Bill Text: IL HB5003 | 2025-2026 | 104th General Assembly | Introduced

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Bill Title: Amends the Wellness and Oversight for Psychological Resources Act. Defines "qualified research program". Provides that the prohibitions on unauthorized therapy services under the Act shall not apply to artificial intelligence-assisted therapy or psychotherapy services provided exclusively within a qualified research program. Sets forth requirements for qualified research programs. Requires a licensed professional participating in a qualified research program to perform certain actions. Provides that academic medical centers shall register existing research programs that meet the criteria for qualified research programs within 90 days after the effective date of the amendatory Act. Provides that the exemption shall apply only to services provided within the context of an approved research protocol and shall not extend to certain services. Sets forth requirements for academic medical centers conducting qualified research programs. Provides that research participants shall not be denied access to standard care as a condition of participating in research involving artificial intelligence-assisted therapy. Sets forth requirements for the Department of Financial and Professional Regulation. Provides penalties for any academic medical center or licensed professional found to have misrepresented a commercial service as qualifying for the research exemption, or to have otherwise violated the requirements of the amendatory Act. Requires the Department to submit a report to the General Assembly evaluating aspects of the qualified research programs. Repeals the provisions on January 1, 2030. Makes other changes.

Sponsorship: Partisan Bill (Democrat 1)

Status: (Introduced - Dead) 2026-03-27 - Rule 19(a) / Re-referred to Rules Committee [HB5003 Detail]

Download: Illinois-2025-HB5003-Introduced.html

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104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026HB5003 Introduced , by Rep. Bob Morgan SYNOPSIS AS INTRODUCED:
225 ILCS 155/20.1 new
Amends the Wellness and Oversight for Psychological Resources Act. Defines "qualified research program". Provides that the prohibitions on unauthorized therapy services under the Act shall not apply to artificial intelligence-assisted therapy or psychotherapy services provided exclusively within a qualified research program. Sets forth requirements for qualified research programs. Requires a licensed professional participating in a qualified research program to perform certain actions. Provides that academic medical centers shall register existing research programs that meet the criteria for qualified research programs within 90 days after the effective date of the amendatory Act. Provides that the exemption shall apply only to services provided within the context of an approved research protocol and shall not extend to certain services. Sets forth requirements for academic medical centers conducting qualified research programs. Provides that research participants shall not be denied access to standard care as a condition of participating in research involving artificial intelligence-assisted therapy. Sets forth requirements for the Department of Financial and Professional Regulation. Provides penalties for any academic medical center or licensed professional found to have misrepresented a commercial service as qualifying for the research exemption, or to have otherwise violated the requirements of the amendatory Act. Requires the Department to submit a report to the General Assembly evaluating aspects of the qualified research programs. Repeals the provisions on January 1, 2030. Makes other changes.
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A BILL FOR
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AN ACT concerning regulation.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Findings. The General Assembly finds that:
(1) responsible scientific research into artificial
intelligence applications for mental health care serves
the public interest by potentially expanding access to
evidence-based treatment for underserved populations;
(2) academic research conducted under rigorous
institutional oversight, with appropriate safeguards and
ethical review, is categorically distinct from unregulated
commercial artificial intelligence therapy services
marketed directly to consumers;
(3) Illinois has a compelling interest in maintaining
its position as a leader in responsible health care
innovation while protecting patients from harm; and
(4) research exemptions with appropriate safeguards
can advance scientific knowledge without compromising the
consumer protection objectives of the original Act.
Section 2. Purpose. The purpose of this Act is to amend the
Wellness and Oversight for Psychological Resources Act to
establish a limited exemption for bona fide clinical research
conducted at academic medical centers, while maintaining the

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Act's core consumer protections against unregulated artificial
intelligence therapy services.
Section 5. The Wellness and Oversight for Psychological
Resources Act is amended by adding Section 20.1 as follows:
(225 ILCS 155/20.1 new)
Sec. 20.1. Artificial intelligence-assisted therapy;
qualified research programs.
(a) As used in this Section, "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

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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

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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

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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 program, subject to the requirements and limitations
specified in this Section.
(c) A licensed professional participating in a qualified
research program 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 professional's supervision
and oversight activities in accordance with the research
protocol.
(d) Academic medical centers shall register qualified
research programs in existence on the effective date of this
amendatory Act of the 104th General Assembly within 90 days

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after the effective date of this amendatory Act of the 104th
General Assembly.
(e) 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) An academic medical center 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) An academic medical center conducting a qualified
research program 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

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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) Research participants shall not be denied access to
standard care as a condition of participating in research
involving artificial intelligence-assisted therapy.
(i) The Department shall comply with the following
requirements:
(1) maintain a public registry of qualified research
programs 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) Any academic medical center or licensed professional
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

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research programs for a period of not less than 2 years.
(k) 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
professionals 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.