L[AI]bility: Who takes the fall?

Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.

Mar 25, 2024 View in browser   By Ben Leonard and Chelsea Cirruzzo With Daniel Payne  Driving the Day Doctors who worry about malpractice suits borne out of AI mistakes see an ally in some lawmakers like Rep. Greg Murphy, who has appealed to the FDA to create "safe harbors" for them. | Joe Raedle/Getty Images WHO PAYS? The health system’s increasing interest in artificial intelligence as a clinical tool raises a new question: Who’s liable if the systems make a mistake? Millions of dollars in payments over medical mistakes are at stake — as well as broader questions about when care is considered good enough and what place AI tools have in American health care, Daniel reports. The issue is of concern to doctors, patients, trial lawyers, tech executives, lawmakers and regulators. And the questions aren’t just hypotheticals. The president of the American Medical Association, Dr. Jesse Ehrenfeld, said doctors are already seeing AI come up in medical malpractice cases. Courts have yet to come to a consensus on who will be considered responsible. So doctors are going on the offensive, asking lawmakers and regulators to proactively consider protections against liability when AI systems contribute to a case that ends up in court. They have allies in Congress, like Rep. Greg Murphy (R-N.C.), a urologist, who wrote to FDA Commissioner Robert Califf earlier this year to suggest a “safe harbor” for doctors and AI software makers if both agree to report on problems they find with the technology. Tech companies, trial lawyers and some hospitals have a different take: Doctors make the final calls in patient care and are ultimately responsible, even if software steers them wrong. That isn’t comforting to some doctors, who say AI systems could make it harder for them to think independently about cases. “The confidence with which AI posits its conclusions makes it really hard as a human to say, ‘Wait a minute, I need to question this,’” said Dr. Wendy Dean, president and co-founder of Moral Injury of Healthcare, an organization that advocates for doctors’ well-being. WELCOME TO MONDAY PULSE. We hope you had as good of a weekend as the bears in England who rode on a swan pedal boat. Reach us and send us your tips, news and scoops at bleonard@politico.com or ccirruzzo@politico.com. Follow along @_BenLeonard_ and @ChelseaCirruzzo. Abortion President Joe Biden gave a campaign speech in Phoenix last week but didn't bring up the subject of abortion. | Jacquelyn Martin/AP Photo WHAT ARIZONA SHOWS US ABOUT 2024 — Democrats hope an Arizona ballot measure codifying abortion rights will juice voter turnout on the left in November, giving them a chance to break the GOP’s majority in the state legislature, win a pivotal Senate seat and deliver the state — and possibly the election — to President Joe Biden. Biden reminded voters in Phoenix last week that he “desperately” needs their help — though he never mentioned abortion, POLITICO’s Alice Miranda Ollstein reports. Vice President Kamala Harris, meanwhile, made Arizona her first stop after the State of the Union and focused her speech on the threat posed by the state supreme court, which could soon reinstate an 1864 abortion ban with no exceptions for rape or incest. Senate hopeful Rep. Ruben Gallego (D-Ariz.) is running as a champion for abortion access — helping collect signatures to put the measure on the ballot, holding events with abortion-rights groups and pledging to abolish the Senate filibuster to help pass national protections if elected. But while his GOP opponent Kari Lake said during her failed bid for governor in 2022 that she would enforce Arizona’s 1864 abortion ban if elected, calling it a “great law,” she has of late tried to sidestep questions about her plans on abortion, telling Alice that “it’s ultimately going to be up to the voters of Arizona to decide” before changing the subject. Advocacy groups on both sides are pouring millions into Arizona, a swing state. Biden won Arizona by just over 10,000 votes in 2020, and the state’s Democratic Attorney General Kris Mayes won her 2022 race by a few hundred votes — a victory she attributes almost entirely to voter outrage over the fall of Roe v. Wade. In Congress SHUTDOWN CLOCK: 189 DAYS (BUT WHO’S COUNTING?) — Congress passed legislation to avoid a partial government shutdown, capping fiscal year 2024 appropriations, though six months late. President Joe Biden signed the package — which includes funding for HHS — into law Saturday. Congress and Biden worked out funding for the VA and the FDA earlier this month. The package gave HHS a slight boost in funding, though short of inflation and reauthorized the global AIDS program PEPFAR for a year. But it was devoid of controversial abortion riders that Republicans had pushed. You can read Pulse’s five takeaways from the spending deal here. On the horizon: The deal will give HHS funding through the end of September. The next round of negotiations could be significantly different, with House Appropriations Committee Chair Kay Granger (R-Texas) saying she’s leaving her post. She said in November she wouldn't seek reelection. Rep. Robert Aderholt (R-Ala.), who chairs the committee’s Labor-HHS-Education subcommittee, has said he's considering a bid for the gavel. Rep. Tom Cole (R-Okla.), a senior Republican appropriator, said he's running to replace Granger. Providers FEDS DOUBLE DOWN ON HIPAA GUIDANCE — Federal officials are doubling down on guidance that warns hospitals their website tracking technology might violate federal privacy laws amid a lawsuit from the American Hospital Association, Chelsea and POLITICO’s Ruth Reader report. Last November, the AHA sued HHS over a bulletin that says tracking visitors on health system websites could violate HIPAA, claiming the agency exceeded its authority. HHS asked the Texas district court judge presiding over the case to reject the AHA’s request for a summary judgment in favor of its own. HHS’ request says the court lacks jurisdiction because the bulletin isn’t a rule; it merely restates obligations required under the privacy law HIPAA. The suit represents some of the most significant pushback by industry groups against the Biden administration’s attempts to tighten federal privacy law. At stake is the push by health systems to use targeted advertising and website analytics tools to gather information about the people visiting their sites. HHS’ Office for Civil Rights has said the website tracking can violate HIPAA. AHA’s biggest gripe with the HHS bulletin is that health systems can’t know why someone visits their websites, so hospitals shouldn’t be penalized for sharing data about a person not seeking health services. HHS has now updated the bulletin to clarify that collecting and sharing user data with unauthorized third-party entities is only an infraction of federal law if the data reveals something about users’ past, present or future health — information protected under privacy rules. HHS did not respond to requests for comment. Health Costs CBO TALKS AI, PREVENTIVE CARE — The nonpartisan Congressional Budget Office views the evidence for artificial intelligence’s utility in health care as "mixed." The scorekeeper said in answers to questions for the record released Friday following a House Energy and Commerce Health Subcommittee hearing in January that there isn't enough evidence to estimate the topline impact of AI on health care spending. AI and machine learning could cut costs by preventing unneeded care or more expensive care later. But they could also add to costs by "spurring the development of expensive new technologies with meaningful health benefits or by identifying additional patients who might benefit from certain medical services,” CBO wrote. Preventive care: In another response to questions for the record, this time from a House Budget Committee hearing, CBO said it’s "well positioned" to offer information that would be required under a bill the House passed last week that would add new requirements for the CBO to help lawmakers evaluate the impact of preventive care. It would require the CBO to weigh whether a bill would save money over a 30-year budget window instead of 10 if Congress requests it. “That additional information would provide policymakers with a more complete picture of the budgetary effects of preventive health care legislation,” CBO wrote. Names in the News FMI has promoted Krystal Register to vice president of health and well-being, Steven Harris to senior director of government relations and strategic initiatives and Tom Cosgrove to director of industry relations. WHAT WE'RE READING KFF examines gaps in data on hospital and health system finances. POLITICO’s David Lim reports on the FDA agreeing to take down its ‘You are not a horse’ ivermectin tweet. The Wall Street Journal reports on doctors testing a brain-computer implant.   Follow us on Twitter Dan Goldberg @dancgoldberg Chelsea Cirruzzo @chelseacirruzzo Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Kelly Hooper @kelhoops Robert King @rking_19 Ben Leonard @_BenLeonard_ David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Megan R. Wilson @misswilson   Follow us

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