A provocative attempt at AI deregulation

Five years into covering the Food and Drug Administration I learned something surprising: Anybody can write to the FDA and just ask that regulators exempt device categories from typical premarket reviews. If the FDA doesn't do anything within 180 days, the exemption is granted.

As I report in a new story, with Katie Palmer, this is exactly what startup Harrison.ai has done: It submitted a petition late last year to exempt from review six different classes of AI products, provided the FDA had previously authorized a relevant product from a company. The FDA has to respond by mid-April, or the petition will be effective.

In ordinary times, sources told me, FDA would almost certainly respond with a detailed explanation of its thinking. But Trump's FDA has made big promises about deregulation. Maybe this offers leaders an opportunity.

Speaking of leaders, last week I broke the news, with Lizzy Lawrence, that Rick Abramson will be the new leader of FDA's Digital Health Center of Excellence. Abramson is a former senior executive at a Harrison.ai subsidiary. Now he directs the office that leads FDA's policy efforts on AI.

telehealth

Hims downplays compounding mess with investors

On a company earnings call, Hims & Hers CEO Andrew Dudum sought to downplay the recent fracas around its practice off compounding cheaper versions of blockbuster obesity and diabetes drugs, Katie Palmer reports.

Dudum said that while GLP-1s have been a "meaningful accelerant" for the company, Hims is more than a one-trick pony: A majority of the company's 2025 revenue came from offerings other than GLP-1s. Nevertheless the company is currently facing a lawsuit and a federal investigation over its GLP-1 compounding. Was it worth it?

policy

HHS health tech advisors meet for first time under Trump

Brittany Trang writes: The Health Information Technology Advisory Committee (HITAC), which advises ASTP/ONC, met last week after meetings were cancelled a year ago when President Trump came into office.

Seth Pazinski, the committee's designated federal officer from ASTP/ONC, said that in contrast to previous years, the committee's annual report will focus only on topics outlined in statute: Interoperability, privacy and security, and patient access to their information. Several HITAC members voiced concern about this, saying that issues like AI and the CMS health tech ecosystem initiative are very important but aren't in statute, and that HITAC should discuss them.
Several people asked why the latest ASTP proposed rule moves away from the model card "nutrition label" for AI models in electronic health records. The reply from Mike Lipinski — director of regulatory and policy affairs at ASTP — made it sound like this was due to the EHR industry. "We heard back from EHR developers the amount of burden that it was creating for them, in terms of cost to do this without definitive evidence that it would create the benefits that we estimated," he said. The fact that only EHR vendors were subject to the rule as opposed to all health AI vendors was a point of contention, too, he said — whether only EHR vendors were being "hindered" in their "attempts at innovation."
HITAC member Anna McCollister brought up the problems ultimately underlying the Particle – Epic and Epic – Health Gorilla lawsuits: People are requesting data under the "treatment" purpose on data exchanges like TEFCA and Carequality because they want to use the data for secondary purposes. By not saying anything, she argued, TEFCA is letting that kind of behavior continue and ruining trust with other users. McCollister is a board member at MediKarma and The Sequoia Project.

Health tech news roundup

Labcorp announced it is expanding its collaboration with PathAI to use its FDA-cleared digital pathology platform.
Signing up for Medicare could soon involve AI that helps you find the best plan, STAT's Bob Herman reports.
Medicare's forthcoming App Library will accept the DiMe Seal from the Digital Medicine Society as a credential for entry. A new app library page from CMS went live last night.
Omada introduced a new cholesterol management offering.
B.well Connected Health, an increasingly popular vendor that helps people access their medical records through different apps and services, announced a new white label health AI assistant that health organizations can use.
AI scribe Heidi Health continued its quest to become a larger platform with the acquisition of AutoMedica, whose technology will underpin Heidi Evidence, a new clinical evidence search tool. Yes, another clinical evidence search tool. Heidi Evidence is also built in part on Anthropic's Claude models.
K Health shutdown its direct-to-consumer AI care offering, Exits & Outcomes reported. The company has a foothold with major health systems and there are a growing number of companies working on direct-to-consumer health care products that use chatbots on the front end.

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