FDA loosens AI oversight: What clinicians need to know about the 2026 guidance
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 …
