HIMSS Analysis: HTI-2 Final Rule Released by ASTP/ONC

Updated Dec. 17, 2024.

HIMSS welcomes the Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (HTI-2) final rule, which was released Dec. 11 by the Assistant Secretary for Technology Policy’s Health Information Technology Certification Program. 

The final rule is available at the Federal Register and will go into effect Jan. 15, 2025. 

The final rule has been more refined to focus on TEFCA requirements than was outlined in the proposed rule, which HIMSS submitted feedback on in October.

The rule details the following regulatory changes: 

• the required information, deadlines and redress mechanisms for applicant organizations to be designated as Qualified Health Information Networks (QHINs) 

• the requirements for a QHIN to maintain its designation and its appeal rights if the designation is removed by ASTP/ONC or their Recognized Coordinating Entity (RCE) 

• clarifies the Information Blocking TEFCA Manner Exception, which defines that an actor who is a participant/subparticipant in TEFCA exchange, to transmit requested information via TEFCA to another TEFCA participant/subparticipant even if the requestor specified a different manner for transmission is not information blocking and the actor would not be subject to a negative payment adjustment (providers) or a civil monetary penalty (other participants/subparticipants) 

• clarifies issues regarding fees and the use of FHIR versioning accepted under the TEFCA Manner Exception

• makes administrative changes to errors and omissions to the HTI-1 Certification Rule 

Based on an initial review, HIMSS is encouraged by ASTP/ONC’s efforts to deliver nationwide interoperability and welcomes an ongoing dialogue with ASTP to digitally transform the healthcare ecosystem of the United States through the power of information and technology.  

HIMSS has developed two HTI-2 fact sheets with further analysis:

• HTI-2 Final Rule Fact Sheet: TEFCA and QHIN Designations, Governance and Appeal Rights
• HTI-2 Final Rule Fact Sheet: TEFCA and the Manner Exception, Administrative Changes to Certification

We understand broader scope items and future provisions are still under consideration and may be released before the end of the Biden administration. 

Previously, HIMSS stated our support of the proposed new and revised certification criteria, adoption standards and launch Insights program. These changes would facilitate nation-wide interoperability. However, HIMSS urged ASTP/ONC to consider the cost and resources for developers and end users to adopt the proposed changes when finalizing rulemaking. 

Stay engaged with HIMSS on social media as our experts provide a deeper analysis of the final rule and other policy-related initiatives.