CET+-+Harmonization



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1.0 Standards Harmonization Overview
Standards Harmonization is the activities within the S&I Framework that analyze candidate standards and implementation guides. The Standards Harmonization process begins by reviewing the candidate standard list developed during Standards Identification and evaluating the candidate standards against harmonization criteria to select a standard for further harmonization. Additional work products from this phase may include an implementation guide, or proposed improvements, or extensions to a standard. The harmonized standard and accompanying work products are further analyzed and revised through the Reference Implementations and Pilots phases, which results in a harmonized standard for recommendation.

The following diagram shows the location of where the Standards Harmonization process is in relation to the S&I Framework Function Life Cycle.



2.0 Harmonization Process
At a high-level, the Standards Harmonization process promotes community adoption of a harmonized standard. While there is a defined process for the selection and harmonization of standards, initiatives members may choose to alter the process, as long as the new process is aligned to the goals and objectives of the initiative. For example, not every workgroup or initiative develops a new standard. At the core, the Standards Harmonization process accomplishes the following:
 * Provides a detailed analysis of candidate standards to determine “fitness for use” in support of workgroup/initiative interoperability requirements
 * Selects a draft harmonized standard to be supported and validated through Reference Implementation and Pilots
 * Promotes ongoing improvement of the draft harmonized standard through community feedback

The following graphic illustrates the breakdown of the Standards Harmonization process.



2.1 Analyze Candidate Standards
The S&I Framework harmonization team should conduct an environmental scan to identify additional details surrounding existing implementation examples of the candidate standards identified in during the use case phase. To expedite the harmonization process, the S&I Framework initiative leads can conduct informal scans to assist in standards evaluation through workgroup meetings or offline. The environmental scan consists of the following steps:
 * **Key Activities** || **Artifacts Developed** ||
 * * Conduct environmental scan
 * Identify real world implementations || * Environmental Scan Wiki Page
 * Consensus Statement ||
 * Outreach to pilot participants, if available, or implementers of the standard
 * Outreach to the Health Information Technology Standards Committee (HITSC)
 * Outreach to Federal Agencies for their guidance and lessons learned

Upon gathering information on the standard, initiatives should summarize their findings on an Environmental Scan Wiki Page for public feedback. 

2.2 Evaluate and Select Standards
S&I Framework Standards Evaluation Process draws from other approaches, such as HITSC, HITSP, and HL7 to evaluate standards and technologies to determine alignment and applicability of standards. Harmonization evaluation is critical to identifying the most appropriate standards to harmonize. The approach to evaluation consists of developing a harmonization criteria and applying the criteria to candidate standards, which results in a selected standard that best aligns to S&I Framework objectives.
 * **Key Activities** || **Artifacts Developed** ||
 * * Develop Harmonization Criteria
 * Apply criteria to standards
 * Select best fit standards || * Harmonization Criteria
 * Recommended standards and Consensus Statement
 * Harmonization Timeline ||

**2.2.1 Harmonization Criteria**
The S&I Framework Harmonization Criteria is designed to lay out a stepwise process for identifying how the S&I Framework applies criteria to evaluate standards. At a high level, the focus of the S&I evaluation process starts with broad evaluation:
 * 1) Evaluate standards with respect to the S&I Framework Use Case provided, and eliminate those that are considered to have a “low” alignment to requirements – this is called “need” within the S&I Framework
 * 2) Evaluate standards on Standards Maturity and Technology Maturity
 * Focus on those standards that are still in development, but use technology that is not deemed as in decline
 * 1) Evaluate standards on Deployment/Operational Complexity and Market Adoption
 * Focus on those standards that are sufficiently simple and adopted, and consider alternatives for those that are highly complex and not broadly adopted.

Upon completion of the broad Evaluation, a detailed evaluation proceeds. The S&I Framework uses additional detailed screening criteria to support review of potential standards based on specific requirements from the S&I Framework Use Case. In addition, the S&I Framework uses this criteria is to identify and apply a more detailed and broad based subjective and objective review of current standards. This list summarizes S&I Framework evaluation criteria – note that these have been reviewed by the Health IT Standards Committee and are in alignment with their standards screening methods.
 * This criteria is used to help identify additional standards
 * This criteria is also used to analyze standards from other S&I Framework or outside standards development initiatives
 * Subjectivity and objectivity are based on a weighting system, as determined by the initiative

Operational Complexity || the industry, disruption of current processes due to conversion, coordination and communication costs born by implementers or the lost revenue of current solutions that will no longer be usable? || Deployment/ Operational Complexity ||
 * **Criteria** || **Criteria Description** || **Alignment to HITSC** ||
 * **Availability** || Is the standard easily available and able to be used/implemented without barriers or significant cost? ||  ||
 * **Expected Total Costs of Implementation** || What are the expected total costs of implementation across the industry, disruption of current processes due to conversion, coordination and communication costs born by implementers or the lost revenue of current solutions that will no longer be usable? || Deployment/
 * **Economic Impacts** || What are the expected business and economic impacts from the selected of this standard? ||  ||
 * **Pilot Recommendations** || Are there existing pilots using the standard that are aligned to the use case requirements? || Market Adoption ||
 * **Conformance Criteria** || Does the standard have standard conformance language to enable testing? ||  ||
 * **Viability** || Does the selection of a standard lead to a specific implementation model that is not viable? || Deployment/Operational Complexity ||
 * **Availability** || Is the standard easily available and able to be used/implemented without barriers or significant cost? ||  ||
 * **Expected Total Costs of Implementation** || What are the expected total costs of implementation across
 * **Economic Impacts** || What are the expected business and economic impacts from the selected of this standard? ||  ||
 * **Pilot Recommendations** || Are there existing pilots using the standard that are aligned to the use case requirements? || Market Adoption ||
 * **Conformance Criteria** || Does the standard have standard conformance language to enable testing? ||  ||
 * **Viability** || Does the selection of a standard lead to a specific implementation model that is not viable? || Deployment/Operational Complexity ||

**2.2.2 Harmonize Standards**
The harmonization criteria should be applied to each candidate standard to gauge the level of fit with the S&I Framework. The standards with the most compatibility are then recommended for further harmonization. The level of fit and final recommendation should include the consensus of the workgroup to ensure a majority agreement. Upon achieving consensus on the selected standards, the initiative leads should begin to define the timeline for the remaining standards harmonization activities.

2.3 Finalize Standard for Recommendation
The harmonization process is achieved through a dataset evaluation, which combs through the datasets and corresponding data elements extracted from the use case. The harmonization process leverages the Dataset Evaluation Spreadsheet, or an appropriate variation to compare selected standards to each other for each identified data element. In some circumstances, a Clinical Element Data Dictionary (CEDD) may be developed as a standard-independent view of the required data elements. An analysis is conducted to identify any required improvements to the selected standard in order to fully support the defined use cases.
 * **Key Activities** || **Artifacts Developed** ||
 * * Review Data Elements in datasets defined
 * Identify and harmonize gaps || * Clinical Element Data Dictionary (CEDD)
 * Dataset Evaluation Spreadsheet
 * Consensus Statement ||

3.0 Harmonization Phases
Additionally, the Standards Harmonization process can be depicted further within the context of the S&I Framework Phases. The following graphic represents a sample work breakdown structure for the most common activities throughout the S&I Framework Life Cycle.



4.0 Harmonization Examples
The following section contains examples of potential outputs from the Standards Harmonization process. These examples are intended to show how the Standards Harmonization process has been followed by previous initiatives.

4.1 Harmonized Value Sets
The CEDD Value Set Index will be represented in the S&I Repository and on the S&I Framework CEDD Wiki site, with a web page that explains what the S&I Framework has reused or defined for value sets and include the links to the sources, including UMLS, HL7, CDC, et al. The following figure provides an overview of the proposed process for value set refinement and development within the S&I Framework:



4.2 Query Health Initiative Clinical Element Data Dictionary (CEDD)
The Query Health CEDD is intended to serve as a "view" of the clinical data that is needed to support a distributed query. In this way, it is not intended to be a new clinical information model, but a representative clinical view of the data needed to support various queries as defined in the Query Health Expanded Analysis user story and Query Health Generic Use Case. It serves as a clinical data dictionary that describes the data elements, the relationships of these data elements, possible datatypes for the elements, and how they are used in support of a specific query (for example, usage in a computation or measure). It is important to clarify that the primary focus of this working group in the short term is to define this data dictionary, to be followed in the short term by the physical representation of the data dictionary (using various possible approaches, including SQL, NOSQL, or other types of representations).

Key steps to develop the Query Health Initiative CEDD have included:


 * Introduction of the Clinical Data Dictionary Crosswalk**
 * Determine areas of reuse for the Query Health Technical Foundation (evaluated using a clinician/researcher focus)
 * Example – where are commonalities among the different technical approaches and their data?
 * Determine gaps, where is there no data defined to support the Expanded Analysis user story or the Generic Use Case
 * Example - where is data missing in the current technical foundation approaches that would be needed in support of a query


 * Formulating Data Dictionary**
 * Develop initial documentation and possible supporting models to provide to the Query Health Initiative. Focus will be on representing the data dictionary in a clinically-relevant and research-oriented format. This may include development of data models using standard data modeling notation to support implementers


 * Schedule subject matter expert discussions on clinical information models that may be of interest**
 * Determine how best to reuse existing clinical information models, and to ensure the data dictionary work is not in conflict with existing clinical information models.

The following figure shows a visual overview of the approach to build the Query Health CEDD:



4.3 Transitions of Care Content Modules Index (Standards Analysis)
The Transitions of Care Content Modules Index (CMI) contains a series of spreadsheets containing preliminary mapping of clinical data elements mapped to the Transitions of Care Use Case. It serves as an example of standards harmonization analysis efforts and is designed to be a joint effort managed by the participants and support staff of S&I.This particular format was used for the Transitions of Care initiative but the harmonization process is designed to be flexible enough to support multiple analysis approaches, dependent on the outcomes and objectives of the S&I participants.

The spreadsheets are used to map Transitions of Care requirements to clinical data elements, to HITSP C154 (also known as Data Element Sets), and to Consolidated CDA and the four specific interoperability requirements of the Transitions of Care Initiative (Discharge Summary, Discharge Instructions, Clinical Summary for Specialist Note, Clinical Summary (Specialist Consultation Referral). A Google documents view of the Transitions of Care Content Modules Index (also known as the Transitions of Care Standards Analysis) is provided below:

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5.0 Templates for Harmonization Artifacts
The following table provides templates of sample artifacts that may be created during the harmonization process. The artifacts listed in the table are high-level outputs that may be modified depending on initiative needs; further, each initiative might package many different lower level artifacts to create these high level artifacts. It is important to note that each artifact below adheres to a consensus process, where the initiatives or workgroups must reach agreement on its content and definitions. Initiatives may also define additional outputs as needed.

(Download) || The High Level Data Model is used to define the data elements, data types and cardinality within a Use Case. || Excel Document, Template || (Download) || A Clinical Element Data Dictionary (CEDD) defines the data elements and corresponding definitions that are necessary to convey the clinical perspective of Initiative Use Case requirements in a way that is understandable to a variety of stakeholders including functional and technical experts. || Word Document, Process || (Download) || An implementation guide provides initiative-specific guidance for the exchange of key clinical information, using a selected standard. The template provides recommended sections to include in the document. This template will likely be modified to fit an initiative's needs. || Word Document, Template || (Link) || Ballot reconciliation is the formal process for addressing the comments submitted by the Health Level Seven (HL7) participants and involves both HL7 and the S&I Framework. The S&I Framework serves as a channel to leverage additional healthcare experts for feedback on how to disposition comments. || Word Document, Process || (Link) || An Exchange Profile documents the preferences and requirements for developers creating EHR systems. The profiles provide non-prescriptive, informative guidance to early adopters who implement the requisite information exchanges. || Word Document, Process ||
 * **Name of Artifact Template** || **Description of Artifact** || **Format** ||
 * [[file:siframework/General SI Framework Standards Analysis CET.xlsx|General SI Framework Standards Analysis.xlsx]] || The S&I Frameworks Standards Evaluation Criteria template is designed to lay out a stepwise process for identifying how the S&I Framework applies criteria to evaluate standards. || Excel Document, Template ||
 * [[file:siframework/DS4P Crosswalk Analysis CET.xlsx|S&I Crosswalk Analysis Template.xlsx]] || The S&I Crosswalk Analysis template is used as a means to capture the applicability of candidate standards to the user scenarios/use cases drafted in the use case document. || Excel Document, Template ||
 * [[file:siframework/Harmonization Artifact_High Level Data Model Template.xls|High Level Data Model]]
 * [[file:siframework/S&I Initiative CEDD_Template.docx|Initiative CEDD]]
 * [[file:siframework/S&I_IG_Template.dotx|S&I_IG_Template.dotx]]
 * Ballot Reconciliation
 * Exchange Profile

This table is by no means all encompassing and throughout the process, additional work products and artifacts could include:
 * SDO Communication Plan - Outreach plan for SDOs to highlight developments
 * Standards Analysis Mapping - Can be used to validate novel standards across existing information models. An example is provided above for Transitions of Care but other methods can be used.
 * Gap Mitigation Plan - Strategic plan developed to address gaps in standards. This is developed in coordination with the Standards Development Support function of the S&I Framework.
 * Implementation Guides - Documents providing clear, and unambiguous recommendations and guidance to the commercial vendor or open source communities

All relevant templates and resources can also be found in the Appendix.

Back to Top  1. **Evaluate** **standards with respect to the S&I Framework Use Case provided, and eliminate those that are considered to have a “low” alignment to requirements – this is called “need” within the S&I Framework** **(WE ARE** **HERE)** 2. Evaluate standards on Standards Maturity and Technology Maturity  a. Focus on those standards that are still in development, but use technology that is not deemed as in decline   3. Evaluate standards on Deployment/Operational Complexity and Market Adoption  a. Focus on those standards that are sufficiently simple and adopted, and consider alternatives for those that are highly complex and not broadly adopted.