2019 WMIF | Standards and Regulation: The Emerging AI Framework

As the health care industry faces an explosion of AI-based tools, the FDA’s approach to these technologies is evolving. This session will focus on the agency’s approach to AI-based products, how to calculate the risk profile of these new technologies, and the challenges of securing adequate data rights.

Moderator: Brent Henry, Member, Mintz Levin

Bethany Hills, Member/ Chair, FDA Practice, Mintz Levin

Michelle McMurry-Heath, MD, PhD, VP, Global Regulatory Affairs and International Clinical Evidence, Johnson & Johnson Medical Devices

Bakul Patel, Associate Director, Digital Health, FDA

Michael Spadafore, Managing Director, Sandbox Industries