HL7_SPEC_PLCPD_R2_O1_2017SEP
HL7 Guidance: Project Life Cycle for Product Development (PLCPD), Release 2
September 2017
HL7 Comment-only Ballot
Sponsored by:
Project Services Work Group
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Table of Contents
Overview - Project Life Cycle for Product Development (PLCPD) 5
Resources 6
Project Management Approach 6
Project Life Cycle for Product Development (PLCPD) 8
HL7 Protocol Specifications (.1) 10
Resources 10
Request Decision (.2) 11
Request to enhance or create a new product (.3) 11
Resources 11
Request to withdraw product (.24) 13
Resources 13
Request approved (.25) 14
Withdraw Product (.26) 14
Resources 14
Project Initiation/Approval (.4) 14
Associated Tasks 16
Resources 17
Approval Received (.5) 18
Associated Tasks 18
Resources 18
Cancel or Withdraw Project(.6) 19
Associated Tasks 19
Resources 20
Analysis (.7) 20
Associated Tasks 20
Resources 21
Design (.8) 21
Associated Tasks 21
Resources 22
Draft Specification (.9) 22
Associated Tasks 22
Resources 23
Seek Comments (.10) 23
Comment-only Ballot (.11) 23
Associated Tasks 23
Resources 24
Determine Ballot type (.12) 24
Resources 25
Standard for Trial Use (STU) (.13) 25
Associated Tasks 26
STU Ballot (.14) 26
Associated Tasks 26
Resources 27
Trial Use (.15) 28
Associated Tasks 28
Resources 29
Informative Ballot (.17) 29
Associated Tasks 29
Resources 30
Normative or Informative (.16) 30
Finalize Specification (.18) 30
Associated Tasks 31
Normative Ballot (.19) 31
Associated Tasks 31
Resources 32
Pass (.20) 32
Resources 33
Publication (.21) 33
Associated Tasks 33
Resources 33
HL7 Protocol Specification Completed (.22) 34
Resources 34
Adoption (.23) 34
Resources 34
Appendix A – Acronyms 35
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
Overview - Project Life Cycle for Product Development (PLCPD)
The objective of the Project Life Cycle for Product Development (PLCPD) is to document the life cycle process to create and maintaindevelop Health Level 7 (HL7) Protocol Specifications from 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. In this document “Protocol Specifications” and “Product” are used interchangeably.
· 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 a 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 Iinitiation & Aapproval, pPlanning, eExecution, Mmonitoring & Ccontrolling, and Cclosing. The management of a project includes identification and documentation of requirements,; balancing stakeholder needs, /expectations,/ and concerns; and balancing 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 project scope 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,document and it is not intended to provide detailed guidance on each step in the life cycle. Instead the PLCPD , but rather refers to applicable resource documents, tools, templates, etc. which the project team canmay 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, and referencinges 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:
· StreamlinedEfficient: 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 are may be available.
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.The following sections describe the Project Life Cycle for Product Development (PLCPD), depicted as a cyclical process flow. Flowchart numbers are for reference to accompanying text and not intended to denote a strict sequential process.
HL7 Protocol Specifications (.1)
HL7 Protocol Specifications are multiple related products end-users canmay acquire to implement the an HL7 standard(s), including Fast Healthcare Interoperability Resources (FHIR®), Reference Information Model (RIM),traditional 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, Clinical Document Architecture (CDA), Clinical Context Management Specification (CCOW), 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., or projects may be introduced by stakeholders seeking to create a new Work Group to sponsor development of new Protocol Specifications
If the project plan calls for the creation of a new Work Group, the participants must prepare a Mission and Charter statement and seek appropriate approvals before moving forward.
Resources
Reference Artifact / Info/Section ReferenceHL7 Governance and Operations Manual (GOM) / · Establishing a Work Group
Agreements / List of agreements that HL7 has with various other Standards Development Organizations and other groups; agreements mustshall be HL7 Board approved.
Statement of Understanding (SOU) Template / Template to request Agreement with new group
HL7's Collaboration with ISO and 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
Work Group New/Creation Template
Work Group Mission and Charter Guidelines
HL7 Standards Master Grid / Published protocol specifications
Request Decision (.2)
Initially, and dependent on the maturity of the product/protocol specification, 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 criteria or even to determine the 'best' work group to primarily manage or sponsor the project and process.
Each project mustshall have a designated sponsoringresponsible primary sponsor/ Work Group and as well as a named project 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.input into project deliverables and may augment available resources, provide the bulk of necessary resources, or underwrite the costs associated with producing deliverables.
The PSS-Lite process may be used to charter an “investigative” project which mustshall 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.