Artificial intelligence and Machine Learning (AI/ML) functionality in medical devices and software has been a focus area for regulators, as these tools represent a rapidly growing frontier in digital health.
Greg Levine, partner and global FDA regulatory group chair, and Lincoln Tsang, partner and head of the firm’s European life sciences practice, presented a HLTH webinar on April 30 on “Regulatory Issues Surrounding AI and Machine Learning Devices: U.S. FDA and European Perspectives.”
Greg moderated the webinar with presenters Lincoln and Sonja Fulmer, Deputy Director, FDA Digital Health Center of Excellence.
The HLTH webinar examined topics including AI/ML device approvals and clearances trends and status in the U.S. and Europe; life cycle management considerations and premarket submissions recommendations for AI/ML-enabled device software functions; and the EU AI Act including a financial penalties proposal for regulatory breach and legislative proposal for non-contractual civil liability rules to AI.
HLTH is a health ecosystem platform focused on health innovation and transformation.
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