Can AI notes help patients? OpenNotes wants to find out

Patient-focused data research group OpenNotes (part of Beth Israel Deaconess Medical Center in Boston) is embarking on its first sponsored study in a new partnership with AI ambient documentation startup Abridge. The six-month study will evaluate the utility and quality of Abridge's visit summary feature for patients, which automatically transcribes clinicians' conversations during medical exams. Executive director Cait DesRoches, also an associate professor of medicine at Harvard, told me OpenNotes had been observing the speed with which generative AI tools were being integrated into health records, and that "there was very little discussion early on about patients" and how the technology could impact their relationship with clinicians or their ability to use their own medical data.

OpenNotes has historically avoided industry partnerships and sponsored studies, especially in its earlier stages when it was focused on community work and evaluating the benefits of health data transparency to patients, DesRoches said. "But now the innovation is happening so fast that if we were trying to rely only on our standard foundation and federal grant support, I don't think we could move as quickly as the industry is moving," she said.

OpenNotes is also exploring partnerships with other ambient documentation companies, though they haven't been announced. But Abridge, she said, made an apt first partner because leadership is "starting from the conversation with the patient. That's the core of their work, and in many ways that's the core of our work as well...we're really interested in how can transparency improve that engagement and discussion and open communication."

OpenNotes' research division, OpenNotes Lab, will host "insight panels" made up of clinicians and patients to examine Abridge's tool and come up with ideas for improving the summaries for patients' use, including its content and tone, or outlining specific followup items, she said. (You may also want to check out this CrazyStupidTech blog post, and the comments, for more perspective on Abridge.)

EHR land

Researchers decry LLM's 'degradation' of records

In a charged New England Journal of Medicine perspective, a pair of clinicians and an informaticist argue that large language model-generated text could actually be harmful if included in patient records — even if it doesn't hallucinate or slip in factual errors. "Far from being generic transcripts of patient encounters, high-quality notes incorporate the physician's reasoning, the patient's values, and aspects of the clinical context that may not be represented elsewhere in the chart," they write. Click-through checklists, and a tendency to structure medical records to reflect patients' problems "has already limited the degree to which documentation reflects the subtleties of clinical reasoning and patients' goals," they warn, adding, "If it continues on its current trajectory, LLM–EHR integration may amplify these tendencies, cementing the EHR as a billing-oriented, unrepresentative proxy of an actual human being." What do you think? If you agree or disagree, drop me a line.

payers

Medicare finalized coverage for some mental health apps. Now what?

My colleague Mario Aguilar has been doggedly tracking Medicare's slow march toward paying for digital health; late last week regulators finalized rules to cover some mental health apps, he reports. That's a big step for digital therapeutics companies whose success depends on insurance companies' willingness to pay for them. Beginning next year, new codes will allow apps authorized by the Food and Drug Administration to be covered, though that's currently limited to treatment for just a few conditions such as depression and substance use disorder.

"Everything up until now was prologue, this is the beginning of digital therapeutics," Andy Molnar, CEO of the Digital Therapeutics Alliance, an advocacy group for developers, told Mario. (Molnar, you may remember, previously worked at Pear Therapeutics, a digital treatment company that went bankrupt in 2023 — in part because of reimbursement challenges.) Read more from Mario.

eradicating bias

Lawsuit to fix pulse oximeter bias makes progress

My colleague Anil Oza has the latest on efforts to address racial biases built into medical devices: The founding CEO of an Oakland community clinic serving mostly Black and brown patients is suing 12 pulse oximeter manufacturers and distributors over biases in pulse oximeters that consistently overestimate blood oxygen levels in people with darker skin tones. Some medical device companies, including Medtronic, have settled; Medtronic is also educating doctors about the devices' shortcomings.

"It's definitely a step in the right direction — labeling is really needed here — but I think it just doesn't go far enough," Sara Gerke, a professor of law at the University of Illinois College of Law, told Anil. "We need to design better products that work for everyone." Read more.

Telehealth

Earnings season: Hims & Hers

Feel like you can't avoid Hims & Hers weight loss ads lately? Makes sense: In its quarterly earnings on Monday, the company reported that it's spent nearly $460 million on marketing in 2024 so far — close to half of the revenue it's taken in, Katie Palmer writes in. Next quarter, the direct-to-consumer telehealth company said to expect even more ad spending, in part "to educate Americans on the evolving dynamics and solutions in the weight management space," chief financial officer Yemi Okupe said in an earnings call.

That includes the company's oral weight loss meds, along with compounded versions of the popular injectable GLP-1s first enabled by ongoing shortages of the branded medications. The looming end to those shortages would mean an end to the party — but Hims continues to argue it will be able to keep compounding "personalized" versions with different doses. "We believe that dosing specifically for this type of a treatment to mitigate side effects is very much right down the center of what that compounding exemption is built for," CEO Andrew Dudum said.

Cybersecurity

Washington ramps up cyber crackdowns

As cyber experts warn providers and health companies to brace for an onslaught of malicious attacks, the federal government is escalating its own enforcement against provider groups deemed unprepared and unfortified. Late last week, the Health and Human Services Department's Office for Civil Rights announced a $500,000 settlement with a Sioux Falls, South Dakota Plastic Surgery group for "several potential violations" of HIPAA following a ransomware attack.

"Ransomware attacks often reveal a provider's underlying failures to comply with the HIPAA Security Rule requirements such as conducting a risk analysis or managing identified risks and vulnerabilities to health information," OCR director Melanie Fontes Rainer said in a press release.

But there's debate about whether holding providers accountable for the cyber attacks that befall them is the best enforcement strategy; it's no surprise that prominent provider groups have opposed these efforts, arguing that it unfairly penalizes already cash-strapped health organizations.

OCR also announced a $90,000 settlement with an Oklahoma emergency medical services group following a cyberattack; the agency concluded that the group hadn't conducted a compliance risk analysis that would have flagged vulnerabilities before the attack. This is the first enforcement action under OCR's "Risk Analysis Initiative."

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What we're reading

Protein design questions that still challenge AI, Nature
Social media misinformation is scaring women about birth control, STAT
Progress in patient-centric health IT, ASTP/ONC blog
7 companies to watch in AI protein design, STAT

Thanks for reading! More on Thursday - Mohana

Mohana Ravindranath is a Bay Area correspondent covering health tech at STAT and has made it her mission to separate out hype from reality in health care.