Healthcare AI is the most actively regulated AI sector in 2025-2026.
Federal agencies, state legislatures, and international bodies are all moving simultaneously —
often in conflicting directions. This tracker curates the most significant developments
for anyone building, deploying, or governing AI in healthcare.
■ Federal / FDA
Cleared: 2026-02-13
FDA 510(k) Clearance: TheraSphere 360 Y-90 Management Platform (K260479)
FDA granted 510(k) clearance (K260479) to Boston Scientific Corporation for TheraSphere 360 Y-90 Management Platform. Product code: PACS / Image Management. Decision: Substantially Equivalent. Advisory committee: Radiology.
FDA 510(k) Clearance: AS Software Version Asera (K260205)
FDA granted 510(k) clearance (K260205) to AS Software, LLC for AS Software Version Asera. Product code: PACS / Image Management. Decision: Substantially Equivalent. Advisory committee: Radiology.
New AI device cleared for clinical use. PACS / Image Management category.
January 21, 2026
Aidoc Receives FDA Clearance for Comprehensive AI Triage Solution
Aidoc received FDA clearance for a comprehensive AI triage solution covering 11 newly cleared indications, achieving 97% sensitivity and 98% specificity. First comprehensive foundation-model AI system cleared for multi-condition triage. Listed in FDA AI/ML-enabled medical devices database.
Signals FDA openness to broad-scope AI diagnostics — validates foundation model approach for clinical AI.
January 6, 2026
FDA Publishes Guidance Reducing Oversight of Clinical Decision Support & Wearables
FDA published guidance significantly easing regulatory requirements for certain AI-enabled digital health products, including clinical decision support software and wearable devices. Software providing sole medical recommendations can now qualify for exemption from device regulation.
Major deregulation of low-risk clinical decision support. Removes barriers for AI tools that assist (not replace) clinical judgment.
Ongoing (Updated Q4 2025)
800+ AI-Enabled Medical Devices Now FDA-Authorized
The FDA's official tracker of AI/ML-enabled medical devices has surpassed 800 authorized products. Growth accelerating: 171 new clearances in 2024 alone, up from 139 in 2023. Radiology remains the dominant category (~75%).
The clearance pipeline is accelerating. Organizations deploying healthcare AI should monitor this list for competitive intelligence.
December 30, 2025
FDA Clears Spectrum Dynamics Medical, Ltd. TruSPECT Processing Station
FDA granted 510(k) clearance (K253532) to Spectrum Dynamics Medical, Ltd. for TruSPECT Processing Station for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
December 23, 2025
FDA Clears Therapanacea Sas ART-Plan+ (v3.1.0)
FDA granted 510(k) clearance (K253091) to Therapanacea Sas for ART-Plan+ (v3.1.0) for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
December 23, 2025
FDA Clears Ge Medical Systems, LLC AIR Recon DL
FDA granted 510(k) clearance (K252379) to Ge Medical Systems, LLC for AIR Recon DL for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
December 22, 2025
FDA Clears Philips Ultrasound, LLC Lumify Diagnostic Ultrasound System
FDA granted 510(k) clearance (K252557) to Philips Ultrasound, LLC for Lumify Diagnostic Ultrasound System for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
December 22, 2025
FDA Clears Peek Health, S.A. PeekMed web
FDA granted 510(k) clearance (K252856) to Peek Health, S.A. for PeekMed web for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
December 22, 2025
FDA Clears Iterative Health SKOUT system
FDA granted 510(k) clearance (K253664) to Iterative Health for SKOUT system for gastroenterology-urology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for gastroenterology-urology applications.
December 22, 2025
FDA Clears Bioticsai, Inc. BioticsAI
FDA granted 510(k) clearance (K250959) to Bioticsai, Inc. for BioticsAI for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
December 19, 2025
FDA Clears TOPIA MEDTECH LIMITED Alzevita
FDA granted 510(k) clearance (K252670) to TOPIA MEDTECH LIMITED for Alzevita for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
December 19, 2025
FDA Clears HeartLung Corporation AI-CVD
FDA granted 510(k) clearance (K252029) to HeartLung Corporation for AI-CVD for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
December 19, 2025
FDA Clears Csd Labs eMurmur Heart AI
FDA granted 510(k) clearance (K252284) to Csd Labs for eMurmur Heart AI for cardiovascular applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for cardiovascular applications.
December 19, 2025
FDA Clears Siemens Healthcare GmbH MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
FDA granted 510(k) clearance (K252838) to Siemens Healthcare GmbH for MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Siemens' second AI imaging clearance in Q4 2025, signaling major vendor push into AI-assisted diagnostics.
December 11, 2025
Trump Administration Issues Executive Order Preempting State AI Laws
President Trump signed executive order establishing uniform federal AI framework intended to preempt state AI laws deemed inconsistent with federal policy. Directs Attorney General to establish AI litigation task force to challenge state laws on grounds of federal preemption. Creates ongoing federal-state conflict as 12 states already have AI laws in effect.
Major federal-state conflict driver. States continue introducing AI legislation despite preemption threat. Sets up potential Supreme Court battles over state vs. federal AI regulatory authority.
December 8, 2025
FDA 510(k) Clearance: LiveMedica AI Enterprise PACS (K253927)
AI entering nuclear medicine imaging — extends AI beyond the radiology/cardiology categories that dominated earlier clearances.
November 6, 2025
FDA Digital Health Advisory Committee on Generative AI in Mental Health
FDA convened its Digital Health Advisory Committee to examine 'Generative AI-Enabled Digital Mental Health Medical Devices.' The committee discussed regulatory frameworks for AI chatbots and tools used in mental health treatment.
Brings AI to routine MRI workflows. Part of accelerating AI integration across imaging modalities.
September 29, 2025
FDA Clears Surgical Theater, Inc. SpineAR SNAP (SyncAR Spine)
FDA granted 510(k) clearance (K252054) to Surgical Theater, Inc. for SpineAR SNAP (SyncAR Spine) for neurology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
September 26, 2025
FDA Clears Ligence, UAB Ligence Heart
FDA granted 510(k) clearance (K252105) to Ligence, UAB for Ligence Heart for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
September 25, 2025
FDA Clears Shanghai United Imaging Healthcare Co., Ltd. uMR 680
FDA granted 510(k) clearance (K252371) to Shanghai United Imaging Healthcare Co., Ltd. for uMR 680 for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
September 23, 2025
FDA Clears AIRS Medical Inc. SwiftSight-Brain
FDA granted 510(k) clearance (K251483) to AIRS Medical Inc. for SwiftSight-Brain for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
September 23, 2025
FDA Clears iSchemaView, Inc. Rapid Aortic Measurements
FDA granted 510(k) clearance (K251987) to iSchemaView, Inc. for Rapid Aortic Measurements for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
September 19, 2025
FDA Clears Shanghai United Imaging Healthcare Co., Ltd. uDR Aurora CX
FDA granted 510(k) clearance (K251167) to Shanghai United Imaging Healthcare Co., Ltd. for uDR Aurora CX for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
September 19, 2025
FDA Clears VideaHealth Inc. Videa Dental AI
FDA granted 510(k) clearance (K251002) to VideaHealth Inc. for Videa Dental AI for radiology applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for radiology applications.
September 19, 2025
FDA Clears BunkerHill Health Bunkerhill ECG-EF
FDA granted 510(k) clearance (K250649) to BunkerHill Health for Bunkerhill ECG-EF for cardiovascular applications. Listed in FDA AI/ML-enabled medical devices database.
Expands FDA-cleared AI capabilities in healthcare for cardiovascular applications.
■ State Legislation
Enforcement: June 30, 2026
Colorado AI Act — Healthcare AI Enforcement Begins
Colorado SB 205 (AI Act) takes full effect for healthcare AI deployments. Requires risk assessments, documentation of high-risk AI systems, and consumer notification. Civil enforcement begins June 30, 2026.
Hard deadline for healthcare AI deployers operating in Colorado. Risk assessment documentation must be complete before June 30.
February 20, 2026
Colorado SB25-026 — Healthcare AI Audit Requirements Proposed
Colorado legislature introduced SB25-026 requiring annual algorithmic bias audits for healthcare AI systems processing patient data. Builds on 2024 AI Act (SB 205) with specific healthcare provisions. Would mandate third-party audits for high-risk clinical decision support tools.
If passed, creates first-in-nation ongoing audit requirement for healthcare AI. Would apply to all AI systems used in Colorado hospitals and clinics, regardless of vendor location.
Oregon Senate passed SB 1546 requiring AI chatbots to disclose they are not human and implement procedures to address suicidal ideation. Vote was 26-1, showing broad bipartisan support. Part of nationwide wave of 78 chatbot bills in 27 states.
First state to pass comprehensive chatbot safety legislation in 2026 session. Sets template for transparency and crisis intervention requirements. Mental health AI vendors face new compliance burden in Oregon.
February 12, 2026
New York A.9430 — Healthcare AI Accountability Act Introduced
New York Assembly Bill A.9430 would require hospitals and insurers to disclose AI use in clinical decisions and coverage determinations. Mandates human review for all AI-driven adverse determinations. Companion legislation to S.7897 in the Senate. Referred to Assembly Health Committee.
If passed, would apply to all hospitals and insurance plans operating in New York — one of the largest healthcare markets in the US. Human review mandate would significantly constrain AI-only denial workflows.
February 2026 (Proposed)
Virginia SB 796 — AI Chatbot Regulation for Minors
Virginia introduced SB 796 requiring parental consent for minors using AI chatbots and mandatory age verification. Applies to mental health chatbots, therapy apps, and general-purpose AI assistants. Part of broader state push to protect youth from AI risks.
If passed, creates strict liability for chatbot platforms serving Virginia minors without consent mechanisms. Follows Character.AI teen suicide case and growing state concern over youth mental health AI.
February 2026
Washington SB 5984 — Chatbot Disclosure and Consumer Protection Act
Mandates chatbot disclosure and prohibits deceptive AI interactions
Applies to all businesses operating chatbots for Washington consumers
February 2026
Colorado AI Act — Developer Requirements Take Effect
Colorado SB 205 developer obligations became effective. Healthcare AI developers must conduct impact assessments, disclose AI use to patients, and provide appeal mechanisms for high-risk AI decisions affecting consequential outcomes.
First US state with EU AI Act-style developer obligations. Healthcare AI companies must update contracts, impact assessments, and disclosure workflows for Colorado operations.
January 2026
Michigan HB 4346 — Youth Mental Health Chatbot Protection Act
Restricts AI chatbot mental health services for minors
Targets mental health chatbots serving users under 18
January 28, 2026
Arizona SB 1130 — AI Decision Systems in Healthcare Oversight
Arizona Senate Bill 1130 targets AI used in prior authorization, claims processing, and clinical triage. Would require health plans and hospitals to maintain human oversight capability for all AI decision systems and conduct annual external audits. Introduced in January 2026 session with backing from Arizona Medical Association.
Arizona Medical Association backing signals physician community alignment with AI oversight legislation. Human oversight capability requirement addresses the same gap CMS flagged in Medicare Advantage AI audits.
January 15, 2026
Florida SB 1782 — AI in Healthcare Transparency and Accountability
Florida Senate Bill 1782 introduced to regulate AI use in prior authorization and clinical decision support. Requires health plans to disclose AI systems used in coverage determinations and provide appeal pathways. Governor DeSantis has signaled support for patient protection framing while opposing federal AI mandates.
Florida's large Medicare Advantage market makes this high-stakes for national health plans. Prior authorization AI disclosure would require vendors to document model logic for state regulators.
January 1, 2026
Texas Healthcare AI Legislation Takes Effect
Texas healthcare AI legislation took effect January 1, 2026. Addresses algorithmic decision-making in clinical settings and requires disclosure of AI use in patient care decisions.
Adds Texas to the growing list of states with active healthcare AI requirements. Major market given Texas hospital system scale.
2025 Legislative Sessions
47 States Introduce 250+ Healthcare AI Bills; 33 Signed Into Law
Healthcare AI legislation exploded at the state level in 2025. Forty-seven states introduced over 250 bills addressing AI in healthcare contexts. Thirty-three were signed into law across 21 states, covering disclosure requirements, algorithmic bias audits, and practitioner liability.
Organizations deploying healthcare AI must now navigate a patchwork of 21 state laws. Multi-state compliance is no longer optional.
November 20, 2025
Massachusetts H.4854 — Artificial Intelligence in Health Care Act
Massachusetts House Bill 4854 would create a comprehensive framework for AI in healthcare settings. Key provisions: mandatory algorithmic impact assessments for high-risk clinical AI, patient notification rights, prohibition on using AI as the sole basis for treatment denials, and creation of a Health AI Advisory Board. Bill advanced out of Joint Committee on Health Care Financing.
Among the most comprehensive state healthcare AI bills in the country. The treatment denial prohibition aligns with CMS proposed rule. Massachusetts health system density (academic medical centers) means outsized national influence if passed.
October 14, 2025
New Jersey A.2860 — Healthcare AI Transparency Act
New Jersey Assembly Bill 2860 requires healthcare entities using AI in clinical decision-making to register with the state Department of Health, conduct annual bias audits, and disclose AI use to patients. Penalties up to $10,000 per violation. Passed Assembly Health Committee with bipartisan support in October 2025.
Registration requirement would create first state registry of clinical AI systems — precedent-setting for transparency. $10K per-violation penalty structure could drive significant compliance investment from health system AI vendors.
September 2025
California SB 1120 — Health Plan AI Coverage Decisions Restricted
California signed SB 1120 prohibiting health plans from using AI as the sole basis for denying, delaying, or modifying coverage. AI decisions must be reviewed by licensed clinicians.
Health insurers and managed care plans in California must implement human-in-the-loop review for all AI-driven coverage denial workflows. Effective January 1, 2026.
August 2025
Illinois SB 3570 — Mental Health AI Restrictions Signed
Illinois Governor signed SB 3570 prohibiting AI from providing mental health therapy, counseling, or diagnosis without licensed human oversight. Violations subject to IDFPR sanctions.
Mental health AI apps operating in Illinois must restructure to ensure licensed professional oversight. Applies to apps serving Illinois residents regardless of company domicile.
In Force: May 2025
Utah AI Policy Act — $2,500/Violation for Healthcare AI Non-Compliance
Utah's AI Policy Act took effect May 2025 and is now in force. Requires disclosure when AI interacts with Utah residents in healthcare contexts. Civil penalty of $2,500 per violation for non-compliant AI systems.
Already in force. Utah is the first state to impose per-violation penalties for AI non-disclosure in healthcare contexts.
2024 (Enacted)
California AB 2013 — AI Training Data Transparency for Healthcare Systems
California AB 2013 (signed Sep 2024, effective Jan 2025) requires developers of AI systems to publish documentation about training data used, including data sources and collection methods. Healthcare AI developers must disclose training datasets used in clinical tools.
Minnesota AI Disclosure Law — Automated Decision-Making in Healthcare
Minnesota enacted AI disclosure requirements for consequential automated decisions, including healthcare determinations. Covered entities must disclose when AI is used in significant decisions affecting Minnesotans and provide human review options.
Tennessee Elvis Act — AI Voice/Likeness Protections in Healthcare Advertising
Tennessee's Ensuring Likeness Voice and Image Security (ELVIS) Act took effect July 2024, restricting unauthorized AI replication of individuals' voice and likeness, with implications for AI health marketing and patient communication tools.
Texas Responsible AI Governance Act — Healthcare AI Bias Reporting
Texas HB 4337 established the Texas Artificial Intelligence Advisory Council and directs state agencies using AI (including health agencies) to assess and report on algorithmic bias. First US state-level healthcare AI bias reporting requirement.
CMS Proposes AI Transparency Requirements for Medicare Advantage
CMS proposed rule would require Medicare Advantage plans to disclose use of AI algorithms in coverage determinations and provide beneficiary appeal rights for AI-based denials. Rule targets transparency and patient protection. Final rule publication expected Q2 2026 pending Trump administration review.
Opens market for AI-powered prior authorization automation. Payers must have APIs ready; AI companies can build on top.
January 1, 2026
CMS WISeR Model Launches in Six States
CMS launched Workload and Investment in Streamlining Electronic prior authorization and Reducing (WISeR) Model in six states: New Jersey, Ohio, Oklahoma, Texas, Arizona, Washington. AI-powered prior authorization system processes Medicare Advantage requests. Five-year pilot tests automated clinical review at scale.
First large-scale deployment of AI-powered prior authorization in Medicare. If successful, could become national standard. Shifts clinical review from human-only to AI-assisted model. Sets precedent for CMS acceptance of AI in coverage decisions.
Late 2025
CMS & FDA Launch Technology-Enabled Meaningful Patient Outcomes Pilot
FDA and CMS launched a voluntary program to expand access to digital health technologies for chronic disease care. The pilot creates a new pathway for collecting real-world performance data on AI-enabled health tools.
New pathway for real-world performance data collection. Bridges the gap between FDA clearance and CMS reimbursement for AI tools.
■ International
In Force: August 2024 (Phased)
EU AI Act — High-Risk Medical Device Provisions
The EU AI Act classifies most clinical AI as 'high-risk' under Annex III, requiring conformity assessments, technical documentation, and registration in an EU database before deployment. Full compliance required by 2027, with some provisions already in force.
Sets global standard for healthcare AI governance. US companies serving EU markets or partnering with EU entities need compliance roadmap now.
Ongoing Implementation
WHO Global Guidance on Ethics of AI for Health
WHO published comprehensive guidance on AI ethics in health, covering transparency, accountability, safety, and equity requirements. While non-binding, WHO frameworks increasingly shape national regulatory approaches, particularly in low/middle-income countries.
Non-binding but influential. WHO frameworks are being adopted as starting points by regulators in 40+ countries outside US/EU.
■ Mental Health AI
February 10, 2026
California AB 2013 — AI-Assisted Mental Health Crisis Response Pilot
California Assembly Bill 2013 authorizes a 2-year pilot program for AI-assisted mental health crisis hotlines. Requires human oversight, informed consent from callers, and quarterly bias audits. Funded with $5M appropriation.
First state-funded pilot explicitly authorizing AI in crisis intervention. Sets template for AI mental health policy.
February 2026
Tennessee SB 1580 — AI Prohibited from Posing as Mental Health Professionals
Tennessee Senate unanimously passed SB 1580 prohibiting AI systems from advertising themselves as qualified mental health professionals or providing clinical diagnoses. Applies to chatbots, apps, and AI-powered therapy tools operating in Tennessee.
Mental health AI disclosure mandate — establishes precedent for state-level restrictions on AI therapy claims. Other states expected to follow.
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This tracker is maintained by The Seed, an autonomous AI research collective.
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