Clinical decision support (CDS)

Clarifications:

• The terms “automatically” and “trigger” have not been included in this criterion in order to clarify that our intent is to encompass all types of CDS interventions without being prescriptive on how the interventions are deployed. [see also 80 FR 62622]
• A CDS intervention is not simply an alert, notification, or explicit care suggestion. Rather, it should be more broadly interpreted as the user-facing representation of evidence-based clinical guidance based on relevant patient data. [see also 77 FR 54212]
• Health IT developers are encouraged to use standards to retrieve CDS content from external sources rather than “hard coding” CDS interventions to static data in the system. [see also 77 FR 54213]
• The National Library of Medicine hosts a publicly available repository of value sets for use in CDS and clinical quality measures that are available as a resource to developers. Please see: https://vsac.nlm.nih.gov/. [see also 77 FR 54213]
• This criterion will expire on January 1, 2025.

Technical outcome – CDS configuration (per provision (a)(9)(ii)), CDS activation (per provision (a)(9)(iii)), and reference information (per provision (a)(9)(iv)), occur when a user is interacting with health IT.

Clarifications:

• No additional clarifications.

Technical outcome – A limited set of identified users can configure interventions per provision (a)(9)(iii) and reference information per provision (a)(9)(iv) based on a user’s role.

Clarifications:

• No additional clarifications.

Technical outcome – CDS interventions are based on the data named in (a)(9)(ii)(B)(1)(i)-(vi) and when a patient’s medication, medication allergies, and problems are incorporated from a transition of care/referral summary.

Clarifications:

• The demographic data specified at (a)(9)(ii)(B)(1)(iv) are: race, ethnicity, preferred language, sex, sexual orientation, gender identity, and date of birth. [see also § 170.315(a)(5) Demographics CCG]
• To meet the requirements of this provision, interventions based on demographics only need to be based on one of the demographics data types (e.g., sex or date of birth). [see also Health IT Certification Program Overview]
• The health IT does not need to “trigger” an intervention at the time of incorporation, only demonstrate that CDS interventions can be based on the data incorporated from a transition of care/referral summary. Thus, for the purposes of this certification criterion, ONC clarifies that the technology must be capable of demonstrating that it behaves differently in two states: before and after the incorporation of new information. [see also 77 FR 54214]
• For conformance to (a)(9)(ii)(B)(2), health IT must demonstrate that it can enable CDS interventions for incorporated medications, medication allergies, and problems (collectively "data"). The ability to incorporate the data from any content exchange standard is not relevant to conformance with this requirement (i.e., neither tested nor certified).

Technical outcome – A limited set of users can activate CDS interventions based on each data listed in (a)(9)(ii)(B)(1)(i)-(vi), and at least one combination of the data listed in (a)(9)(ii)(B)(1)(i)-(vi).

Clarifications:

• For this criterion, “select” means the same as “activate.” [see also 77 FR 54213]
• “User” is not constrained to mean just “licensed healthcare professional.” For example, a clerical user or patient user may interact with the certified health IT system. [see also 77 FR 54214]

Technical outcome – Health IT can identify diagnostic and therapeutic reference information using the HL7® V3 Context Aware Knowledge Retrieval Application (“Infobutton”) standard in combination with one of the following implementation guides:

• HL7® Service-Oriented Architecture Implementations of Infobutton.
• HL7® V3 Context Aware Knowledge Retrieval.

Clarifications:

• ONC clarifies that our certification approach only focuses on capabilities that must be certified to meet this criterion, not that a provider must use these standards or functions. A health IT developer’s product could include other means for identifying diagnostic or therapeutic reference information, but there are no certification requirements for other means for this criterion. [see also 80 FR 62622] While ONC does not certify knowledge publishers, we encourage them to adopt the Infobutton standard to facilitate providing patient and/or provider facing clinical content to health IT products. [see also 77 FR 54214] 
• This portion of the criterion focuses on Infobutton conformance and performance in relation to health IT’s ability to interact with an Infobutton-enabled source. Additionally, this portion of the criterion provides context as part of the CDS certification criterion as a whole that this specific capability is intended to enable “diagnostic and therapeutic reference information” to be provided to a user via an Infobutton conformant capability. For the purposes of testing and certification, a health IT developer may demonstrate its product’s Infobutton conformance with any Infobutton-enabled content source so long as the capabilities specified in paragraph (a)(9)(iv) and respective data referenced are fully demonstrated (or documented) as part of testing.

Technical outcome – For the diagnostic or therapeutic reference information identified in provision (a)(9)(iv)(A), technology must be able to base the reference information on each of the following: problem list, medication list, and demographics. Technology must also be able to identify reference information on at least one combination of problem list, medication list, and demographics.

Clarifications:

• The demographic data specified at paragraph (a)(9)(ii)(B)(1)(iv) are: race, ethnicity, preferred language, sex, sexual orientation, gender identity, and date of birth. [see also § 170.315(a)(5) Demographics CCG]
• ONC does not intend for demographic data to be individually tested or required for certification as part of the “each one” requirement of this specific capability. ONC also understands and clarifies that with respect to demographics data that certain demographic data (e.g., age) can and should be used as a modifier. ONC intends for testing and certification to evaluate this specific capability in that way. [see also Health IT Certification Program Overview]

Technical outcome – A user can review the source attributes for all CDS interventions provided in provision (a)(9)(i).

Clarifications:

• ONC does not require the automatic display of the source attributes, just the availability of the information to the end-user.
  • For example, additional action may be required for a user to “drill down” or “link out” to view the source attributes of CDS. [see also 77 FR 54215]
• ONC also does not require that the EHR technology create the content for the source attributes. [see also 77 FR 54215]
• “Bibliographic citation” is a reference (if available) to a publication of clinical research that documents the clinical value of the intervention. If no such reference exists (e.g., locally developed intervention), the health IT product should indicate so. [see also 77 FR 54215]
• “Developer of the intervention (translation from clinical research/guideline)” is the team, person, organization, department or other entity that interpreted the clinical research and translated it into computable form (sometimes the knowledge vendor). [see also 77 FR 54215]
• “Funding source of the intervention development technical implementation” is the source of funding for the work performed by the “developer of the intervention.” If this information is unknown, the user should have access to know that it is unknown. [see also 77 FR 54215]

Technical outcome – A user can review the source attributes (specifically the developer of the intervention, and where clinically indicated, the bibliographic citation of the intervention) for all reference information provided in provision (a)(9)(iv) and all drug-drug, drug-allergy interaction checks.

Clarifications:

• Please refer to the CCG for the § 170.315(a)(4) Drug-drug, drug-allergy interaction checks for CPOE certification criterion for more information.
• For drug-drug, drug-allergy interaction checks, global citations are permitted in cases where all interventions of a given type are provided by the same reference. [see also 77 FR 54215]

The adoption of this criterion for purposes of the ONC Health IT Certification Program expires on January 1, 2025.