Trump’s FDA commissioner on regulating AI

The ideas and innovators shaping health care

Jul 16, 2024 View in browser   By Ruth Reader, Toni Odejimi, Carmen Paun, Daniel Payne and Erin Schumaker FORWARD THINKING Gottlieb has a plan for regulating AI. | J. Scott Applewhite/AP Photo Former President Donald Trump’s first FDA commissioner, Dr. Scott Gottlieb, is calling on Congress to expand his old agency’s authority over medical artificial intelligence. Why’s that? Gottlieb writes in JAMA Health Forum that medical AI presents a challenge for the Food and Drug Administration because the agency’s regulators can’t simply take the technology apart to see how it works. AI models are black boxes, and “even their developers cannot fully elucidate how these models draw their conclusions,” he writes. So he thinks Congress should empower the FDA to oversee the methods used to develop AI and validate the reliability of individual products. Gottlieb’s plan: He cites legislation Congress considered in 2022, a House bill by Democrat Diana DeGette of Colorado and Republican Larry Bucshon of Indiana, called the Verifying Accurate Leading-edge IVCT Development Act, as a model of how it could work. Then-Republican Sen. Richard Burr of North Carolina introduced a Senate version of the bill. The VALID Act would have boosted the FDA’s authority over laboratory-developed tests for specific patient medical needs. In contrast to the FDA’s traditional regulatory approach, which involves examining how drugs and medical devices work, the bill would have permitted the agency to focus on the “quality systems and processes” of the labs. This “firm-based” method makes sense for AI, he contends, because it would allow the FDA to validate an AI tool’s reliability by focusing on the methods used to build it instead of the black box. Even so: Gottlieb also says Congress should make way for private sector-led certification of less risky AI. The Coalition for Health AI, an organization whose founders include Microsoft and Johns Hopkins Medicine, is already building assurance labs for this purpose.   Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more.     WELCOME TO FUTURE PULSE Schoodic Point, Maine | Shawn Zeller/POLITICO This is where we explore the ideas and innovators shaping health care. Happy AI Appreciation Day to those of you celebrating! Call it dodgy, but that’s a thing now. 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, Erin Schumaker at eschumaker@politico.com, or Toni Odejimi at aodejimi@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp.   WORLD VIEW An increase in vaccination for human papillomavirus was a bright spot in an otherwise bleak report on immunization rates. | AP Vaccination rates for children worldwide declined in 2023, threatening the World Health Organization’s goal of near-universal coverage by 2030. And vaccination rates still haven’t recovered to prepandemic levels, leaving 2.7 million kids unvaccinated or undervaccinated, the WHO said. In a survey of 195 countries by the WHO and UNICEF, vaccination rates stalled for measles and diphtheria, tetanus and pertussis. More than 14 million children haven’t received any of the three vaccine doses for diphtheria, tetanus and pertussis, and only 84 percent of kids were fully covered. Likewise, only 83 percent of children received their first measles vaccine dose, and 74 percent received their second. Meanwhile, public health authorities confirmed more than 300,000 measles cases, three times more than 2022’s numbers, said Dr. Ephrem Lemango, associate director of immunization at UNICEF. Even so: Human papillomavirus vaccination rates for girls rose in 2023 to 27 percent from 20 percent the year before, giving researchers hope that the world can get back on track. What’s next? The WHO and UNICEF are developing plans to increase immunization for children who missed doses during the pandemic. They’re also working with community leaders and social media companies like Meta, owner of Facebook and Instagram, to combat vaccine misinformation.   Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more.     WASHINGTON WATCH Many still don't know there is a hotline for people in mental health crisis. | AP The Biden administration is defending its 988 crisis hotline in the face of recent polling that shows Americans still aren’t very familiar with it. “988 has been a transformation for the crisis continuum in this country,” said a senior administration official whom POLITICO granted anonymity because the official wasn’t authorized to speak publicly. “We are doing everything that we can to ensure that people know." A recent poll from Ipsos and the National Alliance on Mental Illness found that less than a quarter of Americans were at least somewhat familiar with 988. This week the crisis line turned two. The Department of Health and Human Services says it has fielded 10 million calls and texts and invested $1.5 billion into the program. Why it matters: The 988 hotline is part of the Biden administration’s investment in mental health access. In addition to the national crisis line the administration has also put money into building out community behavioral health centers and mental health capacity in schools. Even so: The effort is still early. Only nine states have enacted legislation to support 988 through state tax funding. Also, callers are routed to crisis centers based on their area code, which is not always indicative of where a person is located, rather than their geolocation. The Federal Communications Commission recently proposed a rule that would change that.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

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