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Enrolled
August 27, 2026 |
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Passed
IN
Senate
August 25, 2026 |
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Passed
IN
Assembly
August 24, 2026 |
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Amended
IN
Assembly
August 19, 2026 |
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Amended
IN
Assembly
September 04, 2025 |
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Amended
IN
Assembly
July 17, 2025 |
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Amended
IN
Assembly
July 10, 2025 |
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Amended
IN
Assembly
June 30, 2025 |
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Amended
IN
Senate
April 10, 2025 |
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Amended
IN
Senate
March 25, 2025 |
CALIFORNIA LEGISLATURE—
2025–2026 REGULAR SESSION
Senate Bill
No. 503
| Introduced by Senator Weber Pierson (Coauthors: Senators Richardson and Smallwood-Cuevas) (Coauthors: Assembly Members Bonta, Bryan, Elhawary, Gipson, Jackson, McKinnor, Ransom, Sharp-Collins, and Wilson) |
February 19, 2025 |
An act to add Chapter 25.3 (commencing with Section 22758) to Division 8 of the Business and Professions Code, relating to health care services.
LEGISLATIVE COUNSEL'S DIGEST
SB 503, Weber Pierson.
Health care services: artificial intelligence.
Existing law requires a health facility, clinic, physician’s office, or office of a group practice that uses generative artificial intelligence to generate written or verbal patient communications pertaining to patient clinical information, as defined, to ensure that those communications include both (1) a disclaimer that indicates to the patient that a communication was generated by generative artificial intelligence, as specified, and (2) clear instructions describing how a patient may contact a human health care provider, employee, or other appropriate person. Existing law exempts from this
requirement a communication read and reviewed by a human licensed or certified health care provider.
This bill would require developers and deployers, as defined, of an artificial intelligence system that produces a prediction, classification, recommendation, evaluation, or analysis that aids decisionmaking related to diagnosis or treatment, known as a clinical decision support system, to make reasonable efforts to identify clinical decision support systems
developed for use by deployers that are known or have a reasonably foreseeable risk for biased impacts resulting from
deployment of the system in health programs or activities. The bill would require developers to make a statement describing the intended uses and known or reasonably foreseeable risks associated with the use of the clinical decision support system and certain documentation available to deployers, as specified. The bill would require developers to make reasonable efforts to mitigate known or reasonably foreseeable risk for biased impacts resulting from use of the
clinical decision support system in health programs or activities. The bill would require deployers to regularly monitor clinical decision support systems and take reasonable and proportionate steps to mitigate known or reasonably foreseeable risk of biased impacts. The bill would specify that a person, partnership, state or local governmental agency, or corporation may be both a developer and a deployer.
The people of the State of California do enact as follows:
SECTION 1.
Chapter 25.3 (commencing with Section 22758) is added to Division 8 of the Business and Professions Code, to read:CHAPTER 25.3. Clinical Decision Support Systems
22758.
(a) (1) Developers and deployers shall make reasonable efforts to identify clinical decision support systems developed for use by deployers that are known or have a reasonably foreseeable risk of biased impacts resulting from deployment of the system in health programs or activities.(2) Developers shall make reasonable efforts to mitigate the known or reasonably foreseeable risk of biased impacts resulting from the use of the clinical decision support systems identified pursuant to paragraph (1).
(3) Developers shall make at least the following available to deployers for clinical decision support systems identified pursuant to paragraph (1):
(A) A statement describing the intended uses and known or reasonably foreseeable risks associated with use of the clinical decision support system.
(B) Documentation disclosing all of the following:
(i) High-level summaries of the type or types of data used to train the clinical decision support system, including a description of its demographic representativeness when demographic data is available.
(ii) How the clinical decision support system was evaluated for performance, limitations, and mitigation of biased impacts.
(iii) High-level summaries of data governance measures used to evaluate training datasets and measures used to determine the suitability of data sources and possible
biases.
(iv) Intended benefits and expected outputs of the clinical decision support system.
(v) Any known or reasonably foreseeable risk of biased impacts and efforts to mitigate those risks.
(vi) Recommendations regarding how the clinical decision support system should be used and monitored, and how risks should be mitigated.
(vii) Any other documentation that is reasonably necessary to help deployers understand the outputs and monitor the performance of the clinical decision support system for biased impacts.
(4) In complying with paragraph (3), developers may adhere to nationally recognized or widely adopted industry standards that are developed through multistakeholder consensus,
relevant to bias testing and artificial intelligence systems in health care, or provide the results from regularly conducted algorithmic impact assessments using industry-accepted methodologies, including information relevant to the requirements specified in subparagraph (B) of paragraph (3), and appropriate for the clinical decision support system’s intended use, to the extent that those standards or assessments exist.
(5) Documentation required under paragraph (3) shall be made available to deployers upon request or at the time of initial sale, whichever is earlier, and, as applicable, upon release of material updates to the clinical decision support system.
(6) Paragraph (3) does not prohibit developers from providing deployers with additional documentation upon request or to satisfy a contractual or reporting obligation.
(7) A deployer that also serves as a developer of a clinical decision support system described in paragraph (1) is not required to generate documentation required by subparagraph (B) of paragraph (3) if the system is developed and deployed for internal use and information consistent with the documentation and transparency requirements applicable to developers pursuant to subparagraph (B) of paragraph (3) is readily available to the deployer.
(8) Deployers shall regularly monitor the clinical decision support systems identified pursuant to paragraph (1) and take reasonable and proportionate steps to mitigate the known or reasonably foreseeable risk of biased impacts.
(b) For purposes of this section, a person, partnership, state or local governmental agency, or corporation may be both a developer and a deployer.
(c) For the purposes of this section, the following definitions shall apply:
(1) “Artificial intelligence” has the same meaning as in Section 11546.45.5 of the Government Code.
(2) “Biased impact” means an adverse impact, including diminished access to health care, quality of care, or outcomes, on an individual based on their protected characteristics.
(3) “Clinic” has the same meaning as defined in Section 1200 or 1200.1 of the Health and Safety Code.
(4) “Clinical decision support system” means an artificial intelligence system that produces a prediction, classification, recommendation, evaluation, or analysis that aids clinical decisionmaking related to timing of care, diagnosis, or
treatment. It does not include systems that provide appointment management, such as booking, canceling, and rescheduling appointments, appointment reminders, patient education and previsit materials and preparation, and payment processing, to the extent the independent performance of these activities by the system does not require a professional license.
(5) “Deployer” means a health facility, clinic, physician’s office, or office of a group practice that uses a clinical decision support system.
(6) “Developer” means a person, partnership, state or local governmental agency, corporation, or deployer that designs, codes, substantially modifies, or otherwise produces a clinical decision support system for commercial or public use.
(7) “Health care provider” means a person licensed or certified pursuant to Division 2
(commencing with Section 500).
(8) “Health facility” has the same meaning as Section 1250 of the Health and Safety Code.
(9) “Office of a group practice” means an office or offices in which two or more physicians are legally organized as a partnership, professional corporation, or nonprofit corporation licensed according to subdivision (a) of Section 1204 of the Health and Safety Code.
(10) “Physician’s office” means an office of a physician in solo practice.
(11) “Protected characteristic” means a characteristic listed in subdivision (b) of Section 51 of the Civil Code.
(d) This section is in addition to and does not supplant or replace any other applicable provision of state law
regulating the use of artificial intelligence or automated decision systems. Compliance with this section shall not be used as a defense to a claim of unlawful discrimination.