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All stakeholders are 'struggling' with how to regulate generative AI: FDA commissioner

Food and Drug Administration Commissioner Robert Califf said the agency is grappling with how to regulate the use of generative artificial intelligence in healthcare.

"The thing I think we are all struggling with is generative AI," Califf told Yahoo Finance in an interview Friday, "which is a new thing and something we don't really know how to regulate at this point."

The agency has already been approving the use of AI in medical devices, with a growing list in the hundreds.

"When AI is used for prediction, which is the biggest use right now, we have a regulatory scheme which I think is really good," Califf said.

The potential danger lies in future upkeep. If algorithms are deployed but not regularly fine-tuned, they stop working as well over time, he said.

When it comes to generative AI, in which things like large language models are used to generate text responses, Califf said the FDA will need to take an "ecosystem approach" to put guardrails around this technology. Califf said the agency is currently working on a framework for these efforts.

FILE - A sign for the U.S. Food and Drug Administration is displayed outside their offices in Silver Spring, Md., Dec. 10, 2020. The Indian manufacturer of more than two dozen varieties of eyedrops subject to a U.S. safety warning officially recalled the products, which were sold by CVS Health, Target, Rite Aid and other national retailers. Kilitch Healthcare India issued the recall on Monday, Nov. 13, 2023, and the FDA published the notice Wednesday, Nov 15. (AP Photo/Manuel Balce Ceneta, File)
A sign for the US Food and Drug Administration is displayed outside its offices in Silver Spring, Md., Dec. 10, 2020. (Manuel Balce Ceneta/AP Photo, File) (ASSOCIATED PRESS)

Califf was previously a senior adviser for medical strategy at Alphabet (GOOG, GOOGL), Google's parent company, between stints as head of the FDA. Califf also served in the Obama administration.

The commissioner's comments to Yahoo Finance on Friday came just hours before the shocking news that OpenAI, the company that developed popular generative AI platform ChatGPT, had fired its CEO Sam Altman. Altman's ouster was followed by departures by president Greg Brockman and several top researchers. Altman and Brockman were hired by Microsoft (MSFT) to lead an AI research group early Monday.

The FDA declined to comment following the interview on how these developments could impact the agency's efforts.

Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. Follow Anjalee on all social media platforms @AnjKhem.

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