(a) 1 Duty to disclose.--A facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 shall disclose to patients of the facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 if artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 are or will be used for clinical decision makingClinical decision making"Clinical decision making." A patient-centered problem-solving process focused on a health care provider's direct patient care involving gathering information, diagnosing and planning treatments.35 Pa.C.S. § 3501 or other similar tasks. The disclosure shall be: (1) Provided in all related written communications. (2) Posted on the publicly accessible Internet website of the facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501.

(b)(1)–(2) 2 Communications.-- (1) A facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 that uses artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 to generate written or verbal patient communications pertaining to patient clinical information shall include: (i) A clear and conspicuous disclaimer that indicates that the communication was generated by artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501. (ii) Clear instructions on how the patient may contact a human health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 or relevant employee of the facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 with questions. (2) The requirements under paragraph (1) shall not apply to communications that: (i) only pertain to administrative matters, including appointment scheduling, billing or other clerical or business matters; or (ii) have been individually read and reviewed by a human health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501.

(c) Nature and frequency.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall determine the nature and frequency of disclosure requirements to the patient. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from facilities and health care providersHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 or their representatives in making the determination.

(b)(1) 3 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must not supersede health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 clinical decision makingClinical decision making"Clinical decision making." A patient-centered problem-solving process focused on a health care provider's direct patient care involving gathering information, diagnosing and planning treatments.35 Pa.C.S. § 3501.

(b)(2)–(3) 4 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 and training data sets must not directly or indirectly discriminate against patients in violation of Federal or State law. (3) The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be fairly and equitably applied, including in accordance with any applicable regulations and or guidance issued by the United States Department of Health and Human Services.

(b)(5) 5 The performance, use and outcomes of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be periodically reviewed and revised to maximize accuracy and reliability.

(b)(6) 6 Patient data must not be used beyond the intended and stated purpose of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501, consistent with the laws of this Commonwealth and 42 U.S.C. Ch. 7 Subch. XI Part C (relating to administrative simplification), as applicable.

(b)(7) 7 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must not create foreseeable, material risks of harm to the patient.

(a), (b)(4) Compliance generally.--The criteria for the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must comply with this chapter and applicable Federal and State law. (4) The use of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be disclosed in accordance with section 3502 (relating to disclosure).

(a)–(b) 8 Compliance statement required.--A facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 using artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 for clinical decision makingClinical decision making"Clinical decision making." A patient-centered problem-solving process focused on a health care provider's direct patient care involving gathering information, diagnosing and planning treatments.35 Pa.C.S. § 3501 shall annually file with the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 in the form and manner prescribed by the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 an artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statement. (b) Contents.--Each compliance statement must: (1) Summarize the function and scope of artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 used for clinical decision makingClinical decision making"Clinical decision making." A patient-centered problem-solving process focused on a health care provider's direct patient care involving gathering information, diagnosing and planning treatments.35 Pa.C.S. § 3501. (2) Provide a logic or decision tree of artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 used for clinical decision makingClinical decision making"Clinical decision making." A patient-centered problem-solving process focused on a health care provider's direct patient care involving gathering information, diagnosing and planning treatments.35 Pa.C.S. § 3501. (3) Provide a description of each training data set used by artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 for clinical decision makingClinical decision making"Clinical decision making." A patient-centered problem-solving process focused on a health care provider's direct patient care involving gathering information, diagnosing and planning treatments.35 Pa.C.S. § 3501, including the source of the data. (4) Attest that the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 and the training data sets comply with section 3503 (relating to responsible use) and provide evidence of the compliance. (5) Describe the process of the facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 for overseeing and validating the performance and compliance of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 in accordance with section 3503.

(a)–(b) Annual report required.--No later than one year after the effective date of this chapter and each year thereafter, the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall compile the information from the most recent annual compliance statements under section 3504 (relating to artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statements) and issue a report containing the compiled information, along with any other applicable findings and recommendations. The information in the report shall be aggregated and deidentified. (b) Posting.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall post each report under this section on the publicly accessible Internet website of the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501.

9 The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall establish a record retention policy and determine the amount of time a facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 shall retain records related to artificial-intelligence algorithms. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from facilities and health care providersHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 or their representatives in making the determination under this section.

10 The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request additional information and evidence from a facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 regarding the items provided under sections 3502 (relating to disclosure), 3503 (relating to responsible use) and 3504 (relating to artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statements) that are necessary to ensure compliance with this chapter.

11 A contractor, subcontractor or other third-party vendor that sells, leases, subscribes or otherwise supplies artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 or services based on artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 to the facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 shall be subject to this chapter. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall develop regulations or guidance regarding the responsibility of a contractor, subcontractor or other third-party vendor that sells, leases, subscribes or otherwise supplies artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 or services based on artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 to the facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from facilities, third-party vendors and health care providersHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 or their representatives in making this determination.

This chapter shall not apply to validated, static decision-support tools or tools used for administration, scheduling, scribe applications or clinical calculators.

(a)–(c) Civil penalties.-- (1) Subject to paragraph (2), the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may impose a civil penalty not exceeding $5,000 for a violation of this chapter. For purposes of this paragraph, each instance of nondisclosure shall constitute a separate violation of this chapter. (2) The following apply to limitations on civil penalties under this subsection: (i) A civil penalty imposed against a facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 may not exceed $500,000 in the aggregate during a single calendar year. (ii) A civil penalty imposed against any other person may not exceed $100,000 in the aggregate during a single calendar year. (b) Injunction.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may maintain an action in the name of the Commonwealth for an injunction to prohibit any activity that violates the provisions of this chapter. (c) Nonexclusive remedies.--The enforcement remedies and penalties imposed under this chapter are in addition to any other remedies or penalties that may be imposed under any other applicable law of this Commonwealth, including the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act.

(a)–(c) Authorization.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may require a facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 to develop and adhere to a plan of correction approved by the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may impose a plan of correction in lieu of fines. (b) Compliance.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall monitor compliance with the plan of correction under this section. (c) Availability.--The plan of correction shall, upon request, be made available to patients of the facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501.

(a)–(b) Applicable procedures.--This chapter shall be subject to 2 Pa.C.S. Ch. 5 Subch. A (relating to practice and procedure of Commonwealth agencies). (b) Appeal.--A party against whom penalties are assessed in an administrative action may appeal to Commonwealth Court as provided in 2 Pa.C.S. Ch. 7 Subch. A (relating to judicial review of Commonwealth agency action).

The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall promulgate regulations or guidance necessary to implement, administer and enforce this chapter. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall review regulations or guidance every three years to ensure compliance with Federal law or Federal agency guidance.

The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise: "Artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501. "Artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501." The programming and data sets that inform an artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 system. "Covered personCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201." A policyholder, subscriber or other individual who is entitled to receive health care servicesHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201 under a health insurance policyHealth insurance policy"Health insurance policy." As follows: (1) A policy, subscriber contract, certificate or plan issued by an insurer that provides medical or health care coverage. (2) The term does not include: (i) An accident only policy. (ii) A credit only policy. (iii) A long-term care or disability income policy. (iv) A specified disease policy. (v) A Medicare supplement policy. (vi) A TRICARE policy, including a Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) supplement policy. (vii) A fixed indemnity policy. (viii) A hospital indemnity policy. (ix) A workers' compensation policy. (x) An automobile medical payment policy under 75 Pa.C.S. (relating to vehicles). (xi) A homeowner's insurance policy.40 Pa.C.S. § 5201. "DepartmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501." The Insurance Department of the Commonwealth. "Health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501." As follows: (1) A facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 or individual who is licensed, certified or otherwise regulated to provide health care servicesHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201 under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in 35 Pa.C.S. § 8103 (relating to definitions). "Health care serviceHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 to a covered personCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201 for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policyHealth insurance policy"Health insurance policy." As follows: (1) A policy, subscriber contract, certificate or plan issued by an insurer that provides medical or health care coverage. (2) The term does not include: (i) An accident only policy. (ii) A credit only policy. (iii) A long-term care or disability income policy. (iv) A specified disease policy. (v) A Medicare supplement policy. (vi) A TRICARE policy, including a Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) supplement policy. (vii) A fixed indemnity policy. (viii) A hospital indemnity policy. (ix) A workers' compensation policy. (x) An automobile medical payment policy under 75 Pa.C.S. (relating to vehicles). (xi) A homeowner's insurance policy.40 Pa.C.S. § 5201. "Health insurance policyHealth insurance policy"Health insurance policy." As follows: (1) A policy, subscriber contract, certificate or plan issued by an insurer that provides medical or health care coverage. (2) The term does not include: (i) An accident only policy. (ii) A credit only policy. (iii) A long-term care or disability income policy. (iv) A specified disease policy. (v) A Medicare supplement policy. (vi) A TRICARE policy, including a Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) supplement policy. (vii) A fixed indemnity policy. (viii) A hospital indemnity policy. (ix) A workers' compensation policy. (x) An automobile medical payment policy under 75 Pa.C.S. (relating to vehicles). (xi) A homeowner's insurance policy.40 Pa.C.S. § 5201." As follows: (1) A policy, subscriber contract, certificate or plan issued by an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 that provides medical or health care coverage. (2) The term does not include: (i) An accident only policy. (ii) A credit only policy. (iii) A long-term care or disability income policy. (iv) A specified disease policy. (v) A Medicare supplement policy. (vi) A TRICARE policy, including a Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) supplement policy. (vii) A fixed indemnity policy. (viii) A hospital indemnity policy. (ix) A workers' compensation policy. (x) An automobile medical payment policy under 75 Pa.C.S. (relating to vehicles). (xi) A homeowner's insurance policy. "InsurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201." As follows: (1) An entity licensed by the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 that offers, issues or renews an individual or group health insurance policyHealth insurance policy"Health insurance policy." As follows: (1) A policy, subscriber contract, certificate or plan issued by an insurer that provides medical or health care coverage. (2) The term does not include: (i) An accident only policy. (ii) A credit only policy. (iii) A long-term care or disability income policy. (iv) A specified disease policy. (v) A Medicare supplement policy. (vi) A TRICARE policy, including a Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) supplement policy. (vii) A fixed indemnity policy. (viii) A hospital indemnity policy. (ix) A workers' compensation policy. (x) An automobile medical payment policy under 75 Pa.C.S. (relating to vehicles). (xi) A homeowner's insurance policy.40 Pa.C.S. § 5201 that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301. "Participating network providerParticipating network provider"Participating network provider." A health care provider that has entered into a contractual or operating relationship with an insurer to participate in one or more designated networks of the insurer and to provide health care services to covered persons under the terms of the insurer's administrative policy.40 Pa.C.S. § 5201." A health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 that has entered into a contractual or operating relationship with an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 to participate in one or more designated networks of the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 and to provide health care servicesHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201 to covered personsCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201 under the terms of the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201's administrative policy. "Prior authorization requestPrior authorization request"Prior authorization request." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201." As defined under section 2102 of The Insurance Company Law of 1921. "Utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201." As defined under section 2102 of The Insurance Company Law of 1921.

(a)–(b) 12 Duty to disclose.--An insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 shall disclose to a participating network providerParticipating network provider"Participating network provider." A health care provider that has entered into a contractual or operating relationship with an insurer to participate in one or more designated networks of the insurer and to provide health care services to covered persons under the terms of the insurer's administrative policy.40 Pa.C.S. § 5201 and all covered personsCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201 if artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 are or will be used in the utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201 process of the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201. (b) Posting.--An insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 shall post the information about the use of artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 in the utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201 process of the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 on the publicly accessible Internet website of the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201.

(c) Nature and frequency.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall determine the nature and frequency of disclosure requirements to covered personsCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from insurersInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 or their representatives in making this determination.

(b)(1)–(2) 13 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must base a determination on all of the following: (i) The medical or other clinical history of the covered personCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201. (ii) Individual clinical or nonclinical circumstances as presented by the requesting health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501. (iii) Other relevant clinical or nonclinical information contained in the medical or other clinical record of the covered personCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201. (2) The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must not base a determination solely on a group data set.

(b)(3) 14 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must not supersede decision making of the health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 conducting the utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201.

(b)(4)–(5) 15 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 and training data sets must not directly or indirectly discriminate against covered personsCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201 in violation of Federal or State law. (5) The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be fairly and equitably applied, including in accordance with any applicable regulations or guidance issued by the United States Department of Health and Human Services.

(b)(7) 16 The performance, use and outcomes of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be periodically reviewed and revised to maximize accuracy and reliability.

(b)(8) 17 The data of the covered personCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201 must not be used beyond the intended and stated purpose of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501, consistent with Commonwealth law and 42 U.S.C. Ch. 7, Subch. XI Part C (relating to administrative simplification), as applicable.

(b)(9) 18 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must not create foreseeable, material risks of harm to the covered personCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201.

(a), (b)(6) Compliance generally.--The criteria for the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must comply with this chapter and applicable Federal and State law. (6) The use of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be disclosed in accordance with section 5202 (relating to disclosure).

(a)–(b) 19 Compliance statement required.--An insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 using artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 in the utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201 process shall annually file with the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 in the form and manner prescribed by the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 an artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statement. (b) Contents.--Each compliance statement must: (1) Summarize the function and scope of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 used for utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201. (2) Provide a logic or decision tree of artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 used for utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201. (3) Provide a description of each training data set used by artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 for utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201, including the source of the data. (4) Attest that the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 and the training data sets comply with section 5203 (relating to responsible use) and provide evidence of the compliance. (5) Describe the process of the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 for overseeing and validating the performance and compliance of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 in accordance with section 5203.

20 Prior to issuing or upholding a decision to deny, reduce or terminate benefits for a health care serviceHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201, including a decision to deny a prior authorization requestPrior authorization request"Prior authorization request." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201, a health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 who participates in utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201 on behalf of an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 shall: (1) Review individual clinical records and other relevant information. (2) Document the review under paragraph (1). (3) Based on the review under paragraph (1), exercise judgment independent of any recommendations by the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501.

(a)–(b) Annual report required.--No later than one year after the effective date of this chapter, and annually thereafter, the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall compile the information from the most recent annual compliance statements under section 5204 (relating to artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statements) and issue a report to the General Assembly containing the compiled information, along with any other applicable findings and recommendations. The information in the report shall be aggregated and deidentified. (b) Posting.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall post each report under this section on the publicly accessible Internet website of the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501.

21 The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall establish a record retention policy and determine the amount of time an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 shall retain records. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from insurersInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 or their representatives in making this determination.

22 The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request additional information and evidence from an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 regarding the items provided under sections 5202 (relating to disclosure), 5203 (relating to responsible use) and 5204 (relating to artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statements) that are necessary to ensure compliance with this chapter.

23 A contractor, subcontractor or other third-party vendor that sells, leases, subscribes or otherwise supplies artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 or services based on artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 to the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 services shall be subject to this chapter. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall develop regulations or guidelines regarding the responsibility of a contractor, subcontractor or other third-party vendor that sells, leases, subscribes or otherwise supplies artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 or services based on artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 to the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from insurersInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201, third-party vendors and health care providersHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 or their representatives in making this determination.

This chapter shall not apply to artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 used for administrative, scheduling or other purposes not pertaining to the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201's decision to deny, reduce or terminate benefits.

(a)–(e) Civil penalties.-- (1) Subject to paragraph (2), the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may impose a civil penalty not exceeding $5,000 for a violation of this chapter. For purposes of this paragraph, each instance of nondisclosure shall constitute a separate violation of this chapter. (2) The following apply to limitations on civil penalties under this subsection: (i) A civil penalty imposed against an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 may not exceed $500,000 in the aggregate during a single calendar year. (ii) A civil penalty imposed against any other person may not exceed $100,000 in the aggregate during a single calendar year. (b) Unfair Insurance Practices Act.-- (1) An insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 shall be subject to the act of July 22, 1974 (P.L.589, No.205), known as the Unfair Insurance Practices Act. (2) A violation of any provision of this chapter shall be deemed to be a violation of the Unfair Insurance Practices Act. (c) Injunction.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may maintain an action in the name of the Commonwealth for an injunction to prohibit any activity that violates the provisions of this chapter. (d) Effect on enrollment.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may issue an order temporarily prohibiting an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 that violates this chapter from enrolling new covered personsCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201. (e) Nonexclusive remedies.--The enforcement remedies and penalties imposed under this chapter are in addition to any other remedies or penalties that may be imposed under any other applicable law of this Commonwealth, including: (1) The Unfair Insurance Practices Act. (2) The act of December 18, 1996 (P.L.1066, No.159), known as the Accident and Health Filing Reform Act. (3) The act of June 25, 1997 (P.L.295, No.29), known as the Pennsylvania Health Care Insurance Portability Act.

(a)–(c) Authorization.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may require an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 to develop and adhere to a plan of correction approved by the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may impose a plan of correction in lieu of fines. (b) Compliance.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall monitor compliance with the plan of correction under this section. (c) Availability.--The plan of correction shall, upon request, be made available to covered persons of the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201.

(a)–(b) Applicable procedures.--This chapter shall be subject to 2 Pa.C.S. Ch. 5 Subch. A (relating to practice and procedure of Commonwealth agencies). (b) Appeal.--A party against whom penalties are assessed in an administrative action may appeal to Commonwealth Court as provided in 2 Pa.C.S. Ch. 7 Subch. A (relating to judicial review of Commonwealth agency action).

The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall promulgate regulations or guidance necessary to implement, administer and enforce this chapter. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall review regulations or guidance every three years to ensure compliance with Federal law or Federal agency guidance.

The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise: "Agreement with the departmentAgreement with the department"Agreement with the department." As follows: (1) An agreement between an MA or CHIP managed care plan and the department to manage the purchase and provision of services. (2) The term includes a county or multicounty agreement with the department for behavioral health services.40 Pa.C.S. § 5301." As follows: (1) An agreement between an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 and the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 to manage the purchase and provision of services. (2) The term includes a county or multicounty agreement with the departmentAgreement with the department"Agreement with the department." As follows: (1) An agreement between an MA or CHIP managed care plan and the department to manage the purchase and provision of services. (2) The term includes a county or multicounty agreement with the department for behavioral health services.40 Pa.C.S. § 5301 for behavioral health services. "Artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501. "Artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501." The programming and data sets that inform an artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 system. "DepartmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501." The Department of Human Services of the Commonwealth. "EnrolleeEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301." An individual who is entitled to receive health care servicesHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201 under an agreement with the departmentAgreement with the department"Agreement with the department." As follows: (1) An agreement between an MA or CHIP managed care plan and the department to manage the purchase and provision of services. (2) The term includes a county or multicounty agreement with the department for behavioral health services.40 Pa.C.S. § 5301. "FacilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501." A health care setting or institution providing health care servicesHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501. (6) A facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 licensed by the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501's Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501. (8) A health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner. "Health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501." As follows: (1) A facilityFacility"Facility." A health care setting or institution providing health care services, including: (1) A general, special, psychiatric or rehabilitation hospital. (2) An ambulatory surgical facility. (3) A cancer treatment center. (4) A birth center. (5) An inpatient, outpatient or residential drug and alcohol treatment facility. (6) A facility licensed by the Department of Human Services' Office of Mental Health and Substance Abuse Services. (7) A laboratory, imaging, diagnostic or other outpatient medical service or testing facility. (8) A health care provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner.35 Pa.C.S. § 3501 or individual who is licensed, certified or otherwise regulated to provide health care servicesHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201 under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in 35 Pa.C.S. § 8103 (relating to definitions). "Health care serviceHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 to a covered personCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201 for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policyHealth insurance policy"Health insurance policy." As follows: (1) A policy, subscriber contract, certificate or plan issued by an insurer that provides medical or health care coverage. (2) The term does not include: (i) An accident only policy. (ii) A credit only policy. (iii) A long-term care or disability income policy. (iv) A specified disease policy. (v) A Medicare supplement policy. (vi) A TRICARE policy, including a Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) supplement policy. (vii) A fixed indemnity policy. (viii) A hospital indemnity policy. (ix) A workers' compensation policy. (x) An automobile medical payment policy under 75 Pa.C.S. (relating to vehicles). (xi) A homeowner's insurance policy.40 Pa.C.S. § 5201 or agreement with the departmentAgreement with the department"Agreement with the department." As follows: (1) An agreement between an MA or CHIP managed care plan and the department to manage the purchase and provision of services. (2) The term includes a county or multicounty agreement with the department for behavioral health services.40 Pa.C.S. § 5301. "Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921. "Participating network providerParticipating network provider"Participating network provider." A health care provider that has entered into a contractual or operating relationship with an insurer to participate in one or more designated networks of the insurer and to provide health care services to covered persons under the terms of the insurer's administrative policy.40 Pa.C.S. § 5201." A health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 that has entered into a contractual or operating relationship with an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 to participate in one or more designated networks of the MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 and to provide health care servicesHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201 to enrolleesEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301 under the terms of the or an agreement with the departmentAgreement with the department"Agreement with the department." As follows: (1) An agreement between an MA or CHIP managed care plan and the department to manage the purchase and provision of services. (2) The term includes a county or multicounty agreement with the department for behavioral health services.40 Pa.C.S. § 5301. "Prior authorization requestPrior authorization request"Prior authorization request." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201." As defined under section 2102 of The Insurance Company Law of 1921. "Utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201." As defined under section 2102 of The Insurance Company Law of 1921.

(a)–(b) 24 Duty to disclose.--An MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 shall disclose to a participating network providerParticipating network provider"Participating network provider." A health care provider that has entered into a contractual or operating relationship with an insurer to participate in one or more designated networks of the insurer and to provide health care services to covered persons under the terms of the insurer's administrative policy.40 Pa.C.S. § 5201 and all enrolleesEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301 if artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 are or will be used in the utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201 process of the MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301. (b) Posting.--An MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 shall post the information about the use of artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 in the utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201 process of the MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 on the publicly accessible Internet website of the MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301.

(c) Nature and frequency.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall determine the nature and frequency of disclosure requirements to enrolleesEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from MA or CHIP managed care plansMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 or their representatives in making this determination.

(b)(1)–(2) 25 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must base a determination on all of the following: (i) The medical or other clinical history of the enrolleeEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301. (ii) Individual clinical or nonclinical circumstances as presented by the requesting health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501. (iii) Other relevant clinical or nonclinical information contained in the medical or other clinical record of the enrolleeEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301. (2) The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must not base a determination solely on a group data set.

(b)(3) 26 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must not supersede decision making of the health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 conducting the utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201.

(b)(4)–(5) 27 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 and training data sets must not directly or indirectly discriminate against the enrolleesEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301 in violation of Federal or State law. (5) The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be fairly and equitably applied, including in accordance with any applicable regulations and guidance issued by the United States Department of Health and Human Services.

(b)(7) 28 The performance, use and outcomes of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be periodically reviewed and revised to maximize accuracy and reliability.

(b)(8) 29 The data of the covered personCovered person"Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy.40 Pa.C.S. § 5201 or enrolleesEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301 must not be used beyond the intended and stated purpose of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501, consistent with the laws of this Commonwealth and the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191, 110 Stat. 1936), as applicable.

(b)(9) 30 The artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must not create foreseeable, material risks of harm to the enrolleeEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301.

(a), (b)(6) Compliance generally.--The criteria for the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must comply with this chapter and applicable Federal and State law. (6) The use of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 must be disclosed in accordance with section 5302 (relating to disclosure).

(a)–(b) 31 Compliance statement required.--An MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 using artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 in the utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201 process shall annually file with the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501, in the form and manner prescribed by the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501, an artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statement. (b) Contents.--Each compliance statement must: (1) Summarize the function and scope of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 used for utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201. (2) Provide a logic or decision tree of artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 used for utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201. (3) Provide a description of each training data set used by artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 for utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201, including the source of the data. (4) Attest that the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 and the training data sets comply with section 5303 (relating to responsible use) and provide evidence of the compliance. (5) Describe the process of the MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 for overseeing and validating the performance and compliance of the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 in accordance with section 5303.

32 Prior to issuing or upholding a decision to deny, reduce or terminate benefits for a health care serviceHealth care service"Health care service." Any covered treatment, admission, procedure or other services, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to a covered person for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease under the terms of a health insurance policy.40 Pa.C.S. § 5201, including a decision to deny a prior authorization requestPrior authorization request"Prior authorization request." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201, a health care providerHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 who participates in utilization reviewUtilization review"Utilization review." As defined under section 2102 of The Insurance Company Law of 1921.40 Pa.C.S. § 5201 on behalf of an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 shall: (1) Review individual clinical records and other relevant information. (2) Document the review under paragraph (1). (3) Based on the review under paragraph (1), exercise judgment independent of any recommendations by the artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501.

(a)–(b) Annual report required.--No later than one year after the effective date of this chapter, and annually thereafter, the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall compile the information from the most recent annual compliance statements under section 5304 (relating to artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statements) and issue a report to the General Assembly containing the compiled information, along with any other applicable findings and recommendations. The information in the report shall be aggregated and deidentified. (b) Posting.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall post each report under this section on the publicly accessible Internet website of the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501.

33 The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall establish a record retention policy and determine the amount of time an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 shall retain records. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 or their representative to make this determination.

34 The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request additional information and evidence from an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 regarding the items provided under section 5302 (relating to disclosure), 5303 (relating to responsible use) and 5304 (relating to artificial intelligenceArtificial intelligence"Artificial intelligence" or "AI." A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments that use machine-based and human-based inputs to perceive real and virtual environments, abstract the perceptions into models through analysis in an automated manner and use model inference to formulate options for information or action. The term includes generative artificial intelligence which is the class of models that emulate the structure and characteristics of input data in order to generate derived synthetic content which includes information such as images, videos, audio clips and text that has been significantly modified or generated by algorithms, including by artificial intelligence.35 Pa.C.S. § 3501 compliance statements) that are necessary to ensure compliance with this chapter.

35 A contractor, subcontractor or other third-party vendor that sells, leases, subscribes or otherwise supplies artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 or services based on artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 to the MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 shall be subject to this chapter. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall develop regulations or guidelines regarding the responsibility of a contractor, subcontractor or other third-party vendor that sells, leases, subscribes or otherwise supplies artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 or services based on artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 to the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 or MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may request input from insurersInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201, third-party vendors and health care providersHealth care provider"Health care provider." As follows: (1) A facility or individual who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth. (2) The term does not include an individual providing emergency services under a licensed emergency medical services agency as defined in section 8103 (relating to definitions).35 Pa.C.S. § 3501 or their representatives in making this determination.

This chapter shall not apply to artificial intelligence-based algorithmsArtificial intelligence-based algorithms"Artificial intelligence-based algorithms." The programming and data sets that inform an artificial intelligence system.35 Pa.C.S. § 3501 used for administrative, scheduling or other purposes not pertaining to the decision to deny, reduce or terminate benefits.

(a)–(d) Civil penalties.-- (1) Subject to paragraph (2), the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may impose a civil penalty not exceeding $5,000 for a violation of this chapter. For purposes of this paragraph, each instance of nondisclosure shall constitute a separate violation of this chapter. (2) The following apply to limitations on civil penalties under this subsection: (i) A civil penalty imposed against an insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 may not exceed $500,000 in the aggregate during a single calendar year. (ii) A civil penalty imposed against any other person may not exceed $100,000 in the aggregate during a single calendar year. (b) Unfair Insurance Practices Act.-- (1) An MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 shall be subject to the act of July 22, 1974 (P.L.589, No.205), known as the Unfair Insurance Practices Act. (2) A violation of any provision of this chapter shall be deemed to be a violation of the Unfair Insurance Practices Act. (c) Injunction.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may maintain an action in the name of the Commonwealth for an injunction to prohibit any activity that violates the provisions of this chapter. (d) Effect on enrollment.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may issue an order temporarily prohibiting an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 that violates this chapter from enrolling new enrolleesEnrollee"Enrollee." An individual who is entitled to receive health care services under an agreement with the department.40 Pa.C.S. § 5301.

(a)–(c) Authorization.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may require an MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301 to develop and adhere to a plan of correction approved by the departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 may impose a plan of correction in lieu of fines. (b) Compliance.--The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall monitor compliance with the plan of correction under this section. (c) Availability.--The plan of correction shall, upon request, be made available to enrollees of the insurerInsurer"Insurer." As follows: (1) An entity licensed by the department that offers, issues or renews an individual or group health insurance policy that is offered or governed under any of the following: (i) Chapter 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). (ii) The act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, including section 630 and Article XXIV thereof. (iii) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (2) The term does not include an entity operating as an MA or CHIP managed care plan.40 Pa.C.S. § 5201 or MA or CHIP managed care planMA or CHIP managed care plan"Medical Assistance or Children's Health Insurance Program managed care plan" or "MA or CHIP managed care plan." As defined under section 2102 of the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921.40 Pa.C.S. § 5301.

(a)–(b) Applicable procedures.--This chapter shall be subject to 2 Pa.C.S. Ch. 5 Subch. A (relating to practice and procedure of Commonwealth agencies). (b) Appeal.--A party against whom penalties are assessed in an administrative action may appeal to Commonwealth Court as provided in 2 Pa.C.S. Ch. 7 Subch. A (relating to judicial review of Commonwealth agency action).

The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall promulgate regulations or guidance necessary to implement, administer and enforce this chapter. The departmentDepartment"Department." The Department of Health of the Commonwealth.35 Pa.C.S. § 3501 shall review regulations or guidance every three years to ensure compliance with Federal law or Federal agency guidance.