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), released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule for public comment.
In some 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 (healthcare 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 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 healthcare information in certain circumstances.
Completing the full suite of HTI-2 proposals is the proposal to establish certain Trusted Exchange Framework and Common Agreement (TEFCA) governance rules, which include requirements that implement 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 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.
