A recent lawsuit filed in San Diego Superior Court alleges that Sharp HealthCare recorded conversations between doctors and their patients without written consent, using the information to document visits with an artificial intelligence program developed by a private company in Pittsburgh.<\/p>\n
While the lawsuit focuses on one particular medical provider in San Diego County, attempting to create a class-action claim made up of Sharp patients, it also shines a spotlight on the quiet, but broad adoption of AI-powered clinical transcription software throughout mainstream medicine.<\/p>\n
A survey of San Diego medical providers made after the lawsuit was filed on Nov. 26 shows that several providers in the region are using similar systems.<\/p>\n
Rady Children\u2019s Hospital in San Diego said in an email that it is \u201ccurrently conducting a limited pilot of ambient scribing technology with clinicians required to obtain patient consent prior to use.\u201d UC San Diego Health confirmed that it uses a system called Nabla, which it installed \u201cafter a thorough security review.\u201d The university health system says that it requires patient consent before using the system, which includes \u201can annual written consent (plus) verbal consent from the patient and all parties in the exam room at each visit.\u201d Kaiser Permanente said in a statement that its clinicians \u201chave access to a clinical documentation assistance tool that supports them with securely capturing initial clinical notes during visits with patients, which enables them to focus more on patient care.\u201d Kaiser says its system \u201ccalls for the care team to ask our patients and other individuals accompanying them for their permission before using the tool.\u201d<\/p>\n
Scripps Health, one of the big four medical providers in the San Diego market, declined to discuss whether it uses such a system, saying in a statement that it \u201cisn\u2019t a topic we will be discussing.\u201d<\/p>\n
Paradise Valley Hospital said it is not using any sort of AI note-taking system, while Palomar Health and Tri-City Medical Center in North County did not respond to the query.<\/p>\n
Asked for comment on the lawsuit\u2019s allegation that it did not properly inform patients of its medical documentation system, Sharp said that while \u201cpatient safety and privacy are our top priorities at all times,\u201d it is \u201cunable to comment on pending litigation.\u201d<\/p>\n
The lawsuit, filed on behalf of Sharp patient Jose Saucedo by attorney Robert Salgado, seeks certification as a class action, and alleges that Sharp violated medical privacy laws \u201cby surreptitiously recording entire medical consultations using electronic recording devices and cloud-based processing systems without notice or consent.\u201d<\/p>\n
The suit seeks unspecified compensatory and punitive damages, also stating that the state penal code allows damages of $5,000 per violation.<\/p>\n
Recordings, the lawsuit states, were transmitted to Abridge, a Pittsburgh-based technology company that has recently received major tech sector investment in its AI-enabled system, which it said in a news release on Dec. 10 is now used \u201cacross more than 200 ambulatory care settings annually.\u201d<\/p>\n
The company has posted information on its website that helps its customers and the public learn about how it operates.<\/p>\n
A \u201crecording basics\u201d entry in the company\u2019s customer support center does urge clinicians to \u201cmake sure you follow your organization\u2019s recommended guidelines for patient consent,\u201d even providing sample language that could be used in such situations.<\/p>\n
Abridge suggests that doctors could say: \u201cI 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?\u201d<\/p>\n
The technology uses an application installed on a physician\u2019s smartphone to make the recording, which a list of \u201cbest practices\u201d indicates should be placed \u201cin between you and your patient without any obstructions.\u201d Abridge also says on its website that its technology is \u201c100% HIPAA-compliant, and uses industry best practices to protect patient information,\u201d indicating that the data it collects \u201cis always stored via secure channels\u201d that comply with HIPAA, the Health Insurance Portability and Accountability Act of 1996, which prevents unauthorized disclosure of sensitive patient information.<\/p>\n
But Abridge also indicates in the privacy policy<\/a> for its website that it creates separate privacy agreements with each of its clients, directing patients to \u201crefer to your provider\u2019s Notice of Privacy Practices for information on how they handle your (protected health information). Sharp does list a privacy policy<\/a> on its website, though the document is dated April 14, 2003.<\/p>\n Abridge indicates that it complies with the California Consumer Privacy Act and on its website<\/a> it says that it meets \u201cSystem and Organization Controls\u201d level two requirements created by the American Institute of Certified Public Accountants. Those rules specify how digital information should be kept secure against unauthorized access, free of corruption and private. Abridge indicates that its compliance with SOC 2 rules has been \u201cvalidated by an independent third-party auditor for security and confidentiality.\u201d<\/p>\n A public statement<\/a> that Abridge published on its website in 2020 says that it used 10,000 hours of transcribed conversations between doctors and patients to train its AI models, and that this \u201cdeidentified\u201d information came from \u201cfully informed and consenting patients.\u201d A separate statement<\/a> in 2020 indicates that all research and development uses de-identified data and that such information is \u201cacquired with patient consent.\u201d But it is not clear whether or not the company uses the real-world conversations transmitted from its clients to Abridge\u2019s servers for analysis to train future generations of the company\u2019s models.<\/p>\n The company did not respond to a request for comment on the matter.<\/p>\n Privacy advocates are increasingly concerned about the quick-moving world of AI as it enters the world\u2019s most sensitive spaces.<\/p>\n Sara Geoghegan, senior legal counsel for the Electronic Privacy Information Center in Washington, D.C., said that it is quite clear that patient permission is required when recordings are being made.<\/p>\n \u201cDefinitely, transparency is a necessary step as is disclosure and meaningful consent,\u201d Geoghegan said.<\/p>\n And that consent, she added, should not just be obtained once. It should be obtained on its own, she added, and not tacked onto the voluminous paperwork process that patients often must wade through during an office visit.<\/p>\n \u201cIt should be consent that\u2019s freely informed and can be rescinded,\u201d Geoghegan said. \u201cOnce every 10 years is not enough.\u201d<\/p>\n