Let’s start off simple. What does HTI-5 mean? The HTI is the easy part: Health Data, Technology, and Interoperability. Health data, when shared through networked technology creates interoperability.
Explaining the “5” is a wee bit trickier. While there have been HTI-1 through 4s, the 5 doesn’t refer to the latest version, but rather to the latest installment in ONC’s rule package meaning its less revision than expansion pack. That might not have cleared it up. Let’s try another way.
The ONC is a team in the government that helps doctors and hospitals share your health information safely. They created a rulebook of sorts called the HTI.
HTIs Main focus
Modernizing certification requirements
Expanding and refining information blocking policies
Advancing FHIR-based interoperability
Addressing AI and algorithm transparency in certified health IT
Improving patient access and data sharing capabilities
But HTI-5 didn’t start the rule book tradition. Once upon a time, Congress passed the 21st Century Cures Act Final Rule and it was this Act that HTI built upon.
The 21st Century Cures Act Boiled Down to Basic
You should be able to see your own health information
Your doctors should share it with other doctors when it helps your care
No one should hide your information just to make things harder
Why HTI-5 Matters
The ONC Health IT Certification Program has continued to expand and enrich itself through each of its phases. So why all this fuss around HTI-5? It’s because this rule moves away from the legacy certification requirements and toward a future built on FHIR-based APIs, modern interoperability, and AI-enabled data exchange.
This new rule has not confined itself to enlarging the scope, but rather proposes to diminish some former rulings in an effort to reduce burden while accelerating innovation.
The ONC is serious about information blocking and the new HTI-5 highlights this focus. ONC is proposing updates to information blocking definitions and exceptions to prevent misuse and strengthen patient access to electronic health information.
Tightening the Terms
HTI-5requests updated definitions of “access” and “use” toinclude automated and AI-enabled systems.
This remarkable request for definitional updates signals an explicit acknowledgement of the growing role of AI in healthcare interoperability. The ONC is forecasting that future interoperability frameworks will increasingly involve machine-driven data exchange, analytics, and decision support.
In addition to this AI focus, HTI-5 reveals several existing exceptions that may be removed entirely, reflecting a broader push toward more open and standardized exchange.
HTI-5’s Four Exceptions
1. Infeasibility Exception
ONC is examining whether organizations are overusing “infeasibility” claims to avoid sharing data when exchange is technically possible.
2. Content and Manner Exception
There is increasing scrutiny around limiting the scope or format of shared data in ways that frustrate interoperability.
3. Preventing Harm Exception
ONC has signaled concern that “harm” may sometimes be interpreted too broadly to justify withholding information.
4. Licensing Exception
The agency continues to evaluate whether licensing practices create de facto barriers to exchange or API access.
So their message is resoundingly clear. The ONC wants the rulebook to match interoperability’s evolution from static compliance requirements to a more dynamic ecosystem centered on APIs, automation, and intelligent data use. And they aren’t playing around with stronger enforcement around data availability and usability.
For healthcare organizations, developers, and interoperability networks, HTI-5 is less a routine rule update and more a blueprint for the next generation of health data exchange.
As the ONC Health IT Certification Program continues to evolve, the organizations best positioned for success will be those building for openness, accountability, and AI-ready interoperability from the start.