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 Agreement^TM (TEFCA^TM) governance rules, which include requirements that implement section 4003 of the 21st Century Cures Act.