Federal Legislative and Regulatory Activity
Artificial Intelligence (AI) is increasingly embedded in U.S. healthcare through diagnostic tools, clinical decision support, mental health apps, and insurance authorization systems. In response, state and federal lawmakers are enacting legislation to guide AI’s responsible use, ensure transparency, and safeguard patient rights. This white paper offers a detailed overview of current and proposed laws impacting healthcare-related AI across all 50 states and key federal agencies.
Federal Legislative and Regulatory Activity
Agency/Branch: HHS (OCR)
Policy / Bill: ACA Section 1557 Final Rule
Status: Final
Date: May 2024
Summary of Scope: Prohibits discriminatory clinical algorithms in care.
Relevance to Healthcare AI: The ACA Section 1557 Final Rule, finalized in May 2024, prohibits discrimination in federally funded health programs. While not focused on AI, it clarifies that the use of biased clinical algorithms—including AI tools—could violate civil rights protections, making it indirectly relevant to healthcare AI systems.
Agency/Branch: FDA
Policy / Bill: Predetermined Change Control Plan (PCCP) Guidance
Status: Final
Date: December 2024
Summary of Scope: Allows manufacturers of AI-enabled medical devices to implement pre-approved changes without submitting new marketing applications.
Relevance to Healthcare AI: Supports the development and deployment of adaptive AI tools in diagnostics and medical decision-making.
Agency/Branch: CMS
Policy / Bill: Medicare Advantage AI Rule (Proposed)
Status: Proposed
Date: Apr 2025
Summary of Scope: Would regulate AI use in prior authorizations.
Relevance to Healthcare AI: Not finalized; guidance likely in future.
Agency/Branch: Executive Branch
Policy / Bill: EO 14110 (Archived)
Status: Revoked
Date: Jan 2025
Summary of Scope: Required AI safety and risk assessments across sectors.
Relevance to Healthcare AI: Covered health AI systems; rescinded early 2025
Agency/Branch: FTC
Policy / Bill: AI Bias Enforcement Guidance
Status: Active
Date: Apr 2021
Summary of Scope: Warns against deceptive/discriminatory AI use.
Relevance to Healthcare AI: Applies to digital health and consumer wellness apps.
The EU Artificial Intelligence Act
European regulation on artificial intelligence (AI) which is the first comprehensive regulation on AI by a major regulator. Will US follow?
AI & Health State Legislation
Alabama — H 515 — Artificial Intelligence — Pending
Establishes guidelines for using artificial intelligence in determining eligibility and benefits under health insurance plans.
Alabama — H 557 — Health Insurance — Pending
Clarifies how health benefit plans must handle coverage decisions, with increased oversight from the Department of Insurance.
Alabama — S 294 — Health Insurance — Pending
Aims to modernize and regulate the prior authorization process for health insurance claims.
Arizona — H 2175 — Claims and Prior Authorization — Pending
Requires health insurers to have medical directors personally review denials for medical necessity, using independent judgment.
Arkansas — H 1297 — AI Algorithms — Pending
Regulates how insurers can use artificial intelligence and algorithms in healthcare-related decisions.
Arkansas — H 1816 — Health Care Providers — Pending
Restricts the use of AI in providing healthcare services or generating medical records unless specific conditions are met.
California — A 489 — Health Care Professions: Deceptive Terms or Letters — Pending
Prevents AI systems from using language that misleads users into thinking they are receiving services from licensed professionals.
California — A 512 — Health Care Coverage: Prior Authorization — Pending
Limits the time insurers can take to respond to standard and urgent prior authorization requests.
California — A 551 — Reproductive Health Emergency Preparedness Program — Pending
Creates a grant program to improve access to reproductive health services in emergency departments across the state.
California — A 682 — Health Care Coverage Reporting — Pending
Requires insurers to report monthly claim processing statistics, including totals for processed, denied, and partially denied claims.
California — S 503 — Health Care Services: Artificial Intelligence — Pending
Mandates developers and users of patient care AI tools to identify protected characteristics and reduce discriminatory risk.
California — S 579 — Mental Health and Artificial Intelligence — Pending
Forms a task force to evaluate the role of AI in mental health, with input from health organizations and public meetings.
Connecticut — H 5587 — Health Insurers — Failed
Would have prohibited health insurers from relying on AI as the main tool to deny claims.
Connecticut — H 5590 — AI — Failed
Sought to block the use of AI for making claim denial decisions in the health insurance industry.
Connecticut — H 6060 — Health Data — Failed
Aimed to introduce more stringent standards around how health data is owned, collected, stored, and used.
Connecticut — S 10 — Health Insurance and Patient Protection — Pending
Places the burden of proof on insurers to show a service is not medically necessary if ordered by a licensed provider.
Connecticut — S 447 — Health Carriers and Using Artificial Intelligence — Failed
Would have prohibited insurers from using AI to determine patient access to medications, testing, or procedures.
Connecticut — S 817 — Software Tools and Health Insurance Claims — Failed
Attempted to ban automatic denials or downcoding of claims using AI tools without peer review by a clinician.
Florida — H 907 — Florida Institute for Pediatric Rare Diseases — Pending
Establishes a state institute and pilot programs at Florida State University focused on rare pediatric diseases.
Florida — S 794 — Mandatory Human Reviews of Insurance Claim Denials — Pending
Requires human review and signoff for any insurance claim denials; bans AI from being the sole basis for denial.
Florida — S 1356 — Florida Institute for Pediatric Rare Diseases — Pending
Similar to H 907, outlines responsibilities and data collection for a state-run pediatric rare disease program.
Georgia — SR 290 — Recognitions — Pending – Carryover
Calls for culturally competent risk assessments and improved healthcare interventions for underserved populations.
Hawaii — H 62 — Hospitals and Care Homes Nurse to Patient Ratios — Pending
Implements minimum staffing ratios and compliance audits at hospitals and long-term care facilities.
Hawaii — H 484 — Efficient Transitional Homes Commission — Pending
Creates a commission to improve management and transparency of transitional healthcare housing.
Hawaii — H 716 — Health Infrastructure Grant Program — Pending
Funds implementation of interoperable health technology systems across various federally supported health centers.
Hawaii — H 718 — University Faculty and Staff Positions — Pending
Appropriates funding for academic health roles in biostatistics, tropical medicine, and cardiovascular biology.
Hawaii — HCR 116 — Health Care Technology — Pending
Encourages development of a health tech hub to support workforce growth and technology adoption.
Hawaii — HCR 202 — Patient Bill of Rights — Pending
Endorses a revised 2025 version of the state’s patient bill of rights.
Hawaii — HR 112 — Health Care Technology — Pending
Requests planning of a centralized technology district to advance healthcare innovation.
Hawaii — HR 171 — Rental Price Fixing — Pending
Urges investigation into use of AI and algorithmic tools in rental housing pricing and possible market manipulation.
Hawaii — HR 194 — Patient Bill of Rights — Pending
Supports implementation of updated rights for patients in the state healthcare system for 2025.
Hawaii — S 959 — Health Infrastructure Grant Program — Pending
Sets up funding for tech infrastructure to help health centers implement interoperable systems.
Hawaii — S 1217 — University Positions — Pending
Provides money to hire medical faculty in key fields and an environmental health officer.
Hawaii — SCR 35 — Health Care Technology — Pending
Proposes planning a technology hub in Kakaako to advance the local healthcare tech workforce.
Hawaii — SCR 43 — State Patient Bill of Rights — Pending
Promotes the revised version of the state patient bill of rights for adoption.
Hawaii — SCR 45 — State Patient Bill of Rights — Pending
Similar to SCR 43, expresses support for updated patient rights language in state policy.
Hawaii — SCR 78 — Health Care Technology — Pending
Requests strategic planning for a state health tech hub to support workforce development.
Hawaii — SR 26 — State Patient Bill of Rights — Pending
Reinforces earlier efforts to adopt revised patient protection guidelines for 2025.
Hawaii — SR 28 — State Patient Bill of Rights — Pending
Another resolution to back the 2025 updates to patient rights laws.
Hawaii — SR 61 — Health Care Technology — Pending
Repeats call to build a tech hub supporting medical innovation and training.
Idaho — S 1014 — Preventable Diseases in Infants and Newborns — Enacted
Mandates reporting and testing for specific conditions in newborns, especially for births outside hospitals.
Illinois — H 35 — AI Systems and Health Insurance — Pending
Adds AI oversight to health insurance regulation, especially related to consumer protections.
Illinois — H 1806 — Wellness and Oversight for Psychological Resources Act — Pending
Restricts use of AI for emotion detection in therapy; strengthens confidentiality protections.
Illinois — H 1918 — Managed Care Reform and Patient Rights Act — Pending
Redefines what constitutes a health care plan under the Act.
Illinois — S 1425 — AI Systems and Health Insurance — Pending
Grants authority to the state insurance department to investigate and regulate AI-based health claim systems.
Illinois — S 2259 — Medical Practice Act — Pending
Outlines how generative AI can be used in patient communication under physician supervision.
Illinois — S 2273 — Protect Health Data Privacy Act — Pending
Prohibits selling personal health data and imposes rules on collection and storage by companies.
Indiana — H 1620 — AI Disclosure — Pending
Requires healthcare providers and insurers to tell patients when AI is used in decisions or communication.
Indiana — S 480 — Prior Authorization Limits and Requirements — To Governor
Sets new rules to prevent denial of claims based solely on referring provider’s network status.
Iowa — H 279 — State of Disaster Emergencies — Pending
Expands authority and duties of state officials during declared public health disasters.
Iowa — S 118 — State of Disaster Emergencies — Pending
Similar to H 279, deals with emergency management responsibilities and preparedness.
Iowa — S 562 — Utilization Review Organization — Pending
(Title only listed — additional summary content not parsed.)
Louisiana — H 114 — Health Care and Providers — Pending
Allows health providers to use AI in care delivery under regulation.
Maine — LR 1768 — Use of AI in the Denial of Health — Pending – Carryover
Bans use of AI to deny health insurance claims.
Maine — S 411 — Human Oversight in Medical Insurance Payment Decisions — Pending – Carryover
Requires a human to be involved in decisions on paying medical insurance claims.
Maine — S 509 — Safety of Nurses and Improve Patient Care — Pending
Introduces a state quality care act focused on nurse protection and improved outcomes.
Maine — S 531 — Use of AI in the Denial of Health — Pending
Further restricts insurers from using AI to process or deny claims.
Maryland — H 697 — AI in Health Insurance Decisions — Failed
Would have required insurers to report quarterly on how they use AI in denial decisions.
Maryland — H 820 — Health Insurance Utilization Review — To Governor
Demands fair AI practices in utilization reviews and restricts overreliance on automated tools.
Maryland — H 1240 — AI in Health Care Decision Making — Failed
Bans AI if it’s solely designed to cut costs at the expense of care; mandates data transparency.
Maryland — H 1314 — Health Care Fees and AI Usage — Failed – Adjourned
Would have prohibited automatic denials using AI and banned charging fees to request authorizations.
Maryland — H 1316 — Youth-centric Technology — To Governor
Establishes a mental health and social media resource guide for schools.
Maryland — S 897 — Student Technology and Social Media Resource Guide — Failed – Adjourned
Similar to H 1316, calls for a school resource guide with funding provisions for upcoming years.
Maryland — S 987 — AI Health Software — Failed – Adjourned
Would have required AI tools used in healthcare to be registered and prohibited insurers from using AI to dictate care decisions.
Massachusetts — H 461 — Consumer Health Data — Pending
Proposes new protections for consumer health-related data usage and access.
Massachusetts — H 1136 — Health Insurance Prior Authorization Process — Pending
(Titled only; full summary not included in original parsing.)
Massachusetts — H 1210 — AI Health Communications — Pending
Addresses informed consent and transparency when AI is used in patient communications.
Massachusetts — H 2236 — Petition — Pending
Calls for an investigation into safer social media use and its effects on children’s mental health.
Massachusetts — H 2432 — Incidence and Death from Pancreatic Cancer — Pending
Seeks to reduce pancreatic cancer rates through early detection and health interventions.
Massachusetts — S 35 — Electronic Monitoring Tools — Pending
Limits how electronic monitoring may be used in the workplace to protect employee wellbeing.
Massachusetts — S 46 — Healthcare Decision Making — Pending
Regulates how AI can be used in making health decisions for patients.
Massachusetts — S 250 — Consumer Health Data — Pending
Strengthens controls over consumer health data handling and use.
Massachusetts — S 1403 — Reducing Administrative Burden — Pending
Streamlines healthcare processes to reduce red tape for providers and patients.
Massachusetts — S 1484 — Incidence and Death From Pancreatic Cancer — Pending
Targets lowering pancreatic cancer rates with public health initiatives.
Massachusetts — SD 268 — Use of AI — Pending
Sets standards for AI use in health care decision-making.
Minnesota — H 1838 — Health Insurance — Pending
Prohibits use of AI in utilization review procedures.
Minnesota — H 2289 — Nurse Staffing at Levels — Pending
Requires hospitals to meet national nurse staffing standards and report levels.
Minnesota — H 2500 — Health Insurance — Pending
Bans algorithmic or AI use in prior authorization decisions.
Minnesota — H 2700 — Consumer Protection — Pending
Classifies health data as sensitive and grants more control to consumers over their data.
Minnesota — S 1856 — Health Insurance — Pending
Echoes H 1838 with a ban on AI use in medical utilization reviews.
Minnesota — S 2775 — Nurse Staffing Levels — Pending
Similar to H 2289, it reinforces staffing requirements and includes penalties.
Minnesota — S 2940 — Consumer Protection — Pending
Further develops privacy standards around consumer health information.
Montana — D 3970 — Usage of AI — Pending
Amends regulations to guide how AI is used in healthcare.
Montana — H 556 — Health Insurance — Failed
Would have restructured how AI is implemented in insurance coverage.
Nebraska — L 77 — Ensuring Transparency in Prior Authorization Act — Pending
Promotes accountability and clarity in prior authorization procedures.
Nevada — A 295 — Health Insurance — Failed
Introduced updates to health insurance rules and patient protections.
Nevada — A 406 — Mental Health of Pupils — Pending
Requires mental health support info in schools and limits AI use in school assessments.
Nevada — BDR 780 — AI Transparency in Health Care — Pending
Calls for transparency in how AI is used in patient services and healthcare decision-making.
Nevada — S 128 — Health Care — Pending
Adds prior authorization regulations and sets rules around discussions of stem cell therapies.
Nevada — S 186 — Use of AI In Health Care — Failed
Would have required AI-generated communication to include disclosures in healthcare.
Nevada — S 398 — Certain Medical and Dental Care Authorization — Failed
Focused on insurance requirements, particularly around autism services and public benefit use.
New Jersey — A 3858 — Health Insurers Data Collection — Pending
Mandates that insurers collect and report on decisions influenced by AI tools.
New Jersey — A 4292 — Hospitals and Nursing Homes Interpreter Services — Pending
Requires deaf and hard-of-hearing interpreter services at healthcare facilities.
New Jersey — A 5603 — AI Mental Health Advertising — Pending
Prohibits AI tools from being advertised as licensed mental health professionals.
New Jersey — S 3143 — Interpreter Services — Pending
Companion to A 4292, it ensures accessibility in care facilities for hearing-impaired patients.
New Jersey — S 3298 — Health Insurers Data Collection — Pending
Duplicate of A 3858, requiring reports on AI involvement in health claim outcomes.
New Jersey — S 3612 — Women’s Health Research and Innovations — Pending
Funds research and pilot programs for advancing women’s health.
New Mexico — H 178 — Nursing Practice Changes — Enacted
Clarifies the scope of nursing practice, including anesthesia and licensing updates.
New York — A 1415 — Privacy Standards for Electronic Health Products — Pending
Demands clear consent for personal health data collection and sharing.
New York — A 1456 — Insurer Notice Requirements — Pending
Requires insurers to notify patients when using AI-based systems in utilization review.
New York — A 3991 — Requirements for the Use of AI — Pending
Defines appropriate AI use in healthcare and outlines provider responsibilities.
New York — A 3993 — Discrimination Through the Use of Clinical Algorithms — Pending
Bans biased clinical algorithms and encourages health equity through AI review.
North Carolina — S 287 — Health Benefit Plans — Pending
Ensures medical necessity decisions are made by licensed professionals.
North Carolina — S 315 — Utilization Reviews — Pending
Improves process transparency and review efficiency in medical utilization.
North Carolina — S 316 — Lower Healthcare Costs — Pending
Promotes price transparency and standardized billing in hospitals and clinics.
Ohio — S 164 — AI Use By Health Insurers — Pending
Regulates how health insurers may use artificial intelligence.
Oklahoma — H 1915 — AI — Pending
Creates AI device rules for health, including QA programs and data oversight by licensed users.
Oklahoma — H 2371 — Students — Pending
Encourages AI pilot programs to monitor and support student mental health in collaboration with education agencies.
Oregon — H 2748 — Nurse Title Nonhuman Use — Pending
Prohibits AI and nonhuman systems from using titles like “nurse,” protecting licensed designations.
Oregon — H 3229 — Medical Assistance Program Provider Enrollment — Pending
Directs state agencies to study and implement an automated tool to streamline provider enrollment in Medicaid.
Oregon — H 3613 — Pharmaceutical Purchasing — Pending
Creates a centralized state office to reduce drug prices and promote collaborative pharmaceutical buying.
Pennsylvania — S 631 — Virtual Mental Health Services — Pending
Requires parental consent for schools to offer virtual mental health services to minors.
Rhode Island — H 5172 — Transparency and Accountability of Health Insurers — Pending
Promotes accountability in how health insurers use AI to determine claim outcomes.
Rhode Island — H 5434 — Protect Patients and Traditional Medicare — Pending
A resolution urging federal protection of traditional Medicare from privatized alternatives.
Rhode Island — H 5985 — The State Life Science Hub Act — Pending
Modernizes operations of the life sciences hub and allows tax exemptions and formation of nonprofit funds.
Rhode Island — S 13 — Use of AI by Health Insurers — Pending
Companion to H 5172, reinforces transparency around AI use in insurance decisions.
Rhode Island — S 56 — Protect Patients and Traditional Medicare — Pending
Senate resolution mirroring H 5434, defending traditional Medicare benefits.
Rhode Island — S 627 — Regulatory Provisions on AI Act — Pending
Requires ethical use of high-risk AI systems and mandates assessments to prevent discrimination in health, education, and legal services.
South Carolina — S 443 — Licensed Physician — Pending
Requires that automated healthcare decisions be reviewed and approved by a licensed physician.
Tennessee — H 1382 — Insurance Agents and Policies — Pending
Places restrictions on health insurers’ use of AI for utilization management and review functions.
Tennessee — S 1261 — Insurance Agents and Policies — Pending
Senate version of H 1382, enforcing standards on AI in insurance processes.
Texas — H 1265 — AI Mental Health Services — Pending
Restricts delivery of AI-powered mental health services unless approved by state health authorities.
Texas — H 2298 — Health Care Facility Grant Program — Pending
Supports use of AI for cancer detection through medical image scanning, funded via state grants.
Texas — H 2831 — Collection of Reproductive Health Information — Pending
Regulates the collection of reproductive health data and includes penalties for misuse.
Texas — H 2922 — Use of AI — Pending
Applies rules to how AI can be used in utilization reviews for health benefit plans.
Texas — H 4018 — Use of AI — Pending
Duplicate of H 2922, governing AI use in health plan utilization decisions.
Texas — H 4455 — Use of AI by Health Care Providers — Pending
Establishes guidelines for AI implementation in clinical care by healthcare professionals.
Texas — H 4503 — Electronic Health Record Requirements — Pending
Updates standards for electronic health record systems used by providers.
Texas — H 4585 — Medicaid Managed Care and Child Health Plan Programs — Pending
Improves Medicaid and CHIP claim auditing, submission, and review processes.
Texas — H 4635 — Disclosure of the Use of AI — Pending
Requires insurers to notify individuals when AI is involved in insurance claim denials.
Texas — HR 131 — Recognition Resolution — Adopted
Recognizes UTSA and UT Health San Antonio Day at the Texas Capitol.
Texas — S 815 — AI in Health Benefit Plan Review — Pending
Parallels H 2922, setting regulations for AI use in health insurance reviews.
Texas — S 1188 — Electronic Health Record Requirements — Pending
Aligns health record system standards with current technology practices.
Texas — S 1393 — Electronic Health Record Requirements — Pending
Requires accurate biological sex to be recorded in electronic medical records.
Texas — S 1411 — Use of AI by Health Plans — Pending
Applies responsible use rules to AI systems used by health plans and providers.
Texas — S 1822 — AI Based Algorithms Used for Health Benefit Plans — Pending
Specifies regulatory oversight for algorithms used in utilization review under health plans.
Texas — SR 32 — Recognition Resolution — Adopted
Like HR 131, acknowledges UTSA and UT Health San Antonio Day.
Utah — H 39 — Correctional Health — Enacted
Improves inmate psychiatric care access through telehealth and establishes planning for an EHR system.
Utah — H 121 — Health Education Amendments — Failed
Amends current health education provisions, though specifics were not parsed.
Utah — H 452 — AI Amendments — Enacted
Protects users of mental health chatbots, prohibits data misuse, and mandates transparency.
Virginia — H 747 — AI Developer Act — Failed
Sets operating standards for AI developers, including fairness, impact assessment, and non-discrimination.
Virginia — H 2255 — Hospital Nursing Home Fees — Enacted
Establishes fees for licensing and inspections of nursing homes and hospitals.
Virginia — H 2269 — Threats and Act of Violence Report in Hospitals — Enacted
Requires hospitals to track and report incidents of workplace violence against health staff.
Virginia — H 2468 — Advanced Registered Medication Aides — Enacted
Expands the responsibilities of medication aides in licensed nursing homes.
Virginia — H 2662 — Hospital Oversight Fund — Failed
Would have created oversight mechanisms for credentialing and billing within healthcare.
Virginia — H 2742 — Urine Drug Screening — Enacted
Mandates that hospitals include fentanyl testing in urine drug screenings for diagnostic purposes.
Virginia — S 1152 — Nursing Homes and Certified Nursing Facilities — Enacted
Ensures noneroding malpractice insurance coverage for long-term care facilities.
Virginia — S 1260 — Threats Report Against Health Care Providers — Enacted
Hospitals must report and publish data on violent threats against on-duty healthcare professionals.
Virginia — S 1484 — Hospitals Nursing Homes Fees — Enacted
Authorizes the Board of Health to set and collect inspection and license fees for healthcare facilities.
Washington — H 1566 — Prior Authorization Determination Process — Pending
Improves the transparency and accountability of prior authorization decisions.
Washington — H 1671 — Personal Data Privacy — Pending
Protects the privacy of personal and health data held by institutions.
Washington — S 5395 — Prior Authorization Determination Process — Pending
Senate version of H 1566 with similar provisions for improving authorization transparency.
Wyoming — S 30 — Wyoming’s Investment in Veterans Mental Health — Failed
Proposed a loan repayment program for veterans who serve as mental health professionals in the state.
The convergence of AI and healthcare is prompting a patchwork of new laws focused on transparency, fairness, and oversight. While federal agencies like HHS, FDA, and CMS are laying the groundwork for national frameworks, states are taking bold steps to define AI governance in their healthcare systems. Providers, developers, and policymakers must stay informed to ensure compliance, protect patients, and harness AI’s full potential in mental healthcare delivery.