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Q:  What is the definition of a project?

A:  From the HL7 Development Framework, Section 2.2.1, HL7 Work Effort:

An HL7 work effort represents an activity being undertaken by an existing Work Group or Board appointed committee to achieve specific objectives or to produce specific work products.

A Work Group shall consider a work effort to be a project if one or more of the following is true of that work effort:

  • involves a group outside of HL7 (may require Board approval)
  • requires external funding (may require Board approval)
  • is going to be balloted
  • requires cross-committee participation
  • is determined to be a project by the committee

An HL7 project:

  • has an objective (statement of what is going to be produced),
  • will have a finite existence (the end date to be determined by the resources available and the start date), and
  • if additional funding is required, it will have a budget (including resources and funding sources)
  • will have at least one participant available to contribute and must have a project leader, if only an interim to get the project started
  • will have at least two implementers (unless the project is intended to support the HL7 infrastructure)
  • will have an estimated schedule

Project Management Institute’s PMBOK Guide and the publication “The Fast Forward MBA in Project Management” indicate the following:

Typically, a project is a temporary endeavor undertaken to create a unique product or service.  All projects have two essential characteristics.  (1) Every project has a beginning and an end. (2) Every project produces a unique product.  HL7 also recognizes ‘Maintenance’ projects which usually repeat on an annual basis; these maintenance projects do not need to be re-submitted or have a definite end date.

Temporary means that every project has a definite beginning and a definite end.  Temporary does not necessarily mean short in duration, it just means that projects are not ongoing efforts.  Furthermore, projects involve something that has not been done before and which is, therefore, unique.

Projects shouldn’t be confused with ongoing operations.  Ongoing operations have the opposite characteristics of projects in that they have no defined end and they produce similar, often identical, products.  Examples of ongoing operations are (a) an insurance company processes thousands of claims every day; (b) a bank teller serves over 100 customers daily, providing a few dozen specific services.

The objective of a project is to attain the objective and close the project.  The objective of an ongoing operation is typically to sustain the business.

Q:  Do I need to create a Project Scope Statement if my project isn’t going through the ballot process?

A:  Yes, all projects need to have a Project Scope Statement completed and submitted to the HL7 PMO.  A lot of work done by Education, Marketing, Electronic Services, ArB, PIC, etc. does not need to go through the ballot process; however, visibility of that work is necessary.  Project Scope Statements are the foundation for communicating project information.  They also serve as a tool for Project Facilitators to gather the right information to begin a project as well as track the project’s progress.

Q:  Do I need to create separate Project Scope Statements for each Implementation Guide or other support documents?

A:  A single PSS can indicate multiple deliverables for the standard being addressed, so, no, a separate PSS does not need to be created for each Implementation Guide or support document for that standard.  Simply identify all of the Implementation Guides and documents in the Project Objectives and Deliverables section that are to be produced for the project.


Q:  I have many related projects, should I include them all within one PSS or complete a PSS for each subordinate project?

A:  The Project Services Work Group discourages creating a 'Master Project containing many subordinate projects'.  Instead, multiple individual projects should be created, using the Dependency field to refer to the other related projects.


Q:  The scope or objective of my project changed.  Do I need to create a new PSS?

A:  You may or may not have to as it depends on the change. Oftentimes, the scope or objectives of a project may change during its lifecycle, perhaps due to regulatory changes or tying back to a different standard.  When the scope changes, it is preferred that a new Project Scope Statement NOT be created.  By keeping the same Project ID, the ballot site can readily point the same project ID to both STU and Normative ballots.  

If the change in scope or objectives is minor, simply update the existing project scope statement, and within Project Insight, indicate the modifications in the appropriate fields.  You can also use the ‘Misc. Notes’ text box for documentation.

However, if the change in scope or objectives is major, the Project Facilitator should submit a new Project Scope Statement, as many of the original information won’t accurately reflect what is being done anymore.

Q:  What defines a ‘major’ or ‘significant’ change in scope?

A:  Since ‘major’ and ‘significant’ are subjective terms, examples may provide better comprehension of a “major” or “significant” change to a project scope statement. 

A “major” or “significant change” in project scope includes the following:

  • Creating a new Release of a Normative or Informative artifact (excludes STU, refer to TSC Policy and Guidance to Work Groups on STU Updates vs. STU Ballots)
  • The Project End date extends by 24+ months
  • Additional HL7 funds are required
  • The Project Intent changes (i.e. the project changes from “Revising a Standard” to “Creating a Standard”)
  • The change in scope will result in an item that qualifies as ‘substantive change’ as defined in HL7 Essential Requirements. (Normative ballot)
  • The Realm changes from ‘Realm Specific’ to ‘Universal’ (since additional project resources may be necessary to support that change)
  • The deliverable's backwards compatibility changes from ‘Yes’ to ‘No’ (excludes STU, refer to TSC guidance documents on the TSC Wiki Main Page)

Q:  What approvals are needed if I revise my existing PSS, say the project’s scope changes? 

A:  The same approval process should be followed whether it’s a new project or a scope change to an existing project.

When their is a major scope change to the project, the modified Project Scope Statement needs to go through the normal approval process (i.e. as if it were a new PSS -- the sponsoring WG, Co-Sponsors, Management Groups, US Realm, Steering Division and the the TSC). Approvals must meet the same ballot cycle deadlines as for a new project.  When the scope changes, it is recommended that a new Project Scope Statement NOT be created (use the same form as before).  Also, by keeping the same Project ID, the ballot site can readily point the same project ID to both STU and Normative ballots.  

Q:  I'm taking my project from STU to Normative or Informative to Normative, what should I do first?

A:  Prior to submitting a NIB, notify the TSC (via the TSC Project Manager) that you plan to bring something to Normative ballot by modifying Section 1 of the PSS with the following information and including the current date in the date field.  There is no need to contact the Steering Division of this action.

For existing projects, if there isn't a major change in scope, there is no need to fill out a new PSS; simply add the Normative notification date information below to Section 1 to the PSS document was previously approved by the TSC.  The TSC approval triggers a notification to ANSI of a new standard coming.  It also begins a countdown clock where the project item(s) need to complete balloting within 18 months and then be published within 12 months.

Q:  Are special considerations for FHIR projects?

A:  There is a FHIR Ballot Prep wiki page which provides guidance on ballot dates; these dates will impact the “Project Objectives/Deliverables/ Target Dates" section of the project scope statement.  Additional instructions for FHIR projects are contained in Appendix A – Instructions.

Q:  Do I need to include budget figures in my scope?

A:  Typically projects to produce standards are routinely supported by the volunteer resources committing to complete the project, and HL7 in the form of meeting rooms, conference call facilities, etc.  If additional funding is required from HL7, you must provide a budget for the project.   A proposed budget is required for any project that will be contracted, for example, website redesign.

Q:  Do I need to update the PSS if I discover after it’s approved that I need to coordinate ballots with other HL7 Work Groups?

A:  Yes, we recommend updating the Ballot Strategy section of the Project Scope Statement as well as Project Insight.  Include the ballot name and release/version your project is coordinating with.

Q:  Are there special considerations for STU ballots

A:  Refer to TSC guidance documents on the TSC Wiki Main Page for additional information on STUs available at:


Q:  When withdrawing a published standard or a standard that has gone through balloting, does a PSS need to be created and go through the review/approval process?

A:  In most cases, a PSS is not required.  However a Notice of Withdrawal of a Protocol Specification  form must be completed, approved by the Work Group and submitted to the TSC for their approval, following HL7 Essential Requirements.  This form can be found via > Resources > Templates > Notice of Withdrawal of a Protocol Specification .

In this case ‘withdrawing a standard’ refers to many things, such as choosing not to extend a standard that has reached its 5 year end-of-life or identifying the need to sunset a standard. 

A PSS does need to be created if the standard being withdrawn is intertwined/intermingled with other standards.  The PSS provides visibility so dependencies in other standards can be changed.

Q:  Do I need to go through the project approval process if a standard has expired and will not be reaffirmed? 

A:  No. When a work group has balloted a standard at STU, informative, or normative ballot, and decides the standard will be withdrawn, the withdrawal form at > Resources > Templates > Notice of Withdrawal of a Protocol Specification must be approved by the Work Group and then submitted to and approved by the TSC.

Q:  Should a Work Group create a new PSS when creating a new Release of a Standard?

A:  This is required for Normative and Informative artifacts only.  In most all cases, there will be a significant enough change in the newer Release of the Standard to warrant a new PSS.  New balloted products require a PSS, for example, adding ITS to an existing project creating a DAM (Domain Analysis Model).  Also, a new PSS helps for tracking and historical purposes, as a new PSS assists HQ in keeping a one-to-one relationship of standards to projects (refer to TSC guidance documents on the TSC Wiki Main Page for additional information on STUs; STUs do not require a new PSS for a new release).


Q:  How do I know the approval status of my project?

A:  Look up your project using the HL7 Searchable Project Database (, located on the Homepage).  The search results will reflect SD and TSC approval statuses either by reflecting the date the group approved the project or indicated ‘Awaiting Approval’ if the group has not approved the project.


Q:  I’ve submitted my PSS to my Steering Division for approval but haven’t heard anything from them.  What should I do?

A:  First, check the Steering Division’s meeting minutes.  Look to see if your project was on one of their agendas, and if so, if it was approved or the SD had further questions.  Your first point of contact with the SD should be their Project Facilitator.  If you can’t contact them, contact the Steering Division Representative and Alternate.

If the SD has approved your project, they will submit it to the TSC for approval via GForge’s tracker system.  To view which approvals your project has gathered, find your project by using the HL7 Searchable Project Database (, located on the Homepage). 

Q:  When reaffirming a standard, does a PSS need to be created and go through the review/approval process? What sections need to be filled out?

A:  Yes.  Reaffirmation of a standard requires a normative ballot.  The areas on the PSS that need to be filled out are:

  • Project Name (should be something like: Reaffirmation of Standard XYZ, Release 123)
  • Check the box labeled "TSC Notification Informative/STU to Normative" (since all reaffirmations are direct to Normative projects)
  • Primary Sponsor/Work Group
  • Project Facilitator
  • Project Scope (can be as simple as ‘Reaffirmation of Standard XYZ, Release 123’, which is expiring as of YYYY-MM-DD)
  • Project Objectives / Deliverables / Target Dates (indicate the ballot cycle that the standard will go through its Normative ballot)
  • Products
  • Project Intent (select Reaffirmation of a Standard)
  • Ballot Type (select Normative (no STU)
  • Realm
  • Approval Dates (Reaffirmation projects do need to gather the appropriate approvals -- e.g. Work Group, USRSC (for US Realm projects), Steering Division, TSC, etc.)

Q:  What ballot types are required to go through the project approval process?

A:  All ballot types (Comment-Only, Informative, Normative, STU) need to go through the project approval process, however, as identified in the Project Scope Statement, a single project can define ballot plans for multiple types of ballots for the project, for example, Comment Only > STU > Normative or Informative > Normative.


Q:  What is the approval process for HL7 projects that collaborate with ISO or the JIC?

A:  Follow the process documented on via > Participate > Balloting > HL7's Collaboration with ISO and JIC .


Q:  Do I need additional approvals when creating or modifying an HL7 Policy/Procedure/Process?

A:  Yes.  Work Groups should also have the Architectural Review Board review/approve the PSS.  Work Groups should include the ArB when sending the PSS to their Steering Division for review/approval.  For additional information on creating or modifying HL7 processes, refer to the document Introducing New Processes to HL7.

Q:  How should a Work Group document the voting results after seeking approval for the PSS?

A:  The ideal way is to post it in meeting minutes, so that they are documented and easily referenced.  If that’s not possible, an email to the Listserv will suffice.


Q:  Why does the USRSC review/approval occur before the Work Group review/approval?

A:  One of the tasks of the USRSC is to review and recommend which Work Groups are the best sponsor and cosponsors.  Hence a review by the USRSC will aid in determining these acts in a similar fashion to the International Affiliates.


Q:  Define ‘task’ and ‘activity’ as related to project management.

A:  Theoretically, ‘activity’ is the action verb within a ‘task’.  However, for HL7 projects, ‘task’ and ‘activity’ can be considered synonymous terms. 

Task/activities should be:

  • Specific - a single, well defined, discrete activity. The 8/80 is a good guideline -- no task should be smaller than 8 hours or larger than 80 hours.
  • Achievable - it should be something that can be done as a single deliverable and can be defined as being completed or done such as a document being produced.
  • Measurable - it should be an activity that can be measured such as a deliverable produced, an elapsed period of time or number of iterations

Q:  How should a Work Group document annual work/maintenance within Project Insight?

A:  A project entry should be opened in Project Insight indicating the annual work and the respective years.  This project should have a Project Status of ‘3 Year Plan Item’; note that a Project Scope Statement isn’t needed for this entry because it’s a 3 Year Plan item and only high level information is necessary.    This project can then remain ‘as-is’, or modified so it indicates accurate future years.

When the Work Group actually begins the annual work, they should complete a PSS indicating the scope of work involved and gather the necessary approvals for the PSS.  A new project in Project Insight will be created (and will have a Project Status of ‘Active Project’).  Once the scope of work has been completed for this project, it will be closed/archived.

Hence, the 3-Year Plan project always remains open; the ‘Active Project’ PSS will be the project reflecting the specific annual maintenance being done.

An example of the above situation can be found for Project Service’s annual updates to the PSS Template.  Project 531 is the 3YP entry indicating the need for the work in 2010, 2011, 2012, 2013 and beyond.  Project 581 was created to identify the specific work that would be done for the 2010 updated template.  In January, 2010, project 581 was closed because the new PSS template was released to membership, however project 531 was modified to remove references to ‘2010’ and remains open to indicate the need for the work each year.

Q:  Should a project remain open/active during its STU Test Period?

A:  Yes, it should.  This means that the project will continue to show up in the Searchable Project Database and on Project Insight reports.

Q:  Why was I asked to Disable or Enable a macro when I opened this document?

A:  This document contains a macro that, when run by the user, removes the green ‘help’ text within the template portion of this document and provides a cleaner version of their project scope statement.  To run the macro, select Tools > Macro > Macros… > Run.

Note that the macro will NOT remove the Appendices; the user must remove the Appendix verbiage on their own.

Q:  How do I search/view HL7 Projects?

A:  There are three ways to view HL7 projects, all located at > Participate > Tools and Resources > Project Management and Tracking Tools (

  1. The Searchable Project Database (, located on the Homepage and titled ‘H7 Project Database’.
  2. An Excel spreadsheet of all HL7 projects is available via GForge > Projects » TSC > Releases > HL7 Project List (
  3. Project Insight (a Project Insight User ID and Password is required – this differs from your HL7 User ID and Password). Contact the HL7 PMO for more information (  The URL is:

Q:  How can I view projects which my Work Group is a co-sponsor?

A:  Look up your project using the Searchable Project Database (, located on the Homepage).  Select your Work Group in the "Sponsor" dropdown field. The search results will reflect projects which your Work Group is sponsoring and co-sponsoring.

Q: What should I do if an approval group is unresponsive?

A: For an unresponsive co-sponsor, raise the issue to the co-sponsor's Steering Division, indicating that if the co-sponsor is unable to review the PSS in an acceptable time period (~2 weeks), that they will be removed.

For other unresponsive groups, raise the issue to the TSC.


Q:  Where can I find the Project Scope Statement Template?

A:  The most recent version of the Project Scope Statement Template (MS Word document) is located at within a Zip file at > Participate > Templates > Project Scope Statement and Project Approval Process .

Q:  Do I need to specify a Reference Information Model (RIM) version in the V3 standard I am developing?

A:  Unless specified, it is assumed that a project incorporates the current version of HL7 infrastructure (RIM, Datatypes and Vocabulary).

Project Services recommends that your Work Group’s modeling facilitator monitor proposed RIM changes that may impact the standards you are developing for the duration of your project.  The modeling facilitator can do this by subscribing to the listerv.  For more information on RIM change proposals, contact the MnM Work Group.

Q:  What do I need to do if I want a project document to be publically available outside of HL7?

A:  It’s a rare instance that a project will create and distribute a public document in accordance to the GOM’s ruling.  In the instance that a project deliverable does adhere to it, the project team will need to present a proposal to the Executive Committee to provide funding to create and distribute a document publicly.  GOM Sections 09.01(d) and 16.01 indicate that the Executive Committee determines what is publically available.  More information can be found at:

Q: Do white papers need to be balloted?

A: White papers can either be balloted informative or just reviewed/approved by the Work group.  If the Work Group wants to ballot a White Paper for publication in the Master Grid, it shall be balloted as "Informative" per the TSC, and follow the routine ballot naming convention as defined in Section 12 of the GOM.   Non-balloted Work Group level reviewed/approved white papers will not published in the HL7 Master Grid of Standards nor contain any type of ‘HL7 Stamp’. 

Q: What do I need to do to advance or move an Investigative project (PSS-Lite) to a full project?

A:  A new PSS form needs to be completed (you can use the original form since a lot of the fields will already be filled in).  The new PSS must go through the normal approval process.  The PMO will assign a new project number to it. 


Q: While in the middle of an investigative project (which used a PSS-Lite template), the scope or objective of my project changed.  Do I need to create a new PSS (using the PSS-Lite template)?

A:  No, a new PSS does not need to be created during the investigative period.  Since investigative projects are short term in nature and have the purpose of investigation, research and analysis, it’s quite likely that their scope/objectives could change as information is gathered.  Hence even if the scope’s change is ‘major’ or ‘significant’ as described above in this appendix, a new PSS-Lite template does not need to be created.

Q:  What are the Intellectual Protection requirements for protecting balloted HL7 material (Informative, DSTU, or Normative)?

A:  §16 of the Governance and Operations Manual (GOM) defines Intellectual Property restrictions.  Material that has passed ballot, and continuing for a period of 90 days from the date of publication, is restricted to HL7 International and Affiliate members (unless exception is granted per GOM §16.01.10).  During this “protected period” balloted material can be posted for “Members Only” access to, but should not be distributed to non-members, e.g. via the Work Group’s list or wiki.  For example, Work Group votes to approve ballot reconciliation January 15; editor incorporates reconciliation edits and submits for publication January 30; item approved for publication by TSC, and published by HL7 HQ February 15.  The “protected period” is from January 15 through May 15 (e.g. beginning on the ballot reconciliation approval date and concluding  90 days after the publication date).        

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