“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.”
“When a non-conformity has been identified, a developer can demonstrate commitment to the quality of the technology, the user experience, and patient safety through a corrective action plan (CAP) that will highlight its efforts to notify affected end users and remedy any problems. At the time of this writing of the 993 non-conformities reported on the ONC Certified Health IT Product List (CHPL) since 2016, there were 2 certified health IT products with open non-conformities…”
“These open non-conformities and some associated information related to their compliance activities can be found on the CHPL’s Corrective Action Status page. This information can also be found by searching for either the certified health IT or certified health IT developer and reviewing any related “Compliance Activities.” The CHPL Public User Guide is a helpful reference to better understand how to navigate the CHPL.”
“Public reporting of non-conformities provides market transparency to hold developers accountable to their certification-related obligations. More than a check-the-box exercise, the Certification Program’s conformance review process is a clear oversight and enforcement framework to ensure certified health IT remains compliant with Certification Program requirements after certification testing. We describe below the complaint process and the different types of actions that follow…” Read the full article here.
Source: DYK: There’s a Conformance Review Process for Certified Health IT – By Pablo Ardaya; Laura Urioste and Christopher Monk, February 8, 2022. ONC Health IT Buzz.
