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December 9, 2024
The Artificial Intelligence in Health Services bill signed by Gov. Gavin Newsom imposes new requirements on California health care providers that use generative artificial intelligence tools to generate communications with patients.
The law introduces new guardrails for California health care providers deploying GenAI to reach patients and is part of California's broader efforts to regulate the rapidly growing field of generative artificial intelligence (GenAI). is. Developers of GenAI tools intended for use by health care providers in California should be aware of the new law and coordinate with their customer health care providers to support compliance with these new requirements. There may be cases.
AB 3030 Requirements
The Artificial Intelligence in Health Services Act (AB 3030)(1) specifies that AI-generated patient communications about a patient's clinical information were created using GenAI and that the patient We require you to provide a disclaimer that provides clear instructions on how to contact us. Human health care providers. Specifically, the law requires any “health care facility, clinic, clinic, or group practice” in California that uses GenAI to generate “written or oral patient communications regarding a patient's clinical information.” Applies to
Such GenAI communications from health care providers must also provide clear instructions on how the patient can contact a human health care provider, facility employee, or other appropriate person.
Specifically, the requirements of AB 3030 apply to each communication generated by GenAI that relates to clinical information with a patient, regardless of whether the patient has previously been contacted in a GenAI communication. AB 3030 also includes specific requirements regarding the placement of disclaimers in written, audio, and video communications.
AB 3030 requires only certain GenAI communications to include a disclaimer and/or instructions to contact the appropriate person. Most importantly, AB 3030 does not apply if the communication is “read and reviewed by a human licensed or certified health care provider” before being distributed. This law also does not affect GenAI's communications that do not involve patient customer information, such as communications for scheduling appointments or billing.
The California Medical Board and the California Osteopathic Medical Board have jurisdiction over physicians who violate AB 3030. These committees plan to create a process for reporting complaints on their respective websites, but the implementation date for this reporting process is unknown. Licensed clinics and health care facilities that violate AB 3030 are subject to the enforcement mechanisms described in Chapters 1 and 2 of Title 3 of the California Health and Safety Code.
Background to AB 3030
AB 3030 follows a series of government actions in the field of AI.
Governor Newsom's 2023 State Executive Order to Study the Development, Use, and Risks of AI Technologies. California Privacy Protection Agency's pending regulation of companies that use “automated decision-making technology.” and the Biden-Harris Administration's 2023 Blueprint for AI Bill of Rights.
This is also consistent with the recommendations of the American Medical Association's Principles for the Development, Deployment, and Use of Augmented Intelligence, which advocates transparency and disclosure when using AI-enabled tools.
About GenAI Positive effects and potential risks of implementing GenAI in direct patient care activities.
influence
These new requirements impact both GenAI developers and healthcare providers in California who are currently using or considering using GenAI tools. Developers serving the California healthcare industry may need to update or modify their GenAI tools to meet new disclaimers and instructional requirements regarding AI-generated patient communications. California health care providers using or considering using GenAI tools should exercise due diligence to ensure compliance with these new requirements.
The legal landscape impacting GenAI and other digital health technologies is continually evolving, and healthcare remains a highly regulated area. Both healthcare providers and digital health developers need to stay informed about new laws that may regulate, reimburse, or even limit the use of GenAI and related technologies in the healthcare industry.
This includes not only state requirements, such as California's new law and state medical board requirements, but also federal laws and regulations, such as laws and regulations imposed by the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the Civil Affairs Bureau. It also includes regulations. Rights in the context of federal cybersecurity and data protection law.
how we can help
Morgan Lewis attorneys leverage their experience in GenAI and other digital-related regulations to guide and provide strategic counseling to healthcare providers and developers of artificial intelligence, machine learning, and other medical technology tools to help them navigate regulatory and regulatory issues. We help you assess, anticipate, and respond to legal changes. medical technology at both the federal and state levels;
