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HL7 MODELING & METHODOLOGY COMMITTEE

HL7 Version 3

Message Development Framework
Version 3.3 December 1999 Authors: George W Beeler, Stan Huff, Wesley Rishel, Abdul-Malik Shakir, Mead Walker, Charlie Mead, Gunther Schadow Copyright © 1999 by Health Level Seven, Inc. ALL RIGHTS RESERVED. The reproduction of this material in any form is strictly forbidden without the written permission of the publisher.


Table of Contents
1. INTRODUCTION ....................................................................................................................... 1-1 1.1 1.2 1.3 1.4 1.4.1 1.4.2 1.4.3 1.4.4 1.5 1.6 1.7 1.8 2. 3. ACKNOWLEDGMENTS.............................................................................................................. 1-1 DOCUMENT SCOPE .................................................................................................................. 1-1 OVERVIEW ............................................................................................................................. 1-2 WHY A MAJOR NEW VERSION? ............................................................................................... 1-3 Difficulties with the Existing Process ..................................................................................... 1-3 Opportunities to Improve....................................................................................................... 1-3 Optionality is a Four Letter Word .......................................................................................... 1-4 Limitations of the New Approach ........................................................................................... 1-4 METHODOLOGY PREVIEW ....................................................................................................... 1-5 DOCUMENT STRUCTURE.......................................................................................................... 1-8 METHODOLOGY 2000: MESSAGING AND BEYOND .................................................................... 1-9 REFERENCES......................................................................................................................... 1-10

GLOSSARY OF VERSION 3 TERMS AND ACRONYMS ....................................................... 2-1 PRINCIPLES OF VERSION 3 ................................................................................................... 3-1 3.1 SCOPE, TARGET USERS ........................................................................................................... 3.1.1 Internationalization ........................................................................................................ 3.1.2 Support for Legacy Systems ............................................................................................ 3.2 LOOSELY COUPLED SYSTEMS .................................................................................................. 3.2.1 Modes and Topologies .................................................................................................... 3.3 INTER-VERSION COMPATIBILITY .............................................................................................. 3.3.1 Compatibility with Versions 2.X ...................................................................................... 3.3.2 Compatibility Among Versions 3.X.................................................................................. 3.4 DETERMINING CONFORMANCE ................................................................................................ 3.4.1 Application Role ............................................................................................................. 3.4.2 Conformance Claims ...................................................................................................... 3.5 CONFIDENTIALITY AND SECURITY ........................................................................................... 3.5.1 Confidentiality of Patient Information ............................................................................. 3.5.2 Authenticated Authorization for Services ......................................................................... 3.5.3 Security, Privacy, Non-Repudiation and Integrity ............................................................ 3-1 3-1 3-1 3-1 3-1 3-2 3-2 3-2 3-3 3-3 3-3 3-3 3-3 3-4 3-4

4.

MANAGING MESSAGE DEVELOPMENT.............................................................................. 4-1 4.1 4.2 4.3 4.4 4.5 4.6 4.7 PROJECT SCOPE DEFINITION .................................................................................................... VERSION 3 METHODOLOGY..................................................................................................... DOCUMENT STRUCTURE.......................................................................................................... DATA FIELD DOMAINS ............................................................................................................ QUALITY ASSURANCE PROCESSES ........................................................................................... PROCESS SUPPORT .................................................................................................................. MANAGEMENT........................................................................................................................ 4-1 4-1 4-2 4-2 4-2 4-3 4-3

5.

USE CASE MODEL .................................................................................................................... 5-1 5.1 OVERVIEW ............................................................................................................................. 5-1 5.1.1 HL7 Messages and Use Case Analysis ............................................................................ 5-4 5.1.2 Use Case Analysis and Storyboards ................................................................................ 5-6 5.1.3 Use Case Analysis and the MDF ..................................................................................... 5-7 5.1.4 Actors............................................................................................................................. 5-9 5.1.5 Storyboards, Scenarios, and Use Case Paths................................................................. 5-10 5.2 PROCEDURES ........................................................................................................................ 5-11

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5.3 DOCUMENTATION ................................................................................................................. 5.4 TUTORIAL SUGGESTIONS AND STYLE GUIDE .......................................................................... 5.4.1 Project Scope Statement ............................................................................................... 5.4.2 Use Cases..................................................................................................................... 5.4.3 Actors........................................................................................................................... 5.5 CRITERIA .............................................................................................................................. 6.

5-13 5-14 5-14 5-14 5-17 5-19

INFORMATION MODEL .......................................................................................................... 6-1 6.1 OVERVIEW ............................................................................................................................. 6-1 6.1.1 Information Model Components ...................................................................................... 6-1 6.1.2 Information Model Notation and Meta-Model ................................................................. 6-1 6.1.3 Types of Information Models........................................................................................... 6-2 6.1.4 Information Model Harmonization .................................................................................. 6-2 6.2 WORK PRODUCTS ................................................................................................................... 6-3 6.2.1 Static Structure: Classes and Relationships ..................................................................... 6-3 6.2.2 Information Content: Attributes, Values, and Constraints ................................................ 6-8 6.2.3 Dynamic Behavior: States and Transitions .................................................................... 6-15 6.3 PROCEDURE .......................................................................................................................... 6-17 6.3.1 Construction/Refinement of a Domain Information Model ............................................. 6-18 6.3.2 Update/Harmonization of the Reference Information Model .......................................... 6-37 6.3.3 Construction of the Message Information Model ........................................................... 6-40 6.4 SUMMARY OF INFORMATION MODEL STYLE GUIDELINES ....................................................... 6-41 6.4.1 Classes ......................................................................................................................... 6-41 6.4.2 Relationship ................................................................................................................. 6-42 6.4.3 Attributes, Data Types, Constraints, and Defaults ......................................................... 6-43 6.4.4 States and State Transitions .......................................................................................... 6-44 6.4.5 Prepare RIM Change Proposal ..................................................................................... 6-44 6.4.6 Review RIM Change Proposal with Stewards of Affected Classes .................................. 6-45 6.4.7 Participate in RIM Change Proposal Harmonization Meeting ....................................... 6-46 6.4.8 Define Message-set Specific Association Constraints..................................................... 6-46

7. ASSOCIATING VOCABULARY DOMAINS WITH ATTRIBUTES, ELEMENTS, AND FIELDS................................................................................................................................................ 7-1 7.1 VOCABULARY DOMAINS ......................................................................................................... 7-1 7.1.1 General disclaimer ......................................................................................................... 7-1 7.1.2 Introduction.................................................................................................................... 7-1 7.1.3 Vocabulary Domains, and Vocabulary Domain Specifications......................................... 7-1 7.1.4 Validating Vocabulary Domain Specifications and Constraints ....................................... 7-2 7.1.5 Vocabulary Domain Constraints ..................................................................................... 7-3 7.1.6 The Domain Specification Database ............................................................................... 7-3 7.1.7 Use of the vocabulary domain specification database .................................................... 7-14 7.1.8 Summary of vocabulary domains used in the specification of vocabulary domains (meta domains) 7-15 7.2 THE STRUCTURE OF CODED ELEMENTS IN MESSAGES .............................................................. 7-16 7.3 THE GENERAL PROCESS OF MAINTAINING DOMAIN SPECIFICATIONS ......................................... 7-22 7.4 GOOD VOCABULARY PRACTICES ............................................................................................ 7-24 7.5 USE OF EXTERNAL TERMINOLOGY'S IN HL7 STANDARDS ........................................................ 7-24 7.5.1 Process for registering vocabularies for use in HL7 ...................................................... 7-25 7.6 THE USE OF LOCAL VOCABULARIES IN CODED ELEMENTS ...................................................... 7-27 7.7 HL7 VOCABULARY AND THE UMLS METATHESAURUS ......................................................... 7-27 8. INTERACTION MODEL ........................................................................................................... 8-1 8.1 INTRODUCTION ....................................................................................................................... 8.1.1 Why build the Interaction Model? ................................................................................... 8.2 ELEMENTS OF THE INTERACTION MODEL ................................................................................. 8.2.1 Trigger Event ................................................................................................................. 8-1 8-2 8-2 8-2

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8.2.2 Application Role ............................................................................................................. 8-3 8.2.3 Interaction...................................................................................................................... 8-5 8.2.4 Interaction Sequence ...................................................................................................... 8-6 8.3 DIAGRAMMING INTERACTIONS ................................................................................................ 8-7 8.3.1 Sequence Diagram.......................................................................................................... 8-7 8.3.2 Collaboration Diagram .................................................................................................. 8-8 8.4 CONFORMANCE AND THE INTERACTION MODEL ....................................................................... 8-8 8.5 BUILDING THE INTERACTION MODEL ....................................................................................... 8-8 8.5.1 Defining Scope ............................................................................................................... 8-8 8.5.2 Building Interactions ...................................................................................................... 8-9 8.5.3 Validating Interactions ................................................................................................. 8-10 8.5.4 Grouping Interactions .................................................................................................. 8-10 8.6 INTERACTION MODEL QUALITY CRITERIA ............................................................................. 8-11 9. CONFORMANCE CLAIMS AND ORGANIZATIONAL PRACTICES ................................. 9-1 9.1 INTRODUCTION ....................................................................................................................... 9.1.1 Conformance Claims ...................................................................................................... 9.1.2 Good Organizational Practices ....................................................................................... 9.2 CONFORMANCE CLAIM WORK PRODUCTS ................................................................................ 9.2.1 Conceptual Model of HL7 Conformance Claims.............................................................. 9.2.2 Functional Statement of Conformance Criteria ............................................................... 9.2.3 Technical Statements of Conformance Criteria................................................................ 9.3 GOOD ORGANIZATIONAL PRACTICES ....................................................................................... 9.3.1 Good Organizational Practices for Vocabulary ............................................................... 10. 9-1 9-1 9-2 9-2 9-2 9-6 9-8 9-9 9-9

CREATING MESSAGE SPECIFICATIONS ....................................................................... 10-1

10.1 INTRODUCTION ..................................................................................................................... 10-1 10.1.1 Overview ...................................................................................................................... 10-1 10.1.2 Introduction to Version 3 Message Instances................................................................. 10-5 10.2 WORK PRODUCTS ............................................................................................................... 10-10 10.2.1 Message Information Model........................................................................................ 10-10 10.2.2 Refined Message Information Model ........................................................................... 10-13 10.2.3 Hierarchical Message Definition ................................................................................ 10-18 10.2.4 Common Message Element Type Definition................................................................. 10-22 10.3 PROCEDURES ........................................................................................................................... 23 10.3.1 Create the Message Information Model ............................................................................ 23 10.3.2 Create the Refined Message Information Model ............................................................... 23 10.3.3 Build the Hierarchical Message Definition....................................................................... 26 10.3.4 Creating the Common Message Element Type .................................................................. 29 10.4 DISCUSSION AND HELPFUL HINTS............................................................................................. 30 10.4.1 Representing Associations by Containment: Pseudo-hierarchies ...................................... 30 10.5 CRITERIA FOR EVALUATION OF WORK PRODUCTS ..................................................................... 30 10.5.1 Refined Message Information Model ................................................................................ 30 10.5.2 Hierarchical Message Definition ..................................................................................... 31 11. DEVELOPING HL7 MODELS USING UML AND RATIONAL ROSE ............................ 11-1 11-1 11-1 11-1 11-2 11-2 11-3 11-3 11-5 11-5 11-5

11.1 INTRODUCTION ..................................................................................................................... 11.2 MODEL TERMINOLOGY, PROPERTIES, DESCRIPTIONS AND STEREOTYPES .................................. 11.2.1 Preparing Rose for properties and stereotypes .............................................................. 11.2.2 Package vs. Category ................................................................................................... 11.2.3 The use of added HL7 properties to capture meta-data .................................................. 11.2.4 Capturing rationale. Issues and references in descriptions ............................................ 11.2.5 Use of Rose Stereotypes by HL7 .................................................................................... 11.3 STRUCTURE OF THE HL7 MODELS AS REPRESENTED IN ROSE.................................................. 11.3.1 Overall structure of the Rose model .............................................................................. 11.3.2 Model definition ...........................................................................................................

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11.4 USE CASE MODEL .................................................................................................................. 11-6 11.4.1 Model Structure ............................................................................................................ 11-6 11.4.2 Use case model categories ............................................................................................ 11-6 11.4.3 Use cases ..................................................................................................................... 11-7 11.4.4 Actors........................................................................................................................... 11-7 11.4.5 Use case dependency relationships ............................................................................... 11-7 11.4.6 Linking actors to use cases ........................................................................................... 11-8 11.4.7 Linkage to the subject class for a state transition........................................................... 11-8 11.4.8 Storyboards .................................................................................................................. 11-8 11.5 INFORMATION MODEL ......................................................................................................... 11-10 11.5.1 Model structure .......................................................................................................... 11-10 11.5.2 Subject areas and data type categories........................................................................ 11-10 11.5.3 Classes ....................................................................................................................... 11-11 11.5.4 Attributes.................................................................................................................... 11-11 11.5.5 Generalizations .......................................................................................................... 11-12 11.5.6 Associations ............................................................................................................... 11-12 11.5.7 Composite aggregations ............................................................................................. 11-13 11.5.8 States ......................................................................................................................... 11-13 11.5.9 State transitions .......................................................................................................... 11-14 11.5.10 Data types .............................................................................................................. 11-14 11.5.11 Data type components ............................................................................................. 11-15 11.5.12 Data type generalizations........................................................................................ 11-15 11.5.13 Generic data type instances .................................................................................... 11-15 11.6 INTERACTION MODEL .......................................................................................................... 11-16 11.6.1 Model structure .......................................................................................................... 11-16 11.6.2 interaction model categories ....................................................................................... 11-16 11.6.3 Application roles & Trigger Events ............................................................................. 11-16 11.6.4 Interactions ................................................................................................................ 11-19 11.7 CREATING A MESSAGE INFORMATION MODEL (MIM) .......................................................... 11-20 11.7.1 Model Structure .......................................................................................................... 11-20 11.7.2 Assembling the MIM ................................................................................................... 11-21 11.8 PROPERTIES DEFINED BY HL7 FOR USE IN ROSE ................................................................... 11-22 11.9 OVERVIEW OF USING ROSETREE II AND REVIEWING MODELS ................................................ 11-24 11.9.1 Functional Objectives ................................................................................................. 11-24 11.9.2 User Interface ............................................................................................................ 11-24 11.9.3 Viewing a Model......................................................................................................... 11-26 11.10 BUILDING AN R-MIM IN ROSETREE ................................................................................ 11-28 11.10.1 Building an R-MIM for the First Time ..................................................................... 11-28 11.10.2 R-MIM definition window ....................................................................................... 11-29 11.10.3 R-MIM node types .................................................................................................. 11-30 11.10.4 Adding classes to the R-MIM .................................................................................. 11-30 11.10.5 Cloning classes in an R-MIM .................................................................................. 11-30 11.10.6 Controlling association linkages ............................................................................. 11-30 11.10.7 Saving an R-MIM.................................................................................................... 11-31 11.10.8 Opening a Saved R-MIM from the Repository.......................................................... 11-31 11.10.9 Editing a MOD ....................................................................................................... 11-31 11.11 CONSTRUCTING AN HMD FROM AN R-MIM..................................................................... 11-31 11.11.1 Select root class ...................................................................................................... 11-31 11.11.2 HMD parameters .................................................................................................... 11-31 11.11.3 Walk the walk ......................................................................................................... 11-31 12. 13. 13.1 13.2 EXAMPLE_MODEL_FOR_MDF ........................................................................................ 12-1 SPECIFICATION OF THE HL7 MDF COMPONENTS..................................................... 13-1 META-MODEL ....................................................................................................................... 13-1 LIMITATIONS OF THIS META-MODEL ....................................................................................... 13-1

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13.1.1 13.1.2 13.1.3

Vocabulary domain specifications ................................................................................. 13-1 Use case generalization ................................................................................................ 13-1 Message design model .................................................................................................. 13-1

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Figures
Figure 1-1 Four Stages of Message Development.................................................................................. 1-6 Figure 1-2. HL7 Message Development Process Model ......................................................................... 1-7 Figure 1-3. Message Development Models............................................................................................ 1-8 Figure 5-1. This figure shows the UML representation of a protypical Use Case analysis defining the system boundaries and responsibilities for "Some System." Three Actors using "Some System" have been identified: two human users and one system. The Actors interact with Some System via three Use Cases, each of which represents a system responsibility. Not shown are the associated Products of Value produced for the Actor(s) by Some System as a result of the System's fulfilling of a named Responsibility. ............................................................................................................................... 5-1 Figure 5-2. A schematic representation of the iterative process of Use Case Analysis for defining system boundaries and system responsibilities. System boundaries are defined indirectly through the identification of Actors who lie outside those boundaries. System responsibilities are identified by virtue of the Products of Value that the system produces as a result of an interaction between the Actor and the system. In particular, the Product of Value is the direct result of an interaction between an Actor and the system, and is produced as a result of system fulfillment of one of its responsibilities. The "Product of Value" of Use Case analysis itself, i.e., the collection of Use Case diagrams and associated documentation referred to as the "Use Case model," providers the system's Functional Requirements Specification, as well as a framework for Test Plans and User Documentation/Training materials. ....................................................................................................................................... 5-2 Figure 5-3 . An initial "high-level" Use Case analysis has revealed two System Responsibilities. Responsibility 1 has been "decomposed" into two "lower-level" Use Cases which are contained within a subsystem/package named with the noun phrase "Management of Responsibility 1." Note that as the decomposition of a given high-level system Responsibility occurs, the Actors involved with the lower-level Use Cases may not be the same as those at the higher-level. In particular, other packages representing different "higher-level Use Case Responsibility Management" subsystems may themselves become Actors in a given subsystem's Use Cases because the lower-level Use Cases in the subsystem-of-interest produce a Product of Value for the other subsystem. ..................................... 5-3 Figure 5-4. A simplified high-level Use Case analysis of a virtual HL7 messaging system. System responsibilities are partitioned by message type (and ultimately by message), while Actors are identified by area-of-interest. Each System Responsibility is fulfilled by assembling and transmitting (or receiving and interpreting) the appropriate message(s). ............................................................. 5-4 Figure 5-5. This figure shows a high-level Use Case analysis of a prototypical (real or virtual) healthcare information system. Users (Actors) perform various domain-specific functions using the "system," which is often an interfaced/integrated collection of heterogeneous systems (and/or subsystems.) Message traffic flows between the various systems/subsystems as a direct result of interactions between the various Actors and systems/subsystems. However, the Actors per se are not aware of the messages at the level of construction, transmission, reception, or interpretation. These System Responsibilities are instead handled by the internal messaging subsystems of each of the domainspecific systems/subsystems. A Use Case diagram of a messaging subsystem therefore has nonhuman Actors. The MDF refers to these Actors as "Application Roles." (See text and Figure 5-6 for explanation)................................................................................................................................... 5-5 Figure 5-6. This Figure shows the Use Case relationship between the HL7 Messaging System and its Actors, the MDF-defined Application Roles, as well as the larger contextual relationship between the

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HL7 Messaging Conformance System as a set of responsibilities within a Messaging Subsystem (see Figure 5-6). The Actors receiving Products of Value from the HL7 Messaging Conformance System are noted simply as "Messaging Stakeholder"; however, their presence is meant to emphasize the layered architectural application of Use Case analysis in complex systems. Not mentioned are t