startups
When is an AI doctor a medical device?
Call it a sign of things to come. A startup called Doctronic made a splash recently when it announced the use AI to renew prescriptions without clinician input in the state of Utah. Something didn't sit right with me about the announcement. Sure it got approval from Utah, but why isn't it a medical device subject to Food and Drug Administration review? The company claimed it was "the practice of medicine" and so exempt from FDA authority. That didn't seem entirely right either.
So I did some asking around and after talking to over a dozen executives, legal scholars, and policy experts, it turns out the question is not nearly as clear-cut as Doctronic would have us believe. Indeed, it appears the company may be planning to market a medical device without authorization. In my story, I explain the law and why it all matters.
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policy
How is HHS using AI these days?
The federal health department last week released its annual AI Use Case Inventory, which details how AI is used within the agency. From 2024 to 2025, the number of AI tools the agency uses jumped by 64% and shifted toward early-stage tools in acquisition, development, and pilots, reports STAT's Brittany Trang.
Besides tools called, in true CMS acronym style, C3PO and ELMO, the report sheds light on how agency contractors are using AI for Medicare Advantage audits, and how agency departments are using the tools to cope with the changes to their operations since the beginning of the Trump administration.
Read more in Brittany's story
lawsuits
What to know about Veeva v. Epic
Brittany Trang writes: Late last week, documents for the Veeva v. Epic lawsuit dropped. If you're not familiar, Veeva is the Epic of the pharma and medtech world, offering software that helps manage clinical trials, manufacturing quality, regulatory compliance, drug safety, and so on. Veeva is suing Epic for making its post-employment covenants — including its non-compete clauses and stock purchase agreements — too restrictive.
How does this relate to Veeva? Well, last fall, Epic leader Fritz Schmidt texted Veeva manager and ex-Epic employee Nick Frenzer saying that Veeva's recruitment tactics for Epic employees were "belligerent." Veeva alleges that Epic subsequently added Veeva to the list of companies on its non-compete list, even though the companies do not actually compete with each other. This, in turn, made an Epic employee interviewing at Veeva drop out from the process because they couldn't afford to lose their Epic stock by violating the non-compete.
For now, it looks it like a spat between companies, but it resonates with more consequential litigation. Epic's restrictive non-competes are a (much-redacted) point of contention in the suit against it filed in Texas by state attorney general Ken Paxton. I'm interested to see how the proceeding in the Veeva case affects growing antitrust sentiments towards Epic.
telehealth Lawmakers raise concerns about TrumpRx website
In a letter to the health department's Office of Inspector General, lawmakers raised concerns about how the Trump Administration's website for discounted drugs will work.
Sens. Dick Durbin (D-Ill.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.) hope to learn how telehealth providers are involved in TrumpRx and whether the arrangements might pose conflicts of interest.
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