Clinical Decision Support Case Study: ONC and FDA Perspective

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.

Moderator

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

Speakers:

• 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)