WHAT THIS BILL REGULATES · 2 REQUIREMENT TYPES
How Is This Bill Enforced
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.
(A) 1 THE COMMISSIONCommission"Commission" means the Maryland Health Care Commission.Md. Code, Health–Gen. § 19–101 SHALL MAINTAIN A REGISTRY OF ARTIFICIAL INTELLIGENCE HEALTH SOFTWAREArtificial intelligence health softwareDefinition deferred to regulations adopted by the Maryland Health Care Commission under § 19–150(C)(1).Md. Code, Health–Gen. § 19–150(C)(1) THAT MAY BE DISTRIBUTED OR OPERATED IN THE STATE.
(B) 2 A PERSON MAY NOT DISTRIBUTE OR OPERATE ARTIFICIAL INTELLIGENCE HEALTH SOFTWAREArtificial intelligence health softwareDefinition deferred to regulations adopted by the Maryland Health Care Commission under § 19–150(C)(1).Md. Code, Health–Gen. § 19–150(C)(1) IN THE STATE UNLESS THE SOFTWARE IS REGISTERED WITH THE COMMISSIONCommission"Commission" means the Maryland Health Care Commission.Md. Code, Health–Gen. § 19–101.
(C)(1)–(3) THE COMMISSIONCommission"Commission" means the Maryland Health Care Commission.Md. Code, Health–Gen. § 19–101 SHALL ADOPT REGULATIONS THAT: (1) DEFINE ARTIFICIAL INTELLIGENCE HEALTH SOFTWAREArtificial intelligence health softwareDefinition deferred to regulations adopted by the Maryland Health Care Commission under § 19–150(C)(1).Md. Code, Health–Gen. § 19–150(C)(1); (2) DETERMINE THE INFORMATION ABOUT ARTIFICIAL INTELLIGENCE HEALTH SOFTWAREArtificial intelligence health softwareDefinition deferred to regulations adopted by the Maryland Health Care Commission under § 19–150(C)(1).Md. Code, Health–Gen. § 19–150(C)(1) TO BE COLLECTED FOR THE REGISTRY; AND (3) SET A REGISTRATION DEADLINE FOR WHEN THE COMMISSIONCommission"Commission" means the Maryland Health Care Commission.Md. Code, Health–Gen. § 19–101 WILL BEGIN TO ISSUE FINES TO A PERSON THAT DISTRIBUTES OR OPERATES UNREGISTERED ARTIFICIAL INTELLIGENCE HEALTH SOFTWAREArtificial intelligence health softwareDefinition deferred to regulations adopted by the Maryland Health Care Commission under § 19–150(C)(1).Md. Code, Health–Gen. § 19–150(C)(1) IN THE STATE.
(D)(1)–(2) IF A PERSON DISTRIBUTES OR OPERATES UNREGISTERED ARTIFICIAL INTELLIGENCE HEALTH SOFTWAREArtificial intelligence health softwareDefinition deferred to regulations adopted by the Maryland Health Care Commission under § 19–150(C)(1).Md. Code, Health–Gen. § 19–150(C)(1) IN THE STATE, THE COMMISSIONCommission"Commission" means the Maryland Health Care Commission.Md. Code, Health–Gen. § 19–101 MAY FINE THE PERSON UP TO $10,000 FOR EACH DAY THE VIOLATION OCCURRED. (2) THE AMOUNT OF THE FINE IMPOSED BY THE COMMISSIONCommission"Commission" means the Maryland Health Care Commission.Md. Code, Health–Gen. § 19–101 UNDER PARAGRAPH (1) OF THIS SUBSECTION SHALL BE BASED ON: (I) THE EXTENT OF ACTUAL OR POTENTIAL HARM RELATED TO THE VIOLATION; (II) THE COST OF INVESTIGATING THE VIOLATION; AND (III) WHETHER THE PERSON COMMITTED PREVIOUS VIOLATIONS OF THIS SECTION.
Section 19–150 creates a new regulatory framework requiring the Maryland Health Care Commission to establish and maintain a registry of AI health software that may be distributed or operated in the state. No person may distribute or operate AI health software in Maryland without registering it with the Commission. Notably, the statute delegates the definition of artificial intelligence health software to Commission rulemaking, meaning the precise scope of coverage will not be known until regulations are adopted.
The Commission is directed to adopt regulations defining the covered software, determining what information registrants must submit, and setting a registration deadline after which fines will be imposed. Violations carry administrative fines of up to $10,000 per day, calibrated to actual or potential harm, investigation costs, and the violator's history of prior violations.
(A)(1)–(3) IN THIS SECTION THE FOLLOWING WORDS HAVE THE MEANINGS INDICATED. (2) "ARTIFICIAL INTELLIGENCEArtificial intelligence"Artificial intelligence" means a machine–based system that: (1) can, for a given set of human–defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments; (2) uses machine and human–based inputs to perceive real and virtual environments and abstracts those perceptions into models through analysis in an automated manner; and (3) uses model inference to formulate options for information or action.Md. Code, State Fin. & Proc. § 3.5–801(c)" HAS THE MEANING STATED IN § 3.5–801 OF THE STATE FINANCE AND PROCUREMENT ARTICLE. (3) "CARRIERCarrier"Carrier" means: (I) an insurer; (II) a nonprofit health service plan; (III) a health maintenance organization; (IV) a dental plan organization; or (V) any other person that provides health benefit plans subject to regulation by the State.Md. Code, Ins. § 15–147(A)(3)" MEANS: (I) AN INSURER; (II) A NONPROFIT HEALTH SERVICE PLAN; (III) A HEALTH MAINTENANCE ORGANIZATION; (IV) A DENTAL PLAN ORGANIZATION; OR (V) ANY OTHER PERSON THAT PROVIDES HEALTH BENEFIT PLANS SUBJECT TO REGULATION BY THE STATE.
(B) 3 A CARRIERCarrier"Carrier" means: (I) an insurer; (II) a nonprofit health service plan; (III) a health maintenance organization; (IV) a dental plan organization; or (V) any other person that provides health benefit plans subject to regulation by the State.Md. Code, Ins. § 15–147(A)(3) MAY NOT USE ARTIFICIAL INTELLIGENCEArtificial intelligence"Artificial intelligence" means a machine–based system that: (1) can, for a given set of human–defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments; (2) uses machine and human–based inputs to perceive real and virtual environments and abstracts those perceptions into models through analysis in an automated manner; and (3) uses model inference to formulate options for information or action.Md. Code, State Fin. & Proc. § 3.5–801(c) TO DECIDE OR DIRECTLY INFLUENCE A HEALTH CARE DECISION OR A DECISION DIRECTLY RELATED TO HEALTH CARE.
(C) THIS SECTION MAY NOT BE CONSTRUED TO PROHIBIT A CARRIERCarrier"Carrier" means: (I) an insurer; (II) a nonprofit health service plan; (III) a health maintenance organization; (IV) a dental plan organization; or (V) any other person that provides health benefit plans subject to regulation by the State.Md. Code, Ins. § 15–147(A)(3) FROM USING ARTIFICIAL INTELLIGENCEArtificial intelligence"Artificial intelligence" means a machine–based system that: (1) can, for a given set of human–defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments; (2) uses machine and human–based inputs to perceive real and virtual environments and abstracts those perceptions into models through analysis in an automated manner; and (3) uses model inference to formulate options for information or action.Md. Code, State Fin. & Proc. § 3.5–801(c) TO PERFORM TASKS OR MAKE DECISIONS THAT ARE NOT RELATED TO HEALTH CARE.
Section 15–147 imposes a categorical prohibition on health insurance carriers using artificial intelligence to decide or directly influence any health care decision or decision directly related to health care. The prohibition applies broadly to insurers, nonprofit health service plans, HMOs, dental plan organizations, and any other person providing state-regulated health benefit plans.
A savings clause preserves carriers' ability to use AI for tasks and decisions unrelated to health care — such as fraud detection, administrative processing, or customer service — making clear the prohibition targets only the clinical and coverage decision-making context. This is one of the broadest state-level restrictions on insurer use of AI, going further than most state bills that merely require human oversight of AI-assisted coverage decisions.