HL7 Project Scope Statement

Health Level Seven®, International
2013 Project Scope Statement

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1. Project Name and ID

Consolidated CDA DSTU 2013 Update / Project ID: 1014
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) / Child Health
Patient Care
Project Team:
Project facilitator (1 Mandatory) / Brett Marquard
Keith Boone
Other interested parties / ONC
CMS
GE Healthcare
Multi-disciplinary project team (recommended)
Modeling facilitator / Keith Boone
Publishing facilitator
Vocabulary facilitator / Mark Roche
Domain expert rep / Ben Flessner
George Cole
Rob Hausam
Diana Behling
Gay Dolin
Business requirement analyst
Conformance facilitator (for IG projects)
Other facilitators (SOA, SAIF)
Implementers (2 Mandatory for DSTU projects):

3. Project Definition

3.a. Project Scope

This project will make various updates to Consolidated CDA:
The requirements for this stage are to enable an existing EHR certified under 2014 or 2015 ONC Standards and Certification criteria be able to correctly interpret the content of a C-CDA 2.1 instance supporting compatibility with C-CDA 1.1. This release should enable C-CDA 2.1 instances to be created that can be used without requiring change to the product supporting C-CDA 1.1 presuming that it has followed good development practices in interpretation of the CDA Standards and C-CDA 1.1 specifications.
· Create new versions of C-CDA templates present in Release 2.0 that require changes or clarifications to support compatibility with C-CDA 1.1 in support of use in new US Federal Regulation.
1. Provide guidance on use of new templates with C-CDA 1.1 when compatibility is needed.
2. In templates where vocabulary has changed in a way that is not backwards compatible, allow use of C-CDA 1.1 vocabularies in a compatible way, while requiring C-CDA 2.x vocabulary to appear in either code or translation.
3. Where templates have been deprecated in C-CDA 2.0, (e.g., Problem Status, Allergy Status), provide guidance on use of these deprecated templates when compatibility is needed.
4. Where sections have changed in C-CDA 2.0, address how to use new sections and section codes to support compatibility.
5. Address errata that are supportive of compatibility between C-CDA 1.1 and 2.1.
6. Create a C-CDA 1.1 Errata sheet to incorporate into the C-CDA 1.1 package.
Requirements for prior ballots:
· Updating the existing C-CDA Consult Note and creating Referral Note and Transfer Summary document types, incorporating existing templates and new data elements identified by ONC S&I LCC community providers as priority for the delivery of care when transitioning a patient from one provider and/or setting to another.
· Creating a Care Plan document type, using existing C-CDA templates plus new templates identified by ONC S&I LCC community providers aligned with HL7 Patient Care WG’s Care Plan DAM. Scope includes defining how a Care Plan references other types of Consolidated CDA documents.
· Coordinating with the Security WG, to show where an electronic signature and enveloped XML Digital Signature should reside in a Consolidated CDA instance. (Security WG will work on a sister standard, describing the technical details of an enveloped XML Digital Signature. We anticipate that the Consolidated CDA will reference this work).
· Incorporating C-CDA errata that have been identified and approved by HL7.
· Updating Meaningful Use Stage 2 templates (i.e. those C-CDA templates that map to Meaningful Use Stage 2 data elements) based on comments received through the C-CDA DSTU page.
· Renaming Consolidated C-CDA in accordance with the SDWG group’s prior decision: “Consolidated CDA Templates for Clinical Notes”
· Incorporating Patient Generated Document US Realm header template

3.b. Project Need

Proposed US federal regulation has identified C-CDA 2.0 as being the preferred way forward, but introduces a need for compatibility that was not anticipated for in the original project scope. An update is needed to ensure that new templates are backwards compatible.
Existing Consolidated CDA (C-CDA) needs to be enhanced by adding templates to represent priority data elements, and modified/new section level and document level templates needed for transitions of care and care plans, areas essential to patient care and the meaningful use of EHRs; we need to incorporate errata; and we want to address areas that implementers have found to be ambiguous.

3.c. Success Criteria

Successfully ballot and publish an update to Consolidated CDA including the items listed above.

3.d. Project Objectives / Deliverables / Target Dates

Target Date
Publication of DSTU 2.1 Update for Peer Review in support of compatibility. / June 2015
Resolution of peer feedback / June-July 2015
Submit to TSC for DSTU Approval and publication / July/August 2015

3.e. Project Requirements

The DSTU 2.1 update will ensure that a CCDA 2.1 can be created that will be backwards compatible with DSTU Release 1.1. The requirements are that an existing EHR certified under 2014 or 2015 ONC Standards and Certification criteria be able to correctly interpret the content of a CCDA 2.1 without requiring change to the product presuming that it has followed good development practices in interpretation of the CDA Standards and C-CDA 1.1 specifications.
For previous project requirements, see http://wiki.siframework.org/Longitudinal+Coordination+of+Care+%28LCC%29

3.f. Project Risks

Risk Description / Publication timelines necessary to impact the final rule are tight.
Impact Description / Missing the deadlines will make it impossible for the final rule to reference the standard.
Probability: / High / Medium / Low
/ Severity: / High / Medium / Low
Mitigation Plan / The lightweight DSTU update process is being followed. The project has been tightly scoped to address compatibility issues only. ONC has been made aware of the project, and we have already received some preliminary feedback on deadlines, with more expected. We are communicating internally to ensure quick approval of the updated scope of this project. Initial analysis has already been completed on the work necessary.
Risk Description / There is no guarantee that this project will have any effect on the final rule.
Impact Description / If ONC does NOT utilize the new revision in the final rule, the work being performed will be wasted. The deadline for feedback is May 29th!
Probability: / High / Medium / Low
/ Severity: / High / Medium / Low
Mitigation Plan / Many stakeholders have already been notified, and will be asked to reference this project in their comments. The HL7 Policy Advisory Committee Response has already been updated to incorporate this project in HL7 feedback on the regulation. HL7 should produce a press release announcing this project as soon as it is approved, preparation is already under way.
Risk Description / There are risks to downstream specifications relying on C-CDA 2.0
Impact Description / Downstream specifications referring to C-CDA 2.0 templates may not refer to them in a version independent fashion. This could impact use of these specifications with subsequent editions of C-CDA.
Probability: / High / Medium / Low
/ Severity: / High / Medium / Low
Mitigation Plan / Alert workgroups depending upon C-CDA 2.0 of this project, and propose a general mechanism to support a version independent link between those products and subsequent C-CDA releases.

3.g. Project Dependencies

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=258

3.h. Project Document Repository Location

http://wiki.hl7.org/index.php?title=Consolidated_CDA_R2.1_DSTU_Update
For previous project work see
http://wiki.siframework.org/Longitudinal+Coordination+of+Care+%28LCC%29

3.i. Compatibility

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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
For each revised C-CDA template, we will reference back to the prior version. We will coordinate with Templates WG around template versioning.
Wire-based compatibility with C-CDA 1.1 DSTU will be supported in the C-CDA 2.1 DSTU Update for templates that were updated in C-CDA Release 2.0.
We will identify downstream products and ensure all workgroups responsible for downstream products are aware of this project, are encouraged to engage and supply peer review.

4. Products

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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
Consolidated Clinical Document Architecture (C-CDA) Release 1.1 Published July 2012
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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 / WG Approval Date CCYY-MM-DD
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
Patients

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
The IG will use SNOMED-CT codes and LOINC codes. The project will build on Health Story Supported C-CDA guide. The project will coordinate with overlapping work taking place in IHE.

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
US

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