The FDA’s Digital Health Advisory Committee will meet in November 2024 to discuss generative AI-enabled medical devices. The meeting will focus on lifecycle considerations, safety, performance assessment, and regulation. Generative AI has shown promise in assisting medical professionals in tasks such as cancer and retinopathy detection. Concerns about reliability and potential misuse of generative AI will be addressed at the meeting. The public can participate in the discussion through oral presentations at the meeting or via webcast. Troubling observations about generative AI’s limitations, such as hallucinations and low performance in numerical tasks, will also be discussed.
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Bulletin: USA Health Regulators Eye Artificial Intelligence in Healthcare
