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 465 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
465
Jurisdictions
8
Last update
12/28/2000

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 465 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 includes a direct link to the relevant government, regulator, or research document.

Related

Regulatory intelligence

Track AI-governance change affecting healthcare teams.

AIGI monitors cited regulatory change and delivers decision-ready analysis. It does not monitor customer AI systems or enforce policy.

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