Taking stock of Biden’s AI order

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Nov 01, 2023 View in browser   By Ben Leonard and Chelsea Cirruzzo Presented by With Katherine Ellen Foley Driving the Day President Joe Biden signed a wide-ranging executive order to monitor the risks of artificial intelligence. | Drew Angerer/Getty Images REAX TO AI ORDER — The health care industry largely sees President Joe Biden’s executive order on artificial intelligence as a significant step, but questions remain about the next steps. “I am impressed by the breadth of this Executive Order,” Sen. Mark Warner (D-Va.), chair of the Intelligence Committee, said in a statement. “At the same time, many [sections] just scratch the surface — particularly in areas like health care.” The sweeping order, issued Monday, includes a call for HHS to create an AI task force to craft a strategic plan for deployment, an assurance policy and a safety program for detecting errors. It aims to balance facilitating innovation with mitigating risk. It’s a more unified approach in the sector than before, Jodi Daniel, partner at Crowell & Moring and former policy director at the Office of the National Coordinator for Health IT, told Pulse. “There have been pieces that have been done so far … but not really a comprehensive approach," Daniel said. “We still have to wait for the details that will come out.” Daniel praised the proposed AI safety program, saying it could capture issues that fall outside the FDA’s purview. John Halamka, co-founder of the Coalition for Health AI, which includes Google and the Mayo Clinic, told Pulse that while the order touches on the need for public-private collaboration on AI guardrails, other interested parties will look to fill in how it happens. Privacy: Privacy concerns are discussed in the order, but Daniel said it didn't delve into issues related to health data outside HIPAA — which would need to come through a privacy law. Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee, said she agreed with the Biden administration that the nation needs a “comprehensive” data privacy law to ensure trustworthy artificial intelligence. “The administration needs to work with Republicans and Democrats in Congress to strike the right balance between encouraging entrepreneurship while also ensuring robust protections for people’s data,” she said in a statement. Looking forward: Funding will be key. Cybil Roehrenbeck, executive director of the AI Healthcare Coalition, which includes steering committee members Lantheus and Viz.ai, said some existing federal funding can cover the efforts and more appropriations should be expected. “There’s still work that needs to be done to ensure that AI services are appropriately covered and reimbursed,” said Roehrenbeck, who’s pushing for CMS to have more authority to pay for AI tools for patients. WELCOME TO WEDNESDAY PULSE. We hope you had a great Halloween. What’s your favorite Halloween candy? Mine is Dots — controversial, I know. Reach us at bleonard@politico.com or ccirruzzo@politico.com. Follow along @_BenLeonard_ and @ChelseaCirruzzo. TODAY ON OUR PULSE CHECK PODCAST, host Lauren Gardner talks with POLITICO health care reporter Daniel Payne, who talks through artificial intelligence's rapid expansion into health care with little government regulation, potentially putting patients at risk for misdiagnoses, bias and privacy violations.   GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is proud to partner with the Milken Institute to feature a special edition of our Future Pulse newsletter at the 2023 Milken Institute Future of Health Summit from November 6-8. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators solving the biggest public health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE.     Listen to today’s Pulse Check podcast A message from Optum Rx: 46 million Americans live in rural areas, and community and independent pharmacies play a vital role in their health care. That’s why Optum Rx is proud to partner with more than 26,000 community and independent pharmacies to deliver care, improve the pharmacy experience and help make prescription drugs more affordable. That’s pharmacy care “Optumized.” Learn more.   In Congress Some Democrats are pressing Sens. Chuck Schumer and Mitch McConnell to take action on a supplemental funding package that addresses primary care access and the opioid crisis. | Chip Somodevilla/Getty Images DEMS PUSH SCHUMER ON SUPPLEMENTAL — The battle over the supplemental funding package is shaping up in Congress. Six progressive senators are pushing Senate Majority Leader Chuck Schumer and Minority Leader Mitch McConnell to use a still-forming package to tackle progressive priorities: access to primary care and funding for the opioid crisis, including more resources to fight the scourge of fentanyl. “We have a responsibility to act boldly to respond to ALL of the major emergencies we face — both at home and abroad,” wrote the senators: Bernie Sanders (I-Vt.), Mazie Hirono (D-Hawaii), Ed Markey (D-Mass.), Jeff Merkley (D-Ore.), Elizabeth Warren (D-Mass.) and Peter Welch (D-Vt.). Biden has pushed for $106 billion in emergency aid, including for Israel and Ukraine and humanitarian assistance for Ukraine, Israel and Gaza. Hearing to come: Senate Appropriations Chair Patty Murray (D-Wash.) said Tuesday that the committee will call HHS Secretary Xavier Becerra and DHS Secretary Alejandro Mayorkas before the panel on Nov. 7 and signaled openness to addressing both foreign and domestic issues. “We should also address needs here at home, like the child care crisis, relief for communities struck by disaster, the fentanyl crisis, the needs at our southern border, and more,” Murray said. “If we can pass our domestic priorities right alongside our national security priorities, we absolutely should.” It’s unclear whether the effort could get through the Republican-led House. The White House has asked for funding to counter fentanyl but didn’t ask for primary care funding.   A message from Optum Rx:   Around the Agencies THUMBS UP FOR SICKLE CELL THERAPY — Independent advisers to the FDA met Tuesday and said they support the safety data backing the first potential approved gene-editing therapy, Katherine reports. Vertex and CRISPR Therapeutics have asked the FDA to approve a one-time potential cure for severe sickle cell disease. The candidate, called exa-cel, uses CRISPR, a groundbreaking gene-editing technology to modify patients’ stem cells. FDA scientists raised concerns that the companies might not have conducted adequate modeling to ensure the treatment didn’t edit unintended DNA, which could potentially harm patients. But overall, advisers felt that the companies’ analysis was “quite detailed,” Tabassum Ahsan, vice president of cell and gene therapy operations at City of Hope, said during the meeting. What’s next: The FDA is slated to decide on exa-cel for sickle cell disease by Dec. 8. Vertex and CRISPR Therapeutics have also asked the agency to approve exa-cel for a form of beta thalassemia, a rare blood disease. That decision isn’t expected until March 30. HEP C TESTING FOR BABIES — The CDC has new recommendations for babies born to people with hepatitis C: Test them when they’re 2-6 months old, Chelsea reports. The new recommendations issued Tuesday come after hepatitis C rates nearly tripled from 2011 to 2018 among reproductive-aged people. They build upon universal screening recommendations for adults issued in 2020, which included testing pregnant people during pregnancy. According to the CDC, 6 to 7 percent of infants exposed to hepatitis C in the womb or during delivery will be infected. Background: HHS launched a five-year plan to reduce viral hepatitis in 2021. According to the most recent data, the agency estimated 69,800 new hepatitis C infections in 2021, far from HHS’ target of around 38,200. The agency says children who test positive should be referred to a provider with expertise in pediatric hepatitis C management. HOSPITAL BURNOUT CAMPAIGN — And a new CDC campaign offers hospital leaders with resources to prevent provider burnout, which the agency has described as at crisis levels. Why it matters: The campaign comes after a new CDC report found that, between 2018 and 2022, the number of providers who reported feeling burnt out increased from 11.6 to 19 percent. It also found that more than double the number of health care workers reported being harassed at work in 2022 than in 2018 — and 81 percent of workers who reported harassment in the workplace also reported feeling burnt out. The CDC’s Impact Wellbeing campaign, a response to the report, includes a questionnaire template in which hospital workers can identify how they feel, a guide leaders can use to encourage workers to seek help for mental health concerns and a list of training strategies for supervisors to help them prevent burnout. Names in the News Dr. Jen Brull, vice president of clinical engagement at Aledade, was voted president of the American Academy of Family Physicians. Marvin Figueroa has been tapped to be chief of staff for Sen. Laphonza Butler (D-Calif.). He was director of the Office of Intergovernmental and External Affairs at HHS and previously worked for former Virginia Gov. Ralph Northam and Sen. Mark Warner (D-Va.). WHAT WE'RE READING POLITICO’s Brendan Bordelon reports on the politics of Biden’s AI order. HealthcareInfoSecurity reports on lawsuits claiming Costco sent sensitive health information to Facebook, Google and other marketers.   A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY.     A message from Optum Rx: Optum Rx is providing greater transparency and choice across the pharmacy supply chain, delivering significant cost savings, and better outcomes and experiences for millions of people. Our unique tools and innovative programs help members access the lowest prices. ● PreCheck MyScript allows doctors to see real-time pricing during an office visit, saving an average of about $111 per script ● Optum Perks lets members access the best cash price at more than 67,000 pharmacies ● Price Edge compares direct-to-consumer pricing for traditional generic drugs with insurance pricing to ensure members get the lowest price That’s pharmacy care “Optumized.” Learn more.     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 Evan Peng @thepngfile Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Megan R. Wilson @misswilson   Follow us

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