ONC trims health IT certification standards, saves billions

The U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) published the Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Final Rule today. Under the new measure, 14 existing certification standards are eliminated, while 7 are updated—down from an earlier proposal that sought to scrap 34 criteria in total.

According to the U.S. Department of Health and Human Services (HHS), the rule significantly reduces administrative burdens for health IT developers participating in the ONC Health IT Certification Program. These deregulatory changes free up resources that health IT developers can now apply to enhancing user experiences for patients and clinicians.

Tom Keane, National Coordinator for Health IT, explained that the rule aims to cut down on unnecessary burdens while upholding the basics of interoperability.

According to the ONC, the rule is expected to cut regulatory expenses by over $1.5 billion, enabling health IT developers to reallocate resources toward interoperability, automation, and better 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 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.

Some proposals, such as changes related to information blocking, 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.