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Senators take a step toward AI oversight

The ideas and innovators shaping health care
May 15, 2024 View in browser
 
Future Pulse

By Ruth Reader, Erin Schumaker, Daniel Payne and Carmen Paun

POLICY PUZZLE

Senate Majority Leader Chuck Schumer (D-N.Y.).

Schumer's got an AI roadmap. | Francis Chung/POLITICO

A bipartisan group of senators has released a much anticipated plan it hopes will guide Washington as lawmakers and regulators consider how to handle advances in artificial intelligence.

When it comes to AI in health care, the senators said lawmakers need to ensure the Department of Health and Human Services has the tools it needs to understand the risks and benefits of AI in order to regulate.

The group, which came together a year ago, includes Senate Majority Leader Chuck Schumer (D-N.Y.), as well as Sens. Todd Young (R-Ind.), Martin Heinrich (D-N.M.) and Mike Rounds (R-S.D.)

Why it matters: Federal agencies are grappling with how to oversee AI since President Joe Biden issued an executive order instructing them to last October.

FDA Commissioner Robert Califf has previously said the agency doesn’t have the personnel to adequately police advanced AI in health care, since it's constantly learning and evolving, unlike drugs or medical devices.

The senators’ AI roadmap also calls for $32 billion per year in funding for research and development into AI innovation across agencies, including at the National Institutes of Health, the country’s premier funder of health research.

Even so: Civil rights groups say the senators’ plan lacks needed guidance on how government can prevent known harms like bias in algorithms, and mitigate the effects of errant systems.

“It is light on substantive proposals to solve those problems,” David Brody, managing attorney of the Digital Justice Initiative at the Lawyers' Committee for Civil Rights Under Law, said.

 

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DIAGNOSIS

GULFPORT, MS - SEPTEMBER 01: People stand in line at the Kmart September 1, 2005 in Gulfport, Mississippi. The Kmart which didn't have power was open to help local residents who have been affected by Hurricane Katrina. (Photo by Joe Raedle/Getty Images)

Cancer risk for Black women remains disproportionately high. | Getty Images

The American Cancer Society is launching the largest population-level study of cancer risk and outcomes in Black women in the United States.

The study aims to enroll 100,000 Black women who have not been diagnosed with cancer. It’s looking for women between ages 25 and 55 who live in the 20 states and Washington, D.C., where 90 percent of Black women reside.

The study: Participants will complete an online enrollment survey on their health and life history, then fill out subsequent surveys twice a year for 30 years. By gathering long-term data on a large cohort of Black women, researchers hope to learn more about factors that contribute to cancer risk in Black women — and factors that protect against cancer.

Why it matters: While the cancer death rate has fallen 33 percent over the past three decades, Black women are more likely to die of most cancers — and die more quickly after diagnosis — than women in any other racial or ethnic group, according to the cancer society, which raises money for cancer research.

The study "will finally put Black women front and center for the most comprehensive look at the environmental and social drivers of cancer in this community," Alpa Patel, study co-investigator and senior vice president of population science at the cancer society, told Erin.

"We're already seeing a great response since the launch and grassroots-level enrollment will be critical in the upcoming months to ensure we capture every perspective."

Big picture: While NIH Director Monica Bertagnolli has said that diversifying clinical trials is a top priority for her, expanding access to trials is expensive. And after decades of generous funding bumps, Congress cut NIH’s budget by $378 million this year to $47.1 billion, down from $47.5 billion in fiscal 2023.

 

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TECH MAZE

General bariatric surgeon Dr. Don Davenport explains that the Da Vinci Surgical System is more beneficial than hand held laparoscopic graspers because it is less invasive making for less painful recoveries for patients as well as faster healing time during an interview with the media Tuesday, Sept. 12, 2017, at Medical Center Hospital in Odessa, Texas. (Jacob Ford/Odessa American via AP)

Medical device makers say the FDA is the agency to oversee AI. | AP Photo

Medical device makers have a message for regulators on artificial intelligence: The status quo isn’t so bad.

AdvaMed, a trade group for the companies, recently responded to a request for information from Rep. Ami Bera (D-Calif.), an internist and former health care executive who’s on a House AI task force, about what Congress should do about AI regulation.

The group’s take: not much. It told Bera that the existing regulatory framework for devices, as overseen by the Food and Drug Administration, is robust and could also apply to the latest AI tools.

Even so: Better policies are needed to make sure AI systems are working and the tech continues to grow, the group said.

Medicare and Medicaid could agree to reimburse care providers for AI systems, boosting innovation and adoption, the group suggested.

 

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