Massachusetts · Senate Bill · 194th General Court (2025–2026)
SB46
An Act relative to the use of artificial intelligence and other software tools in healthcare decision-making

Status ● Introduced Effective N/A Passage Likelihood L

WHAT THIS BILL REGULATES · 2 REQUIREMENT TYPES

How Is This Bill Enforced

Enforcement Authority
The Division of Insurance and the Executive Office of Health and Human Services have oversight and audit authority. The bill does not create a private right of action or specify a complaint-driven enforcement mechanism. Enforcement is agency-initiated through existing regulatory authority under Chapter 176O.
Private Right of Action
No private right of action. Enforcement is exclusive to the designated authority.
Penalties
The bill does not specify monetary penalties, damages, or remedies. Enforcement and remedies would follow existing Chapter 176O regulatory enforcement mechanisms administered by the Division of Insurance.

What This Bill Requires

Verbatim statutory text on the left; plain-language analysis and a per-section checklist on the right. Numbered markers cross-link to the matching checklist row.

Statutory Text
Analysis & Obligations
M.G.L. c. 176O, § 12(g)
AI in Utilization Review: Individualized Data, Human Oversight, and Compliance Requirements
Deployer

(g)(1)(A) 1 The artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), 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.

(g)(1)(B) 1 The artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), algorithm, or other software tool does not base its determination solely on a group dataset.

(g)(1)(D) 2 The artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), algorithm, or other software tool does not supplant health care provider decision-making.

(g)(2) 3 Notwithstanding paragraph (1), the artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), 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.

(g)(1)(E)–(F) 4 The use of the artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), 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 intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), 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.

(g)(1)(K) 4 The artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), algorithm, or other software tool does not directly or indirectly cause harm to the insured.

(g)(1)(I) 5 The artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), algorithm, or other software tools performance, use, and outcomes are periodically reviewed and revised to maximize accuracy and reliability.

(g)(1)(J) 6 Patient data is not used beyond its intended and stated purpose, and consistent with state and federal law.

(g)(1)(G) 7 The artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), 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.

(g)(1)(H) 8 Disclosures pertaining to the use and oversight of the artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), algorithm, or other software tool are contained in the written policies and procedures, as required by subsection (a).

(g)(1)(C) The artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), algorithm, or other software tools criteria and guidelines complies with this chapter and applicable state and federal law.

(g)(3) For purposes of this subsection, artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3) means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.

(g)(4) This subsection shall apply to utilization review or utilization management functions that prospectively, retrospectively, or concurrently review requests for covered health care services.

(g)(5) A health benefit plan subject to this subsection shall comply with applicable state and federal rules and guidance regarding the use of artificial intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), 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 intelligenceArtificial intelligenceFor purposes of this subsection, artificial intelligence means an engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.M.G.L. c. 176O, § 12(g)(3), algorithm, or other software tools. Such guidance shall not be subject to chapter 30A.

(g)(6) This subsection applies to a MassHealth managed health benefit plan only to the extent that the executive office of health and human services obtains any necessary federal approvals, and federal financial participation is not otherwise jeopardized.

This subsection establishes a comprehensive set of requirements governing the use of AI, algorithms, and other software tools in healthcare utilization review and utilization management. Paragraph (1) enumerates eleven substantive requirements — from mandating individualized clinical data inputs to periodic performance review and data-use limitations. Paragraph (2) imposes the bill's strongest prohibition: AI tools may not deny, delay, or modify health care services based on medical necessity; only a licensed physician or competent health care professional may make such determinations.

Paragraphs (3) through (6) provide the definitional, scope, compliance, and applicability provisions. The definition of AI tracks the NIST framework. The scope extends to prospective, retrospective, and concurrent utilization review. MassHealth managed plans are covered only to the extent federal approvals are secured.

Compliance actions 8 items
1
CarriersCarrierA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) and utilization review organizationsUtilization review organizationA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) must ensure that any AI, algorithm, or other software tool used in utilization review or utilization management bases its determination on the insured's individual clinical data, including: (1) the insured's medical or other clinical history, (2) individual clinical circumstances as presented by the requesting provider, and (3) other relevant clinical information in the insured's medical or clinical record. The tool must not base its determination solely on a group dataset.
HC-01.3
2
CarriersCarrierA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) and utilization review organizationsUtilization review organizationA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) must ensure that the AI, algorithm, or other software tool does not supplant health care provider decision-making.
HC-01.1
3
AI, algorithms, or other software tools must not deny, delay, or modify health care services based in whole or in part on medical necessity. A determination of medical necessity must be made only by a licensed physician or a licensed health care professional competent to evaluate the specific clinical issues involved in the requested health care services, who must review and consider the requesting provider's recommendation, the insured's medical or clinical history, and individual clinical circumstances.
HC-01.1
4
CarriersCarrierA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) and utilization review organizationsUtilization review organizationA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) must ensure that the use of AI, algorithms, or other software tools does not discriminate, directly or indirectly, against any insured in violation of state or federal law (including Chapter 151B), is fairly and equitably applied in accordance with applicable regulations and guidance, and does not directly or indirectly cause harm to the insured.
H-02.1
5
CarriersCarrierA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) and utilization review organizationsUtilization review organizationA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) must periodically review and revise the performance, use, and outcomes of AI, algorithms, or other software tools used in utilization review to maximize accuracy and reliability.
HC-01.4
6
CarriersCarrierA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) and utilization review organizationsUtilization review organizationA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) must ensure that patient data used by AI, algorithms, or other software tools in utilization review is not used beyond its intended and stated purpose, consistent with applicable state and federal law.
HC-01.5
7
CarriersCarrierA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) and utilization review organizationsUtilization review organizationA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) must ensure that AI, algorithms, or other software tools used in utilization review are open to inspection for audit or compliance reviews by the Division of Insurance and the Executive Office of Health and Human Services pursuant to applicable state and federal law.
HC-01.7
8
CarriersCarrierA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) and utilization review organizationsUtilization review organizationA carrier or a utilization review organization that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity, or that contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review or utilization management functions, based in whole or in part on medical necessity.M.G.L. c. 176O, § 12(g)(1) must include disclosures pertaining to the use and oversight of AI, algorithms, or other software tools in their written utilization review policies and procedures as required by Section 12(a) of Chapter 176O.
HC-01.6

Passage Likelihood

Low
Status Introduced
Chamber No passage
Committee No action
Majority party Yes
Bipartisan No
Prior session None

Legislative History

2025-02-27 Referred to the Joint Committee on Advanced Information Technology, the Internet and Cybersecurity
2025-02-27 House concurred
2025-08-28 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 Accompanied a new draft, see S2632

Entry Last Reviewed

2026-05-20
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