Yonsei University Health System and the National Institute of Medical Device Safety Information will jointly host the “2025 Global Digital Healthcare Symposium” at the Avison Biomedical Research Center of Yonsei University College of Medicine on Aug. 26, focusing on medical artificial intelligence (AI) and digital therapeutics (DTx).
The organizers announced on Wednesday that the symposium will center on the latest industry trends in software as a medical device (SaMD) and strategies to foster the digital healthcare ecosystem, bringing together domestic and international experts from industry, academia, healthcare institutions, and regulatory bodies.
The program will feature three sessions.
In the morning, Korean industry specialists will present on topics including AI-based endoscopy and the future of health screening, AI data collection and analysis in healthcare, AI applications in Parkinson’s disease diagnosis, and real-world adoption of advanced technologies in hospital settings.
The afternoon will shift to international perspectives, with global regulatory updates delivered via pre-recorded video presentations. Speakers include John Hauschild and Nancy Van Len, directors at U.S. medical device company Medtronic, who will address U.S. and European regulatory and reimbursement developments, and Kenji Yashiro, manager at Emergo Japan, who will discuss Japan’s policy landscape.
Korean regulatory experts will also take the stage. Professor Jang Won-seok of Yonsei University’s Department of Medical Device Industry and Han Young-min, an official at the Ministry of Food and Drug Safety, will examine SaMD usability evaluations and the impact of the new Digital Medical Products Act on the industry ecosystem.
The final session will feature a panel discussion on the newly introduced “real-world evaluation” and ways to link it with real-world evidence (RWE).
“The Global Digital Healthcare Symposium has become an established annual platform for information exchange and networking across domestic and global stakeholders,” YUHS Digital Health Department head Lim Joon-seok. “This year’s event will offer timely insights into the evolving regulatory landscape and RWE strategies, guiding the future direction of the digital healthcare industry.”
Pre-registration is open until Aug. 22, and attendance is free for all who register in advance.
“Close communication and collaboration between industry and regulators is essential for the advancement and commercialization of digital medical devices and other cutting-edge technologies,” National Institute of Medical Device Safety Information President Lee Jeong-rim said. “We hope this symposium will be a meaningful step toward sustainable growth and stronger global competitiveness for Korea’s digital healthcare sector.”
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