How the Trump Administration is reshaping health IT regulation

Modern Healthcare – Friday, June 13, 2025
By Brock E.W. Turner

In May, the Centers for Medicare and Medicaid Services and the Assistant Secretary for Technology Policy requested public comment on a variety of health IT topics including which digital health products should be covered for Medicare beneficiaries, the state of data interoperability and broader health technology infrastructure policies. Comments are due Monday.

The request is part of a broader push within the federal government that could reshape health IT regulation, interoperability and how data is exchanged. Existing frameworks like the Trusted Exchange Framework and Common Agreement, or TEFCA, could face an overhaul under President Trump.

As of Thursday, CMS had received 232 comments, which may inform CMS and ASTP’s efforts to increase access to Medicare and Medicaid beneficiaries and boost data availability for providers, payers and other stakeholders.

Nearly five months in, the digital health sector is adapting to President Donald Trump’s second administration. Here are some of the Trump administration’s biggest health IT-related moves thus far:

HHS, CMS announce MAHA goals

Health and Human Services Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz hosted a listening session on June 3 for health IT stakeholders that included speakers from several agencies including CMS, ASTP and the Department of Government Efficiency. The session, which was closed to the media, was tied to its request for information on health IT, the agency said in a release.

Attendees said the session was less about policy specifics and more high-level conversations. Federal government officials were generally seeking feedback from those invited.

As part of the listening session, the agency issued initiatives that aimed to fulfill Kennedy’s Make America Health Again goal. Those frameworks included: Building a dynamic and interoperable national provider directory, improving identity verification for Medicare.gov, expanding functionality of CMS’ patient access application programming interface, transitioning CMS’ data at the Point of Care pilot to general availability and enhancing CMS’ participation in trusted data exchange.

“It seems to be what this whole day, this whole RFI process is conveying is that CMS is in charge,” said Brendan Keeler, interoperability and data liquidity practice lead at HTD Health, a consulting company.

CMS, Oz to focus on AI

During his confirmation hearing in March, Oz said he intended to use artificial intelligence within CMS to reduce healthcare spending and crack down on waste, fraud and abuse. The CMS administrator has previously proposed healthcare price transparency, financial incentives for providers and AI to automate administrative functions for providers.

NIH, FDA also home in on AI

Much like the path CMS is taking, the National Institutes of Health sought information on June 3 from various stakeholder groups as it aims develop its own AI strategy. NIH said in the request it hopes to accelerate research and development through tools like semi-autonomous AI agents and fully autonomous, self-documenting biomedical AI beings. NIH sought public comment on themes, pillars, and specific actions that could shape its upcoming strategic plan and one-year action plan. Responses are due by July 15, 2025.

The Food and Drug Administration is also leaning into AI, having rolled out an AI tool called Elsa on June 2. The tool is a chatbot that is meant to summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.

The Trump administration has not said anything about the future of FDA’s digital advisory committee, established in October 2023 under President Biden.

ASTP names new director

ASTP, formerly known as the Office for the National Coordinator of Health IT, oversees department-level and cross-agency technology, data, AI strategy and policy functions within HHS. On June 3, Dr. Thomas Keane was tapped as ASTP’s new director.

Keane succeeds Micky Tripathi, who was hired by Mayo Clinic in April for a role focused on artificial intelligence. An engineer and physician, Dr. Keane previously served in ASTP and as a Senior Advisor to the Deputy Secretary of HHS, according to an agency news release.

What about TEFCA?

TEFCA which required by the 21st Century Cures Act and signed into law in December 2016 by President Barack Obama, was briefly mentioned in a 2026 budget document published by HHS in May. HHS’ chief technology officer will focus on “promoting a nationwide interoperable health IT infrastructure to ensure providers and patients can efficiently and securely exchange electronic information across all levels of the healthcare continuum,” according to the budget proposal.

The CTO will also continue implementing a nationwide technical floor for healthcare interoperability through TEFCA. But beyond the fact it’s in the proposed budget, the administration hasn’t said much about its future. In the request for proposal it released in May, CMS asked for feedback on TEFCA.

The vision for a national exchange of health information dates back nearly 20 years to when ONC was established in 2004 under President George W. Bush.

HITAC meetings?

The Health IT Advisory Committee, which was established through the 21st Century Cures Act, has not met this year and its future meetings through August are cancelled. The committee recommends standards, implementation specifications and certification criteria aiming to that advances electronic access, exchange, and use of health information.

A spokesperson for the Assistant Secretary for Technology Policy said they were not able to provide additional information on the committee.

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