Public Health and Emergency Response Committee Immunization Domain Analysis Model

1. Public Health and Emergency Response CommitteeImmunization Domain Analysis Model Abdul-Malik Shakir Principal Consultant, Shakir Consulting HL7 Educational Summit, Los Angeles, CA November 2007

2. About Me Abdul-Malik Shakir Principal Consultant, Shakir Consulting, La Verne, CA HL7 Member since 1991 • Principal Consultant with Shakir Consulting • Chief Technical Architect with Cal2Cal Corporation • Co-Chair of the HL7 Education Committee • Member of the HL7 Architectural Review Board • Member of the HL7 Public Health and Emergency Response Committee • Member of the HL7 Regulated Clinical Research Information Management Committee • Member of the HL7 Modeling and Methodology Committee PHER Immunization Domain Analysis Model

3. Part I Background HL7 v3: What and Why HL7 Message Development Framework HL7 Development Framework Domain Analysis Models Requirements Specification UML Diagram Classifications UML Diagram Types Part II POIZ DAM Project Scope Project Progression Development Approach Reference Materials Model Diagrams Walkthrough Source Models Next Steps Questions and Discussion Session Outline PHER Immunization Domain Analysis Model

4. Health Level Seven Version 3.0 What and Why PHER Immunization Domain Analysis Model

5. World-class System Interface Standards • The community of users served by HL7 is continually increasing in size. As the size of the community increases so does the complexity and the diversity of their needs. • HL7 v3.0 adds rigor to the standards development process and make use of modern advances in information technologies. • The HL7 v3.0 development methodology includes the use of a reference information model, robust datatype and vocabulary specifications, and modeling of the dynamic requirements of messages. • HL7 v3.0 increases the quality and reduces the variability in HL7 standards enabling it to address the more complex and diverse needs of the HL7 members. PHER Immunization Domain Analysis Model

6. International National Standards Moving in Ever-Increasing Circles Inter-Enterprise Enterprise Institution Source: Gartner PHER Immunization Domain Analysis Model

7. HL7 Version 3.0: What and Why • Version 3.0 is a fundamental shift in the methodology HL7 uses to develop its standards specifications. • Version 3.0 is a model-driven methodology based upon the Object Management Group’s Unified Modeling Language (UML). • Version 3.0 uses datatype specifications, vocabulary specifications, and a Reference Information Model (RIM), to derive the information component of V3 message specifications. • Version 3.0 reduces optionality, maximizes reuse, and increases consistency in HL7 message specifications. • Version 3.0 improves the quality of HL7 message specifications and includes support for conformance validation. • Version 3.0 enables HL7 implementers to leverage emerging web services standards, conventions, and technologies. PHER Immunization Domain Analysis Model

8. HL7 Message Development Framework PHER Immunization Domain Analysis Model

9. Application Trigger RIM Role Event Derive Information Modeling Storyboard D-MIM Sender Receiver HL7 V3 Message Development Framework Restrict Triggers References Interaction R-MIM Example Serialize Interaction Modeling HMD Restrict Message Design Storyboard Message Example Type Use Case Modeling Content PHER Immunization Domain Analysis Model

10. 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. PHER Immunization Domain Analysis Model

11. Application Trigger RIM Role Event Derive Information Modeling Storyboard D-MIM Sender Receiver HL7 V3 Message Development Framework Restrict Triggers References Interaction R-MIM Example Serialize Interaction Modeling HMD Restrict Message Design Storyboard Message Example Type Use Case Modeling Content PHER Immunization Domain Analysis Model

12. 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? PHER Immunization Domain Analysis Model

13. HL7 Development Framework PHER Immunization Domain Analysis Model

14. Seven Phases of the HDF Methodology • Project initiation • Requirements Documentation • Specification Modeling • Specification Documentation • Specification Approval • Specification Publication • Specification Profiling PHER Immunization Domain Analysis Model

15. HDF Workflow Diagram The HDF workflow is not a waterfall methodology. Each phase builds upon the prior and may cause prior activities to be revisited and their deliverables adjusted. PHER Immunization Domain Analysis Model

16. Project initiation During project initiation the project is defined, a project plan is produced, and project approval is obtained. The primary deliverable produced during project initiation is the project charter. Project Initiation Project Charter • Define project scope, objectives, and intended deliverables • Identify project stakeholders, participants, and required resources • Document project assumptions, constraints, and risk • Prepare preliminary project plan and document inter-project dependencies • Obtain project approval and launch the project PHER Immunization Domain Analysis Model

17. Requirements Documentation During requirements documentation the problem domain is defined, a model of the domain is produced, and the problem domain model is harmonized with HL7 reference models. The primary deliverable produced during requirements documentation is the requirements specification. Project Charter Requirements Documentation Requirements Specification • Document Business Process: Dynamic Behavior and Static Structure • Capture Process Flow: UML Activity Diagram • Capture Structure: Domain Information Model and Glossary • Capture Business Rules: Relationships, Triggers, and Constraints • Harmonize the Domain Analysis Model with HL7 Reference Models PHER Immunization Domain Analysis Model

18. Specification Modeling During specification modeling reference models are constrained into design models through a process of iterative refinement driven by requirements specifications and following specification design rules, conventions, and guidelines. The primary deliverable produced during specification modeling is a set of specification design models. Requirements Specification Specification Modeling Specification Design Models • Build design models of static information views • Construct design models of behavioral views • Define reusable design model components • Construct design models of collaboration and interaction • Harmonize design models with HL7 Reference Models PHER Immunization Domain Analysis Model

19. Specification Documentation During specification Documentation the specification design models are packaged into logical units, supplemented with explanatory text, and prepared for approval. The primary deliverable produced during specification documentation is a proposed specification. Specification Design Models Specification Documentation Proposed Specification • Organize design model elements into logical packages • Compose explanatory text, examples, and design rationale • Update design models and requirement specifications • Assemble a proposed specification package • Submit specification for approval PHER Immunization Domain Analysis Model

20. Specification Approval During specification approval the pre-approval specification is subjected to a series of approvals steps. The specific approval steps vary by kind of specification, level of approval, and realm of interest. The primary deliverable produced during specification approval is an approved specification. Proposed Specification Specification Approval Approved Specification • Obtain TSC and Board approval to ballot specification • Form a ballot pool and conduct specification ballot • Assess negative ballots and affirmative comments • Modify specification in response to ballot comments • Resolve negative ballot responses and if necessary re-ballot PHER Immunization Domain Analysis Model

21. Specification Publication During specification publication the approved specification is prepared for prepared for publication and distribution. The primary deliverable produced during specification publication is a published specification. Approved Specification Specification Publication Published Specification • Obtain TSC and Board approval to publish specification • Prepare specification for publication • Submit publication to standards authorities (ANSI/ISO) • Render the specification in various forms of publication media • Post and distribute approved specifications PHER Immunization Domain Analysis Model

22. Specification Profiling During specification profiling specification models are further refined and specifications furthered constrained following the same set of design rules, conventions, and guidelines used in the development of the specification to produce a profile of the specification for use in a particular environment by a defined community of users. The primary deliverable produced during specification profiling is a set of specification profiles and conformance statements. Published Specification Specification Profiling Specification Profiles and Conformance Statements • Identify community of uses for published specification • Further refine and constrain specification design models • Document exceptions, extensions, and annotations to specifications • Prepare and publish specification profile • Prepare and publish conformance statements PHER Immunization Domain Analysis Model

23. HDF Workflow Diagram The HDF workflow is not a waterfall methodology. Each phase builds upon the prior and may cause prior activities to be revisited and their deliverables adjusted. A Domain Analysis Model is a specification of requirements for a project or domain. The PHER POIZ Domain Analysis Model (DAM) is a requirement specification for PHER sponsored projects in the immunization domain. PHER Immunization Domain Analysis Model

24. PHER POIZ Domain Analysis Model • The PHER POIZ Domain Analysis Model is a UML model representing the structural and behavioral requirements of PHER sponsored projects in the immunization domain. • The PHER POIZ DAM is a collection of UML diagrams and supporting text illustrating the information and processing requirements of the immunization domain from a variety of perspectives. • The PHER POIZ DAM will continually evolve as requirements are discovered and analyzed and as solutions are constructed and evaluated. • The development process for the PHER POIZ DAM is an iterative activity that combines a top-down analytical approach with bottom-up reverse engineering techniques. • Contribution of content, critique, and complements are welcome and encouraged. Those with an interest in this project are requested to subscribe to the PHER list server, participate in PHER conference calls, and attend PHER working group meetings. PHER Immunization Domain Analysis Model

25. UML Diagram Classifications • There are three classifications of UML diagrams: • Behavior diagrams.  A type of diagram that depicts behavioral features of a system or business process.  This includes activity, state machine, and use case diagrams as well as the four interaction diagrams. • Interaction diagrams.  A subset of behavior diagrams which emphasize object interactions.  This includes communication, interaction overview, sequence, and timing diagrams. • Structure diagrams.  A type of diagram that depicts the elements of a specification that are irrespective of time.  This includes class, composite structure, component, deployment, object, and package diagrams.   PHER Immunization Domain Analysis Model

26. POIZ DAM UML Diagram Types PHER Immunization Domain Analysis Model

27. Project Scope Statement • Project Name: Immunization Domain Analysis Model • Sponsoring Committee: PHER SIG • Project Scope: The scope of this project is to develop a Domain Analysis Model for Immunization related projects sponsored by the Public Health and Emergency Response Special Interest Group. • Project Dependencies: All PHER sponsored immunization related projects.Project Objectives: • Project Objectives: The objective of this project create a Domain Analysis model describing the Use Cases, Stakeholders, Activities, Interactions, and Static Information Models needed to express the requirements of PHER sponsored immunization projects. This includes support for V2 and V3 messages, structured documents, EHR and PHR profiles, Service Specifications, Implementation Guides, Templates and Terminologies needed for Immunization. PHER Immunization Domain Analysis Model

28. Project Progression • 05/01/07: Project Approved – Scope Statement • 06/01/07: Project Initiated – Data Gathering • 07/20/07: POIZ DAM v0r1 – Vaccine Admin Message • 08/03/07: POIZ DAM v0r2 – Use case diagram • 08/17/07: POIZ DAM v0r3 – Activity diagram • 08/31/07: POIZ DAM v0r4 – Class Diagram (DIM) • 09/18/07: POIZ DAM v0r5 – Source Data Models • 10/12/07: POIZ DAM v0r6 – HTML Publication PHER Immunization Domain Analysis Model

29. PHER POIZ DAM Development Process • The starting point of development is research; source material is reviewed and analyzed. • The next step is to model; create a UML model of the insights gain during research. • Modeling is followed by review; the models are reviewed by SMEs and interested parties. • The review step is followed by revise; the model is update to reflect the input from peer review. • Additional research is conducted to create the next iteration of the model and the cycle continues. PHER Immunization Domain Analysis Model

30. Subject matter experts are asked to provide source materials for use in informing the DAM. Source materials include existing models, data dictionaries, works in progress, email threads, and other references. The source material is analyzed to discover behavioral or structural requirements. One-on-one dialog between the DAM analyst and the submitter of source material help to improve understanding and implications for the DAM. Research PHER Immunization Domain Analysis Model

31. Model • Insights gained from research are used to adjust or confirm the DAM. • Functional scope is reflected in a Use Case diagram. • Activity control and information flows are reflected in Activity diagrams. • Information requirements are reflected in Class diagrams. • Questions and open issues related to modeling are noted for use in model review. PHER Immunization Domain Analysis Model

32. Review • The model is posted to the PHER email list server. • A peer review of the model is scheduled as an agenda item for PHER conference calls. • Subject matter experts and interested parties attending the PHER call provide confirmation, criticism, and insights related to the model. • The peer review dialog is documented as email threads and conference call minutes. PHER Immunization Domain Analysis Model

33. Revise • The peer review comments create an improved understanding of requirements. • Comments also reveal difficulty in understanding the model. • The model is revised to reflect the improved understanding or to make the model content more comprehensible. • The revised model is then used during analysis of additional input. PHER Immunization Domain Analysis Model

34. POIZ Vaccine Administration RMIM SNHD Immunization System Data Export CA SIIS SIP Immunization Message Profile DSS Conformance Profile for Vaccine Forecasting Implementation Guide for Immunization Data Transactions Using HL7 V.2.3.1 IHE transactions for Patient Identity Feed, utilizing HL7 2.3.1 messages IHE Patient Identifier Cross-Referencing (PIX) transaction, utilizing HL7 2.5 messages. Patient Demographics Query (PDQ) transaction, utilizing HL7 2.5 messages. HSSP Retrieve, Locate, Update Service (RLUS) HSSP Entity Identification Service (EIS) AIRA Messaging Workgroup IIS Standards Working Document Preparatory meeting materials for AIRA Modeling Immunization Registry Operations Workgroup (MIROW) Recommended Immunization Schedule for Persons Aged 0–6 Years—UNITED STATES • 2007 Vaccine Adverse Event Reporting System (VARS) PeDS SIG Immunization Registry Storyboard Dynamical model for the Dutch national youth immunization program PHII – Taking Care of Business HL7 v3 pan-Canadian Messaging Standards Implementation Guide Volume 10 –Immunization U.S. DHHS Immunizations & Response Management Prototype Use Case HL7 v3 Immunization Project Business Scenario Survey AIRA Vaccination Level Deduplication in Immunization Information Systems Reference Materials (as of Oct 07) PHER Immunization Domain Analysis Model

35. Vaccine Administration Message RMIM PHER Immunization Domain Analysis Model

36. POIZ DAM v0r1 – Vaccine Admin Message PHER Immunization Domain Analysis Model

37. POIZ DAM v0r2 – Use case diagram PHER Immunization Domain Analysis Model

38. POIZ DAM v0r3 – Activity diagram PHER Immunization Domain Analysis Model

39. Vaccine Administration Tracking Activity Diagram PHER Immunization Domain Analysis Model

40. POIZ DAM v0r4 – Class Diagram (DIM) PHER Immunization Domain Analysis Model

41. POIZ DAM v0r4 – Class Package Diagram PHER Immunization Domain Analysis Model

42. POIZ DAM v0r4 – Vaccine Product Package PHER Immunization Domain Analysis Model

43. 09/18/07: POIZ DAM v0r5 – Source Models • POIZ Vaccine Administration RMIM • SNHD Immunization System Data Export • CA SIIS SIP Immunization Message Profile • Preparatory meeting materials for AIRA Modeling Immunization Registry Operations Workgroup (MIROW) • PHII – Taking Care of Business PHER Immunization Domain Analysis Model

44. Vaccine Administration Message RMIM PHER Immunization Domain Analysis Model

45. SNHD Immunization System Data Export PHER Immunization Domain Analysis Model

46. CA SIIS SIP Immunization Message Profile PHER Immunization Domain Analysis Model

47. Data Quality Assurance in Immunization Information Systems Preparatory materials for the August 21-23, 2007 meeting of the Modeling Immunization Registry Operations Workgroup (MIROW) of the American Immunization Registry Association (AIRA) July 21, 2007 MIROW PHER Immunization Domain Analysis Model

48. Figure 5. Domain diagram - work in progress PHER Immunization Domain Analysis Model

49. PHII TCB: Immunization Administration PHER Immunization Domain Analysis Model

50. 10/12/07: POIZ DAM v0r6 – HTML Publication PHER Immunization Domain Analysis Model