National Coordinator for Health IT Keane Says Information…

HHS has begun issuing its first enforcement notices to health IT developers suspected of blocking patient access to health data, and it is enlisting the Department of Justice, the Federal Trade Commission, and the HHS Office of Inspector General to back up th…

HHS has begun issuing its first enforcement notices to health IT developers suspected of blocking patient access to health data, and it is enlisting the Department of Justice, the Federal Trade Commission, and the HHS Office of Inspector General to back up the effort. Thomas Keane, MD, MBA, Assistant Secretary for Technology Policy and National Coordinator for Health IT at ASTP/ONC, used a ViVE Conference keynote to declare information blocking a top priority for the administration and to outline an aggressive enforcement posture that puts EHR vendors, hospitals, and providers on notice.

“No one—not a doctor, not a hospital, and not an EHR vendor—should be allowed to hoard health information for their own benefit,” Keane said. “It’s bad for patients, it’s bad for innovation, and quite frankly, it’s bad for business.” ASTP/ONC’s complaint portal has received more than 1,500 information blocking complaints since its launch. HHS announced enforcement actions last fall in what Keane called a first-of-its-kind effort, and the agency is now issuing notices of potential nonconformity to certified health IT developers.

The consequences are significant: developers found to be noncompliant can lose certification, and their customers become ineligible for CMS payment incentives. Keane put the stakes in personal terms, describing a mother who cannot get her child’s records to a specialist in time. “She doesn’t care whether the barrier was a policy, a portal, or a business model,” he said. “She just knows that the system failed her.” The enforcement push sits alongside a broader restructuring of the federal health IT certification program.

In December, ASTP/ONC issued the HTI-5 proposed rule, which would remove or revise the majority of existing certification criteria and recenter the program on FHIR-based APIs. Keane described the transition as a strategic imperative and an investment in the country’s future, one that would allow AI-enabled interoperability solutions that combine FHIR with newer standards as they emerge. The proposed rule also targets what ASTP/ONC has called misuse and abuse of information blocking definitions and exceptions, tightening the rules so that data access obligations extend to automated, system-to-system, and AI-driven processes.

TEFCA, the Trusted Exchange Framework and Common Agreement, has powered nearly 500 million document exchanges since launching in December 2023, up from roughly 10 million in January 2025. Most of that growth occurred in the last six months. Keane compared the persistence of healthcare data silos to a world in which AT&T customers cannot call Verizon or iPhone users cannot text Samsung phone users.

“We solved this problem in telecom 40 years ago,” he said. “We’re just figuring out how to solve it in healthcare now. Clearly, we’re taking a scenic route.” Keane expressed particular enthusiasm for TEFCA’s Individual Access Services use case, which lets patients authorize a website or app to retrieve their health records from multiple providers and consolidate them in one place. He said he recently used an IAS app to download his own medical records through TEFCA.

“We are getting closer to a reality where Americans can access their consolidated medical records from multiple sources on their phone without 17 different logins,” he said. ASTP/ONC finalized the HTI-4 rule in July 2025, introducing certification criteria for real-time prescription benefit tools and electronic prior authorization. The rule gives clinicians the ability to compare drug prices and out-of-pocket costs during prescribing; instead of clinic staff spending an hour on the phone only to discover a prescribed drug is not covered, providers will see covered alternatives at the point of care.

Keane said ASTP/ONC aims to automate prior authorization by the end of 2027, projecting $19 billion in administrative savings over the next decade. “That’s the difference between a cardiologist spending an afternoon on hold with a health plan and spending time improving patients’ lives,” he said. Keane, who spent 20 years using AI in clinical practice as an interventional radiologist, outlined three levers HHS is using to shape AI adoption: risk-based regulation that focuses oversight where clinical risk is real; reimbursement through demonstrations and pilots to build an evidence base before pursuing permanent payment reforms; and research and development focused on real-world implementation.

In December, ASTP/ONC issued a request for information seeking broad input on accelerating AI adoption, reducing provider burden, and lowering costs. “Our focus is on implementation, scalability, and impact, not just technical performance.” Keane closed by urging the industry to hold the federal government accountable and to keep building. “Call us, push us, hold us accountable,” he said, “but mostly, continue to go out and build the future of healthcare.”

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