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FDA asks for feedback on AI medical device regulation
The FDA is seeking feedback on a potential way of regulating medical devices equipped with generative AI features, informed by the process of training human clinicians.Described as a “competency-based approach,” the process would evaluate AI-equipped devices in increasingly clinical scenarios, including potentially with real patients.
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nextgov.com
FDA considers doctor-like ‘competency-based’ tests for medical generative AI
The Trump administration released ideas for regulating large language models used in health care as companies roll out chatbots to help patients manage mental health, diabetes and…
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healio.com
FDA asks for feedback on AI medical device regulation
The FDA is seeking feedback on a potential way of regulating medical devices equipped with generative AI features, informed by the process of training human clinicians.Described…
