Recommendation: HL7 will implement a new business model ...
HL7 STRATEGIC INITIATIVES
AND
IMPLEMENTATION PROPOSAL
July 26, 2006
TABLE OF CONTENTS
Executive Summary 4
Methodology 7
Strategic Initiatives and Proposed Implementation 8
New Business Model and Organizational Structure 8
Task 8
Rationale 8
Implementation Actions 9
Organization Structure 9
Executive Staff 9
Board of Directors 10
Technical Directorate 11
Technical Steering Committee 13
Internationalization 13
Membership 14
Voting on Standards 15
Meetings 15
Voting for HL7 Elected Positions 15
New Business Model 15
Financial Plan 16
Product and Services Strategy 17
Task 17
Rationale 17
Implementation Actions 17
HL7’s Products 18
Optimize Volunteers and Resources 19
Task 19
Rationale 19
Implementation Actions 19
Brand Hierarchy and Communications Strategy 21
Task 21
Rationale 21
Implementation Actions 22
Staffing 22
HL7 Brand 22
Website 23
Outreach 23
Education 26
Product-oriented Project Management Approach 27
Task 27
Rationale 27
Product-Project Lifecycle and Criteria for Proposing, Approving and Executing Projects 28
New Project Management Approach 39
Product-Project Lifecycle Task Force 40
Tooling Support of Project Activities 41
Quality Testing 42
Task 42
Rationale 42
Elements of Quality Testing 42
Quality Testing Measures 43
Evaluation Against Success Criteria 43
QC Process to Leverage Best Practices 43
Appendix 1: 45
Strategic Initiative Task Force 45
Implementation Actions Subgroups 45
New Business Model and Organizational Structure 45
Product and Services Strategy 45
Communications and Branding 46
Productivity Management and QC 46
Methodology 46
Appendix 2: New HL7 Global Organizational Chart 48
Appendix 3: Organizational Changes: New Functions 49
Appendix 4: Revenue Model and Business Plan 51
Appendix 5: Proposed Increase in Membership Fees 53
Appendix 6: Initial Thinking on Product and Services Strategy 57
Initial Product and Services Strategy 57
Product Vision 58
Elements of Product Strategy 58
Elements of Services Strategy 59
Strategic Issues to Address 59
Appendix 7: Branding and Communication Implementation Activities 60
Appendix 8: Project Lifecycle on HL7 Products 62
Product Sunset 64
Executive Summary
In 2005 HL7 was approached by the Robert Wood Johnson Foundation (RWJ) with a proposal to fund a project with the objective of improving the efficiency of the standards development process in our organization. The HL7 Board of Directors (BoD) quickly recognized that the RWJ proposal represented an opportunity to get a new perspective on the HL7 organization and process. A Request for Proposal (RFP) was released and HL7 leadership selected a team of consultants, headed by Cherri McGrew, to lead the project.
The team met with the BoD at their annual retreat in August 2005 to set the objectives for the project. Termed the Strategic Initiatives Project, its purpose and focus was established through discussion with the BoD and the external Advisory Committee. It was determined that to position HL7 for success in the future it would be necessary to restructure the organization to:
➢ More efficiently and expeditiously develop standards,
➢ More effectively address long-term strategic objectives, and
➢ Support its role at the international and affiliate level in an increasingly crowded standards/interoperability space
while maintaining the organization’s essential characteristics: open membership, consensus-based standards development, democratic election of leadership, and not-for-profit status.
The BoD approved the formation of a Strategic Initiatives Task Force (SITF) to work with the consulting team to develop a viable strategic plan including provisions for its announcement and implementation. The SITF was drawn from a broad spectrum of membership domains and functional areas. Task Force members are identified in Appendix 1.
Over the past eleven months the SITF, supported by the McGrew team, has completed significant outreach to the healthcare community; interviewed members and non-members, and collected data via an online questionnaire. From the information gathered the SITF formulated a set of strategic issues that, through a series of meetings and teleconferences, were eventually honed into seven strategic recommendations with key areas for consideration. These initiatives were presented to the BoD in March 2006 and subsequently adopted as the basis for the following proposal.
STRATEGIC INITIATIVES
• HL7 will implement a new business model and organizational structure.
• HL7 will formally approve a product and services strategy that is reviewed annually by the Board of Directors.
• HL7 will optimize the effectiveness of its volunteers and other resources.
• HL7 will develop a brand hierarchy that helps the marketplace understand the relationship of its products to each other and to the overall organization.
• HL7 will develop consistent organizational messages and a communications strategy to disseminate those messages.
• HL7 will implement a product-oriented project management approach to ensure development of high-quality standards and associated products in a committed timeframe.
• HL7 will ensure that all standards undergo quality testing at key stages of the development process.
Implementation of these initiatives will begin in August of 2006. Key activities have been identified for each strategic initiative and are presented in this report.
IMPLEMENTATION PROPOSAL
➢ Business Model and Organization Structure
For too long HL7 existed without a well-conceived or well-communicated business plan and relied on its volunteers to promote its viability and existence. HL7 must clearly position itself as an international standards development organization; yet continue to address the various national initiatives of importance to its affiliates including the United States. HL7 will create a global HL7 and a US affiliate. To further accomplish organizational positioning and provide support for the other strategic initiatives, HL7 must institute a more effective organizational structure including a CEO, CTO, and Technical Directorate with project management capabilities, an enhanced Web presence, and greatly enhanced tooling. With operational control at the executive level, the BoD must assume responsibility for HL7’s strategic direction.
All of this will demand significantly more funding than is currently generated in support of the organization. The new business model includes a strategy for increasing membership fees to provide additional revenue. A comprehensive financial plan will be developed during transition.
➢ Product and Services Strategy
HL7 must have a product and services strategy that both provides coherence and accommodates the stated requirements of HL7 members and industry leaders. This strategy is essential for product positioning and branding and for organizational positioning with various stakeholders. This strategy must support HL7’s commitment to have all global standards adopted internationally through ISO. It must facilitate timely delivery of standards by refining the focus of HL7’s standards work. The product and services strategy will embrace what’s become recognized as HL7’s role as the health information architecture group; supporting messaging, document exchange, and services. It will define HL7’s relationship with other Standards Development Organizations (SDOs) and certification groups. The Board is charged with completing the interim product and services strategy during the August retreat. A recommendation to re-assess V3 and its future viability will occur immediately upon approval of the strategic initiatives.
➢ Optimize Volunteers and Other Resources
Our volunteer culture is fundamental to the organization. However, our extraordinary growth, international reach, and expanded domain coverage has taxed the limits of volunteerism as we know it. Plans to enhance the contributions of our volunteers must focus on three major issues: institutional knowledge, tools, and infrastructure support. Volunteer empowerment comes through greater leadership. HL7 must develop and implement a comprehensive approach to documenting institutional process and procedure and its dissemination through orientation, education, and mentoring of its volunteers, be they committee members or leaders. This process must facilitate the recruiting and retention of new volunteers from yet untapped sectors. Tooling must be developed or purchased to allow the volunteers to focus their efforts on contributing to the standards versus handling the mundane tasks of assembling and bringing the outcome to ballot. Tooling support necessary to achieve these objectives is addressed in the productivity section. Increased staffing support is addressed in the Organization Structure to provide for technical editing, project management, balloting and publishing.
➢ Brand Hierarchy
AND
➢ Consistent Organizational Messages and Communications Strategy
In the past, HL7 the organization was synonymous with HL7 the standard. The change from a single standard to multiple standards began with CCOW and Arden Syntax. What HL7 is/does was further diffused by the introduction of the Reference Information Model (RIM), Version 3, and Clinical Document Architecture (CDA). HL7 has done little to alleviate this situation. HL7 must identify its core products and develop a brand hierarchy that helps the marketplace differentiate the products and better relate to the organization. Having established a branding strategy, communicating it to the industry is imperative. However, HL7 must first identify its target audiences then prepare a comprehensive communications plan, using consistent communication tools, to disseminate its message to its diverse stakeholders. The three key activities identified for immediate action are: re-design of the website to enhance web presence, branding of HL7, and outreach to key constituents.
➢ Product-oriented Project Management Approach
AND
➢ Quality Testing
HL7 must improve its ability to produce high-quality standards and associated products necessary for supporting successful end user implementation in a shorter timeframe in order to maintain its worldwide leadership position in health care information exchange. A project-focus with a well-defined project management approach will improve the predictability of timely delivery of standards that meet end user needs. These strategic initiatives address the developmental process specific to meeting the project-focused objective. Given that quality control is an inherent component of product life-cycle management, a single work group has developed a comprehensive implementation process addressing these two initiatives.
Methodology
The SITF, appointed by the BoD, worked diligently with the McGrew team from August 2005 through July 2006 to develop a set of strategic recommendations and associated implementation strategies for HL7’s future. With the support of the BoD and the involvement of various HL7 members, the SITF set up a framework, established the necessary committees, and completed the strategic initiatives and proposed implementation plans. A summary of the developmental process, a list of the Strategic Initiative Task Force members, and the subgroups established to develop implementation actions appears in Appendix 1.
Strategic Initiatives and Proposed Implementation
Details of the proposed implementation plan for each strategic initiative follow. The members of the subgroups involved in developing the plans are listed in Appendix 1.
Strategic Initiative: HL7 will implement a new business model and organizational structure.
New Business Model and Organizational Structure
Task:
The new organizational structure and associated business model will:
➢ Institute full-time executive leadership (CEO and CTO) to direct HL7 as an ongoing entity focused on standards products and services, and to serve as HL7’s point of contact for external positioning in the health care industry,
➢ Establish new processes and procedures to implement HL7’s product and services strategy to deliver high quality standards in a timely fashion,
➢ Create a new organizational structure that focuses on developing/implementing HL7 products,
➢ Upgrade infrastructure and administrative support systems, and
➢ Develop revenue sources and a funding model to support an expanded infrastructure.
Rationale:
HL7 will continue to focus its energies and resources on what it does best—the development of high-quality standards, however HL7 needs to perform its tasks with greater efficiency and a more defined user-focus. Critical components of this effort include a well-crafted vision/mission statement, strategic priorities set at the board level, resources and committees assigned to support these priorities, and an infrastructure that has the capacity and ease-of-use to support a product focus. End user input (early adopters, etc.) will be solicited for ongoing product design and improvement. As always, HL7 will continue to provide a forum and structure for domains that wish to develop healthcare standards to meet specific needs.
Implementation Actions:
Organization Structure
The keystone to the new organization is to hire full-time, executive-level staff. The CEO will be hired on a consultant arrangement immediately and the CTO position will be phased in when funds are available. The CEO, CTO, staff, and consultants will collaborate with the BoD and volunteer leaders in implementing HL7’s strategic priorities, including tasks such as managing infrastructure, publishing, project management, tooling, web presence, etc. Staff will report to the CEO or CTO depending upon the nature of the work they are hired to perform. HL7’s current Executive Director will serve as a part-time COO, and AMG staff will handle operations during the transition phase. The COO and AMG staff will report to the CEO. The CEO will re-evaluate the arrangements prior to the conclusion of the current AMG contract.
A Technical Directorate includes the volunteer leadership of key project-focused committees, the CTO, and technical staff. The Directorate will oversee project management, tooling, web presence, etc. The work of standards development will remain volunteer-driven with HL7 hiring sufficient staff to support the work of the organization as fiscal resources become available.
The new Organizational Chart is contained in Appendix 2. The objective of the overall management structure is to clarify responsibilities and streamline HL7’s ability to support business processes and functions. Part of the rationale of the new organizational structure is to improve accountability by:
➢ Providing adequate staffing to support the volunteer functions
➢ Defining position descriptions and staff qualification requirements
➢ Defining management and staff accountability for revenue, cost, and quality
➢ Clarifying reporting relationships for both staff and volunteers
A description of the new organizational functions are included in Appendix 3.
Summary responsibilities for the new executive positions, committees, and changes related to the BoD are outlined below:
Executive Staff
Responsibilities of the Executive staff will be as follows:
Chief Executive Officer
➢ Reports to the Board of Directors
➢ Presents the public face of HL7 global (assisted by the Board Chair and Affiliate Council leadership)
➢ Serves as the point person for policy relationships, e.g., Office of National Coordinator (ONC), NHS, etc.
➢ Is responsible for membership development and relations
➢ Manages external relations and marketing
➢ Develops annual fundraising and revenue plan and oversee implementation
➢ Ensures the development of a communications/marketing strategy
➢ Implements the product and services strategy in conjunction with the CTO
➢ Develops an annual business plan based on the product and services strategy
➢ Is responsible for the day-to-day operations of the organization
Chief Technical Officer
➢ Reports to the CEO
➢ Chairs the Technical Directorate
➢ Develops, coordinates, and harmonizes a Technical Architecture
➢ Coordinates resource allocation for priority projects
➢ Has overall responsibility for the technical viability of HL7 specifications
• Acts on recommendations of TD, regarding gaps and overlaps
• Ensures the quality of ballots and specifications
➢ Recommends appointments to the Technical Directorate, subject to review and approval by the BoD and the CEO
➢ Implements the product and services strategy in conjunction with CEO
➢ Oversees the work of staff project managers, ensuring reports on the progress of key projects and specifications
➢ Manages other technical staff and consultants
➢ Manages technical collaboration with other SDOs
Chief Operating Officer/Executive Director
➢ Reports to the CEO
➢ Manages the operational aspects of the standards development process
➢ Implements the operations support required to implement the product and services strategy in conjunction with the CEO
➢ Oversees the work of revenue-producing activities, public relations, internal and external communications, and marketing
➢ Manages the annual operations budget and priorities
Board of Directors
Composition: 13 members total
➢ 3 Directors being the Technical Steering Committee (TSC) co-chairs: 1 each from Foundation & Technologies, Structure and Semantic Design, and Domain Expertise, whose terms shall be concurrent with their positions
➢ 1 Director being the Advisory Committee chair, whose term shall be concurrent with his/her position
➢ 1 Director Emeritus for 5-year termwith life-time tenure (filled by majority vote of the membership when vacant)
➢ 1 Director elected to a two-year term by members of the US affiliate
➢ 1 Director elected to a two-year term by members of the North/Central/South American affiliates excluding the US
➢ 1 Director elected to a two-year term by members of the EU/African/Middle Eastern affiliates
➢ 1 Director elected to a two-year term by members of the Asia/Pacific affiliates
➢ 4 Directors-at-large to provide a balance of clinical/non-clinical, government, and top-tier member organizations elected to three-year terms by the general membership
➢ The members of the Board shall annually designate a Chair and a Recording Secretary, who may serve no more than three consecutive terms
Roles and Responsibilities:
➢ Set strategic direction through mission, vision, strategic priorities
➢ Review the product and services strategy annually and revise as necessary
➢ Review and approve the annual budget as developed by the CEO and Finance Committee
➢ Review and approve the marketing and communication plans proposed by the CEO
➢ Advise the CEO on external relations (new sponsors, new relationships, affiliations)
➢ The responsibilities of the Executive Committee and Finance Committee will be subsumed by the CEO and subcommittees of the BoD.
Criteria for Board membership:
➢ As part of the transition plan, a defined set of qualifications will be developed for Board membership
➢ Cannot be a staff member, consultant to HL7 or anyone under contract to HL7
➢ Strive for a balance between business, technical and clinical perspectives
➢ Criteria will be shared with the members before call for nominees
Nominations for Director-at-large:
Any member in good standing can be nominated through a petition process to be defined by amendment to Policies & Procedures. Criteria will be a certain number of supporters representing a certain number of organizations (for example, 20 members, 10 organizations) with all appearing on the ballot. A nominating committee, will be convened to ensure that an adequate number of candidates representing a balance of constituencies are put forward for ballot. The Nominating Committee will be composed of eight members representing developers, implementers and users of HL7 products
o 2 members elected by the Advisory Committee
o 2 members elected by the TSC
o 4 members elected at-large from a pool of candidates meeting the same criteria as required to be nominated for a committee co-chair; primarily being a member in good standing and an active member of any given committee
Technical Directorate
The Technical Directorate (TD) is responsible for product project approval and management oversight. It will rely on both staff and volunteers with increasing levels of professional staffing as the financial model allows. Note: Volunteer representatives to the TD should have sufficient support from their employers to ensure an average of 3-4 hours/week participation.
Composition:
➢ CTO is chair of the TD
➢ 3 representatives being the co-chairs of the Technical Steering Committee, one each from Foundation & Technologies (F&T), Structure & Semantic Design (S&SD), and Domain Expertise (DE). These are volunteer-filled positions which focus on the technical content of standards development, ensuring that they meet end-user needs, and make recommendations to the Board on project priorities.
➢ 3 representatives appointed by the Affiliates Council and reconfirmed annually with one being a member of the US Affiliate
➢ 2 representatives appointed by the Board on the recommendation of the CTO and re-confirmed by Board vote annually, to fill gaps in skill sets, provide balance and ensure capacity to track and manage joint projects with other SDOs
➢ 2 representatives elected at-large for two-year terms from a slate of candidates prepared by the CTO in collaboration with the TSC co-chairs
➢ Board appoint one additional member
➢ One member elected at large
➢ Technical staff and consultants (non-voting)
Responsibilities:
➢ Supports CTO in development and implementation of HL7 Technical Architecture and standards development
➢ Approves, monitors, and may intervene in product project development
➢ Oversees standards development
➢ Responsible for methods and process for quality assurance
➢ Sets milestones, monitors and ensures that quality assurance has been done
➢ Explains to project-sponsoring committee requirements for quality assurance and monitor committee performance to carry out QA
➢ Approves new work groups based on priority projects
➢ Resolves cross-domain content issues
➢ Oversees continuous quality process
➢ Defines international harmonization mechanism and manages process
➢ Identifies gaps, overlaps and recommends resolution
➢ Refers questions to Technical Steering Committee for discussion
➢ Reviews and approves requests from Technical Committees to initiate a ballot
➢ Reviews requests for new projects. Upon acceptance of the proposal, solicits input from the TSC for appropriate committee placement
➢ Manages progress and productivity, resolves committee charters against the product and services strategy set by the Board
➢ Recommends project probation or dissolution to the Board following collaboration with the TSC
Operation of the TD:
➢ Meets bi-weekly between Working Group Meetings (WGM)
➢ Meets on the opening and closing day of each WGM
➢ Meetings are open to the public, unless called into executive session by CTO; non-members may ask to be recognized
Technical Steering Committee
For the future, HL7 specifications will continue to be developed primarily through volunteer contributions. The co-chairs of the Committees and SIG’s represent the primary labor pool and will remain the core source of technical expertise and development within HL7. The Technical Steering Committee (TSC) is the primary voice and organization belonging to this core cadre of volunteers. It will be re-invigorated by providing self-elected leadership and a voice on the TD and the Board. The TSC is the primary vehicle for communication among the committees and SIG’s. In addition to these new powers, the TSC will adopt a new routine for meetings to facilitate communication and lessen the need for joint meetings.
Composition:
➢ Members shall be the co-chairs of all SIG and TC, excluding Board-appointed committees and those classified as "Production" (Tooling, Education, etc.)
➢ Each SIG and TC have one vote
➢ The TSC shall be divided into the three functional areas identified by the ORC and SITF: Foundation & Technologies (F&T), Structure & Semantic Design (S&SD), and Domain Experts (DE). Each functional area shall elect a TSC co-chair for a two-year term from among its representative co-chairs by paper ballot during the working group meeting.
Roles and Responsibilities:
➢ Identify areas of potential gaps, overlaps as “early warning”, and forward to TD for action
➢ Identify areas requiring harmonization, defining; refers these to the Committees and/or TD
➢ Review individual WGM agendas, ensuring time for joint projects
Meeting Structure:
➢ Meets for half hour every morning during WGM
➢ TSC may convene functional area sub-groups to foster common approach and communication among these groups
➢ May meet in special session for a full quarter or in the evening
Internationalization
One of the most significant organizational changes for HL7 will be to create a US affiliate, and have HL7 global become the host organization. HL7 global will continue to host working group meetings and global standards development. HL7 affiliates will deal with realm localization, education, and realm-specific political issues. HL7 global will develop a new business and global membership structure. This will strengthen our position as an international SDO. The change will take place over a 3-year period and will have an impact on many facets of current policies and procedures. These are outlined below and need to be addressed in more depth during the transition phase.
Membership
“Members” refers to both individual and organizational membership. There will be three levels of membership available:
I. National Affiliate Membership
II. HL7 Global Membership
III. Joint Membership
Joint Membership would convey the highest set of privileges and carry the highest cost. National Affiliate Membership and HL7 Membership reflect the current structure of Affiliates and US members today.
I. National Affiliate Membership
Under this plan, individuals and organizations join an HL7 national affiliate under the membership rules and requirements of that Affiliate. The Affiliate then has certain fiscal responsibilities to HL7 global with some portion of the Affiliate’s dues being allocated to HL7 global. Voting on HL7 standards and for HL7 elected positions is through the Affiliate. The Affiliate designates a fixed number of voting members based on their size. This would be a relatively low-cost option, although Affiliates are free to set their own dues structure. The structure for a US Affiliate should be carefully considered under the development of the new business model.
II. HL7 Membership
This option resembles the membership today. Members do not hold an Affiliate membership and vote directly on standards and for elected positions. The full dues are retained by HL7 global.
III. Joint Membership
This is a new category of membership. It would bear the highest cost and the formula should be carefully considered in the construction of the new business model. The benefits of joint membership are direct participation in standards ballots and elections, as an HL7 global member, and direct participation in the chosen Affiliate. This option allows multinational corporations to establish a position both within national jurisdictions and at HL7 global. Corporate members could join multiple National Affiliates, where they are active, in addition to having HL7 membership.
Rights and privileges will follow the category of membership. For example, members who chose not to participate directly in HL7 would have access to the Affiliate member database, but not the HL7 database. Members of HL7 only would not have access to individual Affiliate databases. Members who choose Joint Membership would have access to both. A possible privilege of Platinum membership could be access to all Affiliate databases in addition to the HL7 database. The details of member privileges should be established in the context of the revenue stream under the new business model during the transition period.
Voting on Standards
Each affiliate will follow its own rules on adopting localizations/extensions of HL7 specifications for Affiliate/realm-specific standards. This will follow current practice and guidelines, with the obvious adjustment of the creation of an HL7 US affiliate, which must set its own policies and procedures. Changes will be addressed in the transition plan.
Voting by Affiliates on standards balloted by HL7 global will remain as it is today, a fixed number of votes cast by designated members of each Affiliate.
Meetings
The transitional strategy must develop a new structure for the Working Group Meetings that supports the new international business model. For the foreseeable future:
➢ HL7 will continue to hold three meetings annually, with two held in the contiguous 48 states and one held outside the US.
➢ The current practice of an Affiliate Council meeting on the Sunday of a Working Group Meeting will be discontinued since the organization as a whole now represents all Affiliates.
➢ HL7 may choose to schedule a half-day or full-day meeting during the WGM for meetings of Affiliate regions (North/Central/South America, EU/Africa/Middle East, Asia/Pacific) since these regions have representatives on the Board of Directors.
➢ Each Affiliate will set its own meeting policy and may choose to hold separate Affiliate-only meetings in addition to meetings in conjunction with HL7.
Voting for HL7 Elected Positions
Membership is a prerequisite for voting (see categories of membership). Voting for HL7 Committee/SIG co-chairs will be reserved for members who meet the criteria defined by Policy and Procedure. Voting for at-large positions on the Board and for any other organization-wide position will be conducted in the same manner as voting on HL7 standards.
New Business Model
HL7 will develop and create new revenue sources and a new financial plan to implement the strategic recommendations. HL7 will develop a licensing structure, maximize the revenue from its products and services, expand the current membership fee structure and establish new revenue streams to include government programs, both national and international, as well as grants and monies from non-governmental organizations (NGOs) and foundations. HL7 will restructure its existing membership fee structure and introduce new levels of membership with additional benefits and fees. It is recommended that certain priority activities receive kick-start funding from HL7 reserves with the proviso that the reserves not be depleted to a level representing less than six months of operation funds. As part of the transition plan, a detailed budget of transition costs must be established.
Proposed opportunities for increasing HL7 revenue are included in Appendix 4. To create new revenue, HL7 must be perceived as an international standards development organization, project-driven, and accountable for producing high quality, timely standards. It is clear that the future in healthcare standards development requires collaboration among the many stakeholders. HL7 must position itself to be a leader in these efforts. HL7 must improve its external positioning around the globe and focus on consistent messages to all of its constituents, including additional outreach to its markets (users, potential users of its standards, and other relevant parties). The Communications and Branding recommendation contains more details about the approach.
Financial Plan
HL7 must shift its thinking to be focus driven rather than resource driven. In the past, HL7 has let the existing revenue dictate what can be accomplished and supported. Instead the organization needs to ask the question, “What standards do we want to have developed in five years?” and then create a revenue stream to support the defined goals.
Initial modeling on the membership fees and other opportunities to increase revenue are included in Appendix 5. Further analysis of the impact of increasing membership fees and modeling will occur during the transition phase.
Strategic Initiative: HL7’s Board will formally approve a product and services strategy that is reviewed annually.
Product and Services Strategy
Task:
HL7 will have a product and services strategy that provides strategic coherence and accommodates selected demands from HL7 members and outside parties. It will develop a Technical Architecture as an ongoing component of the products and services strategy. It also will facilitate timely delivery of standards by refining the focus of HL7’s standards work.
Rationale:
The product and services strategy will embrace what we’ve recognized as HL7’s role as the health information architecture group (in support of messaging, documents, and services) and will define HL7’s role with other SDOs and certification groups. Technical Architecture is a vital missing link in HL7’s products and product planning and should be an integral part of the annual products and services plan. Overall, HL7 is committed to have all standards accepted by national and international organizations such as ANSI and ISO.
Implementation Actions:
The CEO, CTO, Technical Directorate and/or Product and Services Task Force will work collaboratively with the Board to develop a product and services strategy and a technical architecture. The Board will review, update, and approve these plans annually. The CTO and CEO will be responsible for their implementation.
An immediate priority is to assess whether HL7’s V3 product line can be made more attractive to its target audience. Early adopters of HL7 V3 have encountered significant barriers to implementation, including high costs in development, testing, processing time and implementation time. Because of this complexity, HL7 does not make efficient use of other volunteers in V3 development. Most significantly, many aspects of V3 are not relevant to end user needs.
Individual project committees will take direction and receive support from the CTO and Technical Directorate consistent with the Board-approved strategy. Specifically, the CTO will assure that HL7’s products and ongoing standards development work are consistent, with minimal redundancy and inconsistency. Projects, those within existing TC’s and SIG’s and new projects, will be evaluated against a set of project criteria and the strategic plan. The goal will be to maximize the level of integration among HL7 projects and standards. The CTO and Technical Directorate will facilitate the project work of TC’s and SIG’s.
HL7 will act as host to user groups that want to develop standards or implementation guides (and bring their own resources to bear). HL7 will provide an organizational infrastructure to facilitate their work and will maintain an open and flexible approach to new opportunities, with inclusive criteria for new groups. The CTO and Technical Directorate will assure harmonization with existing products and projects. The long-term goal will be to create a complete, seamless set of standards. In general, qualified standards development projects will be incorporated into HL7 unless they clearly are incompatible with HL7’s strategic direction. User groups will work according to HL7’s product and project management policies and practices. The intent is to become the global health care standards development organization of choice for health care domain experts around the world. (Note: This process will also be used to evaluate new project ideas identified by current HL7 members and committees.)
HL7 will continue the policy of collaboration with other standards development and related organizations that may be considered to be “competing” within the same space, to minimize the possible impact of that competition and create synergy. Such collaboration should begin as early as possible to avoid having another organization carve a de facto niche in HL7’s standards development scope.
HL7’s Products
HL7 has three levels of products:
➢ Service line – e.g., V2 Messages, Structured Documents
➢ Product line – single entity, e.g., CDA
➢ Product, e.g., CDA Tutorial
In order for the Board to make educated decisions about the future direction of these products, revenue and expense data is required. Tracking revenue-generating activities by service line, e.g., WG meetings, educational seminars, tutorials, documentation, etc. is essential. For instance, for V2 messaging, staff will track costs, revenue, margin related to V2 messaging from all events and activities. This information will be used to set revenue goals and budgets for the service lines annually.
Strategic Initiative: HL7 will optimize the effectiveness of its volunteers and other resources.
Optimize Volunteers and Resources
Task:
HL7’s volunteer culture is fundamental to the organization. HL7’s extraordinary growth in membership, geographic reach, and domain coverage has taxed the limits of volunteerism. To focus volunteer efforts on the technical aspects of standards development, to grow additional technical expertise, and to minimize volunteer burnout, HL7 will create a volunteer support plan that will enable volunteers to optimize their participation in the development of HL7 products. The plan will include providing orientation, education, training, and mentoring to first-time attendees, new members, new leaders, and returning volunteers.
HL7’s other critical resources are its staff and website-oriented tooling. Both of these resources provide critical support for the volunteer-developed standards products and services. HL7 will engage sufficient staff and “user friendly” website-based tooling to support standards products and serviced development.
Rationale:
HL7’s success is dependent upon the contributions of its volunteer community in the creation of standards. All too often new volunteers have difficulty learning the HL7 standards development process, participating in the process, and finding the particular niche where their expertise can be optimally used. Further, volunteers often undertake tasks (minute taking, for example) that detract from their focus on the primary work. Thus HL7 must develop a Volunteer Resource Management program designed to maximize the effectiveness and value of each volunteer’s effort. The term “management” in this case is not intended to suggest an environment where volunteers are told what to do but rather to support volunteers in a manner that allows them to focus their efforts on standards development. In some cases organizations send “voluntolds” who arrive with specific goals and objectives. The program must facilitate the achievement of these goals and objectives within the context of HL7 goals and objectives.
Implementation Actions:
HL7 will focus its volunteer recruitment for strategic priorities development, implementation, and the vendor community. As part of the annual strategic planning initiative undertaken by the Board, part of the resource discussion should focus on volunteer resources and a strategy for identifying the right volunteer base to accomplish HL7’s strategic goals.
HL7 will provide appropriate tooling to facilitate volunteer effectiveness in the development of HL7 products and services. This tooling must be able to be used “intuitively” by volunteers in support of their work. HL7 will explore more formal collaborative models to resource key projects, e.g., tooling.
HL7 will provide adequate staffing for project management and other support activities. Such support is intended to free up volunteer time for more important activities, thus helping to optimize the use of volunteer resources and demonstrating an effective ROI for corporations providing staff time for standards development activities.
Within the first three months, HL7 will create a volunteer resources group to develop a plan to include:
➢ Assessing the different types of volunteers represented in HL7
➢ Determining type of volunteer skills needed
➢ Identifying new volunteer pools and recruit
➢ Training and education
➢ Mentoring
➢ Networking opportunities
➢ Leadership training
➢ Creating a project and volunteer profile mechanism to assist matching
➢ Matching volunteer skills with HL7 projects
➢ Communicating opportunities
➢ Determining what motivates and rewards volunteers
➢ Developing ROI for sponsoring organizations to donate in kind staff time
In conjunction with the CEO, CTO, and Technical directorate, this group will help identify the level and types of support staff needed to carry out HL7’s strategic goals.
Strategic Initiative: HL7 will develop a brand hierarchy that helps the marketplace understand the relationship of its products to each other and to the overall organization.
AND
Strategic Initiative: HL7 will develop consistent organizational messages and a communications strategy to disseminate those messages.
Brand Hierarchy and Communications Strategy
Task:
HL7 will develop and deliver a consistent image of and messages about HL7. The long-term goal is to develop formal marketing and communications plans that are consistent with HL7’s products and services strategies and priorities. The short-term goal is to focus on three key activities:
➢ Developing a brand presence for HL7
➢ Website redesign
➢ Outreach to current and potential users and emerging markets.
Rationale:
In the past, the HL7 brand was synonymous with the one standard it developed. The change from a single standard to multiple standards began with CCOW and Arden Syntax. This change continues to be more significant with the introduction of new products such as CDA (introduction of a document orientation) and the RIM. HL7 will develop a brand hierarchy that helps the marketplace understand what HL7 the organization is, what it does, and why it is important.
Based on a targeted phone survey and the work of the Marketing Committee, we know that although the major health care and health care IT constituencies have a fairly accurate understanding of what HL7 does, it is general and at a high level. There is a pressing need to communicate more specifically what HL7 has to offer in terms of its standards and how they can be used to solve business problems.
The HL7 website is a critical part of effective communication to members and outside constituents. HL7 will redesign the website to meet member and marketing needs. The website is often the first contact that individual have with HL7, and it is imperative that the messages and information contained on the website be easy to find, current, and meet the users’ needs.
HL7 will target current and emerging markets (users, potential users of its standards, and other relevant parties) and perform focused outreach. The outreach strategies will be to:
➢ Involve/stay in touch with the business needs of its users
➢ Involve and gather input from users (and other relevant parties outside of HL7) to maintain credibility
➢ Inform (and sell) what HL7 has and how it can be used to meet user needs
➢ Show how HL7 fits with other standards
Implementation Actions:
The communication and marketing activities will focus on both external and internal communication needs. The messages will clearly state what HL7 does, how HL7 does it, and why it is important. Audience segmentation will build on the work of the Strategic Initiative and the Marketing Committee. Messages will be consistent with HL7 priorities.
Staffing
A quarter-time marketing professional will be required to help create the HL7 brand, the marketing aspects of the website and tailored messages for outreach. Marketing is critical to building new revenue for HL7. The CEO and Marketing Committee will define the skill set for this strategic position. In addition, HL7 will tap marketing interns to assist in the implementation of marketing strategies.
Communications staff will be needed to implement and update the website monthly, and work with the Marketing Committee to keep the standard presentation, speakers kit, and speakers list current.
HL7 Brand
HL7 will create a brand for the HL7 organization and its products that is consistent with HL7’s organizational objectives. This branding will involve the creation of a combination of attributes communicated through a name (and/or visual elements such as a logo, images, fonts, color schemes, or symbols) that influences a thought-process in the mind of an audience and creates "value". The "value" of a brand resides, for the audience, in the promise that the product has a certain quality or characteristic which make it special or unique.
HL7 will identify what it deems to be its core standards products and develop a brand hierarchy that helps the marketplace to better understand the relationship of the products to each other and to the overall organization. For example:
➢ Organizational Brand: HL7 as global community for health information technology standards development
➢ Product Brand: Messaging, CDA, RIM, etc.
➢ Version: 2.x, 3.0 (so we would refer to “V2” as “HL7 Messaging V2”.)
HL7 will brand the organization as follows:
HL7 is the only globally-oriented, healthcare-focused standards development organization.
HL7 will create a brief positioning whitepaper of no more than 4-5 pages. This document will not talk about the RIM, or about “semantic interoperability”. It will focus on what HL7’s products and services do for users–-not how HL7 does it. The white paper may include:
➢ Beyond messaging: context, documents, decision support and more: this should be the major focus of the paper since it is the primary perceptual hurdle to overcome
➢ HL7 and the clinical community: how professionals and professional societies work with HL7: (discuss in general and the long history of work with ACR, CAP...). That HL7 is somehow divorced from this community is a piece of image mischief fostered on us by ASTM during the CCR/CDA fracas, we need to clear this up
➢ HL7 and the regulatory community: how we work with regulators (FDA involvement in RCRIM, CDC in PH SIG; our participation in HITSP...)
➢ HL7 and the international standards community: how we work around the world as HL7
➢ HL7 and other standards organizations: how nice we are and how productive our MOUs have been
The Marketing Committee will work in conjunction with the Product and Services strategy group to implement consistent messages about HL7’s priorities.
Website
HL7 will improve and update its website. It will make the site accessible and useful both for members and nonmembers alike. The redesign will require partnering between the Marketing Committee, Products and Services strategy group, and the Electronic Services Committee to define a set of criteria and structure content for the website. Professional website developers will define a comprehensive set of requirements and specs. See attached chart for specific activities and timeframe.
Outreach
HL7 will actively identify important opportunities at which HL7 interacts with the public and participate in those events and meetings.
Special Forums
Create “Outreach Forums” and invite (selected or open invitation) individuals from these categories. The forums can be based on the market segments or be further refined – for instance, research and public health are one category but there can be a forum for each; providers can be separated into hospitals (inviting hospitals and the AHA) and providers (inviting doctors and the AMA). It is suggested that one particular Forum be dedicated to RHIOs/HIEs. Although they are comprised of members of the 7 categories, they are a new group and should be explicitly targeted. Many of them will have technical advisory boards and will need to understand and make decisions regarding the use of healthcare standards developed by HL7.
These Forums will serve a number of functions: 1) create/maintain credibility in the community; 2) allow HL7 to understand their business needs for future standards development; 3) provide education on the HL7 organization; 4) provide education (“selling”) on how current HL7 standards can meet their needs; 5) provide education on how HL7 fits with other standards; 6) determine what conferences/trade shows would be best for representatives of HL7 to give presentations, the topic(s) to be covered, and involve these individuals in the presentation and material to be used. Consider co-presentations with members (especially the recognized community leaders) of these Forums.
User Group Events During WGM
➢ Hold a half-day session with non-standards developer stakeholders (target audiences)
• Senior leaders in the industry that are end users
• CHIME and expanded vision of that audience; thought leaders in regional and local areas (RHIOs)
• Use this opportunity to focus on what their needs are and what’s in it for them to support HL7
• Emphasize the benefits of HL7 to their organization
Stand-alone User Group Events
➢ Create a list of conferences to target (HL7 user space)
➢ Develop a plan to reach decision makers (CxOs)
Working Group Meetings--The CEO and marketing professional will examine the design of the week-long meeting and incorporate new and changing organizational needs and enhance communication. Several communication opportunities are recommended as additions to the three WGMs per year:
➢ Keynote speaker – highlight areas of collaboration.
➢ Sessions on HL7 strategic goals.
➢ Consider allowing members of the Forum to attend WGM tutorials free of charge to provide incentive for people to join a Forum as well as inform members of details of our standards.
➢ Plenary sessions--highlight individual group achievements
➢ Enhance internal communication within each WGM
Trade Shows/Exhibits--HL7 will focus on showcasing key strategic initiatives in the HL7 booth including a fully interactive technology demonstration. Showcase leadership in integration.
➢ HIMSS--re-examine whom we are trying to reach, what is our message, and how we are going to deliver that message
➢ Use the exhibit floor to collaborate with HL7 users in their booths through real-time connection as an extension of the HL7 demo booth
➢ Re-establish a primary relationship with HIMSS and IHE
➢ Explore opportunities for participation at additional venues, including TEPR, HIPAA, NHIN summits, AMIA, AHIC, professional society meetings
Tools for Outreach
Standard Presentation
HL7 will develop and maintain a standard set of materials for use by anyone speaking on behalf of HL7. It is critical to present a consistent message to the outside world.
• A PowerPoint presentation, containing mission, vision, strategies, and current focus and projects, will be developed and maintained monthly by communications staff with oversight by the Marketing Committee.
• HL7 will establish a policy that this standard message be used by all persons speaking on behalf of HL7.
Speakers List
HL7 will create and maintain a speakers list.
• HL7 develop a short list of individuals available to speak in behalf of the organization.
• The Marketing Committee and communication staff review and update the list at each Working Group meeting.
• The Committee will become proactive in identifying opportunities for speakers in target audience groups.
Other outreach and communications tactics were identified and will be addressed in years 2 and 3.
Domain Evangelist List (Year 2)
HL7 will create and maintain a list of volunteers with expertise in a particular area(s), (e.g., microbiology) that have agreed to “evangelize” and be available as a resource on the topic. These individuals would include the committee co-chairs (inward for standards development) and experts that can be called on for specific questions (outward facing). Creation of the domain evangelist list will include:
➢ Creating a list of Co-chairs, contact information and areas of expertise
➢ Developing functional description for evangelists
➢ Developing criteria for vetting list along domains
➢ Identifying people to fill role in each domain
External Perception Survey
The Marketing Committee, in conjunction with the CEO, will conduct an informal external perception survey annually or every two years and make recommendations to the Board.
Education
Educational Events/Seminars (Years 2-3)
Education is an important communication and marketing tool. HL7 will develop a strong Educational Committee that creates curriculum in support of HL7’s product and services strategy and priorities. The CEO is responsible for ensuring that educational opportunities are allocated according to strategic direction of the organization. This includes identification of educational needs and selection of course teachers. Once consistent messages are developed and a systematic process to deliver them is defined, the Marketing Committee will be exploring other avenues and venues to provide other educational tutorials, primarily to inform others of HL7 and its products and services.
Webinars
HL7 will create Webinars for decision makers and the press as a means to get up to speed on emerging topics. Benefactors will be approached to underwrite these events.
Online learning
Develop a curriculum that is not only a communication vehicle but is a potential revenue stream. The curriculum must reflect priorities in line with organizational strategies and direction and ensure consistent messages.
Educational opportunities at others’ conferences
Proactively engage HIMSS, AMIA, TEPR, AHIC, Connecting for Health, eHealth Initiative requesting opportunities to present an education track about HL7.
➢ Deliver co-presentations with representatives of other SDOs at selected conferences to demonstrate how standards can fit/work together. Sessions in user group meetings and other places.
➢ Investigate co-presentations with Global Affiliate leaders at selected non-US conferences.
Proposed implementation activities are included in Appendix 7.
Strategic Initiative: HL7 will implement a product-oriented project management approach to ensure development of high-quality standards and associated products in a committed timeframe.
Product-oriented Project Management Approach
Task:
HL7 must improve its ability to produce high quality standards and associated products necessary for supporting successful end user implementations in a shorter timeframe in order to maintain its worldwide leadership in health care administrative and clinical messaging.
Rationale:
During the interviewing and data gathering phase of the Strategic Initiative it was apparent that much of the work done in committees was poorly defined with no clearly articulated objectives. As a result, work has often been submitted for balloting in an incomplete form, resulting in negative or fewer votes and often multiple ballot repetitions. The recommendations put forth by the Process and Productivity subgroup are designed to bring more structure and accountability to the work being performed by the TC’s and SIG’s. Structure implies the creation of a more deliberate strategy for the way in which HL7 products are initially created and subsequently enhanced over time where the work is done through specifically defined and approved projects. Three aspects of projects were critical to the subcommittees work:
➢ A well defined but flexible project lifecycle
➢ Application of an appropriate (based on the lifecycle) project management approach and tool set
➢ Application of appropriate quality control measures and procedures
Throughout the course of the subgroup’s work we struggled with the terms “product” and “project” as they related to the specific environment in which HL7 work is done. Historically, within the HL7 context work deemed completed by a committee and accepted via the balloting process has been known as a product. That is, it was the product of the committee’s work. However, within the context of the Strategic Initiative the definition of a product has acquired an end user perspective as described in the Product and Services subgroup. Thus the definition of the term has transitioned from a committee work result orientation to something HL7 sells/distributes/gives to a standards developing end-user in the assigned HL7 ANSI SDO space. At the same time, the subgroup determined it was impossible to talk about projects without associating them with products since any project commissioned by HL7 should either create the initial version of a new product or enhance an existing product (with the exception of hosting activities). As a result, the reader will see ample use of a combination of the terms in the following material.
Finally, we have adopted the use of the term “Product Lines” to reflect the fact that there may be multiple products associated with a product line (such as V.2) and have included a discussion of how specific products might include specific sunset projects designed to assist end users in moving to the replacement product if appropriate.
This strategic recommendation and the following one address the developmental process dimension of the overall need while previous recommendations address the organizational, product and services strategy, use of resources, branding, and communications. Within this context the specific tasks must be implemented. In both recommendations specific activities have been identified and discussed.
Product-Project Lifecycle and Criteria for Proposing, Approving and Executing Projects
An HL7 Project Development Lifecycle will be developed to monitor the progress, quality and timeliness of projects from initiation to development of implementation guides. The Project Development Lifecycle process will include criteria for project approval, management, quality testing, monitoring interim progress, implementation and training and post-implementation. Figure 1 – HL7 Project Lifecycle and Figure 3 – Product Sunset focus on the project management aspects of the process required to produce standards products, including project work and project management. For additional information on impact on HL7 products, refer to Appendix 8.
Figure 1 – HL7 Project Lifecycle
[pic]
1) HL7 Product Lines
Purpose: Product Lines contain multiple related products end-users will acquire to implement in their environment, for example specifications for traditional messaging, XML schema, CDA, CCOW, the RIM, etc. Feedback on specifications, new requirements, or new opportunities will trigger requests to create or enhance a product. These change requests will be managed as projects. Before initiating a project, interested stakeholders must make a formal request according to HL7 policies and procedures for presentation to the appropriate approval group (e.g. committee or directorate). This may require iterations of negotiation to create a project request that meets HL7 Criteria. While other HL7 Products, such as tutorials or information forums may use a project management approach, this lifecycle is intended primarily for standards products.
Project Work: Complete Project Request per HL7 Methodology. The request describes project classification, justification, benefits, sponsorship, and intended deliverables and implementers.
Project Management Requirements: Coordinate review by appropriate domain committees. Determine project alignment with HL7 business strategy, goals, and objectives. Register project with HL7 Project Management Office (PMO). Assure that quality steps laid forth herein are followed.
2) Appropriate Approvals
Purpose: The TSC, Technical Directorate, or other appropriate approval bodies, as defined by the HL7 organization and policy, review and approve the project request. A project not aligned with HL7 strategies established by the HL7 Board, or requiring extensive resources may not be approved. A “hosted” project may be approved as long as the sponsors provide adequate resources and the project is not detrimental to HL7 strategy.
Project Work: None
Project Management Requirements: Monitor review schedule. Determine next steps if project is not approved.
3) Product Sunset
See Figure 3 – Product Sunset below.
4) Project Initiation
Purpose: The project initiation phase further refines the project request by elaborating scope, objectives, and deliverables that establish the project boundaries and provide a means of measuring the success of the project. Project success is defined as the achievement of predefined project objectives through the production of project deliverables within the boundaries of the project scope. Commitment from project stakeholders, participants, and required resources must be in place to assure the success of the project. Every project must have at least one project sponsor and a responsible party. The project sponsor approves project deliverables and may assist in underwriting the cost of required project resources. The responsible party/project lead is accountable for ensuring project progress and the satisfactory delivery of project deliverables. A project may have many sponsors; however the project must have one responsible party. The DSTU validation is expected to be an implementation by a limited number of implementers, not less than two, that are seen to interoperate in a laboratory situation. Projects should not proceed beyond step (5) without a non-binding commitment of at least two implementers. Assumptions and constraints may be associated with the availability of resources, interdependencies with other projects, the outcome of anticipated decision processes, or any foreseeable circumstance with an unknown outcome that can affect the progress of the project. An important part of project planning is to explicitly identify the planning assumptions and constraints. It is also important to identify potential project risks so that mitigating strategies can be built into the project plan. The project plan will detail project activities, project schedule, inter-project dependencies, and balloting strategy to meet market demand and implementation timelines in a format determined by the HL7 PMO.
The project plan includes, but is not limited to:
a. A proposed Timeline that includes all the steps in the project cycle (described below)
b. Identification of volunteer and non-volunteer resources required to meet the time-line
c. Funding requirements
d. Alignment with market demand and planned implementations
e. High level expectations
f. Balloting strategy for cross-cutting projects
g. Quality criteria for each step in the project lifecycle (described below)
h. An approach for Industry outreach specific to the work product being developed
i. For all standards designed to support interoperability, and other standards as appropriate, a proposed DSTU validation approach for moving from Draft Standard for Trial Use (DSTU) to candidate standard (see below)
j. Plan for interaction with other projects
Project Work: Complete the Project Plan, Project Scope Statement and Charter, adhering to the HL7 PMO methodology. If a new Domain Committee is needed, additional work is required to define mission and charter statements and secure appropriate approvals.
Project Management Requirements: Secure commitments of appropriate stakeholders, e.g. sponsors, responsible party/project lead, intended implementers and other required resources.
5) Quality Verification/Step Decision (QVSD)
Purpose: Assess the work products of this project step against the quality criteria established in the project initiation step and against any relevant organizational quality criteria. The method of making this determination depends on the criteria, and may vary at different steps. Some possibilities include:
a. An explicit self-assessment by the project members resulting in passing a motion that the quality requirements of the step have been met
b. An outside review by an independent panel of volunteers convened for the project
c. An outside review by a standing panel of volunteers and support staff established to work with all projects
The quality criteria stated in the project plan are predetermined for all projects.
It is possible that a QVSD review for a step would cause the project to move back to a prior step rather than go forward or simply require further work in the same step. The QVSD step is required on most of the subsequent steps, for example Requirements Definition and Logical design, indicated by an associated QVSD loop in the graphic.
Project Work: This varies based on the step but, where possible, requires self-assessment, such as conformance to publishing style guides, PMO templates, tooling enforced product quality checks, etc.
Project Management Requirements: Ensure the defined quality criteria are met. Secure approval to pass the QVSD gate.
6) Appropriate Approvals to Move Forward
Purpose: Secure approval of final Project Plan from appropriate stakeholders involved in the project.
Project Work: If warranted, prepare and make presentation on the project plan to the appropriate committees or other interested stakeholders.
Project Management Requirements: Confirm the sponsors, project lead and other required resources approve the final Project Plan.
Although steps 7-9 define a logical succession of steps it is expected that there may be overlap in their execution, particularly of steps 8 and 9. The explicit requirement should be that steps 8 and 9 cannot complete until the prior step has completed and passed the QVSD.
7) Requirements Definition
Purpose: Determine the business requirements that will drive the ultimate project work product using HL7-approved methodologies. For example, for a messaging standard these will be the use cases and other statements of requirements to be fulfilled by the messages.
Project Work: Refine the Project Plan including success criteria as required. Define activities that must be completed and the associated check point date. Perform QVSD before proceeding to the next step.
Project Management Requirements: Confirm the project lead maintains the project plan, tracking completed activities, and assessing impact of altering check point dates. Secure approval to pass the QVSD gate.
8) Logical Design, Methodology Refinement
Purpose: Process the requirements to develop interim work products that constitute the design. For example, for messages, Constrained Information Models based on the Reference Information Model would be produced.
Project Work:
➢ Build specification and documentation
➢ Get feedback from committee and other members
➢ Build implementation outline
• Define implementation plan
• Determine steps required and their sequence
➢ Build user acceptance plans
• Determine what users might define as their requirements
• Validate there are no expectations un-met for user
➢ Build testing plan
• Create criteria for validating project
• Model test plan
➢ Get approval to proceed to draft specification
• This assumes project is at least 90% complete and the draft specification is complete enough to begin testing or at least some phase(s) of a multiple phase project can be independently tested or validated without the other phases being complete
➢ Perform QVSD before proceeding to the next step.
Project Management Requirements: Monitor project to confirm it is on track and meeting checkpoint dates with evolving deliverables meeting product quality criteria. Secure approval to pass the QVSD gate.
9) Draft Specification
Purpose: Prepare the documents for Candidate Standard (DSTU) ballot. The DSTU approach is used for industry stakeholders, including those initially indicating their intent to implement the standard in the project initiation phase, to test the specification in trial implementations.
Project Work:
➢ Put specification into testing mode to validate model
➢ Refine implementation plan and user requirements
➢ Begin validation of specification
➢ Review test plans and determine resources to validate specification
➢ Begin plan to market
• Planning for announcement of project turning into product or update to project
• Notification of sunset of product
➢ Perform QVSD before proceeding to the next step.
Project Management Requirements: Secure approval to pass the QVSD gate.
(10) Candidate Standard (DSTU) Ballot
Purpose: The Candidate Standard (DSTU) ballot is an open consensus review process that may result in modifications to the specification to meet user requirements. For ballot participants not actively participating in the project, this may be their first input on the specification. To promote industry adoption, V2 Candidate Standard (DSTU) ballots may include V3 mapping for any new V2 content; V3 Candidate Standard (DSTU) ballots may include V2 mappings for associated content.
Project Work: Prepare RFI request to ballot, review associated Project Scope Statement. For revisions/iterations of ballots the prior ballot reconciliation process must be completed.
Project Management Requirements: Complete ballot requirements adhering to HL7 methodology.
(11) Candidate Standard (DSTU) Validation
Purpose: An assessment according to the DSTU validation approach defined in the project plan (see below).
Project Work:
➢ Pass Quality Testing
➢ Depending on Quality determines the following:
• Quality as validation step
o Validate quality process was followed during testing
o Approve and sign off that process was followed appropriately
• Quality as approve or disapprove step
o Look for shortcomings
o Publish outcomes
o Reject or approve specification
• Perform QVSD before proceeding to the next step.
Project Management Requirements: Secure approval to pass the QVSD gate.
(12) Accelerated Revisions
Purpose: During Candidate Standard (DSTU) ballot validation the committee will empower a group of its members to provide assistance in interpreting the DSTU and agreeing on modifications to deal with issues that arise that might prevent successful validation. These modifications do not become part of the balloted DSTU but are made publicly available by HL7.
Project Work: Track modifications for inclusion in next version of draft or trial standard.
Project Management Requirements: Monitor modification process.
(13)Wider industry use of DSTU needed?
Purpose: At the end of industry verification, HL7 considers releasing the DSTU to industry for more widespread use.
Project Work:
Trial Implementation Review
➢ Validate trial implementation plans supporting specification installation
• Review post implementation comments to determine if implementations were successful
➢ Approve or reject implementation process worked against project success criteria
• Update document with post implementation feedback
➢ Validate user document supported implementation success against project success criteria
• Update document with user feedback post implementation
➢ Approve or reject user guides against project success criteria
➢ Validate release notes
• Release notes should be consistent with the entire experience pre – post implementation
➢ Approve release notes
Project Management Requirements: Monitor review process for adherence to HL7/PMO Methodology.
(14) Revised DSTU Specifications and Training
Purpose: If DSTU release is chosen, the committee prepares a revised DSTU.
Project Work: Same as Step 9 with training content added.
Project Management Requirements: Secure approval to pass the QVSD gate.
(15) Industry use of DSTU
Purpose: During industry usage the committee maintains the accelerated revision support identified at step 12.
Project Work: Same as Step 11. Track modifications for inclusion in normative ballot
Project Management Requirements: Monitor specification modification process.
(16) Produce complete specifications
Purpose: Produce the final ballotable specification for normative ballot
Project Work:
➢ Revise Implementation and Training content
➢ Share successes that have been validated during QA
➢ Refine market plan developed during draft specification
➢ Prepare RFI request to ballot, review associated Project Scope Statement. For revisions/iterations of ballots the prior ballot reconciliation process must be completed.
➢ Perform QVSD before proceeding to the next step.
Project Management Requirements: Secure approval to pass the QVSD gate.
(17) Normative Ballot
Purpose: The Normative Ballot is an open consensus review process that may result in modification requests. For ballot participants not actively participating in the project or DSTU ballot, this may be their first input on the specification.
Project Work: Prepare RFI request to ballot, review associated Project Scope Statement. For revisions/iterations of normative ballots the prior ballot reconciliation process must be completed.
Project Management Requirements: Complete ballot requirements adhering to HL7 methodology.
(18) Publish final specifications, implementation guidance, training materials
Purpose: Finalize the specification; prepare implementation guidance, and training materials based on DSTU experience.
Project Work: Close the project
➢ Submit all documents for publication
➢ Signal, as per HL7 procedures, that product is ready for release
➢ Perform QVSD before proceeding to the next step.
Project Management Requirements: Complete PMO requirements to finalize and close the project. Secure approval to pass the QVSD gate
Figure 2: Lexicon
|Balloting strategy |Multiple domains or infrastructure committees may be involved in a project. The project plan should include a plan for engagement of impacted committees |
| |and a plan for advancing new or refined content into processes/ballots that are already underway in those committees. |
|DSTU validation |Executing the DSTU validation approach. HL7 will have a modified open approach to DSTU validation. All those participants that made a non-binding |
| |commitment in step (4) 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. |
|DSTU validation approach |A project step that ensures that the DSTU 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 good shot at industry adoption. |
|Industry outreach |Depending on the goals of the project this may be as little as a set of announcements of work going on in HL7 targeted at the impacted stakeholder |
| |communities. For some projects it may involve scheduling out-of-cycle meetings, scheduling meetings jointly with other stakeholder organizations or some |
| |kind of “Town Hall” meetings similar to those used for the HER Functional Requirements DSTU. |
|Non-volunteer resources |Beyond the routine support HL7 headquarters provides for balloting, etc., additional support may be required to assess potential funding requirements. |
| |Hosted projects will be expected to provide associated funding. |
|HL7 project criteria |HL7 projects shall: |
| |Be consistent with Board strategic direction or, if a hosted project, approved as an exception project |
| |Include appropriate project documentation - project charter, scope, resources, timelines, assumptions, constraints, planned deliverables, etc. per PMO |
| |methodology |
| |Be aligned with market demand |
| |Be sponsored by stakeholders intending to implement the product produced by the project |
| |Define a reasonable balloting strategy to meet market demand and implementation timelines |
| |Define how the project will engage with other impacted committees |
| |Follow project approval protocols to ensure appropriate project socialization and sign-off has taken place |
|Project Management Office |The PMO is staffed by HL7 to provide support for committees executing projects. The PMO is responsible for oversight of project methodology, and tracking |
| |the status of HL7 projects. The PMO does not directly manage product related projects. |
|Quality criteria |A project commitment to a measure of the quality for each step of the project cycle. It is expected that most projects will use or possibly adapt |
| |boiler-plate quality criteria developed as part of HL7’s methodology |
|Quality review |An evaluation of whether the work products of a step meet the pre-established quality criteria. At most steps the project team will self-assess against |
| |these criteria and take a vote (not a ballot) to move ahead to the next step. |
|Timeline |A Gantt chart or other project diagram that expresses the estimated times required to complete the steps of the project, synchronized with the dates of HL7|
| |trimester meetings. |
Figure 3 – Product Sunset
[pic]
3) Product Sunset
Upon recommendation by the steward domain committee, the decision to sunset a product must be approved by the TSC, Technical Directorate, or other appropriate approval bodies, as defined by the HL7 organization and policy. Product sunset requires a project, but with significantly fewer steps than required to create a product.
a. Project Initiation
Same as Step 4, but typically does not require funding and has no ballot requirements, but does require a transition plan for the news standard
b. Appropriate Approvals to move forward
Same as Step 2.
c. Review Documentation
Similar to Step 18, but requires technical corrections to the retiring standard.
d. Announce and set sunset Date
Inform Marketing an announce sunset to HL7 Membership.
e. Product Sunset
New Project Management Approach
HL7 will define and recommend a project management approach for the development of new products or enhancement of existing products that values volunteer culture by providing appropriate tooling to support project management.
In a sense, the old adage “form follows function” applies here in that the product-project lifecycle sets forth the framework for the project management activities. Within the HL7 volunteer culture there are other factors that impact on the project management approach, including:
➢ Streamlined: The approach must support macro- rather than micro- management. HL7 has neither the need nor the resources to micro-manage projects. Further, the volunteer culture simply does not lend itself to micro-management. At the same time, as indicated in the previous section, certain lifecycle steps such as project initiation will require the capture of specific criteria that need to be tracked (schedule, resources, objectives/outcomes, etc) in order to measure progress and evaluate status.
➢ Supportive: Because project management skills are not currently readily available in the HL7 community the project management approach must not impose significant work requirements on the project team. Staff consulting resources must be available.
➢ Effective: Must provide appropriate level of sophistication to enable the project manager to determine project status and progress.
➢ Complete: Must be able to track and monitor all the key criteria.
Thus the project management support tooling needs to be:
➢ Easily understood
➢ Able to track and periodically update status of project criteria attributes
➢ Able to track committed resources
➢ Able to determine whether a project is ahead of or behind the proposed schedule
➢ Able to capture progress notes and comments
➢ Able to interface with other projects where there are dependencies (i.e. elements that are required for use in the subject project)
➢ Accessible via the Web with user rights controls
Does not need to be able to:
➢ Support elaborate critical path scheduling
➢ Support resource requirements by type monitoring at the task level
➢ Support resource usage time reporting
Product-Project Lifecycle Task Force
At the last Strategic Initiative Task force meeting a set of implementation “kick start” projects were proposed. Although considerable progress has been made by the Process and Productivity subgroup as reflected in this implementation plan document, additional work is needed to flesh out the product-project lifecycle, the project management plan details, and the quality control overlay. Therefore, the Strategic Initiatives Task Force Process and Productivity subgroup proposes:
➢ A new task force be created to carry on the work of the Process and Productivity subgroup (the “kick start” project for this subgroup)
➢ A minimum of two members of the current subgroup be appointed to the new task force
➢ The task force will:
• Further refine and delineate the tasks in each step of the project lifecycle
• Refine and further elaborate the proposed project management approach in conjunction with the HL7 project manager when the position is filled
• Continue to refine the criteria used to evaluate and approve proposed projects
• Work with the group responsible for tooling and HL7 Website redesign and implementation to develop the necessary tooling needed to support the product-project model
• Serve as the point group, in conjunction with the HL7 PMO, for:
o Transitioning to the new product-project lifecycle model
o Educating committees on the product-project model and preparation of project proposals
o Reviewing project proposals for conformance with required criteria until the Technical Directorate is established
o Establishing the process for dealing with “problem” projects, including placing projects on hold or terminating them until the Technical Directorate is established
o Monitoring project progress and assisting committees in quality control and project management tasks
o Recommending which committees should be included in sign-off activities
o Development of rules for determining when projects are allowed to deviate from the model process
o Development of a plan for migrating existing projects to the new product-project model (i.e. will there be a “grandfather” clause for existing projects, or will they have to submit a project plan subject to approval for continuance of the existing work)
o Selection and adoption of a continuous quality process to leverage best practices and continue to improve the lifecycle model and associated project management activities
o Other associated work as it is identified
Tooling Support of Project Activities
HL7 will develop and or modify tools to support project development and the volunteers charged with developing the standards. Key points are:
➢ Cohesiveness and communication in tool development and roll-out is essential for success
➢ Tooling and process should facilitate consistent look and feel across all HL7 “products”; as a by-product, this should enhance ease of use for end users.
➢ The HL7 website is one of the most useful communication tools for HL7, both internally and externally. Much of the information is difficult to find and to access. The site needs to be redesigned based on a comprehensive requirements definition and then rebuilt with the technical input of this task force.
More specific tooling requirements for the support of product-project management have been delineated in that section. In addition, the subgroup believes there must be a more consistent documentation effort associated with committee work, in that in many cases the work done and decisions made are contained in the memories of the participants. Tooling should be provided for reporting templates in order to support consistent committee documentation and subsequent filing on the Web site with indexing that makes it easy for membership access. Finally, since not all projects are identical, a type categorization needs to be developed, with templates for each project proposal type developed, building on the existing work of the ARB and PMO.
Strategic Initiative: All standards will undergo quality testing at key stages of the development process.
Quality Testing
Task:
The strategic initiative is intended to assure that higher quality material will be put forward at each key stage of development. Care will be taken to ensure that the new process does not interfere with the timely development of standards.
Rationale:
It is apparent from discussions about ballot fatigue and the companion reconciliation of negative votes with commentary that too much material gets to the ballot stage without thorough commentary and content review. Repetitive balloting delays the creation of standards, increases the amount of rework required to obtain a consensus vote, and most likely adversely impacts the size of the ballot pools.
Elements of Quality Testing
The subgroup agreed that quality testing should be about compliance to identified quality criteria. Quality criteria include elements such as:
➢ Completeness--is all the content required present--such as all artifacts expected for the state of the type of product?
➢ Relevance--does the product meet the objectives as expected (is the product “fit for purpose”)?
➢ Accuracy--is the content of the product valid according to established methodology and conformance criteria?
➢ Congruence--does the product “fit in” with other products as expected? The goal should be on convergence and alignment of various products that optimize the utility of the whole.
➢ Ease of use--is the content of the product easy to understand and apply (for specification type products) or easy to use (for tool type products) or easy to apply (for implementation guides)?
➢ Timely--is the product available in a timeframe where it is still useful for the intended purpose?
There are often trade-offs among the quality elements and there may need to be compromise positions that allow progress to be made in a continuous quality loop – where feedback occurs both to the quality of the products as well as to the quality of the criteria and the suitability of the process. Evolutionary development is more robust than waterfall and we won’t get everything right the first time. Both post-project review and quality testing of the product, during each iteration, will be needed.
These concepts have been incorporated into the lifecycle discussion section in the previous section.
Quality Testing Measures
HL7 will ensure that all standards are quality-tested before they are released. A portfolio of quality measures, including issuing standards in a DSTU, functional demonstrations, reference applications, ballot reforms and/or wider pre-ballot review, will be applied before standards are released.
This item has also been incorporated into the lifecycle discussion section in the previous strategic initiative.
Evaluation Against Success Criteria
HL7 will conduct additional quality assurance on products and projects. Products and projects will be evaluated using success criteria defined in the original project plan.
Where possible guidelines, such as the ARB Substantive Change and Publishing Facilitator Guide, which can be “self-administered”, will be used.
The subgroup’s recommendations in this area are incorporated into the lifecycle discussion in the previous initiative.
QC Process to Leverage Best Practices
HL7 will implement a Continuous Quality Process to leverage best practices and continue to examine ways to improve the project management process.
Not only is quality an important element of the product-project lifecycle definition as it relates to committee work, it is important to also evaluate the lifecycle definition and associated project management process itself as it is used over time. The subgroup does not intend to imply that our recommendations and proposal are cast in concrete. It should evolve over time to respond to identified flaws as a result of usage, but also evolve as HL7 continues to evolve as a standards development organization. Thus the organization needs to adopt a continuous quality process. The subgroup explored several models but does not have a specific recommendation at this time. The recommendation for the creation of the Product-Project Lifecycle Task force includes this work.
APPENDICES
Appendix 1:
Strategic Initiative Task Force
➢ Chuck Meyer, Chair of HL7, Co-Chair, SITF
➢ Hans Buitendijk, BoD, Chair of the Organizational Review Committee (ORC), Co-Chair, SITF
➢ Alexis Grassie, HL7 Canada
➢ Freida Hall, Secretary of HL7, ORC member
➢ Dick Harding, HL7 Australia
➢ Charles Jaffe, MD, PhD
➢ Don Kamens, MD
➢ Randy Levin, MD, BoD
➢ Kenneth McCaslin, Co-Chair Electronic Services Committee
➢ Mark McDougall, Executive Director of HL7
➢ Norbert Mikula, Co-Chair Marketing Committee
➢ Sharon Moore, HL7 Canada
➢ David Murray, Co-Chair Marketing Committee
➢ John Quinn, Chair of the Technical Steering Committee, BoD
➢ Laura Sato
➢ Mark Shafarman, Immediate Past Chair of HL7, BoD
➢ Klaus Veil, HL7 Australia
➢ Fran Turisco, RWJ Grant Oversight
➢ Cherri McGrew, Lead consultant
➢ Robert Mittman, Consultant
➢ Pete Kitch, Consultant
➢ Deirdre Crowley, Consultant
Implementation Actions Subgroups
New Business Model and Organizational Structure
Chuck Meyer, chair, Liora Alschuler, Hans Buitendijk, Ed Hammond, PhD, Mark McDougall, Cherri McGrew, Norbert Mikula, Sharon Moore, Dan Russler, MD, Laura Sato, Fran Turisco, Mead Walker, and Klaus Veil
Product and Services Strategy
John Quinn, Allie Grassie, Dick Harding, Co-chairs, Bob Dolin, Bill Braithwaite, Ken McCaslin, Dan Russler, Laura Sato, and Mark Shafarman
Communications and Branding
David Murray, Chair, Liora Alschuler, Chuck Jaffe, Randy Levin, Norbert Mikula, Fran Turisco
Productivity Management and QC
Frieda Hall and Ken McCaslin, Co-chairs, Jane Curry, Sharon Moore, Wes Rishel,
Laura Sato
Methodology
The following is a summary of the work completed in support of this project:
➢ The purpose and focus of the strategic initiative project were confirmed at the August 2005 BoD retreat. Input from the external Advisory Committee was shared during this meeting and select members of that Committee were subsequently interviewed.
➢ The SITF, consisting of 15 HL7 members and staff, covering a broad spectrum of membership and functional areas, was assembled. This group was charged with developing the content of the strategic plan with the guidance and support of the consulting team.
➢ Through the course of 40 face-to-face interviews, 15 responses to the same questionnaire posted on the website, and informal discussions at the working group meetings, the consulting team developed a clear understanding of the various issues facing HL7.
➢ Through a visit to headquarters and review of the technical committees, current development/approval procedures, operational processes and systems, staffing and other critical aspects of the infrastructure, and participation in the ORC and other committee conference calls the consulting team developed a clear understanding of the current state of the organization.
➢ Through an external positioning survey, 15 individuals (not involved with HL7) representing vendors, consultants, healthcare providers, payers, research, public health, standards development organizations, and professional associations were interviewed by the consulting team to understand the external world view of HL7 and its role in healthcare IT.
➢ From these data sources the consulting team developed a set of preliminary issues, which formed the framework for the discussions at the first SITF meeting in October 2005.
➢ At the October SITF meeting, 13 strategic questions were identified. During November and December four SITF subgroups (Product and Services Strategy, Organization, External Positioning, and Process and Productivity) worked, via conference calls and emails, on responses to these questions.
➢ The subgroup chairs met with the consulting team in early January 2006 to review the responses to the 13 strategic questions. The outcome of this meeting was a draft set of strategic recommendations.
➢ Nine strategic recommendations were identified and received preliminary review by the BoD at its January meeting, providing an interim status report on the direction of the project.
➢ As a result of a SITF meeting February 28-March 1, 2006, the nine strategic recommendations were pared down to seven and key issues were identified for each. These strategic recommendations were presented to the BoD and approved on March 6, 2006.
➢ With subsequent BoD input, the SITF developed the proposed implementation action plan for the seven strategic recommendations.
Appendix 2: New HL7 Global Organizational Chart
Appendix 3: Organizational Changes: New Functions
The objective of the overall organization structure is to clarify responsibilities and streamline HL7’s ability to support business processes and functions. At this point it has not been determined who within the organization will perform the following functions so they do not appear on the new organization chart. However, these functions will be further defined and assigned to specific positions during the transition project.
Part of the rationale of the new organizational model is to improve accountability in staffing models by:
➢ Providing adequate staffing to support the volunteer functions
➢ Defining position descriptions and staff qualification requirements
➢ Defining management and staff accountability for revenue, cost, and quality
➢ Clarifying reporting relationships for both staff and volunteers
Key aspects of the new organizational structure include:
Sales: Creates revenue streams from membership, education, working group and user meetings; establish/provide tutorials, support documentation; and pursues grants and other funding mechanisms.
Marketing: Creates, presents and maintains HL7’s image and value proposition to the industry; positions HL7’s products (Messages, Rules, Documents, Services, etc. standards); and manages public relations. Provides branding and image management. See description in Branding recommendation.
Production: Produces HL7 standards for publication on the Web and in print using professional editorial and publishing processes. Provides and maintains the infrastructure necessary to create, document (including technical editing), ballot, and distribute standards.
Project Management: Provides a project management framework and administrative support for the development and production of standards. This position owns project definition, tracking and coordinating deliverables from project inception to publishing.
Volunteer Resources: Elevates volunteer support and coordinates a volunteer resource management program that encompasses volunteer mentoring, training, matching skills to opportunities, and communication.
Product Management: Plans, develops, and harmonizes the various standards (messages, documents, services, rules, etc.) and manages standards development in conjunction with volunteers and staff.
Product managers shall:
➢ Establish the Positioning Statement for a Product Line—Product Envisioning, Business Cases, etc.
➢ Determine the Product Lifecycle for a Product Line (introduction to market, growth, maintenance, and withdrawal from market)
➢ Identify scope of each “version” or “release” of the product
➢ Track and improve the product costs and revenues for the product line
➢ Coordinate with Marketing on communications relevant to the product line, especially around release dates
➢ Coordinate with Marketing on packaging of the product and its relationship to other products
➢ Coordinate with Project Management and Production on release dates, error correction releases, quality, etc.
Within Product Management there is a volunteer focus on:
Foundation & Technologies – Create the fundamental aspects necessary to standards development including the development framework, ITS, RIM, etc.
Standards & Semantic Design – Create key patterns and structures used throughout various standards such as personnel, orders, medication, genomics, clinical statements.
Domain Experts – Create messages, documents, services to meet specific domain needs such as pharmacy, laboratory, pediatrics, etc.
Appendix 4: Revenue Model and Business Plan
IT vendors who use HL7 standards as the messaging standard for interfaces among their products, and pharmaceutical firms and government(s) that use HL7 standards in support of many of their programs (e.g. clinical trials, RHIOs, etc) need to support the development and ongoing support for these standards. The new message for users of HL7’s standards is: “HL7 is the leading SDO for healthcare data and messaging standards and is committed to its continued development and support. Non-provider organizations that greatly benefit from using these standards should financially support standards development in order for HL7 to be efficient and effective. In essence, it is a cost of doing business for them – ‘pay for value’.”
An initial estimate of additional revenue required to implement the SITF recommendations is $1.5 million over the current HL7 budget. For an infusion of revenue in early 2007, the SITF recommends that the membership fees and benefits be restructured to ensure those that benefit financially from HL7 standards share in the cost of their development. There are a number of government agencies, currently building programs on HL7 standards, which are contributing only a minor amount in membership fee revenue to standards development. The SITF recommends that a separate category for government agencies be developed with membership fees commensurate to those for the private sector members.
Also, the SITF recommends that the revenue contribution from affiliates be increased from 10% to 20% of membership fees, phased in as the membership structure is refined.
The worksheets in Attachment 5 demonstrate options for increasing membership fees. These fees are certainly in line with other non-profit organizations, particularly at the benefactor and supporter levels and would net HL7 an additional $1.5-1.8 million annually.
HL7 must develop a ROI for corporate members demonstrating that corporate members will be supporting less of their staff’s time on HL7 support functions and more time on technical standards development activities. This could result in fewer staff at WGMs, shorter WGMs, reviewing multiple, duplicative ballots, etc.
Other revenue options to consider:
➢ Develop a licensing agreement for companies using HL7 standards as the platform for their products or are critical to their data collection efforts (regardless of the size of the company). Including for example:
• Inpatient Clinical systems vendors
o Ambulatory vendors
• Integrators
• Other software/hardware vendors
• Pharmas (semantic interoperability critical for them to be able to use EMR data)
• For government agencies:
o Identify programs relying on HL7 standards for data sharing
o Negotiate grant/contracts to support standards development (particularly the standards Dr. Brailer has called for)
• Develop individual testing/certification for a fee
• Grant funding for specific HL7 standards development projects:
o Government agencies
▪ US
o NIH – e.g. clinical research requirements
o FDA – e.g. medication related projects
o CDC – e.g. bio-surveillance requirements
o Other governments
o Foundations
o Other organizations
• Create marketing opportunities for sponsors on the website; increase sponsorship role in an expanded HL7 exhibit effort
• Look to companies benefiting from HL7 standards to provide in-kind staff support
Appendix 5: Proposed Increase in Membership Fees
|MEYER VERSION | |
|and the one from category 2 ($3,200) would actually be paying $6,400; totaling $22,000 | | | | |
|MCGREW VERSION | |Number of | | |Proposed Dues | | |
|Benefactor |$17,000 |23 |$391,000 | |$50,000 |$1,150,000 |$759,000 |
|Supporter |2 x dues | |$11,000 |6 @ $1,300; 1 @ $3,200 | |$20,000 |$9,000 |
|> $50 Million |$13,000 |14 |$182,000 | |$25,000 |$350,000 |$168,000 |
|$25-50 Million |$9,000 |5 |$45,000 | |$20,000 |$100,000 |$55,000 |
|$10-25 Million |$5,400 |13 |$70,200 | |$10,000 |$130,000 |$59,800 |
|$5-10 Million |$3,200 |18 |$57,600 | |$5,000 |$90,000 |$32,400 |
|$20 Million |$5,500 |7 |$38,500 | |$7,500 |$52,500 |$14,000 |
|$10-20 Million |$4,000 |15 |$60,000 | |$5,000 |$75,000 |$15,000 |
|$5-10 Million |$2,300 |9 |$20,700 | |$3,000 |$27,000 |$6,300 |
|$1-5 Million |$1,450 |35 |$50,750 | |$2,000 |$70,000 |$19,250 |
| $100 Million |$6,000 |5 |$30,000 | |$7,500 |$37,500 |$7,500 |
|$50-100 Million |$4,500 |0 |$0 | | | | |
|$10-50 Million |$3,000 |0 |$0 | | | | |
|$5-10 Million |$1,450 |1 |$1,450 | |$2,000 |$2,000 |$550 |
|< $5 Million |$1,000 |4 |$4,000 | |$1,300 |$5,200 |$1,200 |
|additional members |$450 |1 |$450 | |$1 |$500 |$50 |
| | | | | | | | |
| |$700 |84 |$58,800 | |$1,000 |$84,000 |$25,200 |
|Benefactors |$10,500 |3 |$31,500 | |$15,000 |$45,000 |$13,500 |
|additional members |$450 |13 |$5,850 | |$500 |$6,500 |$650 |
| | | | | | | | |
| |$450 |668 |$300,600 | |$500 |$334,000 |$34,000 |
| |$125 |48 |$6,000 | |$125 |$6,000 | |
| | | | | | | | |
| | | |$55,574 | |20% incr. |$66,690 |$11,116 |
| | | | | | | |$1,501,716 |
|POSSIBLE NEW EXPENSES |
| | |
|CEO |$250,000 |
|CTO |$250,000 |
|.25 Marketing Prof. |$50,000 |
|3 Proj. Mgrs. |$300,000 |
|Tech Editor |$100,000 |
|Overhead&exp. |$300,000 |
|Addit. Staff |$100,000 |
|Total |$1,350,000 |
Appendix 6: Initial Thinking on Product and Services Strategy
The following HL7 Service Lines have been identified:
|Service Line |Status |Focus |Support/Maintain/Retire |
|V3 Structured Documents |Needs reworking |Documentation |Support creation of documentation in |
| | | |next 18 months |
|V3 CDA & Messaging | | | |
|V2 Messaging |Mature | |Maintain and focus on education and |
| | | |certification |
|CCOW |Mature |Tutorials |Are we marketing it? |
|Arden Syntax |Mature | |What to do? |
|V3 Methodology at |New suggestion | | |
|system-level design | | | |
Initial Product and Services Strategy
It is recommended that an assessment of whether V3 can be modified to make it attractive to potential users be conducted immediately. Assuming that V3 (or some modification, repositioning, or subset thereof) is acknowledged as the way to go, it is clear that V3 documentation is not acceptable. One option is to create an implementation guide for V3 and negotiate a joint venture with IHE to present as part of a 200x Connectathon.
V2 will be maintained and the focus will be on education and certification around this product.
It is recommended that the Board address the issue of HL7 positioning in relation to other SDO’s and accreditation organizations. The consistent message from the government has been that we need one set of standards across all healthcare IT applications. It is recommended that the Board explore an overarching role in integration of healthcare standards within the US when it meets in August. What role should HL7 play in national integration.
Product Vision
1. HL7’s products and services will be driven by current and future user priorities and needs, as represented through use cases in different geographies, clinical domains, and user settings.
2. HL7 will create a family of standards so that users can share information from one system, application, or clinical domain with any other without any loss of information or meaning. (HL7 will strive for computable semantic interoperability up and down its product line.)
3. HL7 will recognize that many users will implement different standards from across its product line. Those standards will be designed to be implemented and to work together easily and seamlessly. In particular, many users will have implementations that include elements of the V2 and the V3 messaging standards.
4. HL7 will strive to have its standards recognized by national and international standards bodies.
Elements of Product Strategy
1. Acknowledge the impact of legacy installations of version 2.x primarily as intra-provider, especially in the United States. These thousands of existing interfaces work well but are not, in general, particularly portable outside of their specific environments. It is often difficult to establish a business rationale to upgrade a working interface even when the standard evolves as it does from 2.x to 2.x+1, let alone from version 2.x to 3.
2. Market the RIM as a separate product that is the most widely accepted, comprehensive inventory of data used in health care and relationships between users and the data. Name and position it in a way that is understandable to a general health care IT management audience.
3. Improve the documentation of V3 and, especially, the RIM, so that it is very clear to implementers what is intended. Hire a technical editor to address existing inconsistencies and lack of clarity in that documentation.
4. Market the V3 and the RIM as key tools in distributed, cross-organization environments, such as public health applications, regional health information organizations, etc. Highlight the use of the RIM as a tool for analyzing existing interfaces in a way that allows precise specification of changes needed for achieving semantic interoperability among sites and regions.
5. Recognize CDA, CCOW and Arden Syntax as distinct HL7 products. Document and advertise what they are and how they provide value to their users in language that health IT business people in all industry segments (e.g., payer, pharmaceutical, etc.) can understand.
6. Develop implementation guides and templates that make it easy for users at every stage of standard development, implementation, and use.
Elements of Services Strategy
1. Educate users on the relative positions of Version 2.x and Version 3.0. Provide guides with scenarios of when to apply version 3 and when to maintain existing Version 2.x interfaces. Educate the existing users and potential markets that HL7 Version 3 is designed to have the portability that version 2.x lacks. That it is “the” standard that is being used internationally to connect electronic health information among governments and health provider organizations and that it will be in the best interest of current 2.x interface users to upgrade those interfaces to version 3.x when it makes sense (e.g., when an application is replaced). Create guides that take a user through scenarios where developing new interfaces in HL7 Version 3 make sense and where maintaining existing interfaces in 2.x with an eye towards eventual migration to Version 3 makes sense instead.
2. Emphasize education through white papers, articles, books and other channels that will reach users and implementers (in addition to developers).
3. Create easy-to-use tools for interface developers and health care IT architects. Document those tools, keep them current and then make them available to members for free downloading.
4. Expand certification services to include all products and the use of the tools.
Strategic Issues to Address
1. Our production of tooling for V3 is fragile and dependent on very few individuals. We must build a more robust tool-building system.
2. There are network effects, especially in the US, that reinforce the continued use of V2 messages and impede the implementation of V3, including the large existing installed base of V2, the complexity of interlinked systems that use V2, the complexity and steep learning curve for V3, the lack of robust tooling for V3 implementations, and the lack of critical mass of early V3 adopters.
3. HL7 is too oriented toward “technology push” rather than “market pull.” It must put lace mechanisms to assure it is meeting user needs and that its products will be adopted once produced.
Appendix 7: Branding and Communication Implementation Activities
| |3 months |6 months |9 months |12 months |
|A. HL7 Brand | | | | |
|1. Hire .25 FTE marketing expert|a. Define skill set and profile for | | | |
| |marketing expert; contract with marketing | | | |
| |professional | | | |
| | | | | |
| |Marketing Committee and CEO | | | |
|2. Define the Brand |a. Review materials from SI and Marketing |c. Submit the brand strategy to the Board |d. Once strategy is approved, tailor the |f. Technical review of white paper |
| |Committee |for approval |message | |
| | | | |CTO/Technical Directorate |
| |Marketing expert | |Marketing expert | |
| | | | | |
| |b. Develop the branding strategy | |e. Draft white paper | |
| | | | | |
| |Marketing expert working with the Marketing| |David Murray and Norbert Mikula a. | |
| |Committee to refine | |Technical review of white paper | |
|B. Website Redesign | | | | |
|1. Redesign and implement a new |a. Engage a website development firm to |d. Define specs and content |e. Implement new website |g. Update and maintain the website monthly |
|web presence. |create a new website. | | | |
| | |Marketing Committee, Products and Services |Website design firm and staff |HL7 communications and website staff |
| |b. Provide technical guidance to website |group, Electronic Services Committee, CEO, | | |
| |firm |CTO |f. Refine website | |
| | | | | |
| |Electronic Services Committee, CEO, | |Website design firm and technical group | |
| |Products and Services Group, Productivity | |from 3b | |
| |group, and Marketing Committee | | | |
| | | | | |
| |c. Design website plan including external | | | |
| |and internal messaging | | | |
| | | | | |
| |Website firm with review by above group | | | |
|C. Outreach | | | | |
|4. Create new outreach |a. Develop market segmentation matrix |e. Create targeted messages |f. Develop roll out/marketing plan |h. Develop a marketing campaign |
|opportunities |b. Prioritize segments | | | |
| |c. Develop speakers bureau |Marketing professional |Marketing Committee and marketing |Marketing Committee and marketing |
| | | |professional |professional |
| |Marketing Committee | | | |
| | | |g. Begin defining user group events: |i. Create outreach forums representing |
| |d. Create standard presentations and | |-WGM - Hold ½ day session with |market segments |
| |speaker kit | |non-standards developer stakeholders | |
| | | |-Develop list of conferences to target (HL7|CEO and Marketing Committee |
| |Marketing Committee and marketing | |user space) | |
| |professional | |-develop a plan to reach decision makers |j. Conduct external perception survey |
| | | |(CxOs) | |
| | | | |k. Develop plans for Forums |
| | | |Marketing Committee and CEO | |
| | | | |Marketing Committee and CEO |
Appendix 8: Project Lifecycle on HL7 Products
The following table illustrates the association/impact of the HL7 Project Lifecycle on example HL7 products.
|HL7 Product Lines |V2 |V3 |
|Request for New Product |Steward Domain Committee identifies new project, following HL7 guidelines; or |
| |Other stakeholders identify new project and request Steward Domain Committee to endorse and |
| |host. |
|Request for Enhancement |Steward Domain Committee identifies requirement for enhancement/change to existing product. |
| |Other stakeholders identify enhancement/change to existing project and request Steward Domain|
| |Committee to host. |
|Appropriate Approvals |The Technical Directorate as defined by the HL7 organization and policy, review and approve |
| |the project request |
|Product Sunset (see section at end) | | |
|Project Initiation (Find resources and|Secure resource commitments and other resources to support work (e.g. collaborative tools) |
|find funding, develop project plan) |Prepare budget, secure funding if applicable |
| |Schedule work time, e.g. conference calls, WGM agenda, out-of-cycle meetings (requires Board |
| |approval) |
|Appropriate Approval to Move Forward |Sign off Project Charter by Technical Directorate |
|Requirements Definition |Identified via last ballot reconciliation, |Identified via last ballot reconciliation, or |
| |online database change request submission, or |other request to steward committee. |
| |other request to steward committee. |Draft new content per Publication Style Guide |
| |Draft new content per Publication Style Guide |and HL7 Development Methodology |
|Logical Design & Methodology |Resolve applicable cross-domain issues |Resolve applicable cross-domain issues, e.g. |
|Refinement | |data types, message wrapper, etc. |
| | |RIM Harmonization |
| | |DMIM, RMIM, HMD |
|Draft Specification |DSTU ballot |DSTU ballot |
| |Submit RFI and Project Charter request to |Submit RFI and Project Charter request to |
| |ballot. |ballot |
| |“3 strikes” rule, invokes automatic assessment|“3 strikes” rule, invokes automatic assessment|
| |by Technical Directorate with 3rd failed |by Technical Directorate with 3rd failed |
| |iterative ballot. |iterative ballot. |
|DSTU Ballot |Must pass Publishing criteria to be balloted |Must pass Publishing criteria to be balloted |
| |Must pass V2 database QA |Must pass V3 validation rules. |
| |Must pass message format validation |DSTU should include V2 mapping for associated |
| |(Workbench) |content |
| |Implementation by early adopter, development | |
| |partner, or persistent demo/test lab. | |
| |DSTU may serve as quality test. | |
| |DSTU should include V3 mapping for any new V2 | |
| |content | |
|DSTU Validation (This step may include|DSTU serves as quality test |
|iterations of DSTU with accelerated | |
|revisions based on industry use) | |
|Industry use of DSTU (provides input |Steward committee conducts ‘post mortem’ with input from early adopters |
|to DSTU) | |
|Normative Balloting and Publication |Prerequisite successful DSTU ballot or |Prerequisite successful DSTU ballot or |
| |exception approval |exception approval |
| |Prior ballot reconciliation completed with |Prior ballot reconciliation completed with |
| |appropriate negative vote disposition. |appropriate negative vote disposition. |
| |Must pass Publishing criteria to be balloted |Must pass Publishing criteria to be balloted |
| |Must pass V2 database QA |Ballot must pass successfully with no |
| |Must pass message format validation |substantive change and all negative issues |
| |(Workbench) |resolved. |
| |Ballot must pass successfully with no |“3 strikes” rule, invokes automatic assessment|
| |substantive change and all negative issues |by Technical Directorate with 3rd failed |
| |resolved. |iterative ballot. |
| |“3 strikes” rule, invokes automatic assessment| |
| |by Technical Directorate with 3rd failed | |
| |iterative ballot. | |
|Implementation and Training (completed|Develop appropriate implementation guides, or accept/endorse externally developed. |
|for final specification) |Develop training, or endorse externally developed. |
| |Conformance test packs and reference applications |
|Project Complete – Alert Marketing, |Publish final normative version per publishing guidelines. |
|Product Ready for Delivery | |
Product Sunset
|HL7 Product Lines |V2 |V3 |
|Project Initiation (Find resources and|Steward Committee decides to withdraw standard; recommends sunset to Technical Directorate |
|find funding) | |
|Appropriate Approval to Move Forward |Appropriate Sign off Project Charter |
| |Final review of standard being withdrawn, update to include technical corrections if |
| |applicable. |
| |Develop/publish transition plan to new standard. |
|Review Documentation | |
|Announce and Set Sunset Date |Post final version to member website |
-----------------------
Domain
Expert
Chairs
Other Product Managers
V3 Documents Product Manager
V3 Message Product Manager
V2 Message Product Manager
Product Management
(Product Planning, Revenue Planning, Business Cases, Harmonization,
Authoring, Content Editing)
Operations
COO/Executive Director
Project Management
(Owns the delivery of the projects—tracks and coordinates deliverables from product management to publishing)
External Partnerships
SDO’s, Government, etc
Marketing
(Sales Support)
Product Marketing
Public
Relations
Production
(Document Publication, Web Publication, Technical Editors, Tooling, etc.)
Grants
Documents
Tutorials
Sales
(Revenue Production)
Board of Directors
Donations
HL7 Membership
Tooling Rollout
(Educational/Support Training)
Foundation &
Technologies
Chairs
Affiliate Relations
Membership
Structure &
Semantic Design
Chairs
Technical Directorate
CTO, Technical Advisory Committee, technical staff
Meetings
CEO
Volunteer Resources
Technical Steering Committee
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