~Speakers~
Dr. Kang-Ping Lin, Ph.D.
Secretary General of IFMBE
(International Federation for Medical and Biological Engineering)
Speaker's Biography
Kang-Ping Lin obtained his Ph.D. degree in 1994 at the University of
California, Los Angeles (UCLA) in Biomedical Physics. He is the Distinguished
Professor of Electrical Engineering and the Director of Technology Translation
Center for Medical Device at Chung-Yuan Christian University (CYCU), Taiwan. He
serves several positions including the President of Taiwanese Society of
Molecular Imaging (2019~2022), the Editor-in-Chief of JMBE, the Secretary
General and the Chair of Publicity Committee in IFMBE (2015~2022), and one of
Administrative Council members, the Chair of Public and International Relations
Ad-hoc Committee, and one of the members of Congress Coordinating Committee in
IUPESM (2015~2022). He earned awards including the 2016 Chinese Institute of
Engineers: Outstanding Engineering Professors Award, the 2017 ACCE (USA)
Antonio Hernandez International Clinical Engineering Award, and the 2019 TSBME
Wei Han Biomedical Engineering Service Award. His research interests include
handheld medical devices, physiological signal processing, and medical image
processing. In addition to his research work, he has long been involved in
continuing education and training programs in clinical engineering.
Topic
Wearable
Devices and AI in Medical Applications and Regulatory Status
Abstract
With the rise of the Internet of Things, sensors and computer algorithms, the technology of medical wearable devices has made significant progress compared to the past, and the potential of AI technology in medical applications is even more anticipated. Wearable devices have the characteristics of being wearable, convenient to move, real-time monitoring and remote transmission. They are the best tool for disease monitoring and telemedicine. The range of its technical applications is wide. In addition to the verification of physiological sensing functions, validation and information security protection of the software are also the focused. If AI technology is used as a tool for algorithm analysis, related products need further AI supervision.
On account of the increasing importance of AI in society, as well as considerations such as ethics, privacy, trustworthiness, and data transparency, the review points of AI medical devices in various countries are generally inclined to strengthen quality monitoring mechanisms, and from data collection to algorithms development and design verification should establish management and control requirements. In order to comply with the national digital development policy in the USA, under the current regulatory framework, many products have received market approval through 510K, de novo or PMA. The European Union has raised the regulation level of AI technology with the three elements of "legal", "ethical" and "stable" as the core prerequisites for the development of AI technology. We are trying to build a co-prosperity circle of AI excellence and trust in the medical environment. This also shows that the medical device industry should have high ethical to patient safety and have product capabilities in medical quality standard to meet the expectations of future demand in clinical.