Clarification on §170.315(h)(1) and §170.315(h)(2) Testing Requirement

[Rajkumar P]

Hi everyone,

We have completed the testing for §170.315(h)(1) – Direct Project.

Could someone please clarify whether §170.315(h)(2) – Direct Project, Edge Protocol, and XDR/XDM is also mandatory for ONC certification?

Our understanding is that:

• §170.315(h)(1) – Direct Project: Testing completed.

• §170.315(h)(2) – Direct Project, Edge Protocol, and XDR/XDM: Is this required in addition to h.1, or is it optional depending on the product/certification scope?

• If h.2 is selected for certification, we understand that it involves Live Testing.

Could someone please confirm whether completing h.1 alone is sufficient, or whether h.2 testing is also required or H2 is optional?

Regards,
Rajkumar P.
Mettler Healthcare

[kylem...@gmail.com]

You only need one of h.1 or h.2 - you don't need both. The ONC definition of Base EHR (copied below) shows either h.1 or h.2. Also, if you seek additional confirmation, you can search on the CHPL (https://chpl.healthit.gov/#/search) for certification listings of h.1 AND h.2 and you get exactly 0 results - no one is certified to both. I'm not even sure the ACBs would let you certify both of those criteria. 315.h.1 is basically a subset of h.2 requirements.  

“Base EHR”

(3) Has been certified to the certification criteria adopted by the Secretary in all of the following:
(i) Section 170.315(a)(1), (2), or (3); (a)(5) and (14), (b)(1), (c)(1), and (g)(7), (9), (10); and (h)(1) or (2).
(ii) Section 170.315(a)(9) or (b)(11) for the period up to and including December 31, 2024.
(iii) Section 170.315(b)(11) on and after January 1, 2025.
(iv) Section 170.315(b)(4) on and after January 1, 2028.

https://www.ecfr.gov/current/title-45/part-170/section-170.102#p-170.102(Base%20EHR)

Kyle Meadors

Chart Lux Consulting