Description: This session will acquaint attendees with the current regulations, guidance, and standards applicable to the medical device and health IT space in the U.S.. There will be further discussion on where AI regulatory frameworks are going and the various regulatory bodies that may have enforcement authority in these industries (Hint: It is not just the FDA).
Learning Objectives:
Understand the current AI-related regulatory literature applicable to medical devices and health IT;
Understand work in progress and potential future regulatory frameworks in the medical device and health IT industries;
Gain awareness of the various regulatory bodies with interest and enforcement authority in healthcare-related AI
