{"id":19241,"date":"2022-02-08T11:44:12","date_gmt":"2022-02-08T16:44:12","guid":{"rendered":"https:\/\/healthit-gov.go-vip.net\/buzz-blog\/?p=19241"},"modified":"2026-01-17T21:36:21","modified_gmt":"2026-01-17T21:36:21","slug":"dyk-theres-a-conformance-review-process-for-certified-health-it","status":"publish","type":"post","link":"https:\/\/healthit.gov\/blog\/healthit-certification\/dyk-theres-a-conformance-review-process-for-certified-health-it\/","title":{"rendered":"DYK: There\u2019s a Conformance Review Process for Certified Health IT"},"content":{"rendered":"\n

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 \u201cefficacy\u201d and \u201ceffectiveness\u201d 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 \u2013 sometimes called \u201cnon-conformities\u201d \u2013 the Certification Program\u2019s conformance review process helps provide a path to resolve them.
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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:<\/p>\n\n\n\n

Developer <\/strong><\/td>Product <\/strong><\/td>Version <\/strong><\/td>Edition <\/strong><\/td><\/tr>
Millennium Information Services, LLC<\/td>Millennium Information Services<\/td>2017.1<\/td>2015 Cures Update<\/td><\/tr>
QRS, Inc.<\/td>PARADIGM<\/td>17<\/td>2015<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

These open non-conformities and some associated information related to their compliance activities can be found on the CHPL\u2019s Corrective Action Status page<\/a>. This information can also be found by searching for either the certified health IT or certified health IT developer and reviewing any related \u201cCompliance Activities.\u201d The CHPL Public User Guide<\/a> is a helpful reference to better understand how to navigate the CHPL.<\/p>\n\n\n\n

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\u2019s 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.<\/p>\n\n\n\n

ONC\u2019s Certified Health IT Complaint Process<\/strong><\/h2>\n\n\n\n

ONC recommends end users take three steps when it comes to concerns about certified health IT conformance. This process is outlined on our Certified Health IT Complaint Process webpage<\/a>.<\/p>\n\n\n\n

STEP 1 – Contact the Developer<\/strong><\/div>\n\n\n\n
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