Policy & Regulation

Coverage and structured tracking of regulatory guidance, legislative developments, and institutional policy frameworks governing AI in healthcare. Includes FDA SaMD guidance (e.g., Predetermined Change Control Plans, AI-enabled device lifecycle management), CMS reimbursement decisions, ONC interoperability rules, WHO and OECD ethical frameworks, and state-level AI healthcare legislation. Each piece cites primary source documents and carries a last-reviewed date. Excludes clinical research (covered in Research Digests) and company-specific product news (covered in Technology Profiles). Serves policy professionals, compliance teams, health system legal counsel, and clinicians who need to understand the regulatory environment around AI tools they are evaluating or using.

Editorial standard:Every item cites the primary source document and carries a last-reviewed date. Status badges (proposed, final, under revision, withdrawn) reflect the document's current binding status.

No Policy Items Published Yet

Policy and regulation items are added as guidance documents are issued and reviewed. Items cover FDA SaMD guidance, CMS reimbursement decisions, ONC interoperability rules, WHO ethical frameworks, and state-level AI healthcare legislation.