In the span of a few years, artificial intelligence has moved from the margins of medicine to the center of clinical decision-making in nearly every American hospital — yet the federal government is now proposing to dismantle the only standardized transparency rules that gave institutions a common language for understanding what these tools are and how they behave. The proposed HTI-5 rule, emerging from a broader deregulatory impulse, would remove source-attribute disclosures and risk management requirements at the precise moment when hallucination rates in clinical AI remain measurable in the
FDA's Clinical AI Rollback Leaves Hospitals Without Transparency Standards
Potential patient harm from unmonitored clinical AI drift and hallucinations affecting care decisions in 96% of U.S. hospitals.