Can a nonprofit sort digital health's fact from fiction?

A new $50 million initiative from the Peterson Center on Healthcare aims to help patients, insurers and health systems assess whether health technologies actually impact cost and quality, the nonprofit tells me. The Peterson Health Technology Institute, launched today, plans to share its methodology for evaluating new products and sectors as soon as September.

Today, we're faced with an "an overwhelming number" of digital health products, executive director Caroline Pearson said. "Increasingly, I think patients, health insurers, providers and even investors are really saying, 'How do we make sure digital health tools work, and what does work even mean?'"

PHTI is also partnering with the Institute for Clinical and Economic Review, another nonprofit that evaluates drug cost efficacy and which has ventured into digital health assessments a handful of times — most notably for the now-bankrupt digital therapeutics company Pear.

Whether the industry listens is an open question, said Harvard Business School's Ariel Stern. "Having a really thoughtful neutral party involved in thinking about moving the ball forward could be quite helpful," she said, but added, "understanding who's going to listen becomes vitally important. Otherwise you're just screaming into the void." Read more.

Artificial intelligence

Google and Epic fight stronger AI regulation in health

Also on health records, software titans including Epic are pushing back on proposed federal rules that would increase oversight of tools guiding patient care, Casey writes. Amazon, Google, and health companies spanning providers, insurers and health records vendors are opposing attempts by the Office of the National Coordinator for Health Information Technology to require health software developers inform users about the training and testing of predictive models drawing data from their systems as part of federal certification. The agency also wants developers to evaluate and disclose risks and allow clinicians to report issues.

In public comment on the proposal, Epic said the agency argued that such disclosures might divulge intellectual property. "Considerable imbalance in marketplace transparency — and, ultimately, incentive to innovate — would be created if certified health IT developers have to disclose publicly their intellectual property, while non-certified predictive model developers are not required to make the same disclosure," Epic wrote. Read more on the regulatory debate, and let us know where you stand.

medical devices

Blood tests recalled over missed diagnoses

Device manufacturer QuidelOrtho recalled nearly 8,000 blood tests designed to help determine whether patients are having heart attacks after they inaccurately showed low levels of troponin, a protein indicating drug damage, my colleague Lizzy Lawrence reports.

The consequences of false negatives are grave, potentially leading doctors to conclude patients aren't having heart attacks and delaying diagnosis or treatment. The company told health systems to stop using the tests in May and blamed the error on a "raw material issue."

The Food and Drug Administration deemed the recall "serious" because it could lead to serious injury or death. QuidelOrtho reported 41 complaints but no deaths or injuries so far. Read more from Lizzy.

startups

Here's who's trying to fill the menopause care vacuum

The past few years have seen a new crop of telehealth companies aiming to serve women experiencing or approaching menopause, including with hormone therapy. It's a population that traditional health care has overlooked, STAT's Katie Palmer writes.

"Women fall through the cracks," internist Lisa Larkin, president-elect of The Menopause Society and founder of concierge women's health network Ms. Medicine, told Katie. "That's why the telemedicine business is booming."

Demand is formidable, said Trish Costello, who heads venture firm Portfolia. "There's a number of research groups that have defined menopause just as hot flashes and hormone replacement and supplements, and they'll look at it as maybe a $15 to $18 billion market. But when you start looking at all the parts of women's health that are impacted, you're getting into what some people consider a $600-plus billion dollar market." Read more.

health records

NextGen to pay $31 million to resolve fraud claims

Electronic health record software company NextGen Healthcare will pay $31 million to resolve allegations that it paid customers kickbacks and duped government inspectors, STAT's Casey Ross reports.

Prosecutors said the company gave up to $10,000 in credits to customers whose recommendations generated new sales, and doled out entertainment and sporting event tickets to score sales and referrals.

Justice Department officials said the company used a dummy version of its software for its certification, and that the version it actually distributed fell short — including by being unable to record data on vital signs or completing clinical summaries. Read more from Casey.

Deals

Big Health scoops up mental health app maker Limbix

Mental health app company Big Health announced late last week that it had acquired Limbix, which develops and sells a prescription app for adolescent depression, STAT's Mario Aguilar writes. Terms weren't disclosed.

The deal comes during a particularly fraught period for prescription digital therapeutics companies. Limbix's last round — $15 million at the peak of the digital health funding cycle — was in 2021.

Arun Gupta, who heads Big Health, said the company's heard demand from employer and insurer customers for adolescent mental health solutions. The company could also boost Limbix products through its partnerships with Evernorth and CVS Health. Get the full details on Big Health's strategy here.

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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.