Topic · Medical-device AI, diagnostic models, and clinical deployment
AI in Healthcare
AI in healthcare touches device classification, clinical validation, FDA-equivalent approvals, and patient consent for AI-assisted care. AIGI tracks every primary-source healthcare AI rule across global health authorities. As of the most recent update, AIGI tracks 190 primary-source items on ai in healthcare across global jurisdictions.
Coverage at a glance
- Items tracked
- 190
- Jurisdictions
- 8
- Last update
- —
Most active jurisdictions
Recent ai in healthcare activity
- IA legislation enacted
[IA Legislature] HF 2635
Iowa's HF 2635 prohibits the use of AI as the sole basis for denying, delaying, or downgrading healthcare prior authorization requests based on medical necessity and establishes new audit standards for utilization review organizations, effective January 1, 2027.
Authority: Iowa Legislature
- TN legislation enacted
[TN Legislature] SB1580 (GA114): Health Care — As enacted, prohibits a person from developing or deploying an artificial intelligence system that advertises or represe
Tennessee law prohibits AI systems from advertising or acting as qualified mental health professionals.
Authority: Tennessee Legislature
- IA legislation enacted
[IA Legislature] HF 2635
Iowa House File 2635 prohibits healthcare utilization review organizations from using AI as the sole basis to deny, delay, or downgrade prior authorization requests based on medical necessity, and sets standards for audits and health carrier conduct.
Authority: Iowa Legislature
- IA legislation introduced
[IA Legislature] SF 2226
Iowa Senate File 2226 proposes to regulate the use of automated adjudication systems, including AI and machine learning, by health carriers for processing healthcare claims, requiring human oversight and specific disclosures.
Authority: Iowa Legislature
- IA legislation introduced
[IA Legislature] SSB 3118
Iowa's SSB 3118 proposes to regulate the use of AI in healthcare prior authorization decisions, prohibiting AI from being the sole basis for denials, delays, or downgrades based on medical necessity.
Authority: Iowa Legislature
- IA legislation introduced
[IA Legislature] SF 2226
Iowa Senate File 2226 proposes restrictions on health carriers' use of automated adjudication systems, including AI/ML, requiring human review for claims denials/downcoding and mandating specific disclosures and appeal processes.
Authority: Iowa Legislature
- IA legislation introduced
[IA Legislature] SF 562
Iowa bill SF 562 introduces regulations for health carriers using AI or algorithms for utilization review, mandating human oversight for medical necessity decisions, non-discrimination, transparency, and periodic review.
Authority: Iowa Legislature
- IA legislation introduced
[IA Legislature] HF 2635
Iowa House File 2635 proposes to restrict the use of AI in healthcare prior authorization decisions, prohibiting its use as the sole basis for denying, delaying, or downgrading requests based on medical necessity.
Authority: Iowa Legislature
- IA legislation introduced
[IA Legislature] HSB 766
Iowa HSB 766 introduces a bill establishing a board for autonomous medical practice and requiring licensure for AI-augmented and autonomous clinical service providers, defining key terms and laying groundwork for regulation.
Authority: Iowa Legislature
- TN legislation enacted
[TN Legislature] HB1470 (GA114): Health Care — As enacted, prohibits a person from developing or deploying an artificial intelligence system that advertises or represe
Tennessee law prohibits AI systems from advertising or representing themselves as qualified mental health professionals to the public.
Authority: Tennessee Legislature
- US rulemaking notice comment period 4/29/2026
[FDA] AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information
The FDA is requesting information on an AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program to gather public input by May 29, 2026.
Authority: Food and Drug Administration
- US policy paper 5/19/2026
Expanding our AI and Healthcare Portfolio
A cross-sectoral report by ZS and HLC proposing federal policy recommendations to overcome barriers and enable responsible AI adoption in the U.S. healthcare system.
+ 178 more items in the full archive — start trial for full access.
Frequently asked questions
- What is AI in Healthcare?
- AI in healthcare touches device classification, clinical validation, FDA-equivalent approvals, and patient consent for AI-assisted care. AIGI tracks every primary-source healthcare AI rule across global health authorities.
- How many ai in healthcare laws does AIGI track?
- AIGI currently tracks 190 primary-source items under ai in healthcare — spanning bills, regulations, enforcement actions, court opinions, and agency guidance from authorities across global jurisdictions.
- Which jurisdictions are most active on ai in healthcare?
- Most active jurisdictions on ai in healthcare in the current corpus: US (17), IA (12), NJ (6), TN (5), NY (3).
- How current is AIGI's ai in healthcare coverage?
- AIGI runs continuous ingestion against every active source covering ai in healthcare.
- Where do AIGI's ai in healthcare citations come from?
- Every item on this page links to its primary government or research source. AIGI's citation methodology is documented at /how-we-cite — we do not paraphrase or remix secondary commentary; we resolve every pointer to the underlying authority.
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