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HHS releases HTI-2 proposed rule for interoperability

HHS's HTI-2 proposed rule aims to improve health data interoperability with new certification criteria and updates to information blocking regulations.

Through ONC, HHS has released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing and Public Health Interoperability (HTI-2) proposed rule for public comment.

"The Biden-Harris Administration has been working to expand interoperability and improve transparency when it comes to electronic health information," Xavier Becerra, HHS secretary, said in a press release. "Now we are building on that work to ensure that the entire system that supports patients and providers utilizes the best technology available in a safe and responsible way."

The proposed rule includes two new sets of criteria under the ONC Health IT Certification Program that focus heavily on standards-based APIs to improve health data interoperability.

ONC collaborated with the CDC to create certification criteria IT for public health-oriented health IT that align with the CDC's Data Modernization initiative. Similarly, ONC developed certification criteria for payer-oriented health IT in partnership with CMS to support requirements included in the CMS Interoperability and Prior Authorization final rule.

The HTI-2 proposed rule includes several proposals that build on requirements of the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency and Information Sharing (HTI-1) final rule.

For instance, the HTI-2 proposed rule requires the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028, satisfying HTI-1 USCDI requirements to provide the industry with more long-term planning clarity.

The HTI-2 rule also proposes revisions to certain exceptions to the information blocking regulations.

For instance, this rule proposes a new "Protecting Care Access" information blocking exception, which would address concerns about potential information blocking consequences if an entity decides to limit the sharing of patient reproductive health data in certain circumstances.

Lastly, the proposed rule would implement provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA) to support reliability, privacy, security, and trust within the network.

After publication in the Federal Registrar in the coming days, the HTI-2 proposed rule will be available for public comment for 60 days.

"The HTI-2 proposed rule is a tour de force," said Micky Tripathi, Ph.D., national coordinator for health IT. "We have harnessed all the tools at ONC's disposal to advance HHS-wide interoperability priorities. As always, we look forward to reviewing public comments and engaging with the health IT community in the weeks and months ahead."

Hannah Nelson has been covering news related to health information technology and health data interoperability since 2020.

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