Nov. 21, 2024
The American College of Radiology® (ACR®) presented Nov. 20-21 at the U.S. Food and Drug Administration (FDA) Digital Health Advisory Committee (DHAC) meeting “Total Product Lifecycle Considerations for Generative AI-Enabled Devices.” Bernardo Bizzo, MD, PhD, ACR Data Science Institute® Associate Chief Science Officer, represented the College at the meeting.

The meeting focused on novel oversight challenges and opportunities specific to FDA-regulated generative artificial intelligence (AI)-enabled devices. Per FDA’s definition, generative AI emulates the structure and characteristics of input data in order to generate derived synthetic content, such as images, videos, audio, text and other digital content; this typically is done by approximating the statistical distribution of the input data.

Dr. Bizzo provided overviews of the ACR Recognized Center for Healthcare-AI (ARCH-AI) quality assurance program, including the recently announced Assess-AI registry that provides radiology facilities with analytics on clinical AI performance over time as compared to national benchmarks. He discussed how ACR DSI programs and similar initiatives could be leveraged to help ensure the safety, effectiveness, and quality uses of generative AI-enabled devices.

For more information about ACR’s AI-related initiatives, visit the ACR DSI website. For questions about AI oversight and digital health policy, contact Michael Peters, ACR Senior Director, Government Affairs.

Related ACR News

  • ACR Responds to RFI on AI Regulatory Reform

    ACR urged the White House to enhance AI oversight and payment policies to support safe, effective, and reimbursable clinical AI use.

    Read more
  • CMS WISeR Model

    ACR joined an AMA webinar on CMS’s WISeR Model, launching Jan. 1 in 6 states, targeting Medicare services prone to waste, fraud, and abuse.

    Read more
  • ACR Urges Agencies to Issue Final NSA IDR Operations Rule

    ACR, ACEP and ASA urge federal agencies to finalize the No Surprises Act IDR rule to improve payer-provider communication and streamline disputes.

    Read more