A government AI lab is born

The ideas and innovators shaping health care

Nov 01, 2024 View in browser   By Ruth Reader, Daniel Payne, Erin Schumaker and Carmen Paun WASHINGTON WATCH The VA runs the largest health system in the U.S., serving 9 million veterans. | AP Photo/Charles Dharapak The Department of Veterans Affairs and the FDA are teaming up to launch a virtual health AI lab to vet artificial intelligence tools, they announced at the Veterans Health Administration Innovation Experience conference in Chicago this week. FDA Commissioner Robert Califf calls it the “first intergovernmental health AI laboratory” that will test AI. The FDA regulates AI when it’s incorporated into medical devices. The VA is the largest health system in the country, serving 9 million veterans. Both the FDA and the VA have experience with AI. The FDA has issued discussion documents and guidance on artificial intelligence since 2021. And to date, the agency has authorized more than 1,000 AI products, but Califf has also said the agency will struggle with advanced AI tools whose performance may shift over time or perform differently in different locations. He’s suggested health center vetting labs could help. The VA has tested more than 120 AI tools through its National Artificial Intelligence Institute. Why it matters: The health care industry hasn’t agreed on how health care AI products should be validated to ensure they’re safe and effective for all people. Several industry-led groups have emerged to make recommendations on how to vet AI. The Department of Health and Human Services, of which the FDA is part, plans to publish a cross-agency AI strategy by January 2025. Through its new partnership with the VA, the FDA could gain a valuable test bed for evaluating AI methods and provide insights useful for developing a broader regulatory framework for AI. The VA public health system that operates 170 medical centers nationwide is uniquely situated to evaluate AI’s impacts both centrally and locally. What’s next? Dr. Shereef Elnahal, the VA undersecretary for health, told Nextgov that the VA and FDA will work out how the virtual lab will work over the next six months.   WELCOME TO FUTURE PULSE New Harbor, Maine | Herb Zeller This is where we explore the ideas and innovators shaping health care.  An evolutionary psychologist believes the human kiss evolved from grooming among apes, Science reports. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com, or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp.  FORWARD THINKING Chatbots could help direct patients to mental health services, a company believes. | Getty Images Though artificial intelligence systems may not be ready to deliver care without a clinician, they could guide patients to the appropriate services in the near future. That’s part of Headspace’s vision with its new AI chatbot, Ebb: to offer users an empathetic ear and then guide them to meditations, coaching or clinical care, said Matthew Chester, a clinical psychologist and lead product manager at the firm. Why it matters: With mental health clinicians in short supply, 24/7 chatbot support could provide relief, Chester said. Other parts of the health system are also turning to AI to help move patients to the right services, such as hospitals triaging patients in the emergency room. And growing research on nonclinical interventions, such as mindfulness meditation, shows promise for treating mental health. AI could help integrate those practices with traditional psychological and psychiatric care to achieve better outcomes. Even so: Human health care providers must remain at the center of patient care, Chester said, which means clinical staffing shortages will continue to limit patient access to services. THE LAB A company hopes to offer a synthetic form of magic mushrooms as a depression treatment. | Getty Images A retrenchment is afoot in psychedelic medicine. British biotech company Compass Pathways is delaying results from its late-stage psychedelics trials and laying off 30 percent of its staff. The layoffs include some senior managers. "We have made the difficult decision to reduce our workforce and exit activities that are not directly tied to the completion of the trials, regulatory filing and commercialization if approved," CEO Kabir Nath said in a statement. Why it matters: The fallout is connected to the FDA’s decision this summer to reject an application from Lykos Therapeutics, Compass' competitor and one-time frontrunner in the psychedelics medicine space, to offer MDMA, also known as ecstasy, and therapy as a treatment for post-traumatic stress disorder. A criticism of Lykos’ application was that study participants in its trials were "functionally unblinded," meaning they could tell who received the psychedelic and who received a placebo. Compass, which has taken a more business-first approach to its operations than Lykos, said it pushed back releasing its data partly due to "the increased regulatory scrutiny on functional unblinding." Compass had said topline data from its Phase III trial of a synthetic form of psilocybin, or magic mushrooms, for treatment-resistant depression would be ready in the fourth quarter of 2024. What’s next? Compass is now shooting for mid-2025, it said Thursday. Results from a second study won’t come until the second half of 2026.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

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