HHS published a proposed rule that would roll back multiple Biden‑era policies, pare back health‑tech certification criteria and remove planned transparency requirements for healthcare AI tools. The agency argued the changes would reduce regulatory burden and lower barriers for developers, while critics warned the move could weaken oversight of AI used in clinical settings. The proposal affects certification for health information technology and disclosure rules for AI performance and training data. Developers and compliance teams should track the rule’s comment period and potential legal challenges; the draft signals a near‑term U.S. regulatory window where enforcement and guidance on healthcare AI could shift significantly.