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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: Vocabulary Binding Concepts, Principles, and Practices

Project ID: An ID will be assigned by Project Insight

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

 X

N/A

 

U.S.

Metric

 

Both

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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

Vocabulary

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

Co-sponsor Work Group(s):

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

Conformance

Indicate the level of involvement that the co-sponsor will have for this project:
 Request formal content review prior to ballot
 Request periodic project updates. Specify period
 Other Involvement. Specify details here: 

2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)

Reuben Daniels

Other interested parties and their roles

Frank Oemig (Conformance)

Robert Snelick (Conformance)

Brian Pech (Publishing)

Kelly Burns (TBD)

Multi-disciplinary project team (recommended)


     Modeling facilitator

N/A

     Publishing facilitator

     Vocabulary facilitator

N/A

     Domain expert rep

     Business requirement analyst

N/A

     Conformance facilitator (for IG projects)

N/A (Not an IG)

     Other facilitators (SOA, etc)

N/A



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) N/A

2) N/A

3. Project Definition

3.a. Project Scope


Develop and publish an architectural foundation for vocabulary binding including concepts, principles and best practises in a product family agnostic way i.e. not in conflict with particular models, designs and paradigms in product families, coding systems, or related product family specific models.

As annex describing how to apply the best practices to HL7 Fast Healthcare Interoperability Resources (FHIR) Release 4 (R4).

Additional annexes may be added to cater for other product families (e.g. HL7 Version 2 and Clinical Document Architecture) in order of demand and use.



3.b. Project Need


Binding terminology artifacts (code systems, value sets, codes) to data elements which may carry coded values is commonplace in health informatics. However, few resources exist to describe the concepts, principles, and best practice for doing so which may lead to poor and unpredictable implementations. Further, FHIR which is seeing widespread adoption internationally, supports and extensively uses binding, in particular binding to value sets. Without appropriate guidance and a source of best practice when binding the risk of “not getting right” is much higher in the FHIR ecosystem.

Accordingly, this project seeks to provide sound foundational knowledge and guidance to implementers as well as describing the correct application of the guidance using the FHIR standard.

V2 and CDA have done binding in a way that is not compatible with each other nor necessarily conducive to the current and near term needs of FHIR.

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


None.


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

Example: Submit for STU Ballot(First Ballot Cycle)

2018 Jan Ballot

Example: Complete STU Reconciliation

2018 May WGM

Example: Submit for 2nd STU Ballot

2018 May Ballot

Example: Request STU Publication

2018 Sep WGM

Example: STU Period – 12 months

2019 Jan - 2015 Jan

Example: Submit for Normative Ballot

2019 May Ballot

Example: Complete Normative Reconciliation

2019 Sep WGM

Example: Submit Publication Request

2019 Oct

Example: Receive ANSI Approval

2020 Nov

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.

Enter Project End Date


3.f.   Common Names / Keywords / Aliases


Binding 


3.g. Lineage


N/A

3.h. Project Dependencies


N/A


3.i.   HL7-Managed Project Document Repository Location



3.j.   Backwards Compatibility


Are the items being produced by this project backward compatible?

Yes

No

Unknown

X

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

Unknown

X

N/A



If you check no, please explain the reason:


3.k. External Vocabularies


Will this project include/reference external vocabularies?

X

Yes

No


Unknown

N/A

SNOMED CT

LOINC


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)


V3 Documents – Clinical (e.g. CDA)

X

FHIR Profiles (enter FHIR product version below)


V3 Documents - Knowledge

X

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:

N/A

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


FHIR R4


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;





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:
-    Date it was published (or request for publication, or ANSI designation date)
-    Rationale for revision
-    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.)


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)

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

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?

Was the content externally developed ? :

Y/N

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

Yes

No


6.b. Realm


X

Universal 

- OR -

 

Realm Specific




 

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

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

 
 

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

X
 
 

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

 

 


Other:  Indicate other stakeholders, vendors or providers not listed above.










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

Sponsoring Work Group Approval Date:

WG Approval Date

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date


List each Co-Sponsor and their Approval Date



Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

CDA Projects: CDA Management Group

CDA MG Approval Date

FHIR Projects: FHIR Management Group

FMG Approval Date

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

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

USRSC Approval Date

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

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

Last PBS Metrics Score:

 Green

 Yellow

 Red

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

 Yes

 No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

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

 N/A


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

TSC Approval Date