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A closer look at FDA’s new AI guidance
In new draft guidance earlier this week, the Food and Drug Administration advised developers of medical devices that use artificial intelligence that it would like to see more information about sources and demographics of data used to train and validate their products, and disclose blindspots and potential biases that might impair performance. Specifically, FDA asked for this information to be included in marketing submissions. The new guidance comes shortly after FDA crossed 1,000 AI devices authorized.
As STAT’s Casey Ross notes, the guidance does not specifically call for more testing in live clinical settings as a condition for getting approvals. But it does recommend that device makers submit a plan for monitoring the performance of their devices in clinical settings after they are cleared for commercial use.
Read Casey’s full analysis here
Transcarent spends $621 million acquiring 14 million members
Yesterday, I wrote about Transcarent’s huge acquisition of Accolade. The deal makes sense on many levels. Both companies have a similar mission of helping employers deliver better health care at lower cost for their workers. Transcarent CEO Glen Tullman, through his own funds and close ties to venture firm General Catalyst, has access to lots of capital. And Accolade, which went public during the pandemic digital health frenzy, has struggled to turn a profit, and like other companies in the sector, its stock has suffered.
In an interview, Tullman pointed to things Accolade offers and that Transcarent could use, like advocacy services and virtual primary care. But my take, which is loose and not in my story, is that Transcarent took a half-billion dollar shortcut to jump from 4.5 million in the U.S. to 18 million members. While we don’t know how much Transcarent has spent so far, we do know the company has raised over $400 million to get where it was. It’s now quadrupling its member base and adding more services for $621 million more.
Will it work? Will Tullman reinvent the health care for workers as he has promised? That’s the hard part.
Read my story and interview with Tullman here
New study sheds light on hospital algorithm use
A new study provides an interesting window into how hospitals are using clinical algorithms — and what steps they are taking to ensure the technologies are accurate and unbiased. To paraphrase Health Affairs:
- 65% of U.S. hospitals used predictive models.
- 79% of those used models from their electronic health record developer.
- 61% of hospitals that used models evaluated them for accuracy using data from their health system.
- 44% percent of hospitals reported local evaluation for bias.
The data is based on 2,425 hospitals that answered questions about AI in the 2023 American Hospital Association annual survey IT supplement.
What’s your take? Email: [email protected]. If I get interesting responses, I’ll publish them next week.
Big funding for generative AI and more deals
- Qualified Health, a new company focused on building infrastructure for generative AI in health care, announced a $30 million seed round from investors including SignalFire, Healthier Capital, Town Hall Ventures, and Frist Cressey Ventures. Prominent founders include CEO Justin Norden, who sold his last company Trustworthy AI to Waymo, and Nirav Shah, former COO of Kaiser Permanente SoCal and New York State Health Commissioner.
- FIRE1 raised $120 million to advance it devices-based management system for people with heart failure. The round was led by Polaris Partners and Elevage Medical Technologies.
- Virtual women-focused sexual and reproductive care company Twentyeight Health raised $10 million led by Seae Ventures.
- h2, which helps pharma companies find doctors, acquired Andreessen Horowitz– and General Catalyst-backed Ribbon Health, a health care data platform.
- Highlander Health, the new medical data company from former Verily executives Amy Abernethy and Brad Hirsch, acquired data company Target RWE.
- Anumana, a developer of algorithms that sniff out signs of heart conditions from electrocardiograms, has a new deal to bring its algorithms to devices from AI pioneer AliveCor.
- AI clinical scribe company Abridge, which has been announcing a spree of new deals, announced another: A partnership with Duke Health. Besides making Abridge’s tech available to 5,000 Duke clinicians, the companies formed a “strategic partnership to collaboratively explore new health care AI innovations.”
What we’re reading
- How electrical stimulation can improve rehabilitation after spinal cord injury, STAT
- The death of net neutrality is a bad omen, Wired
- Leaving FDA, Califf is unapologetic — and warns of staff departures, STAT
- HHS proposes new cybersecurity requirements as first major HIPAA update in 10 years, Fierce Healthcare