HL7 Project Scope Statement s3

Health Level Seven®, International

2013 Project Scope Statement

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1. Project Name and ID

HL7 Clinical Document Architecture, Release 2.1 Project ID: TSC Notification Informative/DSTU to Normative Date :

2. Sponsoring Group(s) / Project Team

Primary Sponsor/Work Group (1 Mandatory) Structured Documents WG Templates, Vocabulary, ITS, M&M – pending Co-sponsor Work Group(s) Domain knowledge - Clinical Statement pending

Project Team: Project facilitator (1 Mandatory) Calvin Beebe / Diana Behling Austin Kreisler, Brett Marquard, Sarah Gaunt, Other interested parties and their roles Benjamin Flessner, Kevin Coonan Multi-disciplinary project team (recommended) Modeling facilitator Rick Geimer / Rob Hausam Publishing facilitator Pete Gilbert Vocabulary facilitator Rob Hausam Domain expert rep Business requirement analyst Lisa Nelson? Conformance facilitator (for IG projects) Other facilitators (SOA, SAIF) Templates facilitators – Kai Heitmann

Implementers (2 Mandatory for DSTU projects): 1) 2)

3. Project Definition

3.a. Project Scope

The HL7 Clinical Document Architecture (CDA) is a document markup standard that specifies the structure and semantics of "clinical documents" for the purpose of exchange. The CDA 2.1 project will undertake an incremental refresh of the CDA standard. In order to support backwards compatibility, it will be based on version 2.07 of the HL7 Reference Information Model.

The following updates will be considered to the document model, these include, but are not necessary limited to: a. CDA R2 errata will be included b. Extensions previously required and cited by CDA Implementation Guides c. Attributes omitted from the classes derived from the RIM, where use cases exist for their inclusion d. Additional values to value sets such as Mood codes, will be considered to ensure consistency with modeling from other committees e. The inclusion of tables within tables in the narrative block will be considered as a minor change. f. Include current language about bindings.

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2013 Project Scope Statement

Additional informative content will be considered for a number of topics, including the explanation of the proper use of templates to constrain CDA within specific implementation guides and appropriate vocabulary binding syntax and strategies for CDA R2.1 and CDA IGs. Consider adding an appendix to identify changes coming in the future with Data Types 2.0

The intent of the project team is to limit additions to attributes in the RIM not included in CDA R2.0 classes and used in IGs or specifically requested. All attributes added will need to be included optionally to ensure backwards wire format compatibility.

The addition of new classes to CDA R2.1 will be considered on a case by case basis. The Project team intends to seek SDWG endorsement of any decision to add new classes. This is not expected, but not prohibited out right.

Area considered out of scope for CDA 2.1 include: 1. Wholesale RIM Classes added to the Entry modeling on the right side 2. Wholesale RIM Classes added to the Header to support any participant 3. Wholesale incorporation of the Clinical Statement Pattern 4. Wholesale changes to the CDA Narrative block. These items are out of scope as it is not possible to make these changes and preserve wire format backwards compatibility.

3.b. Project Need The CDA R2.0 standard was released by HL7 in 2005, as a result, significant implementation guide development has occurred based on the CDA standard, which have identified:

1. Extensions required to CDA standard 2. Modeling and vocabulary deficiencies

It is anticipated that an incremental enhancement could potentially alleviate a number of these issues.

Key benefits 1. Support for new vocabulary constructs 2. Ability to develop consistent models with other HL7 committees 3. Current extensions and subschemas will be eliminated

3.c. Success Criteria Publication of the CDA R2.1 as a new normative standard.

3.d. Project Objectives / Deliverables / Target Dates Target Date Project Scope Statement Approved 2014 February Project plan with resource assignments 2014 April Submit for Normative Ballot 2015 May Ballot Complete ballot Reconciliation 2015 August Integrate ballot comments 2015 Oct Submit for Publication 2015 Dec

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2013 Project Scope Statement

Receive ANSI Approval 2016 Feb Project End Date 2016 Feb

3.e. Project Requirements Need to support to the extent possible a single transformation from CDA R2.0 to CDA R2.1 instance.

3.f. Project Risks Given all the demands within the Healthcare IT Industry, volunteers Risk Description will not step up to develop the new standard. The CDA R3 project lost momentum and was unable to successfully complete on time. It is hoped that by limiting the scope of the new CDA R2.1 to an incremental enhancement, that the project will Impact Description be able to obtain sufficient volunteers and be successful. Probability: High Medium Low Severity: High Medium Low The new CDA R2.1 scope is limited over the previous CDA 3.0, it is anticipated that this will ensure that we can complete it in a Mitigation Plan timely fashion. We will take too long to get this project completed before CDA R2.0 Risk Description goes out of effect. Impact Description Could impede implementations in finding copies of standards. Probability: High Medium Low Severity: High Medium Low We will create a project to reaffirm the CDA R2.0 standard for Mitigation Plan another 5 years

3.g. Project Dependencies (scope decisions may create dependencies)Review of known extensions (world wide)

3.h. Project Document Repository Location Gforge for files /folder / WIKI for link to other resource – add some references to how to access the gforge.

3.i. Backwards Compatibility Are the items being produced by this project backward compatible? Yes No Don’t Know N/A The goal of the project will be to maintain backwards compatibility with the CDA R2.0 standard.

4. Products Non Product Project- (Educ. Marketing, Elec. Services, etc.) V3 Documents - Knowledge Arden Syntax V3 Foundation – RIM Clinical Context Object Workgroup (CCOW) V3 Foundation – Vocab Domains & Value Sets Domain Analysis Model (DAM) V3 Messages - Administrative Electronic Health Record (EHR) V3 Messages - Clinical Functional Profile V3 Messages - Departmental V2 Messages – Administrative V3 Messages - Infrastructure V2 Messages - Clinical V3 Rules - GELLO V2 Messages - Departmental V3 Services – Java Services (ITS Work Group) V2 Messages – Infrastructure V3 Services – Web Services V3 Documents – Administrative (e.g. SPL) - New Product Definition - V3 Documents – Clinical (e.g. CDA) - New/Modified HL7 Policy/Procedure/Process -

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2013 Project Scope Statement

5. Project Intent (check all that apply)

Create new standard Supplement to a current standard Revise current standard (see text box below) Implementation Guide (IG) will be created/modified Reaffirmation of a standard Project is adopting/endorsing an externally developed IG New/Modified HL7 Policy/Procedure/Process (specify external organization in Sec. 6 below) Withdraw an Informative Document Externally developed IG is to be Adopted N/A (Project not directly related to an HL7 Standard) Externally developed IG is to be Endorsed CDA R2.0 - May, 2005

5.a. Ballot Type (check all that apply) Comment Only Normative (no DSTU) Informative Joint Ballot (with other SDOs or HL7 Work Groups) N/A (project won’t go through ballot) DSTU to Normative

5.b. Joint Copyright Check this box if you will be pursuing a joint copyright. Note that when this box is checked, a Joint Copyright Letter of Agreement must be submitted to the TSC in order for the PSS to receive TSC approval. Joint Copyrighted Material will be produced

6. Project Approval Dates

Sponsoring Group Approval Date 2014-05-06 Steering Division Approval Date SD Approval Date 2014-10-24 PBS Metrics and Work Group Health Reviewed? (required for SD Approval) Yes No Technical Steering Committee Approval Date TSC Approval Date CCYY-MM-DD Joint Copyright Letter of Agreement received? (req'd for Joint Copyrighted material) Yes No

7. External Project Collaboration

7.a. Stakeholders / Vendors / Providers

Stakeholders Vendors Providers Clinical and Public Health Laboratories Pharmaceutical Clinical and Public Health Laboratories Immunization Registries EHR, PHR Emergency Services Quality Reporting Agencies Equipment Local and State Departments of Health Regulatory Agency Health Care IT Medical Imaging Service Standards Development Organizations Clinical Decision Support Healthcare Institutions (hospitals, long term (SDOs) Systems care, home care, mental health) Payors Lab Other (specify in text box below) Other (specify in text box below) HIS N/A N/A Other (specify below) N/A

7.b. Synchronization With Other SDOs / Profilers

Check all SDO / Profilers which your project deliverable(s) are associated with. ASC X12 CHA LOINC AHIP DICOM NCPDP 0e0671f298067b5acdf83e116ff24036.doc 2013.1 Release Page 4 of 5

2013 Project Scope Statement

ASTM GS1 NAACCR BioPharma Association (SAFE) IEEE Object Management Group (OMG) CEN/TC 251 IHE The Health Story Project CHCF IHTSDO WEDI CLSI ISO Other (specify below)

8. Realm

Universal Realm Specific Check here if this standard balloted or was previously approved as realm specific standard

9. Strategic Initiative Reference – For PMO/TSC Use Only

This section used only for Strategic Initiative Projects. 1. HL7 Recognition 2. HL7 Internal Processes 3. HL7 Implementation

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