WHAT THIS BILL REGULATES · 5 REQUIREMENT TYPES
How Is This Bill Enforced
Verbatim statutory text on the left; plain-language analysis and a per-section checklist on the right. Numbered markers cross-link to the matching checklist row.
(1) "Artificial intelligence (AI) deviceArtificial intelligence (AI) device"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;63 O.S. § 5501(1)" 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) "DeployerDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2)" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes; and
(3) "Qualified end-userQualified end-user"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.63 O.S. § 5501(3)" 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 5501 establishes three key definitions for the act. The AI device definition is anchored to the federal FD&C Act's medical device definition but adds a machine learning functional requirement. The deployer definition limits covered entities to hospitals, physician practices, and healthcare facilities — not device manufacturers or developers. The qualified end-user definition is unusually restrictive, requiring the user to be a licensed physician who could independently perform the same procedure without AI assistance and who has specific AI device training.
(A) 1 All artificial intelligence (AI) devicesArtificial intelligence (AI) device"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;63 O.S. § 5501(1) 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 agencies, including relevant guidance on AI or machine learning-enabled software medical devices.
(B) 2 An AI device shall be used exclusively by a qualified end-userQualified end-user"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.63 O.S. § 5501(3).
(C) 3 DeployersDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) 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 5502 imposes three foundational deployment prerequisites. Subsection (A) requires all AI devices in healthcare to comply with FDA and other federal regulations — effectively incorporating federal requirements by reference and layering state enforcement on top. Subsection (B) restricts use of AI devices exclusively to qualified end-users (licensed physicians meeting the Section 5501 definition). Subsection (C) requires deployers to implement and maintain a Quality Assurance Program as detailed in Section 5504.
The qualified end-user restriction is notable because it excludes nurses, physician assistants, technicians, and other healthcare professionals from operating AI devices, even those cleared by the FDA for broader clinical use.
(A) 4 All relevant artificial intelligence (AI) deviceArtificial intelligence (AI) device"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;63 O.S. § 5501(1)-generated data shall be reviewed for accuracy and validated by a qualified end-userQualified end-user"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.63 O.S. § 5501(3) in accordance with deployerDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2)-documented policies and procedures before patient care decisions are rendered.
(B) 5 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 deployerDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) or any other entity to ignore or alter professional judgement.
(C) 6 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-usersQualified end-user"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.63 O.S. § 5501(3) and, when applicable, participation in national specialty society-administered AI assessment registries. Whenever AI device performance concerns are identified, deployersDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) shall implement appropriate corrective actions to mitigate risk to patients.
(D) 7 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-userQualified end-user"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.63 O.S. § 5501(3) overrides or disagrees with AI device-generated outputs must be maintained through a summary report indicating the frequency and nature of overrides. DeployersDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) shall document the percentage or number of such overrides or disagreements.
Section 5503 imposes the act's core clinical-use requirements. Subsection (A) mandates that all AI device-generated data be reviewed for accuracy and validated by a qualified end-user before patient care decisions are rendered — a pre-decision human-in-the-loop requirement. Subsection (B) preserves the qualified end-user's authority to amend or overrule AI outputs based on professional judgment and explicitly prohibits deployer pressure to override clinical judgment.
Subsection (C) requires deployers to conduct and document regular performance evaluations and risk assessments, incorporating end-user feedback and participation in national specialty society AI registries. It also mandates corrective action when performance concerns arise. Subsection (D) establishes record-keeping requirements including a specific obligation to document and quantify instances where qualified end-users override or disagree with AI outputs.
(A) 8 Deployers of any artificial intelligence (AI) deviceArtificial intelligence (AI) device"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;63 O.S. § 5501(1) shall establish an AI governance group with representation from qualified end-usersQualified end-user"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.63 O.S. § 5501(3). This governance group is responsible for overseeing compliance with this act.
(B) 9 DeployersDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) 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, which shall have the authority to enforce and make rules to enforce this act.
(D) 10 DeployersDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) shall have a diligent review and selection process for the deployed AI device.
(E) 11 DeployersDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) shall document the use case and user training procedure for the AI device.
(F) 12 DeployersDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) shall continuously monitor the performance of all deployed AI devices, including assessing any impact on patient safety or the quality of patient care.
(G) 12 In conducting performance monitoring described in subsection F of this section, deployersDeployer"Deployer" means a hospital, physician practice, or other health care facility responsible for implementing an AI device for patient care purposes;63 O.S. § 5501(2) must participate in national specialty society-administered artificial intelligence assessment registries when feasible.
Section 5504 details the governance infrastructure deployers must establish. Subsection (A) requires an AI governance group with qualified end-user representation, responsible for overseeing compliance. Subsection (B) requires an updated inventory of all deployed AI devices with documentation accessible to end-users. Subsection (C) is the act's enforcement provision, vesting enforcement authority in the State Department of Health and providing that noncompliance results in penalties set by that agency.
Subsections (D) through (G) impose additional operational requirements: a diligent device selection process, documentation of use cases and training procedures, continuous performance monitoring including patient safety impact assessment, and participation in national specialty society AI assessment registries when feasible.
This act shall become effective November 1, 2025.
Section 5 establishes the effective date as November 1, 2025. No compliance obligations arise from this provision.