HL7_SPEC_PLCPD_R2_O1_2017SEP
HL7 Guidance: Project Life Cycle for Product Development (PLCPD), Release 2
Published April, 2018
Sponsored by:
Project Services Work Group
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Table of Contents
Overview - Project Life Cycle for Product Development (PLCPD)
Resources
Project Management Approach
Project Life Cycle for Product Development (PLCPD)
HL7 Protocol Specifications (.1)
Resources
Request Decision (.2)
Request to enhance or create a new product (.3)
Resources
Request to withdraw product (.24)
Resources
Request approved (.25)
Withdraw Product (.26)
Resources
Project Initiation/Approval (.4)
Associated Tasks
Project Management:
Best Practice Recommendations:
Resources
Approval Received (.5)
Associated Tasks
Resources
Cancel or Withdraw Project (.6)
Associated Tasks
Project Management:
Resources
Analysis (.7)
Associated Tasks
Resources
Design (.8)
Associated Tasks
Project Management:
Resources
Draft Specification (.9)
Associated Tasks
Best Practice Recommendation:
Resources
Seek Comments (.10)
Comment-only Ballot (.11)
Associated Tasks
Resources
Determine Ballot type (.12)
Resources
Standard for Trial Use (STU) (.13)
Associated Tasks
STU Ballot (.14)
Associated Tasks
Resources
Trial Use (.15)
Associated Tasks
Project Management:
Resources
Informative Ballot (.17)
Associated Tasks
Resources
Normative or Informative (.16)
Finalize Specification (.18)
Associated Tasks
Normative Ballot (.19)
Associated Tasks
Resources
Pass (.20)
Resources
Publication (.21)
Associated Tasks
Project Management:
Resources
HL7 Protocol Specification Completed (.22)
Resources
Adoption (.23)
Resources
Appendix A – Acronyms
Authors
Rick Haddorff, Project Services Co-ChairMayo Clinic
Freida Hall, Project Services Co-Chair
Quest Diagnostics
Dave Hamill, Director Project Management Office, HL7 Staff / Kenneth H. McCaslin
Accenture
Ioana Singureanu
Eversolve, LLC /Department of Veterans Affairs
Bryant Johnson
LS Technologies LLC
Change History
January 2012 / Updated to include change requests from Project Services Tracker #711May 2013 / Updated to include change requests from Project Services Tracker #711
December 2013 / Updated to include edits from September WGM
November 2016 / Updated to include organization changes since last update – not published
May 2017 / Updated to include organization changes since last update and Tracker 2774
Revise approach to focus on project management requirements
July 2017 / Submit for September 2017 ballot
April 2018 / Publish including ballot reconciliation revisions
Overview - Project Life Cycle for Product Development (PLCPD)
The objective of the Project Life Cycle for Product Development (PLCPD) is to document the lifecycle process to create and maintainHealth Level 7 (HL7) Protocol Specificationsfrom the project management perspective.
“Protocol Specifications” are defined in the HL7 Governance and Operations Manual (GOM), and include the following product families developed and supported by HL7.
- Version 2
- Version 3
- Clinical Document Architecture (CDA®)
- Electronic Health Records System-Functional Model (EHRS-FM)
- Fast Healthcare Interoperability Resources (FHIR®)
- Other product families defined by HL7
In this document “Protocol Specifications” and “Product” are used interchangeably.
The PLCPD is not software or systems development life cycle methodology[1], although there are some similarities between the process for developing HL7 protocol specifications and the development of software/systems, which utilize HL7 protocol specifications.
The PLCPD focuses on project management methodology, which includes meeting project requirements through planning, organizing, measuring, controlling and reporting. Best practices within traditional project management methodology list five main phases that include initiation & Approval, Planning, Execution, Monitoring & Controlling, and Closing. The management of a project includes identification and documentation of requirements; balancing stakeholder needs, expectations, and concerns; and managing competing constraints (scope, quality, schedule, budget, resources, and risk). Within each project phase, tasks are defined to move from one phase to another until the defined projectscope and project deliverables are met and the project is closed, as described in the PLCPD.[2]
Figure 1
The PLCPD is a high level overview document and is not intended to provide detailed guidance on each step in the life cycle. Instead the PLCPD refers to applicable resource documents, tools, templates, etc. which the project team may reference at each step of the life cycle, if needed.
Resources
Reference Artifact / Info/Section ReferenceHL7 Governance and Operations Manual (GOM) /
- Protocol Specifications[3]
HL7 Essential Requirements (ER)
Project Management Approach
HL7’s approach for the development of new products and management of existing products values the volunteer culture, and provides appropriate processes and tooling to support project management. The PLCPD sets forth the framework for project management activities referencing principles from the Project Management Institute’s (PMI) Project Management Body of Knowledge (PMBOK).
Within the HL7 volunteer culture there are other factors that impact the project management approach, including:
- Efficient: The approach endeavors to support macro- rather than micro-management. HL7 has neither the need nor the resources to micro-manage projects. Additionally, the volunteer culture does not lend itself to micro-management. Some projects may be funded and include funding for management of the project. As indicated in the following sections, certain life cycle steps such as project initiation require the capture of specific criteria that need to be tracked and monitored (schedule, resources, objectives/outcomes, etc.) in order to measure progress and evaluate status.
- Supportive: Because project management skills are not always readily available in the HL7 community, the project management approach endeavors to minimize work requirements on the project team. Staff consulting resources for project management may beavailable.
Project Life Cycle for Product Development (PLCPD)
The following sections describe the Project Life Cycle for Product Development (PLCPD), depicted as a cyclical process flow. The flowchart is not intended to denote a strict sequential process. Decisions are diamond shape in the graphic; everything else is a process.
Numbers contained on this flowchart are for identifying accompanying sections of text within this document and are not intended to represent a formal process flow as typically used in IT development.
HL7 Protocol Specifications (.1)
HL7 Protocol Specifications are multiple related products end-users may acquire to implementan HL7 standard(s), includingFast Healthcare Interoperability Resources (FHIR®), Reference Information Model (RIM),Messaging Specifications (V2, V3, as well as FHIR®),Clinical Document Architecture (CDA), Clinical Context Management Specification (CCOW), Arden Syntax,Implementation Guides (for all standards, e.g., LOI for V2, or C-CDA for CDA), Extensible Markup Language (XML) schema, Service Specifications (SOA),etc. Published artifacts are listed in HL7’s Master Grid of Standards.
Feedback from user experience and identification of new requirements or opportunities may result in requests to enhance or create protocol specifications. Some projects may result from collaborative agreement with external organizations.
Resources
Reference Artifact / Info/Section ReferenceAgreements / List of agreements that HL7 has with various other Standards Development Organizations and other groups; agreements shall be HL7 Board approved.
Statement of Understanding (SOU) Template / Template to request Agreement with new group
HL7's Collaboration with ISOand JIC / Process for collaborative projects with International Organization for Standardization (ISO) and the
Joint Initiative Council (JIC)
JIC includes other SDOs: ISO (TC 215), CEN(TC 251), GS1, CDISC, IHTSDO,
HL7 Organizational and Process Introduction / Tutorial slides explaining HL7 organization
HL7 Standards Master Grid / Published protocol specifications
Request Decision (.2)
Initially the project team decides whether they are creating a new product, enhancing an existing product, or withdrawing a product.
Request to enhance or create a new product (.3)
To initiate a project to create or enhance a protocol specification the interested stakeholders approach the appropriate Work Group (WG) to prepare a Project Scope Statement (PSS) that describes the project's scope, justification, and benefits while identifying intended deliverables, project sponsors and co-sponsors, possible implementers, timeline, and planned ballot schedule. This may involve iterative negotiations to complete a PSS that meets established criteriaor even to determine the 'best' work group to primarily manage or sponsor the project and process.
Each project shall have a designated sponsoring Work Groupas well as a namedproject facilitator, while it may have additional Work Groups as co-sponsor. The sponsor has the responsibility to ensure the appropriate processes are followed and that there is transparency into the process. They have final approval of the deliverables.
The PSS-Lite process may be used to charter an “investigative” project which shall be completed or withdrawn after two Working Group Meeting (WGM) cycles. This allows project sponsors time to socialize the project, gather support and requirements to either charter as a full project, or withdraw.
Resources
Reference Artifacts / Info/Section ReferenceProject Management and Tracking Tools: HL7.org > Resources > Tools and Resources > Project Management and Tracking Tools / Multiple project management resources, templates, webinars, etc.
Project Scope Statement Template with Instructions / PSS-Lite instructions and FAQ covering most project questions included in this version of the PSS.
Project Insight ( Work Group Co-Chairs have log in info) / HL7’s project management tool.
Project Insight Tip Sheet / Helpful information for using the Project Insight tool.
HL7 Searchable Project Database / Alternate method to search HL7 projects, updated approximately every two weeks.
Link to Excel Spreadsheet of HL7 Projects / Alternate method to search HL7 projects, updated approximately every two weeks.
Recorded Webinar: HL7 Project Management Tool Overview for HL7 Project Facilitators / Webinar intended for co-chairs and those leading HL7 projects (i.e. Project Facilitators). This webinar demonstrates HL7 project tools including Project Insight (HL7’s primary project repository), the HL7 Searchable Project Database, GForge, as well as review HL7 project processes and methodologies.
Director, HL7 Project Management Office (PMO) / HL7 Staff managing HL7 projects.
Introducing New Processes to HL7 / If the project results in a new process, this document defines the approval and adoption methodology.
Technical Steering Committee (TSC) / The TSC Leadership webpage provides a list of each Steering Division (SD) and SD Co-chair contact information.
The Overview on each SD webpage provides a list of Work Groups in the SD:
- Domain Experts
- Foundation and Technology
- Structured and Semantic Design
- Technical and Support Services
Request to withdraw product (.24)
Product Management or project sponsors, including the sponsoring Work Group, may call for the withdrawal of a protocol specification; the request to withdraw must be initiated and approved by the sponsor Work Group. This includes withdrawing content that has been published but may be outdated, for example replaced by a newer protocol specification. The Work Group shall follow the process defined in the “Notice of Withdrawal of a Protocol Specification” template.
NormativeAmerican National Standards Institute (ANSI) approved American National Standards (ANS) that have not been enhanced or otherwise maintained or updated over a five year period are subject to reaffirmation or withdrawal.In this case “withdrawing a standard” refers to choosing not to extend a standard that has reached its 5 year end-of-life, or identifying the need to withdraw a standard.
Normative ballotprojects may be discontinued as specified in theHL7 ER; Work Group and TSC approval is required.
A PSS is recommended ifthe standard being withdrawn is intertwined/intermingled with other standards. The PSS provides visibility so dependencies in other standards may be addressed.
Resources
Reference Artifact / Info/Section ReferenceHL7 Governance and Operations Manual (GOM) / Withdrawal of an Informative Document.
HL7 Essential Requirements (ER) / Discontinuance of a Standards Project
Withdrawal of an HL7 American National Standard (Normative).
ANSI Essential Requirement / ANSI Essential Requirements: Due process requirements for American National Standards; contains the procedures that govern the American National Standards (ANS) process.
Notice ofWithdrawal of a Protocol Specification / Template to request withdrawal.
Request approved (.25)
The Technical Steering Committee (TSC)shall vote to approve; if applicable, the applicable Product Family Management group approves prior to TSC review.
Withdraw Product (.26)
With the approval to withdraw a protocol specification the responsible Work Group shall:
- Prepare a time line for withdrawal of the protocol specification.
- Prepare an announcement of the action to withdraw the protocol specification.
- Identify where the withdrawn artifacts will be archived.
- Implement the withdrawal plan.
- In the case of an American National Standard, HL7 Headquarters will notify ANSI of the withdrawal of the standard.
- Complete any open tasks in the “Notice of Withdrawal of a Protocol Specification” template.
Resources
Reference Artifact / Info/Section ReferenceNotice of Withdrawal of a Protocol Specification / Template to request withdrawal.
Project Initiation/Approval (.4)
Project initiation isa fundamental step in defining a project to develop an HL7 protocol specification. Project initiation and the subsequent ongoing project management helps ensure the entire HL7 community may track what specifications are developed and how they are progressing.
The PSS identifies the business need that the project addresses and includes a high level description of the project. The PSS is a communication tool that enables HL7 to optimize its collective effort. The objectives are to avoid any duplication of effort, encourage collaboration in areas of common interest and ensure resulting specifications contribute to a coherent approach across all HL7 products.
The initiation phase further refines the project by elaborating on the scope, deliverables, and objectives established in the PSS, and providing quantifiable measures of success. Project success is defined as the achievement of predefined objectives through the production of deliverables within the boundaries established by project scope. The necessary resources and commitment by stakeholders and participants shall be in place to assure success.