| | | | |  | | By Carmen Paun, Ruth Reader, Daniel Payne and Erin Schumaker | | Presented by |  | | | | | | | 
President-elect Donald Trump's not keen on the World Health Organization. | Alex Brandon/AP | Diplomats for the world’s nations are nearly three years into talks aimed at setting countries’ obligations whenever the next pandemic comes. But with President-elect Donald Trump likely to pull the U.S. out of the negotiations, the entire effort could fall apart. A U.S. withdrawal could potentially see other nations withdraw from the talks, as Trump might try to persuade allied nations to follow suit, said Larry Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. “This would be catastrophic after all we suffered with Covid — three years of international negotiations to see it all unravel because of the election of one isolationist,” he said. The U.S. is, far and away, the world’s leader in pharmaceutical innovation, accounting for more than half of new discoveries by some accounts. Terms for sharing those discoveries are a key part of the planned deal. State of play: The two independent leaders, from France and South Africa, steering the talks at the World Health Organization, said disagreements over the sharing of drugs, vaccines and information about pathogens require more time to sort out. Nations missed a deadline to reach an accord in May and have given themselves another year to cut a deal. While developing countries have pressed wealthy nations to require drugmakers to share their inventions, the Biden administration and European powers have resisted. Though Trump hasn’t announced any plans, he’s widely expected to withdraw support, given his attempt to exit the WHO during the waning days of his first term, when he accused the organization, which is a United Nations agency, of covering up China’s role in the Covid-19 pandemic. Congressional Republicans also oppose a pandemic agreement. In May, the Senate Republican Conference called on President Joe Biden to withdraw from negotiations, concerned that a future accord would increase WHO authority, shred intellectual property rights and infringe upon freedom of speech. A Trump transition spokesperson didn’t directly address a question about Trump’s approach to the negotiations. “The American people reelected President Trump because they trust him to lead our country and restore peace through strength around the world,” Karoline Leavitt said. “When he returns to the White House, he will take the necessary action to do just that.”
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Shenandoah National Park, Va. | Shawn Zeller/POLITICO | This is where we explore the ideas and innovators shaping health care. If psychedelic therapy using psilocybin, or magic mushrooms, can gain FDA approval, more than 5 million Americans with severe depression would be eligible , according to a new study. 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.
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AI tools are now part of life in America's hospitals. | AP Photo | Academics, patient advocates and health tech executives have some ideas on how the new regime in Washington should handle artificial intelligence. At an event presented by the National Academy of Medicine and the University of California, San Diego, last week, they suggested: — Standardizing data safeguards and their use in AI — Developing a research strategy to understand AI in health care — Designing open-source frameworks to locally test AI inside of health systems — Creating a mode for patients to report harms — Certifying AI products through assurance labs Attendees noted that AI in medicine is a double-edged sword capable of helping and hurting patients. For example, AI scribes could help doctors reduce administrative burdens like notetaking, allowing them to spend more time with patients, or just accommodate more rushed appointments. Why it matters: So far, health systems and insurers largely adopt AI to boost profitability by automating the billing and claims process. But patients are suing insurers, alleging they use AI to deny care. Some rules exist. The Food and Drug Administration regulates AI medical devices and AI software that assists in clinical decisionmaking, but the agency doesn’t oversee more advanced tools, like chatbots. FDA Commissioner Robert Califf has said he would need a bigger budget and a larger staff to do more. HHS’ assistant secretary for technology policy regulates AI in electronic medical records, and the Office for Civil Rights tries to ensure that health AI doesn’t discriminate. But health AI specialists at the San Diego event were concerned that layering AI on top of a flawed health care system risks amplifying existing problems instead of providing solutions. The success of AI in health care settings hinges on how it’s standardized and implemented, they said. Even so: Most health systems operate on thin margins — between 2 and 5 percent monthly in the last year, according to health care consultant Kauffman Hall. That means health systems don’t have much money to invest in artificial intelligence, and some in health care finance, along with patient advocates, are concerned that the cost of implementing this technology will fall on patients.
| | | | The lame duck session could reshape major policies before year's end. Get Inside Congress delivered daily to follow the final sprint of dealmaking on defense funding, AI regulation and disaster aid. Subscribe now. | | | | | | | | |  A chatbot will now help process mental health patients at Rogers Behavioral Health. | AFP via Getty Images | | An artificial intelligence chatbot will soon help a major mental health provider with patient intake. Rogers Behavioral Health, a mental health care provider that stretches across 10 states, will introduce Limbic AI into its workflow for screening new patients, the groups announced today. It marks the first release of Limbic’s tools in the U.S. The company already has a foothold in the U.K., where the tool is used for more than 350,000 patients and has a medical device approval. “Over the last 18 months, things have really begun to change materially and practically,” said Ross Harper, founder and CEO of Limbic. “Practical value is being created.” Using AI to refer patients to care could help break down the barriers some patients face when seeking help, said Brian Kay, chief strategy officer at Rogers, though phone and in-person intake will remain available. “There are people who may have social anxiety,” he said. “There are people who, for very understandable reasons, may not be comfortable picking up the phone and chatting with someone.” A key goal with the rollout is offering care to patients who otherwise wouldn’t get it, he said. Why it matters: The announcement marks another major rollout of AI in the health industry, where providers and payers are making huge investments in the technology. But how Washington — and a future Trump administration — regulates the technology could prove crucial to its future. What’s next? Kay said AI could eventually play a greater role in the care Rogers is offering — but he said it will never replace clinicians. Limbic will expand "quite substantially” in the U.S. in the future, Harper said.
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