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Real World Testing

Real World Testing is an annual requirement outlined in the ONC 21^st Century Cures Act Final Rule for all health IT developers participating in the ONC Health IT Certification Program. The purpose of this Condition and Maintenance of Certification requirement is for Certified Health IT developers to demonstrate interoperability and functionality of their certified health IT in real world settings and scenarios, rather than in a controlled test environment with an ONC-Authorized Testing Lab. Real World Testing verifies that deployed Certified Health IT continues to perform as intended by conducting and measuring observations of interoperability and data exchange. These observations are described in a public and transparent way through Real World Testing plans and reported as Real World Testing results.

In order to comply with the Real World Testing Condition and Maintenance of Certification requirements, Real World Testing plans should be made publicly available on the Certified Health IT Product List (CHPL) annually on December 15^th. Additionally, Real World Testing results should be publicly available on the CHPL on March 15^th of the subsequent year. Certified Health IT Developers should consult with their ONC-Authorized Certification Body about deadlines for submitting their plans and results. Please refer to the resources below for more information on Real World Testing.

Enforcement Discretion: In accordance with Executive Order 14192, “Unleashing Prosperity Through Deregulation” released on June 30, 2025, ASTP/ONC is exercising enforcement discretion related to certain Real World Testing requirements to reduce regulatory burden for Certified Health IT developers. For calendar year (CY) 2025, a developer is not expected to submit an annual Real World Testing plan to its ONC-Authorized Certification Body (ONC-ACB) for the 2026 Real World Testing year. For CY 2026, ASTP/ONC only expects a developer with a Health IT Module(s) certified to the (g)(7) through (10) certification criteria, as of August 31, 2024, to submit a CY 2025 Real World Testing results report to its ONC-ACB by March 2026. This enforcement discretion will be in effect immediately, and will remain in effect until December 31, 2026, or until the Department of Health and Human Services completes deregulatory action, whichever comes first. Please read the full notice outlining the details of the Real World Testing enforcement discretion.