Questions about the new health AI regulations

Programming Notes: It’s good to be off next week for the holidays but back to your regular schedule on Tuesday January 2nd.

With Megan R. Wilson

AI REG response HHS has new rules set to go into effect in 2025 that force artificial intelligence developers to reveal more information about how their algorithms work, Bain reports.

There is support in the industry, but Pulse has also heard doubts about how effective the rules can be and questions about responsibility and scope.

Background Story: The Office of the National Coordinator for Health IT last week unveiled sweeping rules for AI used in many hospitals and doctor’s offices. In short, the ONC rules will require software developers to provide consumers with more information to help providers determine whether AI products are fair, appropriate, reliable, effective, and safe.

Reaction: Major groups including the Coalition for Health AI with members including Google, Microsoft and Duke Health applauded the regulation.

Putting some standards in place is really important, Duke AI Health’s Michael Pencina and co-founder of the coalition told Plus. They found, for the most part, the right balance in terms of presenting things, but not being too prescriptive.

Agency interaction: Still, there are questions about how ONC and the FDA, which also regulates AI-enabled medical devices, will work together. Sybil Rohrenbeck, executive director of the AI ​​Healthcare Coalition, told Pulse that she hopes the ONC will treat products already regulated by the FDA differently.

Rohrenbeck said the FDAs inspection must count for something.

The ONC said in its rule that it is working with the FDA to adjust the rules to reduce the compliance burden for AI developers covered by both agencies’ regulations.

Responsibility: Rohrenbeck said the ONC’s rule relying on individual clinicians to make calls about the validity of AIs also raises liability concerns. The ONC said these are outside the scope of this rule.

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

And Rohrenbeck said she has received several questions about which algorithms apply to which rules, and that she expects more clarity.

The agency said the rule is broad in scope, covering models not directly involved in clinical decision-making that could affect the delivery of care, such as those assisting with supply chains.

An ONC spokesperson said the agency appreciates the strong public feedback and welcomes it.

Welcome to the latest edition of our Pulse for 2023. Thank you for your readers, comments and tips throughout the year! Well come back in 2024. Please keep sending your tips, scoops and feedback [email protected] and [email protected] and follow @Chelsea Cerrozzo and @_Ben Leonard _.

About us today Checking the pulse podcast, Host Chelsea Ceroso talks with Politico healthcare reporter Daniel Payne about the ways artificial intelligence is already being used in the medical landscape and how regulators are responding.

The grill takes up the lobby Cancer diagnostics company Grail has added to its lobbying list in Washington, hiring high-powered lobbying firms BGR Group and Williams & Jensen to work on issues including Medicare coverage for several cancer-detection tests, Meagan reports.

At BGR Group, Grail has a former high-end partner for the remote speaker Kevin McCarthy (R-Calif.) Ryan Long in his corner. He provides both strategic advice to the company and counsel on issues related to oncology and multi-cancer diagnosis and screening as disclosed.

Long, who left Capitol Hill in October, has a one-year cooling-off period during which he cannot lobby any members or staff in leadership offices but has confirmed that he is in the House in addition to the Biden administration. And the Senate is free to lobby the rest. .

Alec Aramanda, who recently served as the Republican-leaning Republican on the House Energy and Commerce Committee, is one of the lobbyists on the Williams-Jensen deal. The disclosure forms say the company will work on a pair of bills that would allow Medicare to cover tests that Grail produces. Aramanda joined the company last month. He did not respond to a request for comment.

Biotech giant Illumina, which bought Grail in 2021, announced earlier this week that it would split from the company after years of battles with antitrust regulators over the deal. According to the latest published lobbying disclosure, the two companies began work on the grill on December 1.

As Congress prioritizes bipartisan legislation that would ensure Medicare is authorized to cover several early cancer screening tests, Greil continues to educate herself on the science and barriers to access to cancer screening, the company’s The spokesperson said in an email.

Looking forward to the prize Lobbyists for business and consumer groups are planning a series of calls and meetings with lawmakers and staff in the early weeks of 2024 and are considering ad buys expected to attract insurers, pharmacy benefit managers, hospitals and Other healthcare facilities are finally pushing for stricter disclosure requirements. , Megan reports.

“We’re going on vacation so members and staff can enjoy time with their families, but they’ll start hearing from us before they get back to Washington,” said Adam Bucklew, representing Better Solutions for Health Care, a A coalition that includes AHIP. and the American Interest Council.

Earlier this month, the House passed a sweeping healthcare package that would expand Trump-era rules that require hospitals and insurers to post their prices and negotiated rates for services, and the Senate moved the proposal forward. showed interest in Lawmakers in both chambers have advanced measures to force pharmacy benefit managers to mediate between drugmakers and insurers to be more transparent about their business operations.

The moves are part of a year-long effort in Congress to address rising health care costs, an issue that could be especially strong in the 2024 election year.

Naloxone in federal buildings HHS and the General Services Administration, which oversees federal properties, updated a nearly 15-year-old safety manual to say that federal facilities must have naloxone, the opioid overdose-reversal drug, on site.

The updated guidance builds on 2009 recommendations that agencies use automated external defibrillators to treat heart attack patients. The new guidelines recommend that AED stations be converted into safety stations that also contain naloxone and supplies to stop bleeding.

A view of holiday respiratory illness Nearly 172,500 people went to the emergency room last week for influenza, Covid-19 or respiratory syncytial virus, according to CDC data.

While the agency says the numbers are lower than the same time last year, they also point out that the respiratory disease season, which usually lasts through the winter months, is still over.

According to CDC data, more than half of ER visits for the week ending Dec. 16 were for the flu and a third were for Covid-19. RSV accounts for about 13 percent of visits. Most of the patients were children under the age of 12, with visits increasing since October.

Still, vaccination rates remain low with less than half the population getting a flu shot and less than 10 percent getting the latest Covid shot.

Nursing home residents, a vulnerable population that the CDC has prioritized in its vaccination campaign, have a slightly higher rate: As of Dec. 10, 33 percent of nursing residents had received the latest Covid shot.

Meanwhile, 17 percent of adults 60 and older have received their RSV shot.

The Government Accountability Office announced five new Health Information Technology Advisory Committee Members: Dr Lee Fleischer of the University of Pennsylvania School of Medicine, Dr Katrina Parish of the right now Dr Rhonda Perkins of the H. Lee Moffitt Cancer Center, Rochelle Prosser of the Arcade Healthcare Solutions And Dr Mark Sendak of the Duke Institute for Health Innovation.

POLITICO’s Robert King Reports of Congress’ decision to respond to pending cuts to physician Medicare payments without leaving town, which could lead to new headaches for practices and patients, according to physician groups that CMS Ask for help.

The Washington Post Reports of a surprising increase in colon cancer among young people.

Dr. Zeke Emanuel, senior fellow at the Center for American Progressin STAT, explains why health care costs are an exception to inflation.