TOC+Ecosystem+Consensus

include component="page" wikiName="siframework" page="TOC Header" =Introduction= **Note:** The term "Ecosystem Consensus" is used to denote that this recommended standard consensus will also permeate to all other Transitions of Care workgroups as well, including activities in the Clinical Information Model/Vocabulary WG, the Architecture/Implementation RQ WG, and the Reference Implementation & Pilots WG.

The S&I Framework Transitions of Care Initiative was chartered to identify and recommend one or more standards to meet the following requirement for Meaningful Use: Exchange key clinical information among providers of care and with patients and other authorized entities electronically based on level of system capability, i.e., human readable, unstructured text or full interoperable structured data.

An open comment period was held from July 13 to July 20, followed by a formal consensus vote on Wednesday, July 20. The following consensus statements have been approved by the Standards Analysis WG. For further information on the registered votes, please visit Ecosystem Consensus Votes.


 * The general consensus of the Standards Analysis Workgroup is that the CDA is the candidate standard to be recommended for standardizing care transitions.
 * The general consensus of the Standards Analysis Workgroup is that the CCR, while it has specific strengths, is not a candidate standard that aligns to the requirements of the S&I Framework Transitions of Care Use Case.
 * It is also the consensus of the Standards Analysis Workgroup that with the work done to date by the CDA Harmonization and Standards Analysis Work Groups, the content of the CCR is adequately represented in the CDA templates.

The Transitions of Care (TOC) Initiative has identified the HL7 Clinical Document Architecture (CDA), Release 2 as a standard that supports all of the identified system capabilities. This wiki page captures the general consensus of the Standards Analysis Workgroup surrounding this decision.

=Rationale= The following key topics that formed the core basis for the decision to recommend the CDA.

**Participation**
The number of participants who have shown knowledge of CDA and its application to care transitions far exceeds the number of actively participating CCR stakeholders. This affects the ability to develop the appropriate level of implementation guidance that is needed. It also ensures that an adequate base of implementers will have knowledge of how to leverage both the implementation guidance developed to support the Transitions of Care initiative (specific CDA section and document-level templates) and to support the clinical element data dictionary (CEDD).

While time constraints provide a significant limitation on the availability of participants, the level of CCR participation in the Transitions of Care initiative is not considered to be adequate to support the development of implementation guidance.

**Content Coverage**
The Standards Analysis Workgroup mapped the specific care transitions identified in the S&I Framework Transitions of Care Use Case to the sections of the CCR and to the templates in the HL7 CDA Consolidated ballot that was produced by the CDA Harmonization sub-group of this committee. These were then further mapped to or the source of portions of the CEDD.

The results indicate that the CCR does not appear to have an extensible underlying architecture, whereas the CDA was able to accommodate the identified exchange content in all three levels of the system capabilities. The degree of support for robust encoding and controlled vocabulary was also markedly different with CDA supporting a very rich and well-documented encoding environment.

Given the underlying design differences, the CDA has already developed a large library of templates covering a broad range of clinical content, the majority of which are within the scope of the CDA Harmonization Work Group which provides a clear roadmap for incremental interoperability for future Transitions of Care.

Tooling Support
An implied criteria for selection is the support of the model-based standards and development environment envisioned by ONC. To that end, the selected standard must have an underlying design that allows for such models to be derived and defined, or already be model-based.

For CDA, current usage of Model-Driven Health Tools (MDHT) and the Template Database (Tdb) allows for the declaration of entry, section and document-level templates (models) and the generation of supporting artifacts such as computable models, user guides, APIs, etc. The committee was unable to identify available tools or communities of activity that could provide an equivalent level of support for CCR.

Furthermore, in the context of the need to provide supporting UML models for implementors, there appear to be no modeling tools that could support this requirement for CCR. While CCR is XML based and it appears to be capable to be modeled within a toolset, there was no institutional or stakeholder knowledge identified that could support this route.

Testing Support
There is a well documented history of testing of CDA-based documents, and there is on-going active work to improve the current tool set. Both MDHT and Tdb support testing functionality and NIST maintains a suite of CDA test profiles via Schematron here. There was no equivalent level of support identified for CCR validation.

Education Support
CDA is a well documented standard with numerous sources of information and education available for free and for also for fee. These resources support all levels of the HIT implementation team, from executive guidance to implementation (programmer) level offerings. There is a CDA Certification program available through HL7 for the credentialing of CDA experts (not unlike Microsoft and other technology credentialing programs).

There was no identified equivalent level of documentation or community support for CCR beyond the base specification available from ASTM. It is difficult to develop supporting implementation guidance without an appropriate body of documentation available that would allow for working implementation guidance to be developed.

=Conclusions= Overall, the HL7 CDA R2 standard is better positioned to support the existing as well as expected ToC exchange requirements, both from a technical perspective and evidenced by adoption and participation of EHR vendors in the CDA activities. The utility of CCR in specific exchanges remains valid, but without the equivalent community activity it is currently too narrow in scope and lacks sufficient adoption and implementation guidance.

Key short-term milestones based on this consensus are:
 * HL7 CDA R2 will be recommended to the Health IT Standards Committee as the standard to use in support of the meaningful use requirement:
 * //Exchange key clinical information among providers of care and with patients and other authorized entities electronically based on level of system capability, i.e., human readable, unstructured text or full interoperable structured data//
 * Development of system-level implementation guidance for the exchange and processing of CDA instances will begin in the July-August timeframe. This activity will use MDHT and Tdb to produce implementation documentation and artifacts such as models, APIs, Schematron statements, etc., and will be based on the Consolidated CDA Implementation Guide (while the guide continues through ballot a substantial portion of the base templates were unchallenged and can be assumed to be stable.)
 * A greenCDA approach will be defined and presented to the Health IT Standards Committee within the next 1-2 months. This approach will be based on the current maturity level of greenCDA and the Consolidated CDA IG.

Key long-term milestones based on this consensus are:
 * Continue outreach to the CCR community for further analysis and potential role in subsequent phases of this initiative and to provide ongoing development and support for the usage defined in Meaningful Use Stage 1.
 * Design of a CCR-CCD transformation service will begin in the Architecture Workgroup of the Transitions of Care initiative. This will allow for a defined transition path for those providers who will need to move to a CDA-based approach for care transitions.
 * A greenCDA approach will be piloted.

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