FDA considers doctor-like ‘competency-based’ tests for medical generative AI
The FDA is exploring a 'competency-based' evaluation framework for generative AI used in medical settings, modeled loosely on how clinicians are assessed. The proposal comes as companies deploy AI chatbots to help patients manage conditions like diabetes and mental health disorders.
Why this matters: Medical AI is already in patients' hands, and the rules for it are still being written. A competency-based test sounds reasonable, but the details matter enormously. Who designs the test? Who grades it? Can a company pass once and deploy forever, or does the AI get re-evaluated when it changes? These tools are giving people advice about their mental health and chronic conditions. Getting the accountability structure wrong is not an abstract policy problem. It is a patient safety problem.
Who should care: Lawyers · Compliance · General readers · AI governance · Policy
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