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.
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