Real-World Testing Update: What EHRs Need to Know
On June 30, 2025, ASTP/ONC released a policy update affecting Real World Testing (RWT) under the Health IT Certification Program. This update relieves some planning requirements, but several reporting obligations still apply.
If your EHR is certified, here’s what the change means and how Darena Health helps keep you compliant.
Quick Refresher: What is Real-World Testing?
Real World Testing is a required part of ASTP/ONC certification. Each year, developers of certified health IT must show that their software functions as intended in real clinical settings.
There are usually two parts to this process:
· A testing plan, submitted before the testing year begins.
· A results report, submitted after the year ends.
ASTP/ONC’s new policy temporarily removes the need to submit plans for the upcoming cycle in 2026, but some results reports are still required for 2025.
What You Can Skip This Year
You do not need to submit a Real-World Testing Plan in 2025 for the 2026 testing year if your product is certified for any of the following:
· §170.315(b) - All criteria
· §170.315(c)(1), (c)(2), (c)(3)
· §170.315(e)(1)
· §170.315(f) - All criteria
· §170.315(g)(7), (g)(9), (g)(10)
· §170.315(h)
If these criteria are on your CHPL listing, the 2026 RWT Plan is not required.
RWT Action Summary
| Year | Not Required | Still Required |
|---|---|---|
| 2025 | No RWT Plan for 2026 | None |
| 2026 | No RWT Results for most criteria | RWT Results for (g)(7), (g)(9), (g)(10) if certified before August 31, 2024 |
This policy remains in effect through December 31, 2026, unless ONC updates it sooner.
How Darena Health Helps You Stay in Compliance
Darena Health helps EHRs meet certification requirements with less internal effort. We track regulatory updates, interpret the changes, and handle submissions for the criteria we support.
If your product uses Darena Health version 2.0 (formerly MeldRx) and includes §170.315(g)(7) or §170.315(g)(10), we will handle the Real-World Testing Results on your behalf. That means fewer deadlines for your team and more confidence that your documentation is accurate and audit-ready.
We also support public directory listing for FHIR APIs (service-based URLs), Promoting Interoperability alignment, and ONC-certified modules for MIPS.
