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What to watch for in the FDA's meeting on generative AI regulation 

November 19, 2024
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Health Tech Reporter

Hi, I'm health tech reporter Brittany Trang filling in for Mohana, who's out for the next couple weeks. 

I'm starting to get my Christmas music mood on. What are your favorite "new" Christmas songs? A friend recently sent me "DJ Play a Christmas Song" off of Cher's album from last year. It's like "Believe," but Christmas-ified, and it's stuck in my head.

Christmas song suggestions and AI/cybersecurity in health care tips: brittany.trang@statnews.com

Artificial Intelligence

The market for AI medical scribes

Ambient AI medical scribes are about the easiest — and hottest — way into to health care for AI-based startups. Just take a look at this graphic that lists 35 companies who are (or at one point were) trying to use ambient voice for translating the audio of doctors' visits into written notes. The area is both well within the text capabilities of AI tools and also doesn't directly affect patient care — though academics doubt that industry claim — thus making the area unlikely to be burdened by regulations anytime soon (more on that later in this newsletter).

Today Tenet Healthcare, the second-largest for-profit health system in the U.S., announced that it is rolling out Commure's AI scribe to all of its employed physicians. If Commure doesn't quite sound familiar to you, you might instead recognize the name Augmedix. Commure acquired longtime ambient medical scribe company Augmedix in October. 

The acquisition means that Augmedix's scribe can now be marketed within a larger portfolio of solutions — Commure also has revenue cycle management, remote patient monitoring, and staff duress products. In fact, Commure CEO Tanay Tandon said the company is giving away its scribe service for free to anyone who uses its RCM solution.

The ambient scribe space reminds Tandon of the electric scooter space from five or six years ago, he said.

"There were like 18 electric scooter companies and VCs were just pouring money into them and all of them died with the exception of two, which was Uber and Lyft," he said. "If you just offer the electric scooter, you will die because the margin structure long term and the power of bundling is just going to outweigh everything else." 

The trend of packaging scribes with other services was evident in other new additions to the STAT Generative AI Tracker.

Check out the latest additions to the tracker here, and read my story on the AI scribe market, including how Abridge CEO Shiv Rao and Suki CEO Punit Soni see the crowded marketplace evolving


Regulation

The FDA is meeting to discuss regulating generative AI

The Food and Drug Administration's digital health advisory committee is meeting for the first time tomorrow and Thursday. The goal of the meeting is to discuss whether and how the FDA should regulate the use of generative AI by U.S. health care providers.

Though many of the comments ahead of the meeting asked the FDA to regulate ambient scribes like the ones we described above — and the FDA did seem to admit that there could be patient safety risks if such AI scribes hallucinated — it seems that these platforms could fall into a regulatory crack in FDA's system.

For more on what to watch during the meeting, STAT's Katie Palmer and Casey Ross summed up the long documents the FDA released ahead of the convening. Read more in STAT+ for why it's so hard to regulate AI products in medicine before and after they reach patients, especially within the confines of the FDA's purview.

If you hear anything during the meeting that catches your attention, ping me: brittany.trang@statnews.com


Telehealth

Telehealth prescribing abilities extended for one year

On Friday, some great news rolled in for telehealth providers that prescribe opioid addiction or ADHD medications: Federal officials are renewing rules that allow providers to prescribe controlled substances like buprenorphine and Adderall without first meeting a patient in person. Those rules were set to expire on Jan. 1, but have now been extended until the end of 2025.

The Drug Enforcement Agency was supposed to issue a final rule this fall that would have created permanent rules for this, and the uncertainty over the future of controlled substances online prescribing cast a pall over telehealth companies. A former official attributed this failure to inter-agency conflicts and politics. 

The extension kicks the resolution of a years-long debate — one that has already elicited nearly 40,000 comments on earlier proposed rules — to the second Trump administration and agency leadership that is yet to be determined. Read more on the decision and its implications from STAT's Katie Palmer and Mario Aguilar.



Odds and ends:

  • Today smart ring maker Oura announced that glucose biosensing company Dexcom is investing $75 million in its Series D, valuing Oura at more than $5 billion. As part of the partnership, Dexcom's glucose monitoring data will be integrated with Oura's vital sign, sleep, stress, heart health, and activity data.
  • Ali Parsa, the founder and CEO behind the now-bankrupt Babylon Health, is back with a new health tech venture. He posted on LinkedIn recently about Qu, a customizable AI clinician assistant that his new startup Quadrivia has opened for beta testing.
  • Remember Thrive AI Health, the Sam Altman and Arianna Huffington venture that launched with a flashy TIME magazine op-ed earlier this year? TechCrunch found a "bare-bones" demo of the AI health coach wellness app on the Thrive site, and its analysis of the ex-Googler DeCarlos Love-led project is…not that promising.
  • The Government Accountability Office last week released a report that said that the Department of Health and Human Services isn't fulfilling all of its responsibilities as lead of the the nation's health care cyber security practices. Namely, the GAO said that HHS hasn't conducted studies to assess the cyber risk to medical devices (as part of the Internet of Things) and also hasn't evaluated how effective the supports it offers to the sector are — guidance documents, training, threat briefings, etc. — among other things. Read more here.

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Thanks for reading! More on Thursday — Brittany


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