‘They Have To Figure Out If They Can Trust The Software’: Inside the FDA’s AI Push

The AI rollout at the FDA has been rocky. But even critics are optimistic.

Martin Makary, Robert F. Kennedy Jr, Brooke Rollins AP-25195732753944

Manuel Balce Ceneta/AP

The Food and Drug Administration has been ground zero for health secretary Robert F. Kennedy Jr.’s push to implement artificial intelligence tools into the federal public health infrastructure.

On paper, it makes sense: The FDA is notoriously slow, built upon grinding research and product reviews that can drag on for years under strictly human control. Tech leaders have heralded a coming AI “strike team” for the FDA, with promises that industry partnerships will remake the lethargic agency.

But the AI revolution isn’t off to a great start.