Greg Levine and Lincoln Tsang to Present HLTH Webinar on Regulatory Issues Surrounding AI and Machine Learning Devices

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, will present a HLTH webinar on April 30 on “Regulatory Issues Surrounding AI and Machine Learning Devices: U.S. FDA and European Perspectives.”

Greg will moderate the webinar with presenters Lincoln and Sonja Fulmer, Deputy Director, FDA Digital Health Center of Excellence.

The HLTH webinar will examine 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.