STAT+: AI doctors are coming. Should FDA make sure they\u2019re safe?
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Call it a sign of things to come. A startup called Doctronic made a splash recently when it announced the use AI to renew prescriptions without clinician input in the state of Utah. Something didn\u2019t sit right with me about the announcement. Sure it got approval from Utah, but why isn\u2019t it a medical device subject to Food and Drug Administration review? The company claimed\u00a0it was \u201cthe practice of medicine\u201d and so exempt from FDA authority. That didn\u2019t seem entirely right either.\u00a0<\/p>\n
So I did some asking around<\/a> and after talking to over a dozen executives, legal scholars, and policy experts, it turns out the question is not nearly as clear-cut as Doctronic would have us believe. Indeed, it appears the company may be planning to market a medical device without authorization. In my story, I explain the law and why it all matters.<\/p>\n Read more here<\/a><\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n