ONC EOA Final Rule: Establishing ONC Authorization for Testing Labs
This is a blog post in a series on our review of our Enhanced Oversight and Authority (EOA) Final Rule. Check out the others on our blog via the EOA tag.
Summary
Since the ONC Permanent Certification Final Rule, EHR testing was to be completed by labs accredited by NVLAP. However, the approval process was different for testing labs compared to the certification side. Certification bodies not only had to be accredited by ANSI, but they must subsequently be approved and authorized by ONC before issuing certifications. Thus, they were referred to as NVLAP-accredited testing laboratories but not ONC-ATLs. This resulted in less oversight by ONC on testing compared to certification efforts.
In this ruling, ONC changes this and brings the testing laboratories to equal footing with the certification bodies in terms of ONC approval and oversight. Going forward, testing labs must seek ONC approval and accept ONC principles of proper conduct to produce ONC approved test results. For ONC-ACBs, they will eventually only be able to accept test results from ONC-ATLs. Laboratories still must receive NVLAP accreditation in order to be ONC-ATLs.
ONC is allowing a transition period of approximately 8 months from the publication of this Final Rule to allow existing NVLAP-accredited testing laboratories to become ONC-ATL and to allow ONC-ACBs to update their processes to only accept ONC-ATL test results, with the exception of gap inheritance.
After that time, test results can only be accepted from ONC-ATLs. However, ONC-ATL applications do not have to cover all ONC criteria in order to be accredited. ONC allows for a flexible scope of accreditation where a test lab applicant can seek authorization for 1.) all certification criteria (e.g., all 2015 Edition criteria), 2.) a subset (e.g., privacy and security criteria 315(d)(1)-(11)), 3.) one single certification criterion (e.g., ePrescribing 315(b)(3), or 4.) even a subset of a criterion (e.g., only the 315(b)(1)(iii) create CCDA capability of the Transitions of Care criterion).
Analysis
For developers and clinicians, this is largely inconsequential to them. It does not change existing test results nor impacts future selection of approved testing bodies. The four existing NVLAP-accredited testing bodies will all seek and gain approval to be an ONC-ATL, and other new laboratories may appear. It is a good change to give ONC equal oversight to testing as they have currently with certification. It should be noted that the testing laboratories have always consulted with ONC in matters of the program guidance and criteria interpretation so even the ONC-testing laboratory relationship will still act much the same as before.
