HL7 Project Scope Statement s5

/ Health Level Seven®, International
2013 Project Scope Statement

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1. Project Name and ID

HL7 Clinical Document Architecture, Release 3.0 / Project ID:
TSC Notification Informative/DSTU to Normative Date :

2. Sponsoring Group(s) / Project Team

Primary Sponsor/Work Group (1 Mandatory) / Structured Documents WG
Co-sponsor Work Group(s) / Templates, Vocabulary, ITS, M&M – pending
Domain knowledge - Clinical Statement pending
Project Team:
Project facilitator (1 Mandatory) / Calvin Beebe / Diana Behling
Other interested parties and their roles / Austin Kreisler, Brett Marquard, Sarah Gaunt, Kanwarpreet Sethi (KP),Benjamin Flessner, Kevin Coonan
Multi-disciplinary project team (recommended)
Modeling facilitator / Rick Geimer / Rob Hausam
Publishing facilitator / Pete Gilbert / Patrick Loyd
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 3.0 project will undertake an incremental refresh of the CDA standard.
1. It will be based on the current HL7 Reference Information Model. As a result, a number of changes will be considered, including:
a. Updating the context conduction modeling
b. Updating the negation indication modeling
c. Updating the data types to Abstract Data Type R2.0
d. Updating as needed the modeling to be consistent with the current RIM, current modeling methodology and best practices
e. CDA R2 errata will also be included
2. Additional minor updates will be considered to the document model, these include, but are not necessary limited to:
a. Extensions previously required and cited by CDA Implementation Guides
b. Attributes omitted from the classes derived from the RIM, where use cases exist for their inclusion
c. Additional values to value sets such as Mood codes, will be considered to ensure consistency with modeling from other committees
d. The inclusion of tables within tables in the narrative block will be considered as a minor change.
3. 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 R3.0 and CDA IGs.
Area considered out of scope for CDA 3.0 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.

3.b. Project Need

The CDA R2.0 standard was released by HL7 in 2005, as a result, an accumulation of harmonization proposal changes that have occurred since that time, that have not been incorporated into the CDA standard.
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. Support to identify source of identifiers
4. Current extensions and subschemas will be eliminated

3.c. Success Criteria

Publication of the CDA R3.0 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 Jan Ballot
Complete ballot Reconciliation / 2015 June
Integrate ballot comments / 2015 August
Submit for Publication / 2015 Sep WGM
Receive ANSI Approval / 2015 Dec
Project End Date / 2015 Dec

3.e. Project Requirements

Need to support to the extent possible a single transformation from CDA R2.0 to CDA R3.0 instance.

3.f. Project Risks

Risk Description / Given all the demands within the Healthcare IT Industry, volunteers will not step up to development the new standard.
Impact Description / 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 R3.0 to an incremental enhancement, that the project will be able to obtain sufficient volunteers and be successful.
Probability: / High / Medium / Low
/ Severity: / High / Medium / Low
Mitigation Plan / The new CDA R3.0 scope is limited over the previous CDA 3.0, it is anticipated that this will ensure that we can complete it in a timely fashion.
Risk Description / We will take too long to get this project completed before CDA R2.0 goes out of effect.
Impact Description / Could impede implementations in finding copies of standards.
Probability: / High / Medium / Low
/ Severity: / High / Medium / Low
Mitigation Plan / We will create a project to reaffirm the CDA R2.0 standard for 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

HL7 Project Scope Statement v2013.1_template_only / 2013.1 Release / Page 2 of 5

/ Health Level Seven®, International
2013 Project Scope Statement
Are the items being produced by this project backward compatible? / Yes / No / Don’t Know / N/A
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/ Health Level Seven®, International
2013 Project Scope Statement
An attempt will be made to limit the scope of changes to the standard, to enable migration (transformation) from CDA R2.0 to CDA R3.0. However, RIM harmonization changes, RIM data type changes will make wire backwards compatibility impossible.

4. Products

HL7 Project Scope Statement v2013.1_template_only / 2013.1 Release / Page 2 of 5

/ Health Level Seven®, International
2013 Project Scope Statement
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 -

5. Project Intent (check all that apply)

Create new standard
Revise current standard (see text box below)
Reaffirmation of a standard
New/Modified HL7 Policy/Procedure/Process
Withdraw an Informative Document
N/A (Project not directly related to an HL7 Standard)
/ Supplement to a current standard
Implementation Guide (IG) will be created/modified
Project is adopting/endorsing an externally developed IG
(specify external organization in Sec. 6 below)
Externally developed IG is to be Adopted
Externally developed IG is to be Endorsed
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/ Health Level Seven®, International
2013 Project Scope Statement
CDA R2.0 - May, 2005
HL7 Project Scope Statement v2013.1_template_only / 2013.1 Release / Page 2 of 5

/ Health Level Seven®, International
2013 Project Scope Statement

5.a. Ballot Type (check all that apply)

Comment Only
Informative
DSTU to Normative
/ Normative (no DSTU)
Joint Ballot (with other SDOs or HL7 Work Groups)
N/A (project won’t go through ballot)
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/ Health Level Seven®, International
2013 Project Scope Statement

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 / 2014-03-06
Steering Division Approval Date / SD Approval Date CCYY-MM-DD
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2013 Project Scope Statement
PBS Metrics and Work Group Health Reviewed? (required for SD Approval) / Yes / No
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/ Health Level Seven®, International
2013 Project Scope Statement
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

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/ Health Level Seven®, International
2013 Project Scope Statement
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 (SDOs) / Clinical Decision Support Systems / Healthcare Institutions (hospitals, long term 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
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/ Health Level Seven®, International
2013 Project Scope Statement

7.b. Synchronization With Other SDOs / Profilers

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/ Health Level Seven®, International
2013 Project Scope Statement
Check all SDO / Profilers which your project deliverable(s) are associated with.
ASC X12 / CHA / LOINC
AHIP / DICOM / NCPDP
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)
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/ Health Level Seven®, International
2013 Project Scope Statement

8. Realm

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/ Health Level Seven®, International
2013 Project Scope Statement
Universal
/ Realm Specific
Check here if this standard balloted or was previously approved as realm specific standard
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/ Health Level Seven®, International
2013 Project Scope Statement

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

HL7 Project Scope Statement v2013.1_template_only / 2013.1 Release / Page 2 of 5

/ Health Level Seven®, International
2013 Project Scope Statement
This section used only for Strategic Initiative Projects.
1. HL7 Recognition
2. HL7 Internal Processes
3. HL7 Implementation
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/ Health Level Seven®, International
2013 Project Scope Statement
HL7 Project Scope Statement v2013.1_template_only / 2013.1 Release / Page 2 of 5