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What a therapy bot shutdown says about AI regulation

July 3, 2025
Health Tech Correspondent

Good morning health tech readers!

Before your ride off into the long weekend I've got a story for you that explores the tension between FDA regulation and business imperatives.

And if you've been holding out on a STAT subscription, we're having a big 50% off sale for the holiday.

Reach me: mario.aguilar@statnews.com

policy

What happened to Woebot?

Woebot Health this week shut down its core product, a friendly therapy chatbot that guided people through conversations meant to help with anxiety and other issues, using techniques rooted in cognitive behavioral therapy.

In a new story, founder Alison Darcy told me that the end was brought about by the cost and challenge of fulfilling the Food and Drug Administration's requirements for marketing authorization. This was a problem even before the company started trying to figure out how to add generative AI elements to the bot. This highlighted another issue: FDA hasn't offered guidance on how developers should test and validate products that are based on LLMs, creating a lot of uncertainty for startups. Rather than keep running against regulations, Darcy decided to shut the app down.

But Darcy isn't winding down the company. A team of nine people are working on something new. This time they'll steer clear of FDA.

The whole story underscores how regulations have struggled to keep up with new technology — as well as the business challenge of bringing new modalities to market. 

Read more here


Artificial intelligence

Ready to play AI bingo?

Screenshot 2025-07-02 at 4.19.26 PM

In STAT's AI Prognosis newsletter yesterday, my colleague Brittany Trang put together a health AI bingo card for the rest of the year. She asked over 90 health care and life sciences AI experts where they think the tech is headed by the end of 2025. Do you think there will be a lawsuit over a clinical AI making a mistake? Or a lawsuit over a clinician NOT using AI to catch a human mistake? 

Check out the whole edition for a full rundown of comments and a big version of the bingo card you can tack on your bulletin board.



Wearables

ONC relaxes some testing enforcement for EHRs

STAT's Brittany Trang writes: The health department's IT regulator announced this week that as part of a push to reduce costs and work for the private sector, it will not be enforcing some regulations related to certified electronic health records.

For 2025, makers of certified EHRs don't have to submit plans for how they will do real-world testing of their systems' ability to transmit and receive health data. In 2026, those vendors won't be required to do that testing, except for testing various APIs that help software systems talk to each other. This shift to focusing only on APIs echoes what several people in the industry have been pushing for: Certifying critical modern capabilities rather than older tech.


Health techies run for office

Nothing says "I'm a health tech executive" like launching your political campaign on LinkedIn.

This week Tina Shah, who until recently was chief clinical officer of AI scribe company Abridge, announced she was seeking the Democratic nomination to represent New Jersey's 7th congressional district. 

Just a few weeks ago, Owen McCarthy, board president and cofounder of medical device company MedRhythms, announced he was running for the Republican nomination to be the governor of Maine.

Time to find out how health tech polls!


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What we're reading

  • How the tax-cut bill that just passed the Senate would upend health care, STAT
  • A machine learning model using clinical notes to identify physician fatigue, Nature Communications
  • Memo said to describe biotech industry meeting calls RFK Jr. a 'direct threat to public health,' STAT

Thanks for reading! More next time - Mario

Mario Aguilar covers how technology is transforming health care. He is based in New York.


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