KevinMD January 18, 2026
On January 6, 2026, the FDA announced revised guidance that loosens oversight for certain AI-enabled digital health products, most notably clinical decision support (CDS) software. The goal was to cut unnecessary regulation and promote innovation, accelerating time-to-market for tools positioned as clinical assistants rather than autonomous decision-makers.
At first glance, the change looks pragmatic, even overdue. For years, developers and clinicians alike have complained that prior FDA interpretations forced artificial constraints on CDS design, producing tools that were simultaneously less helpful and more confusing. Now, the agency has signaled a willingness to move, in its own words, at something closer to “Silicon Valley speed.”
But speed in medicine is rarely neutral. And when the technology involved is artificial intelligence, capable...
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