In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As the FDA more formally describes it, the agency "intends to apply its regulatory oversight" to software functions that it considers "medical devices" in cases where poor "functionality could pose a risk to a patient's safety."
The agency clarified that its intended "approach applies to generative AI-enabled products as well." That's formal language for a regulatory approach that threatens to rope into the FDA's broad regulatory oversight many AI chatbots that operate as useful wellness applications, not medical devices by any reasonable definition. It would be a mistake for the agency to apply medical device regulations to such wellness chatbots.
