EHRs in the Wild: Real World Testing for Certified Health Record Technology (CEHRT)

By Jim Tate, EMR Advocate
Twitter: @jimtate, eMail: jimtate@emradvocate.com
Host of The Tate Chronicles#TateDispatches

One of the more common complaints heard from providers concerns their unhappiness with EHRs. Sure, the software can boast of achieving ONC Certification but what does that really mean in the real world of patients, referrals, and communication with other providers?

Certification testing takes place in a pristine environment with established workflow scripts and predictable data outputs and validations. EHR vendors know exactly what needs to be demonstrated on ‘test day’ and the outcomes are known and predictable. How does this compare with the expectations of a provider at the end of a busy day who needs to quickly send patient data to the local emergency room? To address this issue, enter ‘Real World Testing’.

The 21st Century Cures Act established Conditions and Maintenance of Certification requirements for the ONC Health IT Certification Program. The regulation outlines seven conditions of Certification that cover issues from information blocking to interoperability.

The introduction of “Real World Testing” is proving to be the most misunderstood condition of the maintenance of Certification. It is an annual requirement to maintain 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 the Office of the National Coordinator for Health Information Technology (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.

The requirement of 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.