| | | | |  | | By Daniel Payne, Ruth Reader, Carmen Paun and Erin Schumaker | | | | | 
Dreyer wants Congress to step up. | Courtesy of Keith Dreyer | | | “I’m not a fan of light touch. We don't want to be overregulated, but I think it’s safe to say that all of us feel that there's regulation necessary.” Dr. Keith Dreyer, chief data science and imaging information officer, Mass General Brigham | | An AI leader in health care made the rounds on Capitol Hill last week with an unusual request: more regulations. Mass General Brigham’s chief officer for data science and imaging information, Dr. Keith Dreyer, met with congressional staffers and asked them to encourage their bosses to play a larger role in governing artificial intelligence. “It needs quite a bit of oversight because, if you build these systems wrong, they will make mistakes,” he told Daniel. “And if you don’t monitor these systems, they might even start out good, but they can turn bad.” Though Congress still has a long way to go before sending an AI-focused law to the president’s desk, Dreyer said the response to his plea was positive. “I’m hearing most everyone talking about this being required,” he said, adding that voluntary guidelines won’t work. “I don’t see health care policing ourselves as much as we need to.” Even so: Some lawmakers have argued for a go-slow approach to regulating AI, fearful that rigid rules could slow innovation. Sen. John Thune (R-S.D.), who’s running to lead Senate Republicans starting in November, said last week that his AI strategy was “using a light touch rather than a heavy hand.” A key question: Can patients trust AI without the regulations Dreyer says are needed? The answer is complicated and partly depends on government oversight that’s possible under the current framework, Dreyer said. A number of AI systems don’t require Food and Drug Administration approval. Other AI tools might go through an approval process but could change after they’ve been given the green light. “The fear that I have today with the way that AI is being regulated is the data is changing under the feet of the algorithm,” he said, noting some years-old algorithms might work differently today because the data they’re trained on has changed. “No one really knows if that means it’s more accurate, less accurate or the same — and there’s no requirements in place to monitor that.” State of play: FDA officials have previously recognized the need to rethink their approach to regulating systems that change over time, but the agency has yet to issue any new AI-focused regulations. That troubles Dreyer. “I had 10 years of experience of watching these algorithms not do good things when they haven’t been approved,” Dreyer said. “There’s no control over how these things are going to get used after they get put out — there’s a lot of unintended consequences.”
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Baltimore, Md. | Shawn Zeller/POLITICO | This is where we explore the ideas and innovators shaping health care. If you’ve ever wondered why clocks are melting in Salvador Dalí’s Persistence of Memory, you can ask him… well, at least an AI version of him. At the Dalí museum in St. Petersburg, Fla., you can pick up the Lobster Telephone and hear the Spanish artist’s AI-generated voice answer your question, Smithsonian Magazine 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.
| | |  Some patients won't find new weight-loss drugs cost effective, compared to an alternative, a study found. | Jeff Haynes/AFP/Getty Images | A minimally invasive procedure could help some patients who are obese better than breakthrough drugs like Ozempic and Wegovy. The procedure, endoscopic sleeve gastroplasty, or ESG, is likely to be more effective and far more affordable, according to a recent analysis published in JAMA Network Open. How so? Researchers from Brigham and Women’s Hospital in Boston, the University of Pittsburgh Medical Center and others said the procedure would likely sustain greater weight loss over five years compared with semaglutide, the active ingredient in the pricey drugs. Both ESG and the medications have, thus far, been found to be safe and effective, they said. The key difference is the cost of the drugs compared with the procedure. For semaglutide to be a cost-effective alternative, the authors argue, its cost would need to drop threefold. Ozempic, for one, costs nearly $1,000 a month if insurance doesn’t pay. Endoscopic sleeve gastroplasty, though a relatively new procedure, has been performed for more than a decade. Instead of the incisions used in other bariatric surgeries, ESG involves inserting an instrument through the throat to suture the stomach internally, making it smaller. Even so: It took time for the cost savings to arrive. ESG doesn’t offer savings unless compared with two years of semaglutide use. The analysis was built around a base case of a 45-year-old patient with a body mass index of 37, meaning the results might not be indicative of those for all patients. The body mass index compares height to weight. People with a BMI greater than 30 are considered obese. Why it matters: Patients, payers and policymakers are intrigued by the new class of obesity drugs but concerned about their cost. At the same time, some policymakers argue not treating obesity will incur higher health care costs in the long term. Treatments other than the drugs may gain traction, some health providers estimate, because of the increased buzz around obesity care of all kinds, sparked by the new medicines. In some cases, drugs and procedures might be used together for more cost-effective treatments, doctors say.
| | | | POLITICO IS BACK AT THE 2024 MILKEN GLOBAL CONFERENCE: POLITICO will again be your eyes and ears at the 27th Annual Milken Institute Global Conference in Los Angeles from May 5-8 with exclusive, daily, reporting in our Global Playbook newsletter. Suzanne Lynch will be on the ground covering the biggest moments, behind-the-scenes buzz and on-stage insights from global leaders in health, finance, tech, philanthropy and beyond. Get a front-row seat to where the most interesting minds and top global leaders confront the world’s most pressing and complex challenges — subscribe today. | | | | | | | | |  HHS wants to make sharing patients' health data a lot easier than it used to be. | Getty Images | | HHS and its nonprofit partner, the Sequoia Project, took another step Monday in implementing a nationwide data-sharing network for patient health data. The Office of the National Coordinator for Health Information Technology at HHS hopes the move will bolster data exchange and better connect providers, public health agencies, researchers and others in medicine. How so? Participants in the project will be required to support a standard for how the data is formatted. The standard, known as FHIR, short for “Fast Healthcare Interoperability Resources,” is intended to facilitate seamless data sharing. HHS has already allowed several “qualified health information networks” to facilitate the data sharing, including electronic health record giant Epic; health information network eHealth Exchange; interoperability platform Health Gorilla; KONZA, a nonprofit that supports health information exchanges; and health IT firm MedAllies. The adoption of the FHIR standard is about keeping "pace with the advanced, secure data services approaches used by the tech industry,” ONC head Micky Tripathi said in a release. It will also allow participants to share data with multiple qualified health information networks. Why it matters: Secure and efficient data sharing has long vexed the health care sector. HHS and the Sequoia Project have made the case that their initiative can help solve interoperability issues that the private sector can't tackle without government help. Many have pointed to buy-in as a potentially significant barrier to the effort’s success. The backstory: The 21st Century Cures Act — enacted in 2016 — called on HHS to create a trusted exchange framework and common agreement to share health care data. HHS put out a first draft of the framework in January 2018 and finalized it in January 2022. | | | | Follow us on Twitter | | | | Follow us | | | | |
