When is an AI doctor a medical device?

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’t sit right with me about the announcement. Sure it got approval from Utah, but why isn’t it a medical device subject to Food and Drug Administration review? The company claimed it was “the practice of medicine” and so exempt from FDA authority. That didn’t seem entirely right either. 

So I did some asking around 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.

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Utah’s recent announcement that it was partnering with a health tech startup that will use artificial intelligence to renew drug prescriptions may offer a glimpse of the futuristic version of AI medicine that’s long been foretold by technologists and venture capitalists.

But it’s only possible because of some pre-approved rule breaking — and may prove a broader test of the Food and Drug Administration’s authority to evaluate a new wave of clinical AI products, according to interviews with executives and experts.

In January, Utah regulators said they had signed an agreement with a startup called Doctronic to launch an AI system that will perform a clinical evaluation of patients and, when deemed appropriate, renew some 200 common medications autonomously.

Continue to STAT+ to read the full story…