Q I heard there is a new California law that regulates the use of artificial intelligence in the healthcare industry. Is this true?

A Yes. On Jan. 1, California’s Assembly Bill 3030 became effective, marking a significant step in California’s regulation of generative artificial intelligence (known as “GenAI”). In general, AB 3030 requires providers in the healthcare industry to notify patients when they utilize GenAI to generate written or verbal communications with the patient. To understand this new law, a brief overview of GenAI is helpful.

GenAI is a type of artificial intelligence that is capable of creating new digital content, including text, audio, images and video, by analyzing vast amounts of data. In healthcare, this technology has transformative potential and can significantly enhance medical research, diagnostics and patient care. However, its use also raises ethical and practical concerns about transparency, accountability and data accuracy. AB 3030 addresses these concerns by requiring healthcare providers to disclose their use of GenAI in creating patient communications.

AB 3030 covers health facilities, clinics, physician’s offices and group practices that use GenAI technology to create verbal or written communications about a “patient’s clinical information.” Under AB 3030, “patient clinical information” means information relating to the health status of a patient, as errors in care-related communications have potential to cause greater patient harm.

Examples of covered communications include automated emails explaining test results, AI-generated summaries of diagnoses or audio recordings providing treatment instructions. Businesses that fall under this category must include two important disclosures in their communications with patients.

First, the covered business must include a disclaimer stating that the communication was generated using GenAI. For written communications involving physical and digital media (e.g., letters and emails), the disclaimer must appear at the beginning of each communication. For written communications involving continuous online interactions (e.g., chat-based telehealth), the disclaimer must be displayed throughout the interaction. For audio communications, the disclaimer must be provided verbally at the start and end of the interaction. For video communications, the disclaimer must be displayed throughout the video.Second, the covered business must provide clear instructions on how patients can contact a licensed or certified healthcare provider or a human employee of the business. This ensures that patients have access to someone who can clarify or expand on the information provided.

AB 3030 includes a significant exception. Under the law, a covered business does not need to provide these two disclosures if the communication has been reviewed and approved by a licensed or certified healthcare provider. Moreover, because the law only applies to communications about a “patient’s clinical information,” the disclosure is not required for communications pertaining to administrative and business matters, such as appointment scheduling, check-up reminders and billing.

AB 3030 includes significant enforcement measures. Health facilities and clinics that fail to comply will be subject to penalties, including fines and licensure actions. Similarly, physicians who violate AB 3030 may be subject to disciplinary action against their licenses.

Covered businesses can avoid these penalties by being proactive in the areas of communication templates, staff training and revised policies and procedures.

Though AB 3030 is currently focused on the healthcare industry, it represents California’s broader effort to regulate and mitigate the potential risks of GenAI in numerous settings. Businesses are encouraged stay up-to-date on the changing legal landscape and may contact their legal counsel with questions about AB 3030 or similar laws.

Marco Lucido is a lawyer with Fenton & Keller in Monterey. This column is intended to answer questions of general interest and should not be construed as legal advice. Email queries to email@fentonkeller.com.