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Template Usage Information:

  1. Consolidated CDA STU 2019 Update and ID



Enter the name of the project here: Consolidated CDA STU 2019 Update

Project ID: 1520

Complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative”.

Forward PSS to the TSC (via tscpm@HL7.org); this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.

 X

TSC Notification:  Informative/STU to Normative 

Date:  07 March 2019

 

- or -                     Direct to Normative (no STU) (includes reaffirmations)       

 

Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:

Includes text from ISO, IEC or ISO/IEC standard: Check here if this standard includes excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption.

Yes

 

No

Select the unit of measure used in the standard; if no measurements are in the standard, select N/A

 

N/A

 

U.S.

Metric

 

Both

 

Investigative Project (aka PSS-Lite)

Date : 

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. Sections 1-Project Name, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3e-Project Objectives/Deliverables/Target Dates, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required for Investigative Project. Investigative Project specific instructions are highlighted in yellow. An investigative project must advance in two WGM cycles, requiring a full scope statement. Otherwise the project will be closed.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

Primary Sponsor/Work Group
(1 (And Only 1) Allowed)

Structured Documents

2.b. Co-sponsor Work Group(s)

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)

Patient Care

Indicate the level of involvement that the co-sponsor will have for this project:

 Request formal content review prior to ballot
X Request periodic project updates. Specify period
X Other Involvement. Specify details here: Requesting engagement in template modeling and content design.

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)

Attachments

Indicate the level of involvement that the co-sponsor will have for this project:
X Request formal content review prior to ballotReview full ballot package
X Request periodic project updates. Specify periodMonthly, and at WG meetings

 Other Involvement. Specify details here: 


All names should have confirmed their role in the project prior to submission to the TSC.
2.c. Project Team

Project facilitator (1Mandatory)

Lisa Nelson, Brett Marquard? (Sean McIlvena or Rick Geimer) for dependent tooling work)

Other interested parties and their roles

CMG, Pharmacy WG, Financial Management, Sequoia Project (CareQuality, eHealthExchange), CommonWell

Multi-disciplinary project team (recommended)


     Modeling facilitator

Brett Marquard

     Publishing facilitator

Sean McIlvena? Rick Geimer? Grahame?

     Vocabulary facilitator

Rob McClure

     Domain expert rep

Lisa Nelson, Brett Marquard, Gay Dolin, Rick Geimer

     Business requirement analyst

Brett Marquard,

     Conformance facilitator (for IG projects)

Sean McIlvena or Rick Geimer, Kai Heitmann, Sean Muir

     Other facilitators (SOA, etc)




Implementers (2Mandatory for STU projects)

FHIR Project Note: The implementer requirement will be handled by the “balloting” project.  Therefore work groups do not fill out the above section.  However, feel free to list implementers specific to your work group’s resources if you know of any.

1) All certified EHR vendors

2) 

3. Project Definition

3.a. Project Scope

This project will migrate the C-CDA R2.1 templates supporting proposed USCDI v1 to a new web publication framework.

In Scope:

As part of the migration, the following will be included:

  • Document Header templates: 
    • US Realm Header and US Realm Header for Patient Generated Document.
    • Document templates will include: (1) Discharge Summary note; (2) History & Physical; (3) Progress Note; (4) Consultation Note; (5) Referral Note, (6) CCD and (7)Unstructured Document.  The project will include guidance to clarify the relationship between these C-CDA document templates and the USCDI v1 Clinical Notes data class.
    • Section templates required and optional in these document types will be included. Entry templates used in included Section templates and supporting proposed USCDI v1 also will be included.
  • C-CDA R2.1 Companion Guide guidance and templates and supplemental templates will be considered for inclusion (may or may not be selected for inclusion)
  • STU comments affecting USCDI v1 and relevant STU comments approved for future release will be considered for inclusion (may or may not be selected for inclusion)
  • The publication will include use of the value sets in June 2019 VSAC update and approved value set binding updates for included templates
  • New design work associated with addressing USCDI v1 requirements.
  • New design beyond USCDI may be considered only If an implementation community, such as Carequality, CommonWell, eHealth exchange, HL7 Implementation-a-thon identifies a critical gap that is supported by existing vendors

Out of Scope:

  • New design work not associated with addressing USCDI v1 requirements, or critical to existing implementation, is out of scope.
  • STU comments not affecting USCDI v1

Other Considerations:

The C-CDA R2.1 Update (Proposed to be called C-CDA R2.2) web publication will be backwards compatible with C-CDA R2.1.

The C-CDA R2.1 Update templates will remain open so systems may still use templates not included in the new web publication. An index in the web publication framework will include a list of templates only available in the prior C-CDA R2.1 PDF publication.





3.b. Project Need

C-CDA R2.1 is increasing in its adoption and as a mature standard it needs to be maintained.  It needs to be updated to align with emerging regulatory requirements, to address STU Comments, to improve alignment across HL7 standards, and to incorporate new publishing capabilities available for HL7 standards.


3.c. Security Risks


Will this project produce executable(s), for example, schemas, transforms, style sheets, executable program, etc.  If so the project must review and document security risks. Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment. 


Yes

X

No


Unknown


3.d. External Drivers


The 21st Century Cures Act includes conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). The pending legislation creates external drivers, such as support for USCDI, which require updates and refinements to the standard.


3.e. Project Objectives / Deliverables / Target Dates

Within each row, enter the explicit work product(s) / objective(s).  Indicate their target date at the right in WGM/Ballot Cycle format.  Include the project end date as the last objective (for standards projects, the end date will be the projected ANSI approval date). 

Target Date(in WGM or ballot cycle format, e.g.

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

Enter objective/deliverable here.

All planned ballots and their target dates should be included

The example below is a "STU to Normative" path

Enter Target Date

Submit for STU Ballot(First Ballot Cycle)

2019 Sept Ballot

Example: Complete STU Reconciliation

2019 Dec

Example: Request STU Publication

2019 Jan WGM

Project End Date (all objectives have been met)

Note:  For PSS-Lite/Investigative Project, End date must be no more than two WGM cycles, e.g. project initiated at January WGM must complete investigation by September WGM.

2019 Jan WGM


3.f.   Common Names / Keywords / Aliases

C-CDA; C-CDA R2.1 Update

What common name does your group use to refer to the product(s) produced?  What alternative names, aliases and keywords does your group use to refer to the product(s) that will be produced?  Some examples: C-CDA, LRI, eDOS.  


3.g. Lineage

CDAR2_IG_CCDA_CLINNOTES_R1_DSTU2.1_2015AUG_2018DEC_with_errata

3.h. Project Dependencies

Enter any dependencies or the name & Project Insight ID of project(s) that this project is dependent upon to achieve its objectives:
 

This project depends on the tooling being able to support the import and editing of C-CDA R2.1 templates in a UI that formulates the template constraints using FHIR Structure Definition and supports electronic IG Publishing with FHIR IG Publishing Tool (stable builds, current build, etc.)

Projects and their Project Insight IDs can be found via http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?ref=common


3.i.   HL7-Managed Project Document Repository Location


Projects must adhere to the TSC's guidelines (which were approved on 2016-04-04 and summarized in Appendix A).

A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page.

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept

https://confluence.hl7.org/x/MQjgAg


3.j.   Backwards Compatibility


Are the items being produced by this project backward compatible?

X

Yes

No

Unknown

N/A

If you check 'Yes' please indicate the earliest prior release and/or version to which the compatibility applies:


For V3, are you using the current data types? 

(Refer to TSC position statement on new projects using R2B for more information on the current V3 data types)

Yes

No

X

Unknown

N/A



If you check no, please explain the reason: Based on CDA R2.0 which is RIM 2.07

If desired, enter additional information regarding Backwards Compatibility.


3.k. External Vocabularies


Will this project include/reference external vocabularies?

X

Yes


No


Unknown


N/A

If Yes, please enter the vocabularies: HCPCS, SNOMED, CPT, ICD, RxNorm, LOINC (A full list of Code Systems used by C-CDA is available here https://vsac.nlm.nih.gov/download/ccda


4. Products (check all that apply)



Arden Syntax


V2 Messages – Administrative


Clinical Information Modeling Initiative (CIMI)


V2 Messages - Clinical


Clinical Context Object Workgroup (CCOW)


V2 Messages - Departmental


Domain Analysis Model (DAM)


V2 Messages – Infrastructure


Electronic Health Record (EHR) Functional Profile


V3 Domain Information Model (DIM / DMIM)


FHIR Extensions


V3 Documents – Administrative (e.g. SPL)


FHIR Implementation Guide (enter FHIR product version below)

X

V3 Documents – Clinical (e.g. CDA)


FHIR Profiles (enter FHIR product version below)


V3 Documents - Knowledge


FHIR Resources


V3 Foundation – RIM


Guidance (e.g. Companion Guide, Cookbook, etc)


V3 Foundation – Vocab Domains & Value Sets


Logical Model


V3 Messages - Administrative


New/Modified/HL7 Policy/Procedure/Process


V3 Messages - Clinical


New Product Definition (please define below)


V3 Messages - Departmental


New Product Family (please define below)


V3 Messages - Infrastructure


Non Product Project - (Educ. Marketing, Elec. Services, etc.)


V3 Rules - GELLO


White Paper


V3 Services – Java Services (ITS Work Group)


Creating/Using a tool not listed in the HL7 Tool Inventory


V3 Services – Web Services (SOA)

If you checked New Product Definition or New Product Family, please define below:


For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?



5. Project Intent (check all that apply)




Create new standard



Supplement to a current standard


Revise current standard (see text box below)


X

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;





Externally developed IG is to be (select one):


White Paper (select one):



Adopted  - OR -


Endorsed



Balloted Informative OR


Non-balloted WG White Paper



N/A  (Project not directly related to an HL7 Standard)











If revising a current standard, indicate the following:


-    Name of the standard being revised:CDAR2_IG_CCDA_CLINNOTES_R1_DSTU2.1_2015AUG
-    Date it was published (or request for publication, or ANSI designation date)August 2015
-    Rationale for revisionRevise to align with emerging regulatory requirements, to address STU Comments, to improve alignment across HL7 standards, and to incorporate new publishing capabilities
-    The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)Replace


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



Comment (aka Comment-Only)



Joint Ballot (with other SDOs)


Informative



N/A  (project won’t go through ballot)

X

STU to Normative     - OR -


Normative (no STU)











If necessary, add any additional ballot information here.  If artifacts will be jointly balloted with other SDOs, list the other groups.



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?



Yes

X

No


6. Project Logistics

6.a. External Project Collaboration


Include SDOs or other external entities you are collaborating with, including government agencies as well as any industry outreach.  Indicate the nature and status of the Memorandum of Understanding (MOU) if applicable.

For projects that have some of their content already developed:

How much content for this project is already developed?

75%

Was the content externally developed ? :

N


Is this a hosted (externally funded) project?  (not asking for amount just if funded)

Y

Yes


No


6.b. Realm



Universal 

- OR -

 X

Realm Specific



X
 

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

US

Enter “U.S.” or name of HL7 affiliate(s) here.  Provide explanation/justification of realm selection. For projects producing deliverables applicable to multiple realms, document those details here. 

For Investigative projects, indicate if the project is planned to be Realm Specific or Universal, if known. Work Groups are encouraged designating project a Universal project initially, and discover which Realms can contribute to the work effort during the discovery phase of the project. Note: This status is subject to change during the investigative process.



6.c. Stakeholders / Vendors / Providers

This section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballots

 

Stakeholders

 

Vendors

 

Providers

Clinical and Public Health Laboratories

 x 

Pharmaceutical

 

Clinical and Public Health Laboratories

x

Immunization Registries

 

EHR, PHR

 

Emergency Services

x 

Quality Reporting Agencies

x
 

Equipment

Local and State Departments of Health

x 

Regulatory Agency

x

Health Care IT

 
 

Medical Imaging Service

 

Standards Development Organizations (SDOs)

Clinical Decision Support Systems

x

Healthcare Institutions (hospitals, long term care, home care, mental health)

 

Payors


 x

Lab

 
 

Other (specify in text box below)

 
 x

Other (specify in text box below)

 

HIS


 
 

N/A


N/A


Other (specify below)


 

 



 

N/A

 

 


Other:  Federal Healthcare Agencies (e.g. CMS), Providers (e.g. Physicians)










6.d. Project Approval Dates

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Structured Documents WG Sponsoring Work Group Approval Date:

WG Approval Date

2019-03-14

Administrative review – in parallel with Work Group Approval

Patient Care WG Co-Sponsor Group Approval DateWG Approval Date2019-03-11

ASIPP (Attachments) WG Co-Sponsor Group Approval Date


WG Approval Date

2019-03-12

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

N/A

CDA Projects: CDA Management Group

CDA MG Approval Date

2019-03-14

FHIR Projects: FHIR Management Group

FMG Approval Date

N/A

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

N/A

US Realm Projects: US Realm Steering Committee Approval
(Email WG approved PSS to: tscpm@HL7.org)

USRSC Approval Date

2019-03-26

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

N/A

Submit PSS to Steering Division after all of the above approvals are received

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date CCYY-MM-DD

2019-03-28

Last PBS Metrics Score:

 Green

X

 Yellow

 Red

PBS Metrics Reviewed? (required for SD Approval if not green)

X

 Yes

 No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

N/A

TSC Approval

If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
signed by both parties.

Yes

No

X

 N/A


Technical Steering Committee Approval Date:
(Email SD WG approved PSS to: tscpm@HL7.org)

TSC Approval Date