HTI-2 proposed rule: A “tour de force” for health data interoperability

Hot on the heels of new guardrails around information blocking, including financial penalties for healthcare providers, the Office of the National Coordinator has released its second major proposed rule around health data interoperability: the HTI-2. 

Formally known as “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability,” the proposal is the follow-on to HTI-1, a sweeping set of regulations finalized in January of 2024 that tackled issues around EHR certification, data exchange, and info blocking. 

“The HTI-2 proposed rule is a tour de force. We have harnessed all the tools at ONC’s disposal to advance HHS-wide interoperability priorities,” said Micky Tripathi, PhD, National Coordinator for Health Information Technology. “As always, we look forward to reviewing public comments and engaging with the health IT community in the weeks and months ahead.” 

New certifications to bring harmony to health IT

HTI-2 furthers the certification conversation by introducing two sets of new certification criteria aimed at strengthening and standardizing the technology used by public health entities and payers.   

According to the ONC, the proposed certification updates focus heavily on standards-based APIs to improve end-to-end interoperability between data exchange partners, such as healthcare providers, public health organizations, and payers. 

In addition, ONC is proposing new certification criteria for real-time prescription benefit tools to offer accurate, transparent, and personalized cost information to patients and their providers at the point of care.  

Further clarification around information blocking

In what is likely to be a very long-term effort, the ONC is continuing to clarify its thinking around information blocking and how it will recommend “disincentives” for those caught on the wrong side of the rules.  

HTI-2 contains several proposals for revisions around previously defined information blocking exceptions, including a new “Protecting Care Access” exception that addresses concerns around the recent HIPAA rule to specifically protect reproductive rights data. 

ONC is also suggesting a “Requestor Preferences” exception, under which actors would not be penalized for info blocking if they’re following a requestor’s guidelines for what information they wish to receive or exclude in specific circumstances. 

Ideally, the fine-tuned exceptions will make it easier for organizations to understand when they might be subject to recently established disincentives, such as restrictions on participating in financial incentive programs.  

Additional technical proposals within HTI-2 

The rule would also push forward several data standards and technology updates to enable more seamless interoperability across data modalities and organizational siloes.  

Among these are adjustments to the QHIN qualification standards under TEFCA and the requirement for entities to adopt Version 4 of the United States Core Data for Interoperability (USCDI) by January 1, 2028. This version of the common data set includes updates designed to enhance health equity, patient experiences, and medication adherence, among other high-priority goals. 

ONC is also seeking to direct organizations to make updates to minimum standards for certain code sets, as well as implement the HL7 FHIR Bulk Data Access v2.0.0: STU 2 implementation specification (Bulk v2 IG) and require specific technical capabilities related to group exports and performance improvement.  

Last but not least, the rule would slim down documentation requirements for completing electronic prior authorization requests for payers, which would make it faster and easier for providers and payers to communicate around approvals for necessary care.  

Laying out the roadmap for the future of interoperability

Entities subject to the rule’s proposals will have several years to put these proposed provisions into action once they are finalized. The ONC’s timeline for the changes contained in the rule stretches out to 2028, with a portion of the requirements due each year along the way. 

To help guide the process, ONC has released a series of fact sheets on each major component of the rule and will be holding a series of informational sessions to share more details and answer questions for the community.  

As usual, ONC officials are eager to accept public comment on the proposals and urge stakeholders to share their thoughts and continue to contribute to the development of the broader interoperability ecosystem. 

Jennifer Bresnick is a journalist and freelance content creator with a decade of experience in the health IT industry.  Her work has focused on leveraging innovative technology tools to create value, improve health equity, and achieve the promises of the learning health system.  She can be reached at jennifer@inklesscreative.com.