The federal government has approved new guidelines that simplify the process for health technology companies to obtain government certification for their software. Under the updated HTI-5 rule, the Office of the National Coordinator for Health Information Technology is eliminating 14 of the 60 existing requirements and modifying seven others in the certification program.
The updates are designed to reduce compliance costs for developers by an estimated $1.5 billion while easing administrative demands.
Changes to Certification Criteria
Developers will no longer need to disclose training datasets for AI-powered tools or demonstrate compliance with specific standards related to functions like documenting patient family medical histories. Additionally, the rule reduces the need for extensive real-world testing to maintain certification status.
Companies are also exempt from submitting yearly plans for clinical testing of their products. The rule further removes the obligation to create AI model cards, which had previously required developers of health IT systems using artificial intelligence, machine learning, or predictive analytics to disclose details about their training, performance, and validation datasets.
Impact on the Healthcare Industry
The final rule advances the Trump administration’s deregulatory agenda, which has slashed regulations across the healthcare industry since 2025. The changes are expected to cut $1.5 billion in regulatory costs and allow health IT developers to focus on improving their technology. Dr. Tom Keane, national coordinator for health IT, stated that the changes will significantly lower the administrative compliance burden for developers.
For instance, technology used as part of the Medicare Promoting Interoperability Program must be ONC-certified. This requirement ensures that healthcare providers use certified technology to improve patient care.
Implementation of the Final Rule
Most of the rule’s changes will be enforced 60 days after its publication in the Federal Register, though some provisions will begin on January 1. Decisions on proposals related to information-sharing restrictions have been postponed, and potential adjustments to privacy and security requirements remain under review.
The final rule does not go as far as the ONC’s proposed HTI-5 rule released in December 2025, which suggested removing 34 criteria from the ONC Health IT Certification Program. However, the changes are expected to have a significant impact on the healthcare industry and health IT developers, allowing them to dedicate more resources to technology development and improvement.
