Using certified health informatics in the clinical environment is complicated. We know that certification testing in the laboratory is different from using certified health informatics in the real world, just like the difference between “efficiency” and “effectiveness” in drug development. For this reason, the ONC Health IT Certification Program (Certification Program) requires participating developers to ensure that their certified Health IT meets all requirements during and after lab testing. When suspected issues arise with certified health IT, sometimes referred to as "non-conformances", the certification program's compliance assessment process helps provide a path to resolution.
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When a non-conformance has been identified, a developer can demonstrate their commitment to technology quality, user experience, and patient safety through a Corrective Action Plan (CAP) that highlights their efforts to Notify affected end users and resolve issues. At the time of writing, of the 993 non-conformances reported on the ONC Certified Health IT Products List (CHPL) since 2016, there were 2 certified health IT products with open non-conformances:
These open non-conformances and some related information about their compliance activities can be viewed on the CHPL Corrective Action Status page. This information can also be found by searching for either a Certified Healthcare IT Professional or a Certified Healthcare IT Developer and reviewing any associated "compliance activities". The CHPL Public User's Guide is a useful reference to better understand how to navigate the CHPL.
What happens when you reach Stage 2, ACB ONC and monitoring activities?
If, after contacting the Health-IT developer, you still have compliance concerns, we recommend that you contact the ONC-ACB, who certified the Health-IT. You can find out which ONC-ACB has certified health informatics on ONC's Certified Health Informatics Product List (CHPL). After being contacted, ONC-ACB conducts a thorough review of the complaint(s), working with developers and end users to understand the nature of the complaint and determine if it is related to the level of capabilities for which the IT of health provided has been certified. If the complaint relates to concerns related to a certified capability, the ONC-ACB initiates an oversight that initiates a process to verify compliance of certified health informatics with specific regulatory requirements. End users should plan to provide additional information to the ONC-ACB so that they can fully assess issues and work with the developer to resolve identified certification issues for all affected end users.
What happens when you reach Stage 3, ONC and direct review activities?
The final step in the Health-IT certified complaint process is to contact ONC through the Health-IT Feedback and Inquiry Portal (Feedback Portal). End users wishing to report issues with their Certified Health IT should select the option in the Complaints section for Certified Health IT, then complete the form with the requested information and provide as much detail and documentation as possible for the ONC to do its best Identify the certified health informatics and coordinate with the concerned ONC-ACB if necessary. ONC and ONC CBAs have reviewed and addressed 383 complaints received since 2017 regarding certified healthcare IT products to ensure compliance with the certification program.
Some certification requirements are beyond the scope and applicability of an ONC-ACB, including those related to meeting the new terms and maintaining certification required by the 21st Century Cures Act. When a potential nonconformity is beyond the competence or capabilities of an ONC ACB, the ONC may choose to engage directly in oversight activities related to certified health informatics and software developers. certified health informatics to ensure compliance with certification program requirements. End users can find more information about Direct Review in the following resources.