AI-ASSISTED THERAPY RESEARCH

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104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026
HB5003

Introduced 2/10/2026, 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.
LRB104 18445 AAS 31887 b

A BILL FOR

HB5003
LRB104 18445 AAS 31887 b
1

AN ACT concerning regulation.

2

Be it enacted by the People of the State of Illinois,
3
represented in the General Assembly:

4

Section 1.
Findings.
The General Assembly finds that:
5

(1) responsible scientific research into artificial
6

intelligence applications for mental health care serves
7

the public interest by potentially expanding access to
8

evidence-based treatment for underserved populations;
9

(2) academic research conducted under rigorous
10

institutional oversight, with appropriate safeguards and
11

ethical review, is categorically distinct from unregulated
12

commercial artificial intelligence therapy services
13

marketed directly to consumers;
14

(3) Illinois has a compelling interest in maintaining
15

its position as a leader in responsible health care
16

innovation while protecting patients from harm; and
17

(4) research exemptions with appropriate safeguards
18

can advance scientific knowledge without compromising the
19

consumer protection objectives of the original Act.

20

Section 2.
Purpose.
The purpose of this Act is to amend the
21
Wellness and Oversight for Psychological Resources Act to
22
establish a limited exemption for bona fide clinical research
23
conducted at academic medical centers, while maintaining the

HB5003
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LRB104 18445 AAS 31887 b
1
Act's core consumer protections against unregulated artificial
2
intelligence therapy services.

3

Section 5.
The Wellness and Oversight for Psychological
4
Resources Act is amended by adding Section 20.1 as follows:

5

(225 ILCS 155/20.1 new)
6

Sec. 20.1.
Artificial intelligence-assisted therapy;
7
qualified research programs.

8

(a) As used in this Section, "qualified research program"
9
means a program of clinical research that satisfies all the
10
following criteria:

11

(1) The research is conducted by or under the
12

supervision of an academic medical center that:
13

(A) is affiliated with an accredited medical
14

school or university;
15

(B) operates under a valid hospital license issued
16

by the Department of Public Health; and
17

(C) maintains accreditation by the Joint
18

Commission or an equivalent national accrediting body.
19

(2) The research protocol has received approval from
20

an Institutional Review Board (IRB) registered with the
21

United States Department of Health and Human Services
22

Office for Human Research Protections and the IRB:
23

(A) has determined that the research satisfies
24

federal regulations for the protection of human

HB5003
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LRB104 18445 AAS 31887 b
1

subjects under 45 CFR Part 46;
2

(B) conducts a continuing review of the research
3

at intervals appropriate to the degree of risk, but no
4

less than annually; and
5

(C) has specific expertise or consultation in
6

mental health research, artificial intelligence
7

applications, and research ethics.
8

(3) All artificial intelligence systems used in the
9

research:
10

(A) are designed and operated in compliance with
11

the Health Insurance Portability and Accountability
12

Act (HIPAA) and all applicable federal and State
13

privacy regulations;
14

(B) undergo documented safety testing to identify
15

and mitigate potential harms before use with human
16

research participants;
17

(C) include real-time monitoring mechanisms to
18

detect and respond to crisis situations, harmful
19

content, or therapeutic errors; and
20

(D) are used only as adjuncts to, and not
21

replacements for, services provided by licensed mental
22

health professionals.
23

(4) All research participants:
24

(A) must provide informed consent that
25

specifically describes the use of artificial
26

intelligence, the experimental nature of the

HB5003
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LRB104 18445 AAS 31887 b
1

intervention, potential risks and benefits, and
2

alternatives to participation;
3

(B) are informed in writing of the participants'
4

right to withdraw from the research at any time
5

without penalty;
6

(C) receive information about how to access
7

licensed mental health professionals outside the
8

research context; and
9

(D) have access to licensed mental health
10

professionals who can intervene if safety concerns
11

arise during the research.
12

(5) The research program maintains:
13

(A) a data safety monitoring plan appropriate to
14

the level of risk;
15

(B) procedures for reporting adverse events to the
16

IRB and, where applicable, to federal oversight
17

agencies;
18

(C) documentation of all protocol modifications
19

and safety incidents; and
20

(D) plans for dissemination of research findings
21

through peer-reviewed scientific publications or
22

presentations.
23

(6) The primary purpose of the research program is to
24

generate generalizable scientific knowledge about the
25

safety, efficacy, or implementation of artificial
26

intelligence applications in mental health care, rather

HB5003
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LRB104 18445 AAS 31887 b
1

than to provide routine clinical services or to market
2

commercial products.
3

(b) The prohibitions under Section 20 of this Act shall
4
not apply to artificial intelligence-assisted therapy or
5
psychotherapy services provided exclusively within a qualified
6
research program, subject to the requirements and limitations
7
specified in this Section.
8

(c) A licensed professional participating in a qualified
9
research program shall:
10

(1) maintain an active, unrestricted license in good
11

standing as required under Illinois law;
12

(2) receive training specific to the artificial
13

intelligence systems used in the research, including the
14

artificial intelligence systems' capabilities,
15

limitations, and potential risks;
16

(3) maintain ultimate clinical responsibility for all
17

care provided to research participants;
18

(4) be available to intervene when safety concerns
19

arise or when the artificial intelligence system's
20

performance is inadequate; and
21

(5) document the licensed professional's supervision
22

and oversight activities in accordance with the research
23

protocol.
24

(d) Academic medical centers shall register qualified
25
research programs in existence on the effective date of this
26
amendatory Act of the 104th General Assembly within 90 days

HB5003
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LRB104 18445 AAS 31887 b
1
after the effective date of this amendatory Act of the 104th
2
General Assembly.
3

(e) The exemption under this Section shall apply only to
4
services provided within the context of an approved research
5
protocol and shall not extend to:
6

(1) clinical services marketed or provided outside a
7

research context;
8

(2) services provided primarily for revenue generation
9

rather than scientific inquiry; and
10

(3) services provided without active IRB approval and
11

oversight.
12

(f) An academic medical center shall not:
13

(1) advertise artificial intelligence therapy services
14

to the general public as routine clinical services;
15

(2) use the exemption under this Section to circumvent
16

licensing requirements for commercial therapy services;
17

and
18

(3) charge research participants fees beyond those
19

disclosed in and permitted by the IRB-approved research
20

protocol.
21

(g) An academic medical center conducting a qualified
22
research program shall:
23

(1) register such programs with the Department within
24

30 days after IRB approval;
25

(2) provide annual reports to the Department
26

summarizing the number of research participants, any

HB5003
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LRB104 18445 AAS 31887 b
1

serious adverse events, any protocol modifications, and
2

any scientific findings; and
3

(3) notify the Department within 10 business days of
4

any IRB suspension or termination of a research protocol.
5

(h) Research participants shall not be denied access to
6
standard care as a condition of participating in research
7
involving artificial intelligence-assisted therapy.
8

(i) The Department shall comply with the following
9
requirements:
10

(1) maintain a public registry of qualified research
11

programs operating under this Section;
12

(2) develop forms and procedures for registration and
13

annual reporting; and
14

(3) coordinate with relevant professional licensing
15

boards to ensure compliance with this Section.
16

(j) Any academic medical center or licensed professional
17
found to have misrepresented a commercial service as
18
qualifying for the exemption under this Section, or to have
19
otherwise violated the requirements of this Section, is
20
subject to the following:
21

(1) immediate loss of exemption status for the program
22

in question;
23

(2) civil penalties under Section 30;
24

(3) referral to the appropriate licensing boards for
25

professional discipline; and
26

(4) prohibition from seeking exemption status for new

HB5003
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LRB104 18445 AAS 31887 b
1

research programs for a period of not less than 2 years.
2

(k) No later than July 1, 2029, the Department shall
3
submit a report to the General Assembly evaluating the
4
following:
5

(1) the number and nature of research programs that
6

have operated under the exemption under this Section;
7

(2) any reported adverse events or safety concerns;
8

(3) scientific findings regarding the safety and
9

efficacy of artificial intelligence applications in mental
10

health care; and
11

(4) recommendations regarding whether the exemption
12

under this Section should be continued, modified, or
13

allowed to expire.

14

(l) Nothing in this Section shall limit the authority of
15
professional licensing boards to discipline licensed
16
professionals for violations of professional standards of
17
care.
18

(m) The provisions of this Section are severable under
19
Section 1.31 of the Statute on Statutes.

20

(n) This Section is repealed on January 1, 2030.

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