Hospital and doctor groups tell FDA: makers should be liable when generative AI medical devices fail
mattlungrenMD · x · 2026-10-25
The American Hospital Association (nearly 5,000 member hospitals and health organizations), the AMA, and the American Telemedicine Association each filed comments urging the FDA to hold device makers—not clinics—accountable when generative AI medical devices fail.
It marks the first coordinated stance from major healthcare groups on liability allocation for generative AI devices, potentially shaping the FDA's regulatory framework.
The linked briefing also covers PROGRESS, a machine-learning score that stratifies mCRPC risk using three routine labs (PSA, alkaline phosphatase, AST), achieving ROC-AUC 0.89 in training and consistent prognostic significance across 1,239 externally validated patients.
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