Md. Code, Insurance § 15-10B-05.1

Md. Code, Insurance § 15-10B-05.1
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§15–10B–05.1. (a) (1) In this section the following words have the meanings indicated. (2) “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. (3) “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. (b) This section applies to: (1) a carrier that: (i) uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review; or (ii) contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review; and (2) a pharmacy benefits manager or private review agent that: (i) contracts with a carrier to provide utilization review on behalf of the carrier; and (ii) uses an artificial intelligence, algorithm, or other software tool for the purpose of conducting utilization review on behalf of the carrier. (c) Subject to subsection (d) of this section, an entity subject to this section shall ensure that: (1) an artificial intelligence, algorithm, or other software tool bases its determinations on: (i) an enrollee’s medical or other clinical history; (ii) individual clinical circumstances as presented by a requesting provider; or (iii) other relevant clinical information contained in the enrollee’s medical or other clinical record; (2) an artificial intelligence, algorithm, or other software tool does not base its determinations solely on a group dataset; (3) the criteria and guidelines for using an artificial intelligence, algorithm, or other software tool for making determinations comply with the requirements of this title; (4) an artificial intelligence, algorithm, or other software tool does not replace the role of a health care provider in the determination process under § 15–10B–07 of this subtitle; (5) the use of an artificial intelligence, algorithm, or other software tool does not result in unfair discrimination; (6) an artificial intelligence, algorithm, or other software tool is fairly and equitably applied, including in accordance with any applicable regulations and guidance issued by the federal Department of Health and Human Services; (7) an artificial intelligence, algorithm, or other software tool is open to inspection for audit or compliance reviews by the Commissioner; (8) written policies and procedures are included in the utilization plan submitted under § 15–10B–05 of this subtitle, including how an artificial intelligence, algorithm, or other software tool will be used and what oversight will be provided; (9) the performance, use, and outcomes of an artificial intelligence, algorithm, or other software tool are reviewed and revised, if necessary and at least on a quarterly basis, to maximize accuracy and reliability; (10) patient data is not used beyond its intended and stated purpose, consistent with the federal Health Insurance Portability and Accountability Act of 1996, as applicable; and (11) an artificial intelligence, algorithm, or other software tool does not directly or indirectly cause harm to an enrollee. (d) An artificial intelligence, algorithm, or other software tool may not deny, delay, or modify health care services.

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