Members of Congress Express Concerns Over Government-Administered AI Assurance Labs
As the U.S. Health and Human Services continues its efforts to establish government-administered artificial intelligence assurance labs, some members of Congress are urging the agency to reconsider and instead create a partnership with industry to develop the AI assurance lab model.
Why It Matters
The incoming Trump Administration in 2025 has made deregulation a priority, prompting concerns from Republicans about the future of AI in healthcare. In a letter addressed to Micky Tripathi, acting chief AI officer at HHS, Reps. Dan Crenshaw, Brett Guthrie, Jay Obernolte, and Dr. Mariannette Miller-Meeks expressed their concerns about the potential regulatory oversight of AI technologies and its impact on innovation.
Part of a larger technology restructuring effort by HHS, the new Assistant Secretary for Technology Policy Secretary and National Coordinator for Health IT (ASTP) announced increased responsibilities over healthcare AI. The creation of assurance labs to supplement the FDA’s review of AI tools raised questions about statutory authorities and potential conflicts of interest.
The Larger Trend
Rep. Miller-Meeks previously questioned FDA officials about the Coalition for Healthcare AI (CHAI) and its members, highlighting concerns about regulatory capture. The involvement of major tech companies like Google and Microsoft in CHAI raised red flags about potential bias and unfair competition in the industry.
CHAI, which has been working on AI transparency standards and guidelines, is set to release an AI nutrition label to provide transparency in healthcare AI. Mayo Clinic, a founding member of CHAI, has been proactive in testing commercial and self-developed algorithms to address bias and ensure fairness in AI applications.
Dr. John Halamka of Mayo Clinic emphasized the importance of identifying and mitigating bias in AI algorithms to prevent harm to patients. CHAI’s efforts align with President Biden’s executive order on AI, directing HHS to establish a safety program for AI technologies.
On the Record
In their letter, the Republican members of Congress emphasized the need for a clear delineation of responsibilities among agencies to avoid confusion and overlapping regulatory efforts in the AI healthcare space.
Andrea Fox, senior editor of Healthcare IT News, highlighted the importance of ongoing dialogue and collaboration to ensure the responsible use of AI in healthcare.
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