The Department of Health and Human Services proposed regulatory changes that would roll back several Biden‑era policies, reduce health tech certification criteria and eliminate planned transparency mandates for healthcare AI tools. HHS framed the proposal as an effort to reduce regulatory burden and speed product development for innovators. The move drew immediate scrutiny from patient‑safety advocates and industry groups: proponents argue the proposal lowers barriers for developers, while critics warn it could weaken guardrails for clinical AI and data transparency. The proposed rule will enter notice‑and‑comment, with stakeholders expected to mount vigorous responses. Changes to AI oversight and certification criteria have implications for digital health startups, device makers and payers designing AI adoption pathways.