HHS Proposes HTI-2 Rule to Improve Patient Engagement, Information Sharing, and Public Health Interoperability

The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), today 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 reflects ONC's focused efforts 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."

In firsts of their kind, the HTI-2 proposed rule has two sets of new certification criteria designed to enable health IT for public health as well as health IT for payers to be certified under the ONC Health IT Certification Program. These new certification criteria, which would improve public health response and advance the delivery of value-based care, focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners (health care providers and public health organizations or payers). The health IT for public health-oriented certification criteria were developed in tandem with the Centers for Disease Control and Prevention (CDC) to support its ongoing Data Modernization Initiative. Similarly, the health IT for payer-oriented certification criteria were developed in coordination with the Centers for Medicare & Medicaid Services (CMS) to support technical requirements included in the CMS Interoperability and Prior Authorization final rule (89 FR 8758).

The proposed rule also includes several proposed technology and standards updates that build on the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, published in January 2024, ranging from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support. The HTI-2 proposed rule also proposes to require the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028, which builds on HTI-1 USCDI requirements to give industry longer term planning clarity. The proposed rule also proposes to implement section 119(b)(3) of the Consolidated Appropriations Act, 2021 by including a new, real-time prescription benefit tool certification criterion, which would empower providers and their patients to make more informed decisions with more transparent information comparing the patient-specific cost of drugs and suitable alternatives.

The HTI-2 proposed rule continues ONC's commitment to further clarifying the information blocking regulations and the ways in which they apply. The proposed rule includes proposed revisions to certain information blocking "exceptions" to address additional scenarios that have recently been identified by the regulated community. This rule also proposes a new "Protecting Care Access" information blocking exception, which would address concerns about potential information blocking consequences if an entity chooses to limit sharing of a patient's reproductive health care information in certain circumstances. This proposal would build on other key steps HHS has taken to strengthen patient and provider privacy, including for those seeking or providing lawful reproductive care.

Completing the full suite of HTI-2 proposals is the proposal to establish certain Trusted Exchange Framework and Common Agreement^TM (TEFCA^TM) governance rules, which include requirements that implement section 4003 of the 21^st Century Cures Act.

The HTI-2 proposed rule is available at healthit.gov/proposedrule and will be published in the Federal Register in the coming days, at which point it will be available for public comment for 60 days.

ONC will be hosting a series of information sessions about the proposed rule in the coming weeks. More information can be found at healthit.gov/proposedrule and via ONC's X account, @ONC_HealthIT

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