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Event Series Event Series: AI Summit Agenda 2023

Clinical Decision Support Case Study: ONC and FDA Perspective

November 16 @ 9:10 am 10:10 am

What happens if an AI-enabled Clinical Decision Support System subject to certification under the ONC scheme is also a medical device and subject to FDA regulatory requirements? In this session, find out from the Agencies themselves how they work together to provide regulatory oversight of AI-enabled CDS medical devices.


  • Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding


  • Sonja Fulmer, Acting Deputy Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA
  • Jeff Smith, Director, Certification and Testing Division, The Office of National Coordinator for Health Information Technology (ONC) (Invited)
21 E 5th Street
Cincinnati, OH 45202 United States
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