Real-world testing is a crucial component of the ONC Health IT Certification Program, mandated by the ONC 21st Century Cures Act Final Rule. It requires health IT developers to demonstrate the interoperability and functionality of their certified health IT products in real-world settings and scenarios, rather than in controlled test environments with ONC-Authorized Testing Labs (ONC-ATLs).
The purpose of real-world testing is to verify that deployed certified health IT continues to perform as intended by conducting and measuring observations of interoperability and data exchange. These observations are documented in real-world testing plans and reported as real-world testing results, which are made publicly available on the Certified Health IT Product List (CHPL) annually.
Certified health IT developers must comply with real-world testing as a Condition of Certification, which includes ongoing Maintenance of Certification requirements. This means that developers with one or more health IT modules certified to specific certification criteria outlined in the ONC Cures Act Final Rule must successfully test the real-world use of those modules.
Real-world testing plans must address various elements, including testing methods, care settings to be tested, conformance to certification criteria requirements, schedules, expected outcomes, measurements, and justifications for the chosen approach. These plans must be publicly available on the CHPL by December 15th of each year.
After submitting the real-world testing plan, developers collect data to represent how their products operate in the real world and submit these results to their ONC-Authorized Certification Bodies (ONC-ACBs). Real-world testing results must be publicly available on the CHPL by March 15th of each year.
Updates to certification criteria, such as the adoption of newer versions of standards or changes in requirements, must also be addressed in real-world testing plans and results. Developers must ensure their certified health IT modules comply with updated criteria and provide instructions on their use during real-world testing.
Overall, real-world testing ensures that certified health IT continues to function effectively in real-world scenarios, promoting interoperability and enhancing the quality of health IT products.
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