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Comment: Updated roles, dates and ballot type


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

Project facilitator (1Mandatory1Mandatory)

Anita Walden and Ed Hammond

Other interested parties and their roles

National Institute of Health-NCATS Will provide guidance on project direction and scope

Federal Drug Administration (FDA): conduct audit of the sites to evaluate the methodology of using FHIR to collect data for clinical research.

Vanderbilt will participate on pilot demonstration project

Multi-disciplinary project team (recommended)

FHIR FacilitatorEd Hammond (Jean Duteau)

     Modeling facilitator

Michael Rutherford

     Publishing facilitator

James Topping

     Vocabulary facilitator

Julie James

     Domain expert rep

Meredith Zozus

     Business requirement analyst

Anita WaldenJames Topping

     Conformance facilitator (for IG projects)

Michael Rutherford

     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 implementer specific to your work group’s resources if you know of any.

1) Duke University

2) University of Arkansas for Medical Sciences

3)   Vanderbilt University

3. Project Definition


Phase II -  Develop standards, prototype and demonstrate automated single internal review board (sIRB) data and document exchange. Where needed the following standards will be developed. Existing FHIR resources will be utilized when appropriate, FHIR documents to support the following data collection and exchange (1) Structured (IRB) Reliance Agreement Determination Letter based on National IRB reliance models, (2) Study protocols, (3) Structured recruitment materials and (4) Structured informed consent documents and (5) Reportable medical (Unanticipated events, Adverse Events and Serious Adverse Events) and non-medical events and (6) Continuing Review and Final Progress Report form. FHIR resources will be utilized when appropriate. Implementation Guides will be created.


Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project..

Federal Policy Change- The Common Rule

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’)

Submit Project Scope Statement

2019 May 23

Gap analysis between needs and existing standards

2019 March2020 February

Development of Implementation Guide/s

2020 March

Host Connect-a-thon2020 May

Notification of Intent to STU Ballot of Implementation Guide

2019 December2020 July

Ballot Implementation Guide STU

2020 Jan/MayJuly

Ballot Reconciliation

2020 JanJuly/MayAugust

Request for Publication

2020 JuneOct

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.

2020 JuneOct

3.f.   Common Names / Keywords / Aliases


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.  

sIRB Project

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:


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?

Not sure yet.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 -


Balloted Informative OR


Non-balloted WG White Paper

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


Comment (aka Comment-Only)

Joint Ballot (with other SDOs)



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.

We will ballot Informative first then once we receive feedback will move to STU. We are also open to doing a "Comment Only" ballot in January because this is a unique application and our main objective this phase is to demonstrate progress and feedback as we move forward.



- OR -


Realm Specific


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

US - because  because this project is supported by the National Institute of Health

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. "U.S." 

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.










Clinical and Public Health Laboratories




Clinical and Public Health Laboratories


Immunization Registries




Emergency Services


Quality Reporting Agencies




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)






Other (specify in text box below)


Other (specify in text box below)








Other (specify below)







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

Academic Medical Centers (clinical sites),
Electronic Data Capture vendors,
eIRB System vendors,
IRB accreditors,
IRB Reliance Organizations,
Commercial IRBs

6.d. Project Approval Dates


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

CIC: 2019-05-07
FHIR_I 2019-05-16

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:

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:





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



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.





Technical Steering Committee Approval Date:
(Email SD WG approved PSS to:

TSC Approval Date