Abstract

Robust certification and verification processes are crucial with the rapid advancement of artificial intelligence (AI) technology in healthcare. Taiwan's AI product certification process is complex and lacks standardization, leading to inefficiencies and increased burdens for developers and regulatory bodies. To address these issues, we propose establishing Taiwan's AI Medical Device Verification Center to provide a single-window service, simplifying and standardizing the certification process. This center will develop standardized electronic application forms, establish a central review committee, and create a federated learning platform to promote data sharing and collaborative learning. Additionally, we will complete the establishment of an electronic medical record (EMR) coding dictionary and achieve cross-hospital data integration through FHIR and TW Core IG technologies. Automated data cleaning tools and developing apps compliant with Smart on FHIR specifications will also significantly enhance data processing efficiency and interoperability. The Clinical AI Certification and Verification Center will collaborate with academic institutions, tech companies, and alliance hospitals to drive data sharing and utilization across Taiwan. We propose the development of a comprehensive public website to provide artificial intelligence developers, alliance hospitals, and patients with a convenient, efficient, and secure platform for service applications, queries, submissions, and case tracking. These measures will improve the efficiency of AI product certification, promote the development of smart medical devices, and align with international standards and regulations, facilitating certification in other countries.

Biography 

Dr. Wei-Ling Chen is the Chief of the Department of Medical Engineering at Taipei Veterans General Hospital. She has a rich background in medical device inspection and regulatory formulation, previously serving as a Technical Specialist at the Taiwan Food and Drug Administration (TFDA). Dr. Chen is a member of the IRB committees at both Taipei and Kaohsiung Veterans General Hospitals and serves on the ethics committees for biobanks and clinical trials. Her expertise ensures regulatory compliance and ethical standards in medical device registration and trials, providing valuable support for advancing healthcare technology.