(a)(1)–(6) 1 As used in this Section, "qualified research programQualified research program"qualified research program" means a program of clinical research that satisfies all the following criteria: (1) The research is conducted by or under the supervision of an academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body. (2) The research protocol has received approval from an Institutional Review Board (IRB) registered with the United States Department of Health and Human Services Office for Human Research Protections and the IRB: (A) has determined that the research satisfies federal regulations for the protection of human subjects under 45 CFR Part 46; (B) conducts a continuing review of the research at intervals appropriate to the degree of risk, but no less than annually; and (C) has specific expertise or consultation in mental health research, artificial intelligence applications, and research ethics. (3) All artificial intelligence systems used in the research: (A) are designed and operated in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and all applicable federal and State privacy regulations; (B) undergo documented safety testing to identify and mitigate potential harms before use with human research participants; (C) include real-time monitoring mechanisms to detect and respond to crisis situations, harmful content, or therapeutic errors; and (D) are used only as adjuncts to, and not replacements for, services provided by licensed mental health professionals. (4) All research participants: (A) must provide informed consent that specifically describes the use of artificial intelligence, the experimental nature of the intervention, potential risks and benefits, and alternatives to participation; (B) are informed in writing of the participants' right to withdraw from the research at any time without penalty; (C) receive information about how to access licensed mental health professionals outside the research context; and (D) have access to licensed mental health professionals who can intervene if safety concerns arise during the research. (5) The research program maintains: (A) a data safety monitoring plan appropriate to the level of risk; (B) procedures for reporting adverse events to the IRB and, where applicable, to federal oversight agencies; (C) documentation of all protocol modifications and safety incidents; and (D) plans for dissemination of research findings through peer-reviewed scientific publications or presentations. (6) The primary purpose of the research program is to generate generalizable scientific knowledge about the safety, efficacy, or implementation of artificial intelligence applications in mental health care, rather than to provide routine clinical services or to market commercial products.225 ILCS 155/20.1(a)" means a program of clinical research that satisfies all the following criteria: (1) The research is conducted by or under the supervision of an academic medical centerAcademic medical centerAn academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body.225 ILCS 155/20.1(a)(1) that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body. (2) The research protocol has received approval from an Institutional Review Board (IRB) registered with the United States Department of Health and Human Services Office for Human Research Protections and the IRB: (A) has determined that the research satisfies federal regulations for the protection of human subjects under 45 CFR Part 46; (B) conducts a continuing review of the research at intervals appropriate to the degree of risk, but no less than annually; and (C) has specific expertise or consultation in mental health research, artificial intelligence applications, and research ethics. (3) All artificial intelligence systems used in the research: (A) are designed and operated in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and all applicable federal and State privacy regulations; (B) undergo documented safety testing to identify and mitigate potential harms before use with human research participants; (C) include real-time monitoring mechanisms to detect and respond to crisis situations, harmful content, or therapeutic errors; and (D) are used only as adjuncts to, and not replacements for, services provided by licensed mental health professionals. (4) All research participants: (A) must provide informed consent that specifically describes the use of artificial intelligence, the experimental nature of the intervention, potential risks and benefits, and alternatives to participation; (B) are informed in writing of the participants' right to withdraw from the research at any time without penalty; (C) receive information about how to access licensed mental health professionals outside the research context; and (D) have access to licensed mental health professionals who can intervene if safety concerns arise during the research. (5) The research program maintains: (A) a data safety monitoring plan appropriate to the level of risk; (B) procedures for reporting adverse events to the IRB and, where applicable, to federal oversight agencies; (C) documentation of all protocol modifications and safety incidents; and (D) plans for dissemination of research findings through peer-reviewed scientific publications or presentations. (6) The primary purpose of the research program is to generate generalizable scientific knowledge about the safety, efficacy, or implementation of artificial intelligence applications in mental health care, rather than to provide routine clinical services or to market commercial products.

(b) The prohibitions under Section 20 of this Act shall not apply to artificial intelligence-assisted therapy or psychotherapy services provided exclusively within a qualified research programQualified research program"qualified research program" means a program of clinical research that satisfies all the following criteria: (1) The research is conducted by or under the supervision of an academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body. (2) The research protocol has received approval from an Institutional Review Board (IRB) registered with the United States Department of Health and Human Services Office for Human Research Protections and the IRB: (A) has determined that the research satisfies federal regulations for the protection of human subjects under 45 CFR Part 46; (B) conducts a continuing review of the research at intervals appropriate to the degree of risk, but no less than annually; and (C) has specific expertise or consultation in mental health research, artificial intelligence applications, and research ethics. (3) All artificial intelligence systems used in the research: (A) are designed and operated in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and all applicable federal and State privacy regulations; (B) undergo documented safety testing to identify and mitigate potential harms before use with human research participants; (C) include real-time monitoring mechanisms to detect and respond to crisis situations, harmful content, or therapeutic errors; and (D) are used only as adjuncts to, and not replacements for, services provided by licensed mental health professionals. (4) All research participants: (A) must provide informed consent that specifically describes the use of artificial intelligence, the experimental nature of the intervention, potential risks and benefits, and alternatives to participation; (B) are informed in writing of the participants' right to withdraw from the research at any time without penalty; (C) receive information about how to access licensed mental health professionals outside the research context; and (D) have access to licensed mental health professionals who can intervene if safety concerns arise during the research. (5) The research program maintains: (A) a data safety monitoring plan appropriate to the level of risk; (B) procedures for reporting adverse events to the IRB and, where applicable, to federal oversight agencies; (C) documentation of all protocol modifications and safety incidents; and (D) plans for dissemination of research findings through peer-reviewed scientific publications or presentations. (6) The primary purpose of the research program is to generate generalizable scientific knowledge about the safety, efficacy, or implementation of artificial intelligence applications in mental health care, rather than to provide routine clinical services or to market commercial products.225 ILCS 155/20.1(a), subject to the requirements and limitations specified in this Section.

(c)(1)–(5) 2 A licensed professionalLicensed professionalA licensed professional participating in a qualified research program who must maintain an active, unrestricted license in good standing as required under Illinois law.225 ILCS 155/20.1(c) participating in a qualified research programQualified research program"qualified research program" means a program of clinical research that satisfies all the following criteria: (1) The research is conducted by or under the supervision of an academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body. (2) The research protocol has received approval from an Institutional Review Board (IRB) registered with the United States Department of Health and Human Services Office for Human Research Protections and the IRB: (A) has determined that the research satisfies federal regulations for the protection of human subjects under 45 CFR Part 46; (B) conducts a continuing review of the research at intervals appropriate to the degree of risk, but no less than annually; and (C) has specific expertise or consultation in mental health research, artificial intelligence applications, and research ethics. (3) All artificial intelligence systems used in the research: (A) are designed and operated in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and all applicable federal and State privacy regulations; (B) undergo documented safety testing to identify and mitigate potential harms before use with human research participants; (C) include real-time monitoring mechanisms to detect and respond to crisis situations, harmful content, or therapeutic errors; and (D) are used only as adjuncts to, and not replacements for, services provided by licensed mental health professionals. (4) All research participants: (A) must provide informed consent that specifically describes the use of artificial intelligence, the experimental nature of the intervention, potential risks and benefits, and alternatives to participation; (B) are informed in writing of the participants' right to withdraw from the research at any time without penalty; (C) receive information about how to access licensed mental health professionals outside the research context; and (D) have access to licensed mental health professionals who can intervene if safety concerns arise during the research. (5) The research program maintains: (A) a data safety monitoring plan appropriate to the level of risk; (B) procedures for reporting adverse events to the IRB and, where applicable, to federal oversight agencies; (C) documentation of all protocol modifications and safety incidents; and (D) plans for dissemination of research findings through peer-reviewed scientific publications or presentations. (6) The primary purpose of the research program is to generate generalizable scientific knowledge about the safety, efficacy, or implementation of artificial intelligence applications in mental health care, rather than to provide routine clinical services or to market commercial products.225 ILCS 155/20.1(a) shall: (1) maintain an active, unrestricted license in good standing as required under Illinois law; (2) receive training specific to the artificial intelligence systems used in the research, including the artificial intelligence systems' capabilities, limitations, and potential risks; (3) maintain ultimate clinical responsibility for all care provided to research participants; (4) be available to intervene when safety concerns arise or when the artificial intelligence system's performance is inadequate; and (5) document the licensed professionalLicensed professionalA licensed professional participating in a qualified research program who must maintain an active, unrestricted license in good standing as required under Illinois law.225 ILCS 155/20.1(c)'s supervision and oversight activities in accordance with the research protocol.

(d) 3 Academic medical centersAcademic medical centerAn academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body.225 ILCS 155/20.1(a)(1) shall register qualified research programsQualified research program"qualified research program" means a program of clinical research that satisfies all the following criteria: (1) The research is conducted by or under the supervision of an academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body. (2) The research protocol has received approval from an Institutional Review Board (IRB) registered with the United States Department of Health and Human Services Office for Human Research Protections and the IRB: (A) has determined that the research satisfies federal regulations for the protection of human subjects under 45 CFR Part 46; (B) conducts a continuing review of the research at intervals appropriate to the degree of risk, but no less than annually; and (C) has specific expertise or consultation in mental health research, artificial intelligence applications, and research ethics. (3) All artificial intelligence systems used in the research: (A) are designed and operated in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and all applicable federal and State privacy regulations; (B) undergo documented safety testing to identify and mitigate potential harms before use with human research participants; (C) include real-time monitoring mechanisms to detect and respond to crisis situations, harmful content, or therapeutic errors; and (D) are used only as adjuncts to, and not replacements for, services provided by licensed mental health professionals. (4) All research participants: (A) must provide informed consent that specifically describes the use of artificial intelligence, the experimental nature of the intervention, potential risks and benefits, and alternatives to participation; (B) are informed in writing of the participants' right to withdraw from the research at any time without penalty; (C) receive information about how to access licensed mental health professionals outside the research context; and (D) have access to licensed mental health professionals who can intervene if safety concerns arise during the research. (5) The research program maintains: (A) a data safety monitoring plan appropriate to the level of risk; (B) procedures for reporting adverse events to the IRB and, where applicable, to federal oversight agencies; (C) documentation of all protocol modifications and safety incidents; and (D) plans for dissemination of research findings through peer-reviewed scientific publications or presentations. (6) The primary purpose of the research program is to generate generalizable scientific knowledge about the safety, efficacy, or implementation of artificial intelligence applications in mental health care, rather than to provide routine clinical services or to market commercial products.225 ILCS 155/20.1(a) in existence on the effective date of this amendatory Act of the 104th General Assembly within 90 days after the effective date of this amendatory Act of the 104th General Assembly.

(e)(1)–(3) The exemption under this Section shall apply only to services provided within the context of an approved research protocol and shall not extend to: (1) clinical services marketed or provided outside a research context; (2) services provided primarily for revenue generation rather than scientific inquiry; and (3) services provided without active IRB approval and oversight.

(f)(1)–(3) 5 An academic medical centerAcademic medical centerAn academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body.225 ILCS 155/20.1(a)(1) shall not: (1) advertise artificial intelligence therapy services to the general public as routine clinical services; (2) use the exemption under this Section to circumvent licensing requirements for commercial therapy services; and (3) charge research participants fees beyond those disclosed in and permitted by the IRB-approved research protocol.

(g)(1)–(3) 4 An academic medical centerAcademic medical centerAn academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body.225 ILCS 155/20.1(a)(1) conducting a qualified research programQualified research program"qualified research program" means a program of clinical research that satisfies all the following criteria: (1) The research is conducted by or under the supervision of an academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body. (2) The research protocol has received approval from an Institutional Review Board (IRB) registered with the United States Department of Health and Human Services Office for Human Research Protections and the IRB: (A) has determined that the research satisfies federal regulations for the protection of human subjects under 45 CFR Part 46; (B) conducts a continuing review of the research at intervals appropriate to the degree of risk, but no less than annually; and (C) has specific expertise or consultation in mental health research, artificial intelligence applications, and research ethics. (3) All artificial intelligence systems used in the research: (A) are designed and operated in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and all applicable federal and State privacy regulations; (B) undergo documented safety testing to identify and mitigate potential harms before use with human research participants; (C) include real-time monitoring mechanisms to detect and respond to crisis situations, harmful content, or therapeutic errors; and (D) are used only as adjuncts to, and not replacements for, services provided by licensed mental health professionals. (4) All research participants: (A) must provide informed consent that specifically describes the use of artificial intelligence, the experimental nature of the intervention, potential risks and benefits, and alternatives to participation; (B) are informed in writing of the participants' right to withdraw from the research at any time without penalty; (C) receive information about how to access licensed mental health professionals outside the research context; and (D) have access to licensed mental health professionals who can intervene if safety concerns arise during the research. (5) The research program maintains: (A) a data safety monitoring plan appropriate to the level of risk; (B) procedures for reporting adverse events to the IRB and, where applicable, to federal oversight agencies; (C) documentation of all protocol modifications and safety incidents; and (D) plans for dissemination of research findings through peer-reviewed scientific publications or presentations. (6) The primary purpose of the research program is to generate generalizable scientific knowledge about the safety, efficacy, or implementation of artificial intelligence applications in mental health care, rather than to provide routine clinical services or to market commercial products.225 ILCS 155/20.1(a) shall: (1) register such programs with the Department within 30 days after IRB approval; (2) provide annual reports to the Department summarizing the number of research participants, any serious adverse events, any protocol modifications, and any scientific findings; and (3) notify the Department within 10 business days of any IRB suspension or termination of a research protocol.

(h) 6 Research participants shall not be denied access to standard care as a condition of participating in research involving artificial intelligence-assisted therapy.

(i)(1)–(3) The Department shall comply with the following requirements: (1) maintain a public registry of qualified research programsQualified research program"qualified research program" means a program of clinical research that satisfies all the following criteria: (1) The research is conducted by or under the supervision of an academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body. (2) The research protocol has received approval from an Institutional Review Board (IRB) registered with the United States Department of Health and Human Services Office for Human Research Protections and the IRB: (A) has determined that the research satisfies federal regulations for the protection of human subjects under 45 CFR Part 46; (B) conducts a continuing review of the research at intervals appropriate to the degree of risk, but no less than annually; and (C) has specific expertise or consultation in mental health research, artificial intelligence applications, and research ethics. (3) All artificial intelligence systems used in the research: (A) are designed and operated in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and all applicable federal and State privacy regulations; (B) undergo documented safety testing to identify and mitigate potential harms before use with human research participants; (C) include real-time monitoring mechanisms to detect and respond to crisis situations, harmful content, or therapeutic errors; and (D) are used only as adjuncts to, and not replacements for, services provided by licensed mental health professionals. (4) All research participants: (A) must provide informed consent that specifically describes the use of artificial intelligence, the experimental nature of the intervention, potential risks and benefits, and alternatives to participation; (B) are informed in writing of the participants' right to withdraw from the research at any time without penalty; (C) receive information about how to access licensed mental health professionals outside the research context; and (D) have access to licensed mental health professionals who can intervene if safety concerns arise during the research. (5) The research program maintains: (A) a data safety monitoring plan appropriate to the level of risk; (B) procedures for reporting adverse events to the IRB and, where applicable, to federal oversight agencies; (C) documentation of all protocol modifications and safety incidents; and (D) plans for dissemination of research findings through peer-reviewed scientific publications or presentations. (6) The primary purpose of the research program is to generate generalizable scientific knowledge about the safety, efficacy, or implementation of artificial intelligence applications in mental health care, rather than to provide routine clinical services or to market commercial products.225 ILCS 155/20.1(a) operating under this Section; (2) develop forms and procedures for registration and annual reporting; and (3) coordinate with relevant professional licensing boards to ensure compliance with this Section.

(j)(1)–(4) Any academic medical centerAcademic medical centerAn academic medical center that: (A) is affiliated with an accredited medical school or university; (B) operates under a valid hospital license issued by the Department of Public Health; and (C) maintains accreditation by the Joint Commission or an equivalent national accrediting body.225 ILCS 155/20.1(a)(1) or licensed professionalLicensed professionalA licensed professional participating in a qualified research program who must maintain an active, unrestricted license in good standing as required under Illinois law.225 ILCS 155/20.1(c) found to have misrepresented a commercial service as qualifying for the exemption under this Section, or to have otherwise violated the requirements of this Section, is subject to the following: (1) immediate loss of exemption status for the program in question; (2) civil penalties under Section 30; (3) referral to the appropriate licensing boards for professional discipline; and (4) prohibition from seeking exemption status for new research programs for a period of not less than 2 years.

(k)–(n) No later than July 1, 2029, the Department shall submit a report to the General Assembly evaluating the following: (1) the number and nature of research programs that have operated under the exemption under this Section; (2) any reported adverse events or safety concerns; (3) scientific findings regarding the safety and efficacy of artificial intelligence applications in mental health care; and (4) recommendations regarding whether the exemption under this Section should be continued, modified, or allowed to expire. (l) Nothing in this Section shall limit the authority of professional licensing boards to discipline licensed professionalsLicensed professionalA licensed professional participating in a qualified research program who must maintain an active, unrestricted license in good standing as required under Illinois law.225 ILCS 155/20.1(c) for violations of professional standards of care. (m) The provisions of this Section are severable under Section 1.31 of the Statute on Statutes. (n) This Section is repealed on January 1, 2030.