With effect from January 15, 2025, this initial release of the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing and Public Health Interoperability, version two rule completes updates to the Common Agreement and Trusted Exchange Framework and implements certain administrative changes.
However, it does not address the issue of certifying improvements in artificial intelligence at this time.
Why it is important
In its announcement of the new Health Data, Technology, and Interoperability: TEFCA rule on Monday, the US Department of Health and Human Services stated that although it received 270 comment submissions on the proposed HTI-2 draft, it currently only reviewed and addressed comments on a smaller number of proposals.
On Monday, the National Coordinator for Health Information Technology’s Assistant Secretary for Technology Policy/Office (ASTP) provided certain administrative updates and summarized and addressed comments regarding TEFCA information blocking exclusions.
For instance, HTI-TEFCA revises several requirements pertaining to the expired clause that allows health IT to provide document-level security tagging of Consolidated-Clinical Document Architecture documents.
According to Leigh Burchell of Altera Digital Health, the current vice-chair and incoming chair of the Electronic Health Records Association Executive Committee, the new final rule focuses on amended information blocking regulations that include definitions related to the TEFCA Manner Exception and implemented provisions to support the framework.
Burchell stated in a statement from the HIMSS EHR Association emailed to Healthcare IT News Thursday that this initial round of finalizing sections of HTI-2 enables ASTP to “solidify pillars” of TEFCA that “outgoing leadership wants to leave as a legacy.”
The ONC HTI-1 Final Rule revisions, which include additional privacy and security certification requirements for algorithmic-based clinical decision support tools, complete the modifications.
Although HTI-1 replaced the phrase “clinical decision support” with a certification criterion for DSI, the agency claimed it made a mistake by failing to propose or complete the necessary privacy and security requirements for DSI module certification.
The government stated, “This omission was an oversight.”
However, the agency stated that reviews and considerations of comments about the Insights Measures, which are essential for obtaining HHS certification for health IT modules, “may be the subject of subsequent final rules related to such proposals in the future.”
The broader pattern
In March, the HTI-1 final rule went into effect, establishing certification standards for HIT developers and implementing the 21st Century Cures Act’s EHR Reporting Program clause.
In order to assist care delivery, HTI-1 required certified health IT developers to report on metrics that shed light on the use of certified health IT.
The extent of effort needed to comply with AI transparency regulations and the strict deadlines for compliance, which the agency did not outline in HTI-1, have long worried developers.
The government stated last year that “we have not finalized proposed requirements that Health IT Modules clearly indicate when source attributes from other parties are unavailable.”
Burchell stated, “We have been emphasizing to ASTP since the release of the HTI-1 proposed rule in 2023 that the Insights Measures as currently drafted are likely to produce data of questionable value.”
“The ambiguity of completed measurements presents issues as the start date of January 1, 2026, draws nearer. We expect that the essential and beneficial clarifications would be included in future rules that finalize HTI-2 proposals.
Not just the health IT sector is worried about HTI-2’s finalization. The American Hospital Association voiced concerns in October about the proposed regulation for healthcare IT interoperability’s “burdensome” encryption standards and delays.
For the record,
Burchell stated in a statement that “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 give priority to the additional technical corrections that are required for health IT vendors, with Insights Measures being the most urgent.” IT News for Healthcare.
