established in 2012 by NIST in partnership with the State of Maryland and Montgomery County, Maryland. To learn more about the NCCoE, visit https://www.nccoe.nist.gov/. To learn more about NIST, visit https://www.nist.gov.

NIST CYBERSECURITY PRACTICE GUIDES NIST Cybersecurity Practice Guides (Special Publication 1800 series) target specific cybersecurity challenges in the public and private sectors. They are practical, user-friendly guides that facilitate the adoption of standards-based approaches to cybersecurity. They show members of the information security community how to implement example solutions that help them align with relevant standards and best practices, and provide users with the materials lists, configuration files, and other information they need to implement a similar approach. The documents in this series describe example implementations of cybersecurity practices that businesses and other organizations may voluntarily adopt. These documents do not describe regulations or mandatory practices, nor do they carry statutory authority.

ABSTRACT Medical imaging plays an important role in diagnosing and treating patients. The system that manages medical images is known as the picture archiving communication system (PACS) and is nearly ubiquitous in healthcare environments. PACS is defined by the Food and Drug Administration (FDA) as a Class II device that “provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.” PACS centralizes functions surrounding medical imaging workflows and serves as an authoritative repository of medical image information.

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PACS fits within a highly complex healthcare delivery organization (HDO) environment that involves interfacing with a range of interconnected systems. PACS may connect with clinical information systems and medical devices and engage with HDO-internal and affiliated health professionals. Complexity may introduce or expose opportunities that allow malicious actors to compromise the confidentiality, integrity, and availability of a PACS ecosystem.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The NCCoE at NIST analyzed risk factors regarding a PACS ecosystem by using a risk assessment based on the NIST Risk Management Framework. The NCCoE also leveraged the NIST Cybersecurity Framework and other relevant standards to identify measures to safeguard the ecosystem. The NCCoE developed an example implementation that demonstrates how HDOs can use standards-based, commercially available cybersecurity technologies to better protect a PACS ecosystem. This practice guide helps HDOs implement current cybersecurity standards and best practices to reduce their cybersecurity risk and protect patient privacy while maintaining the performance and usability of PACS.

KEYWORDS access control; auditing; authentication; authorization; behavioral analytics; cloud storage; DICOM; EHR; electronic health records; encryption; microsegmentation; multifactor authentication; PACS; PAM; picture archiving and communication system; privileged account management; vendor neutral archive; VNA

ACKNOWLEDGMENTS We are grateful to the following individuals for their generous contributions of expertise and time. Name

Organization

Matthew Hyatt

Cisco

Kevin McFadden

Cisco

Cletis McLean

Cisco

Peter Romness

Cisco

Deidre Cruit

Clearwater Compliance

Mike Nelson

DigiCert

Taylor Williams

DigiCert

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Name

Organization

Andy Gray

Forescout

Katherine Gronberg

Forescout

William Canter

Hyland

Kevin Dietz

Hyland

Joseph Davis

Microsoft

Janet Jones

Microsoft

Dan Menicucci

Microsoft

Mehwish Akram

The MITRE Corporation

Steve Edson

The MITRE Corporation

Sallie Edwards

The MITRE Corporation

Donald Faatz

The MITRE Corporation

Harry Perper

The MITRE Corporation

David Alfonso

Philips Healthcare

Jonathan Bagnall

Philips Healthcare

Julian Castro

Philips Healthcare

Sukanta Das

Philips Healthcare

Jason Dupuis

Philips Healthcare

Michael McNeil

Philips Healthcare

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Name

Organization

Dwayne Thaele

Philips Healthcare

Steve Kruse

Symantec

Derek Peters

Symantec

Axel Wirth

Symantec

Bill Johnson

TDi Technologies

Pam Johnson

TDi Technologies

Robert Armstrong

Tempered Networks

Nicholas Ringborg

Tempered Networks

Randy Esser

Tripwire

Onyeka Jones

Tripwire

Jim Wachhaus

Tripwire

Sandra Osafo

University of Maryland University College

Henrik Holm

Virta Labs

Michael Holt

Virta Labs

Ben Ransford

Virta Labs

Jun Du

Zingbox

Damon Mosk-Aoyama

Zingbox

David Xiao

Zingbox

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The Technology Partners/Collaborators who participated in this build submitted their capabilities in response to a notice in the Federal Register. Respondents with relevant capabilities or product components were invited to sign a Cooperative Research and Development Agreement (CRADA) with NIST, allowing them to participate in a consortium to build this example solution. We worked with:

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Technology Partner/Collaborator

Build Involvement

Cisco

Cisco Firepower Version 6.3.0 Cisco Stealthwatch Version 7.0.0

Clearwater Compliance

Clearwater Information Risk Management Analysis

DigiCert

DigiCert PKI Platform

Forescout

Forescout CounterACT 8

Hyland

Hyland Acuo Vendor Neutral Archive Version 6.0.4 Hyland NilRead Enterprise Version 4.3.31.98805 Hyland PACSgear Version 4.1.0.64

Microsoft

Azure Active Directory (AD) Azure Key Vault Version Azure Monitor Azure Storage Azure Security Center Version Standard Azure Private Link

Philips Healthcare

Philips Enterprise Imaging Domain Controller Philips Enterprise Imaging IntelliSpace PACS Philips Enterprise Imaging Universal Data Manager

Symantec, a division of Broadcom

Symantec Endpoint Detection and Response (EDR) Version 4.1.0 Symantec Data Center Security: Server Advanced (DCS:SA) Version 6.7 Symantec Endpoint Protection (SEP 14) Version 14.2 Symantec Validation and ID Protection Version 9.8.4 Windows

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Technology Partner/Collaborator

Build Involvement

TDi Technologies

TDI Technologies ConsoleWorks Version 5.1-0u1

Tempered Networks

Tempered Networks Identity Defined Networking (IDN) Conductor and HIPSwitch Version 2.1

Tripwire

Tripwire Enterprise Version 8.7

Virta Labs

BlueFlow Version 2.6.4

Zingbox

Zingbox IoT Guardian

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Contents 1 Summary .............................................................................................. 1

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

1.1

Challenge ....................................................................................................................... 2

1.2

Solution.......................................................................................................................... 3

1.3

Benefits.......................................................................................................................... 3

2 How to Use This Guide ......................................................................... 4 2.1

Typographic Conventions .............................................................................................. 5

3 Approach ............................................................................................. 6 3.1

Audience ........................................................................................................................ 7

3.2

Scope ............................................................................................................................. 7

3.3

Assumptions .................................................................................................................. 8

3.4

Risk Assessment ............................................................................................................ 8 3.4.1

Establishing the Risk Context ........................................................................................9

3.4.2

System Actors .............................................................................................................11

3.4.3

Use Case Scenarios .....................................................................................................12

3.4.4

Threats ........................................................................................................................17

3.4.5

Vulnerabilities .............................................................................................................20

3.4.6

Risk ..............................................................................................................................23

3.5

Security Control Map................................................................................................... 25

3.6

Technologies................................................................................................................ 38

4 Architecture ....................................................................................... 44 4.1

Architecture Description ............................................................................................. 44 4.1.1

PACS Ecosystem Components ....................................................................................47

4.1.2

Data and Process Flow ................................................................................................48

4.1.3

Security Capabilities ....................................................................................................49

4.1.4

Asset and Risk Management.......................................................................................51

4.1.5

Enterprise Domain and Identity Management ...........................................................51

4.1.6

Network Control and Security ....................................................................................54

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4.1.7

Endpoint Protection and Security ...............................................................................58

4.1.8

Device Hardening and Configuration ..........................................................................59

4.1.9

Data Security ...............................................................................................................59

4.1.10 Remote Access ............................................................................................................60

4.2

Final Architecture ........................................................................................................ 61

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

5 Security Characteristic Analysis .......................................................... 62 5.1

Assumptions and Limitations ...................................................................................... 62

5.2

Scenarios and Findings ................................................................................................ 63

5.3

Analysis of the Reference Design’s Support for Cybersecurity Framework Subcategories .............................................................................................................. 63

5.4

5.3.1

Asset Management (ID.AM) .......................................................................................63

5.3.2

Risk Assessment (ID.RA)..............................................................................................64

5.3.3

Identity Management and Access Control (PR.AC).....................................................64

5.3.4

Data Security (PR.DS) ..................................................................................................66

5.3.5

Information Protection and Procedures (PR.IP) .........................................................67

5.3.6

Protective Technology (PR.PT) ....................................................................................67

5.3.7

Anomalies and Events (DE.AE) and Security Continuous Monitoring (DE.CM) ..........68

Security Analysis Summary.......................................................................................... 69

6 Functional Evaluation ......................................................................... 69 6.1

PACS Functional Test Plan ........................................................................................... 69 6.1.1

PACS Functional Evaluation Requirements.................................................................70

6.1.2

Test Case: PACS-1........................................................................................................71

6.1.3

Test Case: PACS-2........................................................................................................73

6.1.4

Test Case: PACS-3........................................................................................................74

6.1.5

Test Case: PACS-4........................................................................................................75

6.1.6

Test Case: PACS-5........................................................................................................76

6.1.7

Test Case: PACS-6........................................................................................................78

6.1.8

Test Case: PACS-7........................................................................................................79

6.1.9

Test Case: PACS-8........................................................................................................81

6.1.10 Test Case: PACS-9........................................................................................................82

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6.1.11 Test Case: PACS-10......................................................................................................84 6.1.12 Test Case: PACS-11......................................................................................................86 6.1.13 Test Case: PACS-12......................................................................................................87

7 Future Build Considerations ............................................................... 88 Appendix A List of Acronyms .................................................................. 89 This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Appendix B References .......................................................................... 92 Appendix C Pervasive Versus Contextual Controls ................................. 96 Appendix D Aligning Controls Based on Threats ................................... 100

List of Figures Figure 3-1 Notional High-Level Architecture ......................................................................................10 Figure 3-2 Scenario One: Sample Radiology Practice Workflows ........................................................13 Figure 3-3 Scenario Two: Image Data Access Across the Enterprise ....................................................14 Figure 3-4 Scenario Three: Accessing, Monitoring, and Auditing ........................................................15 Figure 3-5 Scenario Four: Imaging Object Change Management.........................................................16 Figure 3-6 Scenario Five: Remote Access ...........................................................................................17 Figure 4-1 High-Level PACS Architecture ...........................................................................................45 Figure 4-2 PACS Ecosystem Components ...........................................................................................47 Figure 4-3 PACS Ecosystem Data Communication Flow ......................................................................49 Figure 4-4 Base Controls on Test Build Components ..........................................................................51 Figure 4-5 NCCoE Lab Environment Network Architecture .................................................................55 Figure 4-6 Microsegmentation Architecture ......................................................................................57 Figure 4-7 PACS Final Architecture ....................................................................................................62

List of Tables Table 3-1 Threats .............................................................................................................................18

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Table 3-2 Vulnerabilities...................................................................................................................20 Table 3-3 Risk ..................................................................................................................................24 Table 3-4 Security Characteristics and Controls Mapping–NIST Cybersecurity Framework .................. 26 Table 3-5 Products and Technologies ................................................................................................38 Table 5-1 Identity Management Characteristics ................................................................................65 This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Table 6-1 Test Case Fields .................................................................................................................69 Table 6-2 Functional Evaluation Requirements..................................................................................70 Table C-1 Pervasive Security Controls ...............................................................................................97

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1 Summary

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Medical imaging is a critical component in rendering patient care. The system that provides the acceptance, transfer, display, storage, and digital processing of medical images is known as a picture archiving and communication system (PACS) [1] and is nearly ubiquitous in healthcare environments. The PACS environment serves as the repository to manage these images and accompanying clinical information within the healthcare delivery organization (HDO). Vendor neutral archive systems (VNAs) perform archive management functions similar to PACS, and hereafter, this practice guide includes VNAs when it refers to PACS. PACS fits within a highly complex HDO environment and may interface with a range of enterprise information technology (IT) systems and healthcare professionals internal and external to the HDO. This complexity leads to cybersecurity challenges. To develop practical cybersecurity guidance for securing PACS, we must consider the ecosystem surrounding PACS, which includes interconnected medical imaging equipment generally described as modalities. The ecosystem also includes modalities; connected clinical systems such as radiology information systems (RIS), health information systems (HIS), or the electronic health record (EHR); cloud storage capabilities; viewer and administration workstations; VNAs; and the PACS itself. The National Cybersecurity Center of Excellence (NCCoE) at the National Institute of Standards and Technology (NIST) built a laboratory that emulates a medical imaging environment, performed a risk assessment, and developed an example implementation that demonstrates how HDOs can use standards-based, commercially available cybersecurity technologies to better protect a PACS ecosystem. Any organization that deploys PACS and medical imaging systems can use the example implementation, which represents one of many possible solutions and architectures, but those organizations should perform their own risk assessment and implement controls based on their risk posture. For ease of use, the following paragraphs provide a short description of each section of this volume. Section 1, Summary, presents the challenge addressed by the NCCoE project, with an in-depth look at our approach, the architecture, and the security characteristics we used; the solution demonstrated to address the challenge; benefits of the solution; and the technology partners who participated in building, demonstrating, and documenting the solution. The Summary also explains how to provide feedback on this guide. Section 2, How to Use This Guide, explains how business decision makers, program managers, IT professionals (e.g., systems administrators), and biomedical engineers might use each volume of the guide. Section 3, Approach, offers a detailed treatment of the scope of the project, the risk assessment that informed platform development, and the technologies and components that industry collaborators gave us to enable platform development.

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Section 4, Architecture, specifies the components within the PACS ecosystem from business, security, and infrastructure perspectives and details how data and processes flow throughout the ecosystem. This section also describes the security capabilities and controls referenced in the NIST Cybersecurity Framework through tools provided by the project collaborators. Section 5, Security Characteristic Analysis, provides details about the tools and techniques used to perform risk assessments pertaining to PACS. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Section 6, Functional Evaluation, summarizes the test sequences employed to demonstrate security platform services, the NIST Cybersecurity Framework Functions to which each test sequence is relevant, and the NIST Special Publication (SP) 800-53 Revision 4 controls demonstrated in the example implementation. Section 7, Future Build Considerations, is a brief treatment of other applications that NIST might explore in the future to further protect a PACS ecosystem. The appendixes provide acronym translations, references, a mapping of the PACS project to the NIST Cybersecurity Framework, and a list of additional informative security references cited in the framework. Acronyms used in figures and tables are in the List of Acronyms appendix.

1.1 Challenge The challenge with PACS is securing disparate, interconnected systems. A medical imaging infrastructure offers a broad attack surface with equipment that may have varying vulnerabilities, configurations, and control implementations. Devices deployed in the ecosystem likely come from different vendors and suppliers, and how one may implement defensive measures can vary based on the nature of the devices and how they function vis-à-vis patients and other clinical systems. The ecosystem may also include legacy devices that are potentially more vulnerable to cyber risks. The care provider team (clinicians and other healthcare professionals) may reside in different departments and may have components hosted and used across a wide geography. HDOs may leverage cloud storage environments to store and maintain medical images. Some actors may be external to the HDO, interacting with sensitive information across the internet. As threats to the operational environment increase, PACS and other healthcare systems may become increasingly vulnerable to: 

system disruption, leading to •

inability to render timely diagnosis and treatment

•

inability to access the system for standard use, including inability to schedule procedures

compromise of image data, leading to incorrect diagnosis and treatment

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compromise of components, allowing malicious actors to use the components as pivot points to attack other parts of the HDO infrastructure

privacy concerns that may lead to •

fraudulent or improper use of data

•

patient identity theft

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

1.2 Solution This NIST Cybersecurity Practice Guide, Securing Picture Archiving and Communication System (PACS), shows how biomedical engineers, networking engineers, security engineers, and IT professionals can help securely configure and deploy PACS within HDOs by using commercially available, open-source tools and technologies that are consistent with cybersecurity standards. This practice guide leveraged the NIST Cybersecurity Framework in selecting privacy and cybersecurity controls. Controls and solutions may be procured, obtained as part of an open-source solution, or internally developed. While the NCCoE obtained commercially available products for this practice guide, these do not represent the only methods available to HDOs in meeting control objectives. The reference architecture features technical and process controls to implement the following solutions: 

a defense-in-depth solution, including network zoning that allows more granular control of network traffic flows and limits communications capabilities to the minimum necessary to support business function

access control mechanisms that include multifactor authentication for care providers, certificate-based authentication for imaging devices and clinical systems, and mechanisms that limit vendor remote support to medical imaging components

a holistic risk management approach that includes medical device asset management augmenting enterprise security controls. It should also leverage behavioral analytic tools for near real-time threat and vulnerability management in conjunction with managed security solution providers

cloud storage for medical images, which makes images scalable and available for HDOs

1.3 Benefits The NCCoE’s practice guide to securing PACS in HDOs can help your organization: 

improve resilience in the network infrastructure, including limiting a threat actor’s ability to leverage components as pivot points to attack other parts of the HDO’s environment

limit unauthorized movement within the HDO enterprise network to address the potential risk of an insider threat or malicious actors who gain network access

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

analyze behavior and detect malware throughout the ecosystem to enable HDOs to determine when components evidence compromise and to enable those organizations to limit the effects of a potential threat such as ransomware

secure sensitive data (e.g., personally identifiable information or protected health information [PHI]) at rest, in transit, and in cloud environments; enhance patient privacy by limiting malicious actors’ ability to exfiltrate or expose that data

consider and address risks of potential cloud solutions to manage an HDO’s medical imaging infrastructure

2 How to Use This Guide This NIST Cybersecurity Practice Guide demonstrates a standards-based reference design and provides users with the information they need to help secure a medical imaging ecosystem. This practice guide builds upon the network zoning concept described in NIST SP 1800-8, Securing Wireless Infusion Pumps in Healthcare Delivery Organizations. As part of the implementation, the project used microsegmentation, role-based access controls, and behavioral analytics in the lab’s security controls. This reference design is modular and can be deployed in whole or in part. This guide contains three volumes: 

NIST SP 1800-24A: Executive Summary

NIST SP 1800-24B: Approach, Architecture, and Security Characteristics – what we built and why (you are here)

NIST SP 1800-24C: How-To Guides – instructions for building the example solution

Depending on your role in your organization, you might use this guide in different ways: Business decision makers, including chief security and technology officers, will be interested in the Executive Summary, NIST SP 1800-24A, which describes the following topics: 

challenges that enterprises face in securing PACS

example solution built at the NCCoE

benefits of adopting the example solution

Technology or security program managers who are concerned with how to identify, understand, assess, and mitigate risk will be interested in this part of the guide, NIST SP 1800-24B, which describes what we did and why. The following sections will be of particular interest: 

Section 3.4, Risk Assessment, provides a description of the risk analysis we performed.

Section 3.5, Security Control Map, maps the security characteristics of this example solution to cybersecurity standards and best practices.

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You might share the Executive Summary, NIST SP 1800-24A, with your leadership team members to help them understand the importance of adopting standards-based, commercially available technologies that can help secure a PACS ecosystem.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

IT professionals who want to implement an approach like this will find the whole practice guide useful. You can use the how-to portion of the guide, NIST SP 1800-24C, to replicate all or parts of the build created in our lab. The how-to portion of the guide provides specific product installation, configuration, and integration instructions for implementing the example solution. We do not re-create the product manufacturers’ documentation, which is generally widely available. Rather, we show how we incorporated the products together in our environment to create an example solution. This guide assumes that IT professionals have experience implementing security products within the enterprise. While we have used a suite of commercial products to address this challenge, this guide does not endorse these particular products. Your organization can adopt this solution or one that adheres to these guidelines in whole, or you can use this guide as a starting point for tailoring and implementing parts of the NCCoE’s risk assessment and deployment of a defense-in-depth strategy. Your organization’s security experts should identify the products that will best integrate with your existing tools and IT system infrastructure. We hope that you will seek products that are congruent with applicable standards and best practices. Section 3.6, Technologies, lists the products we used and maps them to the cybersecurity controls provided by this reference solution. A NIST Cybersecurity Practice Guide does not describe “the” solution, but a possible solution. Comments, suggestions, and success stories will improve subsequent versions of this guide. Please contribute your thoughts to hit_nccoe@nist.gov.

2.1 Typographic Conventions The following table presents typographic conventions used in this volume.

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Typeface/Symbol

Meaning

Example

Italics

file names and path names; references to documents that are not hyperlinks; new terms; and placeholders names of menus, options, command buttons, and fields command-line input, onscreen computer output, sample code examples, and status codes command-line user input contrasted with computer output link to other parts of the document, a web URL, or an email address

For language use and style guidance, see the NCCoE Style Guide.

Bold This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Monospace

Monospace Bold

blue text

Choose File > Edit. mkdir

service sshd start

All publications from NIST’s NCCoE are available at https://www.nccoe.nist.gov.

3 Approach An HDO enterprise network environment is complex, with IT infrastructure to handle a range of functions, including back office billing, supply chain and inventory management, EHRs, and a vast array of connected medical devices. PACS serves an important function within this already complex environment through its role in aggregating and centralizing the medical imaging ecosystem while interfacing with other clinical systems. Specialists involved in the workflow may reside in different departments, be in different parts of an HDO campus, and be external to the HDO, accessing systems and images from the internet. This practice guide seeks to help the healthcare community evaluate the security environment surrounding PACS and medical imaging in a clinical setting. Throughout the Securing PACS project, we collaborated with our NCCoE Healthcare Community of Interest and technology and cybersecurity vendors to identify standard medical imaging workflows and actors, define interactions between actors and systems, and review risk factors. Based on this analysis, the NCCoE developed an architecture and reference design, identified applicable mitigating security technologies, and designed an example implementation to help better secure a PACS ecosystem. This volume provides the approach used to develop the NCCoE reference solution. Elements include risk assessment and analysis, logical design, build development, test and evaluation, and security control mapping. To develop the reference solution, we reviewed known vulnerabilities in PACS, the Digital Imaging and Communications in Medicine (DICOM) protocol [2], [3], and medical imaging process flow, leveraging

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use cases described by Integrating the Healthcare Enterprise (IHE) [4]. We examined how to design the architecture and component integration to increase the security of the device.

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The practice guide used the systems security engineering (SSE) framework discussed in NIST SP 800-160 Volume 1 [5] to introduce a disciplined, structured, and standards-based set of SSE activities and tasks to the project. This SSE framework provides the starting point and the forcing function to introduce engineering-driven actions that lead to more defensible and resilient systems. The SSE framework starts with and builds upon standards for systems and software engineering, then introduces SSE techniques, methods, and practices into these standard system engineering processes. Additionally, this project reviewed NIST SP 800-171 Rev. 1, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations [6], as well as NIST SP 800-181 Rev.1, Workforce Framework for Cybersecurity (NICE Framework) [7], for further guidance. Organizations may refer to these documents in expanding their safeguarding environment as appropriate. These documents serve as background for this project, with primary emphasis on the NIST Cybersecurity Framework [8] and the NIST Risk Management Framework [9].

3.1 Audience The NCCoE provides this guide for professionals implementing security solutions within an HDO. It may also be of interest to anyone responsible for securing nonstandard computing devices (i.e., the Internet of Things [IoT]). More specifically, the NCCoE designed Volume B of this practice guide (NIST SP 180024B) to appeal to a wide range of job functions, including IT operations, storage support engineers, network engineers, PACS support biomedical engineers, cybersecurity engineers, healthcare technology management (HTM) professionals, and support staff who are responsible for medical imaging devices, viewing or administrative workstations, PACS, or VNAs. For cybersecurity or technology decision makers within HDOs, this volume provides a view into how they can make the medical device environment more secure, to help improve their enterprise’s security posture and reduce enterprise risk. Additionally, this volume offers guidance to technical staff on building a more secure medical device network and instituting compensating controls.

3.2 Scope The NCCoE project focused on securing the environment of a PACS ecosystem but not on reengineering medical devices or altering medical imaging processes themselves. This project led to a standards-based practice guide that applies to the wider healthcare ecosystem. This practice guide describes how the project secured PACS in a laboratory environment at the NCCoE that replicated parts of a typical HDO environment. The project considered PACS users internal to the HDO as well as external users and partners needing access to certain components of the HDO environment.

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3.3 Assumptions In building this healthcare practice guide, the NCCoE began the project with the following fundamental assumptions:

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Medical devices will include flaws or weaknesses that may be leveraged as vulnerabilities.

Patches or fixes for these vulnerabilities may not be available or deployable in a timely fashion.

Other components within an HDO’s network may include flaws and vulnerabilities.

Security controls that one may deploy may themselves include flaws or weaknesses that could be used to compromise the HDO network.

This practice guide identifies controls that may be appropriate for mitigating risks associated with the medical imaging ecosystem made up of PACS and VNA. The actual build and example implementation of this architecture occurred in a lab environment at the NCCoE. Although the lab is based on a clinical environment, it does not mirror the complexity of an actual hospital network. It is assumed that any actual clinical environment would represent additional complexity. As a result, in addition to the assumptions noted above, we also assume implementation of pervasive controls, discussed in more detail in Appendix C.

3.4 Risk Assessment NIST SP 800-30 Revision 1, Guide for Conducting Risk Assessments [10], states that risk is “a measure of the extent to which an entity is threatened by a potential circumstance or event, and typically a function of: (i) the adverse impacts that would arise if the circumstance or event occurs; and (ii) the likelihood of occurrence.” The guide further defines risk assessment as “the process of identifying, estimating, and prioritizing risks to organizational operations (including mission, functions, image, reputation), organizational assets, individuals, other organizations, and the Nation, resulting from the operation of an information system. Part of risk management incorporates threat and vulnerability analyses, and considers mitigations provided by security controls planned or in place.” The NCCoE recommends that any discussion of risk management, particularly at the enterprise level, begins with a comprehensive review of NIST SP 800-37 Revision 2, Risk Management Framework for Information Systems and Organizations [11]—material that is available to the public. The Risk Management Framework (RMF) [9] guidance, as a whole, proved to be invaluable in giving us a baseline to assess risks, from which we developed the project, the security characteristics of the build, and this guide. In conducting the risk assessment, this document considers threats and risks grouped under Confidentiality, Integrity, and Availability, commonly referred to as the CIA triad [12].

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3.4.1

Establishing the Risk Context

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As we examine risk, we begin by considering the risk context. The ecosystem itself is complex and presumes different teams of people, varying processes, and different technologies involved in acquisition, interpretation, and maintenance of medical imaging information. This section presents the risk context of the Securing PACS Project, which is established around five scenarios that represent typical processes found in a medical imaging ecosystem [13]. The risk context, which in this practice guide is within the medical imaging ecosystem logical boundary, defines where to perform a risk assessment. Risk context of the PACS environment encompasses the physical and logical components of the medical imaging ecosystem that interconnect with PACS as well as the various stakeholders within the ecosystem. For the NCCoE PACS lab environment, risk context contains the components listed below and the system actors of the PACS, which include both human and system actors, as described in Section 3.4.2. Figure 3-1 depicts the notional high-level architecture that bounds the PACS and medical imaging ecosystem [13]. This depiction provides a starting point in understanding the components addressed in this project. However, this project took a holistic approach in framing the risk context, beyond some of the technology components. This project leveraged concepts described in NIST SP 800-160 [5] in defining context for a PACS ecosystem, understanding risk based on context, and selecting appropriate controls when designing the control environment needed to mitigate that contextual risk. NIST SP 800160, Systems Security Engineering [5], identifies concepts of examining system life cycle and components, performing holistic analysis on both technical and nontechnical processes, to deliver “trustworthy” systems. Trustworthiness describes a solution whose objective is to provide “adequate security” related to stakeholders’ concerns. In order to achieve systems security engineering “trustworthiness” goals, practitioners should consider system life-cycle processes and frame the risk context based on a process and entity relationship analysis [5].

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Figure 3-1 Notional High-Level Architecture

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The system for this project is broadly identified as the PACS, though practically, it incorporates a set of processes and other systems that make up a medical imaging ecosystem [13]. For purposes of this project, and in accordance with NIST SP 800-160 [5], we consider the individual components as “systems of interest,” noted below: 

workstations used to interact with the medical imaging ecosystem •

viewer workstations residing within the HDO perimeter

•

viewer workstations residing external to the HDO perimeter, used by remote care specialists

•

workstations used by clinical staff to access peripheral systems, such as order entry systems, RIS, HIS, or EHR

modalities, or medical imaging devices that acquire medical images and forward those to the PACS, based on orders typically received from the EHR or HIS and following workflows typically defined by the RIS

clinical systems that interface with modalities and the PACS environment, supporting medical imaging processes such as scheduling, annotations, or reporting

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

PACS will support interfaces, depicted in Figure 3-1, as “servers.” These interfaces include the Health Level 7 (HL7) interface that allow clinical systems to interact with the PACS in sharing PHI; the DICOM interface, which represents a communications and medical imaging standard that represents a standard method by which medical imaging modalities interoperate with PACS; and the web server interface, which represents the PACS’ ability to allow clinical interaction with the PACS to retrieve medical images using hypertext transfer protocol (http) via a standard web browser.

a relational database server to manage metadata about the medical images or PACS administration data

PACS and vendor neutral archive (VNA) application servers

In addition to the technology components described above and in the PACS Project Description, we considered other elements, such as stakeholders (system actors) as well as specific business process flows in which those stakeholders may participate. The processes align with profiles established by Integrating the Health Enterprise (IHE) [4], which this project leveraged to determine process and data flows. The four selected profiles translate to the scenarios described below. Based on the PACS Project Description document, the scenarios of note are Sample Radiology Practice Workflows; Access to Aggregations and Collections of Different Types of Images; Accessing, Auditing, and Monitoring; Image Object Change Management; and Remote Access [13]. This practice guide does not examine pervasive risks that an HDO may face but rather focuses on those risks specific to the medical imaging ecosystem. While this guide suggests specific requirements for safely and securely hosting PACS, the intent of the guide is not to serve as an omnibus guide for all facets potentially required to operate a secure HDO infrastructure. This guide addresses measures that would enhance the security posture for the overall PACS and medical imaging ecosystem, but there may be elements that HDOs should address beyond the recommendations offered in safeguarding a PACS and the overall medical imaging ecosystem.

3.4.2

System Actors

This project considered several roles that interact with the PACS and medical imaging system ecosystem. This project looked at both authorized human and system actors. Human actor roles consist of: 

medical imaging technologists

clinicians

clinical systems IT administrators

HTM professionals

IT staff

System actors that interact with the PACS and VNA consist of:

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modalities

RIS and HIS

EHRs

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The system actor list excludes patients. The actions focused on medical images, which include creation of the image, annotation, storage of the image and annotations, interpretation, and changes to those images. The project limited radiology information systems and EHR systems actions to order entry/scheduling procedures and to pointing to images for reading/viewing. The scenarios below note process flows which describe use case profiles defined by IHE, a body that this project identified as authoritative in defining standard imaging workflow processes [4].

3.4.3

Use Case Scenarios

This project assessed risk for the five scenarios [13] described below. Considering threats, vulnerabilities, likelihoods, and impacts on medical imaging operations under these scenarios contributed to the risks documented in Section 3.4.6. These scenarios frame the processes wherein we considered introduction of threats. In addition to the scenario, this document investigates those vulnerabilities, threats, and risks that may be evident based on a holistic view of the architecture, as described in Section 3.4.4, Section 3.4.5, and Section 3.4.6. Within that viewpoint, the scenarios excluded several threats that are relevant for consideration. While this document investigates addressing modality interfaces, it does not examine specific modalities or the risks potentially associated with them. Modality devices themselves are medical devices that may include vulnerabilities or opportunity for systems or data compromise, loss of data integrity, or disruption of service, and HDOs should perform independent risk assessments in addressing those risks.

3.4.3.1 Sample Radiology Practice Workflows Scenario One, shown in Figure 3-2, starts with registration of a patient who requires an imaging procedure be performed [13]. For the purposes of this project, the assumption is that the HDO registers the patient into the EHR, determines the patient has appropriate identifiers to be admitted, and the patient is able to receive procedures. The scenario follows the process flow that begins at scheduling the procedure, acquiring the image, and allowing the care team to analyze and diagnose. The assumption is that all modality devices and clinical staff are on-premise, within the boundaries of the HDO. Systems in this sample radiology practice workflow convey patient information using the HL7 [14] protocol (e.g., patient registration and order entry messages). Medical imaging devices would interact with the PACS/VNA by using DICOM [2], [3].

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Figure 3-2 Scenario One: Sample Radiology Practice Workflows

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The scenario’s processes are as follows: 

Patient Registration: The HDO enters a new patient’s information into an HIS. An HIS may also be referred to as a clinical information system. The function of this process flow is to establish a patient identity within a hospital where one may not previously exist and then administer the patient as appropriate.

Order Entry: Once the HDO establishes a patient identity, a clinician can order a medical imaging procedure for the patient by using some form of computerized physician order entry system.

Order Scheduling: Following a submitted order, clinicians may schedule a medical imaging procedure involving an appropriate medical imaging modality using a RIS.

Image Acquisition: After a clinician creates an order and scheduling has been performed, a clinician performs the imaging procedure using the appropriate modality. Acquisition results in creation of a medical image.

Image Post-Processing: When the modality creates the medical image, imaging technologists will examine the image and may record initial annotations. The image and annotations are then pushed to the PACS.

Image Analysis and Reporting: An imaging clinician may use a viewer workstation to examine the image, analyze, interpret, and diagnose, with subsequent notes pushed to the PACS for reporting.

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Stakeholders: medical imaging technologists, clinicians (medical imaging specialists), and medical imaging devices (modalities) Systems of Interest: order entry, RIS, medical imaging devices, viewer workstations, PACS Protocols Used: DICOM, web (e.g., hypertext transfer protocol secure [https]), HL7, Host Identity Protocol (HIP) This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

3.4.3.2 Image Data Access Across the Enterprise Scenario Two, as shown in Figure 3-3, examines multiple departments that use disparate imaging devices for acquisition and may involve multiple PACS [13]. The assumption is that different departments have separate clinical staff and different medical imaging goals and may use different means to centralize their medical images. This scenario simulates a hospital, in that radiology is not the only department that uses medical imaging, nor does the radiology department mandate use of its PACS to centralize medical images across a hospital. Aggregation and centralized management remain the goal, but the practice guide describes other components in the ecosystem that enable broader clinical functionality. While PACS implements central medical image storage, access to images is not permitted for all clinical staff. Figure 3-3 Scenario Two: Image Data Access Across the Enterprise

In demonstrating that different groups and technologies are involved, this project shows variables as “_a” or “_b.” This allows us to show the separation between two components that may be similar in function but are separate, e.g., “component_a” versus “component_b.”

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Stakeholders: medical imaging staff_a, medical imaging staff_b, healthcare technology management professionals, PACS_a, PACS_b, VNA Systems of Interest: image viewer_a, image viewer_b, PACS_a, PACS_b, VNA

3.4.3.3 Accessing, Monitoring, and Auditing This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Scenario Three, as shown in Figure 3-4, examines the infrastructure required for access control, which includes identity management and authentication for actors who interact with the PACS and VNA environments, as well as logging, auditing, and monitoring actions with the stored information [13]. The scenario considers those actions where individuals or devices retrieve and view information (Read actions) and introduce new information (Write actions), as well as when individuals or devices modify stored information (Change actions). Figure 3-4 Scenario Three: Accessing, Monitoring, and Auditing

This project established identities for users (humans who interact with the system), as well as for devices and systems. This scenario assumed that individuals have been appropriately identity-proofed and are provisioned accounts with which they may access and use viewer applications. Given that this project provisioned identities and accounts for both human and machine actors, all interactions require authentication. Authentication may involve exchange of passwords, passcodes, biometrics, or cryptographic keys to validate the actor. A log file recorded all transactions, including authentication attempts. This scenario examines clinical use system interaction and does not address privileged user access. Controls to manage privileged access are discussed in Section 4.1.5.1.1, Privileged Access Management. Stakeholders: medical imaging staff, medical devices, PACS, VNA

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Systems of Interest: directory servers, user account systems, digital certificate servers Protocols: public key infrastructure (PKI) (associated protocols such as Certificate Management Protocol, http, https), domain name system (DNS), Active Directory

3.4.3.4 Imaging Object Change Management This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Scenario 4, as shown in Figure 3-5 , supports the changes that include (1) object rejection due to quality or patient safety reasons, (2) correction of incorrect modality worklist entry selection, and (3) expiration of objects due to data retention requirements [13]. This diagram depicts the change request process. The scenario considers those actions when an authorized healthcare professional, upon review of the image, determines that errors or qualitative defects found in an image may lead to an inappropriate conclusion. Figure 3-5 Scenario Four: Imaging Object Change Management

Stakeholders: medical imaging clinicians Systems of Interest: PACS, VNA Protocols: HL7, http, https

3.4.3.5 Remote Access Scenario 5, depicted in Figure 3-6, supports external parties who may need access to the PACS ecosystem. The scenario provides a pathway for IT vendors to provide remote systems support as well as for third-party clinical participants to interact with the PACS. IT vendors may consist of clinical systems support staff who may need to help maintain the PACS or VNA system. Third-party clinical participants may consist of medical imaging specialists or teleradiology specialists who may need to review medical images acquired at the HDO.

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Figure 3-6 Scenario Five: Remote Access

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Stakeholders: medical imaging specialists, IT/HTM professionals, teleradiology specialists Systems of Interest: PACS, VNA

3.4.4

Threats

From NIST SP 800-30 Revision 1, “[a] threat is any circumstance or event with the potential to adversely impact organizational operations and assets, individuals, other organizations, or the Nation through an information system via unauthorized access, destruction, disclosure, or modification of information, and/or denial of service” [10]. In layman’s terms, threats are adverse events that may occur. Threat actors may take actions to leverage vulnerabilities (described in the subsection below). Actions may include compromising credentials and accessing, removing, or changing data or making systems not available for legitimate use. The result of threats is risks [10]. Table 3-1 enumerates threats considered within this practice guide.

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Table 3-1 Threats Unmitigated Likelihood

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C/I/A

Threat Event

Description

C

Abuse of credentials or insider threat

Aberrant behavior from an individual who may have legitimate access to the system; however, they may leverage granted privileges for unintended purposes.

High

C

Credential compromise

Malicious actor obtains the means to use credentials provisioned for others. Credentials may involve other users or those used by systems for process or data handling.

High

C

Data exfiltration

Removal of data to an unintended destination. Exfiltration may represent the unauthorized movement of data from one system to uncontrolled physical storage media or may represent movement to uncontrolled virtual destinations such as volatile memory, or to unknown storage such as cloud-hosted or virtual destinations.

High

I

Disruption of data in transit

Distortion or alteration of data in transit that results in potentially invalid information. The attack type seeks to distort or alter data in midcommunication stream. Received data may be unintelligible or otherwise unreadable when it arrives at the destination.

Moderate

I

Data alteration

Unauthorized changes to the content of the data. Moderate Clinicians may not detect altered information and misinterpret the image. The attack type seeks to make changes when data are in an atrest state.

I

Time synchronization

System components may rely on synchronizing internal clocks to ensure network session and data integrity. Attacks may seek to alter time stamping or ability for systems to synchronize with an authoritative time source.

Moderate

I

Introduction of malicious software

Introduction of foreign, unauthorized code into a system. Malicious software deployments may affect servers or workstations or both.

High

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C/I/A

Threat Event

Description

Unmitigated Likelihood

Server components: Server components may run unauthorized code. Workstations: Workstations connected to the PACS ecosystem may run unauthorized code. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

I

Unintended use of service

Operating systems may consist of services or processes used to support a system’s functionality; individuals with access to the system may perform unintended functions.

High

A

Data storage disruption

Physical media or file space disruption evidenced by prolonged read/write access times or by corrupted data, thereby causing unavailability of service.

High

A

Network disruption

Network disruption attacks may take the form of several different approaches. Below are some disruption approaches that this practice guide examines: Denial of service (DoS) or packet flooding: Introduction of above-normal network traffic that saturates network infrastructure components’ ability to deliver network communication appropriately Routing: inefficient network traffic flow DNS or name resolution: Networked hosts are associated with “friendly names” to facilitate interaction; however, name resolution to internet protocol (IP) addressing may be disrupted to make host discovery difficult. Similar or soundalike host and domain names may be introduced to compound confusion. ARP: Address Resolution Protocol (ARP) is a localized means by which hosts resolve IP addresses to media access control (MAC) addresses stored in host tables. Corruption of ARP tables may result in misdirected network traffic or in legitimate devices being unable to connect to the network.

High

A

Backup/recovery disruption

Measures that organizations use as a fail-over or recovery from a prolonged outage may be

High

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C/I/A

Threat Event

Description

Unmitigated Likelihood

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compromised, e.g., through introduction of malicious software to backup storage media, inability to read and restore from backup media, or introduction of a supply chain compromise (per above) at a third-party recovery site. High availability or replication scenarios may also be prone to network disruption. A

Supply chain compromise

3.4.5

Vulnerabilities

System components may be sourced from multiple vendors and may allow introduction of malicious software (noted above).

High

Table 3-2 lists identified vulnerabilities that aggregate vulnerabilities identified in NIST SP 800-30 Revision 1 [10]. As noted in the document, a vulnerability is a deficiency or weakness that a threat source may exploit, resulting in a threat event. The document further describes that vulnerabilities may exist in a broader context, such as in organizational governance structures, external relationships, and mission/business processes. The following table enumerates those vulnerabilities using a holistic approach and represents those vulnerabilities that this project identified and for which it offers guidance. For further description, reference NIST SP 800-30 Revision 1 [10]. Table 3-2 Vulnerabilities

Vulnerability Description

Vulnerability Severity (Qualitative)

Predisposing Condition

Pervasiveness of Predisposing Condition (Qualitative)

Weak or no system use training

Moderate

Workforce may not be aware or may not have received training on appropriate use or configuration of the system. Users may not have sufficient awareness of action consequences.

High

Weak or no security training

High

Workforce may not be aware of procedures on how to report anomalies. Security teams may not have sufficient training on how to investigate or may not have procedures to address security incidents.

Moderate

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Vulnerability Description

Vulnerability Severity (Qualitative)

Predisposing Condition

Pervasiveness of Predisposing Condition (Qualitative)

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Deficient supply chain security controls

High

Organizations may not be aware of thirdparty practices or downstream suppliers who may implement technology into the healthcare organization’s environment.

High

Deficient separation of duties

High

Privileged users may have extended responsibility to ensure system operations. “Super user” identities may allow escalated access to systems, data, and logging features.

High

Weak or no identity management

High

Organizations may have deficient identity proofing or review processes.

Moderate

Weak or no authentication controls

Very High

Very High Trivial forms of authentication or using credentials with no authentication requirement. Also found in this category is the use of default credentials that tend to be generally discoverable.

Permissive privilege

Very High

Credentials may be established without examining the minimum necessary to perform the required function. As a result, credentials may exist with access to perform actions outside the work scope. Note that permissive privilege may extend to system services whereby services may run as “root” or “administrator,” granting that credential the ability to perform inappropriate actions.

Very High

Out-of-date or unmanaged services

High

Operating systems, other third-party software, and the PACS application itself include a variety of services, allowing appropriate functionality. Over time, flaws, in the form of bugs (coding errors) or the use of libraries or binaries determined to have security weakness(es), may be discovered and

Very High

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Vulnerability Description

Vulnerability Severity (Qualitative)

Predisposing Condition

Pervasiveness of Predisposing Condition (Qualitative)

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

subsequently addressed, resulting in patches or updates. Systems that do not apply those patches and updates may operate with out-of-date services. Deficient vulnerability management

Very High

Organizations may have deficient application and operating system vulnerability scanning and monitoring practices. Flaws or deficiencies may exist in software elements associated with the overall medical imaging system.

Deficient data protection

High

High Unauthorized individuals may be able to read, modify, delete, or exfiltrate sensitive data.

Deficient logging and monitoring

High

System interactions may not be captured or retained sufficiently for review. Logs, when tracked, may not be reviewed for anomalies on a timely or consistent basis.

High

Deficient time synchronization

Moderate

Systems may operate on individual internal clocks and may track transactions independently.

High

Permissive network High boundaries

Configuration may permit unauthorized network traffic to access sensitive assets.

Very High

Lack of network segmentation

Very High

Components may operate on the same network or have implied trust with other components.

Very High

Lack of network session security

High

Network sessions may not be secured.

High

Organizations using certificates to safeguard network sessions (e.g., secure sockets layer [SSL]/Transport Layer Security [TLS] certificates) may allow no certificate, expired certificates, or inappropriate certificates.

High

Deficient certificate High management

NIST SP 1800-24B: Securing Picture Archiving and Communication System (PACS)

Very High

22

Vulnerability Description

Vulnerability Severity (Qualitative)

Predisposing Condition

Pervasiveness of Predisposing Condition (Qualitative)

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Misconfigured network

High

Organizations may have misconfigured network routing or switch settings.

High

Misconfigured storage media

High

Medical image storage demands are great, and organizations may have misconfigured storage arrays.

Moderate

Recovery/restore procedures not tested or not performed

Very High

Organizations may not have created or tested recovery procedures.

High

The vulnerabilities in the table above represent types of known vulnerabilities, that is, based on vulnerabilities experienced in existing systems and networks.

3.4.6

Risk

NIST SP 800-30 Revision 1, Guide for Conducting Risk Assessments, defines risk as “a measure of the extent to which an entity is threatened by a potential circumstance or event, and typically a function of: (i) the adverse impacts that would arise if the circumstance or event occurs; and (ii) the likelihood of occurrence” [10]. Risk is the adverse impact; that is, risk is the result when a threat (attack) successfully leverages one or more vulnerabilities. As organizations consider risk, they should note that risk is not discrete; that is, a successful attack may involve multiple threats or take advantage of a combination of vulnerabilities. Also, when an organization suffers from an attack campaign, the organization may realize multiple adverse outcomes. Ransomware or a DoS attack, for example, could adversely impact an HDO by compromising the availability of systems and preventing the HDO from treating patients. This practice guide, however, considers controls and practices that may be appropriate in mitigating or responding to threats affecting confidentiality, integrity, and availability holistically. Another risk noted below is systemic disruption. Systemic disruption may affect availability and integrity of systems or data. An attacker may compromise the targeted system’s operations, or the attacker may use the targeted system as a platform from which to conduct further attacks across an HDO’s network. Systemic disruption prevents the HDO from treating patients by either making systems inoperative or altering patient data when malware is introduced. This practice guide also considers the specific case of when targeted systems are compromised and used to attack other components within the enterprise.

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Table 3-3 is a list of unmitigated risks applicable to the PACS lab environment, based on the examples of threat types (Section 3.4.4) and vulnerabilities (Section 3.4.5). These risks are offered in terms relating to the healthcare environment, and similar risks can be expected in a typical healthcare environment. Note that the likelihood of threats and vulnerabilities would be based on having implemented effective controls, which would also affect the level of risk determined. Table 3-3 Risk This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

C/I/A

Risk

Description

Risk Level

C

Fraudulent use of health-related information

Should unauthorized individuals retrieve PHI that includes health insurance information, those actors may be able to submit fraudulent claims and receive reimbursement from a payer for services not rendered to the patient.

High

C

Identity theft and fraudulent use of PHI

Individuals may receive exfiltrated data to commit identity theft in obtaining healthcare. Fraudulent individuals may receive health services leveraging a victim patient’s information and, as a result, introduce false information into a victim patient’s medical history. This may result in a patient safety concern in that treatments performed for the fraudulent individual would be captured in the victim patient’s history, potentially leading to future inaccurate diagnoses when that patient seeks legitimate care.

High

I

Patient misdiagnosed based on interpretations made from unauthorized changes to medical images

Unauthorized imaging data alteration compromises data integrity resulting in patient safety risk. Should an individual make an unauthorized image alteration, care providers may make inaccurate diagnoses and therefore delay appropriate treatment.

High

A

Patient diagnoses disrupted, leading to patient safety concerns

Patients may have conditions that require timely and accurate diagnosis to achieve optimum mortality rates. Communications disruptions that corrupt or deny data may adversely affect this so that care teams are not able to make a timely diagnosis, and patients may have to repeat imaging processes.

High

A

Process disruption due to malware

PACS or other systems within the ecosystem may succumb to ransomware or other forms of malware, rendering those systems and associated

High

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

C/I/A

Risk

Description Risk Level data unavailable. Ransomware may cause complete system unavailability, while other forms of malware may delay processing capability or introduce data integrity risk. As a result, the HDO may not be able to treat patients appropriately or make diagnoses. Delays may result in patient safety concerns.

A

Systemic disruption due to component compromise

Unauthorized individuals may compromise components within the PACS ecosystem and use compromised components as pivot points to attack other parts of the HDO network. This may result in delays in patient care.

High

The project identified the risks above as requirements that the lab environment should address. Organizations should note that the tables offered here are samples and notionally representative. Characterizing threats, vulnerabilities, and risk is contextual. HDOs with different security deficiencies or unique threat situations in their systems and network environments may find their categorization to be different from what this practice guide describes. HDOs need to consider their unique profile when categorizing vulnerabilities, threats, and risk. This project identified these risk elements and scored them accordingly, based on the assessment performed on the lab environment.

3.5 Security Control Map As the project considered PACS ecosystem risks, the team performed a mapping to the NIST Cybersecurity Framework [8], establishing an initial set of appropriate control functions, categories, and subcategories, demonstrating how selected Cybersecurity Framework subcategories map to controls in NIST SP 800-53 Revision 4 [15]. The table also lists sector-specific standards and best practices from other standards bodies (e.g., the International Electrotechnical Commission [IEC], International Organization for Standardization [ISO]), as well as from the Health Insurance Portability and Accountability Act (HIPAA) [16], [17], [18]. The security control map, shown in Table 3-4, identifies a comprehensive set of controls, including those specifically implemented in the lab build-out, as well as the pervasive set of controls as described in Appendix C that HDOs should deploy.

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Table 3-4 Security Characteristics and Controls Mapping–NIST Cybersecurity Framework NIST Cybersecurity Framework v1.1 Function

Category

Subcategory

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ID.AM-1: Physical devices and systems within the organization are inventoried.

IDENTIFY (ID)

Asset Management (ID.AM)

Sector-Specific Standards and Best Practices NIST SP 800-53 Revision 4

CM-8 PM-5

ID.AM-2: Software platforms and applications within the organization are inventoried.

CM-8 PM-5

ID.AM-3: Organizational communication and data flows are mapped.

AC-4 CA-3 CA-9 PL-8

ID.AM-4: External information systems are catalogued.

AC-20 SA-9

NIST SP 1800-24B: Securing Picture Archiving and Communication System (PACS)

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

N/A

45 C.F.R. §§ 164.308(a)(1)(ii)(A) 164.308(a)(4)(ii)(A) 164.308(a)(7)(ii)(E) 164.308(b) 164.310(d) 164.310(d)(2)(iii)

A.8.1.1 A.8.1.2

N/A

45 C.F.R. §§ 164.308(a)(1)(ii)(A) 164.308(a)(4)(ii)(A) 164.308(a)(7)(ii)(E) 164.308(b) 164.310(d) 164.310(d)(2)(iii)

A.8.1.1 A.8.1.2 A.12.5.1

SGUD

45 C.F.R. §§ 164.308(a)(1)(ii)(A) 164.308(a)(3)(ii)(A) 164.308(a)(8) 164.310(d)

A.13.2.1 A.13.2.2

RDMP

45 C.F.R. §§ 164.308(a)(1)(ii)(A) 164.308(a)(4)(ii)(A) 164.308(a)(7)(ii)(E) 164.308(b) 164.310(d) 164.310(d)(2)(iii)

A.11.2.6

26

NIST Cybersecurity Framework v1.1 Function

Category

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Risk Assessment (ID.RA)

Sector-Specific Standards and Best Practices

Subcategory

NIST SP 800-53 Revision 4

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

ID.AM-5: Resources (e.g., hardware, devices, data, time, personnel, and software) are prioritized based on their classification, criticality, and business value.

CP-2 RA-2 SA-14 SC-6

SGUD

45 C.F.R. §§ 164.308(a)(7)(ii)(E)

A.8.2.1

ID.RA-1: Asset vulnerabilities are identified and documented.

CA-2 CA-7 CA-8 RA-3 RA-5 SA-5 SA-11 SI-2 SI-4 SI-5

MLDP RDMP SGUD

45 C.F.R. §§ 164.308(a)(1)(i) 164.308(a)(1)(ii)(A) 164.308(a)(1)(ii)(B) 164.308(a)(7)(ii)(E) 164.308(a)(8) 164.310(a)(1)

A.12.6.1 A.18.2.3

ID.RA-4: Potential business impacts and likelihoods are identified.

RA-2 RA-3 SA-14 PM-9 PM-11

DTBK SGUD

45 C.F.R. §§ 164.308(a)(1)(i) 164.308(a)(1)(ii)(A) 164.308(a)(1)(ii)(B) 164.308(a)(6) 164.308(a)(7)(ii)(E) 164.308(a)(8)

A.16.1.6 Clause 6.1.2

SGUD

45 C.F.R. §§ 164.308(a)(1)(ii)(A) 164.308(a)(1)(ii)(B) 164.308(a)(1)(ii)(D) 164.308(a)(7)(ii)(D) 164.308(a)(7)(ii)(E) 164.316(a)

A.12.6.1

ID.RA-5: Threats, vulnerabilities, likelihoods, and impacts are used to determine risk.

RA-2 RA-3 PM-16

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NIST Cybersecurity Framework v1.1 Function

Category

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

PROTECT (PR)

Sector-Specific Standards and Best Practices

Subcategory

NIST SP 800-53 Revision 4

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

ID.RA-6: Risk responses are identified and prioritized.

PM-4 PM-9

DTBK SGUD

45 C.F.R. §§ 164.308(a)(1)(ii)(B) 164.314(a)(2)(i)(C) 164.314(b)(2)(iv)

Clause 6.1.3

PR.AC-1: Identities and credentials are issued, managed, verified, revoked, and audited for authorized devices, users, and processes.

AC-1 AC-2 IA-1 IA-2 IA-3 IA-4 IA-5 IA-6 IA-7 IA-8 IA-9 IA-10 IA-11

ALOF AUTH EMRG NAUT PAUT

45 C.F.R. §§ 164.308(a)(3)(ii)(B) 164.308(a)(3)(ii)(C) 164.308(a)(4)(i) 164.308(a)(4)(ii)(B) 164.308(a)(4)(ii)(C) 164.312(a)(2)(i)

A.9.2.1 A.9.2.2 A.9.2.3 A.9.2.4 A.9.2.6 A.9.3.1 A.9.4.2 A.9.4.3

45 C.F.R. §§ 164.308(a)(1)(ii)(B) 164.308(a)(7)(i) 164.308(a)(7)(ii)(A) 164.310(a)(1) 164.310(a)(2)(i) 164.310(a)(2)(ii)

A.11.1.1 A.11.1.2 A.11.1.3 A.11.1.4 A.11.1.5 A.11.1.6 A.11.2.1 A.11.2.3 A.11.2.5 A.11.2.6 A.11.2.7 A.11.2.8

Identity Management and Access Control (PR.AC)

PR.AC-2: Physical access to assets is managed and protected.

PE-2 PE-3 PE-4 PE-5 PE-6 PE-8

NIST SP 1800-24B: Securing Picture Archiving and Communication System (PACS)

PLOK TXCF TXIG

28

NIST Cybersecurity Framework v1.1 Function

Category

Sector-Specific Standards and Best Practices

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Subcategory

NIST SP 800-53 Revision 4

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

PR.AC-3: Remote access is managed.

AC-1 AC-17 AC-19 AC-20 SC-15

ALOF AUTH CSUP EMRG NAUT PAUT

45 C.F.R. §§ 164.308(a)(4)(i) 164.308(b)(1) 164.308(b)(3) 164.310(b) 164.312(e)(1) 164.312(e)(2)(ii)

A.6.2.1 A.6.2.2 A.11.2.6 A.13.1.1 A.13.2.1

PR.AC-4: Access permissions and authorizations are managed, incorporating the principles of least privilege and separation of duties.

AC-1 AC-2 AC-3 AC-5 AC-6 AC-14 AC-16 AC-24

ALOF AUTH CNFS EMRG NAUT PAUT

45 C.F.R. §§ 164.308(a)(3) 164.308(a)(4) 164.310(a)(2)(iii) 164.310(b) 164.312(a)(1) 164.312(a)(2)(i)

A.6.1.2 A.9.1.2 A.9.2.3 A.9.4.1 A.9.4.4 A.9.4.5

MLDP NAUT

45 C.F.R. §§ 164.308(a)(4)(ii)(B) 164.310(a)(1) 164.310(b) 164.312(a)(1) 164.312(b) 164.312(c)

A.13.1.1 A.13.1.3 A.13.2.1 A.14.1.2 A.14.1.3

PR.AC-5: Network integrity is protected (e.g., network segregation, network segmentation).

AC-4 AC-10 SC-7

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NIST Cybersecurity Framework v1.1 Function

Category

Sector-Specific Standards and Best Practices

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Subcategory

NIST SP 800-53 Revision 4

IEC TR 800012-2

PR.AC-7: Users, devices, and other assets are authenticated (e.g., single-factor, multi-factor) commensurate with the risk of the transaction (e.g., individuals’ security and privacy risks and other organizational risks).

AC-7 AC-8 AC-9 AC-11 AC-12 AC-14 IA-1 IA-2 IA-3 IA-4 IA-5 IA-8 IA-9 IA-10 IA-11

PR.DS-1: Data-at-rest is protected.

HIPAA Security Rule

ISO/IEC 27001

ALOF AUTH CSUP EMRG NAUT PAUT

45 C.F.R. § 164.308(a)(4)

A.9.2.1 A.9.2.4 A.9.3.1 A.9.4.2 A.9.4.3 A.18.1.4

MP-8 SC-12 SC-28

IGAU MLDP NAUT SAHD STCF TXCF

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.308(b)(1) 164.310(d) 164.312(a)(1) 164.312(a)(2)(iii) 164.312(a)(2)(iv)

A.8.2.3

SC-8 SC-11 SC-12

IGAU NAUT STCF TXCF TXIG

45 C.F.R. §§ 164.308(b)(1) 164.308(b)(2) 164.312(e)(1) 164.312(e)(2)(i) 164.312(e)(2)(ii) 164.314(b)(2)(i)

A.8.2.3 A.13.1.1 A.13.2.1 A.13.2.3 A.14.1.2 A.14.1.3

Data Security (PR.DS) PR.DS-2: Data-in-transit is protected.

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NIST Cybersecurity Framework v1.1 Function

Category

Subcategory

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PR.DS-5: Protections against data leaks are implemented.

PR.DS-6: Integrity-checking mechanisms are used to verify software, firmware, and information integrity.

Sector-Specific Standards and Best Practices NIST SP 800-53 Revision 4

AC-4 AC-5 AC-6 PE-19 PS-3 PS-6 SC-7 SC-8 SC-13 SC-31 SI-4

SC-16 SI-7

NIST SP 1800-24B: Securing Picture Archiving and Communication System (PACS)

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

AUTH IGAU MLDP PLOK STCF TXCF TXIG

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.308(a)(3) 164.308(a)(4) 164.310(b) 164.310(c) 164.312(a)

A.6.1.2 A.7.1.1 A.7.1.2 A.7.3.1 A.8.2.2 A.8.2.3 A.9.1.1 A.9.1.2 A.9.2.3 A.9.4.1 A.9.4.4 A.9.4.5 A.10.1.1 A.11.1.4 A.11.1.5 A.11.2.1 A.13.1.1 A.13.1.3 A.13.2.1 A.13.2.3 A.13.2.4 A.14.1.2 A.14.1.3

IGAU MLDP

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.312(b) 164.312(c)(1) 164.312(c)(2) 164.312(e)(2)(i)

A.12.2.1 A.12.5.1 A.14.1.2 A.14.1.3 A.14.2.4

31

NIST Cybersecurity Framework v1.1 Function

Category

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Information Protection Processes and Procedures (PR.IP)

Sector-Specific Standards and Best Practices

Subcategory

NIST SP 800-53 Revision 4

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

PR.IP-1: A baseline configuration of information technology/ industrial control systems is created and maintained, incorporating security principles (e.g., concept of least functionality).

CM-2 CM-3 CM-4 CM-5 CM-6 CM-7 CM-9 SA-10

CNFS CSUP DTBK NAUT

45 C.F.R. §§ 164.308(a)(8) 164.308(a)(7)(i) 164.308(a)(7)(ii)

A.12.1.2 A.12.5.1 A.12.6.2 A.14.2.2 A.14.2.3 A.14.2.4

CNFS CSUP DTBK

45 C.F.R. §§ 164.308(a)(8) 164.308(a)(7)(i) 164.308(a)(7)(ii)

A.12.1.2 A.12.5.1 A.12.6.2 A.14.2.2 A.14.2.3 A.14.2.4

DTBK PLOK

164.308(a)(7)(ii)(A) 164.308(a)(7)(ii)(B) 164.308(a)(7)(ii)(D) 164.310(a)(2)(i) 164.310(d)(2)(iv)

A.12.3.1 A.17.1.2 A.17.1.3 A.18.1.3

DIDT

45 C.F.R. §§ 164.310(d)(2)(i) 164.310(d)(2)(ii)

A.8.2.3 A.8.3.1 A.8.3.2 A.11.2.7

PR.IP-3: Configuration change control processes are in place.

CM-3 CM-4 SA-10

PR.IP-4: Backups of information are conducted, maintained, and tested.

CP-4 CP-6 CP-9

PR.IP-6: Data is destroyed according to policy.

MP-6

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NIST Cybersecurity Framework v1.1 Function

Category

Sector-Specific Standards and Best Practices

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Subcategory

NIST SP 800-53 Revision 4

PR.IP-9: Response plans (Incident Response and Business Continuity) and recovery plans (Incident Recovery and Disaster Recovery) are in place and managed. PR.IP-10: Response and recovery plans are tested.

PR.PT-1: Audit/log records are determined, documented, implemented, and reviewed in accordance with policy.

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

CP-2 CP-7 CP-12 CP-13 IR-7 IR-8 IR-9 PE-17

DTBK SGUD

45 C.F.R. §§ 164.308(a)(6) 164.308(a)(6)(i) 164.308(a)(7) 164.310(a)(2)(i) 164.312(a)(2)(ii)

A.16.1.1 A.17.1.1 A.17.1.2 A.17.1.3

CP-4 IR-3 PM-14

DTBK SGUD

45 C.F.R. §§ 164.308(a)(7)(ii)(D)

A.17.1.3

AUDT

45 C.F.R. §§ 164.308(a)(1)(i) 164.308(a)(1)(ii)(D) 164.308(a)(5)(ii)(B) 164.308(a)(5)(ii)(C) 164.308(a)(2) 164.308(a)(3)(ii)(A)

A.12.4.1 A.12.4.2 A.12.4.3 A.12.4.4 A.12.7.1

AUTH CNFS SAHD

45 C.F.R. §§ 164.308(a)(3) 164.308(a)(4) 164.310(a)(2)(iii) 164.310(b) 164.310(c) 164.312(a)(1)

A.9.1.2

AU Family

Protective Technology (PR.PT) PR.PT-3: The principle of least functionality is incorporated by configuring systems to provide only essential capabilities.

AC-3 CM-7

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NIST Cybersecurity Framework v1.1 Function

Category

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DETECT (DE)

Anomalies and Events (DE.AE)

Sector-Specific Standards and Best Practices

Subcategory

NIST SP 800-53 Revision 4

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

PR.PT-4: Communications and control networks are protected.

AC-4 AC-17 AC-18 CP-8 SC-7 SC-19 SC-20 SC-21 SC-22 SC-23 SC-24 SC-25 SC-29 SC-32 SC-36 SC-37 SC-38 SC-39 SC-40 SC-41 SC-43

AUTH MLDP PAUT SAHD

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.312(a)(1) 164.312(b) 164.312(e)

A.13.1.1 A.13.2.1 A.14.1.3

DE.AE-1: A baseline of network operations and expected data flows for users and systems is established and managed.

AC-4 CA-3 CM-2 SI-4

CNFS CSUP MLDP

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.312(b)

A.12.1.1 A.12.1.2 A.13.1.1 A.13.1.2

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NIST Cybersecurity Framework v1.1 Function

Category

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Security Continuous Monitoring (DE.CM)

Subcategory

Sector-Specific Standards and Best Practices NIST SP 800-53 Revision 4

DE.AE-2: Detected events are analyzed to understand attack targets and methods.

AU-6 CA-7 IR-4 SI-4

DE.AE-3: Event data are collected and correlated from multiple sources and sensors.

AU-6 CA-7 IR-4 IR-5 IR-8 SI-4

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

AUDT MLDP

45 C.F.R. §§ 164.308(a)(1)(i) 164.308(a)(1)(ii)(D) 164.308(a)(5)(ii)(B) 164.308(a)(5)(ii)(C) 164.308(6)(i) 164.308(a)(6)(i)

A.12.4.1 A.16.1.1 A.16.1.4

AUDT MLDP SGUD

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.308(a)(5)(ii)(B) 164.308(a)(5)(ii)(C) 164.308(a)(6)(ii) 164.308(a)(8) 164.310(d)(2)(iii)

A.12.4.1 A.16.1.7

A.16.1.4

N/A

DE.AE-5: Incident alert thresholds are established.

IR-4 IR-5 IR-8

DTBK MLDP SGUD

45 C.F.R. §§ 164.308(a)(1)(i) 164.308(a)(1)(ii)(D) 164.308(a)(5)(ii)(B) 164.308(a)(5)(ii)(C) 164.308(6)(i) 164.308(a)(6)(i)

DE.CM-1: The network is monitored to detect potential cybersecurity events.

AC-2 AU-12 CA-7 CM-3 SC-5 SC-7 SI-4

AUDT CNFS CSUP MLDP NAUT

45 C.F.R. §§ 164.308(a)(1)(i) 164.308(a)(1)(ii)(D) 164.308(a)(5)(ii)(B) 164.308(a)(5)(ii)(C) 164.308(a)(2) 164.308(a)(3)(ii)(A)

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NIST Cybersecurity Framework v1.1 Function

Category

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RESPOND (RS)

Response Planning (RS.RP)

Sector-Specific Standards and Best Practices

Subcategory

NIST SP 800-53 Revision 4

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

DE.CM-3: Personnel activity is monitored to detect potential cybersecurity events.

AC-2 AU-12 AU-13 CA-7 CM-10 CM-11

AUDT EMRG PAUT

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.308(a)(3)(ii)(A) 164.308(a)(5)(ii)(C) 164.312(a)(2)(i) 164.312(b) 164.312(d)

A.12.4.1 A.12.4.3

DE.CM-4: Malicious code is detected.

SI-3 SI-8

IGAU MLDP

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.308(a)(5)(ii)(B)

A.12.2.1

DE.CM-7: Monitoring for unauthorized personnel, connections, devices, and software is performed.

AU-12 CA-7 CM-3 CM-8 PE-3 PE-6 PE-20 SI-4

AUDT PAUT PLOK

45 C.F.R. §§ 164.308(a)(1)(ii)(D) 164.308(a)(5)(ii)(B) 164.308(a)(5)(ii)(C) 164.310(a)(1) 164.310(a)(2)(ii) 164.310(a)(2)(iii)

A.12.4.1 A.14.2.7 A.15.2.1

DE.CM-8: Vulnerability scans are performed.

RA-5

MLDP PLOK

45 C.F.R. §§ 164.308(a)(1)(i) 164.308(a)(8)

A.12.6.1

DTBK MLDP SGUD

45 C.F.R. §§ 164.308(a)(6)(ii) 164.308(a)(7)(i) 164.308(a)(7)(ii)(A) 164.308(a)(7)(ii)(B) 164.308(a)(7)(ii)(C) 164.310(a)(2)(i) 164.312(a)(2)(ii)

A.16.1.5

RS.RP-1: Response plan is executed during or after an event.

CP-2 CP-10 IR-4 IR-8

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NIST Cybersecurity Framework v1.1 Function

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

RECOVER (RC)

Category

Recovery Planning (RC.RP)

Subcategory

RC.RP-1: Recovery plan is executed during or after a cybersecurity incident.

Sector-Specific Standards and Best Practices NIST SP 800-53 Revision 4

CP-10 IR-4 IR-8

NIST SP 1800-24B: Securing Picture Archiving and Communication System (PACS)

IEC TR 800012-2

HIPAA Security Rule

ISO/IEC 27001

DTBK MLDP SGUD

45 C.F.R. §§ 164.308(a)(7) 164.308(a)(7)(i) 164.308(a)(7)(ii) 164.308(a)(7)(ii)(C) 164.310(a)(2)(i) 164.312(a)(2)(ii)

A.16.1.5

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3.6 Technologies Table 3-5 lists all the products and technologies used in this project and provides a mapping among the generic application term, the specific product used, and the security control(s) that the product provides or supports. Refer to Table 3-4 for an explanation of the NIST Cybersecurity Framework subcategory codes. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The Products and Technology table represents the solutions provided by the project collaborative partners and applied to the lab environment. This project selected these solutions based on their alignment to the NIST Cybersecurity Framework control objectives. Organizations should note that they may achieve control objectives through any number of means, including open-source or internally developed approaches. Table 3-5 Products and Technologies Component/ Capability

Product

Function

PACS and VNA

Hyland Acuo Vendor Neutral Archive Version 6.0.4

Hyland NilRead Enterprise Version 4.3.31.98805 Hyland PACSgear Version 4.1.0.64

NIST Cybersecurity Framework Subcategories

Provides access to medical images and documents. Stores and retrieves images in a standard format for various vendor-neutral systems to access.

PR.AC-1 PR.AC-4 PR.DS-2 PR.IP-4 PR.PT-1

Provides medical image viewing and manipulation.

PR.AC-1 PR.DS-2 PR.PT-1

Provides ability to capture and share medical images. Provides ability to scan and share medical documents.

PR.AC-1 PR.DS-2 PR.PT-1

 Philips Enterprise Imaging Domain Controller

Provides role-based user-access control.

PR.AC-1

Philips Enterprise Imaging IntelliSpace PACS

Manages medical images through access and collaboration.

PR.DS-2 PR.IP-4 PR.PT-1

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Component/ Capability

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Product

Function

Philips Enterprise Imaging Universal Data Manager

 

DCM4CHEE Open Source Clinical Image  and Object Management Enterprise

NIST Cybersecurity Framework Subcategories

provides web-based DICOM integration provides image life-cycle management

PR.DS-2 PR.IP-4 PR.PT-1

0pen-source PACS solution allows the lab to demonstrate data-in-transit workflow control

N/A

open-source utility used to demonstrate clinical workflow and interaction with medical imaging devices allows the lab to demonstrate data-in-transit workflow between clinical systems and medical devices

N/A

open-source utility used to demonstrate clinical workflow and interaction with medical imaging devices allows the lab to demonstrate data-in-transit workflow between clinical systems and medical devices

N/A

provides discovery, categorization, grouping, tagging, and identification of medical devices provides flexible user-defined risk assessment and scoring provides vulnerability management capabilities

ID.AM-1 ID.AM-2 ID.AM-4 ID.AM-5 ID.RA-1 ID.RA-5 PR.IP-1

Version DCM4CHEE-arclight5 v. 5.21.0 DVTk Modality Emulator

DVTk RIS Emulator

Asset Management

Virta Labs BlueFlow Version 2.6.4

 

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Component/ Capability

Product

Function

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Clearwater Information Risk Management Analysis

Tripwire Enterprise Version 8.7

  Enterprise Domain and Identity Management

Active Directory

DigiCert PKI Platform

  Symantec Validation and ID Protection Version 9.8.4 Windows

NIST Cybersecurity Framework Subcategories

provides reporting on risk and security properties for groups of assets provides threat feed for known medical devices

provides asset inventory management provides risk assessment and compliance

ID.AM-1 ID.AM-2 ID.AM-4 ID.AM-5

provides security configuration management provides file integrity monitoring (FIM) provides patch management.

ID.RA-1 ID.RA-5 PR.DS-6 PR.IP-1 PR.IP-3 PR.PT-3

provides authentication and authorization for users and computers in the domain provides authentication and authorization to multiple applications within the environment

PR.AC-1 PR.AC-4 PR.AC-7 PR.PT-3

provides SSL/TLS certificates for secure communication between devices enables devices to perform data-intransit encryption provides certificate management

PR.AC-1 PR.AC-4 PR.AC-7 PR.DS-2

integrates with TDi ConsoleWorks using the Remote Authentication Dial-In User Service (RADIUS) protocol

PR.AC-1 PR.AC-3 PR.AC-7

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Component/ Capability

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Network Control and Security

Product

Cisco Firepower Management Center (FMC) 6.3.0

Function

NIST Cybersecurity Framework Subcategories

provides multifactor authentication for remote access

provides console management for Firepower Threat Defense provides centralized control over network and communication provides network visibility

PR.AC-5 PR.PT-4

 

Cisco Firepower Threat Defense (FTD) 6.3.0

  

prevents intrusion provides network segmentation provides policy-based network protection

PR.AC-5 PR.PT-4

Tempered Networks Identity Defined Networking (IDN) Conductor and HIPswitch Version 2.1

 

provides network segmentation provides end-to-end encryption for device traffic

PR.AC-5 PR.DS-2 PR.PT-4

Zingbox IoT Guardian

provides passive device discovery and classification provides behavioral modeling to identify suspicious behavior assesses vulnerability

ID.AM-3 ID.RA-1 ID.RA-5 DE.AE-1 DE.AE-2 DE.AE-3 DE.AE-5 DE.CM-1 DE.CM-7

provides passive device discovery and profiling provides network access control

PR.AC-4 PR.AC-7 PR.PT-4 DE.AE-1 DE.AE-3 DE.CM-1 DE.CM-7

 

Forescout CounterACT 8  

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Component/ Capability

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Product

Function

Symantec Endpoint Detection and Response (EDR) Version 4.1.0

centrally manages threats across endpoint, network, and web traffic

DE.CM-1 DE.CM-4

Cisco Stealthwatch Version 7.0.0

provides insight into who and what is on the network analyzes the network through machine learning and global threat intelligence detects malware for encrypted traffic

ID.AM-3 DE.AE-1 DE.AE-2 DE.AE-3 DE.AE-5 DE.CM-1 DE.CM-3 DE.CM-7

provides remote access for external collaborators logs and monitors remote access activities

PR.AC-3 PR.AC-7

protects physical and virtual servers detects and prevents intrusion monitors file integrity

PR.DS-6 PR.IP-3

centrally manages assets through agent-based protection provides advanced machine learning and behavioral analysis techniques to identify known and unknown threats provides anti-virus capabilities

DE.CM-4 DE.CM-8

cloud storage for medical images (unstructured data) access control using storage access keys and policies encryption at rest using servicemanaged or customer-managed keys encryption in transit using https

PR.AC-1 PR.AC-4 PR.AC-7 PR.DS-1 PR.DS-2 PR.DS-6 PR.PT-4

 Secure Remote Access

TDi Technologies ConsoleWorks Version 5.1-0u1

Endpoint Protection and Security

Symantec Data Center Security: Server Advanced (DCS:SA) Version 6.7

Symantec Endpoint Protection Version 14.2

 

 Cloud Storage

Microsoft Azure Block Blob Storage account

  

NIST SP 1800-24B: Securing Picture Archiving and Communication System (PACS)

NIST Cybersecurity Framework Subcategories

42

Component/ Capability

Product

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Microsoft Azure Security Center Standard

Microsoft Azure Key Vault Premium

Function

storage firewalls to limit attack surface and to control communications

strengthen security posture by identifying weak or insecure configurations

identify threats against Azure resources, including Azure Storage accounts safeguard cryptographic keys and other secrets used by cloud applications and services holds storage account encryption key.

 Microsoft Azure Monitor

 

Microsoft Azure Active Directory

 

Microsoft Azure Private Link

NIST Cybersecurity Framework Subcategories

ID.RA-1 ID.RA-5 DE.AE-1 DE.AE-2 DE.CM-1 DE.CM-8 PR.AC-1 PR.DS-1

management and monitoring services centralized collection and retention of audit logs from various Azure services

PR.AC-1 PR.IP-1 PR.PT-1 DE.CM-7

identity and access management for Azure services user and sign-in risk detection and remediation

PR.AC-1 PR.AC-4 PR.AC-7 PR.PT-3 DE.CM-3

private virtual network connectivity for platform as a service (PaaS) services hosted on the Azure platform

PR.DS-2 PR.PT-4

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4 Architecture

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

When designing the PACS reference architecture, this practice guide implements the PACS environment within an HDO enterprise. NIST SP 1800-8, Securing Wireless Infusion Pumps in Healthcare Delivery Organizations describes implementing the HDO enterprise infrastructure and a network zone approach. This practice guide leverages that larger enterprise described in NIST SP 1800-8 and in Section 4.1 identifies zones in as they relate to PACS. This practice guide extends data storage by provisioning a cloud storage provider for long-duration storage. The FDA defines the PACS as “a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification” [19]. In addition to the PACS, this project used VNA solutions that meet the Food and Drug Administration’s definition of PACS but have other features that HDOs may use to enhance their overall image management ecosystem. This guide recognizes that healthcare systems interoperate and that the reference architecture needs to accommodate a broad view of the medical imaging ecosystem.

4.1 Architecture Description This practice guide’s architecture looks at components from three primary layers: 

business, where we deployed our core medical imaging components

security, where we implemented security tools

infrastructure, which represents our network

Figure 4-1 illustrates the project’s high-level architecture.

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Figure 4-1 High-Level PACS Architecture

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

A PACS ecosystem includes components that address data in transit, data at rest, and data processing and provides applications allowing authorized individuals to review and interact with data stored in their respective systems. Clinical systems are also part of our architecture, including imaging modalities and applications such as the RIS, that each play business process roles that interact with the PACS and VNA. Medical imaging generally uses standard protocols, including DICOM. DICOM is an international standard specific to storing, retrieving, printing, processing, and displaying medical information. The DICOM standard assures medical image information operability and provides a common standard, allowing different medical imaging product vendors to integrate their solutions into the medical imaging ecosystem [2], [3].

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In addition to the DICOM standard, PACS uses the HL7 protocol for clinical documentation and image reporting. HL7 defines a markup standard for exchanging health information in a structured format by using a clinical document architecture [20]. This document examines standard technology components in addition to the protocols noted above. Central to PACS are storage media, the network infrastructure, supporting operating systems, as well as application servers to support information exchange (e.g., HL7, DICOM, and web servers). This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The architecture described for this project implemented several zones composed of: Clinical application services consist of systems such as the EHR, order entry, health information systems, and others used by patient care teams in recording information during patient treatment. Clinical workstation/viewer establishes a network zone that segregates clinical workstations from the nonclinical production network. Clinical workstations are special-purpose devices used to interact with clinical systems. Those devices may use vendor-specified operating systems, applications, and configurations that vary from the HDO standard build. Configuration and patch management may be asynchronous with how the HDO manages its productivity or standard build systems. Enterprise network services are grouped into a separate zone for enterprise operations. Enterprise operations include services such as email communications, Active Directory, DNS, and security services that include certificate management. Imaging modalities provide a zone for departments using imaging equipment, generally termed as modalities. These are medical devices using operating systems that are not consistent with an HDO’s baseline. Configuration and patch management are likely asynchronous with how the HDO manages its productivity or standard build systems. For purposes of this project, this zone includes emulated modalities. This project used simulation software to generate medical images. PACS and VNA systems segregate the PACS and VNA applications from clinical applications, general workstations, and storage media. This zone provides the higher-level application functionality to interact with aggregated medical images. Data storage management isolates large-scale storage, such as storage area networks (SANs) or network-attached storage (NAS) devices. Data stored in this zone may be unstructured, large files that may contain sensitive, personal, or PHI. Cloud storage is external to the HDO infrastructure and represents the use of a third-party cloud storage provider where medical images are archived. Vendor Net supports remote connectivity, e.g., remote vendor support. This zone segregates external network traffic used when vendors may need to perform maintenance on systems or other equipment while the support engineer is off premises.

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4.1.1

PACS Ecosystem Components

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The PACS ecosystem includes those components that support the clinical processes associated with medical imaging acquisition, review, annotation, and storage. Clinical applications, such as the RIS, generate image acquisition worklists and apply worklists to associated modalities. Modalities retrieve worklists from the RIS. The lab environment included two distinct PACS and a VNA systems and deployed image viewing software associated with those systems on workstations to review and annotate medical images. In building the lab environment, this project emulated some of the components rather than obtaining full-scale solutions. This project emulated both modalities and an RIS. The project also used a mobile phone device for document scanning. Figure 4-2 depicts a high-level view of these components and how we approached implementing them in the lab environment. Figure 4-2 PACS Ecosystem Components

The open-source tool from DVTk (https://www.dvtk.org) includes packages that allowed this project to emulate medical imaging modalities and an RIS. The project deployed two instances of the RIS Emulator

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into the clinical application services zone. The DVTk RIS Emulators associate the modalities with separate PACS and provide worklists for those modalities associated with two respective PACS, reflective of an HDO that may operate multiple PACS. The project used Philips IntelliSpace PACS and DCM4CHEE (https://www.dcm4che.org/), an open-source PACS, to support this premise. Hyland Acuo VNA was deployed to model HDOs using this technology.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

This project deployed the modalities to a modalities network zone. Using emulated modalities allowed the project team to simulate DICOM image acquisition, interaction with the RIS, and transferring images from the modality device to the PACS and VNA for storage and management. The project used an iPhone to operate the PACS Scan Mobile app provided by Hyland, connecting to a PACSgear Core Server. The iPhone was treated as a modality, with the application facilitating document scanning and, through the PACSgear server, transferring mobile-acquired images to the VNA.

4.1.2

Data and Process Flow

For this project, we examined data and process flows as described in Section 3.4.1, Establishing the Risk Context, that include the following scenarios: 

sample radiology practice flows

access to aggregations and collections of different types of images

accessing monitoring and auditing

image object change management

remote access

The scenarios identify medical imaging acquisition processes, starting with scheduling the patient for a procedure, and follow the life cycle through when the patient interacts with an imaging device to when a medical imaging specialist processes and forwards the annotated image to a clinician for interpretation and diagnosis. Scenarios also examine processes after direct patient interaction, such as when authorized individuals access images for later review or when images need to be updated. Figure 4-3 shows a simplified data communication flow in the PACS ecosystem.

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Figure 4-3 PACS Ecosystem Data Communication Flow

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

A typical radiology department workflow may begin with patient registration and admission, followed by a physician ordering an imaging procedure. The order is entered into a RIS to create a worklist. A medical imaging technologist attends to a patient and performs the image capture procedure. The medical imaging technologist may make annotations for a physician’s review. The system forwards that information to a PACS or VNA. A physician retrieves the images from the PACS or VNA and uses an image viewing station to review the images and document findings and diagnoses. On completion, the physician transfers the information back to the PACS. Results may cross-reference with the EHR system.

4.1.3

Security Capabilities

This practice guide built upon the zoned network architecture described in NIST SP 1800-8, Securing Wireless Infusion Pumps in Healthcare Delivery Organizations [21]. Network zoning provided a baseline upon which engineers deployed the medical imaging ecosystem infrastructure. The practice guide identified and deployed security capabilities to the environment, consisting of the following:

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asset and risk management

enterprise domain and identity management •

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

access control o

privileged access controls

o

user authentication

o

device and system authentication

o

data access control

network control and security •

network segmentation and virtual local area networks (VLANs)

•

firewall and control policies

•

microsegmentation

•

anomalies and events detection (behavioral analytics)

•

intrusion detection and prevention systems

endpoint protection and security •

device hardening and configuration

•

malware detection

data security •

data encryption (at-rest)

•

data encryption (in-transit)

secure remote access

While the project takes a holistic approach when evaluating the medical imaging environment, the control scope noted in this practice guide is bound to those elements that are inherently or highly supportive of acquiring, interpreting, or storing medical images. An HDO’s infrastructure is larger in scope than that used to support the medical imaging environment. An HDO may and should implement additional pervasive controls to secure the overall environment. This document references pervasive controls not implemented during this project and assumes an organization will implement appropriate controls to address its broader risk profiles. Refer to Appendix C for details. Figure 4-4 below depicts contextual controls deployed in the project’s test build.

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Figure 4-4 Base Controls on Test Build Components

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

4.1.4

Asset and Risk Management

Asset management is a critical control that aligns with the function known as Identify in the NIST Cybersecurity Framework [8]. This project assumes a pervasive control exists, such as a governance, risk and compliance (GRC) solution. The HDO manages IT general assets through the GRC solution. Medical imaging devices may fall outside the scope of IT general assets for many HDOs. For this reason, this project implemented Virta Labs BlueFlow for asset and inventory management for medical imaging devices. BlueFlow captures inventory, configuration, and patch management information [16], [22], [23].

4.1.5

Enterprise Domain and Identity Management

This project looked at identity management controls as including several concepts that encompass identity proofing, credentialing, and providing a means to authenticate devices and systems. Human

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

actors (clinical, IT administrative, and general HDO staff), medical devices, and systems may have identities established within the HDO. An identity is a broader concept than credentials or user accounts. This project assumed that HDOs perform adequate identity proofing and provisioning. This involves processes that allow HDOs to verify that an individual is who they claim to be, also ensuring that the individual has appropriate credentials to interact with clinical systems and medical imaging information. Regarding provisioning, this project assumed that following identity proofing, the organization can create and securely deliver credentials (e.g., user accounts in which the individual can select and update passwords or challenge responses known only to that individual). Identities may include multiple user accounts or access mechanisms that may be applied. For example, an individual may have a job function as an IT administrator. As a member of the HDO workforce, they may be credentialed to access certain systems such as email or productivity software. They may also have access to separate privileged accounts to be used when they perform IT administrative duties. Having separate credentials established based on functionality or role is a common practice in healthcare and provides a form of separation of duties. Medical devices and systems may also have identities, that are authenticated using digital certificates, keys, or other unique identifiers such as host identifiers or MAC addresses.

4.1.5.1 Access Control Access control is applied contextually, based on the identity type. This project implemented access control for privileged users, clinical users, devices, and systems. Subsections below provide more detail on the project’s approach. 4.1.5.1.1 Privileged Access Management Privileged access includes those credentials that have permissions to systems that are greater than standard users. Privileged access accounts often allow greater visibility of resources stored on systems and may allow modifying configuration settings or permitting installation of software components. One measure that this guide implements is segregating privileged access accounts. These accounts were unique and distinct from those accounts we created that were able to access information via DICOM viewer applications. When activities required privileged access, access actions routed through lab environment’s TDi ConsoleWorks implementation, which enforced the project’s multifactor authentication solution. For further guidance on privileged account management, HDOs should reference NIST SP 1800-18, Privileged Account Management for the Financial Services Sector [24]. While the document identifies solutions for financial services, the underlying technology solution applies to healthcare and other sectors.

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4.1.5.1.2 User Authentication User authentication involves the use of different factors. Factors are characteristics by which a user may be able to assert their identity. In many cases, users are authenticated using a single factor (e.g., a username and password combination). One means to strengthen single-factor authentication is to use pass phrases rather than passwords. This approach reduces the possibility that a malicious actor may be able to brute-force-attack the credential [25]. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Another aspect that HDOs may consider is to implement multifactor authentication where appropriate or feasible. Multifactor authentication includes a need to pass two or more factors that represent something a user knows, has, or is. Memorized passwords or pass phrases represent factors that a user knows. Including other factors, such as something a user has, which may represent a physical token; or something a user is, such as biometrics that include fingerprints, retinal, or facial scans, would provide greater assurance that the user is whom they claim to be. Multifactor authentication may not be implementable in all cases, and HDOs may need to determine their risk tolerance and implementation practicality when considering enhancing their authentication models [26]. 4.1.5.1.3 Device and System Authentication For this project, we emulated medical imaging devices and implemented the HIP. Emulated modality devices authenticated to a HIPswitch, routing modality traffic across a HIP-secured software-defined network. For further information, refer to the discussion in Section 4.1.6.3, Microsegmentation. For systems authentication within the HDO, this project used digital certificates and keys. This project deployed digital certificates to the PACS and VNA servers as well as to a mobile device where we installed software used to scan documents and images that would be added to our medical imaging store. Authentication between VNA servers and cloud data storage is achieved using access keys. This practice guide uses digital certificates to secure network sessions using a key management solution provided by the cloud provider. The HDO configures key management to maintain private key control. However, this project did not implement a data security manager or hardware security manager on premise. 4.1.5.1.4 Data Access Control PACS and VNA solutions often support a “multitenant” concept to allow for different departments, clinics, or hospitals within a larger healthcare system. These applications may implement or integrate with directory services that allow solutions administrators to provide access based on role or business function. This project used role-based access control capabilities found in the Philips IntelliSpace and Hyland Acuo systems. For this project, the VNA plays a vital role for managing medical images across the simulated HDO. The VNA manages, retrieves, and stores medical images to a cloud storage provider. Access to the data in the storage account is managed through access keys and policies.

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4.1.6

Network Control and Security

This project continued with the network zoning and segmentation concepts established in NIST SP 18008 and built on those concepts by implementing several tools to advance protective and detective capabilities. As examples of these enhancements, this project deployed a next-generation firewall, introduced microsegmentation, and implemented behavioral analytics in its network control and security in its approach. Subsections below provide additional information on these topics. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

4.1.6.1 Network Segmentation and VLANs The PACS ecosystem is made up of a variety of different devices with independent requirements to ensure proper functionality. While some devices may require network access to remote services, others may operate effectively with limited connectivity outside their subnet. To meet these needs, we implemented VLANs to segment the PACS network based on devices of similar needs and functionalities. This complies with the concept of network zoning introduced in NIST SP 1800-8 [21]. With this approach, we eliminated inherent trust between VLANs. The project allowed devices to communicate with only trusted devices based on carefully crafted network policies. The PACS project implemented the architecture described in Section 4.1 by constructing a network that was segmented into VLANs. The project limited the implementation to the main components necessary for the PACS ecosystem. The project segmented the network into the following VLANs: 

vendor net

enterprise services

clinical viewers

PACS A

PACS B

modalities

clinical applications

guest services

databases

remote storage

security services

This project established segmentation through virtualization, with separate subnets implemented for each VLAN listed above. The project placed each VLAN behind a router/firewall that implements policies defined by VLAN’s purpose. Figure 4-5 below depicts the network architecture.

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Figure 4-5 NCCoE Lab Environment Network Architecture

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

4.1.6.2 Firewall and Control Policies This project used Cisco’s Firepower Next Generation Firewall (NGFW). The NGFW provides several features that combine features previously found in separate perimeter security products such as intrusion prevention systems, application firewalls, proxy servers, and network packet inspection tools. The NGFW allows integration of other tools to defend the network against malicious activity. As network and application attacks become more advanced, network controls should be enhanced beyond stateful traffic filtering. NGFW goes beyond ports, protocols, and IP addresses, providing standard policy-based protection, while including more advanced tools such as intrusion prevention systems, application filtering, uniform resource locator (URL) filtering, and geo-location blocking. The PACS ecosystem faces a variety of threats from different sources, and a comprehensive approach to network security is vital. The lab implemented network zoning by using policy and configuration settings through Firepower. This allowed the project to implement network zoning and proactive network traffic filtering.

4.1.6.3 Microsegmentation Microsegmentation uses software-defined networking (SDN) to create a virtual overlay network over the existing network infrastructure. Devices may be grouped based on usage, with developed policies

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

that establish granular degrees of trust. This project implemented the SDN overlay using host identity protocol (HIP) over the existing network infrastructure and offers in-transit network encryption. This project used microsegmentation to establish network control for modalities. Modalities represent medical imaging devices. These endpoint devices may contain exploitable vulnerabilities and may not have practical means to mitigate compromise beyond network protection. While VLAN-defined network zoning may afford network protection, this guide implements microsegmentation for these medical devices to reduce VLAN management complexity and provide more robust network segregation for medical devices. A microsegmentation approach may offer a solution that requires less impact to network configuration while limiting adverse interaction with the modalities. This practice guide implemented microsegmentation through Tempered Networks’ HIP solution that includes HIPswitches implementing HIP, as described in the Internet Engineering Task Force (IETF) request for comments 4423 [27]. HIP provides a cryptographically defined host identifier bound to endpoints rather than IP addresses. Network traffic between HIP-enabled endpoints traverses a series of HIPswitches deployed in the lab network infrastructure, creating a cloaked network that operates on top of the physical network. The cloaked network uses advanced encryption standard (AES)-256 encryption to secure data in transit and uses secure hash algorithm (SHA)-256 to authenticate data packets from HIP-enabled endpoints [27], [28], [29]. Figure 4-6 below depicts the microsegmentation architecture deployed in the project’s test build.

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Figure 4-6 Microsegmentation Architecture

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

While VLAN segmentation can help reduce unwanted lateral movement within a network, it does not restrict lateral movement within that zone. For some devices and workloads, it may be necessary to isolate their operations and allow only a select few interactions with other devices. The project team determined that microsegmentation would be an appropriate control to protect medical imaging devices that may operate embedded operating systems or firmware where patch release cycles may be different from current commercial off-the-shelf operating systems. Microsegmentation provides this fine-grained approach to isolation and can be implemented within an existing network. Within the PACS ecosystem, we identified an area where microsegmentation would improve operational security. This guide implements microsegmentation through a solution based on HIP. HIP uses cryptographic host identifiers rather than IP addresses to address and authenticate endpoints and to create secure tunnels. This guide uses this concept to abstract IP addressing away from the modalities, using identity-defined perimeters where endpoint devices are authenticated to HIPswitches and allow secure tunnel communications to other HIPswitches [27]. For this practice guide’s architecture, it was important to secure this line of communication and ensure that appropriate defenses protect devices from potential threats. To accomplish this, the project

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established two identity-defined perimeters on two separate VLANs. This project then placed a modality behind one perimeter and a PACS behind the other. This project configured these perimeters to allow only authorized traffic between them, meaning the modality was allowed to communicate only with the PACS and vice versa. Additionally, the project encrypted all traffic between the two perimeters, ensuring the data were secure in-transit.

4.1.6.4 Anomalies and Events Detection (Behavioral Analytics) This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Medical devices often operate within strict requirements and limited resources. This makes certain tasks like vulnerability assessment difficult to manage, as they often require obtrusive operations such as a host-installed agent. Network-based behavioral analytics can perform the same assessments, identifying suspicious operations without affecting medical device function or performance. Behavioral analytics is an automated feature that collects and analyzes network traffic flow and compares the results to a preestablished baseline to determine whether devices are operating abnormally. For the PACS architecture, the project identified network flows, primarily among PACS, VNA, and modalities, where it is important to monitor for abnormal behavior. With a baseline established, the project can identify when endpoints attempt to conduct network operations outside their normal profile. With this information, we can verify and remediate the threat. The project implemented the Zingbox IoT Guardian solution.

4.1.6.5 Intrusion Detection and Prevention Systems Components managed through an HDO’s IT operations team would implement control mechanisms to perform malware detection, vulnerability scanning, and remediation. This project involved several workstations (e.g., image viewing devices), as well as servers that may operate commercially available operating systems. This project deployed host-based agents, as appropriate, to permit the IT team to perform regular vulnerability scanning for those non-modality systems. This project implemented Symantec Endpoint Protection on image viewing workstations. Also, the project implemented the Cisco Firepower NGFW that included a network-based intrusion prevention mechanism [30].

4.1.7

Endpoint Protection and Security

This practice guide implements endpoint protection and security through device hardening and configuration controls. Protected endpoints include both workstations and servers. This project used several workstations to represent clinical workstations and used medical image viewers as the means to connect to the PACS and VNA servers. The project deployed endpoint protection to servers by installing Symantec Endpoint Protection as the automated solution addressing vulnerability management requirements. The practice guide installed Tripwire Enterprise for configuration management on the servers.

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Endpoints represent potential targets for malicious actors, and assuring appropriate control is critical to enterprise risk management. Automated tools that leverage endpoint-deployed agents that process policy may provide HDOs greater asset control and limit potential compromise.

4.1.8

Device Hardening and Configuration

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

This project deployed Tripwire Enterprise on server components (e.g., the Hyland Acuo server and the Philips IntelliSpace server) to address device hardening and configuration management. This project deployed a host intrusion prevention system (HIPS) to protect servers performing critical functions in the HDO. The HIPS tool prevents the internals of an operating system from performing unintended or malicious activity. This mechanism can provide further protection from attackers attempting to compromise the system by preventing installation or execution of malicious software. This tool supports policy-based rules for monitoring file system changes of critical operating system application and system file directories. This allows the tool to monitor critical settings of the operating system, such as Windows registry keys. In our environment, we used these tools to ensure that new executables were not installed, thus reducing the attack surface of critical systems. In conjunction with HIPS, a FIM system protects clinical servers in the reference architecture. This system monitors file system changes, looking for suspicious changes. The FIM system also evaluates policy compliance to ensure the critical servers comply with the HDO policies.

4.1.8.1 Malware Detection An endpoint-based malware detection system, commonly referred to as anti-virus software, prevents, detects, and removes malicious software from systems. This function is critical to protecting the systems that healthcare professionals use to interact with the PACS, such as the imaging workstations. The antivirus software implemented in our reference architecture analyzes suspicious behavior, performs firewall functions, and allows custom, policy-based enforcement. These added functions enhance the ability for HDOs to respond to the threat of malicious software on healthcare systems. This practice guide deployed the Symantec Endpoint Protection solution on workstations hosting our DICOM image viewers. A network-based malware detection system, commonly referred to as an intrusion detection system (IDS), detects malicious activity over the network. In our reference architecture, the IDS interfaces directly with the manager of the endpoint-based malware detection system. This gives the IDS the ability to use data collected from the endpoint to better detect malicious activity on the network [30].

4.1.9

Data Security

This project considered challenges associated with data loss and data alteration. A challenge noted while looking at the medical imaging ecosystem is the diversity of data types that may be prone to varying threat types, with compromise resulting in different adverse outcomes. This project examined data

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flows between the implemented components and identified a need to secure data in-transit and data atrest.

4.1.9.1 Data Encryption (at-rest and in-transit)

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Microsoft Azure provides cloud storage for this practice guide. Encrypted network sessions between the HDO and the cloud storage provider use TLS, Internet Protocol Security (IPSec) and Internet Key Exchange (IKE). Azure assigns a storage account to the HDO. Access to medical images stored in the cloud service requires storage account credentials. Azure enforces storage account access control using HTTPS with TLS, Perfect Forward Secrecy, and Rivest-Shamir-Adleman (RSA) cryptosystem 2048-bit encryption keys. Azure assures data-at-rest encryption using service-managed keys. Azure encrypts partitions or blocks of data using AES-256 bit keys [31]. This practice guide recommends referring to NIST SP 1800-11, Data Integrity: Recovering from Ransomware and Other Destructive Events [32], for measures that address backup and recovery. This project implemented PACS and VNA solutions on Windows servers, and this practice guide recommends implementing secure server message block best practices, e.g., as provided by Department of Homeland Security Cybersecurity and Infrastructure Security Agency [33]. Examining the communications traffic flow, the project team determined that relevant data are sensitive in nature. Medical images and accompanying clinical notes and diagnoses are PHI and have requirements that align with confidentiality, integrity, and availability. This project authenticates communications from the modalities to the PACS and VNA using HIP, which also provides network encryption. HIP employs AES-256 encryption [27], [28], [29] to secure network sessions. By deploying HIP, this project sought to defend against network-borne attacks, including manin-the-middle attacks where data may be altered in transit. When multiple PACS data were aggregated into the VNA, the project enabled TLS tunneling. TLS uses DigiCert TLS certificates to implement AES-256 network encryption [28], [29], [35]. Image viewers, as well as mobile devices using Hyland’s PACSgear scanning tool, use https/TLS when connecting and communicating to the VNA or PACS respectively [35].

4.1.10

Remote Access

Both healthcare and IT systems require access by vendor-support technicians for remote configuration, maintenance, patching, and updates to software and firmware. The project used a remote access network segment to provide these external privileged users with privileged access to these components that reside within our reference architecture. A virtual private network (VPN) solution provides a secure way in which an organization can extend its private network across the internet, ensuring that only properly authenticated users can access their organization’s private network. This project configured

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and managed the NCCoE VPN in our environment using vendor-recommended practices [36]. This project implemented TDi ConsoleWorks as a remote access mechanism into the infrastructure.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

To further secure access to remote resources, the team implemented a privileged access management (PAM) solution [24]. The PAM solution provides two-factor authentication (2FA), fine-grained access control, and monitoring user access to remote resources. 2FA is provided via domain-based username and password and an application-based security token available on the user’s mobile device. This project implemented 2FA in the test build using Symantec Validation and ID Protection (VIP) solution. The project integrated Symantec VIP into the ConsoleWorks authentication mechanism to enforce username password plus onetime passcode to make up the two factors.

4.2 Final Architecture The target architecture, depicted in Figure 4-7, demonstrates control measures such as microsegmentation and network segmentation as described by this practice guide. The architecture depicts network zones using VLANs, with the modalities zone implemented using microsegmentation. The target architecture also includes using cloud storage for long-term archiving and serves to enhance resiliency and recoverability should the HDO be subject to an adverse event.

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Figure 4-7 PACS Final Architecture

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

5 Security Characteristic Analysis The purpose of the security characteristic analysis is to understand the extent to which the project meets its objective of demonstrating the security capabilities described in the reference architecture in Section 4. This evaluation focuses on the security of the reference design itself. In addition, it seeks to understand the security benefits and drawbacks of the example solution.

5.1 Assumptions and Limitations The security characteristic analysis has the following limitations: 

It is neither a comprehensive test of all security components nor a red-team exercise.

It cannot identify all weaknesses.

It does not include the lab infrastructure. It is assumed that devices are hardened. Testing these devices would reveal only weaknesses in implementation that would not be relevant to those adopting this reference architecture.

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5.2 Scenarios and Findings

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

One aspect of our security evaluation involved assessing how well the reference design addresses the security characteristics that it was intended to support. The Cybersecurity Framework subcategories were used to provide structure to the security assessment by consulting the specific sections of each standard cited in reference to a subcategory. The cited sections provide validation points that the example solution would be expected to exhibit. Using the Cybersecurity Framework subcategories as a basis for organizing our analysis allowed us to systematically consider how well the reference design supports the intended security characteristics.

5.3 Analysis of the Reference Design’s Support for Cybersecurity Framework Subcategories Using the NIST Cybersecurity Framework subcategories to organize our analysis also provided additional confidence that the reference design addresses our use case security objectives. The remainder of this subsection discusses how the reference design supports each of the identified Cybersecurity Framework subcategories [8]. Table 3-5 lists the reference design functions and the security characteristics, along with products that we used to instantiate each capability. The focus of the security evaluation is not on these specific products but on the Cybersecurity Framework subcategories. There may be other commercially available products that meet the objectives found in the NIST Cybersecurity Framework. Practitioners may substitute other products that provide comparable security control within the reference design.

5.3.1

Asset Management (ID.AM)

This practice guide considered ID.AM-1, ID.AM-2, ID.AM-4, and ID.AM-5 to address asset management. The practice guide implemented ID.AM-1 using Virta Labs BlueFlow to address modality asset management. Establishing an asset inventory is a fundamental component in determining appropriate controls for the environment. The ID.AM-1 Subcategory specifies, “[p]hysical devices and systems within the organization are inventoried,” and ID.AM-2 specifies, “[s]oftware platforms and applications within the organization are inventoried.” This practice guide groups the ID.AM-1 and ID.AM-2 subcategories together. The practice guide identifies tools that align with objectives defined by one or more of the Cybersecurity Framework subcategories. Physical devices include workstation, server, and storage components, whereas software assets include those applications that run on the physical components. The practice guide emulates HDOs in that HDOs often have separate biomedical engineering teams, distinct from central IT operations. The implication is that IT general assets and medical devices may have distinct asset-tracking mechanisms. BlueFlow captures inventory, configuration, and patch management information.

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ID.AM-4 specifies, “[e]xternal information systems are catalogued.” The Clearwater Information Risk Management Analysis tool would track cloud services as part of the IT asset inventory. Medical device asset tracking may be distinct from what is maintained in a general IT asset database. For this project, the team maintained simulated medical imaging devices and implemented the Virta Labs BlueFlow tool for asset tracking and configuration management. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

ID.AM-5 specifies, “[r]esources (e.g., hardware, devices, data, time, personnel, and software) are prioritized based on their classification, criticality, and business value.” To address ID.AM-5, this project implemented solutions to identify communication and data flows between IT and biomedical engineering assets. The project implemented the Zingbox IoT Guardian and Cisco Stealthwatch solution to analyze NetFlow traffic across the laboratory infrastructure. In capturing NetFlow patterns, the project provided two primary benefits: 1) a baseline of communication flows between medical imaging devices, workstations, and PACS/VNA systems, and 2) an ability to determine when communication patterns were anomalous.

5.3.2

Risk Assessment (ID.RA)

This project selected ID.RA-1 and ID.RA-5 to address the Risk Assessment category. ID.RA-1 specifies, “[a]sset vulnerabilities are identified and documented,” and ID.RA-5 specifies “[t]hreats, vulnerabilities, likelihoods, and impacts are used to determine risk.” The project identified and deployed tools to address these control requirements. This project used Symantec’s Endpoint Protection solution to address threats to image viewer workstations. The project used Tripwire Enterprise to monitor server assets. This practice guide implemented Virta Labs BlueFlow to manage and assess medical imaging devices. The project also used Zingbox IoT Guardian to perform NetFlow analysis. Practitioners may use information from these tools when needed to determine the risk profile of the HDO environment.

5.3.3

Identity Management and Access Control (PR.AC)

To implement identity management and access control, the project team focused on PR.AC-1, PR.AC-4, and PR.AC-7 Subcategories. PR.AC-1 specifies, “[i]dentities and credentials are issued, managed, verified, revoked, and audited for authorized devices, users and processes.” PR.AC-4 specifies, “[a]ccess permissions and authorizations are managed, incorporating the principles of least privilege and separation of duties.” PR-AC7 specifies, “[u]sers, devices, and other assets are authenticated commensurate with the risk of the transaction.”

5.3.3.1 Identity Management The project used Microsoft Active Directory to provision human user access to workstations and systems. This project implemented the Symantec VIP. The Symantec VIP tool gave the project multifactor authentication (MFA) capability. MFA enhances non-repudiation within the authentication

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process. MFA provides additional factors, apart from a password, that assures that when an individual presents a credential, they are doing so appropriately. For further information on MFA, practitioners may consult with NIST 800-63-3 Digital Identity Guidelines [34]. Table 5-1 describes how the project managed different user types and describes some general characteristics of that user type. Table 5-1 Identity Management Characteristics This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

User Type

Identity

Tool

Characteristics

Human Users

Active Directory

Active Directory

Human user authentication method dependent on interaction type

Medical Imaging Devices

Host Identifier

Tempered Networks IDN

Imaging devices abstracted from the production network over a cloaked network implementing HIP

System to System

Certificate

DigiCert Managed PKI

Automated interactions between systems authenticated

HDO to Cloud Storage Provider

Access Keys; Azure Active Directory

Microsoft Azure

Authentication to cloud storage provider is provided using access keys.

This project emulated medical imaging devices. They authenticate using HIP, implemented in Tempered Networks’ microsegmentation capability. The Tempered Networks solution, IDN, uses the HIP, which incorporates a key exchange capability between endpoint devices and gateways, or HIPswitches. The practice guide included a document scan utility installed on a mobile device. To enable device authentication in this case, the project used DigiCert Managed PKI, providing certificate-based authentication. The project augmented device authorization management by limiting PACS accessibility based on workstation zone provisioning. The practice guide installed Symantec VIP to enable multifactor authentication for certain devices. The practice guide secured network sessions with TLS applying DigiCert-issued certificates [35].

5.3.3.2 Access Control To implement PR.AC-4, this project used role-based access control (RBAC) features built into the PACS and the VNA systems. Philips IntelliSpace and Hyland Acuo VNA implement RBAC, allowing least privilege access enforcement. This project also took advantage of the network zoning concept and limited access based on firewall policies that restrict traffic between different zones. For example, the project limited image viewer

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workstation network traffic to the PACS and VNA for image retrieval and interaction to specified network zones. Administrative functions are restricted and are performed through TDi ConsoleWorks sessions that enforce multifactor authentication.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The project implemented PR.AC-3 using TDi Technologies ConsoleWorks to provide remote access to the lab network. The ConsoleWorks environment provided a solution for vendor remote access as well as general user remote VPN, including access by third-party medical imaging services that may need access to patient images [36]. To implement PR.AC-5, the project made significant use of network segmentation through VLANs implemented with Cisco Firepower NGFW and through microsegmentation implemented using Tempered Networks IDN. Identity Defined Networking (IDN) implements an SDN that this project used to secure communications between the simulated medical imaging devices and the PACS/VNA environment. The project managed access to Azure resources in two ways. Management plane functions, which include creation, modification, and deletion of cloud resources, are protected using Azure AD and RBAC. Best practices for management plane access include least privilege, MFA, and secure administrative workstations. Access to services inside Azure resources is referred to as data plane functions. Authentication at this layer occurs in multiple ways. For storage accounts, authentication occurs using access keys and policies. The interaction between storage accounts and the Key Vault for encryption key retrieval uses Azure Active Directory.

5.3.4

Data Security (PR.DS)

For this project, the team identified PR.DS-1, “[d]ata-at-rest is protected;” PR.DS-2, “[d]ata-in-transit is protected;” PR.DS-6,“[i]ntegrity checking mechanisms are used to verify software, firmware, and information integrity” subcategories to address data security. This practice guide implements Microsoft Azure for cloud storage. The HDO environment establishes a TLS tunnel using digital certificates that Azure manages. The TLS tunnel assures data-in-transit protection. Azure also implements AES-256 encryption for data-at-rest. The project installed Symantec Encryption Platform to protect workstations in this practice guide. This project implemented TLS and HIP to assure data in-transit protection. Image viewing workstations connecting to the PACS/VNA environments use TLS encryption to ensure data-in-transit protection [27], [28], [35]. This project also implements microsegmentation with Tempered Networks and ensures datain-transit protection by HIP-managed encryption between emulated medical imaging devices and the PACS/VNA environment.

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The practice guide uses Tripwire Enterprise and Symantec DCS:SA to provide integrity monitoring of system software files. PR.DS-6 includes a control objective to additionally manage firmware; however, the lab used emulated medical imaging devices for its modalities, operating as virtual machines. These emulated devices did not include a firmware component. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

5.3.5

Information Protection and Procedures (PR.IP)

This project selected PR.IP-1, PR.IP-3, and PR.IP-4 to implement the Information Protection and Procedures Category. PR.IP-1 specifies, “[a] baseline configuration of information technology/industrial control systems is created and maintained incorporating security principles (e.g., concept of least functionality).” PR.IP-3 specifies, “[c]onfiguration change control processes are in place;” and PR.IP-4 specifies, “[b]ackups of information are conducted, maintained, and tested.” Servers supporting the PACS and VNA systems were built using guidance received from Philips and Hyland, respectively. This project regarded these configurations as baseline configurations and determined them to be based on application functionality requirements. Tripwire Enterprise monitors modifications. Virta Labs BlueFlow manages medical imaging device configurations. The practice guide emulated medical imaging devices deployed in the lab. Emulated medical devices did not involve firmware.

5.3.6

Protective Technology (PR.PT)

To implement Protective Technology, this project selected PR.PT-1, PR.PT-3, and PR.PT-4. PR.PT-1 specifies, “[a]udit/log records are determined, documented, implemented, and reviewed in accordance with policy.” PR.PT-3 specifies, “[t]he principle of least functionality is incorporated by configuring systems to provide only essential capabilities;” and PR.PT-4 specifies, “[c]ommunications and control networks are protected.” To address PR.PT-1, the Hyland Acuo VNA, Hyland NilRead Enterprise, Hyland PACSgear, Philips Enterprise Imaging IntelliSpace PACS, and Philips Enterprise Imaging Universal Data Manager components provided the capability to create audit log records. The practice guide implemented Zingbox IoT Guardian to assure regular network traffic monitoring. The tool aggregated NetFlow traffic across the lab environment and performed behavioral analytics. HDOs should also consider using a security incident event management (SIEM) system that would aggregate logs from different operating systems, applications, and component types. SIEM tools often can support scripts that may trigger alerting to incident response teams. To address PR.PT-3, this project implemented operating systems that were configured with the minimum functionality necessary to support PACS and VNA operations, based on guidance from Hyland

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and Philips, respectively. These collaborators provided configuration recommendations that were applied as baseline settings. The practice guide then used Tripwire Enterprise to monitor this baseline.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

This project implements PR.PT-4 through constructing network zones with VLANs and using the Tempered Networks microsegmentation solution. The project used VLANs to establish a base set of network zones, and the Tempered Networks IDN created a means to control network traffic between the simulated medical imaging devices and the PACS/VNA leveraging the HIP, which protects data on networks via data encryption. The project used the Cisco Firepower NGFW to protect the infrastructure from malicious activity. TLS and IPsec tunneling protected external connections where appropriate [35], [36].

5.3.7

Anomalies and Events (DE.AE) and Security Continuous Monitoring (DE.CM)

This project grouped together the Functions DE.AE Anomalies and Events and DE.CM Security Continuous Monitoring. The project then selected DE.AE-1, DE.AE-2, DE.AE-3, DE.AE-5, DE.CM-1, DE.CM3, and DE.CM-7 to address these control areas. Selected controls for DE.AE Anomalies and Events include DE.AE-1: “[a] baseline of network operations and expected data flows for users and systems is established and managed”; DE.AE-2: “[d]etected events are analyzed to understand attack targets and methods”; DE.AE-3: “[e]vent data are collected and correlated from multiple sources and sensors”; and DE.AE-5: “[i]ncident alert thresholds are established.” This project implemented Zingbox IoT Guardian and Cisco Stealthwatch to achieve these objectives through implementing behavioral analytics. The practice guide configured Zingbox for continuous monitoring by directing NetFlow traffic to its cloud-hosted back end where it performed analysis. The practice guide configured Stealthwatch for monitoring and analysis on-premise. DE.CM-1 specifies, “[t]he network is monitored to detect potential cybersecurity events”; DE.CM-3: “[p]ersonnel activity is monitored to detect potential cybersecurity events”; and DE.CM-7: “[m]onitoring for unauthorized personnel, connections, devices, and software is performed.” The project addresses DE.CM-1 through the Zingbox and Stealthwatch implementations. The solutions perform network monitoring and cybersecurity event detection by analyzing NetFlow traffic. The project performed additional network monitoring using the Cisco Firepower Next Generation Firewall deployment. DE.CM-4 specifies, “[m]alicious code is detected”; and DE.CM-7 specifies, “[m]onitoring for unauthorized personnel, connection, devices, and software is performed.” This project implemented Symantec Endpoint Protection to address DE.CM-4 and DE.CM-7. The practice guide implemented intrusion prevention with the Cisco Firepower Next Generation Firewall. The practice guide deployed Symantec Endpoint Protection on workstations, including image viewer workstations.

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5.4 Security Analysis Summary

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The practice guide’s reference design implementation of security surrounding the PACS/VNA helps reduce risk from the PACS/VNA, even when practitioners identify vulnerabilities in a PACS or VNA. The key feature is the multilayered security capabilities defined in Section 4.1.3. This practice guide followed our collaborative partners’ recommended security practices to harden devices and systems; monitor traffic; limit access to only authorized users, devices, and systems; and ensure data security across the ecosystem. Any organization following this guide must conduct its own analysis of how to employ the elements discussed here, in its own environment. It is essential that organizations follow security best practices to address potential vulnerabilities and to minimize any risk to the operational network.

6 Functional Evaluation We conducted a functional evaluation of our example implementation to verify that several common provisioning functions used in our laboratory test worked as expected. We also needed to ensure that the example solution would not alter normal PACS and VNA functions. In developing a test plan, this project identified implemented cybersecurity controls and identified a method to demonstrate control functionality. Also, this project identified five IHE use case scenarios that implemented multiple cybersecurity controls to augment business process functionality. The identified scenarios found in Section 3.4.3 served as the basis of a functional test plan to demonstrate overall security control efficacy. Section 6.1 describes the format and components of the functional test cases. Each functional test case is designed to assess the security capabilities of the example implementation to perform the functions listed in Section 4.1.3.

6.1 PACS Functional Test Plan Each test case consists of multiple fields that collectively identify the goal of the test, the specifics required to implement the test, and how to assess the results of the test. Table 6-1 describes each field in the test case. Table 6-1 Test Case Fields Test Case Field Parent Requirement Testable Requirement Associated Cybersecurity Framework Subcategories

Description Identifies the top-level requirement or the series of top-level requirements leading to the testable requirement Drives the definition of the remainder of the test case fields and specifies the capability to be evaluated Lists the NIST Cybersecurity Framework Subcategories addressed by the test case

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Test Case Field

Description

Description

Describes the objective of the test case

Associated Test Cases

In some instances, a test case may be based on the outcome of (an)other test case(s). For example, analysis-based test cases produce a result that is verifiable through various means (e.g., log entries, reports, and alerts).

Preconditions

The starting state of the test case. Preconditions indicate various starting-state items, such as a specific capability configuration required or specific protocol and content.

Procedure

The step-by-step actions required to implement the test case. A procedure may consist of a single sequence of steps or multiple sequences of steps (with delineation) to indicate variations in the test procedure.

Expected Results

The expected results for each variation in the test procedure

Actual Results

The observed results

6.1.1

PACS Functional Evaluation Requirements

Table 6-2 identifies the PACS functional evaluation requirements addressed in the test plan and associated test cases. The evaluations are aligned with the basic architecture design and capability requirements from Section 4, Architecture. Table 6-2 Functional Evaluation Requirements Capability Requirement (CR) ID

Parent Requirement

Subrequirement

Test Case

CR-1

Business workflows that support image acquisition and transfer to archival (e.g., PACS and VNA) are performed.

Sample Radiology Practice Workflows

PACS-1 PACS-11

CR-2

Asset and Inventory Management

CR-3

Enterprise Domain and Identity Management–Access Control

PACS-2

CR-3.a

Privileged Access Management

PACS-3 PACS-10

CR-3.b

User Authentication

PACS-3 PACS-4

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Capability Requirement (CR) ID

Parent Requirement

Subrequirement

Test Case

PACS-5 PACS-10 This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

CR-3.c

Device and System Authentication

PACS-3 PACS-4 PACS-5 PACS-11

CR-3.d

Data Access Control

PACS-3 PACS-5

CR-4.a

Network Segmentation and VLANs

PACS-7

CR-4.b

Firewall and Control Policies

PACS-7

CR-4.c

Microsegmentation

PACS-4

CR-4.d

Anomalies and Events Detection (Behavioral Analytics)

PACS-8

CR-4.e

Intrusion Detection and Prevention

PACS-9

CR-5.a

Device Hardening and Configuration

PACS-9

CR-5.b

Malware Detection and Prevention

PACS-9

In-Transit Encryption

PACS-4 PACS-5 PACS-12

Remote Access

PACS-10

CR-4

CR-5

CR-6

Network Control and Security

Endpoint Protection and Security

Data Security

CR-6.a CR-7

6.1.2

Remote Access

Test Case: PACS-1

Parent Requirement

(CR-1) Business workflows that support image acquisition and transfer to archival (e.g., PACS and VNA) are performed.

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Testable Requirement

(CR-1) Sample Radiology Practice Workflows

Description

Demonstrate that the installed PACS can be used to acquire images from a simulated modality, store those images based on department, and view those images by using a DICOM viewer.

Associated Test Case

N/A

Associated Cybersecurity Framework Subcategories

N/A

Preconditions

 Implement PACS architecture, and test that network connections are operational.  Configure DICOM communication between DVTk RIS Emulator and DVTk Modality Emulator.  Load patient studies into the RIS.  Configure DICOM communication between DVTk Modality Emulator and the PACS.  Configure the DICOM viewer to connect to the PACS archiving system.  Provision and give proper permissions to user accounts.

Procedure

1. Start the DVTk RIS simulator. 2. Start the Modality Emulator. 3. Click the Request Worklist button on the Modality Emulator to display the RIS’ preinstalled patient studies. 4. Select one of the Patient Names from the given list. 5. Click the enabled Store Image button to send the images for the selected patient to the connected PACS server. 6. To verify the archived images stored in the Philips PACS server, run Explorer as a Manager. 7. Log in to the client web by using the URL https://192.168.140.131/clientweb. (Alternatively, use a thin client Philips IntelliSpace PACS Enterprise to verify the archived images.) 8. From the Folder List > Exam Lookup, click the Search button to list the patient studies. The image for the patient selected in this test should be listed in the exam lookup view table.

Expected Results

 The user should be able to display the image by using the Philips Client Web or the Philips PACS Enterprise client. Note: If you need to repeat the same procedure using the same samples, clear the stored image from the Philips PACS. The cleared

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image stored in the Default folder will be moved to the Exceptions Lookup folder. Clear the image from the Exceptions Lookup folder as well. Actual Results This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

6.1.3

The implemented PACS environment successfully scheduled images by using the RIS, sent and stored the images in the PACS using the modality, and viewed the stored images using a web client.

Test Case: PACS-2

Parent Requirement

(CR-2) Asset and Inventory Management

Testable Requirement

(CR-2) Asset and Inventory Management

Description

Demonstrate how to identify and manage medical assets.

Associated Test Case

N/A

Associated Cybersecurity Framework Subcategories

ID.AM-1, ID.AM-2, ID.AM-4, ID.AM-5, ID.RA-1, ID.RA-5, PR.IP-1

Preconditions

 PACS network infrastructure is operational.  Virta Labs BlueFlow is deployed in the Security Services VLAN.  Network groups are created in the BlueFlow interface to allow automatic organization of discovered devices.

Procedure

1. Open a web browser, navigate to the Virta Labs BlueFlow web portal URL, and authenticate to the portal. 2. Navigate to Connectors > Discovery. 3. Enter a subnet range (192.168.0.0/16) from which BlueFlow will discover devices. 4. Click Run and allow the discovery process to populate a network group. 5. Navigate to Inventory. Under Networks, click a network object, and display a list of discovered devices. 6. Click a device name, navigate to the Tools tab, and click Fingerprint. 7. Verify the populated information and click Run to perform a scan. 8. Once the scan is complete, navigate back to the device’s information page, and verify that the fingerprint tool has accurately identified information about the device such as operating system and Open TCP Ports. 9. Manually fill in other information about the device if needed.

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Expected Results

 Devices are discovered within the specified subnets and appear as devices in the network group.  The fingerprint tool identifies device operating system and open transmission control protocol (TCP)ports.  Device information can be modified manually.

Actual Results

More than 20 new devices were discovered within the PACS VLANs. These new devices were placed automatically into predefined network segments, and devices that did not fit into a predefined network segment were placed into an Other Assets category. The fingerprint tool populated descriptive information for several discovered devices while all other necessary information was filled in manually.

6.1.4

Test Case: PACS-3

Parent Requirement

(CR-3) Enterprise Domain and Identity Management–Access Control

Testable Requirement

(CR-3.a) Privileged Access Management, (CR-3.b) User Authentication, (CR-3.c) Device and System Authentication, (CR-3.d) Data Access Control

Description

Demonstrate the capability authentication to the PACS application by using enterprise active directory (AD).

Associated Test Case

N/A

Associated Cybersecurity Framework Subcategories

PR.AC-1, PR.AC-4, PR.AC-7  

Preconditions

 

Domain controller has been deployed and configured in the Enterprise Services VLAN. The Philips PACS has been configured to incorporate the enterprise AD with a display name of AD PACS. Domain groups have been created and assigned proper policies and roles. A test user with username pacs-user has been set up in the test AD PACS.

Procedure

1. Launch the IntelliSpace PACS application on the IntelliSpace PACS Enterprise server. 2. To set the authentication source, select AD PACS from the Log on to drop-down list. 3. Enter the username and password, and then click the login button to login.

Expected Results

 

Authentication via AD PACS is successful. Access to patient data is based on group policy settings.

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Actual Results

A PACS-user, who is in the AD, was used to test the access setup. After entering the username and the correct password to the Philips IntelliSpace PACS Enterprise login page by using the AD PACS as the authentication source, the login was successful. The PACS-user account was validated to assure that appropriate access control settings were applied.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

PACS-user authentication was further tested, first by entering an incorrect password and next by incorrectly spelling the username. These attempts failed.

6.1.5

Test Case: PACS-4

Parent Requirement

(CR-4) Network Control and Security (CR-6) Data Security

Testable Requirement

(CR-4.c) Microsegmentation, (CR-6.a) In-Transit Encryption

Description

Demonstrate secure transfer of medical images from modalities to archive systems by using microsegmentation.

Associated Test Case

PACS-3

Associated Cybersecurity Framework Subcategories

PR.DS-2, PR.PT-1, PR.PT-3, PR.PT-4

Preconditions

 Deploy and configure microsegmentation into the network infrastructure.  Install, configure, and deploy modalities.  Configure network connections between RIS and modalities to establish a DICOM connection.  Configure network connections between modalities and PACS to establish a DICOM connection.  Populate RIS with simulated patient studies.  Install and configure a network traffic analyzer.

Procedure

To schedule radiology patient studies with the DVTk Modality Emulator 1. Launch the RIS Emulator desktop application and click the Start button to open a DICOM connection with the Modality Emulator. 2. Using the Modality Emulator, click the Request Worklist button to display a list of requested patient studies being sent from the RIS. 3. Select a requested patient study from the list to send to the Philips PACS server.

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

To store patient studies on the Philips PACS server by using DVTk Modality Emulator 1. Click the Store Images button to send the selected patient study to the Philips PACS. To verify that data are encrypted between the modality and the PACS 1. Start a packet capture with Cisco Firepower between the HIPswitches associated with the modality and the PACS, respectively. A new window will appear with attribute text boxes. For the Source Host, provide the IP address of the modality’s HIPswitch. For the Destination Host, provide the IP address of the PACS HIPswitch. 2. Export the produced packet captures to a packet capture (PCAP) file. 3. Import the PCAP file into Wireshark and try to read the data captured.

Expected Results

 RIS establishes a DICOM connection with the modality to schedule patient studies.  DICOM communications channel is established between modalities and the PACS.  Modality Emulator can send patient studies to the PACS.  In-transit data are encrypted.

Actual Results

The RIS, Modality, and the PACS succeeded in establishing DICOM connections after microsegmentation was implemented. Data being transferred from Modality to the PACS was encrypted through the secured connection.

6.1.6

Test Case: PACS-5

Parent Requirement

(CR-3) Enterprise Domain and Identity Management–Access Control (CR-6) Data Security

Testable Requirement

(CR-3.b) User Authentication, (CR-3.c) Device and System Authentication, (CR-3.d) Data Access Control, (CR-6.a) In-Transit Encryption

Description

Show how clinical departments have access to only their department’s medical images and show that an encrypted connection is used when clinical departments are accessing medical images.

Associated Test Case

PACS-3

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Associated Cybersecurity Framework Subcategories

PR.AC-1, PR.AC-4, PR.AC-7, PR.DS-2, PR.PT-1, PR.PT-3, PR.PT-4 Define different clinical departments (e.g., radiology, cardiology, and dermatology).  Create role-based access control by assigning user accounts to clinical departments.  Configure and enable TLS connections on the PACS and VNA.  Patient records for multiple departments are stored on the VNA. To transfer patient studies from the Philips PACS server to the radiology user group on the Hyland VNA server 1. Log in to the Philips PACS to view stored patient records. 2. Start a packet capture on Cisco Firepower on the PACS A interface. A new window will appear with attribute text boxes. For the Source Host, provide the IP address of the PACS. For the Destination Host, provide the IP address of the VNA. 3. Select a patient study to send to Hyland VNA to be stored in the radiology department. 4. Export the selected patient study to the radiology department on the Hyland VNA. To confirm that Hyland VNA user accounts can access only approved departments 5. Log in to the Hyland VNA by using credentials with access to the radiology department’s patient records. 6. Verify that the patient study sent in the steps above is shown. To evaluate TLS connection from the Philips PACS to Hyland VNA 7. Export the produced packet captures in step 2 to a PCAP file. 8. Import the PCAP file into Wireshark and try to read the captured data. 9. Verify that the PACS applies encryption to data in-transit and is unreadable. 

Preconditions This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Procedure

 Expected Results

 

Actual Results

The PACS transfers patient studies to a specific department group on an archiving system. User accounts on the archiving system are restricted to view records to assigned department. Data transfers from the PACS to the VNA are encrypted through TLS communication.

PACS was able to securely transfer patient studies by using TLS encryption to the radiology group on the archiving system. User

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accounts with access to view radiology patient studies were able to access only studies linked to the radiology department.

6.1.7

Test Case: PACS-6

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Parent Requirement

(CR-3) Enterprise Domain and Identity Management–Access Control (CR-6) Data Security

Testable Requirement

(CR-3.b) User Authentication, (CR-3.c) Device and System Authentication, (CR-6.a) In-Transit Encryption

Description

Show how to securely review archived medical images.

Associated Test Case

PACS-3

Associated Cybersecurity Framework Subcategories

PR.AC-1, PR.AC-4, PR.AC-7, PR.DS-2, PR.PT-1, PR.PT-3, PR.PT-4  

Preconditions

Procedure

Enable https connections on a web server and outside web browser. Configure DICOM image web viewer to connect to outside web browser. Define different clinical departments (e.g., radiology, cardiology, and dermatology), and create user accounts to correspond to clinicians who may work in those departments. Create role-based access-control by assigning user accounts to clinical departments.

To authenticate as a radiology user and securely view patient studies for radiology department on the VNA 1. Access Hyland NilRead on a web browser by using https (https://<ip address of NilRead Viewer>). 2. Start a packet capture on Cisco Firepower on the Clinical Viewers interface. A new window will appear with attribute text boxes. For the Source Host, provide the IP address of the web viewer. For the Destination Host, provide the IP address of the client computer accessing the PACS viewer through a web browser. 3. Log in to the viewer as a radiology user. 4. Click the patient study record stored from Test Case 4 and verify that the viewer is using https when displaying patient images. To evaluate encrypted data transfers from Hyland VNA to Hyland NilRead Viewer 5. Export the produced packet captures in step 2 to a PCAP file.

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6. Import the PCAP file into Wireshark and try to read the data captured. 7. Verify that the VNA applies encryption to data in-transit and is unreadable.  Expected Results This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Actual Results

6.1.8

DICOM image web viewer should be accessible and display patient images using https. Data sent from an archiving server to the DICOM image web viewer should be encrypted.

Web viewer securely connected to the archiving server and transmitted patient images to a client computer over https.

Test Case: PACS-7

Parent Requirement

(CR-4) Network Control and Security

Testable Requirement

(CR-4.a) Network Segmentation and VLANs, (CR-4.b) Firewall, and Control Policies

Description

Demonstrate network segmentation and routing between VLANs within the PACS architecture by restricting guest network access.

Associated Test Case

N/A

Associated Cybersecurity Framework Subcategories

PR.AC-5, PR.PT-1, PR.PT-3, PR.PT-4     

Preconditions

 Procedure

Domain controller is deployed and configured in the Enterprise Services VLAN. Windows computer is deployed to the guest network. Cisco FTD interfaces are configured. Cisco Firepower access control policy, with a default action of Block All Traffic, is created and applied to the Cisco FTD Appliance. Cisco Firepower access control policy is configured with the following access control rules: • Allow dynamic host configuration protocol (DHCP) traffic from Guest network to Domain Controller. • Allow DNS traffic from Guest network to Domain Controller. • Allow http and https traffic from Guest network to wide area network (WAN) interface. DHCP relay is configured on the Guest network interface through Firepower Management Center.

To test that DHCP services are available for Guest network 1. Power on Windows computer on the Guest network and log in.

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2. Right-click the Windows Start button and select Network Connections. 3. Right-click the network interface connected to the Guest network and select Properties. 4. Click Internet Protocol Version 4 (TCP/IPv4), click Properties, select Obtain an IP address automatically, then click OK. 5. Run the Command Prompt from the Windows Start button. 6. At the command line, type ipconfig /all 7. Ensure the DHCP Enabled is set to Yes. 8. Ensure the IPv4 Address, Subnet Mask, Default Gateway, and DHCP Server are populated according to your DHCP settings. To test that DNS services are available for Guest network 1. Right-click the Windows Start button and select Network Connections. 2. Right-click the network interface connected to the Guest network and select Properties. 3. Click Internet Protocol Version 4 (TCP/IPv4) and click Properties. Select Obtain the DNS server address automatically and click OK. 4. Run the Command Prompt from the Windows Start button. 5. At the command line, type ipconfig /all 6. Ensure the DNS Server is populated according to your DHCP settings. 7. At the command line, type nslookup 8. Verify that the Default Address and Address are populated with the correct DNS server. 9. At the prompt, type a URL (nist.gov) and ensure that an IP address (129.6.13.49) is returned by the DNS server. To test that traffic from Guest network to internal VLANs is blocked 1. Open a web browser from the Windows computer connected to the Guest network. 2. Type into the address bar an IP address (192.168.140.131) that corresponds to a PACS web server from one of the internal PACS VLANs. The web browser should not be able to retrieve the web page. 3. Right-click on the Windows Start button and select Command Prompt. At the command line, attempt to ping the VNA server from one of the internal PACS VLANs by typing ping 192.168.130.120

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

4. Ensure command prompt returns Request timed out and no packets are received. To test that only web traffic from Guest network to the WAN is allowed 1. Open a web browser from the Windows computer connected to the Guest network. 2. Type a URL (https://www.nist.gov/) into the address bar. 3. Wait for website to load properly. 4. Right-click the Windows Start button and select Command Prompt. 5. At the command line, attempt to ping an external web server by typing ping nist.gov 6. Ensure the command prompt returns Request timed out and no packets are received. Computers with interfaces connected to the Guest network will automatically be provisioned an IPv4 address.  Computers with interfaces connected to the Guest network will automatically be provisioned a DNS server address.  All traffic, excluding the exceptions for DNS and DHCP, originating from the Guest network and destined for any internal PACS VLAN will be blocked.  http and https traffic originating from the Guest network and destined for the WAN interface will be allowed. Upon booting up for the first time, the Windows computer on the Guest network was allocated an IPv4 address within the DHCP scope address pool and provisioned a DNS server address and was successfully able to resolve the IP address of a provided URL. The computer was not able to communicate with other devices in the internal PACS VLANs (192.168.140.131 and 192.168.130.120) using different network protocols (https and internet control message protocol) but was able to communicate with external web servers through a web browser using http and https. 

Expected Results

Actual Results

6.1.9

Test Case: PACS-8

Parent Requirement

(CR-4) Network Control and Security

Testable Requirement

(CR-4.d) Anomalies and Events Detection (Behavioral Analytics)

Description

Demonstrate the capability to detect abnormal network traffic across the PACS architecture.

Associated Test Case

PACS-7

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Associated Cybersecurity Framework Subcategories

DE.AE-1, DE.AE-2, DE.AE-3, DE.AE-5, DE.CM-1, DE.CM-3, and DE.CM-7

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Preconditions

 PACS architecture is implemented and network connections have been tested and are operational.  Zingbox Inspector is deployed and configured in the Security Services VLAN.  Virta Labs BlueFlow is deployed and configured in the Security Services VLAN.

Procedure

1. Open a web browser and navigate to the web portal of Virta Labs BlueFlow. 2. Enter credentials and log in. 3. Navigate to Connectors > Discovery. 4. Enter a subnet range (192.168.0.0/16) on which BlueFlow will run an IP scan. 5. Click Run and wait for the discovery process to finish. 6. Open a web browser and navigate to the web portal of Zingbox Cloud. 7. Enter credentials and log in. 8. Navigate to Alerts > Security Alerts. 9. Under Alerts, look for an alert named Suspicious internal IP scans and an alert type of scanner. 10. Expand the alert, hover over a subsection, and click View Details. 11. On the Alert Details page, verify that the client IP that the IP scans originated from corresponds to the BlueFlow device.

Expected Results

Actual Results

6.1.10

Zingbox correctly identifies BlueFlow’s IP scan and creates a security alert for suspicious activity. Zingbox identified BlueFlow’s IP scan as suspicious activity and created a security alert. Zingbox also created a security alert the second time a BlueFlow IP scan was run but stopped creating alerts for subsequent IP scans from the BlueFlow device. While the BlueFlow scan was approved and not malicious, this type of scanning can be performed by malicious devices attempting to discover devices on the network. 

Test Case: PACS-9

Parent Requirement

(CR-4) Network Control and Security (CR-5) Endpoint Protection and Security

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Testable Requirement

(CR-4.e) Intrusion Detection and Prevention, (CR-5.a) Device Hardening and Configuration, (CR-5.b) Malware Detection and Prevention

Description

Demonstrate the capability to detect threats affecting PACS servers and related end points. This test also demonstrates an intrusion detection capability.

Associated Test Case

N/A

Associated Cybersecurity Framework Subcategories

DE.CM-1, DE.CM-4, PR.PT-1, PR.PT-3, PR.PT-4 PACS architecture is implemented and network connections have been tested and are operational.  Symantec Endpoint Protection appliance is deployed and configured in the Security Services VLAN.  Symantec Endpoint Protection agent is installed on an end point.  The endpoint agent is connected to the Symantec Endpoint Protection Manager. To verify that the endpoint agent is connected to the SEP management server 1. Log in to the SEP management console (https://192.168.190.172:8443/console/apps/sepm), click Clients, and select the target group (e.g., PACS). 2. Click the Client tab in the PACS group to list the client information in a table. 3. The endpoint is listed under the Name column with a Health State of online. To verify that the endpoint receives the current policy updates 1. Navigate to the Client tab in the SEP management console. 2. The policy serial number should match the serial number of the endpoint found at Help > Troubleshooting in the endpoint agent. To verify that the proper protections are enforced on the endpoint 1. Navigate to the Client tab in the SEP management console. 2. In the PACS group, change the drop-down list selection to Protection Technology, and review the protection categories status (enabled or disabled). To add a System Lockdown policy to prevent unwanted applications from running 1. Enable the System Lockdown policy from the parent group of PACS. 2. Select the Blacklist Mode, add a test application (e.g., 7zFM.exe) to the list, and save the policy. 

Preconditions

Procedure

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

3. From the end point, click the Symantec shield icon, and click Update Policy. To verify that the virus and spyware protection policy works 1. Use a browser on the end point to download an anti-virus test file from the EICAR website (https://www.eicar.org/). 2. Click the image labeled DOWNLOAD ANTI MALWARE TESTFILE. 3. Click the eicar.com link under Download area using the secure, SSL enabled protocol https. 4. A Symantec notification will appear, informing you that a risk is found. Expected Results

Actual Results

Files added to this list are not allowed to be run. Linking to the test virus file will lead to a warning, and the threat should be locked. Prior to the lockdown policy enforcement, the 7zFM.exe file and 7zFM file manager console were able to run on the end point. After the lockdown policy enforcement, the 7zFM.exe file was not able to run, and a warning message appeared stating, “Windows cannot access the specified device, path, or file. You may not have the appropriate permissions to access the item.”  

When accessing the malware test file, the following message appeared: “Symantec Endpoint Protection [SID:24461] Diagnostic: EICAR Standard Anti-Virus Test File detected, Symantec Service Framework.”

6.1.11

Test Case: PACS-10

Parent Requirement

(CR-3) Enterprise Domain and Identity Management–Access Control (CR-7) Remote Access

Testable Requirement

(CR-3.a) Privileged Access Management, (CR-3.b) User Authentication

Description

Demonstrate the capability to provide controlled remote access to PACS using two-factor authentication.

Associated Test Case

PACS-3

Associated Cybersecurity Framework Subcategories

PR.AC-3 

Preconditions

TDi Technology ConsoleWorks is installed and configured to use active directory for username and password authentication. Proper access control rules, tags, and profiles are defined to allow access to necessary resources.

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User accounts for remote access are set up and linked to profiles set for each remote user who needs to access the PACS servers.  Symantec VIP Enterprise Gateway is installed and integrated with ConsoleWorks by using the RADIUS connection.  To supplement standard username/password logins on a variety of servers and services, the VIP Access mobile phone application is installed, and a credential ID has been acquired from Symantec for receiving time-sensitive tokens.  Test user credentials are registered in the VIP manager and associated to the account. To verify that username/password are not sufficient to log in 1. Use a web browser to connect to the TDi console (https://192.168.1.4:5176) and log in with username/password. 2. Verify that the login is unsuccessful. To verify the two-factor authentication using username/password with a VIP token 1. Use a browser to connect to the TDi console: (https://192.168.1.4:5176). 2. Open the VIP Access mobile phone application. It should display a security code with a valid time duration. 3. Log in to the TDi console with username/password followed by the VIP security token found in the mobile phone application. To verify that the user can access only the granted resources 1. Select the Graphical menu to open a Graphical View. 2. Check the list of graphical connections to ensure that only allowed connections are visible. 3. Check each of the graphical connections by clicking Connect and verifying that the console properly connects. 

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Procedure

Logging in to the TDi console with a valid username/password without a 2FA token should fail with the message “Invalid User Credentials.”  Logging in to the TDi console with a valid username/password with valid 2FA token should be successful.  Authenticated user should have access to the list of approved graphical connections and should be able to connect to these servers. Using a pre-created Hyland user as an example, the first attempt to log in to the TDi console with only a username and password failed. The second attempt to log in, this time with a 2FA token, was successful. 

Expected Results

Actual Results

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From the dashboard, the Graphical View menu was opened, and only approved graphical connections that were visible to the Hyland user (e.g., Hyland VNA, Hyland Database). The user was able to connect to these remote servers and authenticate with a Hyland service account.

6.1.12 Test Case: PACS-11 This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Parent Requirement Testable Requirement Description Associated Test Case Associated Cybersecurity Framework Subcategories

(CR-1) Business workflows that support image archiving and retrieving from archival (e.g., PACS and VNA) are performed. (CR-3) Enterprise Domain and Identity Management–Access Control (CR-1) Sample Radiology Practice Workflows, (CR-3.c) Device and System Authentication Demonstrate that the installed PACS and the VNA system can connect to a dedicated remote cloud storage server to archive patient images. PACS-1 PR.AC-1, PR.AC-7 PACS-1 test case produces successful results that prove the PACS created patient studies and the VNA stored the studies.  A Microsoft Azure storage account exists.  The VNA contains a Microsoft Azure storage archive device instance.  The VNA radiology storage application connects to the VNA Azure Archive device. 1. Log in to the Hyland VNA Acuo Admin Portal. 2. Navigate to Storage Management > Archive Devices. 3. Add a New Azure Archive Device. 4. Enter Microsoft Azure account information provided after creating a storage blob for the VNA (e.g., Account Name, Account Key) 5. Click Test Connection. 6. Change a few characters in the Account Key. 7. Click Test Connection. To identify when images should be archived in the Azure cloud storage for testing purposes 8. Log in to Hyland Acuo Admin Portal. 9. Navigate to Storage Applications > RADIOLOGY. 10. Click Azure Archive Device. 11. Set the parameters for when the VNA should store patient studies in Microsoft Azure for archival. For testing purposes, set all parameters to 0. 12. Check Write files to archive. To identify how long images should stay in the cache for testing purposes 

Preconditions

Procedure

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Expected Results

Actual Results

13. Log in to Hyland Acuo Admin Portal. 14. Navigate to Storage Applications > RADIOLOGY. 15. Click Edit Cache Cleaner Configuration. 16. Set the parameters for how long the VNA should retain patient studies in the cache. For testing purposes, keep patient studies in the cache for 3 days. 17. Check Verify Archive Location Before Removing from Image Cache. To store images in Microsoft Azure Cloud Storage 18. Log in to the PACS server. 19. Select a patient study to send to Hyland VNA to store in the radiology department. 20. Export the selected patient study to the radiology department on the Hyland VNA. 21. The VNA will receive the patient study and automatically send the patient study to Microsoft Azure. To retrieve images stored in Microsoft Azure Cloud Storage 22. Log in to NilRead and verify that the patient study stored is accessible. 23. Open the patient study. 24. Verify the study retrieval from cloud storage by evaluating metadata stored in the underlying database. To retrieve images stored in VNA Cache 25. Log in to NilRead and verify that the patient study stored is accessible. 26. Open the patient study. 27. Verify the study retrieval from cache by evaluating metadata stored in the underlying database.  Hyland Acuo VNA should automatically store patient studies in Microsoft Azure within the time frame identified.  VNA should retain studies in the cache for the time frame identified.  The user should be able to retrieve images stored in Microsoft Azure cloud storage or the VNA’s cache. Microsoft Azure successfully received and stored a patient study in the dedicated storage blob. Users were able to retrieve the study stored in the cloud instance and in the VNA’s cache.

6.1.13 Test Case: PACS-12 Parent Requirement Testable Requirement Description

(CR-6) Data Security (CR-6.a) In-Transit Encryption Demonstrate secure transfer of medical images from VNA to Remote Cloud Storage using TLS.

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Associated Test Case Associated Cybersecurity Framework Subcategories

N/A PR.DS-2, PR.PT-4 VNA and Microsoft Azure can communicate with each other. Microsoft Azure cloud storage instance is associated with the VNA’s radiology department.  PACS server contains simulated patient studies.  A network traffic analyzer is set up to evaluate packet transfers between the VNA and Microsoft Azure. 1. Log in to the PACS server. 2. Select a patient study to send to Hyland VNA to store in the radiology department. 3. Export the selected patient study to the radiology department on the Hyland VNA. 4. Start a packet capture on Cisco Firepower on the PACS A interface. A new window will appear with attribute text boxes. For the Source Host, provide the IP address of the VNA. For the Destination Host, provide the IP address of the cloud storage blob. 5. The VNA will receive the patient study and automatically store the patient study to Microsoft Azure. 6. Export the packet captures produced from step 4 to a PCAP file. 7. Import the PCAP file into Wireshark and try to read the data captured. 8. Verify that the VNA applies encryption to data in-transit and is unreadable.  VNA utilizes TLS encryption for data transfers from the VNA to a Microsoft Azure cloud storage blob. VNA was able to securely transfer patient studies by using TLS encryption to the Microsoft Azure storage blob.  

Preconditions This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Procedure

Expected Results Actual Results

7 Future Build Considerations The healthcare landscape continues to evolve as industry develops and adopts new technologies and services. In the medical imaging ecosystem, one such new development is the use of cloud-based enterprise imaging solutions. These solutions can help ensure data security in the event of a disaster, increase patient access to their own data, and improve efficiencies within the HDO. However, cloudbased enterprise imaging solutions may introduce new cybersecurity risks. An update to this practice guide could review the implications and potentially improve the cybersecurity of cloud-based enterprise imaging solutions.

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Appendix A

List of Acronyms

2FA

Two-Factor Authentication

AES

Advanced Encryption Standard

AD

Active Directory

ARP

Address Resolution Protocol

AV

Anti-Virus

CIA

Confidentiality, Integrity, and Availability

CT

Computed Tomography

DHCP

Dynamic Host Configuration Protocol

DICOM

Digital Imaging and Communications in Medicine

DNS

Domain Name System

DoS

Denial of Service

EHR

Electronic Health Record

FDA

Food and Drug Administration

FIM

File Integrity Monitoring

FTD

Firepower Threat Defense

GRC

Governance, Risk, and Compliance

HDO

Healthcare Delivery Organization

HIP

Host Identity Protocol

HIPAA

Health Insurance Portability and Accountability Act

HIPS

Host Intrusion Prevention System

HIS

Health Information System

HL7

Health Level 7

HTM

Healthcare Technology Management

http

Hypertext Transfer Protocol

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https

Hypertext Transfer Protocol Secure

IDN

Identity Defined Networking

IDS

Intrusion Detection System

IEC

International Electrotechnical Commission

IETF

Internet Engineering Task Force

IHE

Integrating the Health Enterprise

IoT

Internet of Things

IPSec

Internet Protocol Security

IT

Information Technology

MAC

Media Access Control

MFA

Multifactor Authentication

MRI

Magnetic Resonance Imaging

NCCoE

National Cybersecurity Center of Excellence

NGFW

Next Generation Firewall

NIST

National Institute of Standards and Technology

PaaS

Platform as a Service

PACS

Picture Archiving and Communication System(s)

PAM

Privileged Access Management

PCAP

Packet Capture

PET

Positron Emission Tomography

PHI

Protected Health Information

PKI

Public Key Infrastructure

RADIUS

Remote Authentication Dial-In User Service

RBAC

Role Based Access Control

RIS

Radiology Information System

RMF

Risk Management Framework

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RSA

Rivest-Shamir-Adleman

SDN

Software Defined Networking

SP

Special Publication

SSE

Systems Security Engineering

SSL/TLS

Secure Socket Layer/Transport Layer Security

TCP/IP

Transmission Control Protocol/Internet Protocol

URL

Uniform Resource Locator

VIP

Validation and ID Protection

VLAN

Virtual Local Area Network

VNA

Vendor Neutral Archive

VPN

Virtual Private Network

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Appendix B

References

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

[1]

Food and Drug Administration, “Display Devices for Diagnostic Radiology, Guidance for Industry and Food and Drug Administration Staff,” Oct. 2, 2017. Available: https://www.fda.gov/media/95527/download.

[2]

National Electrical Manufacturers Association, PS3.1: DICOM PS3.1 2020c Introduction and Overview, 2018. Available: http:/dicom.nema.org/medical/dicom/current/output/pdf/part01.pdf.

[3]

DICOM. Digital Imaging and Communications in Medicine. Available: https://dicomstandard.org.

[4]

Radiology Technical Framework. Integrating the Healthcare Enterprise. Available: http://www.ihe.net/Technical_Frameworks/#radiology.

[5]

R. Ross et al., Systems Security Engineering: Considerations for a Multidisciplinary Approach in the Engineering of Trustworthy Secure Systems, National Institute of Standards and Technology (NIST) Special Publication (SP) 800-160 Volume 1, NIST, Gaithersburg, Md., Nov. 2016. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-160v1.pdf.

[6]

R. Ross et al., Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations, NIST SP 800-171 Revision 2, NIST, Gaithersburg, Md., Feb. 2020. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-171r2.pdf.

[7]

R. Petersen et al., Workforce Framework for Cybersecurity (NICE Framework), NIST SP 800-181 Revision 1, NIST, Gaithersburg, Md., Nov. 2020. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-181r1.pdf.

[8]

Framework for Improving Critical Infrastructure Cybersecurity, Version 1.1, NIST, Gaithersburg, Md., Apr. 16, 2018. Available: https://nvlpubs.nist.gov/nistpubs/CSWP/NIST.CSWP.04162018.pdf.

[9]

NIST. Risk Management Framework: Quick Start Guides. Available: https://csrc.nist.gov/projects/risk-management/risk-management-framework-quick-startguides.

[10] Joint Task Force Transformation Initiative, Guide for Conducting Risk Assessments, NIST SP 80030 Revision 1, NIST, Gaithersburg, Md., Sept. 2012. Available: https://nvlpubs.nist.gov/nistpubs/Legacy/SP/nistspecialpublication800-30r1.pdf.

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[11]

Joint Task Force Transformation Initiative, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, NIST SP 80037 Revision 2, NIST, Gaithersburg, Md., Dec. 2018. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-37r2.pdf.

[12]

NIST. Computer Security Resource Center. Available: https://csrc.nist.gov/glossary/term/confidentiality_integrity_availability.

[13]

National Cybersecurity Center of Excellence, Securing Picture Archiving and Communication System (PACS) Project Description, NIST, Gaithersburg, Md., Jan. 2018. Available: https://www.nccoe.nist.gov/sites/default/files/library/project-descriptions/hit-pacs-projectdescription-final.pdf.

[14]

Health Level 7 International. Introduction to HL7 Standards. Available: http://www.hl7.org/implement/standards/index.cfm?ref=nav.

[15]

Joint Task Force Transformation Initiative, Security and Privacy Controls for Federal Information Systems and Organizations, NIST SP 800-53 Revision 4, NIST, Gaithersburg, Md., Apr. 2013. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf.

[16]

International Electrotechnical Commission (IEC) Technical Report (TR) 80001-2-2, Edition 1.0 2012-07, “Application of risk management for IT networks incorporating medical devices–Part 22: Guidance for the disclosure and communication of medical device security needs, risks and controls.”

[17]

U.S. Department of Health and Human Services Office for Civil Rights, HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework, Feb. 2016. Available: https://www.hhs.gov/sites/default/files/nist-csf-to-hipaa-security-rule-crosswalk-02-22-2016final.pdf.

[18]

International Organization for Standardization/International Electrotechnical Commission, “Information technology–Security techniques–Information security management systems– Requirements,” ISO/IEC 27001:2013, 2013.

[19]

Picture archiving and communications system, §892.2050, July 2020. Available: https://www.ecfr.gov/cgi-bin/textidx?SID=126d1713c9a312989c2173a5bdd4aaae&mc=true&node=se21.8.892_12050&rgn=div8.

[20]

Health Level 7 International. Clinical Document Architecture (CDA®) Release 2. Available: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=7.

[21]

G. O’Brien et al., Securing Wireless Infusion Pumps in Healthcare Delivery Organizations, NIST SP 1800-8, NIST, Gaithersburg, Md., Aug. 2018. Available: https://www.nccoe.nist.gov/sites/default/files/library/sp1800/hit-wip-nist-sp1800-8.pdf.

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[22]

American National Standards Institute /Association for the Advancement of Medical Instrumentation /IEC 80001-1:2010, “Application of risk management for IT networks incorporating medical devices–Part 1: Roles, responsibilities and activities.”

[23]

IEC TR 80001-2-1, Edition 1.0 2012-07, “Application of risk management for IT-networks incorporating medical devices–Part 2-1: Step-by-step risk management of medical IT-networks– Practical applications and examples.”

[24]

K. Waltermire et al., Privileged Account Management for the Financial Services Sector, NIST SP 1800-18, NIST, Gaithersburg, Md., Sept. 2018. Available: https://www.nccoe.nist.gov/sites/default/files/library/sp1800/fs-pam-nist-sp1800-18-draft.pdf.

[25]

NIST. “Easy Ways to Build a Better P@$5w0rd. Available: https://www.nist.gov/blogs/takingmeasure/easy-ways-build-better-p5w0rd.

[26]

M. Grassi et al., Digital Identity Guidelines, NIST SP 800-63-3, NIST, Gaithersburg, Md., June 2017. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-3.pdf.

[27]

R. Moskowitz and P. Nikander, Host Identity Protocol (HIP) Architecture, Request for Comments 4423, May 2006. Available: https://tools.ietf.org/html/rfc4423.

[28]

E. Barker et al., Recommendation for Key-Derivation Methods in Key-Establishment Schemes, NIST SP 800-56C Revision 1, NIST, Gaithersburg, Md., Apr. 2018. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-56Cr1.pdf.

[29]

U.S. Department of Commerce, Advanced Encryption Standard (AES), NIST Federal Information Processing Standard Publication 197, Nov. 26, 2001. Available: https://csrc.nist.gov/csrc/media/publications/fips/197/final/documents/fips-197.pdf.

[30]

K. Scarfone and P. Mell, Guide to Intrusion Detection and Prevention Systems (IDPS) (Draft), NIST SP 800-94 Revision 1 (Draft), NIST, Gaithersburg, Md., July 2012. Available: https://csrc.nist.gov/CSRC/media/Publications/sp/800-94/rev-1/draft/documents/draft_sp80094-rev1.pdf.

[31]

Microsoft, Azure Data Encryption-at-Rest, Apr. 2020. Available: https://docs.microsoft.com/enus/azure/security/fundamentals/encryption-atrest.

[32]

T. McBride et al., Data Integrity: Recovering from Ransomware and Other Destructive Events, NIST SP 1800-11, NIST, Gaithersburg, Md., Sept. 2017. Available: https://www.nccoe.nist.gov/publication/1800-11/index.html.

[33]

U.S. Department of Homeland Security, Cybersecurity & Infrastructure Security Agency. SMB Security Best Practices. Available: https://www.us-cert.gov/ncas/currentactivity/2017/01/16/SMB-Security-Best-Practices.

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[34]

P. Grassi et al., Digital Identity Guidelines, NIST SP 800-63-3, NIST, Gaithersburg, Md., Jun. 2017. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-3.pdf.

[35]

K. McKay and D. Cooper, Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations, NIST SP 800-52 Revision 2, NIST, Gaithersburg, Md., Aug. 2019. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-52r2.pdf.

[36]

E. Barker et al., Guide to IPsec VPNs, NIST SP 800-77 Revision 1, NIST, Gaithersburg, Md., June 2020. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-77r1.pdf.

[37]

Securities and Exchange Commission, Public Company Accounting Oversight Board; Notice of Filing of Proposed Rule on Auditing Standard No. 5, An Audit of Internal Control Over Financial Reporting That is Integrated with an Audit of Financial Statements, and Related Independence Rule and Conforming Amendments. June 7, 2007. Available: https://www.sec.gov/rules/pcaob/2007/34-55876.pdf.

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Appendix C

Pervasive Versus Contextual Controls

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

This practice guide limits its scope to a defined boundary regarding scheduling, acquiring, using, and storing medical imaging and associated information for those images. Conceptually, this is bound in a medical imaging ecosystem and applies contextual controls to that ecosystem. Healthcare delivery organization (HDO) environments, however, feature greater complexity than this practice guide may address. That is, the medical imaging ecosystem resides within an enterprise infrastructure that should implement a pervasive set of controls. The project assumes that an HDO implements pervasive controls that may have material impact on mitigating the HDO’s overall cybersecurity risk profile, but the project did not implement in the lab build. Pervasive controls may be inherited by systems that operate within the HDO infrastructure, but coverage may not be absolute. Therefore, practitioners may implement contextual controls to address gaps or to augment pervasive control capabilities. Pervasive controls tend to be organizational in scope, although they may also apply to specific systems and network components within the organization. Pervasive controls may be technical or procedural in nature. The pervasive control concept is borrowed from auditing frameworks that discuss the use of entity controls that have varying degrees of effects that are pervasive or have a widespread effect across an entity or organization [37]. An analogy can help explain the pervasive control concept. An individual may live in a house or apartment, which exists in a neighborhood. That neighborhood may then be part of a town or a city. The town or city may include a number of services, such as police, fire, and rescue. The town or city (or through a third-party service) may also provide utilities, such as water and electricity, to its residents. Pervasive controls are those that, while available to the house or apartment, the occupant has not implemented or have direct control over. The house or apartment may have locks, alarms, or firesuppressant devices that the occupant installed or has direct control over. Those controls are contextual to the house or apartment. In this analogy, the medical imaging ecosystem is the house that resides in an HDO town or city. Pervasive control examples within HDOs include governance, risk, and compliance (GRC) systems that address a diverse range of functions needed to operate a cybersecurity strategy, including performance and management of enterprise risk, tracking information technology (IT) assets, incident response processes, IT disaster recovery and business continuity, and data loss prevention (DLP), which would prevent data exfiltration by using tools that are outside the picture archiving and communication system (PACS) and medical imaging ecosystem. This project implemented contextual controls pertinent to the medical imaging ecosystem and assumes implementation of pervasive controls across the enterprise. For purposes of this project, pervasive controls that we feel are material but are not implemented in the

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medical imaging ecosystem context pertinent to the immediate control environment of the laboratory’s PACS environment are noted in Table C-1 below. Table C-1 Pervasive Security Controls

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Cybersecurity Framework Subcategory

Description

Potential Implementation

ID.AM-1, ID.AM-2

ID.AM-1: Physical devices and systems within the organization are inventoried. ID.AM-2: Software platforms and applications within the organization are inventoried.

GRC suite that includes an asset management module. A potential tool that may address may be Clearwater Compliance IRM Analysis tool. The application of such tools would address IT general assets such as servers, workstations, and other components that may interact with the PACS environment but do not fall within the control environment established for this project. IT general assets may be managed by a centralized IT organization that is not directly involved in supporting or maintaining the PACS environment or medical imaging devices.

ID.RA-4, ID.RA-6

ID.RA-4: Potential business impacts and likelihoods are identified. ID-RA6: Risk responses are identified and periodized.

These two controls address enterprise risk management. ID.RA-4 may be addressed through implementing business impact assessments or enterprise risk assessments. ID.RA-6 considers the case where enterprise risk has been identified or where the HDO has determined that existing controls need to be enhanced or added. Those determinations are often documented in a Plan of Action and Milestones that describes tasks needing to be addressed, resources required, and milestone dates for realizing tasks. Typical control implementation to address ID.RA-4 and ID.RA-6 would include a GRC suite with an enterprise risk management module. The Clearwater Compliance IRM Analysis tool may be relevant as well.

PR.AC-2

PR.AC-2: Physical access to assets is managed and protected.

Server assets may be hosted in a data center with appropriate physical security and environmental controls.

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Cybersecurity Framework Subcategory

Description

Potential Implementation

PR.DS-5

PR.DS-5: Protections against data leaks are implemented.

This control addresses the possibility of data exfiltration and may consider options wherein clinical or other sensitive data are migrated outside the HDO perimeter by using email or web services. Typical controls to be deployed at the internet border may include DLP tools. An example tool may be the Symantec DLP solution.

PR.IP-6

PR.IP-6: Data is destroyed according to policy.

This control addresses the need to destroy data as appropriate should that data reach its end of life. PACS and VNA control mechanisms would address objects within their purview, but HDOs should look at pervasive mechanisms to address when data may reside on workstations, endpoint devices, or removable media. In addressing appropriate data destruction measures, HDOs should consult National Institute of Standards and Technology Special Publication 800-88 Rev. 1, Guidelines for Media Sanitation.

PR.IP-9 PR.IP-10

PR.IP-9: Response plans (Incident Response and Business Continuity) and recovery plans (Incident Recovery and Disaster Recovery) are in place and managed. PR.IP-10: Response and recovery plans are tested.

These controls pertain to enterprise response and recovery planning, including disaster recovery, and assurance that the plans are regularly tested. Incident response planning may be addressed in several different ways that include establishing an incident response team, capturing data regarding reported or detected security events, and remediating. Inclusive of establishing incident response procedures, organizations may consider developing “play books” that could consist of established procedures based on determining certain threat types that may require courses of action different from standard incident handling. Recovery plans, which may consist of business continuity plans, and disaster recovery plans should be established. Organizations may consider maintaining these plans, including establishing play

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Cybersecurity Framework Subcategory

Description

Potential Implementation books, as maintained out of band, e.g., in physical format or in mechanisms that provide assurance that the plans themselves are inaccessible in case of a security event.

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Management of such plans may be maintained in GRC suites that include modules designed to house such plans and establish regular testing schedules. RS.RP-1

Response plan is executed during or after an event.

Response plans may be managed through a GRC solution. Physical copies of response plans should be maintained to allow for potential system outages.

RC.RP-1

Recovery plan is executed during or after a cybersecurity incident.

Recovery plans may be managed through a GRC solution. Physical copies of recovery plans should be maintained to allow for potential system outages.

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Appendix D

Aligning Controls Based on Threats

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C/I/A

Threat Event

National Institute of Standards and Technology Cybersecurity Framework Mitigating Control

C

Abuse of credentials or insider threat

PROTECT (PR) Access Control User Identification and Authentication DETECT (DE) Anomalies and Events Detection Security Continuous Monitoring

C

Credential compromise

PROTECT (PR) Access Control User Identification and Authentication DETECT (DE) Anomalies and Events Detection Security Continuous Monitoring

C

Data exfiltration

PROTECT (PR) Data Security and Privacy Information Protection Processes and Procedures Protective Technology DETECT (DE) Anomalies and Events Detection Security Continuous Monitoring

I

Data-in-transit disruption

PROTECT (PR) Data Security and Privacy Communications and Network Security DETECT (DE) Anomalies and Events Detection Security Continuous Monitoring

I

Data alteration

PROTECT (PR) Access Control Data Security and Privacy

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C/I/A

Threat Event

National Institute of Standards and Technology Cybersecurity Framework Mitigating Control DETECT (DE) Anomalies and Events Detection Security Continuous Monitoring

I

Time synchronization

PROTECT (PR) Data Security and Privacy Maintenance Communications and Network Security DETECT (DE) Anomalies and Events Detection Security Continuous Monitoring

I

Introduction of malicious software

PROTECT (PR) Protective Technology DETECT (DE) Anomalies and Events Detection Security Continuous Monitoring

I

Unintended use of service

IDENTIFY (ID) ID.AM-2: Software platforms and applications within the organization are inventoried. PROTECT (PR) PR.PT-3: The principle of least functionality is incorporated by configuring systems to provide only essential capabilities. DETECT (DE) Security Continuous Monitoring

A

Data storage disruption

IDENTIFY (ID) ID.BE-5: Resilience requirements to support delivery of critical services are established for all operating states (e.g., under duress/attack, during recovery, during normal operations). PROTECT (PR)

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C/I/A

Threat Event

National Institute of Standards and Technology Cybersecurity Framework Mitigating Control Data Security and Privacy Information Protection Processes and Procedures Communications and Network Security PR.PT-5: Mechanisms (e.g., failsafe, load balancing, hot swap) are implemented to achieve resilience requirements in normal and adverse situations.

A

Network disruption

PROTECT (PR) Data Security and Privacy Communications and Network Security DETECT (DE) Anomalies and Events Detection Security Continuous Monitoring

A

Backup/recovery disruption

PROTECT (PR) Information Protection Processes and Procedures RECOVER (RC) Recovery and Restoration

A

Supply chain compromise

IDENTIFY (ID) ID.SC-5: Response and recovery planning and testing are conducted with suppliers and third-party providers.

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NIST SPECIAL PUBLICATION 1800-24C

Securing Picture Archiving and Communication System (PACS): Cybersecurity for the Healthcare Sector Volume C: How-To Guides

Jennifer Cawthra National Cybersecurity Center of Excellence National Institute of Standards and Technology

Bronwyn Hodges Kevin Littlefield Chris Peloquin Sue Wang Ryan Williams Kangmin Zheng The MITRE Corporation McLean, Virginia

December 2020 FINAL This publication is available free of charge from https://doi.org/10.6028/NIST.SP.1800-24 The first draft of this publication is available free of charge from https://www.nccoe.nist.gov/library/securing-picture-archiving-and-communication-system-nist-sp-180024-practice-guide

DISCLAIMER Certain commercial entities, equipment, products, or materials may be identified by name of company logo or other insignia in order to acknowledge their participation in this collaboration or to describe an experimental procedure or concept adequately. Such identification is not intended to imply special status or relationship with NIST or recommendation or endorsement by NIST or NCCoE; neither is it intended to imply that the entities, equipment, products, or materials are necessarily the best available for the purpose. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

National Institute of Standards and Technology Special Publication 1800-24C, Natl. Inst. Stand. Technol. Spec. Publ. 1800-24C, 255 pages, (December 2020), CODEN: NSPUE2

FEEDBACK As a private-public partnership, we are always seeking feedback on our practice guides. We are particularly interested in seeing how businesses apply NCCoE reference designs in the real world. If you have implemented the reference design, or have questions about applying it in your environment, please email us at hit_nccoe@nist.gov. All comments are subject to release under the Freedom of Information Act.

National Cybersecurity Center of Excellence National Institute of Standards and Technology 100 Bureau Drive Mailstop 2002 Gaithersburg, MD 20899 Email: nccoe@nist.gov

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NATIONAL CYBERSECURITY CENTER OF EXCELLENCE

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The National Cybersecurity Center of Excellence (NCCoE), a part of the National Institute of Standards and Technology (NIST), is a collaborative hub where industry organizations, government agencies, and academic institutions work together to address businesses’ most pressing cybersecurity issues. This public-private partnership enables the creation of practical cybersecurity solutions for specific industries, as well as for broad, cross-sector technology challenges. Through consortia under Cooperative Research and Development Agreements (CRADAs), including technology partners—from Fortune 50 market leaders to smaller companies specializing in information technology security—the NCCoE applies standards and best practices to develop modular, adaptable example cybersecurity solutions using commercially available technology. The NCCoE documents these example solutions in the NIST Special Publication 1800 series, which maps capabilities to the NIST Cybersecurity Framework and details the steps needed for another entity to re-create the example solution. The NCCoE was established in 2012 by NIST in partnership with the State of Maryland and Montgomery County, Maryland. To learn more about the NCCoE, visit https://www.nccoe.nist.gov/. To learn more about NIST, visit https://www.nist.gov.

NIST CYBERSECURITY PRACTICE GUIDES NIST Cybersecurity Practice Guides (Special Publication 1800 series) target specific cybersecurity challenges in the public and private sectors. They are practical, user-friendly guides that facilitate the adoption of standards-based approaches to cybersecurity. They show members of the information security community how to implement example solutions that help them align with relevant standards and best practices, and provide users with the materials lists, configuration files, and other information they need to implement a similar approach. The documents in this series describe example implementations of cybersecurity practices that businesses and other organizations may voluntarily adopt. These documents do not describe regulations or mandatory practices, nor do they carry statutory authority.

ABSTRACT Medical imaging plays an important role in diagnosing and treating patients. The system that manages medical images is known as the picture archiving communication system (PACS) and is nearly ubiquitous in healthcare environments. PACS is defined by the Food and Drug Administration as a Class II device that “provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.” PACS centralizes functions surrounding medical imaging workflows and serves as an authoritative repository of medical image information.

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PACS fits within a highly complex healthcare delivery organization (HDO) environment that involves interfacing with a range of interconnected systems. PACS may connect with clinical information systems and medical devices and engage with HDO-internal and affiliated health professionals. Complexity may introduce or expose opportunities that allow malicious actors to compromise the confidentiality, integrity, and availability of a PACS ecosystem. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The NCCoE at NIST analyzed risk factors regarding a PACS ecosystem by using a risk assessment based on the NIST Risk Management Framework. The NCCoE also leveraged the NIST Cybersecurity Framework and other relevant standards to identify measures to safeguard the ecosystem. The NCCoE developed an example implementation that demonstrates how HDOs can use standards-based, commercially available cybersecurity technologies to better protect a PACS ecosystem. This practice guide helps HDOs implement current cybersecurity standards and best practices to reduce their cybersecurity risk and protect patient privacy while maintaining the performance and usability of PACS.

KEYWORDS access control; auditing; authentication; authorization; behavioral analytics; cloud storage; DICOM; EHR; electronic health records; encryption; microsegmentation; multifactor authentication; PACS; PAM; picture archiving and communication system; privileged account management; vendor neutral archive; VNA

ACKNOWLEDGMENTS We are grateful to the following individuals for their generous contributions of expertise and time. Name

Organization

Matthew Hyatt

Cisco

Kevin McFadden

Cisco

Cletis McLean

Cisco

Peter Romness

Cisco

Deidre Cruit

Clearwater Compliance

Mike Nelson

DigiCert

Taylor Williams

DigiCert

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Name

Organization

Andy Gray

Forescout

Katherine Gronberg

Forescout

William Canter

Hyland

Kevin Dietz

Hyland

Joseph Davis

Microsoft

Janet Jones

Microsoft

Dan Menicucci

Microsoft

Mehwish Akram

The MITRE Corporation

Steve Edson

The MITRE Corporation

Sallie Edwards

The MITRE Corporation

Donald Faatz

The MITRE Corporation

Harry Perper

The MITRE Corporation

David Alfonso

Philips Healthcare

Jonathan Bagnall

Philips Healthcare

Julian Castro

Philips Healthcare

Sukanta Das

Philips Healthcare

Jason Dupuis

Philips Healthcare

Michael McNeil

Philips Healthcare

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Name

Organization

Dwayne Thaele

Philips Healthcare

Steve Kruse

Symantec

Derek Peters

Symantec

Axel Wirth

Symantec

Bill Johnson

TDi Technologies

Pam Johnson

TDi Technologies

Robert Armstrong

Tempered Networks

Nicholas Ringborg

Tempered Networks

Randy Esser

Tripwire

Onyeka Jones

Tripwire

Jim Wachhaus

Tripwire

Sandra Osafo

University of Maryland University College

Henrik Holm

Virta Labs

Michael Holt

Virta Labs

Ben Ransford

Virta Labs

Jun Du

Zingbox

Damon Mosk-Aoyama

Zingbox

David Xiao

Zingbox

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The Technology Partners/Collaborators who participated in this build submitted their capabilities in response to a notice in the Federal Register. Respondents with relevant capabilities or product components were invited to sign a Cooperative Research and Development Agreement (CRADA) with NIST, allowing them to participate in a consortium to build this example solution. We worked with:

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Technology Partner/Collaborator

Build Involvement

Cisco

Cisco Firepower Version 6.3.0 Cisco Stealthwatch Version 7.0.0

Clearwater Compliance

Clearwater Information Risk Management Analysis

DigiCert

DigiCert PKI Platform

Forescout

Forescout CounterACT 8

Hyland

Hyland Acuo Vendor Neutral Archive Version 6.0.4 Hyland NilRead Enterprise Version 4.3.31.98805 Hyland PACSgear Version 4.1.0.64

Microsoft

Azure Active Directory Azure Key Vault Version Azure Monitor Azure Storage Azure Security Center Version Standard Azure Private Link

Philips Healthcare

Philips Enterprise Imaging Domain Controller Philips Enterprise Imaging IntelliSpace PACS Philips Enterprise Imaging Universal Data Manager

Symantec, a division of Broadcom

Symantec Endpoint Detection and Response (EDR) Version 4.1.0 Symantec Data Center Security: Server Advanced (DCS:SA) Version 6.7 Symantec Endpoint Protection (SEP 14) Version 14.2 Symantec Validation and ID Protection Version 9.8.4 Windows

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Technology Partner/Collaborator

Build Involvement

TDi Technologies

TDI Technologies ConsoleWorks Version 5.1-0u1

Tempered Networks

Tempered Networks Identity Defined Networking (IDN) Conductor and HIPSwitch Version 2.1

Tripwire

Tripwire Enterprise Version 8.7

Virta Labs

BlueFlow Version 2.6.4

Zingbox

Zingbox IoT Guardian

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Contents 1 Introduction ......................................................................................... 1

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

1.1

How to Use this Guide ................................................................................................... 1

1.2

Build Overview .............................................................................................................. 2

1.3

Typographic Conventions .............................................................................................. 3

1.4

Logical Architecture Summary ...................................................................................... 3

2 Product Installation Guides .................................................................. 4 2.1

2.2

2.3

2.4

2.5

2.6

Picture Archiving and Communication System (PACS) ................................................. 4 2.1.1

Philips IntelliSpace PACS ...............................................................................................5

2.1.2

DCM4CHEE ..................................................................................................................20

VNA .............................................................................................................................. 25 2.2.1

Hyland Database Server ..............................................................................................25

2.2.2

Hyland Acuo VNA ........................................................................................................26

2.2.3

PACSgear Core Server .................................................................................................28

2.2.4

Hyland NilRead............................................................................................................37

Secure DICOM Communication Between PACS and VNA ........................................... 41 2.3.1

Public Key Infrastructure (PKI) Certificate Creation....................................................41

2.3.2

Public Key Infrastructure (PKI) Certification Installation ............................................43

2.3.3

TLS Secure DICOM Configuration ...............................................................................47

2.3.4

PACS and VNA TLS Integration Tests ..........................................................................55

Modalities .................................................................................................................... 55 2.4.1

DVTk Modality Emulator .............................................................................................55

2.4.2

DVTk RIS Emulator ......................................................................................................60

Asset and Risk Management ....................................................................................... 62 2.5.1

Virta Labs BlueFlow .....................................................................................................62

2.5.2

Tripwire Enterprise .....................................................................................................69

Enterprise Domain Identity Management .................................................................. 95 2.6.1

Domain Controller with AD, DNS, and DHCP ..............................................................96

2.6.2

DigiCert PKI ...............................................................................................................115

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2.7

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2.8

2.9

Network Control and Security ................................................................................... 122 2.7.1

Cisco Firepower.........................................................................................................122

2.7.2

Cisco Stealthwatch ....................................................................................................147

2.7.3

Tempered Networks Identity Defined Networking (IDN) .........................................160

2.7.4

Zingbox IoT Guardian ................................................................................................166

2.7.5

Forescout CounterACT 8 ...........................................................................................173

2.7.6

Symantec Endpoint Detection and Response (EDR) .................................................180

Endpoint Protection and Security ............................................................................. 187 2.8.1

Symantec Data Center Security: Server Advanced (DCS:SA) ....................................187

2.8.2

Symantec Endpoint Protection .................................................................................200

Data Security ............................................................................................................. 212 2.9.1

Microsoft Azure Cloud Storage .................................................................................213

2.9.2

Hyland VNA Cloud Archive Device ............................................................................233

2.10 Secure Remote Access............................................................................................... 237 2.10.1 TDi Technologies ConsoleWorks ...............................................................................237 2.10.2 Symantec Validation and ID Protection (VIP) ...........................................................239

Appendix A List of Acronyms ................................................................ 251 Appendix B References ........................................................................ 254

List of Figures Figure 1-1 PACS Final Architecture ......................................................................................................4 Figure 2-1 Hyland Systems and Applications Connectivity .................................................................25 Figure 2-2 Architecture of Networks IDN......................................................................................... 161

List of Tables Table 2-1 Base VM Configuration Requirements .................................................................................5

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1 Introduction

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The following volumes of this guide show information technology (IT) professionals and security engineers how we implemented this example solution. We cover all of the products employed in this reference design. We do not re-create the product manufacturers’ documentation, which is presumed to be widely available. Rather, these volumes show how we incorporated the products together in our environment. Note: These are not comprehensive tutorials. There are many possible service and security configurations for these products that are out of scope for this reference design.

1.1 How to Use this Guide This National Institute of Standards and Technology (NIST) Cybersecurity Practice Guide demonstrates a standards-based reference design and provides users with the information they need to replicate all or parts of the example implementation that was built in the National Cybersecurity Center of Excellence (NCCoE) lab. This reference design is modular and can be deployed in whole or in part. This guide contains three volumes: 

NIST SP 1800-24A: Executive Summary

NIST SP 1800-24B: Approach, Architecture, and Security Characteristics – what we built and why

NIST SP 1800-24C: How-To Guides – instructions for building the example solution (you are here)

Depending on your role in your organization, you might use this guide in different ways: Business decision makers, including chief security and technology officers, will be interested in the Executive Summary, NIST SP 1800-24A, which describes the following topics: 

challenges that enterprises face in securing a Picture Archiving and Communication System (PACS)

example solution built at the NCCoE

benefits of adopting the example solution

Technology or security program managers who are concerned with how to identify, understand, assess, and mitigate risk will be interested in NIST SP 1800-24B, which describes what we did and why. The following sections will be of particular interest: 

Section 3.4, Risk Assessment, describes the risk analysis we performed.

Section 3.5, Security Control Map, maps the security characteristics of this example solution to cybersecurity standards and best practices.

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You might share the Executive Summary, NIST SP 1800-24A, with your leadership team members to help them understand the importance of adopting standards-based, commercially available technologies that can help secure a PACS ecosystem.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

IT professionals who want to implement an approach like this will find this whole practice guide useful. You can use this How-To portion of the guide, NIST SP 1800-24C, to replicate all or parts of the build created in our lab. This How-To portion of the guide provides specific product installation, configuration, and integration instructions for implementing the example solution. We do not recreate the product manufacturers’ documentation, which is generally widely available. Rather, we show how we incorporated the products together in our environment to create an example solution. This guide assumes that IT professionals have experience implementing security products within the enterprise. While we have used a suite of commercial products to address this challenge, this guide does not endorse these particular products. Your organization can adopt this solution or one that adheres to these guidelines in whole, or you can use this guide as a starting point for tailoring and implementing parts of a PACS security solution. Your organization’s security experts should identify the products that will best integrate with your existing tools and IT system infrastructure. We hope that you will seek products that are congruent with applicable standards and best practices. Section 3.6, Technologies, in NIST SP 1800-24B lists the products that we used and maps them to the cybersecurity controls provided by this reference solution. A NIST Cybersecurity Practice Guide does not describe “the” solution, but a possible solution. Comments, suggestions, and success stories will improve subsequent versions of this guide. Please contribute your thoughts to hit_nccoe@nist.gov. Acronyms used in figures can be found in Appendix A.

1.2 Build Overview The NCCoE built a hybrid virtual-physical laboratory environment to explore methods to effectively demonstrate the capabilities in securing a PACS ecosystem. While the project implemented PACS and vendor neutral archive (VNA) solutions as well as security controls, the environment leveraged modality emulation to simulate medical image acquisition. The project also implemented an emulated radiology information system (RIS), used to generate modality work lists and therefore, support common medical imaging workflows. The project then applied security controls to the lab environment. Refer to NIST Special Publication (SP) 1800-24B, Approach, Architecture, and Security Characteristics, for an explanation of why we used each technology.

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1.3 Typographic Conventions The following table presents typographic conventions used in this volume.

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Typeface/Symbol

Meaning

Example

Italics

For language use and style guidance, file names and path names; references to documents that see the NCCoE Style Guide. are not hyperlinks; new terms; and placeholders

Bold

names of menus, options, command buttons, and fields

Choose File > Edit.

Monospace

command-line input, onscreen computer output, sample code examples, and status codes

mkdir

Monospace Bold

command-line user input contrasted with computer output

service sshd start

blue text

link to other parts of the document, a web URL, or an email address

All publications from NIST’s NCCoE are available at https://www.nccoe.nist.gov.

1.4 Logical Architecture Summary Figure 1-1 depicts a reference network architecture, introduced in NIST SP 1800-24B, Section 4.2, Final Architecture, which defines groupings that translate to network segments or zones. The rationale behind segmentation and zoning is to limit trust between areas of the network. In considering a hospital infrastructure, the NCCoE identified devices and usage and grouped them by usage. The grouping facilitated network zone identification. Once zones are defined, infrastructure components may be configured so that those zones do not inherently have network access to other zones within the hospital network infrastructure. Segmenting the network in this fashion limits the overall attack surface posed to the PACS environment and considers the network infrastructure configuration as part of an overall defense-in-depth strategy.

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Figure 1-1 PACS Final Architecture

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2 Product Installation Guides This section of the practice guide contains detailed instructions for installing and configuring the products that the NCCoE used to build an instance of the example solution. The project implemented security capabilities across the laboratory infrastructure to safeguard the emulated modalities, emulated RIS, viewer workstations, and PACS and VNA systems. Security control products that align with capabilities were implemented for the environment. Products that align with the security capabilities are enumerated in NIST 1800-24B, Section 3.6, Technologies, Table 3-5.

2.1 Picture Archiving and Communication System (PACS) This project implemented two separate PACS: Philips IntelliSpace solution and an open-source PACS (DCM4CHEE). These PACS emulate the case where a healthcare delivery organization (HDO) may have different PACS vendors installed in its environment.

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2.1.1

Philips IntelliSpace PACS

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The project implemented the Philips IntelliSpace PACS solution as a central component to the lab build. IntelliSpace includes several common features, such as the ability to integrate Digital Imaging and Communications in Medicine (DICOM) and non-DICOM images and allowed the project team to emulate common medical-imaging workflow processes. The project deploys an IntelliSpace instance to receive images from an open-source modality emulator tool, which allows the project to simulate working HDO environments. The project integrates IntelliSpace with the Hyland VNA solution also installed in the lab. System Requirements The Philips IntelliSpace system consists of several components installed on different VMware virtual machines (VMs). Table 2-1 depicts base configuration requirements to construct the IntelliSpace VMs. Table 2-1 Base VM Configuration Requirements VM Name

Description

Central Processing Unit (CPU)

Memory

Storage

Operating System

Software

DC1

Domain Controller (DC)

4

8 gigabytes (GB) of random access memory (RAM)

200 GB

Microsoft Windows Server 2012

Microsoft Structured Query Language (SQL) 2012, Internet Information Services (IIS) 7

IntelliSpace Server

Infrastructure, Integration, Rhapsody Health Level 7 (HL7), DICOM processor, SQL Database (DB), Anywhere Viewer (web client)

4

8 GB RAM

200 GB

Microsoft Windows Server 2012

Microsoft SQL 2012, IIS 7

Universal Data Manager (UDM)

UDM, WEB DICOM services Image Lifecycle Management

4

8 GB RAM

200 GB

Microsoft Windows Server 2012

Microsoft SQL 2012, IIS 7

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VM Name

Description

Central Processing Unit (CPU)

Memory

Storage

Operating System

Software

Image prefetching from VNA This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

IntelliSpace PACS Client Installation The project team collaborated with a team of Philips Healthcare deployment engineers to install the environment. Based on the base VM configuration requirements, the NCCoE team created the VMs by using the open virtualization format (OVF) files provided by Philips Healthcare. Philips engineers deployed the applications on the VMs and created instances for DC1, IntelliSpace server, and UDM, as noted in Table 2-1. VM instances were deployed on respective servers. IntelliSpace PACS is a web-based distributed system. Clinicians, referring physicians, nurses, or bioengineers use web-based client applications on workstations to view, analyze, and qualify medical images. Once the server components were installed, the web-based client installation was performed using the following procedures: 1. Open Internet Explorer from a workstation and assign the IntelliSpace server with the internet protocol (IP) address 192.168.140.131. Enter the IntelliSpace server IP address in the address bar by using the following uniform resource locator (URL): https://192.168.140.131/clientweb/installers. 2. Select IntelliSpacePACSEnterpriseSetup.exe under the Standalone Installers bullet list of available IntelliSpace PACS Installers screen to start the installation.

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3. An option to choose setup language displays. Select the English (United States) from the drop-down and click OK.

4. After the setup language has been set, the InstallShield Wizard begins the installation process.

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5. Use the default setting for the Custom Setup and click the Next > button that appears at the bottom of this window.

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6. On the Client Configuration Info window, enter 192.168.140.131 as the Server IP address, and click Install.

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7. When installation is finished, the InstallShield Wizard provides a message indicating successful installation. Click Finish.

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8. Once the installation is done, the installer places an IntelliSpace PACS Enterprise icon on the desktop. Type Tester in the User Name field and the corresponding password in the Password field, then click OK to log in.

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9. When the program launches, the default page launches the Patient Lookup screen.

10. To view an exam, navigate to Exam Lookup, which lists a summary of a patient’s exams. Double-click an exam in the list. If the exam has an image, it will be displayed. An example is below.

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IntelliSpace PACS Client Configuration Philips Deployment Engineers accomplished deployment and configuration by using PowerCLI and scripts. Other basic configurations can be implemented through the administration web page provided by the IntelliSpace PACS by using the URL https://192.168.140.131/PACSAdministration. 1. Enter the admin as the User Name, enter the proper Password, select AD PACS from the Logon to drop-down list, select Password from the Logon Mode, then click OK.

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2. On the admin home page, add a new user by navigating to Security, found on the far-left column of the Common Tasks screen. Click Users, then click Add a New User.

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3. To add a new user, navigate to SECURITY, found on the far-left column of the Common Tasks screen, and click Users. a. Enter the User ID. b. Enter the user’s First Name. c. Enter the user’s Middle Name (optional). d. Enter the user’s Last Name. e. Enter the user’s Email Address (optional). f.

Assign an IntelliSpace PACS AdminTool Password for the user (required). Enter the password again to confirm it.

Configure Sources for User Authentication IntelliSpace supports either a locally hosted or an external authentication source. An authentication source provides a directory structure that authenticates and manages user and group accounts. The internal authentication source, called iSite, implements a local DB of users and groups. IntelliSpace also supports a lightweight directory access protocol (LDAP) server connected to a Microsoft Active Directory (AD). The external user authentication is used as the configuration source. The following steps describe how to create an LDAP authentication source: 1. From the navigation bar, click the Security button, then click Authorities.

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2. Click New to open the External Authentication Source wizard.

3. On the External Authentication Source page, set the following values, then click Next. a. Set Authority Name to AD.PACS.HCLAB. b. Set the Display Name to AD PACS. c. Select HostName for Name Resolution. d. Check the box next to Enabled.

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e. Check the box next to Show in Login Screen.

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4. In the Advanced Directory Configuration, set DNS Host Name as ad.pacs.hclab and Port as 389.

5. Navigate to the Edit External Authentication Source screen. In this project, the Directory Type is ActiveDirectory, and the Supported Credentials is Password. Click Save to save the settings.

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6. The interface provides a test feature to allow engineers to determine connectivity with the external authentication source. From the navigation bar, select Security > Authorities. Click the name of the External Authentication Source, and click Test.

Configure Connection to Modality Emulator We used the open-source DVTk Modality Emulator as a modality for testing the communication between IntelliSpace PACS and a modality. Installation of the DVTk Modality Emulator can be found in Section 2.4.1. The following procedures configure several components. These components include the

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Radiology information system (RIS), modality performed procedure step manager (MPPS manager), and PACS/Workstation systems storage. 1. From the DVTk Modality application, click the Configure Emulator tab to set up a proper System Name, e.g., Modality; an application entity title (AE Title), e.g., DVTK_MODALITY; and a communication Listen Port, e.g., 104 for the emulator itself. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2. From the DVTk Modality application, click the Remote Systems tab to configure the remote systems, including RIS System, MPPS Manager, and PACS/Workstation Systems. Information for each system’s IP address as well as the port number is needed. Particularly, the AE Title for the Philips IntelliSpace PACS is required for the AE Title field. These are the input values: RIS System 

IP Address: 192.168.160.201

Remote Port: 105

AE Title: DVTK_RIS

MPPS Manager 

IP Address: 192.168.160.201

Remote Port: 108

AE Title: DVTK_MPPS

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PACS/Workstation Systems–Storage Config 

IP Address: 192.168.140.131

Remote Port: 104

AE Title: STENTOR_SCP

PACS/Workstation Systems–Storage Commit Config This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

IP Address: 192.168.140.131

Remote Port: 104

AE Title: STENTOR_SCU

3. To configure the Philips IntelliSpace PACS AE Title and communication port, log on to the iSite Administration web site by using the URL https://192.168.140.131/iSiteWeb. Select Configure > DICOM > General, set the following values, and then click Save to save the settings. 

Normal AE Title: STENTOR_SCP

High-Priority AE Title: STENTOR_HI

Port: 104

Secure Port: 2762

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

4. To test the connectivity, go to the DVTk Emulator application, then go to the Modality Emulator home page as shown below. Click the Ping PACS/Workstation and DICOM Echo buttons to verify the success of the pings. You should receive Ping Successful and DICOM Echo Successful messages.

Configure IntelliSpace PACS to Communicate with Hyland VNA Refer to Section 2.2.2 for detailed installation guidance for Hyland VNA. 1. Obtain the Hyland VNA AE Title and port information for communication. Log in to the iSite Administration page by using the URL https://192.168.140.131/iSiteWeb.

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2. From the Configure drop-down list, select DICOM to open the DICOM configuration page. 3. Fill in the known Hyland AE Title (e.g., RADIOLOGY), IP Address (e.g., 192.168.130.120), Port (e.g., 114), and other necessary information.

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4. Log in to the IntelliSpace PACS Administration page by using https://192.168.140.131/PACSAdministration. 5. Click the Configuration button on the left panel to configure the Auto Export Rule. 6. Click the New button to create a new rule named ForwardHylandVNA.

7. Set the Trigger Type as New Data Arrival.

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8. Set the Receiving AE Title as Stentor_SCP, which is the AE Title for Philips IntelliSpace PACS. 9. Choose Hyland VNA (RADIOLOGY) from the Selected Destination box.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2.1.2

DCM4CHEE

DCM4CHEE is a collection of open-source applications that communicate with each other using DICOM and HL7 standards for clinical image management and archival. In this study, DCM4CHEE listens for connection requests from specific application entities like DVTk’s Modality Emulator to receive patient

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studies. DCM4CHEE will store these patient studies in a PostgreSQL DB and can archive these studies to the Hyland VNA. This build utilizes Docker to deploy the DCM4CHEE software. System Requirements

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CPUs: 2

Memory: 4 GB

Storage: 80 GB

Operating System: Ubuntu Linux 18.04

Network Adapter: VLAN 1402

Software: Docker

DCM4CHEE Installation The guide for installing Docker on Ubuntu 18.04 can be found at [1]. 1. Go to https://github.com/dcm4che-dockerfiles/dcm4chee-arc-psql/tree/5.21.0 to download the software. 2. On the right-hand side of the page, click the Clone button to begin the file download. 3. Extract the downloaded content from the dcm4chee-arc-psql-5.21.0.zip file to a preferred directory. 4. Open a terminal with root privileges. 5. Navigate to the directory where the extracted content is located. 6. Run docker-compose up. 7. Open a web browser and navigate to https://localhost:8443/dcm4chee-arc/ui2.

DCM4CHEE to VNA Configuration 1. Click the dark blue menu dongle ( ) on the left-hand side of the screen. 2. Select Configuration.

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3. Select AE list. 4. Click New AET, and provide the following information:

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Name: RADIOLOGY

Hostname: 192.168.130.120

Port: 114

AE Title: RADIOLOGY

5. Click Apply.

DCM4CHEE to DVTk Modality Configuration 1. In the Modality Emulator, click the Configure Remote Systems tab at the top of the window. 2. Navigate to the PACS\Workstation Systems section, and input the information with the following values: RIS System 

IP Address: 192.168.140.160

Remote Port: 105

AE Title: RIS

MPPS Manager 

IP Address: 192.168.140.160

Remote Port: 108

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AE Title: MPPS

PACS/Workstation System–Storage Config 

IP Address: 192.168.141.210

Remote Port: 11112

AE Title: PACS

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PACS/Workstation System–Storage Commit Config 

IP Address: 192.168.141.210

Remote Port: 11112

AE Title: PACS

DCM4CHEE View Stored Data and Archive to VNA 1. Click the dark blue menu dongle (

) on the left-hand side of the screen.

2. Select Navigation. 3. Select DCM4CHEE under Web App Service on the right-hand side of the screen.

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

4. Select Submit to see stored patient studies.

5. Click the dark blue ellipsis ( ) on the left-hand side of the study on the second row. 6. Click the Export (

) icon.

7. Select RADIOLOGY from the drop-down list. 8. Click Export.

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2.2 VNA Hyland Acuo VNA features several different systems and applications, which include:

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Acuo VNA: core application server with services used to store, track, and retrieve digital assets stored in an archive

PACSgear Core Server: image processing and routing server, and back-end services

PACS Scan Mobile/Web: mobile device image acquisition and file-import application

NilRead: enterprise image-viewing application

The diagram in Figure 2-1 shows the connectivity between the Hyland Acuo VNA systems and applications. Figure 2-1 Hyland Systems and Applications Connectivity

Installation procedures for the above Hyland products are described in the sections that follow.

2.2.1

Hyland Database Server

Hyland Database Server supports operations for other Hyland products, including Hyland Acuo VNA and Hyland NilRead. The installation and configuration procedures can be found below: System Requirements 

CPUs: 4

Memory: 12 GB RAM

Storage:

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-

Hard Drive (HD)1: 80 GB (operating system [OS] installation)

-

HD 2: 20 GB (DB drives)

-

HD 3: 10 GB (Tx logs)

Operating System: Microsoft Windows Server 2016

Network Adapter: VLAN 1801

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Hyland Database Server Installation Install the SQL Server 2017 according to the instructions detailed in Install SQL Server from the Installation Wizard (Setup) [2]. Hyland Database Configuration 1. The installation creates default service accounts for each service. The project used these default service accounts. User and privileged login accounts were created for the Hyland application suite and linked to unique Microsoft domain users. The project created the PACS\AcuoServiceUser and PACS\Administrator accounts. 2. The project implemented Windows Authentication Mode for the SQL Server. 3. Application DB instances were created as needed automatically when product applications were installed. 4. This project implemented the following DB instances through the SQL Server Management Studio: AcuoMed, HUBDB, NILDB, and PGCORE. 5. The project also implemented instances for OPHTHALMOLOGY, RADIOLOGY, and WOUND_CARE.

2.2.2

Hyland Acuo VNA

Hyland Acuo VNA provides access to medical images and documents through interactions with a variety of different PACS, modalities, and image viewers. Acuo VNA also supports various standards, including HL7 and DICOM. The installation and configuration procedures can be found below. System Requirements 

CPUs: 6

Memory: 12 GB RAM

Storage: -

HD 1: 80 GB (OS installation)

-

HD 2: 80 GB (Dilib cache drive)

-

HD 3: 500 GB (image cache drive) was installed

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Operating System: Microsoft Windows Server 2016

Network Adapter: VLAN 1301

Hyland Acuo VNA Installation

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1. In the NCCoE test environment, the Hyland Acuo VNA was installed on a VM preconfigured with the OS and network requirements provided by Hyland. Engineers supplied by Hyland performed the installation. 2. Upon completion of the installation, three Windows services were created: AcuoMed, AcuoAudit, and AcuoStore. AcuoMed is associated with a DICOM DB containing the patient, study, and series record information that describes the images physically present on the Acuo VNA archive system. The AcuoStore also has its own DB for storing information related to bulk storage of digital images and related data, including information about the shares and about the applications that use those shares. 3. The installation created a web application for the AcuoAdmin Portal, where a secure sockets layer (SSL) certificate signed by DigiCert was created and assigned to the application for hypertext transfer protocol secure (https) enforcement. Hyland Acuo VNA Configuration Hyland engineers performed configurations using the Microsoft MMC console and the AcuoAdmin Portal (https://192.168.130.120:8099/vnaweb/#1/home). The screenshots of the console management for these administration approaches are below:

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To verify successful completion of the VNA installation, the Hyland engineers launched the Acuo Administrator Portal application from the VNA server (local host). The Acuo Administrator Portal screen sample is below.

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2.2.3

PACSgear Core Server

PACSgear Core Server is a capture and connectivity suite used to process DICOM and non-DICOM medical data, including patient demographics, images, videos, and HL7 messages. PACSgear Core Server can be accessed from a web browser to handle user accounts, security, and client connectivity configuration. Installation and configuration procedures are described below. System Requirements 

CPUs: 4

Memory: 8 GB RAM

Storage: -

HD 1: 80 GB (OS installation)

-

HD 2: 170 GB (application)

Operating System: Microsoft Windows Server 2016

Network Adapter: VLAN 1501

PACSgear Core Server Installation

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Hyland engineers installed the Hyland PACSgear Core Server as listed below: 1. Hyland engineers installed the PACSgear Core Server following their technical guidelines. 2. The installation created a web application for the PACSgear Core Portal, where an SSL certificate signed by DigiCert was created and assigned to the application for https enforcement. PACSgear Core Server Configuration This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The Hyland engineers configured the PACSgear Core Server. The basic configuration involves managing connection settings to external devices, lookup data sources, and event trace-managing departments for multitenancy architecture, and managing user access, among many more features. Each organization will configure the PACSgear based on its specific needs. During the DB configuration, the Hyland engineers created instances for representative departments (e.g., ophthalmology, radiology, and departments that may see patients who need wound treatment). Add New Departments: To add the ophthalmology department, complete the following steps: 1. The Hyland engineers logged on to the PACSgear Admin portal by using https://hylandpgcore.pacs.hclab/PGAPPS/Admin.

2. On the Settings menu, select Departments.

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This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

3. After selecting Departments from the Settings pull-down, the screen advances to a Departments screen. The Departments screen lists sample hospital departments created during the installation. The project then added a new department by clicking the + Add button.

4. After clicking the + Add button, the Add/Edit Department screen opened and allowed the engineers to enter corresponding information.

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5. In the Name text box, the engineers entered Ophthalmology to create a department that ties with the ophthalmology database instance created during DB configuration. Engineers also added the AE title as Ophthalmology and selected a CT Scan for the modality.

6. On the Destinations and Lookup Sources tabs, the engineers set up the destination and lookup sources for each department. 7. On the Client tab, the engineers set up the client access permissions to this department’s resources.

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8. On the Series tab, click Add, type a description, click Save. 9. Verify that the department has been added to the list, based on what is displayed.

Add LDAP/Active Directory Server: To use an LDAP/Active Directory server, configure these parameters: 1. Create an LDAP_User account in Active Directory before proceeding. 2. Using a browser, log on to the PACSgear Admin portal by using https://hylandpgcore.pacs.hclab/PGAPPS/Admin. 3. On the Settings menu, select Users.

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4. On the Users screen, navigate to Restrict access permissions to: and click the LDAP Users button. Enter 192.168.120.100 to populate the Server text box, and then enter pacs.hclab for Domain.

5. Click the Test button located under the Domain entry box. 6. Enter the LDAP_User credentials to verify connectivity to the AD.

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7. A message box displays indicating the test is successful. Click OK.

PACS Scan Mobile Configuration: Install and configure the PACS Scan application to an Apple iPhone by applying these steps: 1. On the iPhone, navigate to the App Store. Search for PACS Scan Mobile, from Perceptive Software. Perceptive Software is a Hyland business unit. Select the GET button to install the software, and then select the OPEN button. Select Allow to permit the software to send notifications. 2. On a workstation, log in to PACSgear Core Server by using the administrator credentials; a dashboard displays and provide a Provision Device QR code.

3. On the mobile device PACS Scan App, tap the Quick Response (QR) code icon that appears under the Log In button. This turns on the built-in camera on the iPhone.

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4. Point the camera at the QR code on the PC screen until a message box appears indicating Setting Updated Your settings have been updated. This setting configures the mobile PACS Scan application to the address of its PACSgear Core Server instance. 5. From a workstation, acquire the trusted root certificate from DigiCert. Further information for using DigiCert is described in Section 2.6.2. 6. Download the root certificate to the workstation local drive and attach the certificate as an email attachment sent to the installer. 7. The installer opens the email from the iPhone and double-clicks on the attachment to install the certificate to the device. 8. To verify the certificate installation, go to Settings > General > Profiles & Device Management to list all the certificate profiles. 9. Find the certificate you installed and click to display the detail. An example appears below:

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10. To verify the PACS Scan Mobile App functionality, from the iPhone, double-click the PACS Scan App. The login page displays. Use an account and password that has been associated with a clinical department to log in. Successful login displays a patient information input page, as shown below:

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2.2.4

Hyland NilRead

Hyland NilRead provides image access and viewing from various devices, including clinical viewing stations, tablets, and mobile devices. NilRead also provides image manipulation, interpretation, and collaboration across departments. The installation and configuration procedures are below. System Requirements This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

CPUs: 6

Memory: 12 GB RAM

Storage: -

HD 1: 80 GB (OS installation)

-

HD 2: 200 GB (web application)

-

HD 3: 100 GB (image cache)

Operating System: Microsoft Windows Server 2016

Network Adapter: VLAN 1301

Hyland NilRead Installation 1. Hyland engineers installed Hyland NilRead based on Hyland’s proprietary installation package and installation guides. NilRead has three services: Hub Front End service, Nil Back End service, and Nil Front End service. The Hub Front End service provides management service for multitenant configuration. The operation context is defined by the Nil DB content and includes user accounts, data life-cycle rules, hanging protocols, DICOM connectivity setup, and cached DICOM data index. 2. The installation created two web applications for the NilHub and NilRead Viewer, where SSL certificates signed by DigiCert were created and assigned to the applications for https enforcement. Hyland NilRead Configuration NilHub configuration is done from the NilHub web application. Launch a web browser from the NilHub server, and authenticate as admin, using the URL https://localhost:8080/, as follows:

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1. To add a new site from the NilHub home page, click the Sites tab in the top left-hand side of the screen.

2. Click the + icon on the right-hand side of the screen to create a new site for the WOUND_CARE department, provide the information below, then click Save.

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Name: WOUND_CARE

Details: Wound Care Department

Code: 974

AE Title: WOUND_CARE

VNA Partition: WOUND_CARE

Database Name: WOUND_CARE

Email: none@hyland.com

3. Log back in to NilHub specifying the WOUND_CARE Site in the top section of the login screen.

4. Click the Settings tab. Navigate to the User Management section and click Accounts.

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5. Click Add on the bottom left-hand side of the screen, and provide this information: 

User Name: pacs\ptester

Last Name: Tester

First Name: Pacs

Role: User

E-Mail: ptester@hyland.pacs.com

Password: *****

6. Identify Member Groups to which the user needs access and click the Add button. 7. Specify the Granted Privileges that the user needs and click the Grant button. 8. Click the Save button on the bottom left-hand side of the screen.

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Hyland engineers repeated the above steps to have multiple sites that accessed different VNA partitions/tenants, such as Radiology with access to all VNA tenants and Ophthalmology with access to only the Ophthalmology VNA partition/tenant.

2.3 Secure DICOM Communication Between PACS and VNA Hyland Acuo VNA and Philips IntelliSpace PACS support DICOM Transport Layer Security (TLS). DICOM TLS provides a means to secure data in transit. This project implemented DICOM TLS between the Acuo VNA and IntelliSpace PACS via mutual authentication as part of the TLS handshake protocol [3].

2.3.1

Public Key Infrastructure (PKI) Certificate Creation

Server/client digital certificates are created for the Hyland Acuo VNA and Philips IntelliSpace server. This project used DigiCert for certificate creation and management. The procedures that follow assume familiarity with DigiCert. Refer to Section 2.6.2 for further detail.

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2.3.1.1 Create PKI Certificate for Hyland Acuo VNA 1. Use the DigiCert Certificate Utility for Windows to generate a certificate signing request (CSR) for Hyland Acuo VNA. Information needed for requesting the certificate for Hyland Acuo VAN is below:

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Common Name: Hyland-VNA.pacs.hclab

Subject Alternative Name: Hyland-VNA.pacs.hclab

Organization: NIST

Department: NCCoE

City: Rockville

State: Maryland

Country: USA

Key Size: 2048

2. Submit the created CSR to DigiCert portal for certificate signing. 3. Download and save the signed certificate along with its root certificate authority (CA) certificate in the .pem file format. 4. Import the saved certificate to DigiCert Certificate Utility for Windows, then export the certificate with its private key in the .pfx format. 5. The certificate is ready for installation.

2.3.1.2 Create PKI Certificate for Philips IntelliSpace PACS 1. Use DigiCert Certificate Utility for Windows to generate a CSR for PACS server. Information needed for requesting the certificate is below: 

Common Name: nccoess1.stnccoe.isyntax.net

Subject Alternative Name: nccoess1.stnccoe.isyntax.net

Organization: NIST

Department: NCCoE

City: Rockville

State: Maryland

Country: USA

Key Size: 2048

2. Submit the created CSR to DigiCert portal for certificate signing.

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3. Download and save the signed certificate along with its root CA certificate in the .pem format. 4. Import the saved certificate to DigiCert Certificate Utility for Windows, then export the certificate with its private key in the .pfx format. 5. The certificate is ready for installation. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2.3.2

Public Key Infrastructure (PKI) Certification Installation

After creating the signed certificates for Acuo and IntelliSpace respectively, the certificates must be installed to the servers. The steps that follow describe how to install those certificates. Certificates must be applied for each server instance and assume access to both.

2.3.2.1 Install PKI Certificate for Hyland Acuo VNA Install the certificate on Hyland Acuo VNA server by using the procedures below: 1. From the Acuo server, click Start > Run > mmc. 2. Select File > Add/Remove Snap-in…

3. Select Certificates and click Add. a. Choose Computer Account. b. Choose Local Computer. 4. Click Finish, then click OK.

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5. Once the snap-in has been added, navigate to Certificates (local computer)/Personal/Certificates.

6. Right-click and select All Tasks/Import. a. Browse to the exported .pfx certificate. b. Select the file and click Open.

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7. Add the appropriate permissions to the newly generated certificate private key. a. Navigate to Certificates > Personal > Certificates. b. Right-click the certificate, select All Tasks > Manage Private Keys… c. Add the AcuoServiceUser and grant full control permissions. Click OK. This procedure also installs the signing root CA certificate (DigiCert Test Root CA SHA2) and its Intermediate Root certificate (DigiCert Test Intermediate Root CA SHA2) into the server computer.

2.3.2.2 Install PKI Certificate for Philips IntelliSpace PACS Install the certificate on the PACS server by using the procedures that follow: 1. From the IntelliSpace server, click Start > Run > mmc. 2. Select File > Add/Remove Snap-in…

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3. Select Certificates and click Add. a. Choose Computer Account. b. Choose Local Computer. c. Click Finish; click OK. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

4. Once the snap-in has been added, navigate to Certificates (local computer)/Personal/Certificates.

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5. Right-click and select All Tasks/Import. a. Browse to the exported .pfx certificate. b. Select the file and click Open.

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

This procedure also installs the signing root CA certificate (DigiCert Test Root CA SHA2) and its Intermediate Root certificate (DigiCert Test Intermediate Root CA SHA2) into the server computer.

2.3.3

TLS Secure DICOM Configuration

With the signed certificates installed to the Acuo VNA and IntelliSpace PACS servers, proceed to configuring DICOM TLS. The procedures that follow describe TLS configuration that must be performed on both Acuo VNA and IntelliSpace PACS. This will enable DICOM TLS communications between these two end points, and secure data-in-transit communications bidirectionally between the VNA and PACS.

2.3.3.1 TLS Configuration for Hyland Acuo VNA For receiving TLS DICOM messages from IntelliSpace PACS, configure a new service-class provider (SCP) in Acuo VNA using Microsoft Windows Console. Configuration is done from the Acuo VNA server. 1. Open Microsoft MMC to access the AcuoMed Image Manager (local): 2. From the Console > AcuoMed Image Manager (local) > DICOM Configuration, right-click Any IP Address > New SCP … to create a new service class provider (SCP) for TLS encryption.

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3. On the Connectivity tab of the SCP Properties page, provide the information below and click Add, Apply, then Finish: 

Port: 1443

Check the TLS checkbox.

Client Certificate CN: nccoess1.stnccoe.issyntax.net

Server Certificate CN: HYLAND-VNA.pacs.hclab

Cipher Suite: TLS_RSA_WITH_AES_128_CBC_SHA

Check the Authenticate Client Certificate checkbox.

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4. To add the Called AE to the SCP, right-click the created SCP [Listening Port:1443] and select New > Called AE … to open the AE Properties form.

5. Fill in the Called AE Name: e.g., RADIOLOGY; and Default Route Name: e.g., RADIOLOGY. After populating the information, click Add.

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For sending a TLS DICOM message to IntelliSpace PACS, configure an External DICOM Device from the Acuo VNA by using Microsoft Windows Console. 1. Open Microsoft MMC to access the Image Manager Server: 2. Navigate to Image Manager Server > Router Configuration > External DICOM Devices, right-click External DICOM Devices, and click New.

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3. On the Main tab of the External DICOM Devices Properties page, provide the information below and click Apply, then click Finish:

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SCP Destination Name: PHILIPS

Called AE Name: STENTOR_SCP

IP Address: 192.168.140.131

SCP Listening Port: 2762

Enable TLS by clicking the TLS checkbox next to the listening port number.

Called AE Name: ACUO

Implementation UID: 1.2.840.114158.1.1.3

Client Certificate CN: HYLAND-VNA.pacs.hclab

Server Certificate CN: nccoess1.stnccoe.isyntax.net

Cipher Suite: TLS_RSA_WITH_AES_128_CBC_SHA

4. Restart the AcuoMed service.

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2.3.3.2 TLS Configuration for Philips IntelliSpace PACS Next, configure TLS on the IntelliSpace PACS server. Take the steps below to enable this feature on the PACS: 1. Access the Philips iSite Administration web site https://192.168.140.131/iSiteWeb by using administrator credentials. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2. Click Configuration > DICOM to navigate to the DICOM configuration screen.

3. On the top menu, click iExport to open the iExport screen. Provide the information below, and click Save: 

AE Title: RADIOLOGY

Description: Hyland VNA

IP Address: 192.168.130.120

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Port: 1443

Use Secure Connection: checked

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4. Click Configuration > Advanced Security, and make these selections: 

TLS 1.0 or higher: Selected

Enable Secure Web Services Communication.

Enable Image Access in Secure Mode.

Default Client Certificate: CN= nccoess1.stnccoe.isyntax.net

Default Server Certificate: CN=HYLAND-VNA.pacs.hclab

Click Save to save the settings.

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5. On the iSite Administration screen, click Next, and click Next again to open the page that follows: a. Enable Validate Client Certificate for DICOM. b. Enable Validate Server Certificate for DICOM. c. Click Save to save the settings.

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6. Restart the iSite Monitor Service.

2.3.4

PACS and VNA TLS Integration Tests

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After implementing the above PKI-certification installation and TLS-enabling configuration, the Acuo VNA and IntelliSpace PACS servers are ready to perform the TLS secure DICOM communication tests. The secure DICOM communication tests were conducted for bidirectional data exchanges between Acuo VNA and IntelliSpace PACS to confirm: 

DICOM communication is still functional.

DICOM communication is encrypted.

The test proves the DICOM communication was successful, with the accurate data exchange between the Acuo VNA and IntelliSpace PACS. The network flow and dataflows monitoring tool indicate that the mutual authentication between Acuo VNA and IntelliSpace PACS is established. Encrypted application data were exchanged.

2.4 Modalities Modalities represent medical devices used to capture medical images. The build did not implement physical devices but rather used virtualized or simulated modalities to source image files. The RIS was also emulated using open-source tools.

2.4.1

DVTk Modality Emulator

DVTk Modality is a modality emulator that can emulate all the DICOM functions of a modality system. It can simulate a real modality to test and verify communication with all the DICOM services. It uses DICOM files as input for queries, MPPS, and storage actions. Consequently, this project used the DVTk Modality as an emulator to test the connectivity, communication, workflow, and interaction between PACS and modality in the lab. System Requirements 

Operating System: Microsoft Windows 7 (with Microsoft .NET 4.0 Framework)

Network Adapter: VLAN 1402

DVTk Modality Installation 1. Download the installation software from the DVTK site [4]. 2. Click the Modality Installation file (e.g., DVTk-Modality-Emulator-5.0.0.msi) to start the installation process.

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3. Follow the wizard instructions to continue the installation until it successfully completes.

4. Close the installation window. 5. The DVTk Modality Emulator can be launched from the PC Start menu. The Modality Emulator interface is below.

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DVTk Modality Configuration Configuration of the DVTk Modality involves configuration of the communications with different external systems, including the RIS, which is the worklist provider or a work-list broker connected to the RIS; the MPPS manager that handles the MPPS messages for status reporting; and the PACS and its DB where the images will be stored. The information needed for these external systems should include the correct IP address, Port number, and Application Entity Title (AE Title). Input the information with these values: 

RIS System

IP Address: 192.168.160.201

Remote Port: 105

AE Title: RIS

MPPS Manager

IP Address: localhost

Remote Port: 105

AE Title: RIS

PACS/Workstation Systems–Storage Config

IP Address: localhost

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Remote Port: 106

AE Title: MPPS

PACS/Workstation Systems–Storage Commit Config

IP Address: localhost

Remote Port: 107

AE Title: PACS

Store Commit Config

IP Address: localhost

Remote Port: 107

AE Title: PACS

The configuration of the modality itself is also needed to indicate its AE Title (e.g., DVTK_MODALITY), Local IP Address (e.g., 172.31.138.126), and Listen Port (e.g., 104) to be paired for association negation with other remote systems. The screenshot that follows indicates the options for the Modality Emulator configuration:

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Several tabs exist for configuring the behavior of the emulator. They can be configured as needed or by using the default settings. Once the configuration is done, the emulator front graphical user interface (GUI) provides some test buttons for verifying the connectivity, including RIS System and PACS/Workstation Systems server Internet Control Message Protocol pings and DICOM echo:

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2.4.2

DVTk RIS Emulator

DVTk, the Health Validation Toolkit, is an open-source software. The DVTk RIS Emulator is an application that handles Modality Worklist and Modality Performance Procedure Step requests from remote applications and then responds with the emulated results using the DICOM files specified by the users. System Requirements This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Operating System: Microsoft Windows 7 (Microsoft .NET Framework 2.0)

DVTk RIS Emulator Installation 1. Download the DVTk RIS Software installer RIS Emulator .msi file from http://www.dvtk.org. 2. Start the installation procedure by double-clicking the .msi installation file. 3. Follow the wizard screen instructions to continue the installation until the end of successful installation displays. 4. Close the installation window and start the RIS Emulator. The user interface of the RIS Emulator tool that follows is shown with the tabs that follow for selecting the modes: 

Worklist

MPPS

Edit DCM Files

Activity Logging

Results

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DVTk RIS Emulator Configuration 1. Worklist Configuration 

Local AE title: AE title of the RIS Emulator

Local Port: the port of the RIS Emulator for incoming association

Remote AE title: AE title for the service-class user paired with the RIS Emulator

View Information Model: information model used for sending the emulator response; default value is taken

2. Select Data Directory for sending WLM responses: location for storing the emulated responses to the Worklist requests. A default setting can be used, which is C:\Progam Files\DVTk\RIS Emulator\Data\Worklist\ 3. The RIS Emulator also supports other parameter configurations such as MPPS and Store Files functionality. These can be done as needed. 4. Configuration of the RIS Emulator and the modality storage emulator should be done accordingly so they can communicate with each other.

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2.5 Asset and Risk Management The build includes commercially available tools used to implement asset and risk management for medical devices. The implemented tool provides an asset inventory of medical devices that are identified via NetFlow traffic data. The tool also automates vulnerability detection and depicts a risk score. In addition to modality devices, we used other tools to manage server components. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2.5.1

Virta Labs BlueFlow

Virta Labs BlueFlow is a medical asset management software that allows discovery and management of medical devices on the network. This project used BlueFlow to create an organized inventory of the medical devices in the PACS architecture. System Requirements 

CPUs: 2

Memory: 8 GB RAM

Storage: 100 GB (thin provision)

Operating System: CentOS 7

Network Adapter: VLAN 1201

Virta Labs BlueFlow Installation 1. Run rpm -ihv blueflow-2.6.0-1.x86_64.rpm in the CentOS 7 terminal. a. Wait for the package installation process to complete. b. Depending on your environment, you may need to install some dependencies before the BlueFlow package can be successfully installed.

2. Run sysyemctl status blueflow.service in the CentOS 7 terminal. 3. Ensure blueflow.service is active.

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4. Visit https://localhost to verify that BlueFlow web service is operating as expected, with a BlueFlow Login page.

Virta Labs BlueFlow Network Groups Configuration 1. Log in to the BlueFlow web console.

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2. Navigate to the Inventory tab. 3. Under the Networks section, click the gear icon.

4. Enter Security Service as a Name for the new network group. 5. Enter 192.168.190.0/24 as a classless inter-domain routing (CIDR) for the new network group. 6. Click create.

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7. Verify that the new network group (Security Services) has been created. 8. Click the name of the new network group.

9. Assets will be listed on this page if they match the network group’s criteria.

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10. If there are no assets currently listed, you can manually add them by navigating to Inventory > Add Inventory or by running an IP discovery scan (detailed in the next section).

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Running an IP Discovery Scan in Virta Labs BlueFlow 1. Log in to the BlueFlow web console.

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2. Navigate to Connectors > Discovery.

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3. Under Discovery, click the gear icon.

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4. Check the box next to allow_create_asset. 5. Click Save.

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6. Enter an IP (e.g., 192.168.190.0/24), host name, or CIDR that you would like to scan. 7. Click Run. 8. Wait for the discovery scan to finish.

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9. Click the row of the completed scan to view more details. Note: From this page, you can view the output of the scan, including how many devices were discovered within the provided network range.

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2.5.2

Tripwire Enterprise

Tripwire Enterprise is a security configuration management software that monitors file integrity through software-based agents. For this project, we used Tripwire Enterprise to monitor file changes on PACS servers and the VNA DB. System Requirements 

CPU: 1

Memory: 4 GB RAM

Storage: 120 GB (thin provision)

Operating System: Microsoft Windows Server 2016

Network Adapter: VLAN 1201

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Tripwire Enterprise Console Installation 1. In the tripwire install folder under java, double-click the jre-8u202-windows-x64 application file.

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2. Click Run.

3. Click Install >.

4. Click OK.

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5. Wait for the installation process to complete.

6. Click Close.

7. With Java installed, double-click the Tripwire install application, install-server-windows-amd64.

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8. Select the version of Java, Oracle/Sun 1.8.0 64-bit, that was previously installed. 9. Click OK.

10. Click Next >.

11. Check I accept the agreement.

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12. Click Next >.

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13. Specify an installation directory, C:\Program Files\Tripwire\TE, for the Tripwire installation. 14. Click Next >.

15. Verify the host name for the machine on which you are installing Tripwire (e.g., WINRUQDO7KL8A7). 16. Click Next >.

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17. Specify the HTTPS Web Services port as 6000, HTTP EMS Integration Port as 8080, and Tripwire Enterprise RMI Port as 9898. 18. Click Next >.

19. Create a password for Tripwire Enterprise services. 20. Click Next >.

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21. Verify that planned installation settings are correct. 22. Click Next >.

23. Check Install Real-time Monitoring. 24. Specify Real-time Port as 1169 for monitoring. 25. Click Next >.

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26. Click Next >.

27. Wait for Tripwire Enterprise installation to complete.

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28. Click Finish.

29. Open SQL Server Configuration Manger. 30. Under SQL Server Network Configuration > Protocols for SQL Server, ensure that the TCP/IP protocol is set to Enabled.

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31. Open SQL Server Management Studio.

32. In the Object Explorer, expand the selection for your DB, right-click Databases, and select New Database…

33. On the left, under Select a page, select General. 34. Enter a Database name as TE_DB. 35. Under Database files, for the data file, set Initial Size to at least 2,000.

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36. Click the button under Autogrowth.

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37. Check Enable Autogrowth, set File Growth to at least 20 MB, and set Maximum File Size to Unlimited. 38. Click OK.

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39. Under Database files, for the log file, set Initial Size to at least 500. 40. Click the in Megabytes button under Enable Autogrowth. 41. Check Enable Autogrowth, set File Growth to at least 20 MB, and set Maximum File Size to Unlimited. 42. Click OK. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

43. On the left, under select a page, select Options. 44. Set Collation to Latin1_General_CS_AI. 45. Set Recovery model to Simple. 46. Under Other Options > Miscellaneous, set ANSI NULL Default to True. 47. Click OK.

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48. In the Object Explorer, right-click your DB and select New Query.

49. Type the following query: ALTER DATABASE [TE_DB] SET READ_COMMITTED_SNAPSHOT ON

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50. Click Execute in the toolbar above the SQL Query window. 51. Under the SQL Query window, in the Messages window, verify that the command completed successfully.

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52. Clear the SQL Query window, then type the following query: SELECT name, is_read_committed_snapshot_on FROM sys.databases WHERE name='<db_name>'

53. Click Execute in the toolbar above the SQL Query window. 54. Under the SQL Query window, in the Messages window, verify the value for is_read_committed_snapshot_on is set to 1.

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55. In the Object Explorer, expand the selection for your DB, expand the Security section, right-click Logins, and select New Login…

56. On the left, under Select a page, select General. 57. Create a Login name.

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58. Select SQL Server authentication. 59. Create a password. 60. For Default database, select the DB previously created. 61. For Default language, select English. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

62. On the left, under Select a page, select User Mapping. 63. Under the Users mapped to this login window, perform these actions for the row containing the previously created DB: a. Check the box in the Map column. b. In the Default Schema column, type the name of the new user being created. 64. Click OK.

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65. In the Object Explorer, expand the selection for your DB, expand the Databases section, right-click the DB created previously, and select Properties.

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66. On the left, under select a page, select Permissions. 67. Under Permissions for user, check the box in the Grant column for the following permissions:

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Connect

Create Function

Create Procedure

Create Table

Create View

Delete

Insert

Select

Update

68. Click OK.

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69. Open Internet Explorer and navigate to the web page of the server where Tripwire Enterprise was installed. 70. Enter the services password created during the installation process. 71. Click Login. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

72. Under Database Configuration Settings, provide the information that follows: 

Remote Database Type: Microsoft SQL Server

Authentication Type: SQL Server

Login Name: ********

Password: *********

Database Host: WIN-RUQDO7KL8A7

Database Name: TE_DB

Instance Name: SCSP (Note: This may not be necessary, depending on how your SQL Server Database is configured.)

SSL: Request

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73. Click Test Database Login and verify that the connection is successful. 74. Click Save Configuration and Restart Console.

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75. Wait for Tripwire Enterprise to restart and redirect you to the login page.

76. Enter the services password created during the installation process. 77. Click Login.

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78. Under Create Administrator Password, create a password for the Tripwire Enterprise administrator account. 79. Click Confirm and Continue.

80. Enter the username and password for the Tripwire Enterprise administrator account. 81. Click Sign In.

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82. Click Configure Tripwire Enterprise to begin the configuration process.

Tripwire Enterprise Agent Installation 1. Run te_agent.msi. 2. Click Next >.

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3. Check I accept the terms in the license agreement. 4. Click Next >.

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5. Specify an installation directory for the Tripwire Enterprise Agent. 6. Click Next >.

7. Enter the TE Server identifier (e.g., WIN-RUQDO7KL8A7) of the server where Tripwire Enterprise is installed. 8. Enter 9898 as the Services Port established during the installation process of Tripwire Enterprise. 9. After installation, check Start Agent.

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10. Check Install Real-Time Monitoring and specify a Monitoring Port. 11. Uncheck Enable FIPS. 12. Click Next >.

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13. Specify a Proxy Host and Proxy Port if necessary. 14. Click Next >.

15. Enter the Services Password created during the installation process for Tripwire Enterprise.

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16. Click Next >.

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17. Click Install.

18. Wait for the installation process to complete.

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19. Click Finish.

2.6 Enterprise Domain Identity Management For this build, enterprise domain identity management relied upon Microsoft Active Directory, domain name system (DNS), and dynamic host configuration protocol (DHCP). Digital certificates were also implemented for services that enable certificate-based authentication. The build implemented these core services.

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2.6.1

Domain Controller with AD, DNS, and DHCP

Within the PACS architecture, we established a Windows Server 2012 R2 Domain Controller to manage AD, DNS, and DHCP services for the enterprise. The following section details how the services were installed. System Requirements This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

CPU: 1

Memory: 4 GB RAM

Storage: 120 GB (thin provision)

Operating System: Microsoft Windows Server 2012 R2

Network Adapter: VLAN 1201

Enterprise Domain Services Installation Install the DC, AD, and DNS appliances according to the instructions detailed in Building Your First Domain Controller on 2012 R2 [5]. DNS Server Forward Lookup Zone Configuration 1. Open Server Manager.

2. In the top right, click Tools > DNS. 3. The DNS forward lookup zone should have already been created during the DNS setup process performed previously. If not, follow these instructions:

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Right-click your server’s name, and select Configure a DNS Server…

Click Next >.

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Click Next >. Under Select Configuration Action, select Create a forward loading zone…

Click Next >.

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Under Primary Server Location, select This server maintains the zone Click Next >.

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Enter PACS.TEST as the Zone name that was established previously during setup. Click Next >.

Select Allow only secure dynamic updates.

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Click Next >.

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Add Forwarders (8.8.8.8 and 8.8.4.4 are Google’s DNS servers). Click Next >.

Click Finish.

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DNS Server Reverse Lookup Zone Configuration 1. Open Server Manager.

2. In the top right, click Tools > DNS.

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3. Right-click Reverse Lookup Zones folder, and select New Zone…

4. Click Next >.

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5. Click Next >. 6. Under Zone Type, select Primary zone. 7. Select the Store the zone in Active Directory… checkbox. 8. Click Next >.

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9. Click Next >. 10. Under Active Directory Zone Replication Scope, Select To all DNS servers running… 11. Click Next>.

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12. Choose the Internet Protocol version 4 (IPv4)—IPv4 Reverse Lookup Zone option—and click Next >.

13. Establish what IP addresses should be included in reverse lookup (the example above encompasses all devices in the 192.168.120.0/24 subnet), then click Next >.

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14. Choose the Allow only secure dynamic updates (recommended for Active Directory) option, then click Next >.

15. Click Finish.

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DHCP Server Installation Install the DHCP server according to the instructions detailed in Installing and Configuring DHCP Role on Windows Server 2012 [6]. DHCP Server Configuration 1. Open Server Manager.

2. In the top right, click Tools > DHCP.

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3. If you see a green check mark on the IPv4 server, the DHCP server is up and running.

DHCP Scopes Configuration Performed on Windows Server 2012 R2 1. Open Server Manager.

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2. In the top right, click Tools > DHCP.

3. Right-click IPv4, and select New Scope…

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4. Click Next >.

5. Provide a Name such as Radiology Devices and a Description such as Collection of hospitals Radiology equipment in the New Scope Wizard. 6. Click Next >.

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7. Establish the IP range (192.168.120.200–192.168.120.254) from which the DHCP server should hand out IPs for devices in this scope. 8. Click Next >.

9. Click Next >.

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10. Configure preferred Lease Duration (e.g., 8 days), and click Next >.

11. Choose Yes, I want to configure these options now, then click Next >.

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12. Enter the subnet’s Default Gateway as 192.168.120.1. 13. Click Add.

14. Click Next >.

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15. Ensure IP address in bottom-right box is the IP address (192.168.120.101) for the DNS server configured earlier. 16. Click Next >.

17. Click Next >.

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18. Choose Yes, I want to activate this scope now option, then click Next >.

19. Click Finish.

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20. Scope should appear under the IPv4 drop-down. Ensure Scope Options are correctly established with these values: 

003 Router: 192.168.120.1

006 DNS Servers: 192.168.120.101

015 DNS Domain Name: PACS.TEST

2.6.2

DigiCert PKI

DigiCert is a cloud-based platform designed to provide a full line of SSL certificates, tools, and platforms for optimal certificate life-cycle management. To use the service, an account must be established with DigiCert. Once an account is established, access to a DigiCert dashboard is enabled. From the dashboard, DigiCert provides a set of certificate management tools to issue PKI certificates for network authentication and encryption for data-at-rest or data-in-transit as needed.

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The instructions below describe the process to obtain an SSL certificate on behalf of medical devices using the DigiCert certificate signing services. Create CSR

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A CSR is represented as a block Base64 encoded Public Key Cryptography Standards (PKCS)#10 binary format text that will be sent to a CA for digital signature when applying for an SSL certificate. The CSR identifies the applicant’s distinguished common name (domain name), organization name, locality, country, and the public key. The CSR is usually generated from the device where the certificate will be installed, but it can also be generated using tools and utilities on behalf of the device to generate a CSR. Below are instructions on how to use the Certificate Utility for Windows (DigiCertUtil.exe) provided by DigiCert to generate CSRs for a medical device or a server. Download and save the DigiCertUtil.exe from the DigiCert site [7]. 1. Double-click DigiCertUtil.exe to run the utility. 2. Click the Create CSR link to open a CSR request window. 3. On the Create CSR window, fill in the key information (some of the information is optional). 

Certificate Type: Select SSL

Common Name: HYLAND-VNA.pacs.hclab

Subject Alternative Names: HYLAND-VNA.pacs.hclab

Organization: ********

Department: HCLAB

City: Rockville

State: Maryland

Country: USA

Key Size: 2048

4. Click Generate to create a CSR. This will also generate a corresponding private key in the Windows computer from which the CSR is requested. The Certificate Enrollment Request is stored under Console Root\Certificates(Local Computer)\Certificate Enrollment Requests\Certificates.

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5. The figure below is a sample CSR.

6. Select and copy the certificate contents to the clipboard or save to an American Standard Code for Information Interchange text file. Use the text contents to paste into the DigiCert order form.

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7. Issue Signed Certificates. With a created applicant CSR, request a signed certificate using DigiCert CertCentral portal by following these steps: a. Log in to a DigiCert dashboard (https://www.digicert.com/account/login.php) with your account username and password. In the portal, select CERTIFICATES > Requests, then navigate to Request a Certificate, and select Private SSL to open a certificate request form. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

b. Paste the CSR information to the area called Add Your CSR, including the -----BEGIN NEW CERTIFICATE REQUEST----- and -----END NEW CERTIFICATE REQUEST----- tags. Once the pasting is done, some of the fields will be populated automatically. c. After filling in all the required information, scroll down to the bottom of the page, and select the I Agree to the Certificate Services Agreement Above checkbox. Next, click the Submit Certificate Request button at the bottom of the form to submit the certificate for signing approval.

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8. The certificate is listed under Orders. Once the order status changes to Issued, the certificate is ready for download.

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9. Click a specific order number to display the certificate details with a list of actions that can be performed. Click Download Certificate As to download certificates with signed CA and Root CA certificates. A variety of certificate formats can be downloaded, such as .crt, .p7b, .pem. 10. Save the downloaded certificate in a location where it can be used for further processing if needed. Import and Export the Signed Certification After downloading the SSL certificate from DigiCert, you can use the DigiCert Certificate Utility for Windows to install it. With the DigiCert Utility tool, you can further manipulate the certificates to combine with the private key and export the signed certificate to the certificate requesting device server. 1. From the DigiCert Certificate Utility for Windows, click the Import button to load the downloaded signed Certificate file to the utility. The downloaded file was saved in step 10 of Section 2.6.2. Click the Next button to import. 2. From the DigiCert Certificate Utility for Windows, click SSL to list all the imported files. 3. To export the certificate, select the certificate you want to export as a combined certificate file and key file in a .pfx file or separated as a certificate file and key file, then click Export Certificate.

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4. Click the Next > button, then follow the wizard instructions to save the certificate file and private key file to a desired location in the device.

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2.7 Network Control and Security Network control and security was implemented throughout the network infrastructure. The build features perimeter security that includes firewall feature sets and network traffic monitoring. The internal lab environment implements VLANs to establish network zones. Modality devices are further isolated by using micro-segmentation. The build also includes behavioral analysis tools that alert upon anomalous activity. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2.7.1

Cisco Firepower

Cisco Firepower, consisting of Cisco Firepower Management Center and Cisco Firepower Threat Defense, is a network management solution that provides firewall, intrusion prevention, and other networking services. For this project, Firepower was used to provide network segmentation and both internal and external routing. Access control and intrusion prevention policies were also implemented. Cisco Firepower Management Center Appliance Information 

CPUs: 8

RAM: 16 GB

Storage: 250 GB (thin provision)

Network Adapter 1: VLAN 1201

Operating System: Cisco Fire Linux

Cisco Firepower Management Center Virtual Installation Guide Install the Cisco Firepower Management Center Virtual appliance according to the instructions detailed in Cisco Firepower Management Center Virtual for VMware Deployment Quick Start Guide [8]. Cisco Firepower Threat Defense Appliance Information 

CPUs: 8

RAM: 16 GB

Storage: 48.5 GB (thin provision)

Network Adapter 1: VLAN 1201

Network Adapter 2: VLAN 1201

Network Adapter 3: VLAN 1099

Network Adapter 4: VLAN 1099

Network Adapter 5: Trunk Port

Network Adapter 6: Trunk Port

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Network Adapter 7: VLAN 1101

Network Adapter 8: VLAN 1101

Network Adapter 9: VLAN 1701

Operating System: Cisco Fire Linux

Cisco Firepower Threat Defense Virtual Installation Guide This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Install the Cisco Firepower Threat Defense Virtual appliance, according to the instructions detailed at Cisco Firepower Threat Defense Virtual for VMware Getting Started Guide [9]. Adding Firepower Threat Defense (FTD) Appliance to Firepower Management Center (FMC) 1. Log in to the FMC Console. 2. Navigate to Devices > Device Management. 3. Click the Add drop-down button and select Add Device.

4. Enter 192.168.120.141 as the IP address of the FTD appliance. 5. Enter FTD-PACS as a display name to identify the FTD appliance. 6. Enter the manager key created when configuring the manager on the FTD appliance. 7. Click the Access Control Policy drop-down and select Create New Policy. a. Create a name for the policy. b. Select Block All Traffic. c. Click Save. 8. Under Smart Licensing, check the boxes next to Malware, Threat, and URL. 9. Under Advanced, check the box next to Transfer Packets.

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10. Click Register.

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11. The FTD appliance will be added to the FMC’s device list.

FTD Interfaces for PACS Architecture Configuration Each physical interface connected to the Cisco FTD will appear in the FMC device management section under the interface tab. To configure the eight subnets needed for the PACS architecture while also allowing management, diagnostic, and wide area network (WAN) traffic, we dedicated two interfaces set up as a redundant pair for all internal subnet traffic. To accomplish this, a sub-interface was created for each of the eight PACS subnets (e.g., Enterprise Services, Imaging Modalities, Security Services) and

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established redundant interfaces for WAN traffic and traffic on VLAN 1101. The following guidance describes how the redundant interfaces and sub-interfaces were created. 1. Log in to the FMC Console. 2. Navigate to Devices > Device Management. 3. Find your FTD device and click the edit icon. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

4. Navigate to Add Interfaces > Redundant Interface.

5. Enter Internal-Network as the name for the redundant interface. 6. Create and/or add a security zone to the redundant interface. 7. Assign a Redundant ID (e.g., Internal-Network) to the redundant interface. 8. Select a primary interface and secondary interface for the redundant pair.

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9. Navigate to the IPv4 tab. 10. Assign an IP address and netmask (e.g., 192.168.100.101/24) to the interface. 11. Click OK.

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12. Navigate to Add Interfaces > Sub Interface.

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13. Enter VNA as the name for the subinterface. 14. Create and/or add a security zone, VNA, to the subinterface. 15. Select an interface under which the subinterface will operate. Note: For our build, we placed each subinterface under Redundant 2, the redundant interface for GigabitEthernet0/2 and GigabitEthernet0/3. These two physical interfaces were the destination for each VLAN’s traffic. 16. Assign 1403 as the Sub Interface ID to the subinterface. 17. Assign 1403 as the VLAN ID to the subinterface.

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18. Navigate to the IPv4 tab. 19. Assign an IP address and netmask (e.g., 192.168.142.1/24) to the subinterface. 20. Click OK.

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21. Click Save. 22. Click Deploy and wait for deployment to FTD to complete. 23. Refresh the page and confirm that the redundant interface and subinterface are running (shown with a green dot on the interface’s icon). This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

DHCP Relay Through Cisco Firepower Management Center Configuration 1. Log in to the FMC Console. 2. Navigate to Devices > Device Management. 3. Find your FTD device and click the edit icon.

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4. Navigate to the DHCP tab.

5. Navigate to the DHCP Relay Agent section.

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6. Under DHCP Relay Agent, click Add.

7. Assign an FTD interface as LAN.

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8. Check the box next to Enable IPv4 Relay. 9. Check the box next to Set Route. 10. Click OK.

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11. Ensure that the new relay, LAN, is in the DHCP Relay Agent list.

12. Under DHCP Servers, click Add.

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13. Click the green + button to create a new object for the DHCP server.

14. Enter Test-DHCP-Server as a name for the DHCP server. 15. Enter 192.168.100.170 as an IP address for the DHCP server. 16. Click Save.

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17. Select the newly created DHCP server. 18. Select an FTD interface through which the DHCP server can be connected. 19. Click OK.

20. Ensure that the new server is in the DHCP Server list.

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21. Click Save. 22. Click Deploy to add the new configuration settings to the FTD appliance.

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Network Address Translation (NAT) Rules Configuration 1. Navigate to Devices > NAT.

2. Click New Policy > Threat Defense NAT.

3. Give the new policy a Name as PACS NAT. 4. Assign the FTD appliance to the new NAT policy. 5. Click Save.

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6. Click the NAT policy’s edit icon. 7. Click Add Rule. 8. Set NAT Rule to Auto NAT Rule. 9. Set Type to Dynamic. 10. Under Interface Objects, set Source Interface Object to one of the FTD appliance’s LAN interfaces. 11. Set Destination Interface Object to the FTD appliance’s WAN interface.

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12. Under Translation, set Original Source to the network that corresponds with the source interface object established in the previous step. 13. Set Translated Source to Destination Interface IP. 14. Click OK.

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15. Ensure that the new NAT Rule has been created. 16. Repeat these steps if needed for each LAN interface attached to FTD appliance. 17. Click Save. 18. Click Deploy to add the changes to the FTD appliance.

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Access Control Policy Through Firepower Management Center Configuration The Firepower Management Center allows configuration of access-control policies that can then be applied to individual FTD appliances. The purpose of the access-control policy is to create rules that specify how traffic is managed within the network. Each access-control policy contains multiple rules followed by a default action established when the policy is created. For the PACS architecture, one access-control policy was established to manage the traffic on each FTD interface. The steps below describe how the policy and rules were created, as well as how to utilize an intrusion policy with the access-control policy. Additional information on the Cisco Firepower access control list and intrusion prevention configuration is available [10]. 1. Navigate to Policies > Access Control > Access Control.

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2. Click New Policy. 3. Enter PACS Global Policy as the name for the access control policy. 4. For Select Base Policy, select None. 5. For Default Action, select Block all traffic. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

6. Add the FTD appliance to the policy. 7. Click Save.

8. Click the access-control policy’s edit icon. Note: The policy in the screenshots that follow contains categories created during the process of building the PACS architecture. These categories are not preconfigured.

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Create a Category 1. Click Add Category. 2. Enter PACS as the name for the category. 3. Insert the category into the Mandatory section. 4. Click OK.

Create a Rule that Allows Application Traffic Between Security Zones

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1. Click Add Rule. 2. Enter PACS-VNA as the name for the rule. 3. Insert the rule into the category created in the previous step. 4. Set Action to Allow. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Note: Because we set the default action to block all traffic when creating the policy, all of the rules we created were set to Allow. 5. Add security zone(s) to the Source Zone, and add security zone(s) to the Destination Zone. Note: The two primary methods for adding source and destination networks to an access control rule are through security zones or networks. Security zones are objects that can contain multiple FTD interfaces. Networks can be different types of network objects, including network segments (192.168.1.0/24) or individual devices (192.168.1.1).

6. Under Applications, add the application(s) you would like to allow between the specified zones. Note: This can also be accomplished by specifying the port you would like to allow under the Ports tab. By specifying a specific port, this will open the port to all traffic regardless of the type of traffic (e.g., DICOM) being sent. 7. Click Add.

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8. Verify that the Rule has been created.

Create a Rule that Allows Traffic on a Specific Port Between Networks 1. Click Add Rule.

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2. Enter PACS-Internet as the name for the rule. 3. Insert the rule into the category created previously. 4. Set Action to Allow. 5. Under Networks, add a source network(s) and destination network(s). This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

6. Under Ports, add (a) port(s) to the Selected Destination Ports. Note: Select from a group of pre-created ports or add your own port by filling out the protocol and port boxes, then click Add under the selected destination ports.

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7. Under URLs, add URL categories that will be allowed (or leave this section blank). Note: Cisco Firepower generates the URL categories and updates them regularly. Within each URL category, you can specify the reputation level that the URL must meet for the rule to match.

8. Under Inspection, add an intrusion policy, or leave this section blank.

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Note: Intrusion policies are created separately from the access-control policy. Once created, an intrusion policy can be applied to a specific access-control rule or an entire access-control policy. See the link posted [10] at the beginning of this section for more information on how to create and use intrusion policies in Cisco Firepower.

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9. Under Logging, select Log at End of Connection, or leave this section blank. Note: If logging is enabled, select Event Viewer. 10. Click Add.

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11. Verify that the access control rules have been created and placed in the proper category. 12. Click Save. 13. Click Deploy to add changes to the FTD appliance.

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2.7.2

Cisco Stealthwatch

Cisco Stealthwatch provides network visibility and analysis through network telemetry. It provides threat detection and remediation as well as network segmentation using machine learning and behavioral modeling. This project integrates Cisco Stealthwatch with Cisco Firepower to allow Cisco FTD to send NetFlow directly to Stealthwatch for analysis. Cisco Stealthwatch Management Console Appliance Information 

CPUs: 3

RAM: 16 GB

Storage: 60 GB (thin provision)

Network Adapter 1: VLAN 1901

Operating System: Linux

Cisco Stealthwatch Management Console Virtual Edition Installation Guide Install the Cisco Stealthwatch Management Console appliance according to the instructions detailed in the Cisco installation guide [11].

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Cisco Stealthwatch User Datagram Protocol (UDP) Director Appliance Information

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CPU: 1

RAM: 4 GB

Storage: 60 GB (thin provision)

Network Adapter 1: VLAN 1901

Network Adapter 2: VLAN 1901

Operating System: Linux

Cisco Stealthwatch UDP Director Virtual Edition Installation Guide Install the Cisco Stealthwatch UDP Director appliance according to the instructions provided in the Cisco installation guide [11]. Cisco Stealthwatch Flow Collector Appliance Information 

CPUs: 2

RAM: 16 GB

Storage: 60 GB (thin provision)

Network Adapter 1: VLAN 1901

Operating System: Linux

Cisco Stealthwatch Flow Collector Virtual Edition Installation Guide Install the Cisco Stealthwatch Flow Collector appliance according to the instructions provided in the Cisco installation guide [11]. Configure NetFlow Parameters for Cisco Firepower 1. Log in to the Cisco Firepower Management Console.

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2. Navigate to Objects.

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3. Navigate to FlexConfig > Text Object.

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4. Under the Name column, find netflow_Destination.

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5. Click the edit icon for netflow_Destination. 6. Set Variable Type to Multiple. 7. Set Count to 3. 8. For Row 1, enter Security-Service to set the name of the Cisco FTD interface to which the Cisco Stealthwatch UDP appliance is connected. 9. For Row 2, enter 192.168.190.120 to set the IP address of the Cisco Stealthwatch UDP appliance. 10. For Row 3, enter 2055 to set a port from which the Cisco Stealthwatch UDP appliance will receive NetFlow traffic. 11. Click Save.

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12. Under the Name column, find netflow_Parameters.

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13. Click the edit icon for netflow_Parameters. 14. Set Variable Type to Multiple. 15. Set Count to 3. 16. For Row 1, enter 1 as a number for minutes between flow update events. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

17. For Row 2, enter 0 as a number for seconds to delay flow create. 18. For Row 3, enter 30 as a number for minutes for template time-out rate. 19. Click Save.

20. Navigate to Devices > FlexConfig.

21. Click New Policy.

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22. Enter a Name (e.g., Netflow) for the policy. 23. Under Selected Devices, add the Cisco FTD. 24. Click Save.

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25. Click the edit icon for the new policy.

26. Under Available FlexConfig, find Netflow_Set_Parameters, and add it to Selected Append FlexConfigs.

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27. Click the magnifier icon for Netflow_Set_Parameters. 28. Under Variables > Default Value, verify the minutes between flow data events, seconds to delay flow create, and minutes for template time-out rate that were set for netflow_Parameters. 29. Click Close.

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30. Under Available FlexConfig, find Netflow_Add_Destination, and add it to Selected Append FlexConfigs. 31. Click the magnifier icon for Netflow_Add_Destination. 32. Under Variables > Default Value, verify the Cisco FTD interface name, IP address of the Cisco Stealthwatch, and the NetFlow traffic port. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

33. Click Close.

34. Click Save. 35. Deploy changes to the Cisco FTD. Forwarding Rules for Cisco Stealthwatch UDP Configuration 1. Log in to the web dashboard of the Cisco Stealthwatch Management Console.

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2. Navigate to Settings > Central Management.

3. Click the ellipsis for the Cisco Stealthwatch UDP appliance and select Edit Forwarding Rules.

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4. Click the ellipsis for the Cisco Stealthwatch UDP appliance, select Configure Forwarding Rules.

5. Under Forwarding Rules, select Add New Rule.

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6. Enter a description (e.g., Firepower FTD) for the rule. 7. For source IP address and source port, enter the IP address and port (e.g., 192.168.190.1:2055) of the Cisco FTD interface sending the NetFlow traffic. Note: These parameters were established in Cisco FTD, found in the previous section, for the netflow_Destination object. 8. For destination IP address, enter the IP address (e.g., 192.168.190.122) of the Cisco Stealthwatch Flow Collector. 9. For destination port, enter the port (e.g., 2055) of the Cisco Stealthwatch Flow Collector. Note: This port was configured during setup of the Flow Collector.

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10. On the Cisco Stealthwatch Management Console dashboard, view the Flow Collection Trend graph to verify that the Cisco Stealthwatch Flow Collector is receiving packets from the Cisco Stealthwatch UDP.

2.7.3

Tempered Networks Identity Defined Networking (IDN)

Tempered Networks IDN provides cryptographically defined host identifiers using the HIP protocol rather than IP addressing. Network traffic traverses an overlay network using HIPswitches that

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effectively cloak that traffic from the production network. A notional architecture appears in Figure 2-2 below. Figure 2-2 Architecture of Networks IDN

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Tempered Networks Conductor is the orchestration engine and intelligence behind an IDN. As shown in the above figure, the Conductor is responsible for creating and executing security policies and overlays. It is also responsible for issuing unique cryptographic IDs to the IDN end points that enforce explicit trust relationships through device-based allow-listing. HIPswitches are typically deployed in front of devices or hosts that cannot protect themselves, like medical devices such as modalities and other legacy systems and machines, or when customers are unable to install the proper endpoint-protection applications. Installation involves deployments of the Tempered Networks Conductor and HIPswitches. Tempered Networks provided a conductor open virtual appliance or application (OVA) file and a HIPswitches OVA file.

2.7.3.1 Conductor Installation System Requirements 

CPUs: 4

Memory: 4 GB RAM

Storage: 120 GB

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Operating System: Linux Red Hat

Network Adapter: VLAN 1201

Tempered Networks Conductor Installation 1. Log in to the vSphere Client. 2. Select File > Deploy OVF Template. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

3. Respond to the prompts with information specific to your deployment, including the ova package location, name and location, storage, networking, and provisioning. 4. Click Power On After Deployment, and click Finish. 5. Once the installation is done, power on the Conductor server, and log in with username macinfo and the corresponding password to set up the necessary MAC address and IP address.

2.7.3.2 HIPswitch Installation System Requirements 

CPUs: 4

Memory: 1 GB RAM

Storage: 1 GB

Operating System: Linux Red Hat

Network Adapter: VLAN 1201

HIPswitch Installation 1. Log in to the vSphere Client. 2. Select File > Deploy OVF Template. 3. Respond to the prompts with information specific to your deployment, including the ova package location, name and location, storage, networking, and provisioning. 4. Click Power On After Deployment, and click Finish. 5. After the installation, use the username and password to connect the HIPswitch to the conductor. 6. Use the username underlayaddress and its corresponding password to set up the IP address, netmask, gateway, and DNS for the HIPswitch. 7. Repeat the above installation procedures to install additional HIPswitches. Tempered Networks Conductor and HIPswitch Configuration

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Configuration for the Conductor and HIPswitches is done through the browser connected to the Conductor https://ConductorIP. The login page appears below. 1. Enter the username and password to open the dashboard.

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2. Click the Settings tab.

3. From this page, you can set up the license and perform the system setup. Click the Setup button to enter the system setup.

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4. Enter the proper network parameters for the Conductor, including the IP address (e.g., 192.168.120.180), Netmask (e.g., 255.255.255.0), Default gateway (e.g., 192.168.120.1), and DNS (e.g., 8.8.8.8, 4.4.8.8), then click Configure.

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5. An overlay is configured to support the micro-segmentation. Click the Overlay tab to open the following page and add a new overlay by clicking the + New Overlay Network… The screenshot below shows a configured overlay called PACS Systems.

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6. Two HIPswitches were installed to test for this project. These two HIPswitches are Model HIPswtich300v, and they are named HIPswitch Internal and HIPswitch Radiology. Both were configured to participate in the PACS Systems overlay network.

7. Two special VLANs were created for each of these two HIPswitches under PACS Systems overlay: 

VLAN 1302 for HIPswitch Internal 1101

VLAN 1303 for HIPswitch Radiology 1501

8. Devices to be protected under the HIP network will be connected to these two HIPswitches through the VLANs: 

PACS servers are connected to VLAN 1302 under the HIPswitch Internal 1101.

Medical imaging devices are connected to VLAN 1303 under the HIPswitch Radiology 1501.

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After creating a secure layer in the Conductor and adding those medical imaging devices and PACS servers to that layer, the medical imaging device and PACS server can be set up as trusted by selecting the Enable button on the overlay page. Once they are trusted, communication between those medical imaging devices and PACS servers will be established. All the communication will be encrypted. The microsegmentation is achieved by using the HIPswitch. Other VMs will not be able to communicate with these two devices unless they are configured to do so. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2.7.4

Zingbox IoT Guardian

Zingbox IoT Guardian consists of two separate components that work together to monitor and analyze network traffic. The first component is a cloud-based platform called Zingbox Cloud, which aggregates and analyzes data to provide insights into the devices on the local network. The second component is Zingbox Inspector, a local appliance that receives network flows from devices on the local network and sends specific metadata to Zingbox Cloud for further analysis. Zingbox Cloud Setup 1. Visit https://zingbox.com and register for an account. 2. Log in to the Zingbox console and navigate to Administration > My Inspectors > Download Inspector. 3. Download either the .ova or the .iso file, depending on your environment’s requirements. System Requirements 

CPUs: 4

Memory: 8 GB RAM

Storage: 256 GB (thin provision)

Operating System: CentOS 7

Network Adapter 1: VLAN 1101

Network Adapter 2: Trunk Port

Zingbox Inspector Installation 1. Create a new virtual machine, and under configuration, select Typical. 2. Click Next >.

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3. Create a Name for the virtual machine and assign it an Inventory Location. 4. Click Next >.

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5. Select a destination storage for the VM. 6. Click Next >.

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7. Check Linux and set the version to CentOS 4/5/6/7 (64-bit). 8. Click Next >.

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9. Connect 2 NICs to the virtual machine and assign them to a network. 10. Check Connect at Power On for both NICs. 11. Click Next >.

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12. Set a Virtual disk size and Provisioning method. 13. Click Next >.

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14. Verify that virtual machine settings are correct. 15. Check Edit the virtual machine settings before completion. 16. Click Continue.

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17. Set memory to 8 GB. 18. Set CPUs to 4. 19. Under New CD/DVD (adding), set these parameters: a. Check Connect at power on. b. Select Datastore ISO File, then browse for the ZingOS.iso file in your data store. 20. Click Finish.

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21. Connect to the inspector console and follow the onscreen prompts to finish the configuration. 22. In a web browser, enter the URL of your Zingbox Cloud instance. 23. Enter your Zingbox Cloud credentials. 24. Click Login. 25. On the home page, navigate to Administration > My Inspectors. 26. Verify that the host name of the Zingbox Inspector set up previously is visible and connected (shown by the green cloud icon).

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2.7.5

Forescout CounterACT 8

Forescout CounterACT is a network access control tool that can perform device discovery and classification, risk assessment, and control automation through passive and active techniques. For this project, the intended use of Forescout is to manage device compliance and perform necessary remediation when devices fall out of compliance. System Requirements 

CPUs: 2

Memory: 8 GB RAM

Storage: 80 GB (thin provision)

Operating System: Linux Kernel 3.10

Network Adapter 1: VLAN 1201

Network Adapter 2: Trunk Port

Forescout Appliance Installation 1. To begin installation, obtain the Forescout ISO file. Load the Forescout ISO file into the VM’s compact disc/digital versatile disc (CD/DVD) drive. Make sure the CD/DVD drive is set to Connect at Power On. 2. Boot up the VM and begin the installation process. 3. Select Install CounterACT. 4. Press Enter to reboot.

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5. Select option 1 to configure CounterACT. 6. Select option 1 for standard installation. 7. Press enter to proceed. 8. Select option 1 for CounterACT Appliance. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

9. Select option 1 for Per Appliance Licensing Mode. 10. Enter appliance description. 11. Give appliance a password. 12. Enter ForescoutCA and apply this as the appliance host name. 13. Assign the appliance IP address 192.168.120.160. 14. Assign appliance network mask 255.255.255.0. 15. Enter 192.168.120.1 as the appliance’s gateway. 16. Enter domain name ******** 17. Enter DNS server address 192.168.120.100. 18. Review configuration and run test. 19. Once the test passes, select done. Forescout CounterACT Console Installation 1. Run Install_Management.exe. 2. Click Next >.

3. Verify Installation Directory as C:\Users\Administrator\ForeScout CounterACT 8.0.1; click Next >.

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4. When the Ready to Install screen appears, click Next > to begin the installation process.

5. An Installing screen will appear that provides a status bar indicating the degree of installation completion. Click the Next > button to allow the installation to proceed.

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6. As the installation nears completion, a screen indicating Completing the ForeScout 8.0.1 Setup Wizard displays. Check Create Desktop shortcut; then click Finish.

7. Launch Forescout CounterACT Console, and enter the information that follows, then click Login: a. Enter 192.168.120.160 in the IP/Name text box. b. Select Password as the Login Method. c. Enter Administrator in the User Name text box. d. Enter the password in the Password box.

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Forescout CounterACT Configuration To use the full function offered by the Forescout CounterACT, proper network configuration is required, which may include the monitor and response interface assignments at the data center, the network VLAN and segmentation information, the IP address range that the CounterACT appliance will protect, user directory account information, domain credentials, the core switch IP address, and vendor and Simple Network Management Protocol parameters. After completing the installation, log in to the CounterACT Console by using the steps below: 1. Select the CounterACT icon from the server on which you installed the CounterACT Console. A logon page displays, as depicted below.

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2. Provide the following information, and select Login to open the console: a. Enter the IP address 192.168.120.160 in the IP/Name field. b. In the User Name field, enter admin. c. In the Password field, enter the admin password, which is defined during the installation. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

The console manager can be used to view, track, and analyze network activities detected by the appliance. It can also be used to define the threat protection, firewall, and other polices. The figure below shows the sample asset inventory page. (Further network configuration will be needed for complete inventory information.)

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The figure below shows the sample Policy Manager page. Further network configuration and policy definition will be needed for complete policy information.

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2.7.6

Symantec Endpoint Detection and Response (EDR)

Symantec Endpoint Detection and Response performs behavioral analytics on endpoint events from Symantec Endpoint Protection to identify potentially malicious behavior. It can sandbox impacted endpoints, prioritize risks, and provide tailored remediation guides. System Requirements This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

CPUs: 12

Memory: 5 GB RAM

Storage: 500 GB (thin provision)

Operating System: CentOS 7

Network Adapter 1: VLAN 1901

Network Adapter 2: SPAN_PACS

Symantec EDR Installation 1. Launch the virtual appliance after deployment of the vendor-provided SEDR-4.0.0-483-VE.ova file. 2. Enter default username admin and default password. You will be required to change the default password by entering a new password. 3. After changing the default password, the bootstrap will automatically launch. Enter the following options during the bootstrap: 

IPv4 address []: 192.168.190.17

IPv4 netmask []: 255.255.255.0

Gateway []: 192.168.190.1

Name server (IPv4) []: 192.168.120.100

Configure another nameserver? [y/n]: n

Configure IPv4 static routes? [y/n]: n

What do you want to call this device?: EDR

Set NTP server []: X.X.X.X

4. After verifying the correct details, enter Y to save changes. The appliance will restart.

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5. Open a web browser, and travel to the virtual appliance at https://192.168.190.170. Enter the username setup and password *****. 6. Follow the prompts to create the initial admin account.

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7. Select the Settings menu, and then select the Global submenu. 8. Ensure Enable Symantec Endpoint Protection Correlation is checked. 9. Select Add SEPM Database.

10. Provide the information that follows, and click Save:

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DB Type: Embedded DB

Entry Name: SEPM

Address: 192.168.190.172

Port: 8081

Connection Password: Enter your connection password.

Enabled: checked

11. After completing the integration with SEPM, select the Settings menu, then select the Appliances submenu. 12. Select Edit Default Appliance. 13. Select Add Internal Network to create and add a Subnet, Netmask, and Description for each internal network listed below. Make sure to save after entering the network details.

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Subnet: 192.168.100.0 Netmask: 255.255.255.0 Description: VLAN 1101

Subnet: 192.168.120.0 Netmask: 255.255.255.0 Description: VLAN 1201

Subnet: 192.168.130.0 Netmask: 255.255.255.0 Description: VLAN 1301

Subnet: 192.168.140.0 Netmask: 255.255.255.0 Description: VLAN 1401

Subnet: 192.168.141.0 Netmask: 255.255.255.0 Description: VLAN1402

Subnet: 192.168.150.0 Netmask: 255.255.255.0 Description: VLAN 1501

Subnet: 192.168.160.0 Netmask: 255.255.255.0 Description: VLAN 1601

Subnet: 192.168.180.0 Netmask: 255.255.255.0 Description: VLAN 1801

Subnet: 192.168.190.0 Netmask: 255.255.255.0 Description: VLAN 1901

14. Select Settings and then Global.

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15. Uncheck Enable ECC 2.0 under Endpoint Communication Channel, SEP Policies, and Endpoint Activity Recorder.

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16. Select Settings and then Appliances.

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17. Select EDR from the appliances list. 18. Turn on Scanning under the Network Interface Settings. Symantec EDR and SEP Correlation 1. Open a web browser and navigate to the virtual appliance at https://192.168.190.170. Log in with your administrator account. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2. From the settings menu, select global settings. 3. Select Download Synapse Log Collector for SEPM Embedded DB. 4. After the SEPMLogCollector.msi finishes downloading, move to the SEP Manager (SEPM). 5. Launch the SEPMLogCollector.msi file from SEPM. 6. Continue through the setup wizard prompts by clicking Next to use the default settings. 7. After installation is complete, launch the Log Collection for SEPM embedded DB configuration utility, and enter the values below: 

Service Hostname (optional): Leave blank.

Service IP address: 192.168.190.172

Service port: 8082

Log Collector connection password: Enter connection password.

Confirm connection password: Enter connection password again.

SEPM embedded database configuration password: Enter the embedded DB password.

8. After entering values into the configuration utility, click Confirm.

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2.8 Endpoint Protection and Security Endpoint protection and security measures are deployed to workstation end points to further emphasize defense in depth. The build includes an agent-based endpoint protection solution that is centrally managed within the enterprise. Endpoint protection provides anti-malware features with centralized servers assuring that managed assets receive regular updates.

2.8.1

Symantec Data Center Security: Server Advanced (DCS:SA)

Symantec DCS:SA utilizes a software agent to provide various server protections, including application allow-listing, intrusion prevention, and file integrity monitoring. For this project, a DCS:SA agent was installed on both PACS servers in our architecture. System Requirements 

CPUs: 4

Memory: 8 GB RAM

Storage: 120 GB (thin provision)

Operating System: Microsoft Windows Server 2016 Datacenter

Network Adapter: VLAN 1901

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Symantec Data Center Security Installation 1. Launch server.exe. 2. Click Next >.

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3. Check I accept the terms of the license agreement. 4. Click Next >.

5. Verify installation location.

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6. Click Next >.

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7. Review settings. 8. Click Install >.

9. Wait for the setup and installation process to complete.

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10. SQL Server will be installed automatically during the setup process.

11. Provide the information below, and click Next: 

Agent port: 443

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Bridge port: 2443

Console port: 4443

Web server administration port: 8081

Web server shutdown port: 8006

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12. Uncheck Enable CWP Bridge and click Next.

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13. Verify settings for FQDN Hostname as WIN-RUQDO7KL8A7, Static IP Address as 192.168.120.207, and Java Heap Size as 6144, then click Next.

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14. Create a password for the DB connection. 15. Click Next.

16. Verify Unified Management Console connection settings. 17. Create a password for the Unified Management Console connection.

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18. Click Next.

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19. Verify the configuration settings and click Next.

20. Wait for the configuration process to complete. 21. Click Finish.

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22. Wait for the installation to complete and click OK.

Symantec Datacenter Security Windows Agent Install 1. Run agent.exe. 2. Click Next >.

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3. Check I accept the terms in the license agreement. 4. Click Next >.

5. Verify the installation and log files directories. 6. Click Next >.

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7. Provide the information below, and click Next >: 

Agent Name: WIN-RUQDO7KL8A

Polling Interval (sec): 300

Check Enable Intrusion Prevention.

Notification Port: 2222

Agent Protocol: HTTPS

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8. Provide the information below, and click Next: 

Primary Management Server: 192.168.120.207

Agent Port: 443

Alternate Management Servers:

Management Server Certificate: C:\User\Administrator\Desktop\agent-cert.ssh

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9. Specify a Server Security Group created through Symantec Datacenter Security Server or leave it blank to use the default security group. 10. Click Next >.

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11. Verify installation and configuration settings and click Install.

12. Wait for the installation process to complete.

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13. Click Finish.

14. Click Yes to restart the agent machine.

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2.8.2

Symantec Endpoint Protection

Symantec Endpoint Protection is an agent-based security solution that provides anti-virus, intrusion prevention, application allow-listing, and other capabilities. For this project, Symantec SEP protects endpoints from malicious software and integrates with Symantec Endpoint Detection and Response to detect suspicious behavior. System Requirements 

CPUs: 4

Memory: 8GB RAM

Storage: 240 GB (thin provision)

Operating System: Microsoft Windows Server 2016

Network Adapter: VLAN 1901

Symantec Endpoint Protection Manager Installation 1. Launch Symantec_Endpoint_Protection_14.2.0.MP1_Part1_Trialware_EN.exe file. 2. Select the Install Symantec Protection Endpoint Manager option.

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3. Proceed through the installation wizard by clicking Next >.

4. Check I accept the terms in the license agreement. 5. Click Next >.

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6. Select the location you want to install Symantec Endpoint Protection Manager and click Next >. Keep the default location of C:\Program Files (x86)\Symantec\Symantec Endpoint Protection Manager\.

7. Select Install.

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8. After installation is complete, click Next > to continue with configuration of the management server.

9. Select Default configuration for new installation…; then click Next >.

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10. Provide the following information and click Next >. 

Company Name: ********

User name: ********

Password: ********

Confirm password: ********

Email address: ********

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11. Confirm that Run LiveUpdate during installation is checked; click Next >.

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12. Uncheck Send anonymous data to Symantec to receive enhanced threat protection intelligence and click Next >.

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13. After installation is completed, check Launch the Symantec Endpoint Protection Manager to configure your hosts; click Finish.

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Symantec Endpoint Protection Host Windows Installation 1. Launch the Symantec Endpoint Protection Manager, and log in as the admin.

2. Select Install the client software on your computers from the Getting Started screen.

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3. Confirm that New Package Deployment is checked and click Next >.

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4. Confirm the settings for the Install Packages: Windows—Symantec Endpoint Protection version 14.2.1023.0100—English, Group: My Company, Install Feature Sets: Full Protection for Clients, Install Settings: Default Standard client installation settings for Windows. Click Next >.

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5. Confirm that Save Package is selected and click Next >.

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6. Specify the location to save the installation files and click Next >.

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7. Confirm the details of the custom installation files and click Next >.

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8. Move the installation package to the operating system where you want to install Symantec Endpoint Protection. 9. Launch the executable file and follow the prompts to install Symantec Endpoint Protection.

2.9 Data Security A cloud storage solution, Microsoft Azure, was used to provide data security safeguards for medical images. The Azure solution provides data-at-rest encryption and, through a combination of access control and encryption, provides data security assurance. The NCCoE lab used several different solutions to address data-in-transit encryption. As described in Section 2.6.2, DigiCert PKI, the lab implemented SSL/TLS encryption using DigiCert-issued certificates. Communications between modalities and clinical systems are secured using HIP, as described in Section 2.7.3, Tempered Networks Identity Defined Networking (IDN).

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2.9.1

Microsoft Azure Cloud Storage

Microsoft Azure is a cloud service provider that provides storage and encryption for unstructured data in a remote location separate from the HDO environment. This project used an Azure blob storage account as a remote archive for medical images managed by the VNA. For more information on configuring Azure Storage accounts, including recommended security practices, visit Microsoft’s Azure Blob Storage Documentation [13]. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Microsoft Azure Blob Storage Creation To proceed with the following steps, a Microsoft Storage account needs to be established. 1. From a web browser, navigate to https://portal.azure.com/. 2. Log in to the Microsoft account. 3. On the home screen, click Create a resource.

4. Type storage account into the search bar, then click Storage account.

5. On the Storage Account screen, click the Create button. A new screen will appear that requires information to be populated, found in the Basics tab. When complete, click the Next: Networking button. Populate the Basics information using the following values:

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a. On the Subscription field, select Enterprise from the pull-down menu. b. Navigate to the Resource Group field. Select the corresponding resource group. If one is not available, create a new resource group. c. Navigate to the Storage Account Name field. From the pull-down menu, select the storage account name that had previously been created. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

d. Navigate to the Location field. From the pull-down menu, select (US) East US. e. Navigate to the Performance field and select Standard. f.

Navigate to the Account Kind field. From the pull-down menu, select StorageV2.

g. Navigate to the Replication field. From the pull-down menu, select Geo-redundant storage (GRS). h. Navigate to the Access Tier field and select Hot.

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6. Select the Networking tab. This will display a form with a series of fields that need to be populated. Fill out the Networking information using the following respective values. a. Navigate to the Connectivity Method field and select Public endpoint (all network). b. Navigate to the Network Routing Preference field and select Microsoft network routing.

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7. After supplying the values above, click the Next: Data Protection button. 8. Select the Data Protection tab, and populate the information as follows: a. Navigate to the Blob Soft Delete field and select Enabled. b. Navigate to the Blob Retainment Period in Days field and enter 60. c. Navigate to the File Share Soft Delete field and select Disabled.

9. Click the Next: Advanced button. 10. Populate the Advanced information as follows:

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a. Navigate to the Secure Transfer Required: field and select Enabled. b. Navigate to the Blob Public Access field and select Disabled. c. Navigate to the Minimum TLS Version pull-down menu and select Version 1.2. 11. Click Next: Tags button. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

12. Fill out the Tags information, then click Next: Review + create.

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13. Review the Create storage account configuration page, verify the configuration information, then click Create. Basics 

Subscription: Visual Studio Enterprise Subscription

Resource group: ********

Location: East US

Storage account name: ********

Deployment model: Resource manager

Account kind: StorageV2 (general purpose v2)

Replication: Geo-redundant storage (GRS)

Performance: Standard

Access tier (default): Hot

Networking 

Connectivity method: Public endpoint (all networks)

Default routing tier: Microsoft network routing (default)

Data protection 

Blob soft delete: Enabled

Blob Retainment Period in Days: 60

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File share soft delete: Disabled

Blob change feed: Disabled

Versioning: Disabled

Advanced This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

Secure transfer required: Enabled

Blob public access: Disabled

Minimum TLS version: TLS 1.2

Large File Shares: Disabled

Hierarchical namespace: Disabled

NSF v3: Disabled

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14. Wait for the deployment process to finish. When the deployment is ready, a screen will announce that the deployment has been created.

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15. Navigate to the home screen and click All resources.

16. Click the newly created storage account. 17. Navigate to Firewalls and virtual networks on the left. 18. Make the following modifications, then click Save: 

Allow access from: Selected networks

Address range: ********

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19. Navigate to Encryption on the left. 20. Under Encryption type, select Customer-managed keys. 21. Under Encryption key, select Select from key vault. 22. Under Key vault and key, click Select a key vault and key.

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23. Under Key Vault, click Create New.

24. On the Create key vault screen, select the Basics tab, and populate the information as follows: a. Navigate to the Resource Group field, select the corresponding resource group. b. Navigate to the Key Vault Name field, select the corresponding key vault name. c. Navigate to the Pricing Tier field; select Premium. d. Navigate to the Soft-Delete field; select Enabled. e. Navigate to the Days to Retain Deleted Vaults field; enter 60. f.

Navigate to the Purge Protection field; select Allow purging.

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25. Click the Next: Access Policy button. 26. Fill out the Access Policy information, then click Next: Networking. a. Navigate to the Enable Access to group, and set the following checkboxes: 

Azure Virtual Machines for deployment: Unchecked

Azure Resource Manager for template deployment: Unchecked

Azure Disk Encryption for volume encryption: Unchecked

b. Navigate to the Current Access Policies: group and keep the Default User Permissions.

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27. On the Create key vault screen, under the Networking tab, navigate to the line labelled Connectivity method and select Public endpoint(all networks) and then click on Next:Tags>.

28. Fill out the Tags information, then click Next: Review + create.

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29. Review the Create key value configuration page, verify the configuration information, then click Create. Basics 

Subscription: Visual Studio Enterprise Subscription

Resource group: ********

Key vault name: ********

Region: East US

Pricing tier: Premium

Soft-Delete: Enabled

Purge Protection During Retention Period: Disabled

Retention period (days): 60 days

Access policy 

Azure Virtual Machines for deployment: Disabled

Azure Resource Manager for template deployment: Disabled

Azure Disk Encryption for volume encryption: Disabled

Permission model: Access control list

Access policies: 1

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Networking 

Connectivity method: Public endpoint (all networks)

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30. Wait for the creation process to finish. 31. Navigate to the Key field and click Create New.

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32. Fill out the form with the following information, then click Create: 

Options: Generate

Name: ********

Key Type: RSA

RSA Key Size: 2048

Enabled?: Yes

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33. Once the key has been successfully created, ensure the values for Subscription, Key Vault, and Key are correct as follows, then click Select: 

Subscription: Visual Studio Enterprise Subscription

Key vault: ********

Key: ********

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34. Verify the following Encryption information, then click Save: 

Encryption type: Customer-managed keys

Encryption key: Select from key vault

Key vault: ********

Key: ********

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35. Take note of the key strings. These will be used to authenticate the VNA’s requests to the storage account: 

Storage account name: ********

Key: ********

Connection string: ********

36. Navigate to Storage Explorer on the left of the Storage Explorer (preview) page. 37. Right-click BLOB CONTAINERS, then click Create blob container.

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38. Fill out value of the Name field for the New container, then click Create.

39. The established storage account is ready for use, and the VNA can be configured to send and receive medical images to and from the storage account container.

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2.9.2

Hyland VNA Cloud Archive Device

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

For this project, a Hyland engineer upgraded the Hyland Acuo VNA v6.0.4 and NilRead Enterprise v4.3.31.98805 to Acuo VNA v6.0.4.2798_H2_P2 and NilRead Enterprise v4.4.32.103830. These upgrades enabled the Hyland VNA to store patient studies in a Microsoft Azure storage account. When configuring the connection to the Azure account, the VNA allowed an engineer to determine the number of days that patient studies were held in the cache. For testing purposes, this project kept studies in the VNA cache for three days and immediately stored these studies in the Azure storage. When configuring for production, identify time frames for cache and cloud storage that coincide with an HDO’s business practices. Hyland NilRead Archive Device Configuration 1. Open a web browser and navigate to the Acuo Admin Portal created in Section 2.2.2, Hyland Acuo VNA. 2. Enter the Username and Password for the Admin Portal, and click Sign In.

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3. Navigate to the Archive Devices section of the portal by clicking the drop-down list on the top left corner of the screen and selecting Storage Management and then Archive Devices.

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4. Click Add New Archive Device in the top of the screen, then select Azure.

5. In the Add New Azure Archive Device window, provide the following Azure account information: 

Name: ********

Container Size: 20 MB

Account Name: ********

Account Key: ******************

6. Click Add Archive Device.

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Connect Microsoft Azure Archive Device to the RADIOLOGY Storage Application 1. Click Storage Applications on the left-hand side of the screen. 2. Click RADIOLOGY. 3. Scroll down and click Add Archive. 

Device: ********

Write files older than: 1 day(s)

Enable Write files to archive.

4. Click Add Archive.

Set Parameters for Image Archival to Microsoft Azure

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1. Select Nccoe-Azure under Archive Devices at the bottom of the screen. 2. Set Write files older than to 0 days. 3. Click Save Changes.

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Set Parameters for Storing Images in the VNA’s Cache 1. Click Edit Cache Cleaner Configuration. 2. Set Clean Files Older Than to 3 days. 3. Click Save Changes.

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2.10

Secure Remote Access

Both healthcare and IT systems require access by vendor support technicians for remote configuration, maintenance, patching, and updates to software and firmware. This project implemented secure remote access by integrating Symantec Validation and ID Protection (VIP) into the ConsoleWorks authentication mechanism. This implementation enforced two-factor authentication with username, password, and a onetime passcode. This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

2.10.1

TDi Technologies ConsoleWorks

The NCCoE lab implemented a VendorNet using TDi ConsoleWorks, which is a browser interface that enables HDOs to manage, monitor, and record activities from external vendors in the IT infrastructure. System Requirements 

CPUs: 1

Memory: 8 GB RAM

Storage: 40 GB

Operating System: CentOS 7

Network Adapter: VLAN 1097

TDi ConsoleWorks Installation The TDi ConsoleWorks installation in this PACS environment replicates the installation in the Wireless Infusion Pumps Project. For detailed installation guidance, please refer to Section 2.1.8, TDi ConsoleWorks External Remote Access, in NIST SP 1800-8C, Securing Wireless Infusion Pumps [12]. TDi ConsoleWorks Radius Authentication Configuration In our project, we integrated TDi ConsoleWorks with the Symantec VIP for two-factor authentication. This section explains how to enable external authentications for ConsoleWorks. In the next section, we explain how we configured Symantec VIP to integrate with ConsoleWorks. 1. Download extern_auth_radius.so file from ConsoleWorks support site [14]. 2. Move extern_auth_radius.so file to /opt/ConsoleWorks/bin directory. 3. Restart ConsoleWorks by executing cw_stop and cw_start scripts located in the /opt/ConsoleWorks/bin directory. 4. From the ConsoleWorks web interface, navigate to Security, and click External Authentication. 5. Click add to create a new external authentication source.

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6. Fill out the required fields. The setup we used is below:

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Record Name: Radius

Ensure Enable is checked.

For Library, select radius.

Parameter 1: 192.168.120.190:1812/*******

Parameter 2: 30

Parameter 6: 15

Template User: CONSOLE_MANAGER

7. Continue through the prompt by clicking Next; click Save on the final prompt.

8. Ensure that Enable External Authentication is checked.

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2.10.2

Symantec Validation and ID Protection (VIP)

Symantec Validation and ID Protection is an authentication service that provides various forms of authentication such as push, short message service (SMS), and biometric. This project used Symantec VIP as a second form of authentication for remote access to the PACS architecture through TDi Technologies ConsoleWorks. System Requirements 

CPUs: 4

Memory: 8192 MB RAM

Storage: 240 GB (thin provision)

Operating System: Microsoft Windows Server 2016

Network Adapter: VLAN 1201

Symantec VIP Installation 1. Right-click on setup.exe file for VIP Enterprise Gateway 9.8.0; select Run as administrator.

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2. Proceed through the installation wizard by clicking Next >.

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3. Check I accept the agreement. 4. Click Next >.

5. Create a username as admin and a password and click Next >.

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6. Keep the default installation location by clicking Next >.

7. Click Install.

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8. Click Finish after installer is complete.

9. On the Symantec VIP local machine, open a web browser, and navigate to http://localhost:8232. Sign in with the User Name as admin and corresponding Password specified during installation.

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10. Select User Store from the menu bar.

11. Add a user store with the following information:

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Name: AD PACS

Connection: ad-main

Host: ad.pacs.hclab

Port: 389

User DN: CN=symantec, DC=pacs, DC=hclab

Password: *********

Base DN: DC=pacs, DC=hclab

User Filter: (&(&objectClass=user)(objectCategory=person))(sAMAcountName=%s))

12. Log into VIP Manager by navigating to https://manager.vip.symantec.com/vipmgr. Use the account provided by Symantec. 13. Select Register Your VIP Credential. Provide the Credential ID and Security Code of your credentials. Credentials can be downloaded by navigating to https://vip.symantec.com/.

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14. After registering the credential, select Go to My Account.

15. Select Account from menu bar, then select Manage VIP Credentials.

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16. Select Request a Certificate.

17. Provide a Certificate Name as NCCoE_VIP_Cert. Click Submit Request.

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18. Select PKCS#12 format and create a password for the requested certificate. Then select Download Certificate.

19. Save the certificate on the Symantec VIP local machine.

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20. Navigate to http://localhoat:8232. After logging, select Add VIP Certificate.

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21. Select Browse and upload the certificate from the previous step. Enter the correct password and alias for the certificate, then click Submit.

22. Select Validation from the menu bar, select Custom configuration, and provide the information that follows: 

Server Name: vip

Local IP: 192.168.120.190

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Port: 1812

RADIUS Shared Secret: *****

Confirm RADIUS Shared Secret: *****

Enable First Factor: Checked

Authentication on: Enterprise

Authentication Sequence: LDAP Password–VIP Authentication

User Store: AD PACS

23. Click Submit.

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24. Ensure that VIP Server Status is set to ON.

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Appendix A

List of Acronyms

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

AD

Active Directory

AES

Advanced Encryption Standard

AE Title

Application Entity Title

CA

Certificate Authority

CIDR

Classless Inter-Domain Routing

CPU

Central Processing Unit

CSR

Certificate Signing Request

DB

Database

DC

Domain Controller

DCS:SA

Data Center Security: Server Advanced

DHCP

Dynamic Host Configuration Protocol

DICOM

Digital Imaging and Communications in Medicine

DNS

Domain Name System

EDR

Endpoint Detection and Response

FMC

Firepower Management Center

FTD

Firepower Threat Defense

GB

gigabyte

GUI

Graphical User Interface

HD

Hard Drive

HDO

Healthcare Delivery Organization

HIP

Host Identity Protocol

HL7

Health Level 7

http

Hypertext Transfer Protocol

https

Hyper Text Transfer Protocol Secure

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IDN

Identity Defined Networking

IIS

Internet Information Services

IoT

Internet of Things

IP

Internet Protocol

IPv4

Internet Protocol Version 4

ISO

International Organization for Standardization

IT

Information Technology

LDAP

Lightweight Directory Access Protocol

MB

Megabyte

MPPS

Modality Performed Procedure Step

NAT

Network Address Translation

NCCoE

National Cybersecurity Center of Excellence

NIST

National Institute of Standards and Technology

NTP

Network Time Protocol

OS

Operating System

OVA

Open Virtual Appliance or Application

OVF

Open Virtualization Format

PACS

Picture Archiving and Communication System

PKCS

Public Key Cryptography Standards

PKI

Public Key Infrastructure

QR Code

Quick Response Code

RAM

Random Access Memory

RIS

Radiology Information System

SCP

Service Class Provider

SEP

Symantec Endpoint Protection

SEPM

Symantec Endpoint Protection Manager

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SMS

Short Message Service

SP

Special Publication

SQL

Structured Query Language

SSL/TLS

Secure Sockets Layer/Transport Layer Security

TCP/IP

Transmission Control Protocol/Internet Protocol

UDM

Universal Data Manager

UDP

User Datagram Protocol

URL

Uniform Resource Locator

VIP

Validation and ID Protection

VLAN

Virtual Local Area Network

VM

Virtual Machine

VNA

Vendor Neutral Archive

WAN

Wide Area Network

WLM

Workload Management

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Appendix B

References

This publication is available free of charge from: https://doi.org/10.6028/NIST.SP.1800-24.

[1]

Docker. Install Docker Desktop on Windows. Available: https://docs.docker.com/docker-forwindows/install/.

[2]

Microsoft Docs. Install SQL Server from the Installation Wizard (Setup). Available: https://docs.microsoft.com/en-us/sql/database-engine/install-windows/install-sql-server-fromthe-installation-wizard-setup?view=sql-server-2017.

[3]

K. McKay and D. Cooper, Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations, National Institute of Standards and Technology (NIST) Special Publication (SP) 800-52 Revision 2, NIST, Gaithersburg, Md., Aug. 2019. Available: https://doi.org/10.6028/NIST.SP.800-52r2.

[4]

DVTk. DVTk open source project main contributors ICT Group and Philips. Available: https://www.dvtk.org/.

[5]

Microsoft TechNet. Building Your First Domain Controller on 2012 R2. Available: https://social.technet.microsoft.com/wiki/contents/articles/22622.building-your-first-domaincontroller-on-2012-r2.aspx.

[6]

Microsoft TechNet. Installing and Configuring DHCP role on Windows Server 2012. Available: https://blogs.technet.microsoft.com/teamdhcp/2012/08/31/installing-and-configuring-dhcprole-on-windows-server-2012/.

[7]

DigiCert. CSR Creation Instructions for Microsoft Servers. Available: https://www.digicert.com/util/csr-creation-microsoft-servers-using-digicert-utility.htm.

[8]

Cisco. Cisco Firepower Management Center Virtual for VMware Deployment Quick Start Guide. Available: https://www.cisco.com/c/en/us/td/docs/security/firepower/quick_start/vmware/fmcv/FMCvquick.html.

[9]

Cisco. Cisco Firepower Threat Defense Virtual for VMware Getting Started Guide. Available: https://www.cisco.com/c/en/us/td/docs/security/firepower/quick_start/vmware/ftdv/ftdvvmware-gsg.html.

[10]

Cisco Systems, Inc. Basic Policy Creation for Firepower. Jan. 30, 2019. Available: https://www.cisco.com/c/dam/en/us/td/docs/security/firepower/SelfHelp/Basic_Policy_Creation_on_Cisco_Firepower_Devices.pdf.

[11]

Cisco Systems, Inc. Cisco Stealthwatch: Installation and Configuration Guide 7.0. 2019. Available: https://www.cisco.com/c/dam/en/us/td/docs/security/stealthwatch/system_installation_config uration/SW_7_0_0_Installation_and_Configuration_Guide_DV_3_1.pdf.

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[12]

G. O’Brien et al., Securing Wireless Infusion Pumps in Healthcare Delivery Organizations, NIST SP 1800-8, NIST, Gaithersburg, Md., Aug. 2018. Available: https://www.nccoe.nist.gov/sites/default/files/library/sp1800/hit-wip-nist-sp1800-8.pdf.

[13]

Microsoft. Storage Account Overview. Available: https://docs.microsoft.com/enus/azure/storage/common/storage-account-overview?toc=/azure/storage/blobs/toc.json.

[14]

TDi Technologies, External Authentication libraries, ConsoleWorks Cybersecurity Operations Platform. Available: https://support.tditechnologies.com/content/external-authenticationlibraries.

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