HL7 “EHR SD RM” Project “EHR System Design Reference Model”

1. HL7 “EHR SD RM” Project • “EHR System Design Reference Model” • Constructing a Future State EHR Reference Architecture • EHR Way Ahead Business Architecture • Healthcare SOA Reference Architecture • Enterprise Information Model • From HL7 and HITSP Artifacts • For presentation at HL7 Rio Workgroup Meeting, 18 May 2010 • Details available at www.HSSP.wikispaces.com/Reference+Architecture Nancy.Orvis@tma.osd.mil, Dir Health Stds Participation Stephen.Hufnagel.ctr@tma.osd.mil, Architect & System Engineer Last Updated 26 March 2010

2. Federal Enterprise Architecture (FEA)www.whitehouse.gov/omb/egov Performance Reference Model - The FEA PRM is a framework to measure the performance of major IT initiatives and their contribution to program performance. The PRM leverages performance measurement best practices from the public and private sectors, including the Balanced Scorecard, Baldrige Criteria, Value Measurement Methodology, program logic models, the value chain, and the theory of constraints. There is an increased emphasis placed on linkage of investment to agency program performance and the PRM will help agencies produce enhanced performance information. Furthermore, the PRM will assist in: improving the alignment of program goals and objectives with Mission Area goals and objectives; improving communication of program contributions such as technology (input) to outputs and outcomes; and in identifying improvement opportunities that span traditional organizational boundaries. Business Reference Model - The Business Reference Model (BRM) is a functional-driven framework for describing and organizing the day-to-day business operations of the Federal Government into Lines of Business (LOBs), independent of the agencies that perform the business operation. The BRM is the first layer of the Federal Enterprise Architecture and it is the organizing construct for the analysis of the other four reference models: performance, service components, data, and technology. Service Component Reference Model - The Service Component Reference Model (SRM) is a functional framework to evaluate to identify government-wide opportunities to leverage IT investments and assets from a service perspective. This model helps understand the services delivered by the government and assess if there is an opportunity to group like services and create leverage opportunities, such as reuse or shared services. Data Reference Model - The Data Reference Model (DRM) describes at an aggregate level, the data and information required to support the Lines of Business (LOBs). The three elements of data exchange that have been standardized include data description, data context, and data sharing. Establishing a common data model streamlines the information exchange process within and across the Federal Government and facilitates the ability to identify duplicative data resources. Technical Reference Model - The Technical Reference Model (TRM) establishes a common technical framework for categorizing standards, specifications, and technologies that support and enable the delivery of services. This framework can be leveraged to support the development, delivery, and exchange of business and application components (Service Components) that may be leveraged in a Component-based or Service Oriented Architecture (SOA). Furthermore, it also serves as the foundation to advance the re-use of technology and best practices from each of the Service Components on a government-wide basis.

3. EHR-SD RM Project Description and Plan PROJECT DESCRIPTION: HL7 EHR System Design Reference Model (EHR SD RM) This project will mature the April 2008 Healthcare Services Oriented Reference Architecture (H-SOA-RA) version 1.0 into H-SOA-RA Version 2.0, for HL7 Architecture Review Board (ArB) consideration, and then integrate it into an EHR System Design Reference Model (EHR-SD RM), using the HL7 SOA-Aware Enterprise Architecture Framework (SAIF), HITSP Multi-Enterprise Architecture of Networked Services Standards (MEANS), EHR System Functional Model (EHR-S FM). Emphasis will be placed on maintaining AHIC, HITSP, NHIN and CCHIT conformance by maintaining Information Exchange Requirements (IERs) and Data Requirements (DRs) traceability. Mapping and analysis of the HL7 product portfolio against the EHR-S FM will be used to integrate the reference architecture with HL7 product lines and initially mature the resulting model as a technical white papers, then an informative reference model and finally a standard reference model. An HSSP based prototype case study architectural specification will be built to validate the effort. Phases: For Project Information, see http://hssp.wikispaces.com/Reference+Architecture • EHR SD RM Framework • Populate the framework with HL7 EHR-S Functional Model content, candidate healthcare Information Exchanges, HITSP capabilities/ services and data architecture • Information Model • Loosely-coupled top-down Framework • Rigorously specified bottom up structure/ content based on HITSP Data Architecture • Socialize EHR SD RM (HL7 Meeting, Jan 2010) • Collaborate with others within HL7 (ongoing) • Publish HL7 HSSP Practical Guide for SOA in Healthcare Part 2: Case Study (May 2010) • Solicit public comment; collaborate with IHE; HL7/OMG SOA Conference (May to Sept) • HL7 Informative ballot (Oct 2010) • HL7 Normative ballot (Oct 2011)

4. EHR SD RM Milestones 2008 2009 2010 2011 Healthcare SOA Reference Architecture (H-SOA-RA) EHR SD RM Immunization & Response Management (IRM) Prototype HSSP Practical Guide for SOA in Healthcare Volume II: IRM Case Study __________ EHR SD RM Informative DSTU EHR SD RM Normative Standard DSTU is Draft Standard for Trial Use (ANSI standards development)

5. Linking Business and Technical Architectures

6. Constructing a Future State EHR Reference Architecture HL7 EHR System Functional Model (EHR-S FM) Healthcare SOA Reference Framework HL7 RIM (Reference Information Model) HITSP Harmonization Framework HITSP Constructs HITSP Data Architecture HITSP Clinical Document Components HITSP/C83 Data Module Categories EHR Way Forward Business Architecture Specification Framework Future State EHR Reference Architecture Adding ARRA and FHIM Basic UML Legend Abbreviations PART II: HL7 SAIF, Requirements Management, Architecture and Governance Processes PART III: Prototype (Immunization and Adverse Event Reporting) Contents

7. Constructing a Future State EHR Reference Architecture • OBJECTIVE: A system agnostic Future State EHR Business Architecture (BA) specified with a lexicon, based upon HITSP’s data architecture, HL7’s System Functional Model (EHR-S FM) and HL7’s Reference Information Model (RIM). • A Health IT EHR BA can be modeled as clinical stakeholder requirements and their workflow-orchestration of • HL7 RIM compliant HITSP data modules manipulated by • HL7 EHR-S FM functions. • An EHR Information Model, for a project or enterprise, can be constructed from the HITSP data models managed by the EHR Functions used within the EHR BA, categorized using the HL7 RIM Entity, Role and Action foundation classes. • These concepts are the topic of this presentation

8. HL7 EHR System Functional Model (EHR-S)> 160 System Functions in 4 level categorization(separate spreadsheet available for full enumeration) EHR-S FM functions can be grouped into Service Components … aka Capabilities (e.g., Lab Order Capability, which does eligibility and authorization function as well as lab order function). System Functions NOTE: “Other” Category - The EHR-S model does NOT include Electronic Resource Planning (ERP) / Logistics and Financial components, which are needed for completeness of a Health IT Enterprise.

9. Healthcare SOA FrameworkBased on HL7 EHR System Functional Model & Thomas Erl’s SOA Layers 8

10. HL7 EHR_S-Based Functional Architecture/Services Analysis Primary Care Critical/Emergency Care Laboratory Pharmacy Dental Non-Surgical Specialty Care Nursing Behavioral Health ETC. Population Health ETC Manage Business Rules Infrastructure Functions Interoperability • Infrastructure • Services • Security • Policy • Records Management • Audit • Terminology • Registry • Workflow • Business Rules • etc Terminology Unique ID, Registry, and Director Information and Records Management Security Lines of Business Record Management Manage Patient History • Core Clinical • Services • Entity Identification • Resource Location and • Updating Services • Decision Support • Orders Management • Scheduling • Image Management • Etc. Preferences, Directives, Consents, and Authorizations Summary Lists Management of Assessment Cross-Cutting Direct Care/ Support Functions Care Plans, Treatment Plans, Guidelines, and Protocols Orders and Referral Management Documentation of Care, Measurement, and Results Record Patient Specific Instructions Clinical Decision Support Clinical Workflow Tasking Support Clinical Communication Support Knowledge Access ETC

11. ANATOMY OF AN ANCILLARY SYSTEM LABORATORY RADIOLOGY PHARMACY CARDIOLOGY OT/PT/SPEECH IDENTITY TERMINOLOGY AUTHORIZATION SCHEDULING CORE BUSINESS SERVICES SUPPLY CHAIN (ORDER/CHARGE) DOCUMENT RECORDS MANAGEMENT s DECISION SUPPORT PERFORMANCE DATA MANAGEMENT 10

12. INTEGRATED REQUIREMENTS DESIGNS: Putting the H-SOA-RA Pieces Together Ancillary Systems PT/OT/SPEECH LABORATORY SPECIALTY CARE RESPIRATORY PHARMACY CARDIOLOGY RADIOLOGY DIETARY IDENTITY TERMINOLOGY Inter-Service TEST ONLY AUTHORIZATION INPATIENT SCHEDULING Federated Business Services SUPPLY CHAIN: (ORDERS/CHARGES) Core Business Services Inter-Agency ER DOCUMENT RECORDS MANAGEMENT ASU Federated Services, may be categorized by: -- Encounter Types -- CMS billing category -- Record type -- Care setting type -- etc. DECISION SUPPORT PERFORMANCE CLINIC Across Providers OUTPATIENT OTHER DATA MANAGEMENT ANALYTIC Agnostic Services SUPPORT Data sets are defined for each system functional-capability-service module IT PLATFORM 11

13. HL7 RIM (Reference Information Model)Six Core Classes Defining a Semantic Framework whichMaintains Clinical Data Context ACT (aka ACTION) ENTITY ROLE Participation Role link Act relationship ACT – something that has happened or may happen Entity – a person, animal, organization, or thing Role – a responsibility of, or part played by, an Entity Participation – the involvement of a Role in an Act Act Relationship – a relationship between two Acts Role Link – a relationship between two Roles. The HL7 RIM expresses the data content needed in a specific clinical or administrative context and provides an explicit representation of the semantic and lexical connections that exist between the information carried in the fields of HL7 messages. Language / communication The HL7 RIM supports EHR interoperability; an EHR may needs additional foundation classes (e.g., Responsibility)

14. HITSP Constructs • A HITSP Interoperability Specification (IS) defines a business context, supports a business workflow, constrains and orchestrates underlying constructs. • A HITSP Capability (CAP) is a specification that assembles HITSP constructs to fulfill a business need for information exchanges. To use a Capability, an Interoperability Specification or an implementation conformance statement must assign Systems to one or more Capability System Roles and identify how the Capability Options are to be addressed. The use of a Capability shall: • for each assigned Capability System Role, the responsibilities of the assigned System Role must be supported, including all interfaces specified by the underlying HITSP constructs according to the conditions specified for the assigned System Role. • If a Capability option is selected, the implementation must conform to the Capability’s specifications for that option. • A HITSP Service Collaboration (SC) binds communications infrastructure, security and privacy constructs together. • A HITSP Transaction Package (TP), Transaction (T), Component (C) is where standards-based Interface Design Specifications are specified and conformance requirements are defined.

15. HITSP Harmonization Framework IS = Interoperability Specification Addressing Business Needs Available for Independent Implementation Providing Infrastructure, Security, Privacy Defining Information Content Data Architecture Base and Composite Standards

16. HITSP Documents are available at www.HITSP.org Detailed HITSP Data Architecture is available online at www.USHIK.org HITSP Data Architecture within HITSP Harmonization Framework GREEN indicates reusable elements

17. HITSP Clinical Document Components HITSP Reuse Paradigm: With HITSP/Capability 119 - Communication of Structured Documents, a HL7 Clinical Data Architecture (CDA) document can be composed, from any group of C83 data modules, and then it can be communicated. Benefit: agile system interoperability.

18. HITSP/C83 Data Module Categories

19. EHR System Design Reference Model (EHR SD RM) Constructing a Future State EHR Reference Architecture Functional Analysis Object Analysis Requirements Analysis Interface Design Analysis Service Analysis

20. Value Proposition of Standards Based Approach Analysis Pre-Done: Analysts from throughout industry have vetted and contributed to the development of thorough specifications Less Customization: COTS vendors are already building applications to meet these specifications. Comprehensive View: Standards provide a way to ensure that requirements and design address all of the necessary issues Lack of unexpected dependencies late in project: All functions and specifications have been pre-analyzed and defined Better Interoperability: Standards based approaches will ensure development between all stakeholders are able to communicate at the project and technical level Across Project Visibility: Normalized requirements and design would allow for “apples to apples” comparison across the portfolio

21. Basic UML Legend

22. Abbreviations B-Case is Business Case BPM is Business Process Model CCD is Continuity of Care Document CCHIT is Certification Commission for Health Information Technology CDRL is Contract Deliverable DBT is Defense Business Transformation IHE is Integrating the Healthcare Enterprise NHIN is National Health Information Exchange PCC is Patient Care Coordination RM-ODP is Reference Model of Open Distributed Processing SOA is Service Oriented Architecture

23. PART II: HL7 SAIF, Requirements Management and Architectural Processes • EHR SD RM within the Requirements and Architecture Development Cycle • The HL7 Services-Aware Interoperability Framework (SAIF) • HL7 SAIF ECCF Specification Stack • HITSP Within HL7 SAIF ECCF Specification Stack • HL7, HITSP, FHIMS and NHIN Within HL7 SAIF ECCF Specification Stack

24. EHR System Design Reference Model (EHR SD RM) Supporting Requirements/ Architecture Development Cycle PROCESS INPUTS -Required Capabilities -Environments -Constraints EHR System Design Reference Model Capabilities - Functions, Information Model Information Exchanges Stakeholder Requirements Definition Functions – Dependencies Requirements Loop Function or Service Interface Design Specifications Requirements Analysis Conformance Criteria Design Loop Architecture Design Test Specifications Verification & Validation Loop Compliancemeans a system provides support for a given standard. Conformanceis a recognition of  formal testing, that prove that a system provides 100% support for a given standard. PROCESS OUTPUTS -System Architecture, -System & Test Specifications -Configuration Management Baselines

25. EHR SD RM Supporting Requirements/ Architecture Development Cycle Stakeholder Requirements Whatis the system supposed to do? Where will the products of the system be used? Under what conditions will the products be used? How often? How long? Who will use the products of the system? Requirements Analysis (“HOW?” using “Action Verbs”) Analyze functions and Services Decompose higher level functions to lower level functions Allocate performance requirements to the functions Architecture Design (Whichhardware/ software elements) Define the physical architecture Each part must perform at least one function Some parts may perform more than one function Requirements Loop • Ensure all requirements are covered by at least one function • Ensure all functions are justified by a valid requirement (no unnecessary duplication) Design Loop • Ensure all functions are covered by at least one hardware or software element • Ensure all elements of physical architecture are justified by a valid functional requirement (no unnecessary duplication) Verification & Validation (V&V) Loop • Each requirement must be verifiable that the solution meets requirements and validated that it meets the user’s needs and expectations. • V&V can be accomplished by: Inspection, Analysis, Demonstration, Test

26. EHR SD RM Supporting Requirements & Architectural Processes 2010 slide

27. The HL7 Services-Aware Interoperability Framework (SAIF) SAIF Contains: • Enterprise Conformance and Compliance Framework (ECCF) is based on RM-ODP • Behavioral Framework (BF) • Interoperability Scenarios supporting the RM-ODP Computational Viewpoint • Governance Framework (GF) • Governance is the overarching policy structure and set of related processes by which a group exercises its authority and demonstrates accountability for accepted responsibilities within a particular jurisdiction. SAIF Principles: • Applicable within each of HL7’s three Interoperability Paradigms (IPs), • (i.e., messages, documents, and services). • Provide support for measurable conformance and compliance. • Define appropriate governance structures and processes. • Provide support for directly implementable solutions. • Address the growing disparity between the various solution sets emerging from HL7. • Utilize existing V3/RIM artifacts and expertise to the maximum degree possible.

28. HL7 SAIF ResponsibilitiesConformance and Compliance Framework (ECCF) Policy “Why” Content “What” Behavior “How” Implementation “Where” Traceable Consistency

29. HL7 SAIF Specification Stack ViewsConformance and Compliance Framework (ECCF) Policy Content Behavior Implementation Traceable Consistency

30. HITSP WithinHL7 SAIF ECCF Specification Stack Policy Content Behavior Implementation HITSP DA HITSP CAP Harmonization Requests/ Use Case HITSP CAP HITSP Harmonization Framework HITSP IS HITSP Component HITSP Transaction, Transaction Package and Service Collaboration Traceable EHR-S FM is EHR System Functional Model EHR SD RM is EHR System Design Reference Model RIM is Reference Information Model FHIMS is Federal Health Information Model & Standards DA is Data Architecture Consistency

31. HL7, HITSP, FHIMS, NIEM and NHIN WithinHL7 SAIF ECCF Specification Stack Policy Content Behavior Implementation HL7 EHR-S FM HITSP Harmonization Framework HL7 RIM FHA FHIMS HITSP DA HITSP CAP Harmonization Requests/ Use Case HITSP Capability Tomcat, JBoss, J2SE, Eclipse, GlassFish ESB, OpenSSO NHIN Connect Services HL7 EHR SD RM HITSP IS HITSP Component NIEM Information Exchange Package NIEM, HITSP Transaction, Transaction Package and Service Collaboration Traceable EHR-S FM is EHR System Functional Model EHR SD RM is EHR System Design Reference Model NIEM is National Information Exchange Model RIM is Reference Information Model FHIMS is Federal Health Information Model & Standards DA is Data Architecture Consistency 30

32. PART III Prototype EXAMPLE • Vaccination and Adverse Event Reporting Prototype • AHIC Use Cases • EHR-S FM • HITSP Capabilities • Information Model

33. EHR-SD RM Prototype [2008 AHIC Use Cases] Immunization and Response Management (IRM) • The IRM AHIC Use Case and HITSP Interoperability Specification are intended to support current interoperability approaches between EHRs and Immunization Information Systems while allowing for a migration toward emerging interoperability implementations and document sharing environments where PHRs are able to be included in the information flow • The Interoperability Specification also allows for basic electronic information exchanges to enable requirement communications and alerting mechanisms and to lay the foundation for future clinical support capabilities • Scenario 1: Vaccine and Drug Administration and Reporting and • Scenario 2: Vaccine and Drug Inventory Reporting

34. EXAMPLE ARTIFACT: Vaccine and Drug Administration and Reporting Information Exchanges

35. EXAMPLE ARTIFACTVaccine and Drug Administration and Reporting Use CaseFull use case available at: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1255&parentname=CommunityPage&parentid=1&mode=2&in_hi_userid=10741&cached=true

36. EHR-SD RM PrototypeInformation Exchange Requirements (IERs)Vaccine and Drug Administration and Reporting Use Case IER10 Identify patient IER13 Send/receive notification of document availability IER18 Send/receive clinical document IER26 Identify communication recipients IER27 Send non-patient notification message or alert IER40 Query for existing data IER42 Request/receive medical concept knowledge IER54 Query/response for clinical message data IER67 Send/receive clinical message IER78 Send/receive Vaccine Inventory Requirements IER79 Query/response for inventory usage data IER80 Send/receive Vaccine Inventory Data For details, see HITSP IS 10 Immunization and Response Management, available at www.HITSP.org

37. DR08 Unstructured Data DR11 Immunization response data DR12 Adverse Event Report DR13 Drug/Vaccine Inventory Data DR14 Drug/Vaccine Inventory Usage Data DR15 Drug/Vaccine Inventory Availability Data DR16 Supply Chain Management Vaccine Recall DR17 Decision Support Data DR18 Vaccination Data DR19 Medication Administration data DR20 Aggregate Inventory of Available Vaccine DR21 Terminology Data DR22 Generic Alert Data DR23 Consumer Vaccination View EHR-SD RM PrototypeData Requirements (DRs)Vaccine and Drug Administration and Reporting Use Case For details, see HITSP IS 10 Immunization and Response Management, available at www.HITSP.org

38. EHR-SD RM PrototypeHITSP Security and PrivacyVaccine and Drug Administration and Reporting Use Case IER01 Provide authorization and consent IER02 Send data over secured communication channel IER03 Create audit log entry IER04 Synchronize system time IER05 Verify entity identity IER06 Provide proof of document integrity and origin IER55 Anonymize patient identifiable data IER56 Pseudonymize patient identifying information For details, see HITSP IS 10 Immunization and Response Management, available at www.HITSP.org

39. EXAMPLE ARTIFACT HL7 Requirements and Certification Criteria and HITSP Design HL7 EHR System Functional Model HITSP Interoperability Specifications

40. EXAMPLE ARTIFACT EHR-S Requirements

41. EXAMPLE ARTIFACTEHR-S FM Dependencies

42. EXAMPLE ARTIFACTHITSP Interoperability Design Specifications

43. IS10 IRM HITSP Constructs Mapped to Standards

44. Contact Information Nancy Orvis Chief Integration Architect Office of the Chief Information Officer DoD Military Health System Email: nancy.orvis@tma.osd.mil Steve Hufnagel Enterprise Architect, TIAG contract support Office of the Chief Information Officer DoD Military Health System Email: steven.hufnagel.ctr@tma.osd.mil