FDA Update on Oversight of AI-Enabled Healthcare Technologies

The U.S. Food and Drug Administration (FDA) published a paper March 15, to update the public about intra-agency activities to oversee artificial intelligence (AI)-enabled healthcare technologies. The paper summarizes priorities shared across the biologics, drugs and medical devices domains of FDA jurisdiction.

Four general focus areas are discussed: fostering collaboration with stakeholders; developing appropriate regulatory approaches; promoting development of standards and best practices; and supporting research on performance evaluation. Moving forward, the FDA intends to evolve its own regulatory approaches with the continued progression of AI tools.

For more information about various American College of Radiology®(ACR®) AI-specific initiatives, visit the ACR Data Science Institute®. For more information about FDA oversight and digital health policy, contact Michael Peters, ACR Senior Government Affairs Director.