Beyond ONC Certification: Sustaining Compliance in Real Environments
Certification proves your EHR works once. Sustained compliance proves it works every day.
As the new aspects of HTI-1 rule edge closer to enforcement in 2026, EHRs are realizing that certification alone is not enough. The real challenge is maintaining compliance and audit readiness as requirements evolve, APIs change, and real-world testing commences.
Most EHRs have already cleared the first hurdle: ONC certification. But staying compliant through USCDI v3, (g)(9), (g)(10), and (b)(11) updates will test how ready your platform truly is. Passing once gets you on the list. Staying compliant keeps you on that list and in business.
Why Certification isn’t the Finish Line
ONC testing validates your system on paper. In practice, that compliance must hold through version changes, customer rollouts, and regulatory audits. That’s where many EHRs stumble.
Common pitfalls include:
Version drift between certified and production environments
Delayed adoption of new data elements such as social determinants of health (SDOH) or expanded demographic fields
Incomplete documentation during Real-World Testing (RWT)
Missing or outdated evidence during post-certification audits
Compliance that exists only in a test environment isn’t real compliance at all. HTI-1 is designed to expose that gap.
The USCDI v3 Reality Check
USCDI v3 expands the definition of clinical data completeness. It introduces richer patient information, from health status and goals to more detailed demographic and social data.
Supporting USCDI v3 is more than a database update. It requires:
Revised data models for new elements
FHIR mapping for interoperability across partners
Stronger validation and provenance controls
Updated exports and APIs for downstream systems
By January 2026, ONC expects these elements to be fully supported in certified systems. That leaves little room for lagging updates or temporary fixes.
Real-World Testing: Where Certification Gets Tested Again
Every certified EHR must complete Real-World Testing (RWT) annually. This is not a repeat of the certification test. It is a live check that your system still functions as certified, across production users and data.
RWT requires:
Updated plans and results every year
Evidence that certified features are deployed and active
Monitoring of production endpoints for reliability and performance
Many EHRs find this stage harder than certification because it demands constant documentation and visibility across customer environments.
Sustaining Compliance: The Quiet Differentiator
The best-performing EHRs are already preparing. They are:
Running internal RWT dry runs each quarter
Enabling early USCDI v3 fields to avoid last-minute updates
Automating compliance evidence through continuous monitoring
Using version-controlled repositories for test plans and documentation
They know that compliance isn’t a seasonal event. It’s a part of operational discipline that builds trust with customers and auditors alike.
How Darena Health Keeps You Ready
Darena Health helps EHRs move from certified to continuously compliant. Our certified modules for (c)(1–4),(g)(7), (g)(9), (g)(10), and (b)(10-11) provide a live, verifiable foundation for sustained HTI-1 alignment.
What makes Darena different:
Built-in Real-World Testing support with templates, logs, and result tracking
Live monitoring tools that document API uptime and data completeness
USCDI v3.1 support across demographics, SDOH, and health status data
FHIR-native, SMART v2.2 –compatible design for seamless interoperability
Evidence automation that keeps every update audit-ready
Darena’s modules don’t just help you pass certification. They help you maintain it, continuously and transparently.
The Deadline is Nearer Than it Looks
January 2026 feels far off, but certification renewals and testing windows start months earlier. EHRs that prepare now will glide through the transition. Those who wait will face crowded testing schedules and rushed compliance cycles.
Darena Health gives you the peace of mind that your certification is not only valid today, but sustainable tomorrow. We keep your system aligned, your evidence complete, and your path to HTI-1 compliance clear.
Certification is proof. Sustained compliance is trust.
Partner with Darena Health to stay both compliant and confident through all HTI-1 deadlines, including USCDI v3.
Discover how we maintain compliance in real-world environments.