Regulating generative AI: FDA’s challenges laid bare by digital health advisory committee

Anne Thompson

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Photography of the US department of health and human services in Silver Spring MD — Manuel Balce Ceneta/AP

By Casey Ross, Katie Palmer, and Brittany Trang

Nov. 22, 2024

The Food and Drug Administration commissioner Robert Califf began a marathon meeting on regulation of generative artificial intelligence this week with an urgent warning. He said clinicians around the country had told him the technology’s adoption in their hospitals and clinics was being driven by financial considerations — not patient care.

“Unless you take this issue very seriously and form alliances with those concerned about improving health outcomes,” Califf cautioned, “this technology will improve profits at the cost of continued deterioration in our overall health status.”

The sobering statement was the prelude to a two-day meeting during which one of the world’s most influential regulatory bodies sought to get its arms around one of the world’s most powerful, and unpredictable, technologies. It also unfolded amid the transition to an incoming Trump administration that may hold starkly different views about AI, and pursue its own course in regulating the technology in medicine and other parts of the economy.

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Casey Ross
Chief Investigative Reporter, Data & Technology
Casey Ross covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy.
Katie Palmer
Health Tech Correspondent
Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses.
Brittany Trang
Health Tech Reporter
Brittany Trang, Ph.D., is a health tech reporter at STAT. Follow her on Threads, Mastodon, and Bluesky.