| | | | |  | | By Chelsea Cirruzzo and Ben Leonard | Presented by Humana | | | | | |  Vice President Kamala Harris looks on as President Joe Biden signs an executive order guiding his administration's approach to artificial intelligence last October. | Chip Somodevilla/Getty Images | AI REGULATIONS SPARK CONCERN — The health care industry is raising concerns about coordination after the Biden administration’s move to mandate more transparency in artificial intelligence, Ben reports. HHS’ Office of the National Coordinator for Health IT finalized rules in December after Biden promised an aligned effort through an executive order to set rules for the new AI expected to transform medicine. The timing was a coincidence, ONC head Micky Tripathi said, since it had already been working on algorithmic bias when ChatGPT took the world by storm. The rules, set to apply at the end of the year, require AI system developers to inform their customers how well the AI’s training data represents patients, how the developers attempt to mitigate bias in the data and how they validate the systems perform as claimed. While many welcome more transparency, AI developers, and even their customers, suggest the rules could signal a scattershot, agency-by-agency approach instead of the coordinated regulatory push Biden promised. “Our concern is that as an innovator or a clinician, you're going have to look toward the rules of umpteen different sub-agencies before you can actually use an AI tool,” Cybil Roehrenbeck, executive director of the AI Healthcare Coalition, said. ONC says its rules will help the industry make more informed choices about AI products. But other agencies — including the FDA, the FTC and the Office for Civil Rights — plan their own rules, and health care leaders fear an impending mess. “History has taught us that government doesn’t work well with itself. That’s the biggest issue I think we run into here,” said Brett Meeks, executive director of the Health Innovation Alliance, which represents providers and insurers. “They're using the authorities they have and stretching them, and you end up with competing regulations or unclear lines.” Tripathi said he understands the concerns, and his agency has coordinated with other agencies to align regulations. He added he’s eyeing a more formalized governance structure for AI across HHS and acknowledged the concerns of startups that all the rules will put them at a disadvantage when competing with more established tech developers. But Tripathi defended his approach. “This is not AI to generate a picture of my favorite kitten," he said. "This is actually used in clinical care. … We ought to have some kind of bar." WELCOME TO MONDAY PULSE. NPR listeners say the secrets to a long life include making friends across generations, putting your mental health first and making your workout a social activity. Send your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_.
| | | | A message from Humana: According to the National Council on Aging, nearly 80% of seniors have two or more chronic conditions. The U.S. healthcare system is complex and often fragmented. Seniors, particularly those with complex, chronic conditions, need solutions that address the full range of their health-related needs. Learn more here. | | | | | | | 
Before he leaves Congress, Rep. Brad Wenstrup hopes to get to the bottom of Covid-19's origins. | Anna Moneymaker/Getty Images | WENSTRUP ON COVID’S CAUSE — Retiring Rep. Brad Wenstrup (R-Ohio) wants to unearth the origins of Covid-19 and possibly crack down on the NIH’s granting process before he leaves Capitol Hill at the end of the year. POLITICO’s Carmen Paun spoke with Wenstrup, who, as chair of the House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic, says he’s racing to outline what worked well and what didn’t in America’s response to the pandemic. But Democrats, HHS and some scientists have accused him of making the panel partisan and raising conspiracy theories that lead nowhere. Wenstrup, who’s also a doctor, told POLITICO he hopes his work will spur discussion about whether high-risk scientific research known as gain of function is needed, given the risk of an enhanced pathogen leaking from a lab and causing a disease outbreak. This interview has been edited for length and clarity. What do you think caused Covid-19? My gut feeling right now is that it was an accidental leak from the lab. Most of the evidence would point toward that, just considering the actions of the Chinese. What are some lessons you can already draw from your work on the Covid committee? We really missed on our messaging. A lot of decisions were made blind, so you’re making your best educated guess. If the government is going to recommend something, then we should explain why we’re recommending it if we don’t have a scientific study to justify it. The one-size-fits-all from Washington wasn’t a great idea. Are you considering legislation that would curtail gain-of-function research? If not now, very soon in the future, we won’t need to be doing gain-of-function research for anything because we can do it through artificial intelligence. With the Covid committee, we can propose legislation, but it would have to go through the committee of jurisdiction. There are processes that we can change. The system in place doesn’t ensure that recipients of government grants are adhering to the tenets of the grants. Read the full interview.
| | | | CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here. | | | | | | | | | FIRST IN PULSE: A NEW HEALTH AI PROPOSAL — A leading health tech advocacy group shares its concerns in a new proposal about a hot topic in artificial intelligence: Who’s responsible when AI goes awry, Ben reports. In the proposal, first obtained by Pulse, the Connected Health Initiative said that parties throughout the chain of AI deployment should minimize risks based on “knowledge and ability” and have “appropriate incentives to do so.” “There is a shared responsibility for ensuring safety,” said Brian Scarpelli, the executive director of the group, whose steering members include Apple, Amazon, the American Medical Association and Roche. “The responsibility to do something will be use-case specific, but should be pegged on the actual knowledge of the party and their ability to do something about it.” The group wants to avoid wasted time finger-pointing, Scarpelli said. The big picture: Liability when artificial intelligence fails is still an open question. A recent paper from Stanford researchers in the New England Journal of Medicine said that as a result, doctors and hospitals are taking on risks when implementing the technology.
| | | | A message from Humana:   | | | | | SHAM HEALTH INSURANCE CRACKDOWN — A Florida-based company will pay the Federal Trade Commission millions of dollars and be banned from selling health care products after charges that it sold sham health care plans. A Florida judge last week granted the FTC’s motion to ban Simple Health and its CEO, Steven J. Dorfman, from any future telemarketing or sales of healthcare products. The company’s assets will be liquidated and turned over to the FTC — resulting in $195 million that the agency said would be used to refund the scheme’s victims. “Simple Health preyed on consumers by selling them bogus health care insurance that cost them thousands of dollars for ‘benefits’ that in fact left consumers unprotected,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a statement. Simple Health and Dorfman couldn’t be reached for comment. The FTC filed a complaint against the company in 2018, alleging that it mislead people into thinking they were buying comprehensive health insurance plans that included lab testing, preexisting conditions, drugs and primary care. However, consumers were paying $500 a month for a plan that was “actually a medical discount program or extremely limited benefit program” that left many consumers with uncovered medical bills, the FTC said in a statement. The company’s chief compliance officer agreed to settle in 2021. HHS FINALIZES TRIBAL SUPPORT RULE — The Biden administration finalized a rule Friday to end the cost-sharing requirement for tribal child support programs, which HHS said would help tribes prop up their own child-support programs. Of 574 federally recognized tribes, only 61 operated tribal child-support programs. In 2022, tribal support programs collected $51 million in child support. In tribes with child-support programs, 53 percent of native children live in single-parent homes. According to the Administration for Children and Families, the requirement to pay a nonfederal share of child support for each program, a contribution toward the program’s operating costs required for the tribe, is a barrier to creating a program. The final rule eliminates this requirement.
| | | | 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. | | | | | | | | | The New York Times reports on an investigation into suspicious claims involving thousands of Medicare beneficiaries made by seven different health care companies. NBC News reports on the first case of plague in Oregon in more than eight years — which likely came from a cat.
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