Clinical Decision Support

Clinical Decision Support

The 2014 Edition EHR certification criterion for CDS also requires EHR technology to provide Infobutton[1]-enabled diagnostic and therapeutic reference information (§170.314(a)(8)(ii)(2)) in accordance with one of the Infobutton implementation specifications at § 170.204(b)(1) or § 170.204(b)(2). Since the 2014 Edition Final Rule’s publication, we received clarifying feedback that the Infobutton standard does not support vital signs and medication allergies data for linked referential CDS and subsequently issued FAQ 34[2] to clarify how 2014 Edition testing and certification would handle this limitation.[3]As a result, we propose that the 2015 Edition CDS certification criterion will not require compliance with the Infobutton-enabled capability for vital signs nor medication allergies data.

CDS WG response #1.1: Release 4 of the HL7 Infobutton URL-based Implementation Guide was approved as a normative specification in January 2014. This release does provide support to represent vital signs and medication allergies. Yet, we agree with the proposal above since there is little experience with the implementation and usefulness of infobuttons with vital signs and medication allergies. Therefore, we agree that these should not be required for certification.

We also propose to discontinue referencing “laboratory values/results” data as we understand from stakeholder feedback that the Infobutton standard cannot support this specific data.

CDS WG response #1.2:Release 4 of the HL7 Infobutton URL-based Implementation Guide does support laboratory test values/results. Based on experience at early adopter sites, infobutton usage from laboratory test results datais fairly high and there are online reference resources that support this kind of data. Therefore, we recommend not discontinuing laboratory test results data as a requirement for certification.

Further, we propose to adopt the HL7 Implementation Guide: Service-Oriented Architecture Implementations of the Context-aware Knowledge Retrieval (Infobutton) Domain, Release 1, August 2013 (at § 170.204(b)(3)) in place of the older version referenced by the 2014 Edition certification criterion.

CDS WG response #1.3: We agree with this proposal. We also recommend referencing the latest release of the HL7 Infobutton URL-based Implementation Guide, which was approved in January 2014 and is officially entitled “HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain, Release 4”. We also recommend referencing the following parent specification, which was alsoapproved in January 2014: “HL7 Version 3 Standard: Context-Aware Knowledge Retrieval Application (Infobutton); Knowledge Request, Release 2”.

Patient-Specific Education Resources

We propose to adopt a 2015 Edition “patient-specific education resources” certification criterion that revises the 2014 Edition version in three ways. Our first proposal is to adopt this certification without the requirement that EHR technology be capable of electronically identifying patient-specific education resources based on “laboratory values/results.” We understand from stakeholder feedback on the 2014 Edition version of this criterion that the Infobutton standard cannot support this level of data specificity, and we do not expect EHR technology developers to develop an alternative method that could electronically identify patient-specific education resources based on laboratory values/results.

CDS WG response #2.1:As mentioned in response #1.2 above, Release 4 of the HL7 Infobutton URL-based Implementation Guide does support laboratory test values/results. However, unlike provider reference information, there are important reasons not to require identifying patient-specific education resources based on “laboratory values/results”.

• Patient education vendors typically do not maintain reference ranges or the clinical rules to be able to interpret whether a lab value would be considered high/low/normal.
• There are few if any patient education reference libraries with sufficient granularity to differentiate between instructions for a lab test with abnormal results versus a lab test with normal results.
• Knowing that a lab test is abnormal does not automatically mean that education would be appropriate. Instead, it's preferable to wait until a diagnosis has been assigned by a qualified professional (e.g. hyperlipidemia) – and provide education based on the diagnosis, not the test results.

Therefore, we agree with the proposal above not to require identifying patient-specific education resources based on laboratory values/results. Yet, we still recommend requiring identifying patient-specific education resources based on laboratory tests (regardless of the results). This kind of laboratory test education could describe the test, its purpose, experiential factors, typical ranges, the meaning of different results, but without interpreting the specific patient’s results.

Our second proposal is to adopt the HL7 Implementation Guide: Service-Oriented Architecture Implementations of the Context-aware Knowledge Retrieval (Infobutton) Domain, Release 1, August 2013. This is the updated IG of the Draft Standard for Trial Use (DSTU) version we adopted for the 2014 Edition “patient-specific education resources” certification criterion. To clearly distinguish this IG in the regulation text from the DSTU version, we propose a technical amendment to § 170.204(b)(2) to note that the version is the DSTU version.

CDS WG response #2.2 (same as response #1.3 above): We agree with this proposal. Please note that the specification referenced above (HL7 Implementation Guide: Service-Oriented Architecture Implementations of the Context-aware Knowledge Retrieval (Infobutton) Domain, Release 1, August 2013) is now a normative specification and no longer a DSTU.

We also recommend referencing the latest release of the HL7 Infobutton URL-based Implementation Guide, which was approved in January 2014 and is officially entitled “HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain, Release 4”.

We also recommend referencing the following parent specification, which was also approved in January 2014: “HL7 Version 3 Standard: Context-Aware Knowledge Retrieval Application (Infobutton); Knowledge Request, Release 2”.

Finally, our third proposal is to revise the regulation text to be more consistent with the intent and interpretation of the 2014 Edition certification criterion regulation text we expressed in the 2014 Edition final rule.[4] The text of the 2015 Edition certification criterion makes clear that the EHR technology must demonstrate the capability to electronically identify patient-specific education resources using Infobutton and an alternative method that does not rely on Infobutton. To note, we propose that the guidance we provided in FAQ 40[5] would still be applicable to the 2015 Edition “patient-specific education resources” certification criterion.

We request comment on whether we should adopt a different approach related to the methods EHR technology uses to electronically identify patient-specific education resources for the 2015 Edition, a potential 2017 Edition “patient-specific education resources” certification criterion, or both. The 2014 Edition and the proposed 2015 Edition EHR certification criteria require EHR technology to demonstrate the capability to electronically identify for a user patient-specific education resources using Infobutton and an alternative method. We seek comment on whether we should: (1) maintain this approach; (2) require EHR technology to demonstrate only the use of Infobutton, but permit EHR technology to be certified to other methods upon an EHR technology developer’s request for the purpose of an EP, EH, or CAH being able to use the alternative certified method for MU (to count such use toward meeting the measure); or (3) certify only the use of Infobutton and consult with CMS regarding a meaningful use policy change that would permit the use of any method (certified or not) to electronically identify patient-specific education resources, provided that the EP, EH, or CAH has EHR technology certified to perform the Infobutton capability.

CDS WG response #2.3: We propose the adoption of option #2 above. Option #1 has generated substantial confusion among implementers and should be discontinued. Option #3 leaves in-place the current proprietary barriers that have hindered the spread of this needed functionality.

We also seek comment on whether we should require that EHR technology be capable of providing patient-specific education resources in a patient's preferred language in the 2015 Edition, in a potential 2017 Edition certification criterion, or in both.

CDS WG response #2.4: We agree with the proposal above. Language preference is not difficult to implement and several online patient education resources have the capability to provide patient education content in the patient’s preferred language. We recommend this capability as a certification criterion both in the 2015 and in the 2017 Edition. Because several patient education resources provide content in both English and Spanish, we suggest support for these two languages as the minimum requirement for certification.

[1]“Infobutton” is typically the shorthand name used to refer to the formal standard’s name: HL7 Version 3 Standard: Context-

Aware Retrieval Application (Infobutton)

[2]

[3]

[4] 77 FR 54216

[5]