AI/Machine Learning: Regulation, Development, and Real-World Performance Evaluation

On March 22, 2022 from 12:30 – 4:00 pm (EDT) the Duke-Margolis Center of Health Policy, with participation from the U.S. Food and Drug Administration (FDA) speakers and panelists, will hold a public webinar to spotlight updates and progress made since the release of FDA’s Artificial Intelligence/Machine Learning Action Plan in early 2021.

There will be a fireside chat between Jeff Shuren, FDA’s director of the Center for Devices and Radiological Health (CRDH), and Mark McClellan, director of Duke-Margolis, followed by three panel discussions focused on the following topics:

• Overarching frameworks for regulating and evaluating AI
• Good machine learning practices (GMLP)
• Post-market evaluation of AI/ML SaMD 

The webinar will end with a business roundtable discussion on how developers and health care systems are considering these issues.