The use of certified health IT in clinical settings is complicated. We know that certification testing in the lab is different from using certified health IT in the real world, somewhat akin to the difference between “efficacy” and “effectiveness” in drug development. This is why the ONC Health IT Certification Program (Certification Program) compels participating developers to ensure that their certified health IT conforms to the full range of requirements during and after lab-based testing. When suspected issues arise with certified health IT – sometimes called “non-conformities” – the Certification Program’s conformance review process helps provide a path to resolve them.

In section 3009A of the 21st Century Cures Act of 2016 (Cures Act), Congress created the “Electronic Health Record Reporting Program” and required health IT developers participating in the ONC Health IT Certification Program to publicly report certain information about their certified health IT products consistent with a new “condition of maintaining certification.” The goal of this program is to bolster market competitiveness by making publicly available comparative information on the capabilities and uses of certified EHR systems.