The Department of Health and Human Services this week finalized a pared-down version of a final rule aimed at advancing health data interoperability and implementing provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA).
The federal government's healthcare tech arm released a sweeping health IT proposed rule back in July with ambitious components related to API capabilities and imaging interoperability and that raised the floor on the United States Core Data for Interoperability to version 4 for certified health IT. The proposed rule also had implications for public health and payer health IT as it included public health data exchange and payer API standards.
The draft HTI-2 rule, developed by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), clocked in at 1,067 pages and built on the agency's HTI-1 final rule published in January. It would have established, for the first time, a path for certification for payers. Further, it would have established voluntary certification for health IT software used by public health organizations and health plans.
However, the rule (PDF) finalized last week, called Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement, left out many of those broader provisions and mainly focused on advancing TEFCA-related proposals from the draft rule. The pared-down version was only 156 pages, as compared to the hefty draft rule.
TEFCA is a governance framework for data exchange that went live last year. It establishes a universal governance, policy and technical floor for nationwide interoperability so healthcare providers, payers and public health organizations can share patients' health information.
The final rule (PDF) is set to publish on the Federal Register on Dec. 16. It will go into effect 30 days later.
An ONC spokesperson told Fierce Healthcare that the scope of the HTI-2 proposed rule and the number of public comments received made it "impracticable to finalize the rule in its entirety in a timely manner."
"We have focused on a specific set of proposals we could finalize and publish in the Federal Register to be responsive to the public comments," the spokesperson said. "Comments received in response to other proposals from the proposed rule are beyond the scope of this final rule and are still being reviewed and considered for purposes of issuing subsequent final rules, including another potential final rule before the end of this administration."
The ONC spokesperson said the healthcare industry should look out for the publication of the 2024 Fall Unified Agenda in the very near future that will "shed more light" on ONC's planned approach.
The HTI-2 rule advances interoperability and supports the access, exchange and use of electronic health information, according to ONC. The HTI-2 final rule amends the information blocking regulations by including definitions related to the TEFCA Manner Exception. It also implements provisions to support the reliability, privacy, security and trust within TEFCA.
Many industry experts speculated that ASTP/ONC broke up the sweeping proposed rule in order to finalize as much as it could before the new administration takes office in January.
"HTI-2 'part 1' is all about TEFCA which makes sense given ASTP/ONC’s substantial investment in TEFCA and its commitment to do everything possible to assure that TEFCA endures beyond the current administration," wrote Gravely Group executives in a LinkedIn post. Gravely Group is a healthcare legal and strategic services company.
"However, it certainly puts the deferred portions of HTI-2 at risk given the incoming administration’s commitment to lesser regulation," the Gravely Group wrote.
The final rule released this week "codifies several key aspects of TEFCA into regulation," the consulting group wrote. "This is somewhat controversial because regulations are more 'rigid', e.g. harder to update and innovate. However, by codifying TEFCA into regulations, ASTP/ONC is hoping to make TEFCA more permanent," executives wrote in the LinkedIn post.
Leigh Burchell, the current vice-chair and incoming chair of the EHR Association Executive Committee, said the focus on TEFCA in the HTI-2 rule allows ASTP to solidify pillars of the program that outgoing leadership wants to leave as a legacy.
"We expect the remaining components of the HTI-2 proposed rule to be split into multiple other final rules. In doing so, the EHR Association hopes that ASTP/ONC will prioritize the necessary additional technical corrections specific to health IT vendors, the most urgent of which relate to Insights Measures. As currently drafted, the Insights Measures are likely to produce data of questionable value—something we have been stressing to ASTP since publication of the HTI-1 proposed rule in 2023," Burchell wrote in a statement ."As we inch closer to the January 1, 2026, start date, the uncertainty of finalized measurements creates challenges. We hope that future rules finalizing HTI-2 proposals will include helpful and necessary clarifications.”
The rule finalized last week sets minimum qualifications needed for a health information network to be designated as a QHIN capable of trusted exchange under TEFCA and establishes procedures governing QHIN onboarding and designation, suspension, termination and further administrative review.
The rule also sets a new TEFCA Manner Exception, which says organizations that only exchange data via TEFCA won’t be considered to be information blocking if they follow certain criteria.
The health IT industry should brace for future regulations coming down the pipeline with the remaining portions of the draft rule back in August, according to health IT experts.
Genevieve Morris, vice president of interoperability and regulatory strategy, network and data at Optum, noted in a LinkedIn post that there is another final rule at the Office of Management and Budget for review called Health Data, Technology, and Interoperability: Protecting Care Access.
"Since I can't remember a proposed rule earlier this year with that name, my best guess is that these are the other provisions of HTI-2 that were pulled into their own rule, especially when you read the description which mentions public health, ePA, patient access, APIs, etc. ASTP/ONC would have to clarify but that's the tea leaves I'm seeing," Morris wrote.