MedPage Today January 17, 2026
The FDA’s planned rollback of oversight shifts risk onto patients and clinicians
A patient arrives for a visit, holding out a phone screen as evidence: an artificial intelligence (AI) tool has labeled their symptoms “high risk” and recommended a next step. The language is polished, the recommendation is specific, and the patient’s anxiety is real. The tool isn’t “making a diagnosis” — technically, it is “providing information.” But it has already done what these tools inevitably do: it has shaped the clinical decision before a clinician ever enters the room.
That is the context in which the FDA’s new posture toward digital health should be evaluated. At the Consumer Electronics Show, FDA Commissioner Marty Makary, MD, MPH, framed the agency’s...
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