HHS Proposes HTI-5 Rule to Streamline Certification Program
The U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), announced today, December 22, the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule. The HTI-5 proposed rule is projected to save a total of $1.53 billion, including $650 million over the next five years for health IT developers, providers, and other stakeholders.
According to a news release, the HTI-5 Proposed Rule has three core goals:
- Easing the load on health IT developers by simplifying ASTP/ONC’s voluntary Health IT Certification Program through the removal of unnecessary requirements.
- Updating the information blocking regulations to better promote access, exchange, and use of electronic health information so that patients can access their data without restrictions.
- Advancing a new foundation of Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces (APIs) that promote AI-enabled interoperability solutions through modernized standards and certification.
HTI-5 plans to remove over 50 percent of the ONC Health IT Certification Program’s (Certification Program) certification criteria, revise several other criteria to lessen health IT developer compliance burdens, and permanently adopt prior enforcement discretion notices. These proposals are projected to save certified health IT developers more than 1.4 million compliance hours in their first year, averaging up to 4,000 hours per developer, allowing developers more capacity to innovate for their customers. The aim is to refocus the Certification Program’s scope on standards-based APIs like FHIR and AI-enabled interoperability solutions.
The HTI-5 Proposed Rule also proposes updates to the information-blocking regulations.
“These proposals reflect a commonsense approach that removes redundant requirements on health IT developers, that better ensures seamless patient access to their information, and that sets a foundation for AI-based data exchange,” Tom Keane, MD, Assistant Secretary for Technology Policy and National Coordinator for Health IT, said in a statement.
The proposed rule is on display in the Federal Register and will be available for public comment for 60 days after publication.
About the Author
Pietje Kobus
Pietje Kobus has an international background and experience in content management and editing. She studied journalism in the Netherlands and Communications and Creative Nonfiction in the U.S. Pietje joined Healthcare Innovation in January 2024.