USA – CALIFORNIA Trends and Developments Contributed by: Lowell Brown and Douglas Grimm, ArentFox Schiff LLP
utilisation management to ensure human oversight in coverage decisions. • The California Attorney General’s legal advisories on AI in healthcare also serve to interpret how existing state laws, including consumer protection and anti-discrimination statutes, apply to AI sys - tems, reinforcing compliance expectations beyond other mandates. Liability and Malpractice Considerations for AI-Assisted Diagnosis and Treatment The integration of artificial intelligence into clinical practice introduces complex liability and medical malpractice considerations that must be carefully managed. Traditional legal doctrines, designed for human-centric medical care, are being re-evaluated in the context of AI-assisted diagnosis and treatment, requiring healthcare providers to implement specific risk management protocols. Consider the standard of care, for example. Standard of Care in an AI-Augmented Environment Medical malpractice claims traditionally hinge on the “standard of care,” defined as the level of skill and judgment that a reasonably competent physician would exercise under similar circumstances. As AI tools become more prevalent and accurate, the standard of care itself may evolve. While litigators may argue that a physician was negligent for under- utilising advanced AI tools that could have improved diagnostic accuracy or treatment outcomes, physi - cians should document their clinical reasoning when choosing not to rely on AI recommendations to dem - onstrate appropriate medical judgment. Conversely, if a physician relies on a faulty AI recom - mendation that leads to patient harm, questions arise about whether the reliance itself was negligent or if the liability extends to the AI developer. Healthcare pro - viders must establish clear protocols for documenting their review and validation of AI recommendations to demonstrate appropriate clinical judgment. The Medical Board of California emphasises that AI tools are generally not capable of replacing a physi - cian’s professional judgment, ethical responsibilities,
or accountability, reinforcing that human oversight remains paramount. The legal system currently lacks extensive precedent for AI-assisted malpractice. The question of whether AI falls under traditional product liability laws (which typically apply to medical devices) or medical mal - practice doctrines remains an open issue for courts. Corporate Practice of Medicine and AI California’s famously stringent prohibition on the cor - porate practice of medicine (CPOM) is particularly relevant to AI in healthcare. This doctrine generally prohibits lay persons or entities from providing or engaging in clinical healthcare practices, ensuring that licensed professionals make medical decisions unhindered by fiscal or administrative management. Now that AI has been grafted onto that ambitious regulatory scheme, the California Attorney General’s office has, of course, stated that AI cannot replace or override healthcare providers’ decisions and using AI to make decisions about patient treatment or to over - ride medical needs may violate this ban. Data Privacy and Security Requirements Specific to Healthcare AI Much as the once-revolutionary electronic medical record, AI’s integration into healthcare systems adds yet another revolutionary impact on the handling of sensitive patient data, necessitating strict adherence to privacy and security regulations. California’s legal framework, encompassing both the CCPA/CPRA and CMIA, imposes significant obligations on healthcare AI stakeholders, including the following. • The CCPA, as amended by the CPRA, is central to data privacy in the state, particularly with its expanded definition of “sensitive personal informa - tion” to include health data and “neural data.” This means that AI systems processing such data must comply with consumer rights, including the right to know what information is collected, the right to delete it, and the right to opt out of its sale or shar - ing. • The CPRA grants consumers the right to limit the use and disclosure of their sensitive personal infor - mation to specific, defined purposes.
152 CHAMBERS.COM
Powered by FlippingBook