Programming notes: We will be closed next week due to the holidays, but we will return to our normal schedule from January 2nd (Tuesday).
with Megan R. Wilson
AI REG’s reaction — HHS has enacted new rules scheduled to go into effect in 2025, requiring artificial intelligence developers to be more transparent about how their algorithms work, Ben reported.
While there is industry support, Pulse also heard skepticism about how effective the rule would be and questions about accountability and scope.
Backstory: Last week, the Office of the National Health IT Coordinator released comprehensive rules for AI used in most hospitals and clinics. in short, ONC regulations require: Software developers will need to provide customers with more data to help providers determine whether their AI products are “fair, appropriate, effective, effective, and safe.”
reaction: Major organizations, including the Coalition for Health AI, whose members include Google, Microsoft, and Duke Health, praised the rule.
“It’s really important to have some standards in place,” Michael Pensina of Duke AI Health and co-founder of the coalition told Pulse. “They found the right balance for the most part in moving things forward but not becoming too prescriptive.”
Interaction with the agency: Still, there are questions about how ONC and the FDA, which also regulates AI-enabled medical devices, will work together. Sybil Lorenbeck, executive director of the AI Healthcare Coalition, told Pulse she wants ONC to treat products already regulated by the FDA differently.
Lorenbeck said the FDA's scrutiny should mean something.
ONC said in the rule that it will work with the FDA to align its regulations to ease the compliance burden for AI developers who are subject to both agencies' rules.
responsibility: Laurenbeck said ONC's rule's reliance on individual clinicians to make inquiries about the trustworthiness of AI also raises liability concerns. ONC said these are outside the scope of the regulations.
“When a medical device fails, we know how to proceed through the process,” Andrew Tomlinson, director of regulation at the American Health Information Management Association, told Pulse. “AI requires the same process.”
Lorenbeck also said he has received some questions about what algorithms the rules apply to and hopes for more clarity.
The agency said the rule is broad in scope and covers models that are not directly involved in clinical decision-making that could impact health care delivery, such as models that support supply chains.
An ONC spokesperson said the agency appreciates the “strong feedback from the public” and welcomes further input.
Welcome to the final edition of PULSE for 2023. Thank you to our readers, feedback, and tips over the year. We'll be back in 2024. Please continue to send us your tips, scoops, and feedback. [email protected] and [email protected] Please follow @chelsea siluzzo and @_Ben Leonard _.
today our pulse check podcast, Host Chelsea Siluzzo talks with POLITICO healthcare reporter Daniel Payne about how artificial intelligence is already being used across the medical community and how regulators are responding.
Holy Grail lobby is up — Cancer diagnostics company Grail has added to its Washington lobbying roster by hiring powerhouse lobbying firms BGR Group and Williams & Jensen to work on issues such as Medicare coverage of multiple cancer detection tests, Megan said. reported.
At BGR Group, former top medical aide Grail ousted as chairman kevin mccarthy (Republican of California) Ryan Long stands in one corner. He provides “strategic advice” to the company and advocates on issues related to oncology and multiple cancer diagnosis and screening, according to the disclosure.
Mr. Long, who left Capitol Hill in October, is subject to a one-year cooling off period during which he cannot lobby members of the leadership or staff, but in addition to Mr. Biden, the House and Senate The administration acknowledged that it was allowed to freely lobby the remaining members.
Alec Allamanda, who most recently served on the Republican Medicare staff on the House Energy and Commerce Committee, is one of the lobbyists for the Williams-Jensen deal. His disclosure filing says the company plans to work on two bills that would allow Medicare to cover the tests Grail makes. Allamanda joined the company last month. He did not respond to requests for comment.
Biotech giant Illumina, which acquired Grail in 2021, announced its divestment from the company earlier this week after years of battle with antitrust regulators over the acquisition. The companies' work on Grail began Dec. 1, according to recently released lobbying disclosures.
“Grail continues to support science education as we prioritize bipartisan legislation that would help ensure Medicare has the authority to cover early detection tests for multiple cancers,” a company spokesperson said in an email. “We will continue to address barriers to access to cancer screening.”
Eyes on the prize — Lobbyists for business and consumer groups are planning numerous calls and meetings with lawmakers and staffers in the first few weeks of 2024 and are considering ad buys. Ultimately, it hopes to impose stricter disclosure requirements on insurance companies, pharmacy benefit managers, hospitals, and other health care facilities. Line, Megan reports.
“We will be taking time off so our members and staff can enjoy time with their families, but you will hear from us again before we return to Washington,” said a lobbyist representing Better Solutions for Healthcare. , said Adam Buckalew. , a coalition that includes AHIP and the American Benefits Council.
Earlier this month, the House of Representatives passed a sweeping health policy expanding Trump-era regulations that require hospitals and insurance companies to post prices and negotiated rates for services, and the Senate has also expressed interest in moving the proposal. ing. Lawmakers in both chambers are moving forward with measures to force pharmacy benefit managers, the intermediaries between drug companies and insurance companies, to be more transparent about how they operate.
The move is part of Congress' yearlong effort to address rising health care costs, an issue that could become especially acute in the 2024 election year.
Naloxone inside federal buildings — HHS and the General Services Administration, which oversees federal real estate, are updating nearly 15 years of safety guidelines to require federal facilities to have naloxone, the drug that reverses opioid overdoses, on site.
The updated guidance builds on a 2009 recommendation that the agency introduce automated external defibrillators to treat people who have had a heart attack. The new guidance recommends converting AED stations into “safety stations” that also include naloxone and items to stop bleeding.
Holiday respiratory disease outlook — Last week, nearly 172,500 people visited emergency rooms for influenza, COVID-19 and respiratory syncytial virus. According to the CDC data.
The agency said the numbers were lower than the same period last year. indicates respiratory disease This season usually lasts through the winter, but has not yet reached its peak.
More than half of emergency department visits in the week ending Dec. 16 were for influenza, and one-third were for COVID-19, according to CDC data. RSV accounted for approximately 13% of visitors. Most of the patients are children under the age of 12, and the number of visits has been increasing since October.
However, vaccination rates remain low, with less than half of the population having received a flu shot and less than 10% having received an up-to-date COVID-19 vaccination.
Nursing home residents are a vulnerable population that the CDC is prioritizing in its vaccination campaign. slightly higher Percentage: As of Dec. 10, 33 percent of nursing home residents had received the latest COVID-19 vaccination.
Meanwhile, 17 percent of adults over 60 have been vaccinated against RSV.
The Board of Audit announced five new cases. Medical Information Technology Advisory Committee Member: Dr. lee flischer of University of Pennsylvania School of Medicine, Dr. Katrina Parrish of humana, Dr. Randa Perkins of Rochelle Prosser, H. Lee Moffitt Cancer Center of Orchid Healthcare Solutions And Dr. mark sendak of Duke Health Innovation Institute.
POLITICO's Robert King report on parliamentary decisions Leaving town without addressing pending Medicare payment cuts for doctors could create new headaches for practices and patients, according to physician groups seeking help from CMS.
washington post Reports of mysterious increase in colon cancer Among young people.
Dr. Zeke Emanuel, Senior Fellow, Center for American Progress, I will explain in STAT Why are medical costs the only exception to inflation?
