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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



Establish IGAMT as the HL7 V2 IG Publication Tool

Project ID:



TSC Notification Informative/STU to Normative          

Date : 

Check this box when the project proceeds from Informative to Normative or STU to Normative status.  Forward to the TSC for notification, as this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.  



Investigative Project

Date : 

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition.  Sections in bold outline are mandatory for project approval of an investigative project; all other sections are optional. Sections 1-Project Name and Scope, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3g-Project Objective, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required.

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.

  1. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

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


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: 

Participate fully

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: 


Co-sponsor Work Group(s)

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


Electronic Services

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: 

Monthly, at WGMs, etc .


Other Involvement. Specify details here: 

Participate fully

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: 

Participate fully

2.c. Project Team

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

Project facilitator ( 1 Mandatory )

Rob Snelick

Other interested parties and their roles

OO, PH, InM, and EST as primary IG authors

Multi-disciplinary project team (recommended)


Modeling facilitator


Publishing facilitator


Vocabulary facilitator


Domain expert rep

Frank Oemig, Brian Pech, John Garguilo, Craig Newman, Hans Buitendijk

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)  PH

2)  OO

  1. Project Definition

3.a. Project Scope

Establish IGAMT (Implementation Guide Authoring and Management Tool) as V2 Publishing Tool

  • Review of IGAMT capabilities
  • Identify/implement minimum enhancements before wider use
    • Best Practices Guide
    • On-Line Help
    • Link to V2+ (depends on enhancements to V2 Chapter 2B Conformance constructs.)
    • Other features tbd.
    • Outreach to regulatory agencies on input/suggestions on minimum IG requirements to enable regulatory references.
  • Tooling
    • Establish hosting approach (NIST, HL7, Other)
    • Determine how to store/link web publication
    • Link to V2+
  • Create IGAMT training program
    • Primary Users (future publishing facilitators)
    • General Users
  • Establish and train/educate IGAMT publishing facilitators for each work group
  • IGAMT Support
    • Establish support process/structure
    • Establish enhancement and issue reporting, prioritization process
  • Create a roadmap to establish IGAMT from an optional tool to a required tool for HL7 V2 based IGs.

Outreach to other IG developers (CDC, IHE, etc.) to gauge interest to join project.


IGAMT is one tool in a tool set supporting HL7 v2 specification development, test plan development (including test data creation), and message validation (conformance testing). Artifacts created in IGAMT are essential in the test plan and validation tools, however, these are out of scope and will be addressed through other projects.


As the IGAMT tool is developed and maintained by a US Federal Agency (NIST – National Institute of Standards and Technology) we need to address how the tool can be supported for non-US users.  This requires further consideration beyond the scope of this project, while we will not restrict use cases to US-Realm.


We also recognize that NIST funding is not guaranteed, thus we need to consider contingency plans for adopting the tool in the event that NIST needs to withdraw its support.  We note that the tools are open-source, providing some level of continuity in such an event.


It is not in scope to clarify IP at a universal, realm, or jurisdiction level.


To support introduction of IGAMT we need various updates to Chapter 2B Conformance constructs, which will be addressed through a separate PSS.


The scope is limited to IGs moving forward rather than retrofitting old IGs, although.  workgroups may decide to create a new version to reap the benefits to the tools.

3.b. Project Need


  • Improved quality of HL7 V2 based IGs
  • Improved consistency across IGs
  • Creation and re-use of IG components (building blocks), e.g., data types.
  • Embed computable conformance constructs into the IG to improve on clarity and reduce ambiguity while reducing the burden on IG developers.
  • Simplify IG maintenance, enhancements, and publication
  • Enable national level IGs using the same tool set to easily customize to local requirements
  • Establishes the groundwork to create unambiguous, encoded test criteria, including requirements traceability.
  • Raises the level of rigorous and more complete conformance testing
  • IGAMT export when paired with any testing framework, e.g., NIST, Gazelle, provides an immediate conformance testing tool (at “no cost”)
  • The tooling capabilities is not limited to US Realm, rather be universally applicable and jurisdiction


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 .











3.d. External Drivers

National programs, e.g., ONC Certification programs, that require consistency and clear, unambiguous implementation guidance to measure conformance.

3.e. Project Objectives / Deliverables / Target Dates


Target Date

(Dependency on Chapter “2B.A” Conformance updates)

Assume May Draft

Final September

Optional Use Phase


Apply Chapter “2B.A” requirements to IGAMT


Improve IGAMT Help (on-line/otherwise)


Establish Training Program for IGAMT Users


Offer Training Sessions

2018-09-01 – 12-31

Start Mandatory Phase


“Integration” of V2+ with IGAMT


3.f.    Common Names / Keywords / Aliases


3.g. Lineage

Not Applicable

3.h. Project Dependencies

Chapter 2.B Conformance Updates


3.i.    Project Document Repository Location



3.j.    Backwards Compatibility

Are the items being produced by this project backward compatible?





















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)





















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?

























If yes, please list the vocabularies: VSAC and others depending on what we prepopulate.


  1. Products (check all that apply)


Arden Syntax



V2 Messages – Administrative


Clinical Context Object Workgroup (CCOW)



V2 Messages - Clinical


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


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 -





Balloted Informative OR


Non-balloted WG White Paper



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


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


Comment (aka Comment-Only)



Joint Ballot (with other SDOs)





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 Copyrighted Material will be produced?









  1. Project Logistics

6.a. External Project Collaboration

NIST, Frank Oemig

For projects that have some of their content already developed:

How much content for this project is already developed?

Indicate % here

Was the content externally developed (Y/N)? 

If Yes, list developers

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













6.b. Realm


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








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.


6.d. Project Approval Dates

Affiliate Approval Date (for Affiliate Specific Projects):

Affiliate Approval Date CCYY-MM-DD or  indicate “N/A”

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

USRSC Approval Date CCYY-MM-DD or  indicate “N/A”

Sponsoring Work Group Approval Date:

WG Approval Date CCYY-MM-DD

Co-Sponsor Group Approval Date

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

Co-Sponsor Approval Date CCYY-MM-DD

FHIR Project: FHIR Management Group Approval Date:

FMG Approval Date CCYY-MM-DD or “N/A”

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date CCYY-MM-DD or “N/A”

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)





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.