Politico July 16, 2024
Ruth Reader, Toni Odejimi, Carmen Paun, Daniel Payne and Erin Schumaker

FORWARD THINKING

Former President Donald Trump’s first FDA commissioner, Dr. Scott Gottlieb, is calling on Congress to expand his old agency’s authority over medical artificial intelligence.

Why’s that? Gottlieb writes in JAMA Health Forum that medical AI presents a challenge for the Food and Drug Administration because the agency’s regulators can’t simply take the technology apart to see how it works.

AI models are black boxes, and “even their developers cannot fully elucidate how these models draw their conclusions,” he writes. So he thinks Congress should empower the FDA to oversee the methods used to develop AI and validate the reliability of individual products.

Gottlieb’s plan: He cites legislation Congress considered in 2022, a House bill by Democrat Diana...

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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Regulations, Technology
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