Some members of Congress are calling on U.S. Health and Human Services to abandon a years-long effort to create government-run artificial intelligence insurance labs and create a model insurance lab of AI in partnership with industry.
“We are writing to express our primary concerns regarding the potential role of insurance labs in regulatory oversight of artificial intelligence technologies, and how this will lead to regulatory capture and stifle innovation,” the representatives said. Dan Crenshaw, R-Texas, Brett Guthrie, R-Ky., Jay Obernolte, R-Calif., and Dr. Mariannette Miller-Meeks, R-Iowa, said in a letter to Micky Tripathi, acting head of AI at HHS.
WHY IT IS IMPORTANT
With deregulation a priority for the incoming Trump administration in 2025, Republicans say they are concerned about how AI in health care will be oriented.
Writing to Tripathi, who also serves as assistant secretary for technology policy and national coordinator for health IT, the representatives asked for clarification on the overarching goals of the agency’s reorganization, according to a statement. history In Policy Monday.
Part of a bigger HHS technology restructuring effortThe new ASTP – formerly the Office of the National Coordinator for Health Information Technology – announced in July that it would have increased responsibilities, including health care AI, as well as new staff and more funding.
The letter also questions the ASTP/ONC’s statutory powers and its role in the overall healthcare system through the creation of assurance labs to supplement the Food & Drug Administration’s review of AI tools. United States and suggests that there would be a significant conflict of interest.
“We are particularly concerned about the potential creation of fee-based insurance labs that would be comprised of competing companies,” the representatives said, adding that large incumbent technology companies could gain an unfair competitive advantage in the sector and impact negative on innovation.
Representatives asked eleven questions and requested answers by December 20.
An ASTP spokesperson said Healthcare IT News via email that the agency is unable to comment on the letter at this time. CHAI did not respond to our request for comment, but this story will be updated if provided.
THE BIGGEST TREND
One of the letter’s signatories, Rep. Miller-Meeks, previously questioned the director of the FDA’s Center for Devices and Radiological Health about CHAI and its members.
During a House Health, Energy and Commerce subcommittee on agency regulation of drugs, biologics and medical devices, Guthrie, as subcommittee chairman, declared during his opening speech that several regulatory missteps have caused “uncertainty among innovators”.
Miller-Meeks specifically asked whether the FDA would outsource certification to the coalition. She pointed out that Google and Microsoft are founding memberswhile the Mayo Clinic, which it says has more than 200 AI deployments, employs some of the coalition’s leaders.
“This does not pass the smell test,” she said, and shows “clear signs of attempted regulatory capture.”
CHAI, which unveiled standards for AI transparency in healthcare consistent with ASTP. requirements to certify health informaticssaid a long-awaited man AI Nutrition Label Coming Soon.
Dr. John Halamka, President of Mayo Clinic Platform, spoke to the substantial potential benefits and real potential harms this could come from predictive and generative AI used in clinical settings, earlier this year at HIMSS24.
“Mayo has an insurance lab and we test commercial algorithms and self-developed algorithms,” he said in March.
“And what you do is identify the bias and then mitigate it. It can be mitigated by returning the algorithm to different types of data, or simply by understanding that the algorithm cannot be completely fair to all patients You just need to be extremely careful where and how you use it.
Since its establishment in 2021, CHAI said it has worked to offer AI transparencycreate guidelines and safeguards to combat algorithmic bias in healthcare taking into account government concerns and build on the White House AI Bill of Rights and the NIST AI Risk Management Framework and support AI assurance as defined in President Joe Biden’s executive order on AI directing for HHS to establish a security program.
ON THE FILE
“The ongoing dialogue around AI in healthcare must take into account the distinct powers and duties of different agencies and offices to avoid overlapping responsibilities, which can lead to confusion among regulated entities,” the four Republican members of Congress said in their letter.
Andrea Fox is the editor-in-chief of Healthcare IT News.
E-mail: afox@himss.org
Healthcare IT News is a HIMSS Media publication.
