One of Southern California’s largest health systems is facing a potential class-action lawsuit alleging that its use of artificial intelligence (AI) to “secretly” record patient-clinician conversations violates state consumer privacy laws, according to court documents filed on November 26 in San Diego Superior Court.
The lawsuit, brought on behalf of patient Jose Saucedo, accuses Sharp HealthCare of allowing clinicians to use an AI-powered ambient documentation tool that “surreptitiously record[ed] entire medical consultations using electronic recording devices and cloud-based processing systems without notice or consent.” Sharp’s affiliated medical groups, including Sharp Rees-Stealy Medical Group, SharpCare Medical Group, and Sharp Community Medical Group, are also named as defendants.
The case raises broader legal and ethical questions about the growing adoption of AI-driven tools in healthcare — now used for decisions ranging from Medicare prior authorizations to prescription renewals — and whether privacy, consent, and disclosure practices have kept pace.
Rather than challenging the use of an ambient AI tool, the lawsuit focuses on whether it was properly disclosed to the patient and if meaningful consent was obtained.
The technology referenced in the complaint is produced by Abridge, a private Pennsylvania-based company led by UPMC cardiologist Shiv Rao, MD. The AI platform records patient-provider conversations, generates a transcript, and uses that audio to draft a clinical note that physicians can review, edit, and sign — a process the company says reduces administrative burden and clinician burnout.
According to its website, Abridge complies with industry-standard security and privacy controls, such as Health Insurance Portability and Accountability Act and the California Consumer Privacy Act, and has been deployed at more than 200 large health systems, including the Department of Veterans Affairs, Johns Hopkins, and the University of Illinois Chicago.
Saucedo’s attorney, Robert Salgado, declined to comment on active litigation. A representative for Sharp HealthCare also declined to comment on the lawsuit but told Medscape Medical News that patient safety and privacy remain top priorities for the organization. Abridge did not respond to a request for comment.
Alleged Recording Without Consent
The lawsuit states that during a routine physical exam at Sharp Rees-Stealy clinic in July 2025, Saucedo was neither informed nor asked to consent to the audio recording of his visit. The visit audio was captured using a clinician’s microphone-enabled device without Saucedo’s knowledge, transmitted to a third-party vendor’s cloud, and used to draft a clinical note.
Saucedo later discovered documentation in the patient portal indicating that he had been “advised” that the visit audio was being recorded and that he had “consented.” The complaint calls that language false.
“Defendants knew they had not implemented a reliable, standardized workflow to ensure that providers advised patients and obtained consent before recording, yet they used boilerplate language [in the health record] indicating that such advisement and consent occurred,” the lawsuit said.
After Saucedo requested that Sharp and Abridge delete the recording and any associated transcripts, court documents indicate that Sharp personnel informed him that the vendor retains the data for 30 days after a visit, so the recording could not be promptly deleted. The lawsuit claims that Sharp instead offered to remove or modify the AI-generated clinical note.
Beyond consent, the lawsuit alleges that Sharp’s use of the AI tool violated multiple California privacy and confidentiality statutes by allowing vendor personnel access to recordings and transcripts. The health system “benefited operationally and financially…without implementing lawful consent, authorization, and deletion safeguards,” the complaint stated.
Sharp HealthCare announced its partnership with Abridge in April 2025. Salgado is seeking class-action certification that could allow any California resident to join the suit if they had a medical visit with a Sharp HealthCare provider that was audio recorded without consent on or after April 1, 2025.
Disclosure and Consent in Practice
As more AI is introduced into the exam room, research has underscored the value of repeatable consent practices that allow adequate time to discuss risks and benefits, are supported by digital resources, and offer clear opt-out options.
Abridge’s support materials recommend that clinicians disclose the use of its recording tool at the start of the visit and follow their organization’s patient-consent policies. The guidance includes a sample script: “I will be using a tool that records our conversation to help me write my clinical note, so I can pay more attention to our conversation and less time on the computer. Is that okay with you?”
James Bigham, MD, family medicine physician at UW Health in Madison, Wisconsin, told Medscape Medical News that he follows a similar script when using the tool. UW Health began piloting the technology in 2024, documenting outcomes through internal studies and publishing an open-source implementation guide to help health systems establish best practices for ambient AI.
If the patient agrees, Bigham places the recording device in view between himself and them. “If someone says, ‘I’m not sure I want this part of the conversation transcribed,’ I’ll just press pause,” he said. “That’s pretty empowering for the patient.”
But the lack of federal laws regulating AI tools in clinical practice has left many states grappling with how to respond to the rapid rise of these technologies, David Simon, JD, associate professor of law at Northeastern University School of Law in Boston, told Medscape Medical News.
Some states, including California, have passed targeted AI laws that prevent AI systems from posing as clinicians, but gaps remain.
“States and the federal government have been slow to develop AI-specific disclosure laws in medicine,” Simon said. Instead, he anticipates that cases like Sharp’s will rely on existing state privacy and consumer protection statutes, such as laws governing the recording of confidential communications, the handling of sensitive medical information, and invasion-of-privacy claims.
While state consumer laws vary in scope, Simon said that California offers several legal avenues for individuals to bring claims and seek statutory damages, making it a common venue to address potential grievances.
Those legal questions often overlap with evolving ethical responsibilities for clinicians, health systems, and technology vendors. In a recent Journal of Clinical Oncology paper examining AI documentation tools, Simon and his co-authors emphasized the importance of maintaining human oversight in AI-generated notes and clearly defining accountability for tools introduced into clinical workflows.
“The best practice is to give the patient a choice and let them direct their own care plan,” Simon said.
Still, disclosure alone isn’t a viable solution. “Health systems and vendors have a responsibility to vet these tools before deployment, train clinicians on their limitations, and keep a close eye on how they perform in practice.”
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.