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1 HL7 Development Framework Tutorial Abdul-Malik Shakir Principal Consultant, Shakir Consulting April 2003

2 HL7 Development Framework Tutorial2 My HL7 Background Abdul-Malik Shakir Principal Consultant, Shakir Consulting, La Verne, CA HL7 Member since 1991 Member of the HL7 Board of Directors Chair of the Education and Implementation Committee Member of the Architectural Review Board Member of the Process Improvement Committee Co-Chair of the Modeling and Methodology Committee Project Manager for the HL7 Development Framework Project

3 April 2003HL7 Development Framework Tutorial3 Session Objectives To raise awareness of the HL7 Development Framework (HDF) project. To summarize the accomplishments and remaining planned activities of the HDF project. To introduce the HDF metamodel and its relationship to the UML metamodel To introduce the HDF methodology and its relationship to the MDF methodology To encourage your participation in designing and deploying the HDF methodology.

4 April 2003HL7 Development Framework Tutorial4 Session Overview Session I HL7 Development Framework Project Unified Modeling Language Metamodel HDF UML Profile and Metamodel HDF Model Interchange Format Session II HL7 Message Development Framework HDF Development Methodology HDF Pilot Projects HDF Developers Guide HDF Transition Planning

5 April 2003HL7 Development Framework Tutorial5 HL7 Development Framework Project

6 April 2003HL7 Development Framework Tutorial6 Project Introduction The purpose of the Health Level Seven (HL7) Development Framework Project is to research, analyze, design, and document the processes, policies, and artifacts associated with development of HL7 published specifications and standards. The HL7 Development Framework (HDF) project will: Expand HL7s modeled-based approach for standards development beyond messaging to its other standards such as structured documents, context management, and standards related to electronic health records; Maximize the benefits HL7 derives from using the Unified Modeling Language (UML) as a foundation for its model-based approach to standards development; Facilitate increased participation of HL7 members, subject matter experts, and implementers in the development of HL7 standards. Enable HL7 to remain the industry leader in model-driven development of comprehensive standards for application interoperability in the Health industry.

7 April 2003HL7 Development Framework Tutorial7 Project Background – Health Level Seven The mission of HL7 is to provide a comprehensive framework and related standards for the exchange, integration, storage, and retrieval of health information that support clinical practices and the management, delivery and evaluation of health services. HL7 began developing standards in 1987 with the publication of its messaging specification - the Application Protocol for Electronic Data Exchange in Healthcare Environments. In the years since its founding, HL7 has evolved beyond traditional messaging protocols to include clinical document architectures, medical logic modules, component specifications, and standards, guidelines, and related services for the management of electronic health records.

8 April 2003HL7 Development Framework Tutorial8 The Family of HL7 Specifications and Standards Version 2.x and 3.x messaging specifications; Knowledge representation and clinical decision support (Arden Syntax); Specification of components for context management (CCOW); Standardization of clinical document structures (CDA); Vocabulary definitions for use in clinical messages and documents; Standards, methodologies and services related to electronic health records (EHR); Informative specifications in the area of security, privacy, and accountability.

9 April 2003HL7 Development Framework Tutorial9 Project Background – HL7 V3 Methodology In 1992 HL7 made a fundamental shift in the method it uses to develop its specifications and standards. The new methodology, referred to as HL7 Version 3.0 (or V3), is a model-driven standards development methodology based upon modern object-oriented software development practices. In January 1996, the HL7 Technical Steering Committee adopted the model-driven approach and the Modeling and Methodology Technical Committee assumed primary responsibility for ongoing development of the V3 methodology.

10 April 2003HL7 Development Framework Tutorial10 Project Background – HL7 MDF Process Model

11 April 2003HL7 Development Framework Tutorial11 HL7 Message Development Framework The HL7 Message Development Framework (MDF) defines the HL7 V3 message development process. It identifies the phases, activities, and models used in the process of developing HL7 message specifications. The HL7 MDF was first published in It has undergone two major revisions since then; once in 1998 and again in The current version of the MDF (v3.3), published in December 1999, has not been maintained and is consequently out of alignment with current message development practices.

12 April 2003HL7 Development Framework Tutorial12 HDF Development Methodology Specification The HDF Development Methodology Reference Manual is a replacement for and an extension to the HL7 Message Development Framework (MDF). The HDF Development Methodology Reference Manual differs from the MDF in terms of: Scope of Coverage Alignment with UML Maintenance/versioning Procedures Companion documents to the HDF Development Methodology Reference Manual are: The HDF Metamodel Specification The HDF Developers Guide

13 April 2003HL7 Development Framework Tutorial13 HDF Project Scope and Objectives Project Scope: Develop and publish the HDF Development Methodology Reference Manual Develop and publish the HDF UML Profile and Metamodel Specification Develop and publish the HDF Developers Guide Project Objectives: Expand the modeled-based approach for standards development beyond the HL7 messaging standard. Embrace the UML standard, conventions, and practices as the foundation for the HL7 model-based approach to standards development. Facilitate the participation of HL7 members, subject matter experts, and implementers in the development of HL7 standards. Enable HL7 to remain the industry leader in model-driven development of comprehensive standards for application interoperability in the Health industry.

14 April 2003HL7 Development Framework Tutorial14 HDF 2002 Accomplishments Defined the HDF project scope and objectives Organized project team and team member assignments Mapped the MDF to the UML metamodel Reconciled MDF and UML metamodel discrepancies Used UML extension mechanisms to define an HL7 UML Profile Established a broad outline of the HDF development process Prepared and reviewed initial drafts of the seven chapters describing the phases of the HDF development lifecycle Prepared and presented tutorials on the HDF at two HL7 working group meetings

15 April 2003HL7 Development Framework Tutorial15 HDF 2003 Objectives Prepare phase II project charter Obtain project approval and funding Finalize documentation of the development lifecycle Conduct pilots of the development process Publish release 1 of the HDF Development Methodology Reference Manual Publish release 2 of the HDF UML Profile and Metamodel Publish release 1 on the HDF Model Interchange Format Prepare an initial draft of an HDF Developers Guide Establish a transition plan for the HDF process and metamodel

16 April 2003HL7 Development Framework Tutorial16 HDF Phase II Subproject Timelines and Task Leaders HDF Project Planning and Management 01/06/2003 ~ 01/05/2004 – Abdul-Malik Shakir HDF Development Methodology Reference Manual 01/06/2003 ~ 12/26/2003 – Abdul-Malik Shakir HDF Metamodel and Model Interchange Format 02/03/2003 ~ 12/26/2003 – Tony Mallia and Lloyd Mckenzie HDF Pilot Projects 01/06/2003 ~ 09/05/2003 – Charlie Mead HDF Developers Guide 06/23/2003 ~ 12/05/2003 – Woody Beeler HDF Transition Planning 06/23/2003 ~ 12/26/2003 – Mead Walker

17 April 2003HL7 Development Framework Tutorial17 Unified Modeling Language Metamodel

18 April 2003HL7 Development Framework Tutorial18 Unified Modeling Language Overview The models used in the HL7 V3 process are based upon the Unified Modeling Language (UML). UML is a graphical language for visualizing, specifying, constructing, and documenting the artifacts of a software-intensive system. UML is an Object Management Group standard that represents the unification of best practices in practical object-oriented modeling. Development of the UML began in 1994 when James Rumbaugh and Grady Booch of Rational Software Corporation began combining the concepts from the Object Modeling Technique (OMT) and Booch methods, resulting in a unified specification in In the Fall of 1995, Ivar Jacobson joined Rational and the unification effort, merging in the Object-Oriented Software Engineering method (OOSE). The joint work of Rumbaugh, Booch, and Jacobson was called the Unified Modeling Language (UML).

19 April 2003HL7 Development Framework Tutorial19 UML Core Development Team Colorado State University: Robert France Computer Associates: John Clark Concept 5 Technologies: Ed Seidewitz Data Access Corporation: Tom Digre Enea Data: Karin Palmkvist Hewlett-Packard Company: Martin Griss IBM Corporation: Steve Brodsky, Steve Cook I-Logix: Eran Gery, David Harel ICON Computing: Desmond DSouza IntelliCorp and James Martin & Co.: James Odell Kabira Technologies: Conrad Bock Klasse Objecten: Jos Warmer MCI Systemhouse: Joaquin Miller OAO Technology Solutions: Ed Seidewitz ObjecTime Limited: John Hogg, Bran Selic Oracle Corporation: Guus Ramackers PLATINUM Technology Inc.: Dilhar DeSilva Rational Software: Grady Booch, Ed Eykholt, Ivar Jacobson, Gunnar Overgaard, Jim Rumbaugh SAP: Oliver Wiegert SOFTEAM: Philippe Desfray Sterling Software: John Cheesman, Keith Short Sun Microsystems: Peter Walker Telelogic: Cris Kobryn, Morgan Björkander Taskon: Trygve Reenskaug Unisys Corporation: Sridhar Iyengar, GK Khalsa, Don Baisley The following persons were members of the core development team for the UML proposal or served on the first or second UML Revision Task Force:

20 April 2003HL7 Development Framework Tutorial20 Primary Design Goals of the UML Provide users with a ready-to-use, expressive visual modeling language to develop and exchange meaningful models. Furnish extensibility and specialization mechanisms to extend the core concepts. Support specifications that are independent of particular programming languages and development processes. Provide a formal basis for understanding the modeling language. Encourage the growth of the object tools market. Support higher-level development concepts such as components, collaborations, frameworks and patterns. Integrate best practices.

21 April 2003HL7 Development Framework Tutorial21 UML Model Views and Diagrams

22 April 2003HL7 Development Framework Tutorial22 UML Model Diagrams and Views Use Case Diagram Class Diagram Behavior Diagrams: State-chart Diagram Activity Diagram Interaction Diagrams: Sequence Diagram Collaboration Diagram Implementation Diagrams: Component Diagram Deployment Diagram

23 April 2003HL7 Development Framework Tutorial23 Packages of the UML Metamodel Foundation Core Datatypes Extension Mechanisms Behavioral Elements Common Behavior Collaborations State Machines Activity Graphs Use Cases Model Management

24 April 2003HL7 Development Framework Tutorial24 UML Metamodel - Foundation Core

25 April 2003HL7 Development Framework Tutorial25 UML Metamodel - Foundation Core Models contain Model Elements including the generalizable element Classifier. Classifiers have structural and behavioral Features such as attributes, operations, and methods. Models contain Model Elements including the generalizable element Classifier. Classifiers have structural and behavioral Features such as attributes, operations, and methods.

26 April 2003HL7 Development Framework Tutorial26 UML Metamodel – Model Management

27 April 2003HL7 Development Framework Tutorial27 UML Metamodel – Model Management A Package forms a Namespace for the model Elements it owns. A Package may import Model Elements owned by other Packages. A model is a type of Package. A Package forms a Namespace for the model Elements it owns. A Package may import Model Elements owned by other Packages. A model is a type of Package.

28 April 2003HL7 Development Framework Tutorial28 UML Metamodel – Common Behaviors

29 April 2003HL7 Development Framework Tutorial29 UML Metamodel – Common Behaviors UML Behavioral specifications include a sequence of Actions with an ordered set of Arguments. UML Actions include create, call, return, send, terminate, destroy, and uninterpreted actions. UML Behavioral specifications include a sequence of Actions with an ordered set of Arguments. UML Actions include create, call, return, send, terminate, destroy, and uninterpreted actions.

30 April 2003HL7 Development Framework Tutorial30 UML Metamodel - Extension Mechanisms

31 April 2003HL7 Development Framework Tutorial31 UML Metamodel - Extension Mechanisms The UML Metatmodel is extended by using: Stereotypes Tag Definition Constraints Tagged Values. The UML Metatmodel is extended by using: Stereotypes Tag Definition Constraints Tagged Values.

32 April 2003HL7 Development Framework Tutorial32 UML Extension Mechanisms Stereotype A stereotype is, in effect, a subclass of an existing metamodel element with the same form (attributes and relationships) but with different intent. A stereotyped element may have additional constraints on it from the base metamodel class. It may also have tagged values that add information needed by elements branded with the stereotype. Tag Definition Tag definitions specify new kinds of properties that may be attached to model elements. The actual properties of individual model elements are specified using Tagged Values. Tag definitions are used to define the virtual meta attributes of the stereotype to which they are attached. Stereotype Constraint Designates constraints that apply to all model elements branded by the stereotype to which they are attached. A constraint is semantic information attached to a model element that specifies conditions and propositions that must be maintained as true; otherwise, the associated model element is not well-formed. Tagged Value A tagged value is a keyword-value pair that may be attached to any kind of model element. The keyword is called a tag. Each tag represents a particular kind of property applicable to one or many kinds of model elements.

33 April 2003HL7 Development Framework Tutorial33 HL7 Development Framework Metamodel

34 April 2003HL7 Development Framework Tutorial34 HDF Metamodel Development MDF Metamodel v1.16 UML Metamodel v1.4 Compare the MDF Metamodel to the UML Metamodel MDF to UML Comparision Construct the HDF Metamodel and Profile Specification Proposed revisions to the vocabulary portion of the MDF metamodel HDF Metamodel Specification HDF Metamodel UML Profile Specification

35 April 2003HL7 Development Framework Tutorial35 HL7 Message Development Framework Metamodel The MDF metamodel v1.13 is included in the December 1999 MDF (v3.3). The MDF metamodel was updated in August 2000 (v1.14) to include major revisions to the message design model. The MDF metamodel was updated again in May of 2002 (v1.16) to reflect major revisions to the practice of producing design information models based upon the RIM. The HDF Metamodel is base upon a comparison of the UML v1.4 metamodel to v1.16 of the MDF metamodel (including proposed revisions to the vocabulary portion).

36 April 2003HL7 Development Framework Tutorial36 Packages of the MDF Metamodel Model Identification and Scope Use Case Model Reference Information Model Information Model Vocabulary Domain Model Datatype Model Message Specification Model Design Information Model Hierarchical Message Description Interaction Model Application Roles Interactions

37 April 2003HL7 Development Framework Tutorial37 Packages of the UML Metamodel Foundation Core Datatypes Extension Mechanisims Behavioral Elements Common Behavior Collaborations State Machines Activity Graphs Use Cases Model Management

38 April 2003HL7 Development Framework Tutorial38 Mapping of the MDF to UML

39 April 2003HL7 Development Framework Tutorial39 MDF to UML Metamodel Mapping Discrepancies Model identification data needs to be expanded to include data needed for HL7 model management such as responsible HL7 committee and project. Provisions are needed to address the MDF meta-classes Composite Datatype and Datatype Component. Significant enhancements to the UML metamodel is needed to address the issue of Vocabulary domains. The concepts introduced by MDF in the Design Information Model and Hierarchical Message Description packages are completely addressed within the UML metamodel however; significant rethinking of the jargon and processes in this area is required. The mapping of concepts in the Interaction Portion of the MDF metamodel is fairly straight forward. Most of the conceptual difficulties come as a result of unfortunate homonyms between the two metamodels. For example, each model includes the terms Interaction but with different semantics. The UML metamodel features used to express constraints will need to be more elaborate than a simple Boolean text expression. Constraints are a major component of any HL7 standard specification. The MDF concepts of Receiver Responsibility and Trigger Event will need to be resolved with the overlapping concepts of Action and Event in the UML metamodel.

40 April 2003HL7 Development Framework Tutorial40 MDF: Model Identification and Scope

41 April 2003HL7 Development Framework Tutorial41 UML Metamodel – Model Management

42 April 2003HL7 Development Framework Tutorial42 HDF: Model Management Extensions to the UML Metamodel

43 April 2003HL7 Development Framework Tutorial43 The HL7 UML Profile uses the UML extension mechanisms to define HL7 stereotypes and tags. Each HL7 Stereotype is associated with a single UML base class. A list of Tags and Constraints is specified for each stereotype. A definition is provided for each Tag specified for sterotypes.

44 April 2003HL7 Development Framework Tutorial44 UML Metamodel - Extension Mechanisms

45 April 2003HL7 Development Framework Tutorial45 Stereotypes in the HL7 Profile Clone CodedValue CodeSet DataTypes DIM HL7Attribute HL7DataType HL7Model HL7ModelElement HL7Package RegisteredCodeSystem RIM UsageContext Vocabulary VocabularyDomain

46 April 2003HL7 Development Framework Tutorial46 HDF UML Profile Stereotype Specifications

47 April 2003HL7 Development Framework Tutorial47 HDF UML Profile Tag Value Specifications

48 April 2003HL7 Development Framework Tutorial48 HDF Metamodel UML Metamodel v1.4 HDF UML Profile v1.0 HDF Metamodel v1.0 HDF Metamodel = UML Metamodel + HDF UML Profile

49 April 2003HL7 Development Framework Tutorial49 HDF Model Interchange Format

50 April 2003HL7 Development Framework Tutorial50 Model Interchange Requirements Model Repository Design Database / Publication Database Rational Rose Rational Rose Tree Rose Tree RMIM Designer RMIM Designer Schema Generator Schema Generator

51 April 2003HL7 Development Framework Tutorial51 Model Interchange Format Objectives Leverage the technology independent characteristic of XML Establish stability in the format of files used to exchange model artifacts between tools Facilitate the validation of model interchange files Facilitate the exchange of model artifacts with external entities Prepare for implementation of registries, templates, and conformance profiles

52 April 2003HL7 Development Framework Tutorial52 MIF Schema Specifications mifBase.xsd mifConformanceProfile.xsd mifDatatype.xsd mifDynamicElements.xsd mifExtendedMarkup.xsd mifGlossary.xsd mifImplementationElements.xsd mifPackage.xsd mifPatternTypes.xsd mifStaticBase.xsd mifStaticModelBase.xsd mifStaticModelFlat.xsd mifStaticModelSerialized.xsd mifTemplateElements.xsd mifVocabularyElements.xsd pubDisplayMarkup.xsd

53 April 2003HL7 Development Framework Tutorial53 Planned MIF Activities Conduct a peer-review of the MIF schema specifications Align relevant portions of the MIF schema specifications with the HDF metamodel Migrate existing tooling interfaces to use the MIF schemas Use the MIF schema specifications for definition of an HL7 artifact registry Extend the MIF schema specifications for use in conformance, templates, localizations,...

54 April 2003HL7 Development Framework Tutorial54 Session I Review HL7 Development Framework Project Unified Modeling Language Metamodel HDF UML Profile and Metamodel HDF Model Interchange Format

55 April 2003HL7 Development Framework Tutorial55 Cookie Break – 30 Minutes

56 April 2003HL7 Development Framework Tutorial56 Session II Overview HL7 Message Development Framework HDF Development Methodology HDF Pilot Projects HDF Developers Guide HDF Transition Planning

57 April 2003HL7 Development Framework Tutorial57 HL7 Message Development Framework

58 April 2003HL7 Development Framework Tutorial58 The MDF Methodology Overview

59 April 2003HL7 Development Framework Tutorial59 Use Case Model Use Case Diagram Spec UCM Spec Associate Actors and Use Cases Develop Scope Identify actors and Use Cases MDF Models and Process Flow Message Design 2-nd Order 1 choice of 0-n Drug 0-1 Nursing h//mt:50d … Develop Refined Message Information Model (RMIM) Specify HMD & METs with constraints Specify CMET Information Model State DiagramClass Diagram Define vocabulary domains and codes Define states, transitions and triggers Define classes, attributes, and relationships Spec RIM Spec Interaction Model Interaction Diagram Define Application Roles Define Interactions Define Conformance Criteria Spec Inter Spec Storyboard

60 April 2003HL7 Development Framework Tutorial60 HL7 V3 Conceptual Model

61 April 2003HL7 Development Framework Tutorial61 HL7 V3 Conceptual Model An Application Role is the sender or receiver of one or more Interaction. An Interaction fulfills a information exchange requirement defined in Storyboards and exemplified in Storyboard Examples. An Application Role sends an Interaction in response to a Trigger Event or as part of its receiver responsibility. A Trigger Event is associated with a state transition of a Reference Information Model (RIM) class or with a temporal event. An Interaction contains one or more Message Type defined in an Hierarchal Message Description (HMD). An HMD is a constrained tabular view of hierarchically ordered data structures from a Refined Message Information Model (R-MIM). A R-MIM is a constrained refinement of a Domain Message Information Model (D-MIM). A D-MIM is a domain specific instantiation of a subset of classes, attributes, and relationships derived from the RIM.

62 April 2003HL7 Development Framework Tutorial62 Simplified MDF Metamodel Use Case Modeling Information Modeling Interaction Modeling Message Design

63 April 2003HL7 Development Framework Tutorial63 MDF Methodology in a nut shell Use Case Modeling Produce a storyboard example Generalize the storyboard example into a storyboard Information Modeling Define classes, attributes, datatypes, and relationships Define vocabulary domains, value sets, and code systems Define states, trigger events, and transitions Interaction Modeling Define application roles Define interactions Message Design Define D-MIM, R-MIM, and CMETs Define HMD and Message Types

64 April 2003HL7 Development Framework Tutorial64 HL7 V3 Methodology (in English) What application interface problem are we trying to solve? What application systems are within the scope of the problem domain? What information needs to be communicated between the in-scope applications? What is the definition, format, and interrelationship of the information to be communicated? What events initiate communication between applications? How should the information to be communicated between applications be structured and packaged?

65 April 2003HL7 Development Framework Tutorial65 HL7 Development Framework Methodology

66 April 2003HL7 Development Framework Tutorial66 Seven Phases of the HDF Methodology 1.Project initiation and management 2.Requirements gathering and analysis 3.Requirements normalization and harmonization 4.Specification design and packaging 5.Specification publication and balloting 6.Specification refinement and localization 7.Specification implementation and validation

67 April 2003HL7 Development Framework Tutorial67 HDF Methodology Phases Project Initiation and Management: Prepare project charter and define the scope, objective, and approach for the project. Requirements Gathering and Analysis: Prepare a requirement specification with models of the static, behavioral, and business rule requirements of the standards to be developed. Requirements Normalization and Harmonization: Normalize the requirements models to adhere to the structure and style of the HL7 reference models and reconcile variances between the requirements models and the HL7 reference models. Specification Design and Packaging: Derive specification design models from HL7 Reference Models guided by the contents of the requirements specification. Specification Publication and Balloting: Assemble the specification designs into ballot packages and conduct committee and membership level ballots. Publish the membership approved specification as a standard. Specification Refinement and Localization: Define context sensitive refinements of balloted standards and register the refined specification as a usage template for the standard. Refine and extend balloted specifications to accommodate unique local requirements within the jurisdiction of HL7 international affiliates. Specification Implementation and Validation: Prepare and register implementation profiles describing the implementation of the HL7 specification within a particular application or vendor product line. Prepare a conformance profile documenting the adherence of a particular implementation to standard, template, or localization specifications.

68 April 2003HL7 Development Framework Tutorial68 The HDF Methodology Workflow

69 April 2003HL7 Development Framework Tutorial69 Eight Work Products of the HDF Methodology Project Charter Requirements Specification Reference Model Design Model Standard Specification Template Specification Implementation Profile Conformance Specification

70 April 2003HL7 Development Framework Tutorial70 HDF Development Methodology Reference Manual Core Chapters 1.Project initiation and management Jane Curry 2.Requirements gathering and analysis Charlie Mead 3.Requirements normalization and harmonization Abdul-Malik Shakir 4.Specification design and packaging Abdul-Malik Shakir 5.Specification publication and balloting Karen VanHentenryck 6.Specification refinement and localization Jenny Puyenbroek 7.Specification implementation and validation Jenny Puyenbroek

71 April 2003HL7 Development Framework Tutorial71 Project Initiation Define the project scope and objectives Identify project assumptions and constraints Identify major project deliverables Identify project resource requirements Develop project plan with timeline for project phases, activities, and tasks Obtain required project approvals

72 April 2003HL7 Development Framework Tutorial72 Project Charter Content What is the name and description of the project? Who are the stakeholders involved? What are their roles? Why is the project necessary? What benefit or value will it produce? What are the objectives of the project? What are the expected outputs? What will need to be done to accomplish the objectives? What skills are needed? What tools will be used? Is this project dependent on the output or decisions of other work? What is the expected duration of the project? What is the expected work effort? What are the expected costs? What are the possible risks, both technical and organizational, in undertaking this project? What are the assumptions or constraints that must be accommodated?

73 April 2003HL7 Development Framework Tutorial73 Requirements Gathering and Analysis Prepare storyboards and storyboard examples that elaborate upon the project scope statement. Conduct an analysis of the storyboards to identify potential Actors, Activities, and Use Cases. Construct Use Case and Activity models depicting the behavioral component of the requirements. Identify information requirements and construct an information model depicting the static component of the requirements. Prepare Collaboration and Sequence diagrams to depict the interaction requirements. Document relevant business rules and constraints governing models, diagrams, and specifications. Update the Project Charter as needed.

74 April 2003HL7 Development Framework Tutorial74 Requirements Specification Content A dynamic description (via UML Activity Diagram) of the healthcare business process(es) driving the required data/information exchange A static description (via UML Class Diagram) of the concepts involved in the business process (including the structure and relationships of the data/information to be exchanged in the course of the business process) A glossary which carefully and completely defines each of the concepts (and concept attributes) depicted in the static diagram A Use Case model which identifies the system involved in the actual HL7 data/information exchange and the Conformance- based Application Roles that govern this conformance

75 April 2003HL7 Development Framework Tutorial75 Requirements Normalization and Harmonization Map models from the Requirements Specification to Reference Models. Revise models in the Requirements Specification based upon discoveries made during the mapping process. Document proposed changes to Reference Models to accommodate previously unidentified requirements. Follow the reference model harmonization process to adjudicate the proposed changes to Reference Models. Revise the Requirements Specification as needed and its mapping to the Reference Models.

76 April 2003HL7 Development Framework Tutorial76 Requirements Normalization and Harmonization Requirements Normalization A cross-reference between static requirements and HL7 reference models; An updated requirements specification document; A collection of proposed enhancements to the HL7 reference models. Requirements Harmonization Adjudicated Reference Information Model change proposals; An updated Reference Information Model; A re-expression of the static requirements using terms and structures from the updated Reference Information Model.

77 April 2003HL7 Development Framework Tutorial77 Specification Design and Packaging The Requirements Specification is used to drive the transformation of Reference Models into Design Models. The HDF UML Profile provides constraints to aid in ensuring that design models are well-formed and depict the requirements in a way that remains consistent and traceable back to harmonized reference models. The contents of design models are organized into interdependent packages that partition the design space by domain, sub-domain, and target standard type (message, document, component). Common or reusable design artifacts are packaged in a way that makes them assessable across design models and design model packages.

78 April 2003HL7 Development Framework Tutorial78 Specification Design and Packaging Specification Design Information Structure Design Behavioral Features Design Business Rules Design Specification Packaging Packaging Reusable Specifications Packaging According to Specification Type Packaging Normative And Informative Specifications

79 April 2003HL7 Development Framework Tutorial79 Specification Publication and Balloting Design model content from multiple committees are merged and re-packaged in preparation for publishing. Conflicts and inconsistencies among design models are resolved, including the resolution of artifact identifiers and inter-model references. A publication package is assembled for each specification to be balloted and a committee level ballot is conducted. Multiple committee level ballots may be required to resolve negative comments received during balloting. A full membership ballot is conducted and upon successful completion the design specification becomes an HL7 standard. At the discretion of the HL7 Board selected HL7 balloted standards are submitted for publication as national or international standards (i.e., ANSI or ISO).

80 April 2003HL7 Development Framework Tutorial80 Committee and Member Level Ballot Committee Level Ballot Announcing your committees plans to ballot Submitting your committee ballot content Monitoring the ballot responses Resolving negative votes submitted against your TC/SIG content Advising the submitters of negative votes/comments of the disposition of their vote/comment Member Level Ballot Obtain the TSC Chairs authorization to submit your content for membership ballot Announcing your committees plans for a membership ballot Monitoring the ballot responses Building membership consensus on the disposition of the negative votes/comments Advising the submitters of negative votes/comments of the disposition of their vote/comment Appealing the disposition of their votes/comments

81 April 2003HL7 Development Framework Tutorial81 Specification Refinement and Localization Specification refinement involves the application of additional restrictions to balloted specifications to constrain the standard for use in a particular context. Specification localization is a privilege available only to HL7 international affiliates. It includes specification refinement and RIM-based extensions to the content of balloted HL7 standards.

82 April 2003HL7 Development Framework Tutorial82 Specification Refinement and Localization The balloted HL7 Standard is designed to serve the needs of a large and diverse population of users. It is sometimes necessary to defined additional refinements and constraints to the standard to facilitate its use in a particular context. Context for used of a standard might be influenced by uniqueness in the jurisdiction, region, or clinical discipline for which the standard is to be applied. Because of the international nature of the HL7 standard the need for regional or local refinements is anticipated and the process for localization of the standard is formalized in the HDF. Refinements are applied to the standard specification much in the same way as the iterative refinement that occurred during design. Each refinement may further constrain multiplicities and optionality specified in the standard and may include allowed datatype or vocabulary domain substitutions. The resulting refined/localized standard is a template specification. The template may be registered with HL7 where others in the community defined by the context of the template may access it for use as an extension to the standard specification.

83 April 2003HL7 Development Framework Tutorial83 Specification Implementation and Validation Standard specifications, templates, and localizations are input to the specification implementation and validation phase. New and/or revised template specifications are output from the implementation and validation phase. Implementation profiles and conformance specifications are the primary outputs of the specification and validation phase.

84 April 2003HL7 Development Framework Tutorial84 Specification Implementation and Validation Implementation of the standard involves mapping the information component of the standard to data structures in a particular application and incorporating the behavior aspects of the standard into the behavior of the application. The standard specification or localization along with template specifications are used by implementers to develop an implementation profile that describes the design of a particular implementation. The implementation profile includes documentation of the use of extension mechanisms built into the standard, the resolution of choice and optional structures, and a statement of the adherence of the application to sender and receiver responsibilities defined in the standard or template. An Implementation Profile may be used to represent the capabilities of a particular developers application or it may be used to represent the implementation specific requirements of a potential consumer of a vendor product. A conformance specification documents the implementation profile in a format that can be validated against the standard. The conformance specification once validated would highlight those portions of the Implementation Profile that are non-conformant with HL7 standard specifications and localizations.

85 April 2003HL7 Development Framework Tutorial85 The HDF Methodology Overview

86 April 2003HL7 Development Framework Tutorial86 HDF Methodology Tasks and Timeline 01/06/03 ~ 03/07/03 Complete preliminary version of core chapters 03/10/03 ~ 04/04/03 Review preliminary version of core chapters 03/31/03 ~ 06/20/03 Finalize core chapters 05/26/03 ~ 06/20/03 Prepare ancillary chapters 06/16/03 ~ 07/25/03 Prepare HDF master document 07/28/03 ~ 11/28/03 Review and finalize the HDF methodology reference manual 12/01/03 ~ 12/26/03 Publish release 1 of the HDF development methodology reference manual

87 April 2003HL7 Development Framework Tutorial87 HDF Pilot Projects

88 April 2003HL7 Development Framework Tutorial88 Pilot Projects The objectives of HDF pilot projects are to: Aid in process definition and the discovery of best practices Validate assumptions concerning the development processes Demonstrate the development methodology processes Exemplify deliverables of the methodology Roster of project pilots: NICTIZ Perinatology Project – Irma Jongeneel X12N-TG3-WG2 – Kathleen Connors IDPH Trauma Registry Export – Abdul-Malik Shakir Pilot Project Activities 01/06/03 ~ 03/28/03 – Identify projects to use as pilots 03/31/03 ~ 08/01/03 – Apply the HDF process to the pilot projects 05/05/03 ~ 09/05/03 – Document pilot outcomes and process feedback

89 April 2003HL7 Development Framework Tutorial89 HDF Developers Guide

90 April 2003HL7 Development Framework Tutorial90 Developers Guide The HDF Developers Guide is one of many anticipated companion documents of the HDF Development Methodology Reference Manual Content of the HDF Developers Guide: Initiation thru Design ~ Charlie Mead Design thru Implementation ~ Jennifer Puyenbroek Tools and Techniques ~ Woody Beeler HDF Developers Guide Activities 06/23/03 ~ 10/24/03 – Prepare the HDF Developers Guide 10/27/03 ~ 12/05/03 – Publish the HDF Developers Guide

91 April 2003HL7 Development Framework Tutorial91 HDF Transition Planning

92 April 2003HL7 Development Framework Tutorial92 HDF Transition Planning Communication Awareness Raising Soliciting Support Managing Expectations Validating Assumptions Retaining Motivation Coordination Within the project team Between Committees Between Projects With External Activities Education Practitioners Administrators Implementers

93 April 2003HL7 Development Framework Tutorial93 Session Overview Session I HL7 Development Framework Project Unified Modeling Language Metamodel HDF UML Profile and Metamodel HDF Model Interchange Format Session II HL7 Message Development Framework HDF Development Methodology HDF Pilot Projects HDF Developers Guide HDF Transition Planning

94 April 2003HL7 Development Framework Tutorial94 Thank You Abdul-Malik Shakir Principal Consultant Shakir Consulting 1911 Foothill Blvd., Suite 148 La Verne, CA Office: (909) Mobile: (626)

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