Real World Testing is an annual requirement outlined in the ONC 21st 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 15th. Additionally, Real World Testing results should be publicly available on the CHPL on March 15th 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.
Resources
Applicable Real World Testing Certification Criteria
- § 170.315(f)(1) Transmission to immunization registries
- § 170.315(f)(2) Transmission to public health agencies – syndromic surveillance
- § 170.315(f)(3) Transmission to public health agencies – reportable laboratory tests and value/results
- § 170.315(f)(4) Transmission to cancer registries
- § 170.315(f)(5) Transmission to public health agencies – electronic case reporting
- § 170.315(f)(6) Transmission to public health agencies – antimicrobial use and resistance reporting
- § 170.315(f)(7) Transmission to public health agencies – health care surveys