Questions about the new health AI rules

PROGRAMMING NOTE: Please be on vacation next week, but we will return to our normal schedule on Tuesday, January 2nd.

With Megan R. Wilson

AI REG REACTION HHS has new rules coming into effect in 2025 that will require AI developers to disclose more about how their algorithms work, Ben reports.

There is support in the industry, but Pulse also heard skepticism about the effectiveness of the rules and questions about liability and scope.

Background story: Last week, the Office of the National Coordinator for Health IT announced broad rules for the use of artificial intelligence in most hospitals and doctors’ offices. In short, the ONC regulations require software developers to provide more information to customers so that service providers can determine whether AI products are fair, appropriate, valid, effective, and safe.

Reaction: Major groups including the Coalition for Health AI, whose members include Google, Microsoft and Duke Health, praised the rules.

“Having some standards in place is really important,” Michael Pencina of Duke AI Health and co-founder of the coalition told Pulse. They struck the right balance of mostly bringing things up, but not being too overbearing.

Office interaction: Still, there are questions about how ONC and the FDA, which also regulates medical devices equipped with artificial intelligence, will work together. Cybil Roehrenbeck, executive director of the AI ​​Healthcare Coalition, told Pulse that she hopes ONC will treat products already regulated by the FDA differently.

FDA oversight should count for something, Roehrenbeck said.

In its rule, ONC said it was working with the FDA to harmonize regulations to reduce the compliance burden on AI developers covered by both agencies’ rules.

Responsibility: Roehrenbeck said that ONC rules rely on individual doctors to make calls about the reliability of AI also raises liability issues. ONC said they are not part of its rule.

If a medical device fails, we know how to go through the process, Andrew Tomlinson, director of regulatory affairs at the American Health Information Management Association, told Pulse. We need to have the same process for AI.

And Roehrenbeck said he has received several questions about which algorithms the rules apply to, and that he hopes for more clarity.

The agency said the rule has a broad scope, covering models that do not directly participate in clinical decision-making and may affect the delivery of care, such as models that assist supply chains.

An ONC spokeswoman said the agency appreciates the strong public input and hopes for more.

WELCOME TO OUR LAST PULSE OF 2023. Thanks for the reader, feedback and tips all year! Come back in 2024. Send your tips, Feedback and Feedback to [email protected] and [email protected] and follow along @Chelsea Cirruzzo and @_BenLeonard _.

TODAY WITH US PULSE CHECK PODCASTS, host Chelsea Cirruzzo talks with POLITICO’s health reporter Daniel Payne about the ways artificial intelligence is already being used in the medical environment and how regulators are responding.

THE GRAIL LOBBY UP Cancer diagnostics company Grail added to its lobbying list in Washington, hiring powerful lobbying firms BGR Group and Williams and Jensen to address issues such as Medicare coverage of tests to detect several cancers, Megan reports.

Grail has a former top healthcare aide to the ousted Speaker at BGR Group Kevin McCarthy (R-Calif.) Ryan Long in its corner. He gives both strategic advice to the company and talks about oncology and multi-cancer diagnostics and screening.

Long, who left Capitol Hill in October, has a one-year grace period during which he cannot lobby members of executive offices or staff, but confirmed he is free to lobby the rest of the House and Senate in addition to the Biden administration. .

Alec Aramanda, who most recently served as the Republican staffer on Medicare on the House Energy and Commerce Committee, is one of the lobbyists behind Williams and Jensen’s deal. The filings say the company is working on a pair of bills that would allow Medicare to cover tests produced by Grail. Aramanda joined the company last month. He did not respond to a request for comment.

Biotech giant Illumina, which acquired Grail in 2021, announced earlier this week that it was exiting the company after a years-long battle over a deal with antitrust regulators. According to newly released lobbying records, the two companies’ work on Grail began on December 1st.

As Congress prioritizes bipartisan legislation to help ensure Medicare has the authority to cover early detection tests for multiple cancers, Grail will continue to educate the science and engage with barriers to cancer screening, a company spokeswoman said in an email.

EYES OF THE PRIZE Lobbyists for business and consumer groups are planning numerous phone calls and meetings with lawmakers and staff in the first weeks of 2024 and are mulling ad buys in the hope that stricter disclosure requirements from insurance companies, pharmacy lobbyists, hospitals and other health care facilities will be overcome. , Megan reports.

“They were going to take a break so members and staff could enjoy time with their families, but they’re going to start hearing from us again before they even get back to Washington,” said Adam Buckalew, a lobbyist who represents the Better Solutions for Healthcare coalition, of which AHIP is a member. and the American Benefits Council.

Earlier this month, the House passed a sweeping health package that would expand Trump-era regulations requiring hospitals and insurers to report prices and negotiated rates for their services, and the Senate has expressed interest in moving the proposal. Lawmakers in both chambers have advanced measures that would force pharmacy benefit managers, intermediaries between drugmakers and insurance companies, to be more transparent about their business.

The moves are part of Congress’s annual effort to tackle rising health care costs, which could become especially powerful in the 2024 election year.

NALOXONE IN UNION BUILDING HHS and the General Services Administration, which oversees federal properties, have updated nearly 15-year-old safety guidelines to say federal facilities should have naloxone, an opioid overdose reversal drug, on hand.

The updated guidelines build on 2009 recommendations that agencies use automated external defibrillators to treat people who have had a heart attack. The new guideline recommends that AED stations be turned into emergency stations that also have naloxone and anti-bleeding agents.

HOLIDAY RESPIRATORY DISEASE OUTLOOK Nearly 172,500 people went to emergency rooms last week for the flu, Covid-19 or respiratory syncytial virus, according to CDC data.

While the agency says the numbers are down from the same time last year, they also show that the respiratory illness season, which typically lasts through the winter months, has not yet peaked.

According to data from the CDC, more than half of emergency room visits in the week ending December 16 were related to the flu, and a third to Covid-19. RSV’s share of the visits was about 13 percent. Most of the patients were children under the age of 12, whose visits have increased since October.

However, the vaccination rate is still low, as less than half of the population receives the flu vaccine and less than 10 percent the latest Covid vaccine.

For nursing home residents, a vulnerable population that the CDC has prioritized in its vaccination campaign, the rate is slightly higher: As of December 10, 33 percent of nursing home residents had received the latest Covid vaccine.

Meanwhile, 17 percent of adults age 60 and older have received the RSV vaccine.

The Government Accountability Office announced five new ones Health Information Technology Advisory Committee members: dr. Lee Fleisher -from University of Pennsylvania School of Medicine, Dr. Katrina Parrish / human, Dr. Randa Perkins -from H. Lee Moffitt Cancer Center, Rochelle Prosser / Orchid Healthcare Solutions and Dr. Mark Sendak -from Duke Institute for Health Innovation.

POLITICIAN Robert King reports of a congressional decision to bypass the city without addressing a pending cut to physician Medicare payments could create new headaches for practices and patients, according to physician groups seeking help from CMS.

The Washington Post reported a disconcerting increase in colorectal cancer in young adults.

Dr. Zeke Emanuel, senior fellow at the Center for American Progressexplains in STAT why health costs are the only exception to inflation.

CLARIFICATION: An earlier version of this newsletter was unclear as to whether Alec Aramanda had lobbying restrictions. He does not


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