It’s been just over a year since certified Health IT developers aligned their Health IT Modules with the requirements outlined in the Cures Act Final Rule. As part of this transformative update, developers of certified application programming interface (API) technology completed certification to 45 CFR 170.315(g)(10) Standardized API for patient and population services. We’re excited to report that as of this blog post’s publication, over 290 products have been certified to §170.315(g)(10) within the ONC Health IT Certification Program (Certification Program).

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The 2015 Edition Cures Update made several changes to the ONC Health IT Certification Program (Certification Program), including new functionalities; new, removed, and revised criteria; and new requirements establishing the Conditions and Maintenance of Certification. This means that most health IT developers of certified health IT (certified health IT developers) will be required to update their certified Health IT Modules by December 31, 2022. As we approach this deadline, it is important to remember that meeting the Certification Program requirements and avoiding non-conformities is up to each certified health IT developer.

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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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