Generative AI in focus as FDA’s digital health committee meets

Robert Califf has made no secret of the Food and Drug Administration’s struggles to regulate generative AI. Large language models and their application to health care “provide a massive example of a technology with novel needs,” FDA commissioner Califf said in an address earlier this year to the Coalition for Health AI. 

This week, the agency will turn toward that challenge, focusing the first-ever meeting of its Digital Health Advisory Committee on the question of whether and how generative AI should be regulated by the FDA. Over two full days, the committee will discuss questions about how to evaluate the performance of generative AI-enabled devices before and after they reach patients, and the risks that come with the technology.  

Why is it so hard to regulate generative AI products in medicine? To start, FDA officials wrote in an executive summary shared before the meeting, it’s hard to know when it qualifies as a device under the agency’s definitions.