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ONC Regulation FAQs

#34 Question [12-12-034-1]

Will the demonstration/use of vital signs and/or medication allergies data be individually required for testing and certification of the linked referential clinical decision support (CDS) capability specified in the certification criterion adopted at 45 CFR 170.314(a)(8)?

Answer:

The specific capability for linked referential CDS is found at 45 CFR 170.314 (a)(8)(ii)(A), which states:

“(A) EHR technology must be able to:

(1) Electronically identify for a user diagnostic and therapeutic reference information; or

(2) Electronically identify for a user diagnostic and therapeutic reference information in accordance with the standard specified at § 170.204(b) and the implementation specifications at § 170.204 (b)(1) or (2).

and, further 45 CFR 170.314 (a)(8)(ii)(B) states:

(B) For paragraph (a)(8)(ii)(A) of this section, EHR technology must be able to electronically identify for a user diagnostic or therapeutic reference information based on each one and at least one combination of the data referenced in paragraphs (a)(8)(i)(A) through (F) of this section.”

Based on analysis and stakeholder feedback (with which we agree), we clarify that testing for the linked referential CDS capability will not require the individual demonstration/use (i.e, the “each one” requirement) of vital signs or medication allergies data.

We understand that for the Infobutton-enabled capability at (a)(8)(ii)(A)(2), the implementation guides do not support either of these two data. Thus, we do not intend for testing or compliance with this specific capability within the certification criterion to be based on the individual assessment of vital signs or medication allergies data (i.e., the “each one” requirement) to meet the capability specified at (a)(8)(ii)(A)(1) or (a)(8)(ii)(A)(2).

We also understand and clarify that with respect to demographics data that certain demographic data (e.g., age) can and should be used as a modifier. We intend for testing and certification to evaluate this specific capability in that way. Similar to the prior clarification we do not intend for demographic data to be individually tested or required for certification as part of the “each one” requirement of this specific capability.

In summary, for the purposes of testing and compliance with the capability specified at (a)(8)(ii)(A)(1) or (a)(8)(ii)(A)(2) in the CDS certification criterion, demographics, vital signs, and medication allergies data are not expected to be individually tested or required for certification as part of the “each one” requirement of this specific capability.

 

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