The Governance Gap in Clinical AI

This August 6, 2026 commentary examines a governance gap in U.S. clinical AI policy, focusing on the Department of Health and Human Services’ proposed HTI‑5 rule that would scale back transparency requirements for AI used in decision support interventions. HTI‑5 would remove model‑card transparency, source‑attribute disclosures, and intervention risk management provisions that had formed the first federal transparency requirements for predictive AI in certified electronic health records, raising concerns about oversight standards.