WHAT THIS BILL REGULATES · 6 REQUIREMENT TYPES
How Is This Bill Enforced
Verbatim statutory text on the left; plain-language analysis and a per-section checklist on the right. Numbered markers cross-link to the matching checklist row.
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. "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." A patient-centered problem-solving process focused on a health care provider's direct patient care involving gathering information, diagnosing and planning treatments. "Department." The Department of Health of the Commonwealth. "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 services, 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 Department of Human Services' 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 provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner. "Health care provider." 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 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).
Section 3501 defines key terms for Chapter 35, including artificial intelligence, artificial-intelligence-based algorithms, clinical decision making, facility, and health care provider. The facility definition is broad, encompassing hospitals, ambulatory surgical facilities, cancer treatment centers, birth centers, substance abuse treatment facilities, laboratories, and physician offices. Emergency medical services personnel are carved out of the health care provider definition.
(a) 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 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 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 provider 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 provider.
(c) The department shall determine the nature and frequency of disclosure requirements to the patient. The department may request input from facilities and health care providers or their representatives in making the determination.
Section 3502 imposes two distinct disclosure obligations on facilities. Subsection (a) requires disclosure to patients when AI-based algorithms are used for clinical decision making, both in written communications and on the facility's website. Subsection (b) requires that AI-generated patient communications pertaining to clinical information carry a clear disclaimer identifying AI authorship and instructions for contacting a human provider, with carve-outs for purely administrative communications and communications individually reviewed by a human provider.
Subsection (c) delegates to the Department of Health the authority to determine the nature and frequency of disclosures.
(a) 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.
(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 provider 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)(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).
(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.
Section 3503 establishes the core responsible-use requirements for AI-based algorithms used in facility clinical decision making. The section imposes seven distinct operational requirements: (1) AI must not supersede provider clinical judgment; (2) AI and training data must not discriminate; (3) AI must be fairly and equitably applied consistent with HHS guidance; (4) AI use must be disclosed per § 3502; (5) AI performance must be periodically reviewed for accuracy and reliability; (6) patient data must not be used beyond the AI system's stated purpose, consistent with HIPAA; and (7) AI must not create foreseeable, material risks of harm.
(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 department in the form and manner prescribed by the department 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.--A 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.
Section 3504 requires facilities using AI for clinical decision making to annually file a compliance statement with the Department of Health. The statement must include a summary of AI function and scope, a logic or decision tree, a description of each training data set and its source, an attestation of compliance with the responsible-use requirements of § 3503, and a description of the facility's oversight and validation process.
(a)–(b) Annual report required.--No later than one year after the effective date of this subsection and each year thereafter, the department 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 department shall post each report under this section on the publicly accessible Internet website of the department.
Section 3505 directs the Department of Health to compile information from facility compliance statements into an annual aggregated and de-identified report and to post it on the department's website. This is a government reporting obligation, not a direct obligation on facilities.
9 The department 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 department may request input from facilities and health care providers or their representatives in making the determination under this section.
Section 3506 directs the Department of Health to establish a record retention policy specifying how long facilities must retain AI-related records. The specific retention period is deferred to future rulemaking.
10 The department 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.
Section 3507 authorizes the Department of Health to request additional information and evidence from facilities regarding disclosure, responsible use, and compliance statements to ensure chapter compliance. This is a regulatory oversight power, not an affirmative obligation on facilities beyond responding to requests.
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 department 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 department may request input from facilities, third-party vendors and health care providers or their representatives in making this determination.
Section 3508 extends all Chapter 35 obligations to third-party vendors — contractors, subcontractors, and other vendors that sell, lease, subscribe, or otherwise supply AI-based algorithms or AI-based services to facilities. The department will develop regulations regarding third-party vendor responsibilities.
This chapter shall not apply to validated, static decision-support tools or tools used for administration, scheduling, scribe applications or clinical calculators.
Section 3509 exempts validated, static decision-support tools, administration tools, scheduling tools, scribe applications, and clinical calculators from Chapter 35's requirements.
(a)–(c) Civil penalties.-- (1) Subject to paragraph (2), the department 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 department 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.
Section 3510 establishes the enforcement framework for Chapter 35. The Department of Health may impose civil penalties of up to $5,000 per violation, with each nondisclosure constituting a separate violation. Aggregate annual caps are $500,000 for facilities and $100,000 for other persons. The department may also seek injunctive relief. Remedies are nonexclusive and supplement penalties under other law including the Health Care Facilities Act.
(a)–(c) Authorization.--The department 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 department. The department may impose a plan of correction in lieu of fines. (b) Compliance.--The department 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.
Section 3511 authorizes the Department of Health to require a facility to develop and adhere to a plan of correction, potentially in lieu of fines. The department monitors compliance with the plan, and the plan must be made available to patients upon request.
(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).
Section 3512 subjects Chapter 35 proceedings to the Commonwealth Agencies Practice and Procedure Act and provides for appeal of penalty assessments to Commonwealth Court.
The department shall promulgate regulations or guidance necessary to implement, administer and enforce this chapter. The department shall review regulations or guidance every three years to ensure compliance with Federal law or Federal agency guidance.
Section 3513 directs the Department of Health to promulgate implementing regulations, with a mandatory three-year review cycle to ensure alignment with federal law and 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 services 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. "Department." The Insurance Department of the Commonwealth. "Health care provider." 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 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 35 Pa.C.S. § 8103 (relating to definitions). "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 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 department 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 provider." A health care provider 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 services 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.
Section 5201 defines key terms for Chapter 52, which governs AI use by health insurers. Key terms include artificial intelligence, AI-based algorithms, covered person, insurer, health care service, health insurance policy, participating network provider, prior authorization request, and utilization review. The insurer definition is broad, covering entities licensed by the Insurance Department that issue health insurance policies, but explicitly excluding MA or CHIP managed care plans.
(a)–(b) 12 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.--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 provider 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) The department 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 department 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.
Section 5202 requires insurers to disclose to participating network providers and all covered persons when AI-based algorithms are or will be used in the insurer's utilization review process. The disclosure must also be posted on the insurer's public website. The Insurance Department determines the nature and frequency of disclosure requirements.
(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 provider. (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 provider 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)(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).
(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.
Section 5203 establishes responsible-use requirements for insurer AI in utilization review. It contains nine requirements paralleling the facility chapter but with additions specific to the insurance context: AI must base determinations on the covered person's individual medical history, individual clinical circumstances, and relevant clinical record data; AI must not base determinations solely on group data sets; AI must not supersede the reviewing health care provider's decision making; AI must not discriminate; AI must be fairly applied per HHS guidance; use must be disclosed; performance must be periodically reviewed; data must not be used beyond stated purposes; and AI must not create foreseeable material risks of harm.
(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 department in the form and manner prescribed by the department 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.--A 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.
Section 5204 requires insurers using AI in utilization review to annually file a compliance statement with the Insurance Department, paralleling the facility requirement in § 3504. Contents are identical: function/scope summary, logic or decision tree, training data descriptions, attestation of compliance, and a description of the insurer's oversight process.
20 Prior to issuing or upholding a decision to deny, reduce or terminate benefits for a health care service, 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 provider 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.
Section 5205 imposes obligations on health care providers participating in utilization review on behalf of insurers. Before issuing or upholding an adverse benefit decision (including denial of a prior authorization request), the provider must review individual clinical records, document the review, and exercise judgment independent of AI recommendations.
(a)–(b) Annual report required.--No later than one year after the effective date of this subsection, and annually thereafter, the department 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 department shall post each report under this section on the publicly accessible Internet website of the department.
Section 5206 directs the Insurance Department to compile annual compliance statement data into an aggregated, de-identified report to the General Assembly and post it on the department's website. This is a government reporting duty.
21 The department 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 department 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.
Section 5207 directs the Insurance Department to establish a record retention policy for insurers, paralleling § 3506 for facilities.
22 The department 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.
Section 5208 authorizes the Insurance Department to request additional information and evidence from insurers regarding disclosure, responsible use, and compliance statements to ensure chapter compliance.
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 department 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 department 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 providers or their representatives in making this determination.
Section 5209 extends all Chapter 52 obligations to third-party vendors supplying AI-based algorithms or services to insurers, paralleling § 3508 for facilities.
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.
Section 5210 exempts AI-based algorithms used for administrative, scheduling, or other purposes not pertaining to benefit denial, reduction, or termination decisions from Chapter 52's requirements.
(a)–(e) Civil penalties.-- (1) Subject to paragraph (2), the department 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 department 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 department 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.
Section 5211 establishes the enforcement framework for Chapter 52. Civil penalties of up to $5,000 per violation apply, with aggregate annual caps of $500,000 for insurers and $100,000 for other persons. Violations are deemed violations of the Unfair Insurance Practices Act. The department may seek injunctive relief and may temporarily prohibit violating insurers from enrolling new covered persons. Remedies are nonexclusive.
(a)–(c) Authorization.--The department 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 department. The department may impose a plan of correction in lieu of fines. (b) Compliance.--The department 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.
Section 5212 authorizes the Insurance Department to require an insurer to develop and adhere to a plan of correction, potentially in lieu of fines. The plan must be made available to covered persons upon request.
(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).
Section 5213 subjects Chapter 52 proceedings to the Commonwealth Agencies Practice and Procedure Act and provides for appeal of penalty assessments to Commonwealth Court.
The department shall promulgate regulations or guidance necessary to implement, administer and enforce this chapter. The department shall review regulations or guidance every three years to ensure compliance with Federal law or Federal agency guidance.
Section 5214 directs the Insurance Department to promulgate implementing regulations, with a mandatory three-year review cycle for federal law alignment.
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 department." 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 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. "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. "Department." 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 services under an agreement with the department. "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 services, 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 department'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 provider office or clinic that is owned by or employs a Commonwealth-licensed physician, physician assistant or nurse practitioner. "Health care provider." 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 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 35 Pa.C.S. § 8103 (relating to definitions). "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 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 department. "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 provider." A health care provider 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 services 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 department. "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.
Section 5301 defines key terms for Chapter 53, governing AI use by Medical Assistance or Children's Health Insurance Program managed care plans. Definitions parallel Chapters 35 and 52, with the addition of terms specific to the managed care context: agreement with the department, enrollee, and MA or CHIP managed care plan. The supervising department is the Department of Human Services.
(a)–(b) 24 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.--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 provider 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) The department 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 department 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.
Section 5302 requires MA or CHIP managed care plans to disclose to participating network providers and all enrollees when AI-based algorithms are or will be used in the plan's utilization review process. The disclosure must also be posted on the plan's public website.
(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 provider. (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 provider 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)(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).
(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.
Section 5303 establishes responsible-use requirements for AI used in utilization review by MA or CHIP managed care plans, mirroring § 5203 for insurers. All nine requirements are substantively identical: individualized data basis, no sole reliance on group data sets, no superseding provider judgment, nondiscrimination, equitable application, disclosure, periodic review, data use limitation, and no foreseeable material harm.
(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 department, in the form and manner prescribed by the department, 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.--A 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.
Section 5304 requires MA or CHIP managed care plans using AI in utilization review to annually file a compliance statement with the Department of Human Services, paralleling §§ 3504 and 5204.
32 Prior to issuing or upholding a decision to deny, reduce or terminate benefits for a health care service, 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 provider 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.
Section 5305 imposes obligations on health care providers participating in utilization review on behalf of MA or CHIP managed care plans, identical to § 5205 for insurers. Before issuing or upholding an adverse benefit decision, the provider must review individual clinical records, document the review, and exercise independent judgment.
(a)–(b) Annual report required.--No later than one year after the effective date of this subsection, and annually thereafter, the department 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 department shall post each report under this section on the publicly accessible Internet website of the department.
Section 5306 directs the Department of Human Services to compile annual compliance statement data into an aggregated, de-identified report to the General Assembly and post it on the department's website.
33 The department 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 department 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.
Section 5307 directs the Department of Human Services to establish a record retention policy for MA or CHIP managed care plans.
34 The department 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.
Section 5308 authorizes the Department of Human Services to request additional information and evidence from MA or CHIP managed care plans to ensure chapter compliance.
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 department 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 department 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 providers or their representatives in making this determination.
Section 5309 extends all Chapter 53 obligations to third-party vendors supplying AI-based algorithms or services to MA or CHIP managed care plans.
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.
Section 5310 exempts AI-based algorithms used for administrative, scheduling, or other purposes not pertaining to benefit denial, reduction, or termination decisions from Chapter 53.
(a)–(d) Civil penalties.-- (1) Subject to paragraph (2), the department 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 department 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 department 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.
Section 5311 establishes the enforcement framework for Chapter 53, paralleling § 5211. Civil penalties of up to $5,000 per violation, aggregate annual caps, Unfair Insurance Practices Act applicability, injunctive relief, and temporary enrollment prohibition are all available.
(a)–(c) Authorization.--The department 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 department. The department may impose a plan of correction in lieu of fines. (b) Compliance.--The department 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.
Section 5312 authorizes the Department of Human Services to require an MA or CHIP managed care plan to develop and adhere to a plan of correction, potentially in lieu of fines. The plan must be made available to enrollees upon request.
(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).
Section 5313 subjects Chapter 53 proceedings to the Commonwealth Agencies Practice and Procedure Act and provides for appeal to Commonwealth Court.
The department shall promulgate regulations or guidance necessary to implement, administer and enforce this chapter. The department shall review regulations or guidance every three years to ensure compliance with Federal law or Federal agency guidance.
Section 5314 directs the Department of Human Services to promulgate implementing regulations, with a mandatory three-year review cycle.