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STATE OF OKLAHOMA
1st Session of the 60th Legislature (2025)
HOUSE BILL 1915 By: Alonso-Sandoval
AS INTRODUCED
An Act relating to artificial intelligence (AI);
providing definitions; mandating that AI devices in
health care be deployed and utilized in accordance
with certain regulations; requiring exclusive use by
qualified end-user; directing deployers to implement
Quality Assurance Program; requiring device-generated
data be reviewed; authorizing qualified end-users to
amend or overrule outputs; requiring performance
evaluations; mandating all documentation comply with
certain record-keeping requirements; directing
deployers establish an AI governance group; requiring
deployers to maintain updated inventory; directing
the State Department of Health to enforce act;
requiring diligent review and selection process for
deployed AI device; requiring documentation of use
case and user training procedure; directing deployers
to monitor the performance of deployed AI devices
continuously; requiring deployers participate in
national specialty society-administered AI assessment
registries when feasible; providing for codification;
and providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 5501 of Title 63, unless there
is created a duplication in numbering, reads as follows:
As used in this act:
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1. "Artificial intelligence (AI) device" or "machine learning-
enabled device" means a medical device as defined by Section
201(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
that includes a machine-based function that, based on training data,
infers from the input it receives how to generate outputs that
enhance or support a medical diagnosis, prognosis, or treatment;
2. "Deployer" means a hospital, physician practice, or other
health care facility responsible for implementing an AI device for
patient care purposes; and
3. "Qualified end-user" means a user of an AI device that is a
licensed physician with the necessary qualifications and training to
independently provide the same diagnostic, prognostic, or
therapeutic procedure without the aid of the AI device, and who
possesses specific qualifications and training in the use of the AI
device, including the ability to assess the validity of its output.
SECTION 2. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 5502 of Title 63, unless there
is created a duplication in numbering, reads as follows:
A. All artificial intelligence (AI) devices or machine
learning-enabled devices used in health care settings that meet the
definition of a medical device under Section 201(h)(1) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) shall be deployed
and utilized in accordance with federal regulations established by
the U.S. Food and Drug Administration (FDA) and other federal
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agencies, including relevant guidance on AI or machine learning-
enabled software medical devices.
B. An AI device shall be used exclusively by a qualified end-
user.
C. Deployers shall implement and maintain a Quality Assurance
Program, as outlined in Section 4 of this act, to ensure the safe,
effective, and compliant use of AI devices in patient care.
SECTION 3. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 5503 of Title 63, unless there
is created a duplication in numbering, reads as follows:
A. All relevant artificial intelligence (AI) device-generated
data shall be reviewed for accuracy and validated by a qualified
end-user in accordance with deployer-documented policies and
procedures before patient care decisions are rendered.
B. The qualified end-user of the AI device shall retain
authority to amend or overrule outputs from the device based on
their professional judgment, and without pressure from the deployer
or any other entity to ignore or alter professional judgement.
C. Deployers of an AI device shall conduct and document regular
performance evaluations and risk assessments of the device. Such
evaluations and assessments should be informed by invited feedback
from qualified end-users and, when applicable, participation in
national specialty society-administered AI assessment registries.
Whenever AI device performance concerns are identified, deployers
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shall implement appropriate corrective actions to mitigate risk to
patients.
D. All documentation shall comply with state and federal
medical record-keeping requirements and be accessible for regulatory
review. Documentation of relevant instances where a qualified end-
user overrides or disagrees with AI device-generated outputs must be
maintained through a summary report indicating the frequency and
nature of overrides. Deployers shall document the percentage or
number of such overrides or disagreements.
SECTION 4. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 5504 of Title 63, unless there
is created a duplication in numbering, reads as follows:
A. Deployers of any artificial intelligence (AI) device shall
establish an AI governance group with representation from qualified
end-users. This governance group is responsible for overseeing
compliance with this act.
B. Deployers shall maintain an updated inventory of deployed AI
devices, with device instructions for use and any relevant safety
and effectiveness documentation made accessible to all qualified
end-users of the device.
C. Deployers of AI devices shall ensure compliance with all
requirements herein, as well as with applicable federal and state
security, privacy, and nondiscrimination regulations. Noncompliance
will result in penalties set by the State Department of Health,
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which shall have the authority to enforce and make rules to enforce
this act.
D. Deployers shall have a diligent review and selection process
for the deployed AI device.
E. Deployers shall document the use case and user training
procedure for the AI device.
F. Deployers shall continuously monitor the performance of all
deployed AI devices, including assessing any impact on patient
safety or the quality of patient care.
G. In conducting performance monitoring described in subsection
F of this section, deployers must participate in national specialty
society-administered artificial intelligence assessment registries
when feasible.
SECTION 5. This act shall become effective November 1, 2025.
60-1-11174 MJ 01/08/25