Overview: The HL7 Project Approval Process for International Council Sponsored Projects

In summary, the HL7 project approval process is as follows:

• Step 1:  Create a Project Scope Statement (PSS)
• Step 2:  Submit Project Scope Statement to the International Council for review/approval
• Step 3:  International Council reviews/approves the Project Scope Statement
• Step 4:  PMO enters the Project Scope Statement into Project Insight
• Step 5:  Submit Project Scope Statement to TSC for review
• Step 6:  The HL7 PMO and Project Services Committee TSC insure that HL7 project methodology is adhered to 

What approvals do I need to obtain?

The table below summarizes the approvals needed based on the group sponsoring the project.

Note:  The Project Approval process for

If the Project’s Sponsor is…

Approvals shall be gathered from the following committees…

The following committees will be informed of the project…

HL7 International Council

(all project deliverables are council business and not technical in nature)

1. International Council

1. Co-Chairs
2. TSC

Work Group

(one of the project deliverables is technical in nature)

If a project deliverable is technical, then the project sponsor or co-sponsor should be an HL7 Work Group rather than an HL7 Affiliate.  The project facilitator should follow the Project Approval Process for TSC Work Groups from this point forward.  This process is located at www.HL7.org > Participate > Templates (http://www.hl7.org/participate/templates.cfm). 

1. International Affiliates
2. Co-Chairs

The groups above are communicated via TSC Update emails issued by the TSC Project Manager

PSS approvals are typically done via conference calls.  However, if desired, the approval can be through email or a poll (say, a Doodle Poll via www.doodle.com), if the Work Group, Committee, or Council has defined an e-Vote process in their Decision Making Practices.  When doing this, include the URL to the Doodle poll and indicate a deadline date for the review and approval within the email requesting review/approval.  Approvals are by simple majority vote of the approving body.

Shall / Should / May Definitions*

This describes the terminology for expressing the stringency of a conformance statement.   

Example

Required/Mandatory:    

SHALL / SHALL NOT

You SHALL clean your room before going out.

The action is REQUIRED. If the specified action is not performed, the following action is NOT allowed.

Best Practice/Recommendation:  

SHOULD / SHOULD NOT

You SHOULD clean your room before going out.

The action is RECOMMENDED or a BEST PRACTICE. This is a practice that is believed to be beneficial.

Acceptable/Permitted:     

MAY / NEED NOT

You MAY clean your room before going out.

This action is ALLOWED.This action is ALLOWED.

*Sources for the above:

• ISO/IEC Directives document - Appendix H (http://www.iec.ch/members_experts/refdocs/iec/Directives-Part2-Ed5.pdf).

• Version 3 Publishing Facilitator's Guide - Section 5.1.1 Use of SHALL, SHOULD and Other Modal Verbs (http://www.hl7.org/v3ballot/html/help/pfg/pfg.html).

Detailed Steps: The HL7 Project Approval Process for International Council Sponsored Projects

Step 1:  Create a Project Scope Statement (PSS) 

If the Project Sponsor is…

Actions

Deliverables

HL7 International Council

(all project deliverables are affiliate business and not technical in nature)

If all project deliverables are council business (e.g. translation services or regional office management), then the project sponsor should be the International Council and no Work Group needs to be specified as a sponsor or co-sponsor.

PSS completed and ready to be reviewed by the International Council.

TSC Work Group

(one of the project deliverables is technical in nature) 

If a project deliverable is technical, then the project sponsor or co-sponsor should be an HL7 Work Group rather than the International Council.  The project facilitator should follow the Project Approval Process for TSC Work Groups from this point forward.  This process is located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm). 

Project Approval Process for TSC Work Groups

Step 2:  Submit Project Scope Statement to the International Council for review/approval

Reviews should focus on the following within the PSS:

• is this PSS clear in terms of its scope and deliverable(s)
• is it within the scope of the sponsoring committee
• how is it related to other projects
• how is it related to the activities of other committees

PSS approvals are typically done via conference calls.  However, if desired, the approval can be through email or a poll (say, a Doodle Poll via www.doodle.com), if the Work Group, Committee, or Council has defined an e-Vote process in their Decision Making Practices.  When doing this, include the URL to the Doodle poll and indicate a deadline date for the review and approval within the email requesting review/approval.  Approvals are by simple majority vote of the approving body.

If the Project Sponsor is…

Actions

Deliverables

HL7 International Council

(all project deliverables are council business and not technical in nature)

The Project Facilitator shall submit the completed PSS to:

• International Council
• HL7 Project Management Office (pmo@hl7.org)

The Project Facilitator may create a Project Page on the HL7 Wiki using http://wiki.hl7.org/index.php?title=Template:Project_Page.

PSS emailed to International Council and PMO.

Project Page created on the HL7 Wiki.

TSC Work Group

(one of the project deliverables is technical in nature)

Refer to the Project Approval Process for TSC Work Groups, located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm). 

Refer to the Project Approval Process for TSC Work Groups, located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm). 

Step 3:  International Council reviews/approves the Project Scope Statement

Reviews should focus on the following within the PSS:

• is this PSS clear in terms of its scope and deliverable(s)
• is it within the scope of the sponsoring committee
• how is it related to other projects
• how is it related to the activities of other committees

PSS approvals are typically done via conference calls.  However, if desired, the approval can be through email or a poll (say, a Doodle Poll via www.doodle.com), if the Work Group, Committee, or Council has defined an e-Vote process in their Decision Making Practices.  When doing this, include the URL to the Doodle poll and indicate a deadline date for the review and approval within the email requesting review/approval.  Approvals are by simple majority vote of the approving body.

If the Project is…

Actions

Deliverables

HL7 International Council

(all project deliverables are affiliate business and not technical in nature)

The International Council (IC) shall review/approve the PSS and direct any questions / concerns to the Project Facilitator.

During their review, the IC should assess whether any project deliverables are technical in nature.  If any are deemed technical, the Project Facilitator shall return to Step 1 of the Project Approval Process and follow the TSC Work Group Project Approval Process.

IC determines if any project deliverables are technical in nature.

The Project Facilitator should attend the International Council conference call which has the PSS review on its agenda.

However, due to the size of the IC, it may be easiest for the Project Facilitator to gather review/approval via a Doodle Poll at www.doodle.com.

Project Facilitator attends IC conference call or creates a Doodle Poll.

PSS approved by the International Council.

The Project Facilitator shall resolve any questions/concerns brought forth by the International Council.

TSC Work Group

(one of the project deliverables is technical in nature)

Refer to the Project Approval Process for TSC Work Groups, located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm).

Refer to the Project Approval Process for TSC Work Groups, located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm). 

Step 4:  PMO enters the Project Scope Statement into Project Insight

If the Project Sponsor is…

Actions

Deliverables

HL7 International Council

(all project deliverables are affiliate business and not technical in nature)

PMO shall review the PSS and direct questions / concerns to the Project Facilitator.  The primary review of the PSS by the PMO is to insure the PSS is filled out completely.

The Project Facilitator shall resolve any questions/concerns brought forth by the PMO.

If updates are necessary to the PSS, the Project Facilitator shall provide an updated PSS to the following:

• International Council

The PMO shall enter the PSS into Project Insight along with any updates/approvals that may have occurred during the IC review/approval step.

PSS added to Project Insight. 

Project Insight assigns a unique Project ID.

TSC Work Group

(one of the project deliverables is technical in nature)

Refer to the Project Approval Process for TSC Work Groups, located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm). 

Refer to the Project Approval Process for TSC Work Groups, located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm). 

Step 5:  Submit Project Scope Statement to TSC for review

Reviews should focus on the following within the PSS:

• is this PSS clear in terms of its scope and deliverable(s)
• is it within the scope of the sponsoring committee
• how is it related to other projects
• how is it related to the activities of other committees

PSS approvals are typically done via conference calls.  However, if desired, the approval can be through email or a poll (say, a Doodle Poll via www.doodle.com), if the Work Group, Committee, or Council has defined an e-Vote process in their Decision Making Practices.  When doing this, include the URL to the Doodle poll and indicate a deadline date for the review and approval within the email requesting review/approval.  Approvals are by simple majority vote of the approving body

If the Project is… 

Actions

Deliverables

HL7 International Council

(all project deliverables are affiliate business and not technical in nature) 

Project Facilitator shall email the IC-approved PSS to the:

• TSC Project Manager (TSC PM)

PSS emailed to the TSC PM.

The TSC PM shall

• Create a GForge Tracker requesting the IC-approved PSS review by the TSC
• Add the PSS review to a TSC conference call agenda
• Email the IC-approved PSS to WG co-chairs and International Affiliates; include the Project Facilitator as a ‘cc’ in this email.

GForge Tracker created

The TSC shall review the IC-approved PSS and direct any questions / concerns to the Project Facilitator.

PSS reviewed by the TSC

The Project Facilitator should attend the TSC Conference Call which has the PSS review on its agenda

Project Facilitator attends TSC Conference Call.

The Project Facilitator shall resolve any questions/concerns brought forth by the TSC.

If updates are necessary to the PSS, the Project Facilitator shall provide an updated PSS to the following:

• International Council
• The PMO

Note:  Based on the updates, it may be necessary for the PSS to go through International Council review/approval again.  However, "minor" changes can be agreed on-the-spot without a cycle-back to the International Council.

Resolutions to questions/concerns and update PSS if needed.

Provide the International Council and PMO with an Updated PSS.

Upon review, TSC PM shall communicate the review via the weekly TSC update email sent to the co-chair and International Affiliates listserv. 

The TSC PM shall close the GForge Tracker.

The PMO shall update Project Insight with the review date.

PSS reviewed by the TSC

HL7 members notified.

GForge Tracker closed.

Project Insight updated with TSC review date and other modifications.

TSC Work Group

(one of the project deliverables is technical in nature)

Refer to the Project Approval Process for TSC Work Groups, located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm). 

Refer to the Project Approval Process for TSC Work Groups, located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm). 

Step 6:  The HL7 PMO and Project Services Committee insure that HL7 project methodology is adhered to

NOTE: No definable actions are documented; Project Facilitators are encouraged to attend the ‘Open Forum’ session held at the beginning of every Project Services Work Group conference call if they have any issues to discuss.  Upcoming calls can be viewed via the Project Services Work Group page on www.HL7.org.

FAQ – Frequently Asked Questions

How do I search/view HL7 Projects?

There are three ways to view HL7 projects, all located at www.HL7.org > Resources > Tools and Resources > Project Tracking Tools

(http://www.hl7.org/participate/toolsandresources.cfm):

1. The Searchable Project Database (http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm, located on the www.HL7.org Homepage and titled ‘Search current projects from Project Insight)

2. An Excel spreadsheet of all HL7 projects is available via GForge > TSC File tab (http://gforge.hl7.org/gf/).

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 (pmo@hl7.org).  The URL is: http://healthlevelseven.projectinsight.net/l.aspx?ReturnUrl=%2fdefault.aspx.

Where can I find the Project Scope Statement Template?

The most recent version of the Project Scope Statement Template (MS Word document) is located at within a Zip file at www.HL7.org > Participate > Templates > Project Scope Statement and Project Approval Process .

Who is the project facilitator?

The Project Facilitator named in the Project Scope Statement serves as the Project Lead; the 'go to' person for the project who can answer questions regarding status, scope, objectives, issues, risks, etc. regarding the project.

How do I know the approval status of my project?

Look up your project using the HL7 Searchable Project Database (http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm), located on the www.HL7.org Homepage).  The search results will reflect approval statuses by the various groups.

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

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 the Steering Division Leaders.

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 (http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm), located on the www.HL7.org Homepage). 

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

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 recommended 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.

Best practice:  Use Microsoft Word’s ‘Track Changes’ tool to highlight the changes being made to the Project Scope Statement.

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

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

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)

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

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

When the scope is changed in a project, the modified Project Scope Statement will be approved by the primary WG and the SD, providing the TSC using the same time line and deadlines as submissions for new projects.  When the scope changes, it is recommended 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.  

Best practice:  Use Microsoft Word’s ‘Track Changes’ tool to highlight the changes being made to the Project Scope Statement.

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

Projects for 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. 

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

Yes, in all cases, a new PSS should be created whenever work on a new Release of a Standard is being done and go through the appropriate approval process.  Do not modify the PSS that refers to a prior Release.  In most all cases, there will be a significant enough change in the newer Release of the Standard to warrant a new PSS.  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.

When reaffirming a standard, does a PSS need to be created and go through the review/approval process?

Yes.  Reaffirmation of a standard requires a normative ballot.

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?

Artifacts that have been balloted AND published at any level (normative, informative or STU) MUST have a PSS created and go through the review/approval process.  

Artifacts that have balloted at any level (normative, informative or STU) but were NOT published, do NOT require a new PSS be created. 

For further information, see Appendix A in the Notice of Withdrawal of a Protocol Specification template.

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

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 www.HL7.org > Resources > Templates > Notice of Withdrawal of a Protocol Specification is needed for ANSI notification and must be approved by the Work Group and then submitted to and approved by the TSC.

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?

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. 

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

Follow the process documented on via www.HL7.org > Resources > Balloting > HL7's Collaboration with ISO and JIC .

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

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.

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

Record the approval of the project team; approval shall be recorded in the Work Group’s minutes. 

What should I do if an approval group is unresponsive?

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.