Laws & Statutes › MA › MA-S-46
S-46
MA · State · USA
MA
USA
● Pre-filed
Proposed Effective Date
2025-01-10
An Act relative to the use of artificial intelligence and other software tools in healthcare decision-making (Senate No. 46)
Amends Massachusetts General Laws Chapter 176O, Section 12, to regulate the use of AI, algorithms, and other software tools by health insurance carriers and utilization review organizations for utilization review or utilization management functions based on medical necessity. Requires that AI tools base determinations on individualized patient clinical data rather than solely on group datasets, prohibits AI from making medical necessity determinations (reserving those for licensed physicians or competent health care professionals), and mandates non-discrimination, periodic performance review, patient data use limitations, and regulatory audit accessibility. Applies to prospective, retrospective, and concurrent review of covered health care services. The Division of Insurance and Executive Office of Health and Human Services have oversight and may issue implementing guidance.
Passage Likelihood
Low
Chamber No passage
Committee No action
Majority party Yes
Bipartisan No
Prior session None
Legislative History
2025-02-27 committee referral Referred to the Joint Committee on Advanced Information Technology, the Internet and Cybersecurity
2025-02-27 chamber passage House concurred
2025-08-28 other Hearing rescheduled to 09/11/2025 from 01:00 PM-05:00 PM in A-2 and Virtual Hearing updated to include Virtual
2025-10-16 other Accompanied a new draft, see S2632
Mapped Requirements
HC-01 Healthcare AI Decision Restrictions H-02 Non-Discrimination & Bias Assessment
Official Sources
Full Text ↗
Entry Last Reviewed
2026-03-28
AI generated
Summary

Amends Massachusetts General Laws Chapter 176O, Section 12, to regulate the use of AI, algorithms, and other software tools by health insurance carriers and utilization review organizations for utilization review or utilization management functions based on medical necessity. Requires that AI tools base determinations on individualized patient clinical data rather than solely on group datasets, prohibits AI from making medical necessity determinations (reserving those for licensed physicians or competent health care professionals), and mandates non-discrimination, periodic performance review, patient data use limitations, and regulatory audit accessibility. Applies to prospective, retrospective, and concurrent review of covered health care services. The Division of Insurance and Executive Office of Health and Human Services have oversight and may issue implementing guidance.

Enforcement & Penalties
Enforcement Authority
The Division of Insurance and the Executive Office of Health and Human Services have oversight authority, including the power to conduct audits and compliance reviews of AI tools used in utilization review. The bill does not create a private right of action. Enforcement is agency-initiated through existing regulatory authority under Chapter 176O. The Division and EOHHS may also issue guidance to implement the provisions. No cure period or safe harbor is specified.
Penalties
The bill does not specify monetary penalties, civil damages, or specific remedies. Enforcement would rely on existing regulatory authority under Chapter 176O of the General Laws, which may include administrative enforcement actions against carriers and utilization review organizations.
Who Is Covered
Compliance Obligations 8 obligations · click obligation ID to open requirement page
HC-01 Healthcare AI Decision Restrictions · HC-01.3 · Deployer · Healthcare
Ch. 176O § 12(g)(1)(A)-(B)
Plain Language
AI tools used for utilization review must base their determinations on the individual insured's medical history, clinical circumstances as presented by the requesting provider, and other relevant clinical information in the insured's record. The tool may not base determinations solely on aggregate or group-level datasets. This means carriers must configure or select AI tools that ingest and weigh individualized patient data — a tool that applies only population-level statistical models without considering the specific patient's clinical record would violate this requirement.
Statutory Text
(A) The artificial intelligence, algorithm, or other software tool bases its determination on the following information, as applicable: (i) An insured's medical or other clinical history. (ii) Individual clinical circumstances as presented by the requesting provider. (iii) Other relevant clinical information contained in the insured's medical or other clinical record. (B) The artificial intelligence, algorithm, or other software tool does not base its determination solely on a group dataset.
HC-01 Healthcare AI Decision Restrictions · HC-01.1HC-01.2 · Deployer · Healthcare
Ch. 176O § 12(g)(2)
Plain Language
AI tools are categorically prohibited from denying, delaying, or modifying health care services on the basis of medical necessity. All medical necessity determinations must be made by a licensed physician or a licensed health care professional who is competent to evaluate the specific clinical issues at hand. That professional must review and consider the requesting provider's recommendation, the insured's medical/clinical history, and individual clinical circumstances. This means AI may inform or assist a utilization review process, but the final adverse determination on medical necessity must always be made by a qualified human clinician — the AI cannot serve as the decision-maker.
Statutory Text
(2) Notwithstanding paragraph (1), the artificial intelligence, algorithm, or other software tool shall not deny, delay, or modify health care services based, in whole or in part, on medical necessity. A determination of medical necessity shall be made only by a licensed physician or a licensed health care professional competent to evaluate the specific clinical issues involved in the health care services requested by the provider, as provided in subsection (a), by reviewing and considering the requesting providers recommendation, the insured's medical or other clinical history, as applicable, and individual clinical circumstances.
HC-01 Healthcare AI Decision Restrictions · HC-01.4 · Deployer · Healthcare
Ch. 176O § 12(g)(1)(I)
Plain Language
Carriers and utilization review organizations must periodically review the performance, use, and outcomes of AI tools used in utilization review and revise them as needed to maximize accuracy and reliability. This is an ongoing operational obligation — not a one-time pre-deployment check. The statute does not specify a review frequency, leaving carriers to establish a reasonable cadence.
Statutory Text
(I) The artificial intelligence, algorithm, or other software tools performance, use, and outcomes are periodically reviewed and revised to maximize accuracy and reliability.
HC-01 Healthcare AI Decision Restrictions · HC-01.5 · Deployer · Healthcare
Ch. 176O § 12(g)(1)(J)
Plain Language
Patient data used by AI tools in utilization review or utilization management may not be repurposed beyond the intended and stated purpose of that review. This aligns with HIPAA minimum necessary principles and state health privacy law, but creates an independent state-law obligation that AI tools processing patient data for UR purposes must not use that data for secondary purposes such as marketing, risk profiling, or model training beyond the stated utilization review function.
Statutory Text
(J) Patient data is not used beyond its intended and stated purpose, and consistent with state and federal law.
HC-01 Healthcare AI Decision Restrictions · HC-01.7 · Deployer · Healthcare
Ch. 176O § 12(g)(1)(G)-(H)
Plain Language
Carriers must ensure that their AI utilization review tools are available for regulatory inspection by the Division of Insurance and the Executive Office of Health and Human Services. Additionally, the carrier's written utilization review policies and procedures (required under existing subsection (a) of Section 12) must contain disclosures about how the AI tool is used and how it is overseen. This means the use of AI must be documented in the same policies filed with the Division — it cannot be a hidden back-end process undisclosed in the carrier's official UR documentation.
Statutory Text
(G) The artificial intelligence, algorithm, or other software tool is open to inspection for audit or compliance reviews by the division and by the executive office of health and human services pursuant to applicable state and federal law. (H) Disclosures pertaining to the use and oversight of the artificial intelligence, algorithm, or other software tool are contained in the written policies and procedures, as required by subsection (a).
H-02 Non-Discrimination & Bias Assessment · Deployer · Healthcare
Ch. 176O § 12(g)(1)(D)-(F)
Plain Language
Carriers must ensure that AI utilization review tools do not supplant health care provider decision-making, do not discriminate directly or indirectly against any insured in violation of state or federal anti-discrimination law (including Massachusetts Chapter 151B), and are applied fairly and equitably in accordance with applicable regulations and agency guidance. The non-discrimination obligation is broad — covering both direct and indirect (disparate impact) discrimination — and is referenced to existing anti-discrimination frameworks rather than creating a standalone bias testing regime. The fair-and-equitable-application standard incorporates any future state or federal agency guidance as a continuing compliance benchmark.
Statutory Text
(D) The artificial intelligence, algorithm, or other software tool does not supplant health care provider decision-making. (E) The use of the artificial intelligence, algorithm, or other software tool does not discriminate, directly or indirectly, against any insured in violation of state or federal law, including but not limited to chapter 151B. (F) The artificial intelligence, algorithm, or other software tool is fairly and equitably applied, including in accordance with any applicable regulations and guidance issued by state and federal agencies.
Other · Healthcare
Ch. 176O § 12(g)(1)(K)
Plain Language
Carriers must ensure that AI tools used in utilization review do not directly or indirectly cause harm to the insured. This is a broad, general duty that goes beyond specific procedural requirements — it creates a results-based standard under which any harm to an insured attributable to an AI utilization review tool could constitute a violation, regardless of whether the carrier complied with the other procedural requirements of this subsection.
Statutory Text
(K) The artificial intelligence, algorithm, or other software tool does not directly or indirectly cause harm to the insured.
Other · Healthcare
Ch. 176O § 12(g)(1)(C), (5)
Plain Language
AI tools used in utilization review must comply with all applicable provisions of Chapter 176O and other state and federal law. Health benefit plans must also comply with any state or federal rules and guidance regarding AI use. The Division of Insurance and EOHHS are authorized to issue implementing guidance within one year of any federal rulemaking by HHS on AI tools — and that guidance is exempt from the Massachusetts Administrative Procedure Act (Chapter 30A). These provisions create no standalone new obligation but serve as compliance pass-throughs to existing and future regulatory frameworks and as a delegation of guidance-issuing authority.
Statutory Text
(C) The artificial intelligence, algorithm, or other software tools criteria and guidelines complies with this chapter and applicable state and federal law. (5) A health benefit plan subject to this subsection shall comply with applicable state and federal rules and guidance regarding the use of artificial intelligence, algorithm, or other software tools. The division and the executive office of health and human services may issue guidance to implement this paragraph within one year of the adoption of state or federal rules or the issuance of guidance by the federal Department of Health and Human Services regarding the use of artificial intelligence, algorithm, or other software tools. Such guidance shall not be subject to chapter 30A.