HHS Finalizes New Health IT Certification Rules: What Healthcare Technology Professionals Should Know

HHS Finalizes New Health IT Certification Rules: What Healthcare Technology Professionals Should Know
Published November 1, 2026

The U.S. Department of Health and Human Services has finalized new rules affecting how healthcare technology products are certified.

Announced October 26, 2026, the Health Data, Technology, and Interoperability rule, known as HTI-5, changes several requirements within the federal Health IT Certification Program.

The changes are intended to reduce administrative requirements for technology developers while allowing greater flexibility in how healthcare systems are designed and maintained.

For healthcare IT professionals, the announcement matters because it affects the standards and certification processes for electronic health record systems and related healthcare technology.

What Is the HTI-5 Rule?
HTI-5 is a federal regulation that updates requirements within the Health IT Certification Program administered by the Office of the National Coordinator for Health Information Technology.

The program establishes technical criteria used to evaluate certain healthcare software products.

These products may support activities such as maintaining electronic health records, exchanging clinical information, and providing patients with access to their health data.

The October 26 announcement finalized changes previously proposed.

According to HHS, the changes are intended to reduce unnecessary regulatory requirements and give developers more flexibility.

What Changed?
The federal certification program previously contained 60 certification criteria.

Under HTI-5:
- 14 certification criteria are removed.
- Seven certification criteria are revised.
- 39 certification criteria remain unchanged.

The changes affect selected requirements involving healthcare technology functionality, documentation, testing, and reporting.

Some removed requirements relate to capabilities that HHS considers well established in existing healthcare technology products.

Other changes reduce certain administrative obligations for developers participating in the certification program.

The agency estimates that the final rule will reduce regulatory costs by more than $1.5 billion. That figure is an agency projection, not a measured amount already saved. HHS.gov

Why Does This Matter for Healthcare IT?
Healthcare organizations rely on technology systems to maintain records, coordinate care, and exchange information.

Healthcare IT professionals must understand how those systems meet applicable standards.

When certification requirements change, technology developers may need to review their existing documentation, compliance processes, and product development plans.

Healthcare organizations may also want to understand whether the changes affect the products they use.

However, removing a federal certification requirement does not necessarily mean a healthcare organization should stop using the corresponding functionality.

Organizations still need to consider clinical needs, patient safety, privacy, security, and other applicable requirements.

What About Healthcare Data Sharing?
One important part of the HTI-5 announcement concerns interoperability.

Interoperability refers to the ability of different healthcare technology systems to exchange and use information.

HHS has emphasized the continued development of systems using Fast Healthcare Interoperability Resources, commonly called FHIR.

FHIR is a standard that supports electronic healthcare data exchange.

The agency describes HTI-5 as part of a broader effort to modernize healthcare interoperability and support future technology development.

For professionals working with healthcare APIs, EHR integrations, and clinical data exchange, understanding FHIR remains relevant.

The final rule does not mean every healthcare system will immediately change how it exchanges information.

Does HTI-5 Change Professional Certifications?
No changes to individual professional certification examinations were announced as part of HTI-5.

This distinction matters because "certification" can mean different things.

The ONC Health IT Certification Program evaluates healthcare technology products.

Professional certifications such as RHIA, RHIT, and CPHIMS recognize individuals' qualifications.

These are separate certification systems.

Candidates preparing for professional examinations should continue following the current examination content outlines published by their credentialing organizations.

When Does the New Rule Take Effect?

Most provisions of HTI-5 take effect December 28, 2026.

Certain provisions take effect later, on January 1, 2027.

Professionals responsible for healthcare technology compliance should review the official final rule to determine which provisions apply to their organizations.

The effective dates and regulatory requirements are documented in the October 28 Federal Register publication. GovInfo

What Should Healthcare IT Professionals Do?
First, understand which certification requirements have changed.

Healthcare technology developers should review the official rule and determine whether it affects their products or compliance processes.

Professionals in healthcare organizations can use the announcement to strengthen their understanding of interoperability, electronic health records, and technology governance.

For people pursuing careers in health informatics, these subjects are important because healthcare technology involves more than software development.

It also requires understanding clinical workflows, data exchange, regulatory requirements, and patient information management.

The Bottom Line
The HTI-5 final rule represents a significant change to the federal certification requirements for healthcare technology products.

HHS has removed 14 criteria, revised seven, and retained 39 unchanged.

The changes primarily affect health IT developers and the regulatory framework surrounding healthcare software.

For healthcare IT professionals and certification candidates, the announcement provides an opportunity to better understand how healthcare technology standards continue to evolve.