Katie Palmer

As AI device market grows, FDA's accounting goes silent As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.

It's been 6 months since the FDA updated its public list of authorized AI-enabled devices. So @statnews.com went ahead and checked how things are going.

At least 167 more AI-enabled devices have gotten cleared or approved since the last one added to FDA's list:

www.statnews.com/2025/06/20/f...

Are you a physician or health care provider using AI tools like OpenEvidence? I want to hear about your experience!

I'm a health tech journalist @statnews.com reporting on clinical AI, and you can find me on Signal at palmer.01 (email in bio)

Health systems in limbo as HHS stays quiet on nondiscrimination rules for AI, algorithms Lack of clarity from officials delay providers' efforts to ensure clinical decision support tools don't discriminate.

May 1 is the deadline for health systems to make sure that AI and other tools informing patient care don't discriminate. But the Trump admin scrubbed information about the civil rights rule months ago. What does that mean for compliance?

My latest for @statnews.com www.statnews.com/2025/04/30/h...

Health systems in limbo as HHS stays quiet on nondiscrimination rules for AI, algorithms Lack of clarity from officials delay providers' efforts to ensure clinical decision support tools don't discriminate.

Work on insuring clinical algorithms are free of bias has been underway for years. Now a May 1 deadline to show tools are bias-free is in limbo as all information about the new rules have been removed from HHS websites. More from @katiepalmer.bsky.social

www.statnews.com/2025/04/30/h...

The end of compounded GLP-1 copies leaves many patients in a ‘lose-lose’ position With GLP-1 shortage officially over, patients who relied on compounded copies have only bad options to choose from

The explosion of compounded GLP-1 offerings is ending, and many patients are left with no good options.

Telehealth companies and compounders are pursuing workarounds that may be riskier. At the same time, patients still can't afford the branded drugs. w/ @katiepalmer.bsky.social

HHS will not enforce gender and sexual orientation requirements for medical records HHS will not enforce standards that medical records be able to capture patients’ sexual orientation and gender identity.

In 2026, HHS was set to require fields for sexual orientation and gender identity in EHRs, supporting research and better care for LGBTQ+ patients.

Now, HHS won't enforce those requirements. Read in @statnews.com about impacts on providers and EHR vendors: www.statnews.com/2025/04/01/h...

Hi @jenniferholton7.bsky.social , I'm a health tech reporter at STAT News interested in hearing more about your experience. If you're open to sharing, feel free to reach out at katie.palmer@statnews.com

Are you affected by the HHS cuts and restructuring? HHS is set to cut 10,000 jobs and consolidate divisions — have you been affected? @statnews would like to hear from you.

Reporters @statnews.com are following the HHS restructuring closely — on the health tech team, we especially want to hear from those impacted by the IT consolidation and those impacted at OCR. Reach out here: www.statnews.com/2025/03/27/h...

Both of these stories highlight a consistent concern I hear reporting on direct-to-consumer telehealth: That, although it is important to increase access, framing virtual health care around specific drugs risks leaving patients with significant gaps in their health care

Telehealth platforms in senators' crosshairs over relationship with Eli Lilly, Pfizer Senators ask if contracts between drugmakers and telehealth companies violate the federal anti-kickback statute.

And another dispatch on telehealth's role as an access point for drugs for @statnews.com: Senators are again questioning the financial relationship between pharma giants Eli Lilly and Pfizer and the telehealth companies they link to: www.statnews.com/2025/03/12/t...

As GLP-1 compounding stares down a wall, telehealth companies pivot to hormones As it gets harder to offer compounded GLP-1s, many telehealth companies are pivoting to hormone replacement therapy.

Facing a shrinking market for compounded GLP-1 weight loss drugs, dozens of telehealth companies are marketing hormone therapies for men and women — many of them compounded options that use the same backbone built to capitalize on intense GLP-1 demand www.statnews.com/2025/03/11/t...

Are we adopting AI scribes based on... vibes? The web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to AI in health care and medicine.

In today's edition of AI Prognosis we:

-Address the question of whether health care's adoption of AI scribes is entirely vibes-based

-Have an exclusive Q&A with co-founder of an AI deep research tool made specifically for scientists who just raised a $22M Series A

-Recommend a 🔥 Song of the Week

@benecal.bsky.social I'm a reporter working to understand the impacts of communications and grant freezes on business. If your friend would be open to speaking, they can reach me on Signal at palmer.01

I'm looking to talk with VA employees who may be directed to alter gender-related fields in medical records. Signal: palmer.01. Please boost! #journorequest #veterans

Are you affected by firings at federal health agencies? Have you been affected by firings at federal health agencies? @statnews would like to hear from you.

And here's the form on its own: www.statnews.com/2025/02/14/f...

Trump administration lays off FDA employees The cuts are part of a purge of 5,200 probationary workers across federal health agencies that started Friday.

On Saturday, Trump's layoffs hit the FDA.

If you've been affected by the firings in federal health agencies, you can contact STAT using the form in this story.

www.statnews.com/2025/02/15/t...

STAT is backing up and monitoring CDC data in real time: See what's changing STAT is backing up and monitoring CDC data in real time: See what's changing.

Two weeks of work went into this and I’m not done yet. Coming soon:

- explore diffs of all datasets that have been republished with changes

- search and access all archived data

www.statnews.com/2025/02/14/t...

Trump policies spark fears of brain drain, threatening to undermine U.S. dominance in biomedicine A torrent of Trump administration policies is alarming scientists who fear the current climate is weakening researchers’ resolve to stick with careers in academic science.

A potent story from @jonathanwosen.bsky.social and @angusrohan.bsky.social showing that threats to federal science funding are already having an impact on career choices for talented scientists, threatening the US's leadership position in biomedical research. www.statnews.com/2025/02/12/t...

As a health tech reporter at STAT News, I cover the role of technology in health care and clinical research — including artificial intelligence, telehealth, EHRs, and remote patient monitoring. Is there an untold story about how tech is impacting patients? Contact me securely on Signal: palmer.01

I'd appreciate the chance to learn more, Julie — email is in my bio if you'd like to reach out

As deadline looms, health systems rush to ensure clinical algorithms don’t discriminate A deadline is fast approaching for federally funded health systems to show that clinical algorithms don't discriminate based on protected traits such as sex or race.

There's a hard deadline coming up in May for health care providers to vet clinical decision support tools for discrimination — but “most health systems just aren’t looking," one source told me.

Via @statnews.com:

www.statnews.com/2025/01/14/c...

FDA's new guidance on AI in drug development centers the risk introduced by the technology After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug development.

FDA's AI device count has now ticked over 1,000. But it has also quietly received over 500 drug submissions with AI, and today it put out an anticipated draft guidance on AI in drug development.

What does high-risk AI in drugs mean to FDA? Read in @statnews.com:
www.statnews.com/2025/01/06/a...

Truth-teller or reflexive contrarian: Which Marty Makary would run the FDA? Pancreatic surgeon Marty Makary is a long-time critic of the medical establishment who's now set to regulate food, drugs, and medical devices at the FDA.

NEW: Some consider him a fearless truth-teller with a deep respect for science. Others consider him a contrarian for contrarian’s sake, opining on matters for political clout. Which Marty Makary would run the FDA?
www.statnews.com/2024/12/17/m...

FDA authorizes many AI devices for use in kids. Are they validated in a pediatric population? A new study resurfaces long-simmering concerns about the lack of transparency in data used to train and validate AI and ML-enabled devices.

A surprising finding in this analysis of FDA-authorized AI/ML devices: 22 devices indicated for use in kids were validated in adult datasets only.

That's part of a much broader problem in how representative (or not) AI devices' training and validation data are:
www.statnews.com/2024/12/16/f...

FDA-cleared apps for everything from depression to opioid use disorder have struggled to gain adoption, and one company just abandoned its app after 4 years of development. @mariojoze.bsky.social explains the dynamics behind a struggling digital therapeutic: www.statnews.com/2024/12/03/o...

(And then down the line a bit, how much lower?)

This is astonishing especially because self-reported large health data breaches hit an all-time high last year, impacting more than 165 million individuals — half the U.S. population. Imagine how much higher the number would be if OCR did regular audits.

UnitedHealth pays its own physician groups considerably more than others, driving up consumer costs and its profits First-of-its-kind data analysis finds UnitedHealth Group pays many of its own physician practices significantly more than the average it pays other doctors in the same markets

NEW: UnitedHealth Group is paying many of its own physician practices significantly more than it pays other doctor groups in the same markets for similar services, undermining competition and driving up costs for consumers and businesses.
www.statnews.com/2024/11/25/u...

Props to the incredible @statnews.bsky.social team on this late Friday night

Trump to nominate former Fox News contributor as surgeon general Janette Nesheiwat, a medical doctor and former Fox News contributor, will be nominated to be surgeon general, President-elect Donald Trump announced Friday night.

And Janette Nesheiwat for surgeon general www.statnews.com/2024/11/22/j...