AMA outlines path forward for FDA oversight of generative AI in medicine
HealthcareLdr · x · 2026-10-22
The American Medical Association has formally responded to the FDA's Aug. 18 discussion paper on regulating genAI-enabled medical devices, in a letter to Digital Health Center of Excellence director Rick Abramson. Key principles:
- Regulatory agility cannot come at the expense of safety and effectiveness: evolving genAI capabilities may require novel evaluation methods, but the FDA's responsibility for reasonable assurance of safety and effectiveness must be preserved, with oversight matched to intended use and potential harm
- Real-world performance focus: the AMA proposes evaluating genAI performance in real clinical settings, strengthening post-market surveillance, and engaging physicians in defining the standard of care
A authoritative signal of how organized medicine wants genAI medical device regulation to evolve.
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