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
FDA loosens AI oversight: What clinicians need to know about the 2026 guidance originally appeared in KevinMD.com.
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