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 244 primary-source items on ai in healthcare across global jurisdictions.
Coverage at a glance
- Items tracked
- 244
- Jurisdictions
- 8
- Last update
- —
Most active jurisdictions
Recent ai in healthcare activity
- TX legislation enacted
[TX Legislature] SB815 (89R): Relating to the use of certain automated systems in, and certain adverse determinations made in connection with, the health benefit claims p
Texas SB815, enacted on June 20, 2025, and effective September 1, 2025, regulates the use of automated systems and adverse determinations in health benefit claims processes.
Authority: Texas 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
- GB guidance effective 7/29/2026
[MHRA] Guidance: Digital mental health technology: qualification and classification
MHRA guidance defines characteristics, regulatory qualification, and classification for digital mental health technologies (DMHTs), including those using AI algorithms and chatbots, under UK medical device regulations.
Authority: Medicines and Healthcare products Regulatory Agency
- VA legislation introduced 1/12/2026
[VA Legislature] SB269: Mental health service providers; definitions, use of artificial intelligence system, civil penalty.
Virginia SB269 permits mental health providers to use AI for assistance with full human responsibility, prohibits unsupervised AI therapy, and establishes a civil penalty up to $10,000 for violations.
Authority: Virginia General Assembly
- TX legislation enacted
[TX Legislature] SB1188 (89R): Relating to electronic health record requirements; authorizing a civil penalty.
Texas SB1188 enacts new electronic health record requirements, including those potentially affecting AI, and authorizes civil penalties, effective September 1, 2025.
Authority: Texas Legislature
- NY legislation committee 3/4/2021
[NY Legislature] A6005 (2021-2022): Relates to prohibiting certain suicide prevention and mental health services hotlines from being automated
New York bill A6005 prohibits the automation of state-operated or sponsored suicide prevention and mental health services hotlines.
Authority: New York Legislature
- US regulation final rule 1/9/2024
[HHS OCR] Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing
This final rule updates the ONC Health IT Certification Program, establishing new requirements for health IT developers to enhance interoperability, algorithm transparency, and information sharing under the 21st Century Cures Act.
Authority: HHS Office for Civil Rights
- US regulation effective 6/13/2025
[HHS OCR] Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software
The FDA is classifying radiological computer-assisted detection and diagnosis software into Class II (special controls) to ensure safety and effectiveness while reducing regulatory burdens.
Authority: HHS Office for Civil Rights
- US guidance effective 12/4/2024
[HHS OCR] Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industr
The FDA issued final guidance recommending Predetermined Change Control Plans for AI-enabled medical device software functions to ensure ongoing safety and effectiveness.
Authority: HHS Office for Civil Rights
- US regulation final rule 3/25/2026
[HHS OCR] General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed
The FDA reclassifies optical and electrical impedance skin lesion diagnostic devices as Class II software-aided devices, establishing special controls.
Authority: HHS Office for Civil Rights
- AL legislation enacted
[AL Legislature] SB63 (2026): Health care plans; to regulate the use of artificial intelligence in determinations of coverage
Alabama's SB63 has been enacted to regulate the use of artificial intelligence by health care plans in making coverage determinations.
Authority: Alabama Legislature
- NJ legislation committee 1/13/2026
[NJ Legislature] A799 (2026-2027): Prohibits advertising artificial intelligence system as licensed mental health professional.
This New Jersey bill prohibits the advertising of artificial intelligence systems as licensed mental health professionals.
Authority: New Jersey Legislature
+ 232 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 244 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 (18), NJ (6), TN (5), NY (4), VA (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 includes a direct link to the relevant government or research document.
Related
Regulatory intelligence
Follow reviewed ai in healthcare changes across jurisdictions.
AIGI monitors cited regulatory change and delivers decision-ready analysis. It does not monitor customer AI systems or enforce policy.