Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) Proposed Rule

ONC's HTI-2 proposed rule implements provisions of the 21st Century Cures Act and reflects ONC’s focused efforts to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities.

Key proposals include:

  • 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. Both sets of certification criteria focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners (health care providers to public health and to payers, respectively).
  • Technology and standards updates that build on the HTI-1 final rule, ranging from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support.
  • Requiring the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028.
  • Adjustments to certain “exceptions” to the information blocking regulations to cover additional practices that have recently been identified by the regulated community, including a new “Protecting Care Access” exception, which would cover practices an actor takes in certain circumstances to reduce its risk of legal exposure stemming from sharing information.
  • Establishing certain Trusted Exchange Framework and Common AgreementTM (TEFCATM) governance rules, which include requirements that implement section 4003 of the 21st Century Cures Act.
Notice: This HHS-approved document has been submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display or published in the Federal Register. The document may vary slightly from the published document if minor editorial changes have been made during the OFR review process. The document published in the Federal Register is the official HHS-approved document.

Press Release

Information Sessions

ONC will host information sessions to explain the proposed rule. The sessions will be recorded.

HTI-2 Proposed Rule Overview Information Session

                 Wednesday July 17, 2024 at 2pm ET

                 View Recording

HTI-2 Proposed Rule Public Health Information Session

                Tuesday, July 30, 2024 at 2pm ET

                Register for the information session

HTI-2 Proposed Rule Information Blocking Information Session

               Thursday, August 8, 2024 at 2pm ET

               Register for the information session

HTI-2 Proposed Rule Patient, Payer, Provider API Information Session

             Thursday, August 15, 2024 at 2pm ET

             Register for the information session