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PSS-Lite/Investigative Projects:  Sections surrounded by a BOLD OUTLINE must be completed for approval of "Investigative Projects" (a.k.a PSS-Lite).

  1. Project Name and ID

 

 

BRIDG Model Update

Project ID:

 

 

TSC Notification Informative/STU to Normative          

Date : 

N/A   

 

 

Investigative Project

Date : 

N/A

  1. 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 ( 1 Mandatory )

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

 

Vocabulary facilitator

 

Domain expert rep

David Clunie, Ulrike Wagner (NBIA team)

Business requirement analyst

 

Conformance facilitator (for IG projects)

 

Other facilitators (SOA, etc)

 

 

 

Implementers (2 Mandatory 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) 

  1. 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 3.2, and additional diagrams and reorganization changes to make BRIDG more accessible and easily navigated. 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, 21 st Century Cures Act, FDA Common Data Model Harmonization

3.e. Project Objectives / Deliverables / Target Dates

 

Target Date

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 3.1.3 to SDTM 3.2 and additional diagrams and reorganization changes to make BRIDG more accessible and easily navigated.

 

 

Near term deliverables:

 

  • Release BRIDG 5.3 package on BRIDG website and provide to HL7 the GitHub link for the release package

2019 March

  • 2019 May informative ballot opens

2019 April

  • Submit PSS for BRIDG 5.4 (or 6.0?) to be balloted in Sept 2019

2019 April 7 th due date

  • May 2019 informative ballot for BRIDG 5.3 closes and reconciliation begins

2019 May Ballot

  • Complete informative ballot reconciliation on 5.3 ballot comments

2019 June

  • Release informative ballot comment reconciliation changes as BRIDG 5.3.1 on BRIDG website and provide to HL7 the GitHub link for the release package

2019 July

 

 

Work described in this Project Scope Statement 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 July

3.f.    Common Names / Keywords / Aliases

BRIDG, BRIDG Model, Biomedical Research Integrated Domain Group Model

3.g. Lineage

New model version will replace previous model version.

3.h. Project Dependencies

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.

3.i.    Project Document Repository Location

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

3.j.    Backwards Compatibility

Are the items being produced by this project backward compatible?

 

 

Yes

 

 

No

 

X

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)

 

x

Yes

 

 

No

 

 

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

If you check 'No' please explain the reason:

 

3.k. External Vocabularies

Will this project include/reference external vocabularies?

 

 

Yes

 

 

No

 

x

Unknown

 

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

Currently, the model doesn’t bind to any external vocabularies, however, we expect to provide bindings in the future.

 

  1. Products (check all that apply)

 

Arden Syntax

 

 

V2 Messages – Administrative

 

Clinical Context Object Workgroup (CCOW)

 

 

V2 Messages - Clinical

X

Domain Analysis Model (DAM)

 

 

V2 Messages - Departmental

 

Electronic Health Record (EHR) Functional Profile

 

 

V2 Messages – Infrastructure

 

FHIR Extensions

 

 

V3 Domain Information Model (DIM / DMIM)

 

FHIR Implementation Guide

 

 

V3 Documents – Administrative (e.g. SPL)

 

FHIR Profiles

 

 

V3 Documents – Clinical (e.g. CDA)

 

FHIR Resources

 

 

V3 Documents - Knowledge

 

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

 

 

V3 Foundation – RIM

 

Logical Model

 

 

V3 Foundation – Vocab Domains & Value Sets

 

New/Modified/HL7 Policy/Procedure/Process

 

 

V3 Messages - Administrative

 

New Product Definition (please define below)

 

 

V3 Messages - Clinical

 

New Product Family (please define below)

 

 

V3 Messages - Departmental

 

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

 

 

V3 Messages - Infrastructure

 

White Paper

 

 

V3 Rules - GELLO

 

 

 

 

V3 Services – Java Services (ITS Work Group)

 

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

 

 

V3 Services – Web Services (SOA)

 

  1. 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;

 

Withdraw an Informative Document

 

 

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 5.2.1/HL7 BRIDG r5

-         Date it was published (or request for publication, or ANSI designation date): Jan. 2019.

-         Rationale for revision – changes to model. Adding new semantics in support of the National Biomedical Imaging Archive Harmonization project. NBIA is a DICOM-base image repository. SDTM 3.1.3 will be upgraded to SDTM 3.2 and additional diagrams and reorganization changes will be made to make BRIDG more accessible and easily navigated.

-         The relationship between the new standard and the current standard is:  the new standard is intended to replace the current standard.

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

 

Comment (aka Comment-Only)

 

 

Joint Ballot (with other SDOs)

x

Informative

 

 

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

 

STU to Normative     - OR -

 

Normative (no STU)

 

 

 

 

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 copyright material will be produced with CDISC and ISO.

 

x

Yes

 

 

No

 

 

  1. Project Logistics

6.a. External Project Collaboration

CDISC, DICOM, FDA, ISO, NCI

For projects that have some of their content already developed:

How much content for this project is already developed?

98%

Was the content externally developed (Y/N)?  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

 

 

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

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

 

 

 

6.d. Project Approval Dates

Affiliate Approval Date (for Affiliate Specific Projects):

N/A

US Realm Steering Committee Approval Date
(for US Realm Specific Projects):

N/A

Sponsoring Work Group Approval Date:

Jan. 15, 2019

Co-Sponsor Group Approval Date

(Copy this entire row for each co-sponsor; indicate the specific cosponsor that issued approval)

N/A

FHIR Project: FHIR Management Group Approval Date:

N/A

Architectural Review Board Approval Date:

(required for externally developed content)

N/A

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date 2019-02-05

Last PBS Metrics Score :

 

Green

 

Yellow

 

Red

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

 

Yes

 

No

Technical Steering Committee Approval Date:

TSC Approval Date CCYY-MM-DD

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

 

 

 

 

 

 

 

 

Yes

 

No

 

N/A