HL7 Development Who Does it and How Do They Do It?

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HL7 DevelopmentWho Does itand How Do They Do It?

• Shari Dworkin
• CIHI
• June 7, 2001
• SHIN HL7 Workshop

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Presentation Overview

• Who - The Movers and Shakers
• Membership
• Working Group
• Collaboration
• How - The Evolution of the Standard
• Balloting
• v2.x Development
• v3 Development
• Publications

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Who - The Movers and Shakers

• Membership
• Working Group
• Collaboration

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Who are Members of HL7 (.org)

• 450 Organizational Members, 2131 Members of HL7
  (US)
• 946 Vendors
• 641 Providers
• 256 Consultants
• 119 Non Profits
• 13 Payors
• 18 Pharmacy
• 60 Affiliates
• 24 Students
• 54 Unknown

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What Do HL7 Members Do?

• Members develop the standard
• Participation in Working Group Meetings
• Voting on HL7 Ballots
• Providing input on listservers and
  teleconferences
• Informing HL7 Canada of issues or recommendations
  regarding the HL7s standard

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What is an HL7 Working Group?

• The Working Group is the name that shall be given
  to those activities related to the production and
  use of the Standard.
• The Working Group consists of the set of
  individual Technical Committees and Special
  Interest Groups which are focused on particular
  HL7 protocol specification issues and areas.
• Taken from HL7 Bylaws

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Key to HL7 - The Working Group

• Draws equally from providers, software vendors,
  and consultants (interested parties)
• Group sets aside their individual interests,
  rolls up their sleeves and collaborates to get
  the tough work done
• Most discussions stem from
• violent agreement, but failure to see the
  agreement
• passionate beliefs
• Strong facilitators in the working group that
  help to resolve issues
• Hard Work
• 12 hours x 5 days x 3 general meetings / year
• 12 hours x 3 days x 3 harmonization meetings /
  year
• Active electronic collaboration in between

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HL7 TCs and SIGs

• Technical Committees (TCs)
• Responsible for the development and maintenance
  of a section of the standard (usually a chapter)
• Exceptions (Vocabulary, Education, Marketing,
  Publishing, and International Affiliates)
• Special Interest Groups (SIGs)
• Represent a variety of major initiatives in
  healthcare
• Work in conjunction with TCs to advance the
  efforts of HL7

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HL7 (.org) Technical Committees

• CCOW
• Clinical Decision Support
• Control / Query
• Data Warehousing
• Education
• Implementation
• International Affiliates
• Marketing
• Medical Records / Info. Management
• Modeling and Methodology

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HL7 (.org) Technical Committees (contd)

• Orders / Observations
• Pt. Admin. / Financial Management
• Patient Care
• Personnel Management
• Publishing
• Scheduling and Logistics
• Structured Documents
• Vocabulary

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HL7 (.org) Special Interest Groups (SIGs)

• Arden Syntax
• Attachments
• Blood Bank
• Clinical Guidelines
• Clinical Trials
• Community-Based Health Services
• Conformance
• Government Projects
• Image Management
• Lab Automation

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HL7 (.org) Special Interest Groups (SIGs) - contd

• Medication
• Patient/Provider Messaging
• Security and Accountability
• Templates
• XML

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HL7 (.org) Works with Other Key Stakeholders
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Collaboration Among Standard Development
Organizations

• X12 and HL7 - Claims Attachment and Data Modeling
• DICOM WG20 and HL7 Imaging SIG - Joint Image
  Management SIG, IHE Demo
• IEEE and HL7 - Merged Activities
• HL7 and CEN - Message Development Framework, RIM
  and XMl syntax
• HL7 and ISO TC215 - Message Development Framework

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So How does all this lead to a new standard?
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How - The Evolution of the Standard

• Balloting
• v2.x Development
• v3 Development
• Publications

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Balloting

• HL7 (.org) is an ANSI approved Standards
  Development Organization
• According to ANSI rules, this means that
• All new versions of the HL7 standard must undergo
  a balloting process that is open to all members

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Balloting - The 5Ws

• HOW does something go to ballot?
• TCs propose new and/or improved content for the
  standard to HL7 Head Quarters
• WHO votes?
• HL7 (.org) have 1 vote
• HL7 International Affiliates have up to 8 votes
• WHEN do ballots take place?
• 120 day cycle, Three cycles per year

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Balloting - The 5Ws (continued)

• WHERE can you vote?
• Online - Ballots are available on the HL7 (.org)
  site and the HL7 Canada site
• WHY would want to vote?
• To influence the standard

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Balloting Procedures

• Two Rounds of Balloting
• Technical Committee Ballot
• Membership Level Ballot
• All negative ballots must be addressed
• According to ANSI rules, 90 of ballots must be
  affirmative

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HL7 v2.x Development

• New and/or improved content came from TCs and
  SIGs
• Members wrote specific chapters of the standard
  without considerations from other TCs or SIGs
• Content was added as needed, and under the
  discretion of the TC or SIG

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Limitations of Version 2.x

• No explicit information model
• Events not tightly coupled to use cases
• Need for controlled vocabularies
• No explicit support for security functions
• Optionality is troublesome
• Lack of harmonization between chapter domains
• Expansion of the standard led to incoherence

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Versions 2.x

• Strengths
• broad functional coverage
• highly adaptable
• IS environments differ
• system capabilities variations
• vocabulary independent
• least common denominator technological base

• Difficulties
• broad functional coverage
• highly adaptable
• Seen one? Seen one.
• vendor capability mismatch
• vocabulary independent
• least common denominator technological base

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HL7 Version 3 -

• HL7 grew up on the Version 2 series,
  culminating in 2.4
• But now, HL7 is into Version 3
• How is it different?
• Why is it important?

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HL7 v3 Development - We do it with Models!
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Version 3 Goals

• Provide a Message Development Framework based on
  modeling
• Improve clarity and precision of specification
• Improve adaptability of standards to change
• Work with other standards initiatives, such as
  DICOM
• Begin to approach plug and play

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Benefits of V3 to HL7

• Reduces optionality results in more specific
  messages
• Uncovers hidden assumptions about application
  boundaries (for everything there is a reason)
• Facilitates defining clear, fine-grained,
  conformance claims
• Allows for multiple implementation specifications
  (XML, CORBA, etc..)

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HL7 Version 3 Development Approach

• 1. Define a consensus reference information model
  (RIM) that defines the data of interest in the
  healthcare domain.
• 2. Assemble the terminology and data types
  necessary to express the attributes of the RIM
• 3. Apply the model, vocabulary and types to
  messages, patient record DTDs, medical logic
  modules, component specifications, etc.

Done
Done
Happening Now
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HL7 Version 3 Development Approach

• 4. For any particular application, draw from the
  RIM to construct an abstract message structure -
  the Hierarchical Message Description (HMD)
• 5. For any particular implementation technology,
  HL7 will define an implementation technology
  specification (ITS) for mapping the HMD to that
  technology.
• 6. When the message (or equivalent) is sent, the
  HMD is used to marshal the data, and the ITS is
  used to format the data for communication.

Beginning Now
Focus on XML
Implementation
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HL7 Modeling
Abstractions
Version 2.x focused its energies at the
communication level and covered the other
abstractions only loosely in the specifications.
Activities(Use Case Model)
Objects (Information Model)
Communication (Interaction and Message Models)
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HL7 Version 3 Models and Specifications

• Captures healthcare requirements
• Defines scope for TSC approval

• Specifies data and its semantics
• Specifies major state transitions
• Specifies vocabulary for domains

• Defines information flows
• Defines communication roles
• Forms basis for conformance claims

• Defines message contents
• Apply constraints to the information model and
  vocabulary

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HL7 V3 Message Development Lifecycle
Analysis
Design
Application
Messaging Message Types for use with
XML, ER7, etc (MET)
Requirements Analysis Use
Case Model (UCM)
Domain Analysis Information Model
Vocabulary (RIM)
Interaction Design Interaction Model (IM
)
Message Design HierarchicalMessageDescr
iptions (HMD)
Documents Document Types forHL7
PRA (DTD)
Medical logic Variable definition for
Arden syntax (AVD)
TYPE MPSLOC CONTAINS idid.TYPE
IID nmname.TYPE ST adaddr.TYPE
XAD phphon.TYPE XTN email_address
emlAdr.TYPE XTN
2-nd Order 1 choice of 0-n Drug
0-1 Nursing
lt!ENTITY DT_MPSLOCMPSLOC.id, MPSLOC.name?,
MPSLOC.addr?, MPSLOC.phon?, MPSLOC.emlAdr?"gt
datalocation_of_action READ LAST
MPSLOC patient location
Reference Model Repository
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How do we get to Version 3?
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v3 Strategy

• Board appointed V3 steering committee
• Woody Beeler (Chair), Wes Rishel, Abdul-Malik
  Shakir, Mark Shafarman, W. Ed Hammond
• Focus more working group time on Version 3
• One day on Version 2.X
• 4 days on Version 3
• Emphasize Version 2.x XML encoding for early
  adopters
• Move quickly on first V3 products
• CDA (Clinical Document Architecture) (Unanimous
  Approval)
• Version 3 data types
• V3 data type XML ITS (Implementable Technology
  Specification)

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Old and new will coexist.

• How will transition happen?
• Never touch a running system!
• HL7 v2.x versions will be operational for an
  extended transition period (5 to 10 years)
• HL7 v2.x will continue to be maintained for
  errors and clarification
• new features will only go into new versions of v2
  and HL7 v3
• New implementations may use HL7 v3 once it has
  been balloted
• V2 and v3 interfaces will coexist for the
  extended transition period.

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HL7 v3 Balloting
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Legend
Reference Content is harmonized during HL7
meetings or approved by the HL7 Board. It is not
subject to ballot acceptance
Informative Content is balloted by general
membership however, it is not considered to be a
structural part of the standard, only supporting
information.
Normative Content is balloted by general
membership and is considered structural component
of HL7 standard. Negative ballots MUST be
resolved.
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HL7 3.0 Core Publication Structure

• V3 Backbone
• Welcome
• Introduction
• V3 Principles
• Quick Start
• Getting Started
• Glossary

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V3 Backbone

• Equivalent to the 2.x Chapter 1
• Introduction
• Principles
• Managing message development
• Quick Start
• Getting Started
• Glossary
• Links to all other documents content.

• V3 Backbone
• Welcome
• Introduction
• Quick Start
• Getting Started
• Glossary

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HL7 3.0 Section Publication Structure
CMET
R-MIM
HMD
Message Type
Sub-sections
Domain
Application Roles
R-MIM
HMD
Message Type
Storyboard
Interaction Category
Storyboard Examples
Trigger Event
Interaction
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Committee Deliverables
Design Repository
Visio files
R-MIM
HMD
Message Type
R-MIM
Domain MDB
Domain
Application Roles
Storyboard
Interaction Category
Storyboard Examples
Trigger Event
Interaction
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Publication Format

• Publication in two final formats
• PDF
• appropriate for printing, submission to ANSII and
  off-line viewing
• Each document available as stand alone or will
  be inter-linked
• HTML
• Appropriate for viewing online
• Each document can be downloaded separately
• Backbone is required

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Publication Schedule

• June 15th Deadline for non-Section content
• July 9th Deadline for Section content
• July 9th to 13th Ann Arbour tiger team
  meeting to convert and test content
• July 17th to 19th Indianapolis meeting to
  review content with TCs
• August 8th Committee Ballot opens
• October - Reconciliation of negative Ballots
• January - Membership Level Ballot
• May - HL7 Version 3 Approved Standard

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Questions?