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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: BRIDG Model Update

Project ID: 1531

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:  Submission date

 

- 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)

Biomedical Research and Regulation (BR&R)

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

Co-sponsor Work Group(s):

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

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)

Ed Helton (BR&R co-chair, NCI)

Other interested parties and their roles


Multi-disciplinary project team (recommended)


     Modeling facilitator

Smita Hastak, Wendy Ver Hoef

     Publishing facilitator

Myron Finseth

     Vocabulary facilitator

Enter a name here (or ask Vocab for a name):

     Domain expert rep

David Clunie, Ulrike Wagner (NBIA team)

     Business requirement analyst


     Conformance facilitator (for IG projects)


     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) 

2) 

3. Project Definition

3.a. Project Scope

The scope of this project is to ballot a new release of BRIDG.


3.b. Project Need


The BRIDG Model has added new semantics since the last ballot, in support of NCI, DICOM & the National Biomedical Imaging Archive (NBIA), updated CDISC SDTM to SDTM 3.3, and ballot comment reconciliation changes from the previous ballot. This is to bring in research components of NBIA that are not represented in DICOM. The updated model which provides additional semantics to r5 needs to be re-balloted as r5.3 for acceptance by the HL7 community.


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

NCI Research Data Commons, Beau Biden Moonshot Initiative, 21st Century Cures Act, FDA Common Data Model Harmonization


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.

To ballot a new version of the BRIDG model that supports the additional semantics in support of NCI, DICOM and the National Biomedical Imaging Archive, the update of SDTM 3.2 to SDTM 3.3 and ballot comment reconciliation changes from the previous ballot.

Enter Target Date

Submit for Informative Ballot

2019 May Ballot

Complete informative ballot Reconciliation

2018 June















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.

Ongoing


3.f.   Common Names / Keywords / Aliases


BRIDG, BRIDG Model, Biomedical Research Integrated Domain Group Model 


3.g. Lineage


If your project creates a Post-Release 1 version; indicate the name of the prior product and if it is supplanting, replacing or coexisting with a previous release: New model version will replace previous model version.

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:

There is a dependency on outside direction by the BRIDG Steering Committee as well as timely allocation of resources by the Steering Committee to ensure our project timelines can be met.
 

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

BR&R WG page:  http://www.hl7.org/Special/committees/rcrim/index.cfm

BR&R Wiki page:  http://wiki.hl7.org/index.php?title=Biomedical_Research_and_Regulation_(BR%26R)

BRIDG model home:  https://bridgmodel.nci.nih.gov


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
HTTP://


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: BRIDG 3.0.1


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:

If desired, enter additional information regarding Backwards Compatibility.


3.k. External Vocabularies


Will this project include/reference external vocabularies?

Yes

No

X

Unknown

N/A

If Yes, please enter the vocabularies:


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

X

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)


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

X

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:BRIDG Release 5.2/HL7 BRIDG r5
-    Date it was published (or request for publication, or ANSI designation date)None
-    Rationale for revisionChanges to model. Added new semantics in support of the National Biomedical Imaging Archive Harmonization project. NBIA is a DICOM-base image repository. SDTM 3.2 will be upgraded to SDTM 3.3 and ballot comment reconciliation changes will be implemented.
-    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.)The new standard is intended to replace the current standard.


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


Comment (aka Comment-Only)


X

Joint Ballot (with other SDOs)

X

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.

Other SDO’s will be CDISC and ISO


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?


X

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?

90%

Was the content externally developed ? :

Y/N

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

X

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

 X

Pharmaceutical

  

Clinical and Public Health Laboratories

  

Immunization Registries


EHR, PHR

  

Emergency Services

  

Quality Reporting Agencies

  

Equipment

  

Local and State Departments of Health


Regulatory Agency

 X

Health Care IT

 X

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

 

 


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

2018-10-03

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