HHS published a proposed rule that would roll back several Biden‑era policies, eliminate many health‑tech certification criteria and remove planned transparency requirements for healthcare AI tools. The agency framed the proposal as reducing regulatory burden to spur innovation, while critics say it would weaken consumer protections and oversight of AI in clinical settings. The proposal explicitly targets certification criteria and AI transparency rules, potentially shifting responsibility for safety and efficacy onto vendors and purchasers. The comment period and stakeholder responses will shape the final contours and likely trigger industry lobbying from both tech vendors and provider groups.