Who will ensure AI doesn’t discriminate?

Presented by Johnson&Johnson: The ideas and innovators shaping health care

Sep 09, 2024 View in browser   By Ruth Reader, Carmen Paun, Erin Schumaker and Daniel Payne Presented by  POLICY PUZZLE Ensuring AI isn't biased is a complicated assignment. | AP HHS has rules to prevent discrimination in care, but they don’t go far enough to root out bias in health care artificial intelligence, legal experts argue in two new papers. They’re calling on regulators to address gaps in the system. In April, HHS’ Office for Civil Rights issued a final rule that said health providers can’t discriminate against patients by using biased decision-support tools, including those powered by AI. But Stanford’s Michelle M. Mello and Emory’s Jessica L. Roberts think many providers aren’t equipped to comply. While larger health systems might have the resources to vet AI systems and ensure they’re not delivering biased results, smaller health systems might not, according to the scholars. “It is dispiriting to contemplate that the OCR’s effort to protect vulnerable patients may have the weakest effect in the settings that have the biggest role in serving them,” Mello and Roberts wrote in JAMA Health Forum. Why it matters: Developers of AI tools aren’t required to share information about the data they use to train their systems or whether they’ve tested them for biased results. They should be required to, according to three Medstar Health researchers in JAMA. “All AI developer transparency disclosures should be stored in a central repository and accessible to the public,” wrote Raj M. Ratwani, Karey Sutton and Dr. Jessica E. Galarraga. What they recommend: The authors want HHS to require more transparency from technology developers. While the agency requires developers of tools it certifies to disclose some information about how their tools work, certification is voluntary. Ratwani, Sutton and Galarraga also said HHS should vet and monitor decision-support tools that rely on AI. To ensure that smaller health systems can keep up, the authors suggest that HHS agencies, such as the Health Resources and Services Administration or the Agency for Healthcare Research and Quality, fund the development of software for testing and monitoring discrimination in patient-support tools. The Patient-Centered Outcomes Research Institute, a private nonprofit that funds research on the effectiveness of health care tools, could also play a role, they said. Even so: Ensuring that AI is safe and free of discrimination costs money. “The question of who will pay for AI assessments looms large, especially in light of congressional efforts to ensure that no taxpayer dollars are used,” said Mello and Roberts, adding that the cost of compliance could stall AI adoption.   A message from Johnson&Johnson: J&J is teaming up with over 100+ community-based organizations to close the gaps between community and care in our backyards and across the country. Learn More.   WELCOME TO FUTURE PULSE Arlington, Va. | Shawn Zeller/POLITICO This is where we explore the ideas and innovators shaping health care. An implantable device they’ve developed can detect opioid overdose and deliver an antidote, researchers at Brigham and Women’s Hospital and MIT say. 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.    A message from Johnson&Johnson:   WORLD VIEW Mosquitoes spread chikungunya virus, but there's a vaccine that could help. | AFP via Getty Images The world’s first vaccine against chikungunya, a mosquito-transmitted infection that’s typically mild but can cause debilitating, long-term muscle pain, could soon be available in Brazil. Thomas Lingelbach, the CEO of the French company Valneva, which manufactures the vaccine, known commercially as Ixchiq, told Carmen he expects it to be approved there early next year. Valneva will manufacture ingredients in Scotland and then ship them to Brazil, where the Butantan Institute, a government-owned vaccine manufacturer, will produce the shot. That collaboration, Lingelbach hopes, will serve as a model for other countries. Why it matters: Brazil reported a quarter million cases of chikungunya this year and 161 deaths from the infection.  What’s next? Valneva is working on a partnership with at least one Asia-based manufacturer to produce the shot for India, Lingelbach said.   A message from Johnson&Johnson: What does health look like to you? At J&J, we believe a healthy community is one served by health workers who are supported and thriving. We are working with partners across the country to achieve health equity and eradicate inequities & health disparities. Learn More.   WASHINGTON WATCH The FDA isn't convinced MDMA helps people with post-traumatic stress disorder. | Fernando Vergara/AP Federal health officials feel good about the future of post-traumatic stress disorder treatments, despite a recent FDA decision rejecting a highly touted psychedelic therapy. At a public meeting on accelerating PTSD treatments hosted by the Food and Drug Administration and the independent nonprofit Reagan-Udall Foundation for the FDA on Friday, panelists said that while new treatments and drug approvals are needed, existing treatments aren't being used to their full capacity. The group included Elyse Katz, who works on warfighter brain health projects at the Department of Defense; Dr. Leith States, chief medical officer to the assistant secretary for health at the Department of Health and Human Services; Dr. Neeraj Gandotra, chief medical officer at SAMHSA; Marta Sokolowska, deputy center director for substance use and behavioral health at the FDA's Center for Drug Evaluation and Research; Paula Schnurr, executive director of the National Center for PTSD at the VA; and Miriam Smyth, acting director of the VA’s Clinical Science Research & Development Service. While some said they thought the approval process for new treatments is moving too slowly, States said he felt encouraged. "At the end of the day, we’re moving forward," he said. "We’re pushing forward in an incremental way." By the numbers: In 2021, 14.5 million American adults had at least one major depressive episode and 13 million people had PTSD, according to federal data. Advocates often stress that there's a pressing need for better treatments. No new drug has been approved for the condition in decades and existing drugs don't work for everyone, they say. State-of-play: Advocates of using psychedelic drugs to treat mental illness took a big hit last month when the FDA rejected drugmaker Lykos Therapeutics' application for MDMA and therapy as a PTSD treatment. In a separate virtual meeting on Friday, Dr. Michael Mithoefer, senior medical director for medical affairs at the Multidisciplinary Association for Psychedelic Studies — Lykos' nonprofit arm — said he thought the federal panelists overstated the efficacy of existing PTSD therapies.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

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