Project Scope Statement Purpose:
This Project Scope Statements is intended for products used outside HL7, such as projects to produce standards or Implementation Guides. Infrastructure projects (the RIM, HL7 maintained vocabulary, wrappers, and methodology) should also use this scope statement but are not required to complete all sections as noted in the instructions.
The objective of this template is to communicate the type of activities a group is undertaking to achieve specific objectives or to produce specific work products. Project Scopes should provide sufficient information to allow inexperienced individuals to anticipate what a group is working on and decide if they wish to become involved. Project Scope statements should also assist committee chairs to manage the workload of the committee and help to set priorities and recognise inter-dependencies with the work of other committees.
The Steering Divisions, TSC, and other appropriate approval bodies, as defined by the HL7 organization and Project Approval and Initiation Process, review and approve the project request. This includes analysis to avoid project overlaps or dependency gaps. A project not aligned with HL7 strategies established by the HL7 Board, or requiring extensive resources may not be approved. A “hosted” project (funded by an external source) may be approved as long as the sponsors provide adequate resources and the project is not detrimental to HL7 strategy; funding may be in the form of resources or financial support, grants, etc.
The HL7 Project Management Office (PMO) will review project statements to ensure the names and descriptions are clear and unambiguous across all projects and that required information is provided so as to obtain project approval.
Project Insight Note:
The following instructions indicate how the information in this form is mapped to certain fields in Project Insight’s project description form. The fields are mapped to specific fields in the project description form available in Project Insight: http://healthlevelseven.projectinsight.net/Login.aspx?ReturnUrl=%2fdefault.aspx
If you need system login setup for Project Insight, contact the HL7 Director of the Project Management Office at firstname.lastname@example.org
Recommendation for Non-infrastructure Projects:
The HL7 Product Lifecycle recommends ballots proceed through Informative à STU à Normative phases, however, HL7 policy allows projects to proceed to normative ballot without an Informative or Draft Standard for Trial Use (STU) in special circumstances, such as such the need to respond to government mandate or resolve a critical issue raised by a stakeholder or noted in an existing American National Standard. Bypassing the Informative and/or STU ballot must be approved by the TSC. Refer to the HL7 Governance and Operations Manual Section 13 – Review Ballot and HL7 Essential Requirements.
Project Name and ID
The name should be concise, based on the objective and unique among all other projects the group takes on; refer to GOM §12.02 Naming Convention for naming convention guidance.
Project Insight: Enter into “Name”.
Project ID: A project ID will be assigned by Project Insight
TSC Notification Informative/STU to Normative: The Project Facilitator shall complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative” and send the PSS to the TSC (via the TSC Project Manager). It is not necessary to notify the Steering Division (SD) Co-Chairs to seek re-approval unless there has been a “major” or “significant’ change in the project scope (as described in the FAQ section). Since the projected project/ballot dates often change during the course of a project, TSC notification that the project is moving to a normative state is required to fulfill ANSI Project Initiation Notification (PINS) reporting requirements. Please refer to the HL7 Governance and Operations Manual and ANSI Essential Requirements for more detail. Project Insight: Enter into “Misc Notes”.
Sponsoring Group(s) / Project Team
Primary Sponsor/Work Group (1 Mandatory): Every project must have only one project sponsor and at least one project facilitator; a multi-disciplinary project team is recommended, e.g. domain expert, UML modeling facilitator, HL7 modeling facilitator, requirements process facilitator, data analyst facilitator, business requirement analyst. Sponsorship may be in the form of resources or funding. Project Insight: Enter into “Sponsor(s)”.
|Co-Sponsor: When Co-sponsor Work Groups are defined, the Primary Sponsor/Work Group shall negotiate with the Co-Sponsor Work Groups the extent of their involvement; this task may be assigned to the Project Facilitator. Examples of negotiated agreements:· Request formal content review prior to ballot· Request period project updates, specify period (for example, monthly, at trimester Working Group Meetings, etc)· Other agreementsProject Insight: Enter into “Co-Sponsor(s)"|
|Project Facilitator (1 Mandatory): This is mandatory for all projects and should be the contact person if there are questions about the Project Scope Statement. The Project Facilitator 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. Additional definitions of Project Facilitator responsibilities are at: http://gforge.hl7.org/gf/project/psc/docman/Project%20Facilitator%20Responsibilities. Project Insight: Enter into “Project Facilitator”.|
Other Interested Parties: This section should also describe other ‘interested parties’, e.g. anticipated interactions with other committees or other projects.
Examples of anticipated interactions that must be negotiated in advance:· Request content review prior to ballot· Request period project updates, specify period (for example, monthly, at trimester Working Group Meetings)· Other agreements
Facilitators: Modeling, Publishing, and Vocabulary facilitators are formal roles recognized by HL7, and highly recommended as project participants. If your project has not filled this role, please indicate a contact person for the role, for example, your project may not have a formal vocabulary facilitator but a committee participate has volunteered to serve as liaison with the Vocabulary Committee. .Descriptions of facilitator roles and their responsibilities can be found on the HL7 Wiki via PIC's Find or Be a Volunteer for an HL7 Work Group .
Infrastructure projects, for example, the RIM, HL7 maintained vocabulary, wrappers, and methodology are required to name only the Primary Sponsor and Project Facilitator.
Implementers (2 Mandatory): If this project will produce a standard, identify at least two implementers who agree to implement a STU prior to normative ballot (this is a non-binding agreement). Contact information is mandatory. The intended implementers must be identified at project initiation; however, it is a non-binding agreement. Refer to explanation of Candidate Standard validation below for additional information. Project Insight: Enter into “Project Implementers”.
Candidate Standard validation
Candidate Standard validation
Executing the Candidate Standard validation approach. HL7 will have a modified open approach to candidate standard validation. All those participants that made a non-binding commitment when the project was initiated will be included if they choose to honor the commitment. Others may be added to achieve a balance or for other necessities for validation. The previous notwithstanding, HL7 will limit the number of participants to ensure a manageable process and reasonable time frame.
Candidate Standard validation approach
A project step that ensures that the Candidate Standard is validated by external industry resources before it is finalized as a normative standard. Where the standard is for interoperability, it is expected that the validation will include at least two independent entities (vendors, user organizations, etc.) building trial implementations and testing them together. Where the standard serves another purpose the validation approach will involve a trial effort to use the draft standard in the manner for which it was created.
At the planning stage the entities willing to test must make a non-binding declaration of their intent to participate in validation. Without such a declaration the project should not be initiated.
Comment: This is expected to be a significant hurdle for new project initiation. At the same time it helps to assure that HL7 member resources will be concentrated on efforts that have a greater likelihood at industry adoption.
Project Definition / Project Scope
The detail should be sufficient that an individual with no previous exposure to the group (or even HL7) could understand the expected activities and results. The scope description should also include high level expectations for the project and indicate alignment with market demands or other drivers for the project, such as government mandates, requirements from industry interoperability connectathon, etc. Also include if the project is abandoning or replacing anything, as well as if the deliverables are applicable to multiple realms. Be sure to spell out all acronyms which the HL7 community is not familiar with as these are carried forward to the NIB (Notice of Intent to Ballot) for ballot announcements.
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, you must provide a budget for the project. A proposed budget is required for any project that will be contracted, for example, website redesign or tooling development.
Project Insight: Enter into “Description”.
FHIR Project: This project will identify and define the initial set of “key” FHIR resources related to the domain of Your domain name. These resources will be defined using the available FHIR tooling and in accordance with documented quality guidelines and balloted as part of the initial FHIR specification. Expected FHIR resources to be produced include: List expected resource names (need not be all and need not be pre-approved).
In addition, as the committee deems appropriate and time availability permits, it will define a small number of FHIR extensions relevant to domain content and expected to be necessary to support consistent early implementations.
Explain the reason behind the need for this project. This may be related to legislative requirements, industry needs or similar justifications.
This section must be completed for projects containing items that are expected to be ANSI approved, as it is an ANSI requirement for all ballots. The information will be used in the NIB form.
Project Insight: Enter into “Project Need”
FHIR Project: FHIR is a major new initiative by HL7 intended to significantly speed and enhance interoperability between healthcare systems. The FHIR methodology is dependent on the existence of a number of discrete data structure definitions called “resources”. This project will create the set of essential resource definitions related to the domain of Your domain name here.
If the project is creating implementation/executable deliverables, the Work Group will need to do a Security Risk Analysis prior to submitting a publication request. The Yes/No/Unknown checkbox is informative; changing the response does not require submission of a new scope statement. Updates to the project artifacts in subsequent projects may not require a new security risk assessment with each updated publication, but an umbrella assessment for the standard or for a product family may be required.
Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment.
Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project. These drivers typically stem from other SDOs or governmental agencies or initiatives.
Project Objectives / Deliverables / Target Dates
Enter a list of objectives the project is trying to meet. If the project is to develop one or more work products, the work products’ descriptions should be clear, concise and unambiguous. Work products intended to produce a standard should be in terms of the deliverables:
· new elements methodology (e.g. a new way of deriving message specification from a in information model)
· new interface specification for services or application roles
· new functional models
· new message specification (e.g. a new message structure that refers a the state transitions of a new type of clinical act)
· new standard profiles (e.g. CDA implementation guide)
· new terminology subsets or mapping
· new tools intended to improve productivity and support the methodology
In those cases where the objectives are not work products, they should be described so that an outside observer can answer “yes” or “no” to the question “has this objective been met?”
As the project progresses, objectives and work products can be refined. Target Dates may be updated and typically do not require re-approval unless a major change occurs as defined in the FAQ.
Projects that have more than one work product to deliver should list each work product’s expected delivery date, taking into consideration expected dependencies among work products.
Project Insight: Enter into “Pjt Objectives and Deliverables”.
Exact dates are not needed.
Enter in WGM or ballot cycle format, e.g. : ‘2010 Sept WGM’ or
‘2010 Jan Ballot’.
Target dates in Project Insight are only provided in the above format.
Target dates can be updated.
Example of Objectives / Deliverables / Target Dates:
The following attempts to convey how to identify various objectives /deliverables and their target dates.
Objective / Deliverable
Complete analysis, design, draft specification work on Standard XYZ
2009 May WGM
Submit for STU Ballot (First Ballot Cycle)
2010 May Ballot/ WGM
2010 May Ballot/ WGM
Submit for 2nd STU Ballot
2010 Sept Ballot/ WGM
Request TSC Approval for STU publication
2011 Jan Ballot/WGM
STU Period – 12 months
Jan, 2011 – Jan, 2012
Submit Implementation Guide for Informative Ballot
2011 Jan Ballot/ WGM
Reconcile Informative Ballot
2011 May Ballot/ WGM
Submit Publication Request for Implementation Guide
2012 Sept Ballot/ WGM
Submit Standard XYZ for Normative Ballot
2012 May Ballot/ WGM
Reconcile from Normative Ballot
2012 Sept Ballot/ WGM
Submit Publication Request
2013 Jan Ballot/ WGM
ANSI Approves Standard XYZ
2013 May Ballot/ WGM
Close Project (project end date)
2013 May Ballot/ WGM
FHIR Project: The artifacts produced by this project will be balloted as part of the FHIR STU project (Project Insight ID TBD).
Refer to FHIR Ballot Prep wiki page for additional information and dates
Common Names / Keywords / Aliases
List all common names, aliases, alternative names and keywords related to the product(s) this project is producing.
Common Name - this would be the 'familiar name' or a 'convenience name' of a product, used in place of long and unwieldy names.
Keyword - Any words that would assist a user when searching for the product
Alias - This would be the "also known as" name, or a slant term, or even the old name before it become formal
Project Insight: Enter into “Common Names / Keywords / Aliases"
To assist with ballot documentation and cross referencing, for any project creating a subsequent release of a product (i.e. Release 2 or 'higher'), indicate the name of the prior product and if it's supplanting, replacing or coexisting with a previous release.
Project Insight: Enter into “Lineage"
This section is not required for Infrastructure Projects.
The dependency may be the work of another project undertaken by this group or by another group. Anticipating dependencies can allow groups to coordinate their effort to ensure the overall objectives of HL7 can be met. An example of a dependency is: The CDA ballot needed the Data Types produced by Infrastructure and Management Project to be through ballot before the CDA ballot could be finalised.
Project Insight: Enter into “Pjt Dependencies”.
Project Document Repository Location.
Indicate where one can go to find deliverables/documents created by the project team by entering the EXACT URL(s) where one can go to find deliverables, documents, artefacts created by the project team for this project. The URL could point to the HL7 Wiki, TSC Wiki, GForge, Project Insight, etc. A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page
The following summarizes the TSC's guidelines for project document repository locations (these were approved on 2016-04-04):
1. HL7 Projects and External Projects with no formal agreement
a. From the point at which material is ready for ballot all work products SHALL be maintained on HL7 managed platforms.
b. Work groups SHALL maintain all of their development material on HL7 managed platforms so that backup and long-term availability is maintained.
c. Any deviations SHALL require approval by Electronic Services and Tools WG.
2. External projects when formal agreement(s) exist between HL7 and the external organization on document location e.g. National Council for Prescription Drug Programs, (NCPDP)
a. Material SHALL exist at the location defined in the agreement
b. HL7 Participants SHALL have access to the material(s).
3. Work groups SHALL publish the location of their documents on their webpage (which may point to their wiki).
Project Insight: Enter into “Project Document Repository”.
Indicate the backward compatibility of the expected project artefacts/deliverables, if known. Refer to the Product Family definition of backward compatibility for additional constraints.
Project Insight: Enter into “Backward Compatibility”; enter additional information into ‘Misc. Notes’.
FHIR Project: Mappings between existing static models and created resources may eventually be defined, but this work is out of scope for this project.
TSC position statement on new projects using R2B
· HL7's primary specification for Data Types to be used in Interoperability is "HL7 Version 3 Standard: Data Types - Abstract Specification, Release 2" Any specification, other than HL7 Version 2 is expected to use or base its data types on this specification (which is also an ISO standard).
· In order to facilitate selected applications originally implemented in Release 1 of this standard, the Implementation Technology Specification Work Group, created an implementation specification "HL7 Version 3 Standard: XML Implementation Technology Specification - Data Types - Abstract DT R2 Implemented in Wire Format Compatible With DT R1, Release 1" This specification is known in short-hand as Data Types R2B.
· The purpose of this specification was to support active projects, with functioning implementations that originated in the R1 data types. Future use of the "R2B" Implementation Technology is limited to projects that:
a) Were originally developed AND implemented in DT R1
b) Are being corrected or extended in the same functional space for use by the original community of implementers.
c) Whose use of the R2B specification is noted in the Project Scope Statement - "Does this project seek to use ITS R2B or its Datatype representations?"
d) Have received permission from the TSC for such use of R2B
If the project will reference any external vocabularies, for example SNOMED, LOINC, ICD-10, list the external vocabularies.
Product(s): Indicate the associated Product line(s); check all that apply. Additional information regarding HL7 Products is available at www.HL7.org > Standards > Introduction. For additional information on creating or modifying HL7 processes, refer to the document Introducing New Processes to HL7 posted in the Standards Master Grid.
By selecting the checkbox for "Creating/Using a tool not listed in the HL7 Tool Inventory" (located at HL7.org > Resources > Tools and Resources), it will assist the Electronic Services and Tools Work Group to keep the HL7 Tools and Services Inventory up to date.
Project Insight: Enter into “Product Type”.
Indicate if/how this project affects a standard or HL7 policy/procedure/process.
The GOM is available at: http://www.hl7.org/documentcenter/public/membership/HL7_Governance_and_Operations_Manual.pdf).
The HL7 Essential Requirements are available at: http://www.hl7.org/documentcenter/public/procedures/HL7_Essential_Requirements.pdf.
If the Work Group wants to ballot a White Paper for publication in Master Grid, it shall be balloted as "Informative" per the TSC, and follow the routine ballot naming convention as defined in Section 12.02 of the GOM. Non-balloted Work Group level white papers still require normal PSS approval and are not published in the HL7 Master Grid of Standards. The template for non-balloted WG White Papers is posted at: http://www.hl7.org/permalink/?WGWhitePaperTemplate.Project Insight: Enter into “Project Intent”.
FHIR Project: Resources will be published as part of the FHIR STU ballot
If applicable, indicate the type of balloting the deliverables will go through. Additional information in determining the correct ballot strategy can be found in the Technical Steering Committee (TSC) Guidance on Ballot Levels. TSC also offers guidance on balloting and re-balloting. Project Insight: Select a value from the “Type” dropdown.
FHIR Project: This project will not ballot directly. Instead, content will be combined with resources from other committees and jointly balloted as part of the FHIR STU ballot (managed as a distinct TSC project).
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 to for the PSS to receive TSC approval.
Project Insight: Enter into “Joint Copyright”.
- Project Logistics
- External Project Collaboration Click here to return to this section in the template above.
Include SDOs or other external entities you are collaborating with, including government agencies. Indicate the nature and status of the Memorandum of Understanding (MOU) if applicable.
Agreement Status: Memorandum of Understanding (MOU) or Associate Charter Status types are: Negotiating or signed (please indicate the date signed.) Leave blank if there is no agreement in place. Refer to http://www.hl7.org/about/agreements.cfm for a current listing of HL7’s agreements.
Project Insight: Enter into “Collaboration Efforts”.
FHIR Project: In producing resources, the committee will consult specifications from a wide variety of external organizations, including OpenEHR, IHE, various affiliates, government organizations and other SDOs. However, this consultation will not require direct interaction with these other organizations. (Though some may be involved in the ballot review process.)
Feel free to note specific additional collaborations you intend to use in the development of your resources if applicable.
Indicate whether the project is applicable globally (universal), or intended for a specific country or region (realm). Note that Non-US realm project scope statements should be directed to the appropriate HL7 Affiliate.
Projects meeting one or more of the following guidelines are candidates for being universal realm projects.
· Stakeholders representing 2 Realms at a minimum, where stakeholder should be interpreted as a specific group or organization listed in the External Project Collaboration section or the Stakeholders / Vendors / Providers section of the project scope statement
· Requirements coming from a minimum of 2 Realms
· Project will be implemented in a minimum of 2 Realms
· Minimum of 2 Realms represented on project team
Also note that if the Realm changes from ‘Realm Specific’ to ‘Universal’ additional project resources may be necessary to support that change. This is considered a ‘significant’ or ‘major’ change and should go through the project approval process as a Universal Realm project.
If a project is initially proposed as "Realm Specific" but the Work Group participants vote to change the realm to "Universal", the Work Group members supporting "Universal" for use in their country must designate a representative team member (within “Other Interested Party” in the PSS) to participate in the project to insure their requirements are met. Note this is not applicable to Investigative projects (aka PSS-Lite)
If applicable, check the box to indicate that the standard balloted or was previously approved as realm specific standard.
For projects producing both universal and realm specific deliverables, document those details here (specify which deliverables are Universal and which are Realm Specific).
Project Insight: Enter into “Realm” and “HL7 Affiliate” (if applicable).
Stakeholders / Vendors / Providers
This section must be completed for all projects. It is used to determine if a project is a ‘US Government Interest’ project. It also is an ANSI requirement and is included in the NIB form.
Indicate the associated stakeholders, vendors and providers for which this project is intended. Check all that apply.
Project Insight: Enter into “Stakeholders / Vendors / Providers”; enter additional information into ‘Misc. Notes’.
Project Approval Dates
Approvals are by simple majority vote of the approving body.
Sponsoring Work Group Approval Date: The date the sponsoring Work Group approved the project. Following Work Group Approval, forward the PSS to the PMO (email@example.com):
Co-Sponsor Group Approval Date(s): The dates that each of the co-sponsors approved the project.
Project Insight: Select appropriate dropdown value.
US Realm Steering Committee (USRSC) Approval Date: Forward the PSS to the TSC Project Manager and request a time to review the project with the US Realm Steering Committee (USRSC).
Affiliate Approval Date: The date the sponsoring HL7 Affiliate approved the project. Following Affiliate Approval, forward the PSS to the PMO (firstname.lastname@example.org):
SD Approval Date: The date the sponsor’s Steering Division approved the project. When multiple WGs co-sponsor a project, it’s the “Primary Sponsor/Work Group” Steering Division that must approve the project. Project Insight: Enter into “SD Approval Date”.
The "PBS Metrics Reviewed?" checkbox is a reminder for the Steering Divisions to look at the Work Group’s PBS Metrics during their SD review process to insure that the Work Group has the bandwidth to take on additional project work.
PBS Metrics Reviewed? (required for SD Approval): Additional information regarding this task can be found via www.HL7.org > Resources > Tools and Resources > Project Management and Tracking Tools > Guidance for Steering Division Co-Chairs to Evaluate Work Group Capacity to Undertake New Effort
ARB Approval Date: Submit your PSS for ARB approval when creating or modifying an HL7 Policy/Procedure/Process or content is being externally developed. 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.
Joint Copyright Letter of Agreement received? (req'd for Joint Copyrighted material): When the Joint Copyright box is checked; a Joint Copyright Letter of Agreement that contains the verbiage outlined within the SOU must be signed by both parties and submitted to the TSC in order for the PSS to receive TSC approval.
TSC Approval Date: The date the Technical Steering Committee approved the project. Project Insight: Enter into “TSC Approval Date”.