The Governance Gap in Clinical AI

This Regulatory Review article analyzes the governance implications of the U.S. Department of Health and Human Services’ proposed HTI‑5 rule, which would scale back transparency and risk‑management requirements for AI-based decision support interventions in certified electronic health records. It warns that removing model‑card disclosures, source-attribute reporting, and structured intervention risk management could widen the safety and accountability gap for clinical AI.