By Jim Tate, EMR Advocate
Twitter: @jimtate, eMail: jimtate@emradvocate.com
Host of The Tate Chronicles – #TateDispatches
The 21st Century Cures Act established Conditions and Maintenance of Certification for the ONC Health IT Certification Program. The regulation outlines seven conditions of Certification that cover issues ranging from information blocking to interoperability.
The introduction of Real World Testing is proving to be the most misunderstood requirement of the Conditions and Maintenance of Certification. This is an annual requirement to maintain active Certification and applies to health IT developers with Health IT Module(s) certified to certain certification criteria focused on interoperability and data exchange (i.e., §§ 170.315(b), (c)(1) through (c)(3), (e)(1), (f), (g)(7) through (g)(11), and (h)).
Here are the facts, straight from ONC:
What is Real World Testing? “Real World Testing is a process by which Health IT Developers demonstrate interoperability and functionality of their Certified Health IT in real world settings and scenarios, rather than in a controlled test environment with an ONC-Authorized Testing Lab (ONC-ATL).”
Who Is Required to Conduct Real World Testing? “In order to maintain their certification(s), ongoing Maintenance of Certification requirements specify that Health IT Developers must develop a plan and submit a results report for these same criteria on an annual cycle for each of the setting types in which their Certified Health IT Module(s) are marketed.”
What are the deadlines associated with Real World Testing?
- “Real World Testing plans must be publicly available on the CHPL (Certified Health IT Product List) by December 15th of each year.”
- “After submitting their Real World Test plan, Health IT Developers will gather data to represent how their products operate in the real world and submit these results to their ONC-ACB.”
- “Real World Testing results must be publicly available on the CHPL by March 15th of each year.”
The graphic below from ONC outlines the deadlines for the Real World Testing requirement for relevant ONC certified criteria. Note that deadlines for criteria certified after 8/15/2021 are pushed forward one year.
The requirement for Real World Testing of CEHRT should not be taken lightly by vendors or developers. It is not a simple attestation but requires an administrative and technical process that must occur on an annual basis to maintain active Certifications status.