Industry · AI in clinical care, diagnostic devices, and protected health information

AI Compliance for Healthcare

Healthcare AI compliance moves on three regulatory axes at once. FDA governs AI/ML-enabled medical devices through the SaMD framework, the Predetermined Change Control Plan guidance, and an active pre-market and post-market surveillance pipeline that has cleared over 1,000 AI-enabled devices to date. HHS OCR enforces HIPAA on protected-health-information handling by AI vendors and, through the Section 1557 final rule, prohibits discrimination in patient-care decision-support tools — including third-party clinical algorithms hospitals merely use. State insurance regulators have layered additional AI rules on payers (NAIC Model Bulletin, Colorado SB21-169, New York Circular Letter 7). The EU AI Act classifies most medical-device AI as high-risk and adds conformity-assessment obligations on top of the existing MDR/IVDR regime. Enforcement is no longer hypothetical: HHS OCR has opened Section 1557 investigations into hospital algorithms, FDA has issued warning letters on undisclosed model updates, and state AGs have begun probing AI tenant-style screening of patients for prior authorization. AIGI tracks every primary-source rule, guidance, enforcement action, and bill in this stack — across hospitals, payers, life sciences, and digital health. As of the most recent update, AIGI tracks 2 primary-source items affecting healthcare.