STAT+: Four pressing challenges facing Trump's health regulators as AI makes deeper inroads into medicine

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As artificial intelligence evolves and gains new capabilities in health care, it is becoming increasingly difficult to keep tabs on how it’s being used to make decisions about patient care.

Hospitals and insurers are adopting applications that may save them time and money, but there is no way to track its impact on patients’ costs and outcomes, or to determine which AI models are subject to government regulation.  

“If a provider creates a generative AI solution with their own data and uses it in their facility, is that a (medical) device?” asked Keith Dreyer, chief data science officer at Mass General Brigham. “There’s not a lot of clarity on that.”

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