Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical Trial

Project Summary I. Project Objectives With the rapid advancement of medical technology, smart medical devices have become one of the key components of modern healthcare. However, integrating these emerging technologies into the national health insurance (NHI) reimbursement system while ensuring their clinical value and economic benefits remains a major challenge worldwide. The primary goal of this project is to assist commercialized smart medical device products-those that have passed TFDA review and seek NHI reimbursement-in conducting comprehensive evaluations of their clinical effectiveness and medical economic impact. Through scientific data and standardized impact assessment procedures, the project aims to provide localized evidence to support reimbursement policy decisions and facilitate the market adoption of smart medical technologies. Ultimately, this project seeks to balance therapeutic efficacy and cost control, offering a scientific foundation for NHI decision-making and paving the way for the sustainable development of AI-driven healthcare innovations. II. Implementation Methods 1. Multi-center Collaborative Network This project will be led by Taichung Veterans General Hospital (TCVGH) as the principal site, with collaboration from Kaohsiung Medical University Chung-Ho Memorial Hospital and Changhua Show Chwan Memorial Hospital. This cross-institutional, cross-regional alliance ensures diverse clinical samples, enhances the representativeness of study results, and allows evaluation of AI medical devices across different healthcare systems and environments. 2. Clinical Trial Design and Implementation for Smart Medical Devices The project will design and execute systematic clinical trials for smart medical devices using methodologies such as randomized controlled trials (RCTs), before-and-after studies, pragmatic RCTs (PCTs), cluster RCTs, and stepped-wedge RCTs. These rigorous designs will ensure scientific validity, reproducibility, and pra