Discussion on Latest Trends Including the Digital Medical Product Act and RWE Utilization
Yonsei University Medical Center and the Korea Medical Device Safety Information Institute announced on August 13 that they will co-host the "2025 Global Digital Healthcare Symposium" at the Avison Biomedical Research Center, Yonsei University College of Medicine, on August 26.
The symposium will focus on medical artificial intelligence (AI) and digital therapeutics (DTx), featuring presentations and discussions on the latest industry trends related to SaMD (Software as a Medical Device) and strategies to vitalize the digital healthcare ecosystem.
The event will consist of three sessions in total. During the morning session, domestic industry experts will present on topics including: AI-based endoscopy and the future of medical screening; collection and analysis of medical AI data; AI utilization for Parkinson’s disease diagnosis; and case studies of advanced technology implementation in hospital settings.
In the afternoon session, international experts will participate to introduce global regulatory trends in digital healthcare. John Haushild and Nancy Van Rent, directors at U.S. medical device company Medtronic, as well as Kenji Yashiro, manager at Emergo Japan, will each deliver video (VOD) presentations on regulatory policies and reimbursement approval trends for digital healthcare in the U.S., Europe, and Japan.
Lectures by domestic regulatory experts will follow. Professor Jang Wonseok from the Department of Medical Device Industry at Yonsei University College of Medicine, and Han Youngmin, officer at the Digital Health Regulatory Support Division of the Ministry of Food and Drug Safety, will address key issues and implications, focusing on SaMD usability evaluation and ecosystem changes brought about by the enactment of the Digital Medical Product Act.
The final session will feature a panel discussion on the newly introduced "real-world use evaluation" provision in the Digital Medical Product Act and strategies for linking with real-world evidence (RWE).
Lim Junseok, Director of Digital Health at Yonsei Medical Center, said, "The Global Digital Healthcare Symposium, now in its fourth year, has established itself as an annual event and a platform for continuous information exchange and networking among stakeholders in industry, academia, research, hospitals, government, and institutions both domestically and internationally. In particular, we expect this symposium to serve as an opportunity to suggest the future direction of the digital healthcare industry, through discussions on the changing regulatory environment and strategies for utilizing RWE."
Lee Jeongrim, President of the Korea Medical Device Safety Information Institute, also commented, "Close communication and collaboration between industry and regulatory agencies are essential for the advancement and commercialization of cutting-edge medical devices, including digital medical devices. We hope this symposium will serve as a meaningful occasion to drive sustainable growth and strengthen the global competitiveness of Korea’s digital healthcare industry."
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