The Governance Gap in Clinical AI: Proposed Federal Rule Would Roll Back Transparency Requirements

A Regulatory Review analysis warns of a growing governance gap in clinical AI as a proposed Health IT rule (HTI-5) would scale back key transparency and risk management requirements for AI-based decision support interventions. The article notes that the earlier rule required developers to disclose extensive information on training data, validation, performance, and maintenance, and argues that weakening these obligations could leave clinicians and patients with less insight into how AI tools work.