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EXPLANATION: CAPITALS INDICATE MATTER ADDED TO EXISTING LAW.
[Brackets] indicate matter deleted from existing law.
*hb1385*
HOUSE BILL 1385
J5 6lr2916
By: Delegates Hill, Kaiser, Moreno, Palakovich Carr, Ruth, Schindler, Turner,
White Holland, and Wu
Introduced and read first time: February 13, 2026
Assigned to: Health
A BILL ENTITLED
AN ACT concerning 1
Health Insurance – Use of Artificial Intelligence – Human Evaluation 2
FOR the purpose of requiring that certain audits and compliance reviews of an artificial 3
intelligence, algorithm, or other software tool used for utilization review include a 4
certain evaluation by a licensed health care professional; requiring that the review 5
and revision of the performance, use, and outcom es of an artificial intelligence, 6
algorithm, or other software tool used for utilization review include a certain human 7
evaluation and use of the finding s of the evaluation for a certain purpose ; and 8
generally relating to the use of artificial intelligence and health insurance. 9
BY repealing and reenacting, with amendments, 10
Article – Insurance 11
Section 15–10B–05.1 12
Annotated Code of Maryland 13
(2017 Replacement Volume and 2025 Supplement) 14
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 15
That the Laws of Maryland read as follows: 16
Article – Insurance 17
15–10B–05.1. 18
(a) (1) In this section the following words have the meanings indicated. 19
(2) “Artificial intelligence” means an engineered or machine–based system 20
that varies in its level of au tonomy and that can, for explicit or implicit objectives, infer 21
from the input it receives how to generate outputs that can influence physical or virtual 22
environments. 23
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(3) “Carrier” means: 1
(i) an insurer; 2
(ii) a nonprofit health service plan; 3
(iii) a health maintenance organization; 4
(iv) a dental plan organization; or 5
(v) any other person that provides health benefit plans subject to 6
regulation by the State. 7
(b) This section applies to: 8
(1) a carrier that: 9
(i) uses an artificial intelligence, algorithm, or other software tool 10
for the purpose of utilization review; or 11
(ii) contracts with or otherwise works through an entity that uses an 12
artificial intelligence, algorithm, or other software tool for the purpose of utilization review; 13
and 14
(2) a pharmacy benefits manager or private review agent that: 15
(i) contracts with a carrier to provide utilization review on behalf of 16
the carrier; and 17
(ii) uses an artificial intelligence, algorithm, or other software tool 18
for the purpose of conducting utilization review on behalf of the carrier. 19
(c) Subject to subsection (d) of this section, an entity subject to this section shall 20
ensure that: 21
(1) an artificial intelligence, algorithm, or other software tool bases its 22
determinations on: 23
(i) an enrollee’s medical or other clinical history; 24
(ii) individual clinical circumstances as presented by a requesting 25
provider; or 26
(iii) other relevant clinical information contained in the enrollee’s 27
medical or other clinical record; 28
HOUSE BILL 1385 3
(2) an artificial intelligence, algorithm, or other software tool does not base 1
its determinations solely on a group dataset; 2
(3) the criteria and guidelines for using an artificial intelligence, algorithm, 3
or other software tool for making determinations comply with the requirements of this title; 4
(4) an artificial intelligence, algorithm, or other software tool does not 5
replace the role of a health care provider in the determination process under § 15 –10B–07 6
of this subtitle; 7
(5) the use of an artificial intelligence, algorithm, or other software tool 8
does not result in unfair discrimination; 9
(6) an artificial intelligence, algorithm, or other software tool is fairly and 10
equitably applied, including in accordance with any app licable regulations and guidance 11
issued by the federal Department of Health and Human Services; 12
(7) an artificial intelligence, algorithm, or other software tool is open to 13
inspection for audit or compliance reviews by the Commissioner IN ACCORDANCE WITH 14
SUBSECTION (E) OF THIS SECTION; 15
(8) written policies and procedures are included in the utilization plan 16
submitted under § 15 –10B–05 of this subtitle, including how an artificial intelligence, 17
algorithm, or other software tool will be used and what oversight will be provided; 18
(9) the performance, use, and outcomes of an artificial intelligence, 19
algorithm, or other software tool are reviewed and revised, if necessary and at least on a 20
quarterly basis, to maximize accuracy and reliability , IN ACCORDAN CE WITH 21
SUBSECTION (F) OF THIS SECTION; 22
(10) patient data is not used beyond its intended and stated purpose, 23
consistent with the federal Health Insurance Portability and Accountability Act of 1996, as 24
applicable; and 25
(11) an artificial intelligence, algorithm, or other software tool does not 26
directly or indirectly cause harm to an enrollee. 27
(d) An artificial intelligence, algorithm, or other software tool may not deny, 28
delay, or modify health care services. 29
(E) AN AUDIT OR COMPLIANC E REVIEW OF AN ARTIFICIAL INTELLIGENCE, 30
ALGORITHM, OR OTHER SOFTWARE TO OL UNDER SUBSECTION (C)(7) OF THIS 31
SECTION SHALL INCLUDE THE HUMAN EVALUATION OF A PATIENT ’S MEDICAL 32
RECORDS BY A LICENSE D HEALTH CARE PROFES SIONAL THAT TAKES INTO 33
CONSIDERATION THE PA TIENT’S SPECIFI C CIRCUMSTANCES AND ALLOWS THE 34
LICENSED HEALTH CARE PROFESSIONAL TO QUES TION, MODIFY, OR OVERRIDE A 35
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DETERMINATION MADE BY THE ARTIFICIAL INTELLIGENCE, ALGORITHM, OR OTHER 1
SOFTWARE TOOL. 2
(F) A REVIEW OF THE PERFORMANCE, USE, AND OUTCOMES OF ARTIFICIAL 3
INTELLIGENCE, ALGORITHM, OR OTHER SOFTWARE TO OLS UNDER SUBSECTION 4
(C)(9) OF THIS SECTION SHALL INCLUDE: 5
(1) A HUMAN EVALUATION OF THE REAL–WORLD HEALTH OUTCOMES 6
OF DECISIONS MADE BY THE ARTIFICIAL INTEL LIGENCE, ALGORITHM, OR OTHER 7
SOFTWARE TOOL; AND 8
(2) USE OF THE FINDINGS MADE BY THE EVALUATION REQUIRED 9
UNDER ITEM (1) OF THIS SUBSECTION TO IMPROVE THE ARTIFICIAL INTELLIGENCE, 10
ALGORITHM, OR OTHER SOFTWARE TO OL AND MAKE THE DECISIONS OF THE 11
ARTIFICIAL INTELLIGENCE, ALGORITHM, OR OTHER SOFTWARE TOOL SAFER, MORE 12
ACCURATE, AND MORE RESPONSIVE TO PATIENT NEEDS. 13
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 14
October 1, 2026. 15