Shown verbatim: the complete text as captured from the official PDF posted by the Oklahoma Legislature, fetched 2026-07-23. Page and line markers are part of the official record; nothing is edited or removed. The official bill page.
1 STATE OF OKLAHOMA
2 1st Session of the 60th Legislature (2025)
3 HOUSE BILL 1915 By: Alonso-Sandoval
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6 AS INTRODUCED
7 An Act relating to artificial intelligence (AI);
providing definitions; mandating that AI devices in
8 health care be deployed and utilized in accordance
with certain regulations; requiring exclusive use by
9 qualified end-user; directing deployers to implement
Quality Assurance Program; requiring device-generated
10 data be reviewed; authorizing qualified end-users to
amend or overrule outputs; requiring performance
11 evaluations; mandating all documentation comply with
certain record-keeping requirements; directing
12 deployers establish an AI governance group; requiring
deployers to maintain updated inventory; directing
13 the State Department of Health to enforce act;
requiring diligent review and selection process for
14 deployed AI device; requiring documentation of use
case and user training procedure; directing deployers
15 to monitor the performance of deployed AI devices
continuously; requiring deployers participate in
16 national specialty society-administered AI assessment
registries when feasible; providing for codification;
17 and providing an effective date.
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20 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
21 SECTION 1. NEW LAW A new section of law to be codified
22 in the Oklahoma Statutes as Section 5501 of Title 63, unless there
23 is created a duplication in numbering, reads as follows:
24 As used in this act:
Req. No. 11174 Page 1
1 1. "Artificial intelligence (AI) device" or "machine learning-
2 enabled device" means a medical device as defined by Section
3 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
4 that includes a machine-based function that, based on training data,
5 infers from the input it receives how to generate outputs that
6 enhance or support a medical diagnosis, prognosis, or treatment;
7 2. "Deployer" means a hospital, physician practice, or other
8 health care facility responsible for implementing an AI device for
9 patient care purposes; and
10 3. "Qualified end-user" means a user of an AI device that is a
11 licensed physician with the necessary qualifications and training to
12 independently provide the same diagnostic, prognostic, or
13 therapeutic procedure without the aid of the AI device, and who
14 possesses specific qualifications and training in the use of the AI
15 device, including the ability to assess the validity of its output.
16 SECTION 2. NEW LAW A new section of law to be codified
17 in the Oklahoma Statutes as Section 5502 of Title 63, unless there
18 is created a duplication in numbering, reads as follows:
19 A. All artificial intelligence (AI) devices or machine
20 learning-enabled devices used in health care settings that meet the
21 definition of a medical device under Section 201(h)(1) of the
22 Federal Food, Drug, and Cosmetic Act (FD&C Act) shall be deployed
23 and utilized in accordance with federal regulations established by
24 the U.S. Food and Drug Administration (FDA) and other federal
Req. No. 11174 Page 2
1 agencies, including relevant guidance on AI or machine learning-
2 enabled software medical devices.
3 B. An AI device shall be used exclusively by a qualified end-
4 user.
5 C. Deployers shall implement and maintain a Quality Assurance
6 Program, as outlined in Section 4 of this act, to ensure the safe,
7 effective, and compliant use of AI devices in patient care.
8 SECTION 3. NEW LAW A new section of law to be codified
9 in the Oklahoma Statutes as Section 5503 of Title 63, unless there
10 is created a duplication in numbering, reads as follows:
11 A. All relevant artificial intelligence (AI) device-generated
12 data shall be reviewed for accuracy and validated by a qualified
13 end-user in accordance with deployer-documented policies and
14 procedures before patient care decisions are rendered.
15 B. The qualified end-user of the AI device shall retain
16 authority to amend or overrule outputs from the device based on
17 their professional judgment, and without pressure from the deployer
18 or any other entity to ignore or alter professional judgement.
19 C. Deployers of an AI device shall conduct and document regular
20 performance evaluations and risk assessments of the device. Such
21 evaluations and assessments should be informed by invited feedback
22 from qualified end-users and, when applicable, participation in
23 national specialty society-administered AI assessment registries.
24 Whenever AI device performance concerns are identified, deployers
Req. No. 11174 Page 3
1 shall implement appropriate corrective actions to mitigate risk to
2 patients.
3 D. All documentation shall comply with state and federal
4 medical record-keeping requirements and be accessible for regulatory
5 review. Documentation of relevant instances where a qualified end-
6 user overrides or disagrees with AI device-generated outputs must be
7 maintained through a summary report indicating the frequency and
8 nature of overrides. Deployers shall document the percentage or
9 number of such overrides or disagreements.
10 SECTION 4. NEW LAW A new section of law to be codified
11 in the Oklahoma Statutes as Section 5504 of Title 63, unless there
12 is created a duplication in numbering, reads as follows:
13 A. Deployers of any artificial intelligence (AI) device shall
14 establish an AI governance group with representation from qualified
15 end-users. This governance group is responsible for overseeing
16 compliance with this act.
17 B. Deployers shall maintain an updated inventory of deployed AI
18 devices, with device instructions for use and any relevant safety
19 and effectiveness documentation made accessible to all qualified
20 end-users of the device.
21 C. Deployers of AI devices shall ensure compliance with all
22 requirements herein, as well as with applicable federal and state
23 security, privacy, and nondiscrimination regulations. Noncompliance
24 will result in penalties set by the State Department of Health,
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1 which shall have the authority to enforce and make rules to enforce
2 this act.
3 D. Deployers shall have a diligent review and selection process
4 for the deployed AI device.
5 E. Deployers shall document the use case and user training
6 procedure for the AI device.
7 F. Deployers shall continuously monitor the performance of all
8 deployed AI devices, including assessing any impact on patient
9 safety or the quality of patient care.
10 G. In conducting performance monitoring described in subsection
11 F of this section, deployers must participate in national specialty
12 society-administered artificial intelligence assessment registries
13 when feasible.
14 SECTION 5. This act shall become effective November 1, 2025.
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16 60-1-11174 MJ 01/08/25
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Req. No. 11174 Page 5Every fact on this page links to its source, starting with the official bill record.