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 401 primary-source items affecting healthcare.

Who tracks this?

Typically: Chief Compliance Officer, hospital General Counsel, or Chief Medical Officer. AIGI is built to put primary-source AI updates affecting healthcare in front of this role daily — with citation chains, status timelines, and obligation mapping.

Coverage at a glance

Items tracked
401
Jurisdictions
8
Last update
12/23/2025

Most active jurisdictions for healthcare AI

Recent healthcare AI activity

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Frequently asked questions

Which AI laws apply to healthcare?
AI in healthcare touches medical-device classification, AI-assisted diagnosis, protected health information, Section 1557 nondiscrimination, FDA-equivalent approvals, and patient consent for AI-assisted care. AIGI tracks every primary-source AI rule affecting hospitals, payers, life-sciences companies, and digital-health platforms.
Who at a healthcare company should track these rules?
Chief Compliance Officer, hospital General Counsel, or Chief Medical Officer is typically the role accountable for healthcare-AI compliance. AIGI is designed to put primary-source updates in front of this role daily.
How many healthcare AI items does AIGI track?
AIGI currently tracks 401 primary-source items where healthcare appears as an affected industry, spanning 8+ jurisdictions. The corpus is updated continuously.
Which jurisdictions are most active on healthcare AI?
Activity varies by sub-sector. AIGI's coverage map shows per-jurisdiction depth, and each item links to its primary authority source. See /coverage for the live distribution.
Where do AIGI's healthcare citations come from?
Every item on this page links to its primary government, regulator, or research source. AIGI does not paraphrase secondary commentary — our citation methodology is documented at /how-we-cite.

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