The Office of the National Coordinator for Health Information Technology (ONC) at the U.S. Department of Health and Human Services (HHS) today released the Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Final Rule. The rule removes 14 certification criteria and revises seven, following a proposal to eliminate 34 criteria.

In a press release, HHS stated that the rule significantly reduces administrative burdens for health IT developers participating in the ONC Health IT Certification Program (Certification Program). These deregulatory changes free up resources that health IT developers can now apply to enhancing user experiences for patients and clinicians.

On Monday, October 26, the ONC hosted a virtual press call to provide an overview of the rule. During the call, Tom Keane, National Coordinator for Health IT, said the rule is designed to reduce unnecessary burdens while preserving the foundations of interoperability. “A successful certification program should establish the floor healthcare needs without becoming the ceiling innovation keeps hitting,” Keane said.

ONC projects the rule will save more than $1.5 billion in regulatory costs, allowing health IT developers to redirect resources toward interoperability, automation and improved experiences for patients and clinicians.

The final rule retains several requirements related to privacy, security, patient safety and accessibility. Michael Lipinski, Division Director, Regulatory Affairs Division, Office of Programs and Implementation, with the ONC, explained that 13 of the 20 criteria that were not removed related to privacy and security. The agency also retained certain safety and clinical information reconciliation requirements, while modifying some provisions to reduce burden.

The rule also reduces reporting obligations tied to real-world testing and the health IT reporting program. However, developers must continue real-world testing, and reporting remains required for certain application programming interface (API) criteria. ONC retained reporting requirements related to bulk data exchange through the FHIR standard, citing concerns about problems with that functionality.

Some proposals were not resolved in the final rule. ONC removed certain transparency requirements for predictive decision support interventions, citing limited demonstrated benefit and the costs and burden of implementation. The agency said it may reconsider some transparency requirements for evidence-based decision support in future rulemaking.

Proposed changes related to information blocking also remain under consideration. Keane said the department’s commitment to enforcement has not changed, adding that HHS is working with the Office of Inspector General (OIG) to hold organizations accountable for blocking patient information.

Looking ahead, ONC expects a future HTI rule to address interoperability standards, expanded use of APIs and successor technologies, and more targeted certification conditions.