Politico September 3, 2024
AROUND THE AGENCIES
Concern about FDA regulation of artificial intelligence tools used in medicine is growing among former agency officials and other medical specialists.
That’s the bad news. The good: Plenty of people have ideas about how to improve it.
The latest example of their concern is a review in Nature Medicine of 521 FDA-authorized AI medical devices. Forty-two percent lacked published clinical validation data, according to the researchers from the University of North Carolina at Chapel Hill and other institutions.
That lack of rigor, they wrote, gets in the way of health systems that want to adopt the tools: “Patients and providers need a gold-standard indicator of efficacy and safety for medical AI devices.”
They called on the FDA...
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