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# AI in Clinical Decision Tools Will Challenge FDA: Califf
- URL: https://www.fdaweb.com/ai-in-clinical-decision-tools-will-challenge-fda-califf/
- Published: 2024-02-01T12:00:00.000Z
- Updated: 2026-09-14T14:21:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156268

FDA Commissioner **Robert Califf** says artificial intelligence (AI) embedded in clinical decision support or the integration of AI into clinical practice is at a really interesting phase, and it is going to “grow like wildfire,” requiring the agency to hire “three or four times as many people to take on what's coming.” Speaking at an online update to the Alliance for a Stronger FDA 1/31, Califf borrowed a prediction from UCSF medicine chair **Robert Wachter**, agreeing that AI in medicine is at a Hemingway moment — a moment in time when something suddenly starts to turn after being talked about for quite some time. \[Editor’s note: Califf urged the audience to watch Wachter’s grand rounds Youtube video [*“Generative AI in Healthcare: Is This our Hemingway Moment?”*](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwiL5NrErYqEAxUMkYkEHcwsBokQtwJ6BAg2EAI&url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3D2wPZ4kf1kLE&usg=AOvVaw1jRjtDNr3fL4fexCd9yHn9&opi=89978449)\] 

Califf told the Alliance that for AI in clinical decision/support tools, or health systems for that matter, to be adequately regulated will require an ecosystem that is “much more accountable than it's been.” He said CDRH is working with external groups on agreed-upon standards and methods and approaches to validating algorithms, particularly that the algorithms can stand the test of time. 

The best algorithms after they are put in place accrue data and experience and they change over time, “which means you’re not just approving something like a drug that's going to be the same drug 10 years later,” Califf said. “And then you’ve got generative AI, where I can say for sure having talked to many of the leaders, no one knows exactly how to regulate it or where it's going to go because generative implies something that has a life of its own and that’s not necessarily easily controllable. So how to deal with all this we need an ecosystem which is much more accountable than it's been.” 

At FDA, Califf believes AI will also be transformative for the agency’s internal operations. AI can help product reviewers by making sure “the documents are reconciled when the information comes together, and if the searches are right.” He told the Alliance that FDA is now looking at AI companies to help put together all of the medical literature in an approach called RAG, which he explained would rely on generative AI to curate approved, high-quality literature. 

“So I can see FDA reviewers spending much more of their time doing the cognitive work that we really want FDA reviewers to be doing, and much less time doing row work,” Califf continued. “Also, you think about the supply chain issues that we’re dealing with, and there is so much progress that could be made with a digital supply chain to be able to model what’s going to happen… But you know, it’s not just AI, it’s quantum computing now on the horizon, and it’s for real and we've got to be ready to deal with that.”

Moving to reforming the advisory committee process, Califf said this is a special project headed by principal deputy commissioner **Namandjé Bumpus**, who replaced now-retired **Janet Woodcock** effective 2/1\. Califf says the agency has already done a lot of work on the advisory committees behind the scenes by working with the Centers, which have their own separate systems for obtaining committee input. 

“I think if you look right now,” Califf continued, “you’ll see the advisory committees are working better… and we’re getting better experts and this is complicated because of conflict of interest issues… And I think this issue of whether to take a vote or not and the discussion about that has sharpened the way the meetings are held. … I still believe we don't need to take a vote at most meetings, and there are some where a vote is crucial.”