| | | | |  | | By Daniel Payne, Carmen Paun, Erin Schumaker and Ruth Reader | | | | | 
Even AI that summarizes doctors' notes could affect care, a new JAMA paper argues. | Adam Berry/Getty Images | Did federal regulators give artificial intelligence developers a roadmap to avoid their oversight? In a limited way, they did, according to University of Maryland researchers. In a new paper in JAMA, the researchers say the FDA inadvertently revealed a loophole when it said that some AI products, such as those that summarize doctors’ notes, wouldn't be considered medical devices subject to FDA rules. The loophole was included in the FDA’s guidance for “clinical decision support software,” which it issued in September 2022. The guidance, released just two months before ChatGPT revolutionized AI, suggested that the agency didn’t consider note-taking AI within its purview because such technology doesn’t make specific predictions or disease estimates. That’s too bad, the researchers argue, because AI that merely tries to make sense of the mountains of clinical documentation could still need regulatory oversight and harm patients without it. How so? The words the AI chooses to create the summaries could nudge clinicians in one direction or another. AI systems have also exhibited bias toward producing what a target audience expects — which could reinforce a doctor’s own biases. Meanwhile, even small errors in summarizing notes could adversely affect care delivery. What’s next? The authors say that even if the FDA were to seek to write rules for AI that summarize doctors’ notes, it might fail without receiving explicit new authority from Congress.
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Mt. Washington, N.H. | Sam Oates | This is where we explore the ideas and innovators shaping health care. Stop the spread? Maybe not. Three in four people say they've hidden a contagious illness, or would do so in the future, according to a new study. Why? They didn't want to miss work, upend travel plans or skip social events. A caveat: Only 1 in 5 people said they’d hide a Covid infection. 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.
| | |  An avatar therapist can always find time for an appointment. | AFP via Getty Images | Virtual reality powered by AI could help close the gap between the number of people who could benefit from therapy and the number of therapists available to treat them. That is, if people don’t mind meeting with a therapy bot, POLITICO’s Gregory Svirnovskiy reports. Researchers at Cedars-Sinai Medical Center in Los Angeles say their small study in which 14 people met with a therapy avatar in relaxing settings shows promise. npj Digital Medicine published the study on Jan. 26. The avatar relied on XAIA, short for the eXtended-reality Artificial Intelligence Assistant, a large language model, to guide its exchanges with the participants during 30-minute sessions. The participants brought up issues such as divorce, job loss, and substance abuse and testified to the program’s benefits. What did they like? The avatar’s accessibility, anonymity, empathy and calming demeanor. Even so: Some people preferred the deeper and more nuanced engagement that comes from interaction with real therapists. Why it matters: An estimated 57.8 million adults lived with mental illness in 2021, according to the National Survey on Drug Use and Health. But almost 55 percent of adults with mental illnesses don’t receive treatment, per Mental Health America’s 2023 Access to Care Ranking. Availability — and cost — continues to be a central issue. “While this technology is not intended to replace psychologists — but rather augment them — we created XAIA with access in mind, ensuring the technology can provide meaningful mental health support across communities,” Brennan Spiegel, one of the study’s authors, said in a press release. Of note: The technology could have merit, but the study is too small to draw definitive conclusions and more robust research is needed.
| | | | DON’T MISS POLITICO’S GOVERNORS SUMMIT: Join POLITICO on Feb. 22 to dive into how Governors are wielding immense power. While Washington remains gridlocked, governors are at the center of landmark decisions in AI and tech, economic development, infrastructure, housing, reproductive health and energy. How are they setting the stage for the future of American politics, policies and priorities? How are they confronting major challenges? Explore these questions and more at the 2024 Governors Summit. REGISTER HERE. | | | | | | | | |  Researchers are pursuing new pain medications that don't pose an overdose risk. | ERIC BARADAT/AFP via Getty Images | Imagine a prescription opioid that alleviates pain but can’t cause an overdose. California-based Ensysce Biosciences is working to bring one to market, and the Food and Drug Administration gave its efforts a boost this month when it granted its experimental opioid the agency’s breakthrough designation. That means the FDA wants the drug developed and reviewed faster than usual because preliminary evidence shows it could be better than similar medicines. The drug has already cleared a Phase I clinical trial funded by the National Institute on Drug Abuse. How it works: The experimental drug is an oxycodone derivative combined with an inhibitor of the digestive enzyme trypsin, which activates the opioid in the intestine. If people take more than the prescribed amount, the inhibitor will block the enzyme, impeding the opioid from passing into the bloodstream. “And that’s where you’re getting this overdose protection,” Ensysce CEO Lynn Kirkpatrick told Carmen. Bragging rights: The company said it believes the drug is the first in any drug class to come with oral overdose protection. “It’s quite incredible that the FDA granted a breakthrough status to an opioid product,” Kirkpatrick said, noting health care experts and politicians are wary of the pain relievers since overprescribing has caused hundreds of thousands of fatal overdoses over the past two decades. “We do need opioids. We just need safer opioids, and I'm glad they recognized the fact that we have innovation in the opioid field,” Kirkpatrick said of the FDA. | | | | Follow us on Twitter | | | | Follow us | | | | |
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