FDA wants to talk about AI mental health devices

The Food and Drug Administration last week announced it will convene its Digital Health Advisory Committee on Nov. 6 to discuss how to regulate mental health devices using generative AI. Companies and researchers are developing a growing number of therapy chatbots powered by large language models, but the FDA has yet to offer clear guidance on how developers might pursue approval for generative AI products that claim to treat depression, anxiety, or other conditions. There's concern about using chatbots in health care because their outputs are unpredictable.

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research

Are AI therapy bots actually using AI?

Speaking of AI, mental health, and chatbots, STAT's Rose Broderick writes: The scientific literature on the efficacy of chatbots in mental health care has not caught up to the public's use of these technologies, according to a systematic review published Monday.

The authors analyzed 160 studies from the last five years and found that the vast majority of papers look at the efficacy of simple, rule-based chatbots. These systems lack the conversational sophistication of chatbots driven by large language models, like Open AI's ChatGPT, which offer tantalizing therapeutic possibilities. That research gap has closed in recent years — nearly half of new studies published in 2024 looked at generative AI models (see chart above) — but the published literature still focuses on their technical feasibility, instead of their clinical efficacy.

Medical professionals suggest that chatbots could offset the growing demand for mental health services and therapy. But evidence for their success is currently scant, even as numerous media reports detail the harrowing effects that large language model-based chatbots can have on a person's mental health. An uncertain regulatory landscape has not helped matters, as the recent demise of Woebot's therapy chatbot exposed.

investment

How General Catalyst helps WellSpan invest

WellSpan Health earlier this month announced it's working to develop new health technology applications with General Catalyst's (GC) HATCo. A closer look at the deal underscores how the health system stands to win both medically and financially through its cozy relationship with the venture capital giant.

The trend: A growing number of nonprofit health systems are teaming up with venture firms on for-profit businesses. Aegis Ventures this week announced that Yale New Haven Health System, Keck Medicine of USC, and Hartford HealthCare joined its Digital Consortium that seeks to develop AI health care solutions. Earlier this year, I wrote about Cedars-Sinai's plan to create companies with Redesign Health.

"We created a couple of our own companies several years ago, really small companies that we deployed for a while," WellSpan CEO Roxanna Gapstur told me. "But what we know about most health care systems is the kind of talent that we have internally isn't really the talent that you need for startups."

Backstory: WellSpan operates nine hospitals serving Pennsylvania and Maryland, and its relationship with GC goes back three years to a higher-level collaborative the venture firm announced with over a dozen health systems. HATCo, or Health Assurance Transformation Company, is a GC venture that's in the process of acquiring Ohio-based health system Summa Health.

The plan: Gapstur told me that under the new deal, WellSpan will work with HATCo to develop a three-year roadmap for solutions they would like to "co-create."

Getting in on the action: While some of the solutions developed through the partnership may be sourced from existing GC companies, Gapstur said it's also possible that all this ideation may result in entirely new companies backed by WellSpan investment. She said guidance on where to invest was part of the appeal of working with GC. WellSpan also has connections to Andreessen Horowitz and 7wireVentures.

These investments are already happening: WellSpan touted how it works with GC-backed Aidoc and Hippocratic AI. The health system is actually an investor in both, too.

Use cases so far: WellSpan uses Aidoc's tech that helps analyze mammograms and other imaging, and it has used Hippocratic AI's agent, Anna, to conduct more than a million phone calls to aid with tasks like colonoscopy prep and surgical pre-operative calls in Spanish.

What's the future? Gapstur said WellSpan hopes to develop solutions to automate administrative tasks, like revenue cycle management; for workforce augmentation, where AI can improve the performance of humans, like Aidoc's radiology solutions; and for care navigation, to help "navigate people through the system in a way that feels personal, simple, [and] friendly."

Health tech news roundup

The Food and Drug Administration warned Hims & Hers over "false or misleading" advertising as part of a broad crackdown on drug marketing undertaken by the agency, the New York Times reported. In an opinion essay over the weekend, commissioner Marty Makary wrote that the company "ran a Super Bowl ad parading the benefits of GLP-1 drugs without any mention of side effects," something STAT's Katie Palmer pointed out in January.
This one is fun: Luminopia, maker of a VR headset-based treatment device that treats childhood lazy eye while letting kids watch entertaining content, has a new deal to bring Pokemon to the device.
Conceivable Life Sciences raised a $50 million Series A round to launch its "AI-powered automated IVF lab." The round was led by Advance Venture Partners.
Inbox Health raised a $22 million Series B round for its billing communications platform. The funding was led by Ten Coves Capital. Inbox Health says that more than 2,600 medical practices use it tech.
GE HealthCare acquired Icometrix, maker of AI tech for analyzing MRIs. The acquisition was announced just days after I wrote about a Duke experiment with Icobrain Aria, the company's product that helps clinicians spot brain abnormalities that are a dangerous side effect of Alzheimer's drug therapies. That's right! They call me the deal whisperer. If I write about your company, it will be acquired.
Penguin AI raised a $25 million Series A round led by Greycroft. The company develops AI products to tackle administrative tasks for both payers and providers.
Goodpath, a virtual chronic care company, raised an $18 million Series A round led by MassMutual Ventures.