1339.78.
(a) On or before July 1, 2027, a health facility, clinic, physician’s office, or office of a group practice that uses or deploys a clinical decision support system for patient care shall
make available, upon request from a licensed health care professional or other person using a clinical decision support system or viewing outputs from a clinical decision support system, an inventory of all clinical decision support systems currently in use or deployed for patient care. This list shall be updated at least annually.(b) A health facility, clinic, physician’s office, or office of a group practice that uses or deploys a clinical decision support system for patient care shall make available, upon request from a licensed health care professional or other person using a clinical decision support system or viewing outputs from a clinical decision support system, information about the clinical decision support system. Information required by this subdivision shall include all of the following:
(1) A summary of the clinical decision support system, including developer and description of the output produced by the system.
(2) Intended use of the clinical decision support system, including intended patient population, intended users, and intended
role in supporting clinical decisionmaking.
(3) Cautioned out-of-scope use of the clinical decision support system, including known risks and limitations.
(4) Summary of how the clinical decision support system generates outputs.
(5) Summary of the training set or clinical research underlying recommendations, including demographic representativeness and known biases based on protected characteristics.
(6) Summary of the validation process.
(7) Summary of qualitative measures of performance.
(8) A link to the Certified
Health IT Product List produced by the Office of the National Coordinator for Health Information Technology at the United States Department of Health and Human Services.
(c) A health facility, clinic, physician’s office, or office of a group practice that uses or deploys a clinical decision support system for patient care shall notify a licensed health care professional or other person whose duties include using a clinical decision support system or viewing outputs from a clinical decision support system, upon hire and annually, of their right to request the inventory of all clinical decision support systems currently in use or deployed for patient care.
(d) (1) A violation of this section by a licensed health facility is subject to the enforcement
mechanisms described in Sections 1280 and 1280.3.
(2) A violation of this section by a licensed clinic is subject to the enforcement mechanisms described in Section 1229.
(3) A violation of this section by a physician is subject to the jurisdiction of the Medical Board of California or the Osteopathic Medical Board of California, as appropriate.
(e) For purposes of this section, the following definitions shall apply:
(1) “Artificial intelligence” has the same meaning as in Section 1339.75.
(2) (A) “Automated decision system” means a computational process
derived from machine learning, statistical modeling, data analytics, or artificial intelligence that issues simplified output, including a score, classification, or recommendation, that is used to assist or replace human discretionary decisionmaking and materially impacts natural persons.
(B) “Automated decision system” does not include a spam email filter, firewall, antivirus software, identity and access management tools, calculator, database, dataset, or other compilation of data.
(3) “Clinic” has the same meaning as defined in Section 1200.
(4) “Clinical decision support system” means an automated decision system or generative artificial intelligence system whose outputs produce
that produces a prediction, classification, recommendation, evaluation, or analysis that is used to inform clinical decisionmaking with respect to the provision, timing, or course of patient care.
(5) “Generative artificial intelligence” has the same meaning as defined in Section 1339.75.
(6) “Health facility” has the same meaning as defined in Section 1250.
(7) “Office of a group practice” has the same meaning as defined in Section 1339.75.
(8) “Physician’s office” has the same meaning as defined in Section 1339.75.
(f) This section does not apply to the use of a clinical decision support system for documentation, communication, or other administrative tasks that do not involve the application of professional judgment by a licensed health care professional, including, but not limited to, automated messages to inform patients of their health records.