By Jim Tate, EMR Advocate
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Host of The Tate Chronicles – #TateDispatches
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Executive Orders (EO) issued by President Trump are continuing to affect the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) Certification process for health information technology. As detailed in an earlier post EO #14168 modified required data fields in the demographics criteria. Now, ASTP/ONC on 6/30/25 released guidance based on EO #14192 that will be welcomed by many health information technology vendors.
The annual requirement for applicable Certified criteria to submit Real World Testing plans and subsequent data collection and reporting has been significantly modified.
In the just released “Enforcement Discretion Notice” ATSP/ONC states:
For calendar year (CY) 2025:
“ASTP/ONC will not exercise its direct review authority under 45 CFR 170.580 for any non-conformity, potential or actual, that arises solely from a health IT developer not complying with 45 CFR 170.405(b)(1). This means that a developer with a Health IT Module(s) certified to one or more of the criteria referenced in 45 CFR 170.405(a) is not expected to submit an annual real world testing plan to its ONC-Authorized Certification Body (ONC-ACB) for the 2026 real world testing year…..ASTP/ONC will not conclude that an ONC-ACB has failed to adhere to 45 CFR 170.523(p)(1) and (3), find a violation of 45 CFR 170.560(a), or take any enforcement action under 45 CFR 170.565 against an ONC-ACB for not reviewing CY 2026 real world testing plans and submitting the plans to ASTP/ONC for public availability.”
For calendar year (CY) 2026:
“ASTP/ONC will not exercise its direct review authority under 45 CFR 170.580 for any non-conformity, potential or actual, that arises solely from a health IT developer not complying with 45 CFR 170.405(b)(2), except with respect to Health IT Modules certified to the certification criteria specified in 45 CFR 170.315(g)(7) through (10). This means that ASTP/ONC only expects a developer with a Health IT Module(s) certified to the (g)(7) through (10) certification criteria, as of August 31, 2024, will submit a CY 2025 real world testing results report to its ONC-ACB by March 2026…..ASTP/ONC will not conclude that an ONC-ACB has failed to adhere to 45 CFR 170.523(p)(2) and (3), find a violation of 45 CFR 170.560(a), or take any enforcement action under 45 CFR 170.565 against an ONC-ACB if an ONC-ACB does not review and confirm that applicable health IT developers submit real world testing results reports, except with respect to Health IT Modules certified to the criteria specified in 45 CFR 170.315(g)(7) through (10).
As is often the case, this action bring up additional questions. For those that created Real World Test Plans for 2025, are they still required to perform Real World Testing in 2025 and submit the report in early 2026? What other plans does ASTP/ONC have in an effort to “reduce burden and costs for regulated entities”? More guidance and clarification is expected from ASTP/ONC in the coming weeks.