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The ideas and innovators shaping health care | | | | |  | | By Ruth Reader, Evan Peng, Daniel Payne and Erin Schumaker | | | | | 
AI regulations are coming, but industry is skeptical. | Josep Lago/AFP/Getty Images | | | “Does the FDA even have the regulatory process to enable them to proactively monitor models absent an adverse-event reporting incident?” — Dr. Brian Anderson, chief digital health physician at MITRE | | There’s lots of optimism about the role AI can play in health care. Panelists at the Milken Institute’s 2023 Future of Health Summit said it can help alleviate doctor burnout, diversify clinical trials and better reach patients. Even so: They’re concerned it will be hard to regulate. In addition to questioning the Food and Drug Administration’s regulatory process, AI panel member Dr. Brian Anderson, chief digital health physician at MITRE, a nonprofit that works with the government on technology projects, wondered whether the agency even has the authority to set rules for advanced AI that doesn’t now qualify as a medical device. President Joe Biden’s new executive order aims to ensure that AI is safe, secure and trustworthy and could give federal agencies more insight into AI models through its reporting requirements. However, Srini Iyer, chief technology officer of Leidos’ health technology group, said the rules might be easy to dodge. The order seeks specifically to regulate next-gen, self-supervised models trained on extremely large, broad datasets that could pose a risk to national security or public safety. Iyer said companies would only have to say their AI models don’t fall under that definition because they know enforcement will likely be underfunded. That would lead to a bleak future with a lot of what Iyer called shadow AI: “People are going to be doing stuff and not reporting it because they’re going to look for that loophole.”
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| This is where we explore the ideas and innovators shaping health care. 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 health care reporter Chelsea Cirruzzo, who reports on a proposed update to the CDC's infection-control guidelines, which would better help clinicians limit transmission of viral infections in health care facilities.
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Milken panelists discussed the misinformation conundrum. | Evan Peng/POLITICO | Artificial intelligence could help combat public health misinformation by distilling data and helping people decipher what’s real and what’s not. But the bad news is that AI could also help spread it, panelists at the Future of Health Summit said. AI can create and disseminate falsehoods, including voice and video deepfakes attributing words to people who didn’t say them. “AI is in its infancy right now, and there’s a lot of really amazing things that it can do, but I think we all should be a little cautious,” said Ellen Patterson, the president of EVERFI, a digital education company. Education is key. Government must promote media literacy in schools and aggressively promote reliable public health information in its messaging, panelists said. Such an approach is more likely to succeed than trying to shut down misinformation-spreaders, said Andrew Friedson, director of health economics at the Milken Institute. Even so: Political fights over education can affect how students are taught media literacy, warned panelist Dr. Reed Tuckson, former commissioner of public health for the District of Columbia. He pointed to school board debates over educational curricula and particularly religious agendas of conservative groups over science education. Why it matters: Misinformation, deliberate or not, can impact public health outcomes, as the pandemic has shown.
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Panelists said the cost-benefit of new weight-loss drugs is still uncertain. | Daniel Payne/POLITICO | The federal government is making the case to health insurers it works with that they should sometimes cover new drugs that help people lose weight but also come with a high price tag. Dr. Christa-Marie Singleton, chief medical officer of the U.S. Office of Personnel Management, the HR department for the executive branch, said at the Future of Health Summit that employers — including the government — can determine the care available for patients. How so? Singleton stressed that drugs for obesity should be administered as part of a comprehensive coverage plan, including other services like nutrition counseling. Joseph Nadglowski, president and CEO of the Obesity Action Coalition, an advocacy group for people with the condition, said that OPM might have the most comprehensive obesity care for employees. But that doesn’t mean access is easy. Nadglowski said care is often stigmatized and difficult to get, arguing that even when patients have good coverage, the hoops and hurdles to access care can be significant. Another factor: The drugs’ long-term costs and benefits. Groups representing insurance plans, employers and patients — as well as the makers of the drugs — are trying to figure out how much money a reduction in obesity will save the health care system by improving overall health. Gregory Daniels, vice president and head of global public policy at drugmaker Eli Lilly, which is developing a new drug for obesity, is among them. “It’s too early to tell,” he said of the drugs’ potential long-term benefits. | | | | 
Sens. Bennet (center) and Young (right) hope the third time's the charm on their PASTEUR Act. | Daniel Payne/POLITICO | Sens. Michael Bennet (D-Colo.) and Todd Young (R-Ind.) aren’t giving up on their effort to develop drugs that can fight infections resistant to current therapeutics. How so? They’ve introduced their legislation, the PASTEUR Act, three times now, but they said at the Future of Health Summit that they’re still trying to convince their colleagues to pass it. “There’s amazing focus right now,” Young said. “We have a responsibility to tackle this issue.” The senators, in a bid to pass the bill, have lowered its price tag from $11 billion in the 2020 version to $6 billion in its current form. Whether that trim would be “penny-wise and pound-foolish,” Bennet said, remains to be seen. “We hope the $6 billion will be sufficient,” Young said. Why it matters: The bipartisan effort began in the wake of the pandemic, as the senators realized that earlier investment and market forces weren't sufficient to produce the needed drugs. “We weren’t as prepared as we could have been,” Bennet said. “I do think it’s important for the U.S. to be the global leader here.” Should the bill eventually pass, Bennet said he expects new drug development to be “relatively quick.”
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