45 CFR Part 164 — Security and Privacy

PART 164—SECURITY AND PRIVACY Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2(note)); and secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279. Source: 65 FR 82802, Dec. 28, 2000, unless otherwise noted. Subpart A—General Provisions § 164.102 Statutory basis. The provisions of this part are adopted pursuant to the Secretary's authority to prescribe standards, requirements, and implementation specifications under part C of title XI of the Act, section 264 of Public Law 104-191, and sections 13400-13424 of Public Law 111-5. [78 FR 5692, Jan. 25, 2013] § 164.103 Definitions. As used in this part, the following terms have the following meanings: Common control Common ownership Covered functions Health care component Hybrid entity (1) That is a covered entity; (2) Whose business activities include both covered and non-covered functions; and (3) That designates health care components in accordance with paragraph § 164.105(a)(2)(iii)(D). Law enforcement official (1) Investigate or conduct an official inquiry into a potential violation of law; or (2) Prosecute or otherwise conduct a criminal, civil, or administrative proceeding arising from an alleged violation of law. Plan sponsor Required by law Required by law [68 FR 8374, Feb. 20, 2003, as amended at 74 FR 42767, Aug. 24, 2009; 78 FR 34266, June 7, 2013] § 164.104 Applicability. (a) Except as otherwise provided, the standards, requirements, and implementation specifications adopted under this part apply to the following entities: (1) A health plan. (2) A health care clearinghouse. (3) A health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter. (b) Where provided, the standards, requirements, and implementation specifications adopted under this part apply to a business associate. [68 FR 8375, Feb. 20, 2003, as amended at 78 FR 5692, Jan. 25, 2013] § 164.105 Organizational requirements. (a)(1) Standard: Health care component. (2) Implementation specifications: (i) Application of other provisions. (A) A reference in such provision to a “covered entity” refers to a health care component of the covered entity; (B) A reference in such provision to a “health plan,” “covered health care provider,” or “health care clearinghouse,” refers to a health care component of the covered entity if such health care component performs the functions of a health plan, health care provider, or health care clearinghouse, as applicable; (C) A reference in such provision to “protected health information” refers to protected health information that is created or received by or on behalf of the health care component of the covered entity; and (D) A reference in such provision to “electronic protected health information” refers to electronic protected health information that is created, received, maintained, or transmitted by or on behalf of the health care component of the covered entity. (ii) Safeguard requirements. (A) Its health care component does not disclose protected health information to another component of the covered entity in circumstances in which subpart E of this part would prohibit such disclosure if the health care component and the other component were separate and distinct legal entities; (B) Its health care component protects electronic protected health information with respect to another component of the covered entity to the same extent that it would be required under subpart C of this part to protect such information if the health care component and the other component were separate and distinct legal entities; (C) If a person performs duties for both the health care component in the capacity of a member of the workforce of such component and for another component of the entity in the same capacity with respect to that component, such workforce member must not use or disclose protected health information created or received in the course of or incident to the member's work for the health care component in a way prohibited by subpart E of this part. (iii) Responsibilities of the covered entity. (A) For purposes of subpart C of part 160 of this subchapter, pertaining to compliance and enforcement, the covered entity has the responsibility of complying with this part. (B) The covered entity is responsible for complying with §§ 164.316(a) and 164.530(i), pertaining to the implementation of policies and procedures to ensure compliance with applicable requirements of this part, including the safeguard requirements in paragraph (a)(2)(ii) of this section. (C) The covered entity is responsible for complying with §§ 164.314 and 164.504 regarding business associate arrangements and other organizational requirements. (D) The covered entity is responsible for designating the components that are part of one or more health care components of the covered entity and documenting the designation in accordance with paragraph (c) of this section, provided that, if the covered entity designates one or more health care components, it must include any component that would meet the definition of a covered entity or business associate if it were a separate legal entity. Health care component(s) also may include a component only to the extent that it performs covered functions. (b)(1) Standard: Affiliated covered entities. (2) Implementation specifications Requirements for designation of an affiliated covered entity. (B) The designation of an affiliated covered entity must be documented and the documentation maintained as required by paragraph (c) of this section. (ii) Safeguard requirements. (c)(1) Standard: Documentation. (2) Implementation specification: Retention period. [68 FR 8375, Feb. 20, 2003, as amended at 78 FR 5692, Jan. 25, 2013] § 164.106 Relationship to other parts. In complying with the requirements of this part, covered entities and, where provided, business associates, are required to comply with the applicable provisions of parts 160 and 162 of this subchapter. [78 FR 5693, Jan. 25, 2013] Subpart B [Reserved] Subpart C—Security Standards for the Protection of Electronic Protected Health Information Authority: 42 U.S.C. 1320d-2 and 1320d-4; sec. 13401, Pub. L. 111-5, 123 Stat. 260. Source: 68 FR 8376, Feb. 20, 2003, unless otherwise noted. § 164.302 Applicability. A covered entity or business associate must comply with the applicable standards, implementation specifications, and requirements of this subpart with respect to electronic protected health information of a covered entity. [78 FR 5693, Jan. 25, 2013] § 164.304 Definitions. As used in this subpart, the following terms have the following meanings: Access Administrative safeguards Authentication Availability Confidentiality Encryption Facility Information system Integrity Malicious software Password Physical safeguards Security or Security measures Security incident Technical safeguards User Workstation [68 FR 8376, Feb. 20, 2003, as amended at 74 FR 42767, Aug. 24, 2009; 78 FR 5693, Jan. 25, 2013] § 164.306 Security standards: General rules. (a) General requirements. (1) Ensure the confidentiality, integrity, and availability of all electronic protected health information the covered entity or business associate creates, receives, maintains, or transmits. (2) Protect against any reasonably anticipated threats or hazards to the security or integrity of such information. (3) Protect against any reasonably anticipated uses or disclosures of such information that are not permitted or required under subpart E of this part. (4) Ensure compliance with this subpart by its workforce. (b) Flexibility of approach. (2) In deciding which security measures to use, a covered entity or business associate must take into account the following factors: (i) The size, complexity, and capabilities of the covered entity or business associate. (ii) The covered entity's or the business associate's technical infrastructure, hardware, and software security capabilities. (iii) The costs of security measures. (iv) The probability and criticality of potential risks to electronic protected health information. (c) Standards. (d) Implementation specifications. (1) Implementation specifications are required or addressable. If an implementation specification is required, the word “Required” appears in parentheses after the title of the implementation specification. If an implementation specification is addressable, the word “Addressable” appears in parentheses after the title of the implementation specification. (2) When a standard adopted in § 164.308, § 164.310, § 164.312, § 164.314, or § 164.316 includes required implementation specifications, a covered entity or business associate must implement the implementation specifications. (3) When a standard adopted in § 164.308, § 164.310, § 164.312, § 164.314, or § 164.316 includes addressable implementation specifications, a covered entity or business associate must— (i) Assess whether each implementation specification is a reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting electronic protected health information; and (ii) As applicable to the covered entity or business associate— (A) Implement the implementation specification if reasonable and appropriate; or (B) If implementing the implementation specification is not reasonable and appropriate— $( 1 $( 2 (e) Maintenance. [68 FR 8376, Feb. 20, 2003; 68 FR 17153, Apr. 8, 2003; 78 FR 5693, Jan. 25, 2013] § 164.308 Administrative safeguards. (a) A covered entity or business associate must, in accordance with § 164.306: (1)(i) Standard: Security management process. (ii) Implementation specifications: (A) Risk analysis (Required). (B) Risk management (Required). (C) Sanction policy (Required). (D) Information system activity review (Required). (2) Standard: Assigned security responsibility. (3)(i) Standard: Workforce security. (ii) Implementation specifications: (A) Authorization and/or supervision (Addressable). (B) Workforce clearance procedure (Addressable). (C) Termination procedures (Addressable). (4)(i) Standard: Information access management. (ii) Implementation specifications: (A) Isolating health care clearinghouse functions (Required). (B) Access authorization (Addressable). (C) Access establishment and modification (Addressable). (5)(i) Standard: Security awareness and training. (ii) Implementation specifications. (A) Security reminders (Addressable). (B) Protection from malicious software (Addressable). (C) Log-in monitoring (Addressable). (D) Password management (Addressable). (6)(i) Standard: Security incident procedures. (ii) Implementation specification: Response and reporting (Required). (7)(i) Standard: Contingency plan. (ii) Implementation specifications: (A) Data backup plan (Required). (B) Disaster recovery plan (Required). (C) Emergency mode operation plan (Required). (D) Testing and revision procedures (Addressable). (E) Applications and data criticality analysis (Addressable). (8) Standard: Evaluation. (b)(1) Business associate contracts and other arrangements. (2) A business associate may permit a business associate that is a subcontractor to create, receive, maintain, or transmit electronic protected health information on its behalf only if the business associate obtains satisfactory assurances, in accordance with § 164.314(a), that the subcontractor will appropriately safeguard the information. (3) Implementation specifications: Written contract or other arrangement (Required). [68 FR 8376, Feb. 20, 2003, as amended at 78 FR 5694, Jan. 25, 2013] § 164.310 Physical safeguards. A covered entity or business associate must, in accordance with § 164.306: (a)(1) Standard: Facility access controls. (2) Implementation specifications: (i) Contingency operations (Addressable). (ii) Facility security plan (Addressable). (iii) Access control and validation procedures (Addressable). (iv) Maintenance records (Addressable). (b) Standard: Workstation use. (c) Standard: Workstation security. (d)(1) Standard: Device and media controls. (2) Implementation specifications: (i) Disposal (Required). (ii) Media re-use (Required). (iii) Accountability (Addressable). (iv) Data backup and storage (Addressable). [68 FR 8376, Feb. 20, 2003, as amended at 78 FR 5694, Jan. 25, 2013] § 164.312 Technical safeguards. A covered entity or business associate must, in accordance with § 164.306: (a)(1) Standard: Access control. (2) Implementation specifications: (i) Unique user identification (Required). (ii) Emergency access procedure (Required). (iii) Automatic logoff (Addressable). (iv) Encryption and decryption (Addressable). (b) Standard: Audit controls. (c)(1) Standard: Integrity. (2) Implementation specification: Mechanism to authenticate electronic protected health information (Addressable). (d) Standard: Person or entity authentication. (e)(1) Standard: Transmission security. (2) Implementation specifications: (i) Integrity controls (Addressable). (ii) Encryption (Addressable). [68 FR 8376, Feb. 20, 2003, as amended at 78 FR 5694, Jan. 25, 2013] § 164.314 Organizational requirements. (a)(1) Standard: Business associate contracts or other arrangements. (2) Implementation specifications (Required) Business associate contracts. (A) Comply with the applicable requirements of this subpart; (B) In accordance with § 164.308(b)(2), ensure that any subcontractors that create, receive, maintain, or transmit electronic protected health information on behalf of the business associate agree to comply with the applicable requirements of this subpart by entering into a contract or other arrangement that complies with this section; and (C) Report to the covered entity any security incident of which it becomes aware, including breaches of unsecured protected health information as required by § 164.410. (ii) Other arrangements. (iii) Business associate contracts with subcontractors. (b)(1) Standard: Requirements for group health plans. (2) Implementation specifications (Required). (i) Implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits on behalf of the group health plan; (ii) Ensure that the adequate separation required by § 164.504(f)(2)(iii) is supported by reasonable and appropriate security measures; (iii) Ensure that any agent to whom it provides this information agrees to implement reasonable and appropriate security measures to protect the information; and (iv) Report to the group health plan any security incident of which it becomes aware. [68 FR 8376, Feb. 20, 2003, as amended at 78 FR 5694, Jan. 25, 2013; 78 FR 34266, June 7, 2013] § 164.316 Policies and procedures and documentation requirements. A covered entity or business associate must, in accordance with § 164.306: (a) Standard: Policies and procedures. (b)(1) Standard: Documentation. (ii) If an action, activity or assessment is required by this subpart to be documented, maintain a written (which may be electronic) record of the action, activity, or assessment. (2) Implementation specifications: (i) Time limit (Required). (ii) Availability (Required). (iii) Updates (Required). [68 FR 8376, Feb. 20, 2003, as amended at 78 FR 5695, Jan. 25, 2013] § 164.318 Compliance dates for the initial implementation of the security standards. (a) Health plan. (2) A small health plan must comply with the applicable requirements of this subpart no later than April 20, 2006. (b) Health care clearinghouse. (c) Health care provider. Appendix A to Subpart C of Part 164—Security Standards: Matrix Standards Sections Implementation Specifications (R) = Required, (A) = Addressable Administrative Safeguards Security Management Process 164.308(a)(1) Risk Analysis (R) Risk Management (R) Sanction Policy (R) Information System Activity Review (R) Assigned Security Responsibility 164.308(a)(2) (R) Workforce Security 164.308(a)(3) Authorization and/or Supervision (A) Workforce Clearance Procedure Termination Procedures (A) Information Access Management 164.308(a)(4) Isolating Health care Clearinghouse Function (R) Access Authorization (A) Access Establishment and Modification (A) Security Awareness and Training 164.308(a)(5) Security Reminders (A) Protection from Malicious Software (A) Log-in Monitoring (A) Password Management (A) Security Incident Procedures 164.308(a)(6) Response and Reporting (R) Contingency Plan 164.308(a)(7) Data Backup Plan (R) Disaster Recovery Plan (R) Emergency Mode Operation Plan (R) Testing and Revision Procedure (A) Applications and Data Criticality Analysis (A) Evaluation 164.308(a)(8) (R) Business Associate Contracts and Other Arrangement 164.308(b)(1) Written Contract or Other Arrangement (R) Physical Safeguards Facility Access Controls 164.310(a)(1) Contingency Operations (A) Facility Security Plan (A) Access Control and Validation Procedures (A) Maintenance Records (A) Workstation Use 164.310(b) (R) Workstation Security 164.310(c) (R) Device and Media Controls 164.310(d)(1) Disposal (R) Media Re-use (R) Accountability (A) Data Backup and Storage (A) Technical Safeguards Access Control 164.312(a)(1) Unique User Identification (R) Emergency Access Procedure (R) Automatic Logoff (A) Encryption and Decryption (A) Audit Controls 164.312(b) (R) Integrity 164.312(c)(1) Mechanism to Authenticate Electronic Protected Health Information (A) Person or Entity Authentication 164.312(d) (R) Transmission Security 164.312(e)(1) Integrity Controls (A) Encryption (A) Subpart D—Notification in the Case of Breach of Unsecured Protected Health Information Source: 74 FR 42767, Aug. 24, 2009, unless otherwise noted. § 164.400 Applicability. The requirements of this subpart shall apply with respect to breaches of protected health information occurring on or after September 23, 2009. § 164.402 Definitions. As used in this subpart, the following terms have the following meanings: Breach (1) Breach excludes: (i) Any unintentional acquisition, access, or use of protected health information by a workforce member or person acting under the authority of a covered entity or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under subpart E of this part. (ii) Any inadvertent disclosure by a person who is authorized to access protected health information at a covered entity or business associate to another person authorized to access protected health information at the same covered entity or business associate, or organized health care arrangement in which the covered entity participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under subpart E of this part. (iii) A disclosure of protected health information where a covered entity or business associate has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information. (2) Except as provided in paragraph (1) of this definition, an acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the protected health information has been compromised based on a risk assessment of at least the following factors: (i) The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification; (ii) The unauthorized person who used the protected health information or to whom the disclosure was made; (iii) Whether the protected health information was actually acquired or viewed; and (iv) The extent to which the risk to the protected health information has been mitigated. Unsecured protected health information [78 FR 5695, Jan. 25, 2013] § 164.404 Notification to individuals. (a) Standard General rule. (2) Breaches treated as discovered. (b) Implementation specification: Timeliness of notification. (c) Implementation specifications: Content of notification Elements. (A) A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known; (B) A description of the types of unsecured protected health information that were involved in the breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved); (C) Any steps individuals should take to protect themselves from potential harm resulting from the breach; (D) A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to individuals, and to protect against any further breaches; and (E) Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address. (2) Plain language requirement. (d) Implementation specifications: Methods of individual notification. (1) Written notice. (ii) If the covered entity knows the individual is deceased and has the address of the next of kin or personal representative of the individual (as specified under § 164.502(g)(4) of subpart E), written notification by first-class mail to either the next of kin or personal representative of the individual. The notification may be provided in one or more mailings as information is available. (2) Substitute notice. (i) In the case in which there is insufficient or out-of-date contact information for fewer than 10 individuals, then such substitute notice may be provided by an alternative form of written notice, telephone, or other means. (ii) In the case in which there is insufficient or out-of-date contact information for 10 or more individuals, then such substitute notice shall: (A) Be in the form of either a conspicuous posting for a period of 90 days on the home page of the Web site of the covered entity involved, or conspicuous notice in major print or broadcast media in geographic areas where the individuals affected by the breach likely reside; and (B) Include a toll-free phone number that remains active for at least 90 days where an individual can learn whether the individual's unsecured protected health information may be included in the breach. (3) Additional notice in urgent situations. § 164.406 Notification to the media. (a) Standard. (b) Implementation specification: Timeliness of notification. (c) Implementation specifications: Content of notification. [74 FR 42767, Aug. 24, 2009, as amended at 78 FR 5695, Jan. 25, 2013] § 164.408 Notification to the Secretary. (a) Standard. (b) Implementation specifications: Breaches involving 500 or more individuals. (c) Implementation specifications: Breaches involving less than 500 individuals. [74 FR 42767, Aug. 24, 2009, as amended at 78 FR 5695, Jan. 25, 2013] § 164.410 Notification by a business associate. (a) Standard General rule. (2) Breaches treated as discovered. (b) Implementation specifications: Timeliness of notification. (c) Implementation specifications: Content of notification. (2) A business associate shall provide the covered entity with any other available information that the covered entity is required to include in notification to the individual under § 164.404(c) at the time of the notification required by paragraph (a) of this section or promptly thereafter as information becomes available. [74 FR 42767, Aug. 24, 2009, as amended at 78 FR 5695, Jan. 25, 2013] § 164.412 Law enforcement delay. If a law enforcement official states to a covered entity or business associate that a notification, notice, or posting required under this subpart would impede a criminal investigation or cause damage to national security, a covered entity or business associate shall: (a) If the statement is in writing and specifies the time for which a delay is required, delay such notification, notice, or posting for the time period specified by the official; or (b) If the statement is made orally, document the statement, including the identity of the official making the statement, and delay the notification, notice, or posting temporarily and no longer than 30 days from the date of the oral statement, unless a written statement as described in paragraph (a) of this section is submitted during that time. § 164.414 Administrative requirements and burden of proof. (a) Administrative requirements. (b) Burden of proof. Subpart E—Privacy of Individually Identifiable Health Information Authority: 42 U.S.C. 1320d-2, 1320d-4, and 1320d-9; sec. 264 of Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); and secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279. § 164.500 Applicability. (a) Except as otherwise provided herein, the standards, requirements, and implementation specifications of this subpart apply to covered entities with respect to protected health information. (b) Health care clearinghouses must comply with the standards, requirements, and implementation specifications as follows: (1) When a health care clearinghouse creates or receives protected health information as a business associate of another covered entity, the clearinghouse must comply with: (i) Section 164.500 relating to applicability; (ii) Section 164.501 relating to definitions; (iii) Section 164.502 relating to uses and disclosures of protected health information, except that a clearinghouse is prohibited from using or disclosing protected health information other than as permitted in the business associate contract under which it created or received the protected health information; (iv) Section 164.504 relating to the organizational requirements for covered entities; (v) Section 164.512 relating to uses and disclosures for which individual authorization or an opportunity to agree or object is not required, except that a clearinghouse is prohibited from using or disclosing protected health information other than as permitted in the business associate contract under which it created or received the protected health information; (vi) Section 164.532 relating to transition requirements; and (vii) Section 164.534 relating to compliance dates for initial implementation of the privacy standards. (2) When a health care clearinghouse creates or receives protected health information other than as a business associate of a covered entity, the clearinghouse must comply with all of the standards, requirements, and implementation specifications of this subpart. (c) Where provided, the standards, requirements, and implementation specifications adopted under this subpart apply to a business associate with respect to the protected health information of a covered entity. (d) The standards, requirements, and implementation specifications of this subpart do not apply to the Department of Defense or to any other federal agency, or non-governmental organization acting on its behalf, when providing health care to overseas foreign national beneficiaries. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53266, Aug. 14, 2002; 68 FR 8381, Feb. 20, 2003; 78 FR 5695, Jan. 25, 2013] § 164.501 Definitions. As used in this subpart, the following terms have the following meanings: Correctional institution Other persons Data aggregation Designated record set (1) A group of records maintained by or for a covered entity that is: (i) The medical records and billing records about individuals maintained by or for a covered health care provider; (ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or (iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals. (2) For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity. Direct treatment relationship Health care operations (1) Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities; patient safety activities (as defined in 42 CFR 3.20); population-based activities relating to improving health or reducing health care costs, protocol development, case management and care coordination, contacting of health care providers and patients with information about treatment alternatives; and related functions that do not include treatment; (2) Reviewing the competence or qualifications of health care professionals, evaluating practitioner and provider performance, health plan performance, conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers, training of non-health care professionals, accreditation, certification, licensing, or credentialing activities; (3) Except as prohibited under § 164.502(a)(5)(i), underwriting, enrollment, premium rating, and other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits, and ceding, securing, or placing a contract for reinsurance of risk relating to claims for health care (including stop-loss insurance and excess of loss insurance), provided that the requirements of § 164.514(g) are met, if applicable; (4) Conducting or arranging for medical review, legal services, and auditing functions, including fraud and abuse detection and compliance programs; (5) Business planning and development, such as conducting cost-management and planning-related analyses related to managing and operating the entity, including formulary development and administration, development or improvement of methods of payment or coverage policies; and (6) Business management and general administrative activities of the entity, including, but not limited to: (i) Management activities relating to implementation of and compliance with the requirements of this subchapter; (ii) Customer service, including the provision of data analyses for policy holders, plan sponsors, or other customers, provided that protected health information is not disclosed to such policy holder, plan sponsor, or customer. (iii) Resolution of internal grievances; (iv) The sale, transfer, merger, or consolidation of all or part of the covered entity with another covered entity, or an entity that following such activity will become a covered entity and due diligence related to such activity; and (v) Consistent with the applicable requirements of § 164.514, creating de-identified health information or a limited data set, and fundraising for the benefit of the covered entity. Health oversight agency Indirect treatment relationship (1) The health care provider delivers health care to the individual based on the orders of another health care provider; and (2) The health care provider typically provides services or products, or reports the diagnosis or results associated with the health care, directly to another health care provider, who provides the services or products or reports to the individual. Inmate Marketing: (1) Except as provided in paragraph (2) of this definition, marketing means to make a communication about a product or service that encourages recipients of the communication to purchase or use the product or service. (2) Marketing does not include a communication made: (i) To provide refill reminders or otherwise communicate about a drug or biologic that is currently being prescribed for the individual, only if any financial remuneration received by the covered entity in exchange for making the communication is reasonably related to the covered entity's cost of making the communication. (ii) For the following treatment and health care operations purposes, except where the covered entity receives financial remuneration in exchange for making the communication: (A) For treatment of an individual by a health care provider, including case management or care coordination for the individual, or to direct or recommend alternative treatments, therapies, health care providers, or settings of care to the individual; (B) To describe a health-related product or service (or payment for such product or service) that is provided by, or included in a plan of benefits of, the covered entity making the communication, including communications about: the entities participating in a health care provider network or health plan network; replacement of, or enhancements to, a health plan; and health-related products or services available only to a health plan enrollee that add value to, but are not part of, a plan of benefits; or (C) For case management or care coordination, contacting of individuals with information about treatment alternatives, and related functions to the extent these activities do not fall within the definition of treatment. (3) Financial remuneration Payment (1) The activities undertaken by: (i) Except as prohibited under § 164.502(a)(5)(i), a health plan to obtain premiums or to determine or fulfill its responsibility for coverage and provision of benefits under the health plan; or (ii) A health care provider or health plan to obtain or provide reimbursement for the provision of health care; and (2) The activities in paragraph (1) of this definition relate to the individual to whom health care is provided and include, but are not limited to: (i) Determinations of eligibility or coverage (including coordination of benefits or the determination of cost sharing amounts), and adjudication or subrogation of health benefit claims; (ii) Risk adjusting amounts due based on enrollee health status and demographic characteristics; (iii) Billing, claims management, collection activities, obtaining payment under a contract for reinsurance (including stop-loss insurance and excess of loss insurance), and related health care data processing; (iv) Review of health care services with respect to medical necessity, coverage under a health plan, appropriateness of care, or justification of charges; (v) Utilization review activities, including precertification and preauthorization of services, concurrent and retrospective review of services; and (vi) Disclosure to consumer reporting agencies of any of the following protected health information relating to collection of premiums or reimbursement: (A) Name and address; (B) Date of birth; (C) Social security number; (D) Payment history; (E) Account number; and (F) Name and address of the health care provider and/or health plan. Psychotherapy notes Psychotherapy notes Public health authority Research Treatment [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53266, Aug. 14, 2002; 68 FR 8381, Feb. 20, 2003; 74 FR 42769, Aug. 24, 2009; 78 FR 5695, Jan. 25, 2013] § 164.502 Uses and disclosures of protected health information: General rules. (a) Standard. (1) Covered entities: Permitted uses and disclosures. (i) To the individual; (ii) For treatment, payment, or health care operations, as permitted by and in compliance with § 164.506; (iii) Incident to a use or disclosure otherwise permitted or required by this subpart, provided that the covered entity has complied with the applicable requirements of §§ 164.502(b), 164.514(d), and 164.530(c) with respect to such otherwise permitted or required use or disclosure; (iv) Except for uses and disclosures prohibited under § 164.502(a)(5)(i), pursuant to and in compliance with a valid authorization under § 164.508; (v) Pursuant to an agreement under, or as otherwise permitted by, § 164.510; and (vi) As permitted by and in compliance with any of the following: (A) This section. (B) Section 164.512 and, where applicable, § 164.509. (C) Section 164.514(e), (f), or (g). (2) Covered entities: Required disclosures. (i) To an individual, when requested under, and required by § 164.524 or § 164.528; and (ii) When required by the Secretary under subpart C of part 160 of this subchapter to investigate or determine the covered entity's compliance with this subchapter. (3) Business associates: Permitted uses and disclosures. (4) Business associates: Required uses and disclosures. (i) When required by the Secretary under subpart C of part 160 of this subchapter to investigate or determine the business associate's compliance with this subchapter. (ii) To the covered entity, individual, or individual's designee, as necessary to satisfy a covered entity's obligations under § 164.524(c)(2)(ii) and (3)(ii) with respect to an individual's request for an electronic copy of protected health information. (5) Prohibited uses and disclosures Use and disclosure of genetic information for underwriting purposes: health plan, (A) Except as provided in paragraph (a)(5)(i)(B) of this section: ( 1 ( 2 ( 3 ( 4 (B) Underwriting purposes does not include determinations of medical appropriateness where an individual seeks a benefit under the plan, coverage, or policy. (ii) Sale of protected health information: (A) Except pursuant to and in compliance with § 164.508(a)(4), a covered entity or business associate may not sell protected health information. (B) For purposes of this paragraph, sale of protected health information means: ( 1 2 ( 2 ( i ( ii ( iii ( iv ( v ( vi ( vii ( viii (iii) Reproductive health care Prohibition. ( 1 ( 2 ( 3 1 2 (B) Rule of applicability. ( 1 ( 2 ( 3 (C) Presumption. 1 2 ( 1 ( 2 (D) Scope. (b) Standard: Minimum necessary Minimum necessary applies. (2) Minimum necessary does not apply. (i) Disclosures to or requests by a health care provider for treatment; (ii) Uses or disclosures made to the individual, as permitted under paragraph (a)(1)(i) of this section or as required by paragraph (a)(2)(i) of this section; (iii) Uses or disclosures made pursuant to an authorization under § 164.508; (iv) Disclosures made to the Secretary in accordance with subpart C of part 160 of this subchapter; (v) Uses or disclosures that are required by law, as described by § 164.512(a); and (vi) Uses or disclosures that are required for compliance with applicable requirements of this subchapter. (c) Standard: Uses and disclosures of protected health information subject to an agreed upon restriction. (d) Standard: Uses and disclosures of de-identified protected health information Uses and disclosures to create de-identified information. (2) Uses and disclosures of de-identified information. i.e., (i) Disclosure of a code or other means of record identification designed to enable coded or otherwise de-identified information to be re-identified constitutes disclosure of protected health information; and (ii) If de-identified information is re-identified, a covered entity may use or disclose such re-identified information only as permitted or required by this subpart. (e)(1) Standard: Disclosures to business associates. (ii) A business associate may disclose protected health information to a business associate that is a subcontractor and may allow the subcontractor to create, receive, maintain, or transmit protected health information on its behalf, if the business associate obtains satisfactory assurances, in accordance with § 164.504(e)(1)(i), that the subcontractor will appropriately safeguard the information. (2) Implementation specification: Documentation. (f) Standard: Deceased individuals. (g)(1) Standard: Personal representatives. (2) Implementation specification: Adults and emancipated minors. (3)(i) Implementation specification: Unemancipated minors. in loco parentis (A) The minor consents to such health care service; no other consent to such health care service is required by law, regardless of whether the consent of another person has also been obtained; and the minor has not requested that such person be treated as the personal representative; (B) The minor may lawfully obtain such health care service without the consent of a parent, guardian, or other person acting in loco parentis, (C) A parent, guardian, or other person acting in loco parentis (ii) Notwithstanding the provisions of paragraph (g)(3)(i) of this section: (A) If, and to the extent, permitted or required by an applicable provision of State or other law, including applicable case law, a covered entity may disclose, or provide access in accordance with § 164.524 to, protected health information about an unemancipated minor to a parent, guardian, or other person acting in loco parentis (B) If, and to the extent, prohibited by an applicable provision of State or other law, including applicable case law, a covered entity may not disclose, or provide access in accordance with § 164.524 to, protected health information about an unemancipated minor to a parent, guardian, or other person acting in loco parentis (C) Where the parent, guardian, or other person acting in loco parentis, in loco parentis, (4) Implementation specification: Deceased individuals. (5) Implementation specification: Abuse, neglect, endangerment situations. (i) Paragraphs (g)(5)(i)(A) and (B) of this section both apply. (A) The covered entity has a reasonable belief that any of the following is true: ( 1 ( 2 (B) The covered entity, in the exercise of professional judgment, decides that it is not in the best interest of the individual to treat the person as the individual's personal representative. (ii) The covered entity does not have a reasonable belief under paragraph (g)(5)(i)(A) of this section if the basis for their belief is the provision or facilitation of reproductive health care by such person for and at the request of the individual. (h) Standard: Confidential communications. (i) Standard: Uses and disclosures consistent with notice. (j) Standard: Disclosures by whistleblowers and workforce member crime victims Disclosures by whistleblowers. (i) The workforce member or business associate believes in good faith that the covered entity has engaged in conduct that is unlawful or otherwise violates professional or clinical standards, or that the care, services, or conditions provided by the covered entity potentially endangers one or more patients, workers, or the public; and (ii) The disclosure is to: (A) A health oversight agency or public health authority authorized by law to investigate or otherwise oversee the relevant conduct or conditions of the covered entity or to an appropriate health care accreditation organization for the purpose of reporting the allegation of failure to meet professional standards or misconduct by the covered entity; or (B) An attorney retained by or on behalf of the workforce member or business associate for the purpose of determining the legal options of the workforce member or business associate with regard to the conduct described in paragraph (j)(1)(i) of this section. (2) Disclosures by workforce members who are victims of a crime. (i) The protected health information disclosed is about the suspected perpetrator of the criminal act; and (ii) The protected health information disclosed is limited to the information listed in § 164.512(f)(2)(i). [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53267, Aug. 14, 2002; 78 FR 5696, Jan. 25, 2013; 89 FR 33063, Apr. 26, 2024] § 164.504 Uses and disclosures: Organizational requirements. (a) Definitions. Plan administration functions Summary health information (1) That summarizes the claims history, claims expenses, or type of claims experienced by individuals for whom a plan sponsor has provided health benefits under a group health plan; and (2) From which the information described at § 164.514(b)(2)(i) has been deleted, except that the geographic information described in § 164.514(b)(2)(i)(B) need only be aggregated to the level of a five digit zip code. (b)-(d) [Reserved] (e)(1) Standard: Business associate contracts. (ii) A covered entity is not in compliance with the standards in § 164.502(e) and this paragraph, if the covered entity knew of a pattern of activity or practice of the business associate that constituted a material breach or violation of the business associate's obligation under the contract or other arrangement, unless the covered entity took reasonable steps to cure the breach or end the violation, as applicable, and, if such steps were unsuccessful, terminated the contract or arrangement, if feasible. (iii) A business associate is not in compliance with the standards in § 164.502(e) and this paragraph, if the business associate knew of a pattern of activity or practice of a subcontractor that constituted a material breach or violation of the subcontractor's obligation under the contract or other arrangement, unless the business associate took reasonable steps to cure the breach or end the violation, as applicable, and, if such steps were unsuccessful, terminated the contract or arrangement, if feasible. (2) Implementation specifications: Business associate contracts. (i) Establish the permitted and required uses and disclosures of protected health information by the business associate. The contract may not authorize the business associate to use or further disclose the information in a manner that would violate the requirements of this subpart, if done by the covered entity, except that: (A) The contract may permit the business associate to use and disclose protected health information for the proper management and administration of the business associate, as provided in paragraph (e)(4) of this section; and (B) The contract may permit the business associate to provide data aggregation services relating to the health care operations of the covered entity. (ii) Provide that the business associate will: (A) Not use or further disclose the information other than as permitted or required by the contract or as required by law; (B) Use appropriate safeguards and comply, where applicable, with subpart C of this part with respect to electronic protected health information, to prevent use or disclosure of the information other than as provided for by its contract; (C) Report to the covered entity any use or disclosure of the information not provided for by its contract of which it becomes aware, including breaches of unsecured protected health information as required by § 164.410; (D) In accordance with § 164.502(e)(1)(ii), ensure that any subcontractors that create, receive, maintain, or transmit protected health information on behalf of the business associate agree to the same restrictions and conditions that apply to the business associate with respect to such information; (E) Make available protected health information in accordance with § 164.524; (F) Make available protected health information for amendment and incorporate any amendments to protected health information in accordance with § 164.526; (G) Make available the information required to provide an accounting of disclosures in accordance with § 164.528; (H) To the extent the business associate is to carry out a covered entity's obligation under this subpart, comply with the requirements of this subpart that apply to the covered entity in the performance of such obligation. (I) Make its internal practices, books, and records relating to the use and disclosure of protected health information received from, or created or received by the business associate on behalf of, the covered entity available to the Secretary for purposes of determining the covered entity's compliance with this subpart; and (J) At termination of the contract, if feasible, return or destroy all protected health information received from, or created or received by the business associate on behalf of, the covered entity that the business associate still maintains in any form and retain no copies of such information or, if such return or destruction is not feasible, extend the protections of the contract to the information and limit further uses and disclosures to those purposes that make the return or destruction of the information infeasible. (iii) Authorize termination of the contract by the covered entity, if the covered entity determines that the business associate has violated a material term of the contract. (3) Implementation specifications: Other arrangements. (A) The covered entity may comply with this paragraph and § 164.314(a)(1), if applicable, by entering into a memorandum of understanding with the business associate that contains terms that accomplish the objectives of paragraph (e)(2) of this section and § 164.314(a)(2), if applicable. (B) The covered entity may comply with this paragraph and § 164.314(a)(1), if applicable, if other law (including regulations adopted by the covered entity or its business associate) contains requirements applicable to the business associate that accomplish the objectives of paragraph (e)(2) of this section and § 164.314(a)(2), if applicable. (ii) If a business associate is required by law to perform a function or activity on behalf of a covered entity or to provide a service described in the definition of business associate in § 160.103 of this subchapter to a covered entity, such covered entity may disclose protected health information to the business associate to the extent necessary to comply with the legal mandate without meeting the requirements of this paragraph and § 164.314(a)(1), if applicable, provided that the covered entity attempts in good faith to obtain satisfactory assurances as required by paragraph (e)(2) of this section and § 164.314(a)(1), if applicable, and, if such attempt fails, documents the attempt and the reasons that such assurances cannot be obtained. (iii) The covered entity may omit from its other arrangements the termination authorization required by paragraph (e)(2)(iii) of this section, if such authorization is inconsistent with the statutory obligations of the covered entity or its business associate. (iv) A covered entity may comply with this paragraph and § 164.314(a)(1) if the covered entity discloses only a limited data set to a business associate for the business associate to carry out a health care operations function and the covered entity has a data use agreement with the business associate that complies with §§ 164.514(e)(4) and 164.314(a)(1), if applicable. (4) Implementation specifications: Other requirements for contracts and other arrangements. (A) For the proper management and administration of the business associate; or (B) To carry out the legal responsibilities of the business associate. (ii) The contract or other arrangement between the covered entity and the business associate may permit the business associate to disclose the protected health information received by the business associate in its capacity as a business associate for the purposes described in paragraph (e)(4)(i) of this section, if: (A) The disclosure is required by law; or (B)( 1 ( 2 (5) Implementation specifications: Business associate contracts with subcontractors. (f)(1) Standard: Requirements for group health plans. (ii) Except as prohibited by § 164.502(a)(5)(i), the group health plan, or a health insurance issuer or HMO with respect to the group health plan, may disclose summary health information to the plan sponsor, if the plan sponsor requests the summary health information for purposes of: (A) Obtaining premium bids from health plans for providing health insurance coverage under the group health plan; or (B) Modifying, amending, or terminating the group health plan. (iii) The group health plan, or a health insurance issuer or HMO with respect to the group health plan, may disclose to the plan sponsor information on whether the individual is participating in the group health plan, or is enrolled in or has disenrolled from a health insurance issuer or HMO offered by the plan. (2) Implementation specifications: Requirements for plan documents. (i) Establish the permitted and required uses and disclosures of such information by the plan sponsor, provided that such permitted and required uses and disclosures may not be inconsistent with this subpart. (ii) Provide that the group health plan will disclose protected health information to the plan sponsor only upon receipt of a certification by the plan sponsor that the plan documents have been amended to incorporate the following provisions and that the plan sponsor agrees to: (A) Not use or further disclose the information other than as permitted or required by the plan documents or as required by law; (B) Ensure that any agents to whom it provides protected health information received from the group health plan agree to the same restrictions and conditions that apply to the plan sponsor with respect to such information; (C) Not use or disclose the information for employment-related actions and decisions or in connection with any other benefit or employee benefit plan of the plan sponsor; (D) Report to the group health plan any use or disclosure of the information that is inconsistent with the uses or disclosures provided for of which it becomes aware; (E) Make available protected health information in accordance with § 164.524; (F) Make available protected health information for amendment and incorporate any amendments to protected health information in accordance with § 164.526; (G) Make available the information required to provide an accounting of disclosures in accordance with § 164.528; (H) Make its internal practices, books, and records relating to the use and disclosure of protected health information received from the group health plan available to the Secretary for purposes of determining compliance by the group health plan with this subpart; (I) If feasible, return or destroy all protected health information received from the group health plan that the sponsor still maintains in any form and retain no copies of such information when no longer needed for the purpose for which disclosure was made, except that, if such return or destruction is not feasible, limit further uses and disclosures to those purposes that make the return or destruction of the information infeasible; and (J) Ensure that the adequate separation required in paragraph (f)(2)(iii) of this section is established. (iii) Provide for adequate separation between the group health plan and the plan sponsor. The plan documents must: (A) Describe those employees or classes of employees or other persons under the control of the plan sponsor to be given access to the protected health information to be disclosed, provided that any employee or person who receives protected health information relating to payment under, health care operations of, or other matters pertaining to the group health plan in the ordinary course of business must be included in such description; (B) Restrict the access to and use by such employees and other persons described in paragraph (f)(2)(iii)(A) of this section to the plan administration functions that the plan sponsor performs for the group health plan; and (C) Provide an effective mechanism for resolving any issues of noncompliance by persons described in paragraph (f)(2)(iii)(A) of this section with the plan document provisions required by this paragraph. (3) Implementation specifications: Uses and disclosures. (i) Disclose protected health information to a plan sponsor to carry out plan administration functions that the plan sponsor performs only consistent with the provisions of paragraph (f)(2) of this section; (ii) Not permit a health insurance issuer or HMO with respect to the group health plan to disclose protected health information to the plan sponsor except as permitted by this paragraph; (iii) Not disclose and may not permit a health insurance issuer or HMO to disclose protected health information to a plan sponsor as otherwise permitted by this paragraph unless a statement required by § 164.520(b)(1)(iii)(C) is included in the appropriate notice; and (iv) Not disclose protected health information to the plan sponsor for the purpose of employment-related actions or decisions or in connection with any other benefit or employee benefit plan of the plan sponsor. (g) Standard: Requirements for a covered entity with multiple covered functions. (2) A covered entity that performs multiple covered functions may use or disclose the protected health information of individuals who receive the covered entity's health plan or health care provider services, but not both, only for purposes related to the appropriate function being performed. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53267, Aug. 14, 2002; 68 FR 8381, Feb. 20, 2003; 78 FR 5697, Jan. 25, 2013] § 164.506 Uses and disclosures to carry out treatment, payment, or health care operations. (a) Standard: Permitted uses and disclosures. (b) Standard: Consent for uses and disclosures permitted. (2) Consent, under paragraph (b) of this section, shall not be effective to permit a use or disclosure of protected health information when an authorization, under § 164.508, is required or when another condition must be met for such use or disclosure to be permissible under this subpart. (c) Implementation specifications: Treatment, payment, or health care operations. (2) A covered entity may disclose protected health information for treatment activities of a health care provider. (3) A covered entity may disclose protected health information to another covered entity or a health care provider for the payment activities of the entity that receives the information. (4) A covered entity may disclose protected health information to another covered entity for health care operations activities of the entity that receives the information, if each entity either has or had a relationship with the individual who is the subject of the protected health information being requested, the protected health information pertains to such relationship, and the disclosure is: (i) For a purpose listed in paragraph (1) or (2) of the definition of health care operations; or (ii) For the purpose of health care fraud and abuse detection or compliance. (5) A covered entity that participates in an organized health care arrangement may disclose protected health information about an individual to other participants in the organized health care arrangement for any health care operations activities of the organized health care arrangement. [67 FR 53268, Aug. 14, 2002, as amended at 78 FR 5698, Jan. 25, 2013] § 164.508 Uses and disclosures for which an authorization is required. (a) Standard: Authorizations for uses and disclosures Authorization required: General rule. (2) Authorization required: Psychotherapy notes. (i) To carry out the following treatment, payment, or health care operations: (A) Use by the originator of the psychotherapy notes for treatment; (B) Use or disclosure by the covered entity for its own training programs in which students, trainees, or practitioners in mental health learn under supervision to practice or improve their skills in group, joint, family, or individual counseling; or (C) Use or disclosure by the covered entity to defend itself in a legal action or other proceeding brought by the individual; and (ii) A use or disclosure that is required by § 164.502(a)(2)(ii) or permitted by § 164.512(a); § 164.512(d) with respect to the oversight of the originator of the psychotherapy notes; § 164.512(g)(1); or § 164.512(j)(1)(i). (3) Authorization required: Marketing. (A) A face-to-face communication made by a covered entity to an individual; or (B) A promotional gift of nominal value provided by the covered entity. (ii) If the marketing involves financial remuneration, as defined in paragraph (3) of the definition of marketing at § 164.501, to the covered entity from a third party, the authorization must state that such remuneration is involved. (4) Authorization required: Sale of protected health information. (b) Implementation specifications: General requirements Valid authorizations. (ii) A valid authorization may contain elements or information in addition to the elements required by this section, provided that such additional elements or information are not inconsistent with the elements required by this section. (2) Defective authorizations. (i) The expiration date has passed or the expiration event is known by the covered entity to have occurred; (ii) The authorization has not been filled out completely, with respect to an element described by paragraph (c) of this section, if applicable; (iii) The authorization is known by the covered entity to have been revoked; (iv) The authorization violates paragraph (b)(3) or (4) of this section, if applicable; (v) Any material information in the authorization is known by the covered entity to be false. (3) Compound authorizations. (i) An authorization for the use or disclosure of protected health information for a research study may be combined with any other type of written permission for the same or another research study. This exception includes combining an authorization for the use or disclosure of protected health information for a research study with another authorization for the same research study, with an authorization for the creation or maintenance of a research database or repository, or with a consent to participate in research. Where a covered health care provider has conditioned the provision of research-related treatment on the provision of one of the authorizations, as permitted under paragraph (b)(4)(i) of this section, any compound authorization created under this paragraph must clearly differentiate between the conditioned and unconditioned components and provide the individual with an opportunity to opt in to the research activities described in the unconditioned authorization. (ii) An authorization for a use or disclosure of psychotherapy notes may only be combined with another authorization for a use or disclosure of psychotherapy notes. (iii) An authorization under this section, other than an authorization for a use or disclosure of psychotherapy notes, may be combined with any other such authorization under this section, except when a covered entity has conditioned the provision of treatment, payment, enrollment in the health plan, or eligibility for benefits under paragraph (b)(4) of this section on the provision of one of the authorizations. The prohibition in this paragraph on combining authorizations where one authorization conditions the provision of treatment, payment, enrollment in a health plan, or eligibility for benefits under paragraph (b)(4) of this section does not apply to a compound authorization created in accordance with paragraph (b)(3)(i) of this section. (4) Prohibition on conditioning of authorizations. (i) A covered health care provider may condition the provision of research-related treatment on provision of an authorization for the use or disclosure of protected health information for such research under this section; (ii) A health plan may condition enrollment in the health plan or eligibility for benefits on provision of an authorization requested by the health plan prior to an individual's enrollment in the health plan, if: (A) The authorization sought is for the health plan's eligibility or enrollment determinations relating to the individual or for its underwriting or risk rating determinations; and (B) The authorization is not for a use or disclosure of psychotherapy notes under paragraph (a)(2) of this section; and (iii) A covered entity may condition the provision of health care that is solely for the purpose of creating protected health information for disclosure to a third party on provision of an authorization for the disclosure of the protected health information to such third party. (5) Revocation of authorizations. (i) The covered entity has taken action in reliance thereon; or (ii) If the authorization was obtained as a condition of obtaining insurance coverage, other law provides the insurer with the right to contest a claim under the policy or the policy itself. (6) Documentation. (c) Implementation specifications: Core elements and requirements Core elements. (i) A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion. (ii) The name or other specific identification of the person(s), or class of persons, authorized to make the requested use or disclosure. (iii) The name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure. (iv) A description of each purpose of the requested use or disclosure. The statement “at the request of the individual” is a sufficient description of the purpose when an individual initiates the authorization and does not, or elects not to, provide a statement of the purpose. (v) An expiration date or an expiration event that relates to the individual or the purpose of the use or disclosure. The statement “end of the research study,” “none,” or similar language is sufficient if the authorization is for a use or disclosure of protected health information for research, including for the creation and maintenance of a research database or research repository. (vi) Signature of the individual and date. If the authorization is signed by a personal representative of the individual, a description of such representative's authority to act for the individual must also be provided. (2) Required statements. (i) The individual's right to revoke the authorization in writing, and either: (A) The exceptions to the right to revoke and a description of how the individual may revoke the authorization; or (B) To the extent that the information in paragraph (c)(2)(i)(A) of this section is included in the notice required by § 164.520, a reference to the covered entity's notice. (ii) The ability or inability to condition treatment, payment, enrollment or eligibility for benefits on the authorization, by stating either: (A) The covered entity may not condition treatment, payment, enrollment or eligibility for benefits on whether the individual signs the authorization when the prohibition on conditioning of authorizations in paragraph (b)(4) of this section applies; or (B) The consequences to the individual of a refusal to sign the authorization when, in accordance with paragraph (b)(4) of this section, the covered entity can condition treatment, enrollment in the health plan, or eligibility for benefits on failure to obtain such authorization. (iii) The potential for information disclosed pursuant to the authorization to be subject to redisclosure by the recipient and no longer be protected by this subpart. (3) Plain language requirement. (4) Copy to the individual. [67 FR 53268, Aug. 14, 2002, as amended at 78 FR 5699, Jan. 25, 2013] § 164.509 Uses and disclosures for which an attestation is required. (a) Standard: Attestations for certain uses and disclosures of protected health information to persons other than covered entities or business associates. (2) A covered entity or business associate that uses or discloses protected health information potentially related to reproductive health care for purposes specified in § 164.512(d), (e), (f), or (g)(1), in reliance on an attestation that is defective under paragraph (b)(2) of this section, is not in compliance with this section. (b) Implementation specifications: General requirements Valid attestations. (ii) A valid attestation verifies that the use or disclosure is not otherwise prohibited by § 164.502(a)(5)(iii). (iii) A valid attestation may be electronic, provided that it meets the requirements in paragraph (c)(1) of this section, as applicable. (2) Defective attestations. (i) The attestation lacks an element or statement required by paragraph (c) of this section. (ii) The attestation contains an element or statement not required by paragraph (c) of this section (iii) The attestation violates paragraph (b)(3) of this section. (iv) The covered entity or business associate has actual knowledge that material information in the attestation is false. (v) A reasonable covered entity or business associate in the same position would not believe that the attestation is true with respect to the requirement at paragraph (c)(1)(iv) of this section. (3) Compound attestation. (c) Implementation specifications: Content requirements and other obligations Required elements. (i) A description of the information requested that identifies the information in a specific fashion, including one of the following: (A) The name of any individual(s) whose protected health information is sought, if practicable. (B) If including the name(s) of any individual(s) whose protected health information is sought is not practicable, a description of the class of individuals whose protected health information is sought. (ii) The name or other specific identification of the person(s), or class of persons, who are requested to make the use or disclosure. (iii) The name or other specific identification of the person(s), or class of persons, to whom the covered entity is to make the requested use or disclosure. (iv) A clear statement that the use or disclosure is not for a purpose prohibited under § 164.502(a)(5)(iii). (v) A statement that a person may be subject to criminal penalties pursuant to 42 U.S.C. 1320d-6 if that person knowingly and in violation of HIPAA obtains individually identifiable health information relating to an individual or discloses individually identifiable health information to another person. (vi) Signature of the person requesting the protected health information, which may be an electronic signature, and date. If the attestation is signed by a representative of the person requesting the information, a description of such representative's authority to act for the person must also be provided. (2) Plain language requirement. (d) Material misrepresentations. [89 FR 33063, Apr. 26, 2024] § 164.510 Uses and disclosures requiring an opportunity for the individual to agree or to object. A covered entity may use or disclose protected health information, provided that the individual is informed in advance of the use or disclosure and has the opportunity to agree to or prohibit or restrict the use or disclosure, in accordance with the applicable requirements of this section. The covered entity may orally inform the individual of and obtain the individual's oral agreement or objection to a use or disclosure permitted by this section. (a) Standard: Use and disclosure for facility directories Permitted uses and disclosure. (i) Use the following protected health information to maintain a directory of individuals in its facility: (A) The individual's name; (B) The individual's location in the covered health care provider's facility; (C) The individual's condition described in general terms that does not communicate specific medical information about the individual; and (D) The individual's religious affiliation; and (ii) Use or disclose for directory purposes such information: (A) To members of the clergy; or (B) Except for religious affiliation, to other persons who ask for the individual by name. (2) Opportunity to object. (3) Emergency circumstances. (A) Consistent with a prior expressed preference of the individual, if any, that is known to the covered health care provider; and (B) In the individual's best interest as determined by the covered health care provider, in the exercise of professional judgment. (ii) The covered health care provider must inform the individual and provide an opportunity to object to uses or disclosures for directory purposes as required by paragraph (a)(2) of this section when it becomes practicable to do so. (b) Standard: Uses and disclosures for involvement in the individual's care and notification purposes Permitted uses and disclosures. (ii) A covered entity may use or disclose protected health information to notify, or assist in the notification of (including identifying or locating), a family member, a personal representative of the individual, or another person responsible for the care of the individual of the individual's location, general condition, or death. Any such use or disclosure of protected health information for such notification purposes must be in accordance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this section, as applicable. (2) Uses and disclosures with the individual present. (i) Obtains the individual's agreement; (ii) Provides the individual with the opportunity to object to the disclosure, and the individual does not express an objection; or (iii) Reasonably infers from the circumstances, based on the exercise of professional judgment, that the individual does not object to the disclosure. (3) Limited uses and disclosures when the individual is not present. (4) Uses and disclosures for disaster relief purposes. (5) Uses and disclosures when the individual is deceased. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53270, Aug. 14, 2002; 78 FR 5699, Jan. 25, 2013] § 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required. Except as provided by § 164.502(a)(5)(iii), a covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section and § 164.509. When the covered entity is required by this section to inform the individual of, or when the individual may agree to, a use or disclosure permitted by this section, the covered entity's information and the individual's agreement may be given verbally. (a) Standard: Uses and disclosures required by law. (2) A covered entity must meet the requirements described in paragraph (c), (e), or (f) of this section for uses or disclosures required by law. (b) Standard: Uses and disclosures for public health activities Permitted uses and disclosures. (i) A public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions; or, at the direction of a public health authority, to an official of a foreign government agency that is acting in collaboration with a public health authority; (ii) A public health authority or other appropriate government authority authorized by law to receive reports of child abuse or neglect; (iii) A person subject to the jurisdiction of the Food and Drug Administration (FDA) with respect to an FDA-regulated product or activity for which that person has responsibility, for the purpose of activities related to the quality, safety or effectiveness of such FDA-regulated product or activity. Such purposes include: (A) To collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations; (B) To track FDA-regulated products; (C) To enable product recalls, repairs, or replacement, or lookback (including locating and notifying individuals who have received products that have been recalled, withdrawn, or are the subject of lookback); or (D) To conduct post marketing surveillance; (iv) A person who may have been exposed to a communicable disease or may otherwise be at risk of contracting or spreading a disease or condition, if the covered entity or public health authority is authorized by law to notify such person as necessary in the conduct of a public health intervention or investigation; or (v) An employer, about an individual who is a member of the workforce of the employer, if: (A) The covered entity is a covered health care provider who provides health care to the individual at the request of the employer: ( 1 ( 2 (B) The protected health information that is disclosed consists of findings concerning a work-related illness or injury or a workplace-related medical surveillance; (C) The employer needs such findings in order to comply with its obligations, under 29 CFR parts 1904 through 1928, 30 CFR parts 50 through 90, or under state law having a similar purpose, to record such illness or injury or to carry out responsibilities for workplace medical surveillance; and (D) The covered health care provider provides written notice to the individual that protected health information relating to the medical surveillance of the workplace and work-related illnesses and injuries is disclosed to the employer: ( 1 ( 2 (vi) A school, about an individual who is a student or prospective student of the school, if: (A) The protected health information that is disclosed is limited to proof of immunization; (B) The school is required by State or other law to have such proof of immunization prior to admitting the individual; and (C) The covered entity obtains and documents the agreement to the disclosure from either: ( 1 in loco parentis ( 2 (2) Permitted uses. (c) Standard: Disclosures about victims of abuse, neglect, or domestic violence Permitted disclosures. (i) To the extent the disclosure is required by law and the disclosure complies with and is limited to the relevant requirements of such law; (ii) If the individual agrees to the disclosure; or (iii) To the extent the disclosure is expressly authorized by statute or regulation and: (A) The covered entity, in the exercise of professional judgment, believes the disclosure is necessary to prevent serious harm to the individual or other potential victims; or (B) If the individual is unable to agree because of incapacity, a law enforcement or other public official authorized to receive the report represents that the protected health information for which disclosure is sought is not intended to be used against the individual and that an immediate enforcement activity that depends upon the disclosure would be materially and adversely affected by waiting until the individual is able to agree to the disclosure. (2) Informing the individual. (i) The covered entity, in the exercise of professional judgment, believes informing the individual would place the individual at risk of serious harm; or (ii) The covered entity would be informing a personal representative, and the covered entity reasonably believes the personal representative is responsible for the abuse, neglect, or other injury, and that informing such person would not be in the best interests of the individual as determined by the covered entity, in the exercise of professional judgment. (3) Rule of construction. (d) Standard: Uses and disclosures for health oversight activities Permitted disclosures. (i) The health care system; (ii) Government benefit programs for which health information is relevant to beneficiary eligibility; (iii) Entities subject to government regulatory programs for which health information is necessary for determining compliance with program standards; or (iv) Entities subject to civil rights laws for which health information is necessary for determining compliance. (2) Exception to health oversight activities. (i) The receipt of health care; (ii) A claim for public benefits related to health; or (iii) Qualification for, or receipt of, public benefits or services when a patient's health is integral to the claim for public benefits or services. (3) Joint activities or investigations. (4) Permitted uses. (e) Standard: Disclosures for judicial and administrative proceedings Permitted disclosures. (i) In response to an order of a court or administrative tribunal, provided that the covered entity discloses only the protected health information expressly authorized by such order; or (ii) In response to a subpoena, discovery request, or other lawful process, that is not accompanied by an order of a court or administrative tribunal, if: (A) The covered entity receives satisfactory assurance, as described in paragraph (e)(1)(iii) of this section, from the party seeking the information that reasonable efforts have been made by such party to ensure that the individual who is the subject of the protected health information that has been requested has been given notice of the request; or (B) The covered entity receives satisfactory assurance, as described in paragraph (e)(1)(iv) of this section, from the party seeking the information that reasonable efforts have been made by such party to secure a qualified protective order that meets the requirements of paragraph (e)(1)(v) of this section. (iii) For the purposes of paragraph (e)(1)(ii)(A) of this section, a covered entity receives satisfactory assurances from a party seeking protected health information if the covered entity receives from such party a written statement and accompanying documentation demonstrating that: (A) The party requesting such information has made a good faith attempt to provide written notice to the individual (or, if the individual's location is unknown, to mail a notice to the individual's last known address); (B) The notice included sufficient information about the litigation or proceeding in which the protected health information is requested to permit the individual to raise an objection to the court or administrative tribunal; and (C) The time for the individual to raise objections to the court or administrative tribunal has elapsed, and: ( 1 ( 2 (iv) For the purposes of paragraph (e)(1)(ii)(B) of this section, a covered entity receives satisfactory assurances from a party seeking protected health information, if the covered entity receives from such party a written statement and accompanying documentation demonstrating that: (A) The parties to the dispute giving rise to the request for information have agreed to a qualified protective order and have presented it to the court or administrative tribunal with jurisdiction over the dispute; or (B) The party seeking the protected health information has requested a qualified protective order from such court or administrative tribunal. (v) For purposes of paragraph (e)(1) of this section, a qualified protective order means, with respect to protected health information requested under paragraph (e)(1)(ii) of this section, an order of a court or of an administrative tribunal or a stipulation by the parties to the litigation or administrative proceeding that: (A) Prohibits the parties from using or disclosing the protected health information for any purpose other than the litigation or proceeding for which such information was requested; and (B) Requires the return to the covered entity or destruction of the protected health information (including all copies made) at the end of the litigation or proceeding. (vi) Notwithstanding paragraph (e)(1)(ii) of this section, a covered entity may disclose protected health information in response to lawful process described in paragraph (e)(1)(ii) of this section without receiving satisfactory assurance under paragraph (e)(1)(ii)(A) or (B) of this section, if the covered entity makes reasonable efforts to provide notice to the individual sufficient to meet the requirements of paragraph (e)(1)(iii) of this section or to seek a qualified protective order sufficient to meet the requirements of paragraph (e)(1)(v) of this section. (2) Other uses and disclosures under this section. (f) Standard: Disclosures for law enforcement purposes. (1) Permitted disclosures: Pursuant to process and as otherwise required by law. (i) As required by law including laws that require the reporting of certain types of wounds or other physical injuries, except for laws subject to paragraph (b)(1)(ii) or (c)(1)(i) of this section; or (ii) In compliance with and as limited by the relevant requirements of: (A) A court order or court-ordered warrant, or a subpoena or summons issued by a judicial officer; (B) A grand jury subpoena; or (C) An administrative request for which response is required by law, including an administrative subpoena or summons, a civil or an authorized investigative demand, or similar process authorized under law, provided that: ( 1 ( 2 ( 3 (2) Permitted disclosures: Limited information for identification and location purposes. (i) The covered entity may disclose only the following information: (A) Name and address; (B) Date and place of birth; (C) Social security number; (D) ABO blood type and rh factor; (E) Type of injury; (F) Date and time of treatment; (G) Date and time of death, if applicable; and (H) A description of distinguishing physical characteristics, including height, weight, gender, race, hair and eye color, presence or absence of facial hair (beard or moustache), scars, and tattoos. (ii) Except as permitted by paragraph (f)(2)(i) of this section, the covered entity may not disclose for the purposes of identification or location under paragraph (f)(2) of this section any protected health information related to the individual's DNA or DNA analysis, dental records, or typing, samples or analysis of body fluids or tissue. (3) Permitted disclosure: Victims of a crime. (i) The individual agrees to the disclosure; or (ii) The covered entity is unable to obtain the individual's agreement because of incapacity or other emergency circumstance, provided that: (A) The law enforcement official represents that such information is needed to determine whether a violation of law by a person other than the victim has occurred, and such information is not intended to be used against the victim; (B) The law enforcement official represents that immediate law enforcement activity that depends upon the disclosure would be materially and adversely affected by waiting until the individual is able to agree to the disclosure; and (C) The disclosure is in the best interests of the individual as determined by the covered entity, in the exercise of professional judgment. (4) Permitted disclosure: Decedents. (5) Permitted disclosure: Crime on premises. (6) Permitted disclosure: Reporting crime in emergencies. (A) The commission and nature of a crime; (B) The location of such crime or of the victim(s) of such crime; and (C) The identity, description, and location of the perpetrator of such crime. (ii) If a covered health care provider believes that the medical emergency described in paragraph (f)(6)(i) of this section is the result of abuse, neglect, or domestic violence of the individual in need of emergency health care, paragraph (f)(6)(i) of this section does not apply and any disclosure to a law enforcement official for law enforcement purposes is subject to paragraph (c) of this section. (g) Standard: Uses and disclosures about decedents Coroners and medical examiners. (2) Funeral directors. (h) Standard: Uses and disclosures for cadaveric organ, eye or tissue donation purposes. (i) Standard: Uses and disclosures for research purposes Permitted uses and disclosures. (i) Board approval of a waiver of authorization. (A) An Institutional Review Board (IRB), established in accordance with 7 CFR lc.107, 10 CFR 745.107, 14 CFR 1230.107, 15 CFR 27.107, 16 CFR 1028.107, 21 CFR 56.107, 22 CFR 225.107, 24 CFR 60.107, 28 CFR 46.107, 32 CFR 219.107, 34 CFR 97.107, 38 CFR 16.107, 40 CFR 26.107, 45 CFR 46.107, 45 CFR 690.107, or 49 CFR 11.107; or (B) A privacy board that: ( 1 ( 2 ( 3 (ii) Reviews preparatory to research. (A) Use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research; (B) No protected health information is to be removed from the covered entity by the researcher in the course of the review; and (C) The protected health information for which use or access is sought is necessary for the research purposes. (iii) Research on decedent's information. (A) Representation that the use or disclosure sought is solely for research on the protected health information of decedents; (B) Documentation, at the request of the covered entity, of the death of such individuals; and (C) Representation that the protected health information for which use or disclosure is sought is necessary for the research purposes. (2) Documentation of waiver approval. (i) Identification and date of action. (ii) Waiver criteria. (A) The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements; ( 1 ( 2 ( 3 (B) The research could not practicably be conducted without the waiver or alteration; and (C) The research could not practicably be conducted without access to and use of the protected health information. (iii) Protected health information needed. (iv) Review and approval procedures. (A) An IRB must follow the requirements of the Common Rule, including the normal review procedures (7 CFR 1c.108(b), 10 CFR 745.108(b), 14 CFR 1230.108(b), 15 CFR 27.108(b), 16 CFR 1028.108(b), 21 CFR 56.108(b), 22 CFR 225.108(b), 24 CFR 60.108(b), 28 CFR 46.108(b), 32 CFR 219.108(b), 34 CFR 97.108(b), 38 CFR 16.108(b), 40 CFR 26.108(b), 45 CFR 46.108(b), 45 CFR 690.108(b), or 49 CFR 11.108(b)) or the expedited review procedures (7 CFR 1c.110, 10 CFR 745.110, 14 CFR 1230.110, 15 CFR 27.110, 16 CFR 1028.110, 21 CFR 56.110, 22 CFR 225.110, 24 CFR 60.110, 28 CFR 46.110, 32 CFR 219.110, 34 CFR 97.110, 38 CFR 16.110, 40 CFR 26.110, 45 CFR 46.110, 45 CFR 690.110, or 49 CFR 11.110); (B) A privacy board must review the proposed research at convened meetings at which a majority of the privacy board members are present, including at least one member who satisfies the criterion stated in paragraph (i)(1)(i)(B)(2) of this section, and the alteration or waiver of authorization must be approved by the majority of the privacy board members present at the meeting, unless the privacy board elects to use an expedited review procedure in accordance with paragraph (i)(2)(iv)(C) of this section; (C) A privacy board may use an expedited review procedure if the research involves no more than minimal risk to the privacy of the individuals who are the subject of the protected health information for which use or disclosure is being sought. If the privacy board elects to use an expedited review procedure, the review and approval of the alteration or waiver of authorization may be carried out by the chair of the privacy board, or by one or more members of the privacy board as designated by the chair; and (v) Required signature. (j) Standard: Uses and disclosures to avert a serious threat to health or safety Permitted disclosures. (i)(A) Is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public; and (B) Is to a person or persons reasonably able to prevent or lessen the threat, including the target of the threat; or (ii) Is necessary for law enforcement authorities to identify or apprehend an individual: (A) Because of a statement by an individual admitting participation in a violent crime that the covered entity reasonably believes may have caused serious physical harm to the victim; or (B) Where it appears from all the circumstances that the individual has escaped from a correctional institution or from lawful custody, as those terms are defined in § 164.501. (2) Use or disclosure not permitted. (i) In the course of treatment to affect the propensity to commit the criminal conduct that is the basis for the disclosure under paragraph (j)(1)(ii)(A) of this section, or counseling or therapy; or (ii) Through a request by the individual to initiate or to be referred for the treatment, counseling, or therapy described in paragraph (j)(2)(i) of this section. (3) Limit on information that may be disclosed. (4) Presumption of good faith belief. (k) Standard: Uses and disclosures for specialized government functions Military and veterans activities Armed Forces personnel. Federal Register (A) Appropriate military command authorities; and (B) The purposes for which the protected health information may be used or disclosed. (ii) Separation or discharge from military service. (iii) Veterans. (iv) Foreign military personnel. Federal Register (2) National security and intelligence activities. et seq. e.g., (3) Protective services for the President and others. (4) Medical suitability determinations. (i) For the purpose of a required security clearance conducted pursuant to Executive Orders 10450 and 12968; (ii) As necessary to determine worldwide availability or availability for mandatory service abroad under sections 101(a)(4) and 504 of the Foreign Service Act; or (iii) For a family to accompany a Foreign Service member abroad, consistent with section 101(b)(5) and 904 of the Foreign Service Act. (5) Correctional institutions and other law enforcement custodial situations Permitted disclosures. (A) The provision of health care to such individuals; (B) The health and safety of such individual or other inmates; (C) The health and safety of the officers or employees of or others at the correctional institution; (D) The health and safety of such individuals and officers or other persons responsible for the transporting of inmates or their transfer from one institution, facility, or setting to another; (E) Law enforcement on the premises of the correctional institution; or (F) The administration and maintenance of the safety, security, and good order of the correctional institution. (ii) Permitted uses. (iii) No application after release. (6) Covered entities that are government programs providing public benefits. (ii) A covered entity that is a government agency administering a government program providing public benefits may disclose protected health information relating to the program to another covered entity that is a government agency administering a government program providing public benefits if the programs serve the same or similar populations and the disclosure of protected health information is necessary to coordinate the covered functions of such programs or to improve administration and management relating to the covered functions of such programs. (7) National Instant Criminal Background Check System. (i) Is a State agency or other entity that is, or contains an entity that is: (A) An entity designated by the State to report, or which collects information for purposes of reporting, on behalf of the State, to the National Instant Criminal Background Check System; or (B) A court, board, commission, or other lawful authority that makes the commitment or adjudication that causes an individual to become subject to 18 U.S.C. 922(g)(4); and (ii) Discloses the information only to: (A) The National Instant Criminal Background Check System; or (B) An entity designated by the State to report, or which collects information for purposes of reporting, on behalf of the State, to the National Instant Criminal Background Check System; and (iii)(A) Discloses only the limited demographic and certain other information needed for purposes of reporting to the National Instant Criminal Background Check System; and (B) Does not disclose diagnostic or clinical information for such purposes. (l) Standard: Disclosures for workers' compensation. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53270, Aug. 14, 2002; 78 FR 5699, Jan. 25, 2013; 78 FR 34266, June 7, 2013; 81 FR 395, Jan. 6, 2016; 89 FR 33064, Apr. 26, 2024] § 164.514 Other requirements relating to uses and disclosures of protected health information. (a) Standard: De-identification of protected health information. (b) Implementation specifications: Requirements for de-identification of protected health information. (1) A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable: (i) Applying such principles and methods, determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is a subject of the information; and (ii) Documents the methods and results of the analysis that justify such determination; or (2)(i) The following identifiers of the individual or of relatives, employers, or household members of the individual, are removed: (A) Names; (B) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: ( 1 ( 2 (C) All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; (D) Telephone numbers; (E) Fax numbers; (F) Electronic mail addresses; (G) Social security numbers; (H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account numbers; (K) Certificate/license numbers; (L) Vehicle identifiers and serial numbers, including license plate numbers; (M) Device identifiers and serial numbers; (N) Web Universal Resource Locators (URLs); (O) Internet Protocol (IP) address numbers; (P) Biometric identifiers, including finger and voice prints; (Q) Full face photographic images and any comparable images; and (R) Any other unique identifying number, characteristic, or code, except as permitted by paragraph (c) of this section; and (ii) The covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information. (c) Implementation specifications: Re-identification. (1) Derivation. (2) Security. (d)(1) Standard: minimum necessary requirements. (2) Implementation specifications: Minimum necessary uses of protected health information. (A) Those persons or classes of persons, as appropriate, in its workforce who need access to protected health information to carry out their duties; and (B) For each such person or class of persons, the category or categories of protected health information to which access is needed and any conditions appropriate to such access. (ii) A covered entity must make reasonable efforts to limit the access of such persons or classes identified in paragraph (d)(2)(i)(A) of this section to protected health information consistent with paragraph (d)(2)(i)(B) of this section. (3) Implementation specification: Minimum necessary disclosures of protected health information. (ii) For all other disclosures, a covered entity must: (A) Develop criteria designed to limit the protected health information disclosed to the information reasonably necessary to accomplish the purpose for which disclosure is sought; and (B) Review requests for disclosure on an individual basis in accordance with such criteria. (iii) A covered entity may rely, if such reliance is reasonable under the circumstances, on a requested disclosure as the minimum necessary for the stated purpose when: (A) Making disclosures to public officials that are permitted under § 164.512, if the public official represents that the information requested is the minimum necessary for the stated purpose(s); (B) The information is requested by another covered entity; (C) The information is requested by a professional who is a member of its workforce or is a business associate of the covered entity for the purpose of providing professional services to the covered entity, if the professional represents that the information requested is the minimum necessary for the stated purpose(s); or (D) Documentation or representations that comply with the applicable requirements of § 164.512(i) have been provided by a person requesting the information for research purposes. (4) Implementation specifications: Minimum necessary requests for protected health information. (ii) For a request that is made on a routine and recurring basis, a covered entity must implement policies and procedures (which may be standard protocols) that limit the protected health information requested to the amount reasonably necessary to accomplish the purpose for which the request is made. (iii) For all other requests, a covered entity must: (A) Develop criteria designed to limit the request for protected health information to the information reasonably necessary to accomplish the purpose for which the request is made; and (B) Review requests for disclosure on an individual basis in accordance with such criteria. (5) Implementation specification: Other content requirement. (e)(1) Standard: Limited data set. (2) Implementation specification: Limited data set: (i) Names; (ii) Postal address information, other than town or city, State, and zip code; (iii) Telephone numbers; (iv) Fax numbers; (v) Electronic mail addresses; (vi) Social security numbers; (vii) Medical record numbers; (viii) Health plan beneficiary numbers; (ix) Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers, including license plate numbers; (xii) Device identifiers and serial numbers; (xiii) Web Universal Resource Locators (URLs); (xiv) Internet Protocol (IP) address numbers; (xv) Biometric identifiers, including finger and voice prints; and (xvi) Full face photographic images and any comparable images. (3) Implementation specification: Permitted purposes for uses and disclosures. (ii) A covered entity may use protected health information to create a limited data set that meets the requirements of paragraph (e)(2) of this section, or disclose protected health information only to a business associate for such purpose, whether or not the limited data set is to be used by the covered entity. (4) Implementation specifications: Data use agreement Agreement required. (ii) Contents. (A) Establish the permitted uses and disclosures of such information by the limited data set recipient, consistent with paragraph (e)(3) of this section. The data use agreement may not authorize the limited data set recipient to use or further disclose the information in a manner that would violate the requirements of this subpart, if done by the covered entity; (B) Establish who is permitted to use or receive the limited data set; and (C) Provide that the limited data set recipient will: ( 1 ( 2 ( 3 ( 4 ( 5 (iii) Compliance. (1) Discontinued disclosure of protected health information to the recipient; and (2) Reported the problem to the Secretary. (B) A covered entity that is a limited data set recipient and violates a data use agreement will be in noncompliance with the standards, implementation specifications, and requirements of paragraph (e) of this section. (f) Fundraising communications Standard: Uses and disclosures for fundraising. (i) Demographic information relating to an individual, including name, address, other contact information, age, gender, and date of birth; (ii) Dates of health care provided to an individual; (iii) Department of service information; (iv) Treating physician; (v) Outcome information; and (vi) Health insurance status. (2) Implementation specifications: Fundraising requirements. (ii) With each fundraising communication made to an individual under this paragraph, a covered entity must provide the individual with a clear and conspicuous opportunity to elect not to receive any further fundraising communications. The method for an individual to elect not to receive further fundraising communications may not cause the individual to incur an undue burden or more than a nominal cost. (iii) A covered entity may not condition treatment or payment on the individual's choice with respect to the receipt of fundraising communications. (iv) A covered entity may not make fundraising communications to an individual under this paragraph where the individual has elected not to receive such communications under paragraph (f)(2)(ii) of this section. (v) A covered entity may provide an individual who has elected not to receive further fundraising communications with a method to opt back in to receive such communications. (g) Standard: Uses and disclosures for underwriting and related purposes. (h)(1) Standard: Verification requirements. (i) Except with respect to disclosures under § 164.510, verify the identity of a person requesting protected health information and the authority of any such person to have access to protected health information under this subpart, if the identity or any such authority of such person is not known to the covered entity; and (ii) Obtain any documentation, statements, or representations, whether oral or written, from the person requesting the protected health information when such documentation, statement, or representation is a condition of the disclosure under this subpart. (2) Implementation specifications: Verification Conditions on disclosures. (A) The conditions in § 164.512(f)(1)(ii)(C) may be satisfied by the administrative subpoena or similar process or by a separate written statement that, on its face, demonstrates that the applicable requirements have been met. (B) The documentation required by § 164.512(i)(2) may be satisfied by one or more written statements, provided that each is appropriately dated and signed in accordance with § 164.512(i)(2)(i) and (v). (ii) Identity of public officials. (A) If the request is made in person, presentation of an agency identification badge, other official credentials, or other proof of government status; (B) If the request is in writing, the request is on the appropriate government letterhead; or (C) If the disclosure is to a person acting on behalf of a public official, a written statement on appropriate government letterhead that the person is acting under the government's authority or other evidence or documentation of agency, such as a contract for services, memorandum of understanding, or purchase order, that establishes that the person is acting on behalf of the public official. (iii) Authority of public officials. (A) A written statement of the legal authority under which the information is requested, or, if a written statement would be impracticable, an oral statement of such legal authority; (B) If a request is made pursuant to legal process, warrant, subpoena, order, or other legal process issued by a grand jury or a judicial or administrative tribunal is presumed to constitute legal authority. (iv) Exercise of professional judgment. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53270, Aug. 14, 2002; 78 FR 5700, Jan. 25, 2013; 78 FR 34266, June 7, 2013] § 164.520 Notice of privacy practices for protected health information. (a) Standard: Notice of privacy practices Right to notice. (2) Notice requirements for covered entities creating or maintaining records subject to 42 U.S.C. 290dd-2. (3) Exception for group health plans. (A) From the group health plan, if, and to the extent that, such an individual does not receive health benefits under the group health plan through an insurance contract with a health insurance issuer or HMO; or (B) From the health insurance issuer or HMO with respect to the group health plan through which such individuals receive their health benefits under the group health plan. (ii) A group health plan that provides health benefits solely through an insurance contract with a health insurance issuer or HMO, and that creates or receives protected health information in addition to summary health information as defined in § 164.504(a) or information on whether the individual is participating in the group health plan, or is enrolled in or has disenrolled from a health insurance issuer or HMO offered by the plan, must: (A) Maintain a notice under this section; and (B) Provide such notice upon request to any person. The provisions of paragraph (c)(1) of this section do not apply to such group health plan. (iii) A group health plan that provides health benefits solely through an insurance contract with a health insurance issuer or HMO, and does not create or receive protected health information other than summary health information as defined in § 164.504(a) or information on whether an individual is participating in the group health plan, or is enrolled in or has disenrolled from a health insurance issuer or HMO offered by the plan, is not required to maintain or provide a notice under this section. (4) Exception for inmates. (b) Implementation specifications: Content of notice Required elements. (i) Header. “THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.” (ii) Uses and disclosures. (A) A description, including at least one example, of the types of uses and disclosures that the covered entity is permitted by this subpart to make for each of the following purposes: treatment, payment, and health care operations. (B) A description of each of the other purposes for which the covered entity is permitted or required by this subpart to use or disclose protected health information without the individual's written authorization. (C) If a use or disclosure for any purpose described in paragraphs (b)(1)(ii)(A) or (B) of this section is prohibited or materially limited by other applicable law, such as 42 CFR part 2, the description of such use or disclosure must reflect the more stringent law as defined in § 160.202 of this subchapter. (D) For each purpose described in paragraph (b)(1)(ii)(A) or (B) of this section, the description must include sufficient detail to place the individual on notice of the uses and disclosures that are permitted or required by this subpart and other applicable law, such as 42 CFR part 2. (E) A description of the types of uses and disclosures that require an authorization under § 164.508(a)(2)-(a)(4), a statement that other uses and disclosures not described in the notice will be made only with the individual's written authorization, and a statement that the individual may revoke an authorization as provided by § 164.508(b)(5). (F) A description, including at least one example, of the types of uses and disclosures prohibited under § 164.502(a)(5)(iii) in sufficient detail for an individual to understand the prohibition. (G) A description, including at least one example, of the types of uses and disclosures for which an attestation is required under § 164.509. (H) A statement adequate to put the individual on notice of the potential for information disclosed pursuant to this subpart to be subject to redisclosure by the recipient and no longer protected by this subpart (iii) Separate statements for certain uses or disclosures. (A) In accordance with § 164.514(f)(1), the covered entity may contact the individual to raise funds for the covered entity and the individual has a right to opt out of receiving such communications; (B) In accordance with § 164.504(f), the group health plan, or a health insurance issuer or HMO with respect to a group health plan, may disclose protected health information to the sponsor of the plan; (C) If a covered entity that is a health plan, excluding an issuer of a long-term care policy falling within paragraph (1)(viii) of the definition of health plan, (D) Substance use disorder treatment records received from programs subject to 42 CFR part 2, or testimony relaying the content of such records, shall not be used or disclosed in civil, criminal, administrative, or legislative proceedings against the individual unless based on written consent, or a court order after notice and an opportunity to be heard is provided to the individual or the holder of the record, as provided in 42 CFR part 2. A court order authorizing use or disclosure must be accompanied by a subpoena or other legal requirement compelling disclosure before the requested record is used or disclosed; or (E) If a covered entity that creates or maintains records subject to 42 CFR part 2 intends to use or disclose such records for fundraising for the benefit of the covered entity, the individual must first be provided with a clear and conspicuous opportunity to elect not to receive any fundraising communications. (iv) Individual rights. (A) The right to request restrictions on certain uses and disclosures of protected health information as provided by § 164.522(a), including a statement that the covered entity is not required to agree to a requested restriction, except in case of a disclosure restricted under § 164.522(a)(1)(vi); (B) The right to receive confidential communications of protected health information as provided by § 164.522(b), as applicable; (C) The right to inspect and copy protected health information as provided by § 164.524; (D) The right to amend protected health information as provided by § 164.526; (E) The right to receive an accounting of disclosures of protected health information as provided by § 164.528; and (F) The right of an individual, including an individual who has agreed to receive the notice electronically in accordance with paragraph (c)(3) of this section, to obtain a paper copy of the notice from the covered entity upon request. (v) Covered entity's duties. (A) A statement that the covered entity is required by law to maintain the privacy of protected health information, to provide individuals with notice of its legal duties and privacy practices, and to notify affected individuals following a breach of unsecured protected health information; (B) A statement that the covered entity is required to abide by the terms of the notice currently in effect; and (C) For the covered entity to apply a change in a privacy practice that is described in the notice to protected health information that the covered entity created or received prior to issuing a revised notice, in accordance with § 164.530(i)(2)(ii), a statement that it reserves the right to change the terms of its notice and to make the new notice provisions effective for all protected health information that it maintains. The statement must also describe how it will provide individuals with a revised notice. (vi) Complaints. (vii) Contact. (viii) Effective date. (2) Optional elements. (ii) For the covered entity to apply a change in its more limited uses and disclosures to protected health information created or received prior to issuing a revised notice, in accordance with § 164.530(i)(2)(ii), the notice must include the statements required by paragraph (b)(1)(v)(C) of this section. (3) Revisions to the notice. (c) Implementation specifications: Provision of notice. (1) Specific requirements for health plans. (A) No later than the compliance date for the health plan, to individuals then covered by the plan; (B) Thereafter, at the time of enrollment, to individuals who are new enrollees. (ii) No less frequently than once every three years, the health plan must notify individuals then covered by the plan of the availability of the notice and how to obtain the notice. (iii) The health plan satisfies the requirements of paragraph (c)(1) of this section if notice is provided to the named insured of a policy under which coverage is provided to the named insured and one or more dependents. (iv) If a health plan has more than one notice, it satisfies the requirements of paragraph (c)(1) of this section by providing the notice that is relevant to the individual or other person requesting the notice. (v) If there is a material change to the notice: (A) A health plan that posts its notice on its web site in accordance with paragraph (c)(3)(i) of this section must prominently post the change or its revised notice on its web site by the effective date of the material change to the notice, and provide the revised notice, or information about the material change and how to obtain the revised notice, in its next annual mailing to individuals then covered by the plan. (B) A health plan that does not post its notice on a web site pursuant to paragraph (c)(3)(i) of this section must provide the revised notice, or information about the material change and how to obtain the revised notice, to individuals then covered by the plan within 60 days of the material revision to the notice. (2) Specific requirements for certain covered health care providers. (i) Provide the notice: (A) No later than the date of the first service delivery, including service delivered electronically, to such individual after the compliance date for the covered health care provider; or (B) In an emergency treatment situation, as soon as reasonably practicable after the emergency treatment situation. (ii) Except in an emergency treatment situation, make a good faith effort to obtain a written acknowledgment of receipt of the notice provided in accordance with paragraph (c)(2)(i) of this section, and if not obtained, document its good faith efforts to obtain such acknowledgment and the reason why the acknowledgment was not obtained; (iii) If the covered health care provider maintains a physical service delivery site: (A) Have the notice available at the service delivery site for individuals to request to take with them; and (B) Post the notice in a clear and prominent location where it is reasonable to expect individuals seeking service from the covered health care provider to be able to read the notice; and (iv) Whenever the notice is revised, make the notice available upon request on or after the effective date of the revision and promptly comply with the requirements of paragraph (c)(2)(iii) of this section, if applicable. (3) Specific requirements for electronic notice. (ii) A covered entity may provide the notice required by this section to an individual by e-mail, if the individual agrees to electronic notice and such agreement has not been withdrawn. If the covered entity knows that the e-mail transmission has failed, a paper copy of the notice must be provided to the individual. Provision of electronic notice by the covered entity will satisfy the provision requirements of paragraph (c) of this section when timely made in accordance with paragraph (c)(1) or (2) of this section. (iii) For purposes of paragraph (c)(2)(i) of this section, if the first service delivery to an individual is delivered electronically, the covered health care provider must provide electronic notice automatically and contemporaneously in response to the individual's first request for service. The requirements in paragraph (c)(2)(ii) of this section apply to electronic notice. (iv) The individual who is the recipient of electronic notice retains the right to obtain a paper copy of the notice from a covered entity upon request. (d) Implementation specifications: Joint notice by separate covered entities. (1) The covered entities participating in the organized health care arrangement agree to abide by the terms of the notice with respect to protected health information created or received by the covered entity as part of its participation in the organized health care arrangement; (2) The joint notice meets the implementation specifications in paragraph (b) of this section, except that the statements required by this section may be altered to reflect the fact that the notice covers more than one covered entity; and (i) Describes with reasonable specificity the covered entities, or class of entities, to which the joint notice applies; (ii) Describes with reasonable specificity the service delivery sites, or classes of service delivery sites, to which the joint notice applies; and (iii) If applicable, states that the covered entities participating in the organized health care arrangement will share protected health information with each other, as necessary to carry out treatment, payment, or health care operations relating to the organized health care arrangement. (3) The covered entities included in the joint notice must provide the notice to individuals in accordance with the applicable implementation specifications of paragraph (c) of this section. Provision of the joint notice to an individual by any one of the covered entities included in the joint notice will satisfy the provision requirement of paragraph (c) of this section with respect to all others covered by the joint notice. (4) The permission in paragraph (d) of this section for covered entities that participate in an organized health care arrangement to issue a joint notice may not be construed to remove any obligations or duties of entities creating or maintaining records subject to 42 U.S.C. 290dd-2, or to remove any rights of patients who are the subjects of such records. (e) Implementation specifications: Documentation. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53271, Aug. 14, 2002; 78 FR 5701, Jan. 25, 2013; 89 FR 33064, Apr. 26, 2024] § 164.522 Rights to request privacy protection for protected health information. (a)(1) Standard: Right of an individual to request restriction of uses and disclosures. (A) Uses or disclosures of protected health information about the individual to carry out treatment, payment, or health care operations; and (B) Disclosures permitted under § 164.510(b). (ii) Except as provided in paragraph (a)(1)(vi) of this section, a covered entity is not required to agree to a restriction. (iii) A covered entity that agrees to a restriction under paragraph (a)(1)(i) of this section may not use or disclose protected health information in violation of such restriction, except that, if the individual who requested the restriction is in need of emergency treatment and the restricted protected health information is needed to provide the emergency treatment, the covered entity may use the restricted protected health information, or may disclose such information to a health care provider, to provide such treatment to the individual. (iv) If restricted protected health information is disclosed to a health care provider for emergency treatment under paragraph (a)(1)(iii) of this section, the covered entity must request that such health care provider not further use or disclose the information. (v) A restriction agreed to by a covered entity under paragraph (a) of this section, is not effective under this subpart to prevent uses or disclosures permitted or required under § 164.502(a)(2)(ii), § 164.510(a) or § 164.512. (vi) A covered entity must agree to the request of an individual to restrict disclosure of protected health information about the individual to a health plan if: (A) The disclosure is for the purpose of carrying out payment or health care operations and is not otherwise required by law; and (B) The protected health information pertains solely to a health care item or service for which the individual, or person other than the health plan on behalf of the individual, has paid the covered entity in full. (2) Implementation specifications: Terminating a restriction. (i) The individual agrees to or requests the termination in writing; (ii) The individual orally agrees to the termination and the oral agreement is documented; or (iii) The covered entity informs the individual that it is terminating its agreement to a restriction, except that such termination is: (A) Not effective for protected health information restricted under paragraph (a)(1)(vi) of this section; and (B) Only effective with respect to protected health information created or received after it has so informed the individual. (3) Implementation specification: Documentation. (b)(1) Standard: Confidential communications requirements. (ii) A health plan must permit individuals to request and must accommodate reasonable requests by individuals to receive communications of protected health information from the health plan by alternative means or at alternative locations, if the individual clearly states that the disclosure of all or part of that information could endanger the individual. (2) Implementation specifications: Conditions on providing confidential communications. (ii) A covered entity may condition the provision of a reasonable accommodation on: (A) When appropriate, information as to how payment, if any, will be handled; and (B) Specification of an alternative address or other method of contact. (iii) A covered health care provider may not require an explanation from the individual as to the basis for the request as a condition of providing communications on a confidential basis. (iv) A health plan may require that a request contain a statement that disclosure of all or part of the information to which the request pertains could endanger the individual. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53271, Aug. 14, 2002; 78 FR 5701, Jan. 25, 2013] § 164.524 Access of individuals to protected health information. (a) Standard: Access to protected health information Right of access. (i) Psychotherapy notes; and (ii) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding. (2) Unreviewable grounds for denial. (i) The protected health information is excepted from the right of access by paragraph (a)(1) of this section. (ii) A covered entity that is a correctional institution or a covered health care provider acting under the direction of the correctional institution may deny, in whole or in part, an inmate's request to obtain a copy of protected health information, if obtaining such copy would jeopardize the health, safety, security, custody, or rehabilitation of the individual or of other inmates, or the safety of any officer, employee, or other person at the correctional institution or responsible for the transporting of the inmate. (iii) An individual's access to protected health information created or obtained by a covered health care provider in the course of research that includes treatment may be temporarily suspended for as long as the research is in progress, provided that the individual has agreed to the denial of access when consenting to participate in the research that includes treatment, and the covered health care provider has informed the individual that the right of access will be reinstated upon completion of the research. (iv) An individual's access to protected health information that is contained in records that are subject to the Privacy Act, 5 U.S.C. 552a, may be denied, if the denial of access under the Privacy Act would meet the requirements of that law. (v) An individual's access may be denied if the protected health information was obtained from someone other than a health care provider under a promise of confidentiality and the access requested would be reasonably likely to reveal the source of the information. (3) Reviewable grounds for denial. (i) A licensed health care professional has determined, in the exercise of professional judgment, that the access requested is reasonably likely to endanger the life or physical safety of the individual or another person; (ii) The protected health information makes reference to another person (unless such other person is a health care provider) and a licensed health care professional has determined, in the exercise of professional judgment, that the access requested is reasonably likely to cause substantial harm to such other person; or (iii) The request for access is made by the individual's personal representative and a licensed health care professional has determined, in the exercise of professional judgment, that the provision of access to such personal representative is reasonably likely to cause substantial harm to the individual or another person. (4) Review of a denial of access. (b) Implementation specifications: Requests for access and timely action Individual's request for access. (2) Timely action by the covered entity. (A) If the covered entity grants the request, in whole or in part, it must inform the individual of the acceptance of the request and provide the access requested, in accordance with paragraph (c) of this section. (B) If the covered entity denies the request, in whole or in part, it must provide the individual with a written denial, in accordance with paragraph (d) of this section. (ii) If the covered entity is unable to take an action required by paragraph (b)(2)(i)(A) or (B) of this section within the time required by paragraph (b)(2)(i) of this section, as applicable, the covered entity may extend the time for such actions by no more than 30 days, provided that: (A) The covered entity, within the time limit set by paragraph (b)(2)(i) of this section, as applicable, provides the individual with a written statement of the reasons for the delay and the date by which the covered entity will complete its action on the request; and (B) The covered entity may have only one such extension of time for action on a request for access. (c) Implementation specifications: Provision of access. (1) Providing the access requested. (2) Form of access requested. (ii) Notwithstanding paragraph (c)(2)(i) of this section, if the protected health information that is the subject of a request for access is maintained in one or more designated record sets electronically and if the individual requests an electronic copy of such information, the covered entity must provide the individual with access to the protected health information in the electronic form and format requested by the individual, if it is readily producible in such form and format; or, if not, in a readable electronic form and format as agreed to by the covered entity and the individual. (iii) The covered entity may provide the individual with a summary of the protected health information requested, in lieu of providing access to the protected health information or may provide an explanation of the protected health information to which access has been provided, if: (A) The individual agrees in advance to such a summary or explanation; and (B) The individual agrees in advance to the fees imposed, if any, by the covered entity for such summary or explanation. (3) Time and manner of access. (ii) If an individual's request for access directs the covered entity to transmit the copy of protected health information directly to another person designated by the individual, the covered entity must provide the copy to the person designated by the individual. The individual's request must be in writing, signed by the individual, and clearly identify the designated person and where to send the copy of protected health information. (4) Fees. (i) Labor for copying the protected health information requested by the individual, whether in paper or electronic form; (ii) Supplies for creating the paper copy or electronic media if the individual requests that the electronic copy be provided on portable media; (iii) Postage, when the individual has requested the copy, or the summary or explanation, be mailed; and (iv) Preparing an explanation or summary of the protected health information, if agreed to by the individual as required by paragraph (c)(2)(iii) of this section. (d) Implementation specifications: Denial of access. (1) Making other information accessible. (2) Denial. (i) The basis for the denial; (ii) If applicable, a statement of the individual's review rights under paragraph (a)(4) of this section, including a description of how the individual may exercise such review rights; and (iii) A description of how the individual may complain to the covered entity pursuant to the complaint procedures in § 164.530(d) or to the Secretary pursuant to the procedures in § 160.306. The description must include the name, or title, and telephone number of the contact person or office designated in § 164.530(a)(1)(ii). (3) Other responsibility. (4) Review of denial requested. (e) Implementation specification: Documentation. (1) The designated record sets that are subject to access by individuals; and (2) The titles of the persons or offices responsible for receiving and processing requests for access by individuals. [65 FR 82802, Dec. 28, 2000, as amended at 78 FR 5701, Jan. 25, 2013; 78 FR 34266, June 7, 2013; 79 FR 7316, Feb. 6, 2014] § 164.526 Amendment of protected health information. (a) Standard: Right to amend. Right to amend. (2) Denial of amendment. (i) Was not created by the covered entity, unless the individual provides a reasonable basis to believe that the originator of protected health information is no longer available to act on the requested amendment; (ii) Is not part of the designated record set; (iii) Would not be available for inspection under § 164.524; or (iv) Is accurate and complete. (b) Implementation specifications: Requests for amendment and timely action Individual's request for amendment. (2) Timely action by the covered entity. (A) If the covered entity grants the requested amendment, in whole or in part, it must take the actions required by paragraphs (c)(1) and (2) of this section. (B) If the covered entity denies the requested amendment, in whole or in part, it must provide the individual with a written denial, in accordance with paragraph (d)(1) of this section. (ii) If the covered entity is unable to act on the amendment within the time required by paragraph (b)(2)(i) of this section, the covered entity may extend the time for such action by no more than 30 days, provided that: (A) The covered entity, within the time limit set by paragraph (b)(2)(i) of this section, provides the individual with a written statement of the reasons for the delay and the date by which the covered entity will complete its action on the request; and (B) The covered entity may have only one such extension of time for action on a request for an amendment. (c) Implementation specifications: Accepting the amendment. (1) Making the amendment. (2) Informing the individual. (3) Informing others. (i) Persons identified by the individual as having received protected health information about the individual and needing the amendment; and (ii) Persons, including business associates, that the covered entity knows have the protected health information that is the subject of the amendment and that may have relied, or could foreseeably rely, on such information to the detriment of the individual. (d) Implementation specifications: Denying the amendment. (1) Denial. (i) The basis for the denial, in accordance with paragraph (a)(2) of this section; (ii) The individual's right to submit a written statement disagreeing with the denial and how the individual may file such a statement; (iii) A statement that, if the individual does not submit a statement of disagreement, the individual may request that the covered entity provide the individual's request for amendment and the denial with any future disclosures of the protected health information that is the subject of the amendment; and (iv) A description of how the individual may complain to the covered entity pursuant to the complaint procedures established in § 164.530(d) or to the Secretary pursuant to the procedures established in § 160.306. The description must include the name, or title, and telephone number of the contact person or office designated in § 164.530(a)(1)(ii). (2) Statement of disagreement. (3) Rebuttal statement. (4) Recordkeeping. (5) Future disclosures. (ii) If the individual has not submitted a written statement of disagreement, the covered entity must include the individual's request for amendment and its denial, or an accurate summary of such information, with any subsequent disclosure of the protected health information only if the individual has requested such action in accordance with paragraph (d)(1)(iii) of this section. (iii) When a subsequent disclosure described in paragraph (d)(5)(i) or (ii) of this section is made using a standard transaction under part 162 of this subchapter that does not permit the additional material to be included with the disclosure, the covered entity may separately transmit the material required by paragraph (d)(5)(i) or (ii) of this section, as applicable, to the recipient of the standard transaction. (e) Implementation specification: Actions on notices of amendment. (f) Implementation specification: Documentation. § 164.528 Accounting of disclosures of protected health information. (a) Standard: Right to an accounting of disclosures of protected health information. (i) To carry out treatment, payment and health care operations as provided in § 164.506; (ii) To individuals of protected health information about them as provided in § 164.502; (iii) Incident to a use or disclosure otherwise permitted or required by this subpart, as provided in § 164.502; (iv) Pursuant to an authorization as provided in § 164.508; (v) For the facility's directory or to persons involved in the individual's care or other notification purposes as provided in § 164.510; (vi) For national security or intelligence purposes as provided in § 164.512(k)(2); (vii) To correctional institutions or law enforcement officials as provided in § 164.512(k)(5); (viii) As part of a limited data set in accordance with § 164.514(e); or (ix) That occurred prior to the compliance date for the covered entity. (2)(i) The covered entity must temporarily suspend an individual's right to receive an accounting of disclosures to a health oversight agency or law enforcement official, as provided in § 164.512(d) or (f), respectively, for the time specified by such agency or official, if such agency or official provides the covered entity with a written statement that such an accounting to the individual would be reasonably likely to impede the agency's activities and specifying the time for which such a suspension is required. (ii) If the agency or official statement in paragraph (a)(2)(i) of this section is made orally, the covered entity must: (A) Document the statement, including the identity of the agency or official making the statement; (B) Temporarily suspend the individual's right to an accounting of disclosures subject to the statement; and (C) Limit the temporary suspension to no longer than 30 days from the date of the oral statement, unless a written statement pursuant to paragraph (a)(2)(i) of this section is submitted during that time. (3) An individual may request an accounting of disclosures for a period of time less than six years from the date of the request. (b) Implementation specifications: Content of the accounting. (1) Except as otherwise provided by paragraph (a) of this section, the accounting must include disclosures of protected health information that occurred during the six years (or such shorter time period at the request of the individual as provided in paragraph (a)(3) of this section) prior to the date of the request for an accounting, including disclosures to or by business associates of the covered entity. (2) Except as otherwise provided by paragraphs (b)(3) or (b)(4) of this section, the accounting must include for each disclosure: (i) The date of the disclosure; (ii) The name of the entity or person who received the protected health information and, if known, the address of such entity or person; (iii) A brief description of the protected health information disclosed; and (iv) A brief statement of the purpose of the disclosure that reasonably informs the individual of the basis for the disclosure or, in lieu of such statement, a copy of a written request for a disclosure under § 164.502(a)(2)(ii) or § 164.512, if any. (3) If, during the period covered by the accounting, the covered entity has made multiple disclosures of protected health information to the same person or entity for a single purpose under § 164.502(a)(2)(ii) or § 164.512, the accounting may, with respect to such multiple disclosures, provide: (i) The information required by paragraph (b)(2) of this section for the first disclosure during the accounting period; (ii) The frequency, periodicity, or number of the disclosures made during the accounting period; and (iii) The date of the last such disclosure during the accounting period. (4)(i) If, during the period covered by the accounting, the covered entity has made disclosures of protected health information for a particular research purpose in accordance with § 164.512(i) for 50 or more individuals, the accounting may, with respect to such disclosures for which the protected health information about the individual may have been included, provide: (A) The name of the protocol or other research activity; (B) A description, in plain language, of the research protocol or other research activity, including the purpose of the research and the criteria for selecting particular records; (C) A brief description of the type of protected health information that was disclosed; (D) The date or period of time during which such disclosures occurred, or may have occurred, including the date of the last such disclosure during the accounting period; (E) The name, address, and telephone number of the entity that sponsored the research and of the researcher to whom the information was disclosed; and (F) A statement that the protected health information of the individual may or may not have been disclosed for a particular protocol or other research activity. (ii) If the covered entity provides an accounting for research disclosures, in accordance with paragraph (b)(4) of this section, and if it is reasonably likely that the protected health information of the individual was disclosed for such research protocol or activity, the covered entity shall, at the request of the individual, assist in contacting the entity that sponsored the research and the researcher. (c) Implementation specifications: Provision of the accounting. (i) The covered entity must provide the individual with the accounting requested; or (ii) If the covered entity is unable to provide the accounting within the time required by paragraph (c)(1) of this section, the covered entity may extend the time to provide the accounting by no more than 30 days, provided that: (A) The covered entity, within the time limit set by paragraph (c)(1) of this section, provides the individual with a written statement of the reasons for the delay and the date by which the covered entity will provide the accounting; and (B) The covered entity may have only one such extension of time for action on a request for an accounting. (2) The covered entity must provide the first accounting to an individual in any 12 month period without charge. The covered entity may impose a reasonable, cost-based fee for each subsequent request for an accounting by the same individual within the 12 month period, provided that the covered entity informs the individual in advance of the fee and provides the individual with an opportunity to withdraw or modify the request for a subsequent accounting in order to avoid or reduce the fee. (d) Implementation specification: Documentation. (1) The information required to be included in an accounting under paragraph (b) of this section for disclosures of protected health information that are subject to an accounting under paragraph (a) of this section; (2) The written accounting that is provided to the individual under this section; and (3) The titles of the persons or offices responsible for receiving and processing requests for an accounting by individuals. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53271, Aug. 14, 2002] § 164.530 Administrative requirements. (a)(1) Standard: Personnel designations. (ii) A covered entity must designate a contact person or office who is responsible for receiving complaints under this section and who is able to provide further information about matters covered by the notice required by § 164.520. (2) Implementation specification: Personnel designations. (b)(1) Standard: Training. (2) Implementation specifications: Training. (A) To each member of the covered entity's workforce by no later than the compliance date for the covered entity; (B) Thereafter, to each new member of the workforce within a reasonable period of time after the person joins the covered entity's workforce; and (C) To each member of the covered entity's workforce whose functions are affected by a material change in the policies or procedures required by this subpart or subpart D of this part, within a reasonable period of time after the material change becomes effective in accordance with paragraph (i) of this section. (ii) A covered entity must document that the training as described in paragraph (b)(2)(i) of this section has been provided, as required by paragraph (j) of this section. (c)(1) Standard: Safeguards. (2)(i) Implementation specification: Safeguards. (ii) A covered entity must reasonably safeguard protected health information to limit incidental uses or disclosures made pursuant to an otherwise permitted or required use or disclosure. (d)(1) Standard: Complaints to the covered entity. (2) Implementation specification: Documentation of complaints. (e)(1) Standard: Sanctions. (2) Implementation specification: Documentation. (f) Standard: Mitigation. (g) Standard: Refraining from intimidating or retaliatory acts. (1) May not intimidate, threaten, coerce, discriminate against, or take other retaliatory action against any individual for the exercise by the individual of any right established, or for participation in any process provided for, by this subpart or subpart D of this part, including the filing of a complaint under this section; and (2) Must refrain from intimidation and retaliation as provided in § 160.316 of this subchapter. (h) Standard: Waiver of rights. (i)(1) Standard: Policies and procedures. (2) Standard: Changes to policies and procedures. (ii) When a covered entity changes a privacy practice that is stated in the notice described in § 164.520, and makes corresponding changes to its policies and procedures, it may make the changes effective for protected health information that it created or received prior to the effective date of the notice revision, if the covered entity has, in accordance with § 164.520(b)(1)(v)(C), included in the notice a statement reserving its right to make such a change in its privacy practices; or (iii) A covered entity may make any other changes to policies and procedures at any time, provided that the changes are documented and implemented in accordance with paragraph (i)(5) of this section. (3) Implementation specification: Changes in law. (4) Implementation specifications: Changes to privacy practices stated in the notice. (A) Ensure that the policy or procedure, as revised to reflect a change in the covered entity's privacy practice as stated in its notice, complies with the standards, requirements, and implementation specifications of this subpart; (B) Document the policy or procedure, as revised, as required by paragraph (j) of this section; and (C) Revise the notice as required by § 164.520(b)(3) to state the changed practice and make the revised notice available as required by § 164.520(c). The covered entity may not implement a change to a policy or procedure prior to the effective date of the revised notice. (ii) If a covered entity has not reserved its right under § 164.520(b)(1)(v)(C) to change a privacy practice that is stated in the notice, the covered entity is bound by the privacy practices as stated in the notice with respect to protected health information created or received while such notice is in effect. A covered entity may change a privacy practice that is stated in the notice, and the related policies and procedures, without having reserved the right to do so, provided that: (A) Such change meets the implementation specifications in paragraphs (i)(4)(i)(A)-(C) of this section; and (B) Such change is effective only with respect to protected health information created or received after the effective date of the notice. (5) Implementation specification: Changes to other policies or procedures. (i) The policy or procedure, as revised, complies with the standards, requirements, and implementation specifications of this subpart; and (ii) Prior to the effective date of the change, the policy or procedure, as revised, is documented as required by paragraph (j) of this section. (j)(1) Standard: Documentation. (i) Maintain the policies and procedures provided for in paragraph (i) of this section in written or electronic form; (ii) If a communication is required by this subpart to be in writing, maintain such writing, or an electronic copy, as documentation; and (iii) If an action, activity, or designation is required by this subpart to be documented, maintain a written or electronic record of such action, activity, or designation. (iv) Maintain documentation sufficient to meet its burden of proof under § 164.414(b). (2) Implementation specification: Retention period. (k) Standard: Group health plans. (i) The group health plan provides health benefits solely through an insurance contract with a health insurance issuer or an HMO; and (ii) The group health plan does not create or receive protected health information, except for: (A) Summary health information as defined in § 164.504(a); or (B) Information on whether the individual is participating in the group health plan, or is enrolled in or has disenrolled from a health insurance issuer or HMO offered by the plan. (2) A group health plan described in paragraph (k)(1) of this section is subject to the standard and implementation specification in paragraph (j) of this section only with respect to plan documents amended in accordance with § 164.504(f). [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53272, Aug. 14, 2002; 71 FR 8433, Feb. 16, 2006; 74 FR 42769, Aug. 24, 2009] § 164.532 Transition provisions. (a) Standard: Effect of prior authorizations. (b) Implementation specification: Effect of prior authorization for purposes other than research. (c) Implementation specification: Effect of prior permission for research. (1) An authorization or other express legal permission from an individual to use or disclose protected health information for the research; (2) The informed consent of the individual to participate in the research; (3) A waiver, by an IRB, of informed consent for the research, in accordance with 7 CFR 1c.116(d), 10 CFR 745.116(d), 14 CFR 1230.116(d), 15 CFR 27.116(d), 16 CFR 1028.116(d), 21 CFR 50.24, 22 CFR 225.116(d), 24 CFR 60.116(d), 28 CFR 46.116(d), 32 CFR 219.116(d), 34 CFR 97.116(d), 38 CFR 16.116(d), 40 CFR 26.116(d), 45 CFR 46.116(d), 45 CFR 690.116(d), or 49 CFR 11.116(d), provided that a covered entity must obtain authorization in accordance with § 164.508 if, after the compliance date, informed consent is sought from an individual participating in the research; or (4) A waiver of authorization in accordance with § 164.512(i)(1)(i). (d) Standard: Effect of prior contracts or other arrangements with business associates. (e) Implementation specification: Deemed compliance Qualification. (i) Prior to January 25, 2013, such covered entity, or business associate with respect to a subcontractor, has entered into and is operating pursuant to a written contract or other written arrangement with the business associate that complies with the applicable provisions of § 164.314(a) or § 164.504(e) that were in effect on such date; and (ii) The contract or other arrangement is not renewed or modified from March 26, 2013, until September 23, 2013. (2) Limited deemed compliance period. (i) The date such contract or other arrangement is renewed or modified on or after September 23, 2013; or (ii) September 22, 2014. (3) Covered entity responsibilities. (f) Effect of prior data use agreements. (1) The date such agreement is renewed or modified on or after September 23, 2013; or (2) September 22, 2014. [65 FR 82802, Dec. 28, 2000, as amended at 67 FR 53272, Aug. 14, 2002; 78 FR 5702, Jan. 25, 2013; 78 FR 34266, June 7, 2013] § 164.534 Compliance dates for initial implementation of the privacy standards. (a) Health care providers. (b) Health plans. (1) Health plans other than small health plans. (2) Small health plans. (c) Health clearinghouses. [66 FR 12434, Feb. 26, 2001] § 164.535 Severability. If any provision of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy is held to be invalid or unenforceable facially, or as applied to any person, plaintiff, or circumstance, it shall be construed to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which case the provision shall be severable from this part and shall not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other dissimilar circumstances. [89 FR 33066, Apr. 26, 2024]

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