Xavier Becerra, Secretary and Deputy Secretary & Andrea Palm, Deputy Secretary | https://www.hhs.gov/about/leadership/xavier-becerra.html https://www.hhs.gov/about/leadership/andrea-palm.html
The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule for public comment. The HTI-2 proposed rule aims to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities.
“The Biden-Harris Administration has been working to expand interoperability and improve transparency when it comes to electronic health information,” said HHS Secretary Xavier Becerra. “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 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, Ph.D., 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.”
The HTI-2 proposed rule introduces two sets of new certification criteria designed to enable health IT for public health as well as health IT for payers under the ONC Health IT Certification Program. These criteria aim to improve public health response and advance value-based care delivery by focusing on standards-based application programming interfaces for better data exchange between healthcare providers, public health organizations, or payers.
The public health-oriented certification criteria were developed with input from the Centers for Disease Control and Prevention (CDC) as part of its Data Modernization Initiative. Similarly, payer-oriented certification criteria were developed in coordination with the Centers for Medicare & Medicaid Services (CMS) to support technical requirements included in CMS's Interoperability and Prior Authorization final rule.
The proposed rule also includes several updates building on previous regulations published in January 2024. These updates range from enhancing capabilities like exchanging clinical images (e.g., X-rays) to adding multi-factor authentication support. It proposes adopting United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028.
Additionally, it seeks to implement section 119(b)(3) of the Consolidated Appropriations Act, 2021 by including a new real-time prescription benefit tool certification criterion aimed at providing more transparent drug cost information.
Further clarifications on information blocking regulations are also part of this proposal. Revisions include addressing additional scenarios identified by stakeholders and introducing a new "Protecting Care Access" exception concerning reproductive healthcare information sharing limitations.
Finally, it proposes establishing governance rules under Trusted Exchange Framework and Common AgreementTM (TEFCATM), implementing section 4003 of the 21st Century Cures Act.
The HTI-2 proposed rule is available at healthit.gov/proposedrule and will be published in the Federal Register soon. It will be open for public comment for 60 days following publication.
ONC will host a series of informational sessions about the proposed rule in upcoming weeks. More details can be found at healthit.gov/proposedrule or via ONC’s X account @ONC_HealthIT.
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