Apply to trial NCT07620834

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 practical feasibility in real-world clinical settings. 3. Health Economic Evaluation A key component of this project is the medical economic assessment, conducted by experienced health economists through cost-effectiveness analysis. The evaluation will focus on how smart medical devices reduce healthcare costs, improve diagnostic efficiency, and enhance treatment outcomes, quantifying their economic value within the NHI system. This evidence will guide policy makers in making data-driven reimbursement decisions. 4. Standardized Impact Assessment Process To ensure high-quality research, the project will establish a comprehensive standardized impact assessment framework covering trial design, data collection, statistical analysis, economic evaluation, and ethical review. This standardized approach not only improves the precision of the study but also accelerates the clinical translation of AI medical devices through streamlined application and review processes. 5. Research Case Study and Clinical Application The featured case study in this project is "VeriOsteo OP® Smart Bone Screening System," which targets early osteoporosis screening among adults aged 40 to 80 years in high-risk groups. This study will evaluate the clinical accuracy of AI-based osteoporosis screening and assess its economic contribution to healthcare cost reduction. The findings will directly inform the Ministry of Health and Welfare's NHI Administration in formulating reimbursement standards for AI medical devices. 6. Data Sharing and Information Security Throughout the project, all research data collection, exchange, and sharing will strictly adhere to cybersecurity and privacy regulations. The AI models involved will undergo validation to ensure the reliability and scientific rigor of the results. Furthermore, the project will promote collaboration between manufacturers and healthcare institutions to support the adoption of smart medical technologies. 7. Final Outcomes and Future Development The final deliverables will include a comprehensive evaluation report on the clinical and economic performance of the AI medical device, along with recommendations for NHI reimbursement application. The results will provide a reference model for future AI medical devices entering the reimbursement system and further advance the field of smart healthcare. In the long term, the center aims to expand its research to other disease domains while strengthening data security and ethical oversight to ensure the feasibility and credibility of AI applications in clinical practice. III. Expected Outcomes and Future Vision By implementing a multi-center collaborative framework, this project aims to promote clinical adoption and economic evaluation of smart medical devices, offering concrete data to support NHI policy-making. Over time, the project is expected to establish a robust evaluation system for AI medical devices, facilitate broader market adoption, and enhance patient outcomes whi