Where the FDA is on AI

The ideas and innovators shaping health care

Oct 30, 2023 View in browser   By Daniel Payne, Erin Schumaker and Evan Peng TECH MAZE Advanced AI is already transforming medicine. | Olivier Morin/AFP via Getty Images The Biden administration hasn’t decided how to handle emerging tools like chatbots that interact with patients and answer doctors’ questions – even though some are already in use. Biden is taking a step toward addressing that today with an executive order that calls on the Department of Health and Human Services to create a task force to develop a strategic plan within a year on the responsible use of AI, POLITICO’s Mohar Chatterjee and Rebecca Kern reported. State of play: The Food and Drug Administration has approved about 520 AI-enabled devices — mostly for radiology, where the technology has shown promise in reading X-rays. FDA Commissioner Robert Califf said in an August meeting he believed the agency has done well with predictive AI systems, which take data and conjecture an outcome. But many products in development are using newer, more advanced technology capable of responding to human queries — something Califf has called a “sort of scary area” of regulation. Those present even more challenges to regulators, experts said. Troy Tazbaz, the director of the FDA’s Digital Health Center of Excellence, told Daniel his agency recognizes it needs to do more. Emerging regulation: AI products made for health care use and similar to Chat-GPT, the bot that can pass medical exams, require “a vastly different paradigm” to regulate, Tazbaz explained. But the agency is still working on that. There are no regulations specifically addressing the technology, so the FDA is planning a novel system. Tazbaz believes the FDA will create a process of ongoing audits and certifications of AI products, hoping to ensure continuing safety as the systems change. Even so: There’s risk that rules that are too onerous could quash innovation that might yield benefits for patients if it can make care better, cheaper and more equitable. The FDA is taking care not to stunt the new tech’s growth, Tazbaz said, talking with industry leaders, hearing their concerns and sharing the agency's thinking. “How do we actually regulate something like that without necessarily losing the pace of innovation?” Tazbaz asked. Safety first: In the absence of new rules, doctors are rapidly deploying AI — to interpret tests, diagnose diseases and provide behavioral therapy. Products that use AI are going to market without the kind of data the government requires for new medical devices or medicines. That worries Tazbaz. “The medical community needs to effectively look at the liabilities,” he said of AI used to diagnose patients. “Would I personally feel safe? I think it depends on the use case.”   GO INSIDE THE CAPITOL DOME: From the outset, POLITICO has been your eyes and ears on Capitol Hill, providing the most thorough Congress coverage — from political characters and emerging leaders to leadership squabbles and policy nuggets during committee markups and hearings. We're stepping up our game to ensure you’re fully informed on every key detail inside the Capitol Dome, all day, every day. Start your day with Playbook AM, refuel at midday with our Playbook PM halftime report and enrich your evening discussions with Huddle. Plus, stay updated with real-time buzz all day through our brand new Inside Congress Live feature. Learn more and subscribe here.     WELCOME TO FUTURE PULSE Old Rag Summit, Va. | Shawn Zeller This is where we explore the ideas and innovators shaping health care. Buzzkill: Using cannabis to ease anxiety might actually make your symptoms worse, according to The Wall Street Journal. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Evan Peng at epeng@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. Today on our Pulse Check podcast, host Kelly Hooper talks with POLITICO Morning Score author Madison Fernandez about what's at stake as Ohio voters decide next week whether to amend their state constitution to protect abortion rights, overriding the state's six-week ban. Listen to today’s Pulse Check podcast WASHINGTON WATCH Schumer says Congress will take the time to get AI legislation right. | AP Lawmakers are thinking about AI regulation, too, but are likewise months away from substantive action, Senate Majority Leader Chuck Schumer said recently at a Washington Post forum. “If you move too quickly on this, you may screw it up,” Schumer said. Schumer said lawmakers don’t want to squelch innovation and pointed to corporate concerns about the emerging EU AI Act becoming a compliance headache, reports POLITICO’s Mohar Chatterjee. “The EU went very fast, and now they’re backing off because they realize they made a lot of mistakes,” Schumer said. GOP views: Rep. Greg Murphy of North Carolina, co-chair of the Doctors Caucus, wants state governments to lead the technology’s regulation. Louisiana Sen. Bill Cassidy, ranking member of the committee that oversees health policy, has said Congress should do more — but without making it more difficult to innovate. Cassidy’s plan addresses many concerns raised by researchers, regulators and industry leaders, but he hasn’t proposed a bill to implement it. What’s next? Schumer said he’s organizing a forum on Wednesday on the risk of biased data in health care AI.   DOWNLOAD THE POLITICO APP: Stay in the know with the POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need. DOWNLOAD FOR iOS – DOWNLOAD FOR ANDROID.     PANDEMIC Far fewer people are eligible for the new Covid jab in Europe, than in the U.S. | AFP via Getty Images The Biden administration is recommending the latest Covid vaccine to all Americans, age 6 months and up, on the grounds that the shot provides at least some protection against infection for even those at low risk from the disease itself. But Europe doesn’t see it that way. A review of policies by POLITICO’s Claudia Chiappa found that not one country across the pond is recommending another dose for healthy young people, with some exceptions. Who’s getting a shot in Europe? The most common priority groups include people aged 60 and over (some countries have their cut-off at 65); pregnant women; people with conditions that compromise their immune systems; adults with other chronic diseases or severe obesity; and health care workers. While most countries recommend vaccinations for people older than 60 or 65, there are a few exceptions: The Czech Republic and Ireland offer it from age 50, for example. In some countries, young, fit people could be offered a shot because they live with someone belonging to a vulnerable group (Luxembourg and Spain), while others — such as Belgium, Sweden and Austria — also prioritize people living in nursing homes. Can others get jabbed anyway? In some countries, such as Spain and Belgium, they can. But in the U.K., people who do not belong to a high-risk group can't get a booster, even if they want one. Denmark will sell the vaccine to anyone who is not high-risk — while still offering it at no cost to those in priority groups. Even so: Part of Europe’s calculation is financial. Governments there don’t think the benefit of universal vaccination for their public health systems justifies the cost. “From a cost-benefit analysis, it doesn’t look that it’s recommended,” said Peter Piot, former head of the London School of Hygiene and Tropical Medicine and scientific adviser to the European Commission during the pandemic.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Evan Peng @thepngfile   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Please click here and follow the steps to unsubscribe.