STAT Staff and Mario Aguilar , 2025-05-01 20:52:00
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Last week, I flagged a proposal for “Smart Deregulation” by the EHRA, which represents medical record software companies like Epic Systems and Oracle Health. The organization basically wants the federal health department to walk back certain requirements for software used by health systems that work with programs like Medicare. These rules are the standards across the industry.
Yesterday, Josh Mandel, Microsoft Research‘s chief architect for health, wrote that the proposal would “dismantle critical data access capabilities.” He focuses on two requirements around exporting patient records but more broadly points out that new features that benefit patients and the health care system often require significant investment. “Without clear regulatory drivers… the market historically underprovided these foundational capabilities.”
HHS quiet on nondiscrimination rule
Last year, the Biden administration issued a final rule clarifying that clinical decision support tools, including some using AI, should not discriminate against patients based on traits like age, sex, race, and disability. That rule is supposed to go into effect for federally-funded health systems today, May 1, but as Katie Palmer reports, the systems are in limbo owing to lack of clarity about how to comply with the rule. The Trump administration has been hostile to anything with that sounds like it might be related to DEI, and early on, it removed from health department websites information about the rule. Read more here
Telehealth deals: Mental health, GLP-1s, women’s health
- Yesterday, Teladoc Health announced it acquired UpLift, a virtual mental health company, for $30 million — with up to $15 million in additional earnout payments. You might be thinking: Doesn’t Teladoc already have a huge mental health company in BetterHelp? It does! But UpLift works with health plans and boasts “arrangements” covering over 100 million people. Consumers usually pay for BetterHelp out of pocket, and securing benefits coverage for the services is one of the ways Teladoc hopes to stabilize BetterHelp’s revenues. As I wrote in January, Teladoc is doing its best to rebuild investor confidence after disappointing results that followed huge growth during the pandemic. The company yesterday reported unremarkable earnings, highlighting the company’s ongoing effort to get back on track.
- Novo Nordisk announced a deals with telehealth providers including Hims & Hers , Ro, LifeMD, and others to make lower-cost versions of its GLP-1 drugs more easily available on the platforms. The deals are notable because Novo has been at odds with telehealth companies that dispense compounded copies of its blockbuster diabetes and weight loss drugs. Read more from STAT’s Elaine Chen here.
- LifeMD this week also announced it acquired Optimal Human Health MD, a women’s health virtual care provider that will serve as the foundation for an offering “focused on hormone health, bone density, metabolism, and long-term wellness.”
Many AI devices cleared by FDA without clinical data
A bit more than half of the AI medical devices authorized by the Food and Drug Administration reported data about their clinical performance, according to a new study in JAMA Network Open. Researchers analyzed 901 AI devices listed on the agency’s website at the end of August 2024 and found 505 reported clinical studies — 218 explicitly stated that no performance studies had been conducted. The authors point out that without data, it’s impossible to assess the generalizability of a device’s performance. This is an ongoing concern and underscores that an FDA greenlight does not mean a device should be adopted in a given population. Relatedly, Katie recently wrote about missing data around the performance of devices in pediatric populations.
New remote monitoring bills would increase payments in rural areas
Lawmakers in the House and Senate this week introduced bills that would have the result of increasing Medicare payments for remote monitoring of patients in rural areas. The bills come amid a broadening debate about how much and when to pay for doctors to monitor remotely collected patient data from blood pressure cuffs and other devices.
The formula Medicare uses to arrive at payment amounts for different services results in lower payments in rural areas. The bills would set a floor on the formula’s inputs for practice expenses and malpractice expenses for RPM services. The hope is to incentivize the use of RPM in rural areas where some argue it has the most potential impact.
Verily’s Parkinson’s deal, Stanford AI pilot, and more
- Verily this week announced a $14.7 million grant from the Michael J. Fox Foundation to create a molecular dataset for Parkinison’s disease research.
- Atropos Health, which helps clinicians use real world evidence, announced a new pilot with Stanford Health Care. The company last year raised $33 million.
- Two Chairs, a provider of virtual and in-person mental health services, announced it will launch psychiatry services. The company last year announced it raised $72 million.
