0. From HL7 and HITSP Artifacts
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 Phoenix Workgroup Meeting, January 2010
Details available at
Chief of Integration & Interoperability
Architect & System Engineer
Alean Kirnak, President, Software Partners

1. 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.

2. 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 (SAEAF), 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.
NEXT STEPS: For Project Information, see
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)
1 - Populate a framework of candidate healthcare services, with IERs, based on SAEAF service categories
Define priority Information Exchange Requirements (IERs) Define priority Data Requirements (DRs) along with IERs
Map IERs and DRs to the framework of candidate healthcare services
Build Catalog of candidate Services from 2008 H-SOA-RA work
Show AHIC-HITSP traceability (e.g., AHIC IERs to HITSP ISs to standards)
Show NHIN traceability (align with NHIN services)
Show CCHIT traceability (align with CCHIT test criteria)
Compare and contrast framework of candidate healthcare services with Canada Infoway’s SOA and/or other SOA
2 - Define EHR-SD RM
Map Priority IERs and DRs to EHR-S FM
Map candidate services to EHR-S FM
Define EHR-SD RM based Business Transformation Architecture methodology for
Identify gaps and overlaps in HL7’s portfolio
Identify artifacts that do not now exist but are indicated in the EHR-S FM
Identify the extent of duplication that may exist across HL7 artifacts
3 - Create prototype EHR-SD RM validation case study prototype, using
AHIC-HITSP Public Health and Emergency Response use cases and Interoperability Specifications
Services Aware Enterprise Architecture Framework (SAEAF)
HITSP Multi-Enterprise Architecture of Networked Services Standards (MEANS) and
HL7 HSSP Practical Guide for SOA in Healthcare “sample health” example specifications
Include mapping to MHS and DOD specific IERs and DRs
Publish HL7 HSSP Practical Guide for SOA in Healthcare Part 2: Case Study
To show HITSP, NHIN and CCHIT conformance criteria, use OMG Object Constraint Language and/or OWL Semantic Ontology specification language

3. Linking Business and Technical Architectures

4. Contents
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 SAEAF, Requirements Management Process and Governance
PROTOTYPE: Immunization and Adverse Event Reporting

5. 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

6. 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
Other
O Electronic Resource Planning (ERP)
O Finances
O Other
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. 6

7. Healthcare SOA Framework Based on HL7 EHR System Functional Model & Thomas Erl’s SOA Layers
HL7 System Functions 
Direct Care
Supportive
Information Infrastructure
Other
Business
Process
Value Chains
Composite
Services
Federated Composition (e.g., Choreograph or Orchestration) Within and Across Business Areas
Core Business
Functional
Areas + Focal Classes
Entity
Information
Management
Reporting and Management
Agnostic Services
C r o s s T e c h n I c a l “Common S e r v I c e s”
(e.g., Security, Privacy, Auditing, Logging…)
Application
Ambulatory Care Systems,
In Patient Care Systems
Logistics Systems
Financial Systems
Decision Support Systems
Data Marts
Repositories
Business Objects
Implementation
Profiles
Integrated Healthcare Enterprise (IHE) Profiles
Analysis Profiles
Communications Profiles/Stacks
Implementation Profiles
Re: Focal Classes:
 The issue is less the idea of a focal class than a business focal class.
The difference is that when you model the service, you are generally modeling a service that will express the state changes of a business.
For example, via analysis, you would find the states of a business focal class (canceled, new, active, signed, finalized in lab orders for
example) and the trigger events that would correspond to state changes ("a lab is ordered", "a lab is canceled", "a lab specimen is corrupted", and so on).
 You could say that a "patient" is a focal class, but a patient ID service generally doesn't express operations to modify the state of that "object". Rather, a patientID service would generally encompass operations that would express information about the class (reconcileID or lookUpID, eg) rather than tying the service functional components to changes in the state of that class.
 It is not a subtle distinction - most clinical domains are focused on a focal class (an order, an encounter, an appointment, a schedule, a lab).
A business service is focused with exposing that class to the enterprise.
 Infrastructure services (or the subset information services) are generally function calls or based on exposing sets of information. The functional profiles of the service are generally not focused on the state of the underlying information or in the trigger events that modify the state of that information. They tend to be focused along different lines - typically along the lines of an information profile (a RIM-based patient class, eg, or a CDA-based CCD).
The focal class is explicit in a business service, generally implicit in other services. 7 7

8. HL7 RIM (Reference Information Model) Six Core Classes Defining a Semantic Framework which Maintains Clinical Data Context
ENTITY
ROLE
ACT (aka ACTION)
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)

9. 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.
HITSP Transaction Packages/ Transactions/ Components (TP/T/Cs) are where standards-based Interface Design Specifications are specified are given and conformance requirements are defined.

10. HITSP Harmonization Framework
IS = Interoperability Specification IS
Capability
Service Collaboration
Transaction, Transaction Package
Components
Addressing
Business
Needs
Available
for Independent
Implementation
Providing
Infrastructure,
Security,
Privacy
Defining
Information
Content
Data Architecture

11. HITSP Data Architecture within HITSP Harmonization Framework
HITSP Documents are available at
Detailed HITSP Data Architecture is available online at
GREEN indicates reusable elements

12. HITSP Clinical Document Components
HITSP Reuse Paradigm:
With HITSP/Capability 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.

13. HITSP/C83 Data Module Categories
Module Category
Description
Personal Information
The personal information includes name, address, contact information, personal identification information, ethnic and racial affiliation and marital status of a person
Support
Support includes the patient's sources of support, such as immediate family, relatives and/or guardians. This includes next of kin, caregivers, support organizations, and key contacts relative to healthcare decisions. Support providers may include providers of healthcare related services, such as a personally controlled health record, or registry of emergency contacts
Healthcare Providers
This includes a list of the healthcare providers and organizations that provide or have provided care to the patient
Insurance Providers and Payers
Insurance providers include data about the organizations or individuals who may pay for a patient's healthcare, and the relationships, demographics and identifiers of those individuals with respect to the payer. Such organizations or individuals may be health insurance plans, other payers, guarantors, parties with financial responsibility, some combination of payers or the patient directly
Allergies and Drug Sensitivities
This includes the allergy or intolerance conditions, severity and associated adverse reactions suffered by the patient
Conditions
This includes relevant clinical problems and conditions for which the patient is receiving care, including information about onset, severity, and providers treating the condition. Conditions are broader than, but include diagnoses
Medications
This includes the patient's prescription or non-prescription medications and medication history, and may include prescriptions, fulfillments and medication administration activities
Immunizations
This includes data describing the patient's immunization history
Vital Signs
This includes data about the patient’s vital signs
Test Results
This includes data about current and historical test results from laboratory or other diagnostic testing performed on the patient
Encounter
This includes data describing the interactions between the patient and clinicians. Interaction includes both in-person and non-in-person encounters such as telephone and
Procedures
This includes data describing procedures performed on a patient
Family History
Data defining the patient’s genetic relatives in terms of possible or relevant health risk factors that have a potential impact on the patient’s health
Social History
Data defining the patient’s occupational, personal (e.g. lifestyle), social, and environmental history that have a potential impact on the patient’s health
Medical Equipment
Medical Equipment includes implanted and external medical devices and equipment that a patient’s health status depends on, as well as any pertinent equipment or device history
Functional Status
Data defining the patient’s functional status with respect to, ambulatory ability, mental status or competency, activities of daily living, including bathing, dressing, feeding, grooming, home/living situation having an effect on the health status of the patient, and ability to care for self
Plan of Care
The plan of care contains data defining prospective or intended orders, interventions, encounters, services, and procedures for the patient

14. Requirements Analysis Interface Design Analysis
EHR Future State Reference Architecture … EHR Way Forward Business Architecture Specification Framework
Functional Analysis
Object Analysis
Requirements Analysis
Interface Design Analysis
Service Analysis
Slide 14

15. EHR Future State Reference Architecture Adding ARRA and FHIMS
For Project Information, see
Slide 15

16. 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

17. PART II: HL7 SAEAF, Requirements Management and Governance
The HL7 Services-Aware Enterprise Architecture Framework (SAEAF)
HL7 SAEAF ECCF Specification Stack
HITSP Within HL7 SAEAF ECCF Specification Stack
HL7, HITSP, FHIMS and NHIN Within HL7 SAEAF ECCF Specification Stack
Business Capability Lifecycle (BCL)
Develop/ Update Reference Architecture
Requirements Management Process
BACKUP SLIDES: Example (Immunization and Adverse Event Reporting)

18. The HL7 Services-Aware Enterprise Architecture Framework (SAEAF)
SAEAF 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.
SAEAF 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.

19. HL7 SAEAF Conformance and Compliance Framework (ECCF) Specification Stack Views
Policy
Content
Behavior
Implementation
Traceable
Consistency

20. HITSP Within HL7 SAEAF ECCF Specification Stack
Topic
Specification
Enterprise / Business View
“WHY”
Information
View
“WHAT”
Computational
“HOW”
Engineering
“WHERE”
Conceptual
Business Context, Reference Context
Domain Analysis (Information) Model
Collaboration Analysis, Functional Profile(s), Service Roles and Relationships
Existing Platform capabilities
Platform-
Independent
Business Governance
Project-oriented Domain Information Model, Constrained Information Model, Localized Information Model, Hierarchical Message Definition
Collaboration Types, Interface Specification and Functional Groups, Interaction Types and Collaboration Participations, Contracts Parts
Existing Platform models, libraries, etc.
Specific
Rules, Procedures
Localized Information Model, Transforms, Schema
Collaboration scripts, Orchestrations, Realized Interfaces
Execution Context, Platform Bindings, Deployment Model
Policy
Content
Behavior
Implementation
HITSP IS
HITSP DA
HITSP CAP
Harmonization Requests/ Use Case
HITSP CAP
HITSP Harmonization Framework
HITSP C
HITSP
T, TP and SCs
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 20

21. HL7, HITSP, FHIMS and NHIN Within HL7 SAEAF ECCF Specification Stack
Topic
Specification
Enterprise / Business View
“WHY”
Information
View
“WHAT”
Computational View
“HOW”
Engineering
“WHERE”
Conceptual
Business Context, Reference Context
Domain Analysis (Information) Model
Collaboration Analysis, Functional Profile(s), Service Roles and Relationships
Existing Platform capabilities
Platform-
Independent
Business Governance
Project-oriented Domain Information Model, Constrained Information Model, Localized Information Model, Hierarchical Message Definition
Collaboration Types, Interface Specification and Functional Groups, Interaction Types and Collaboration Participations, Contracts Parts
Existing Platform models, libraries, etc.
Specific
Rules, Procedures
Localized Information Model, Transforms, Schema
Collaboration scripts, Orchestrations, Realized Interfaces
Execution Context, Platform Bindings, Deployment Model
Policy
Content
Behavior
Implementation
HL7 EHR-S FM
HITSP IS
HL RIM
FHA FHIMS
HITSP DA
HITSP CAP
Harmonization Requests/ Use Case
HITSP CAP
Tomcat, JBoss, J2SE, Eclipse, GlassFish ESB, OpenSSO
HL7 EHR SD RM
HITSP Harmonization Framework
HITSP C
HITSP
T, TP and SCs
NHIN Connect
Services
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 21

22. HITSP and Immunization Use Case#
Capability
Patient Identification
Data Retrieval and Update
Decision Support 1
Standards Org
HL7 2
Service Specification
Identification Service Functional Model
Retrieve, Locate, Update SFM
Decision Support SFM 3
OMG 4
Identification Service Specification
Retrieve, Locate, Update Spec
Decision Support Service Spec 5
Profile Org
IHE 6
SOA Profile
SOA White Paper 7 8
Immunization Profile
PIX/PDQ SC110
Query for Existing Data (QED) CAP123 SC113
Immunization Content (IC) CAP119 CAP133 SC112
Request for Clinical Guidance CAP133
(IC payload) 9
American Immunization Registry Association/CDC 10
Draft: 2.5 Impl Guide 11
2.3.1 Impl Guide CAP131 CAP132 SC115
2.3.1 Impl Guide CAP131 CAP132 SCII5 12 13
Original Standard V2
V3 Patient Admin messaging
V3 Care Record messaging
V3 (POIZ) Immunization messaging
V3 Care Record CDA
V3 POIZ messaging

23. Immunization Use Case - Simplified#
Capability
Patient Identification
Data Retrieval and Update
Decision Support 1
Standards Org
HL7 2
Service Specification
Identification Service Functional Model
Retrieve, Locate, Update SFM
Decision Support SFM 3
OMG 4
Identification Service Specification
Retrieve, Locate, Update Spec
Decision Support Service Spec 5
Profile Org
IHE 6
SOA Profile
SOA White Paper 7
IHE/American Immunization Registry Association/CDC 8
Immunization Profile
PIX/PDQ SC110
Future Draft: 2.5 Impl Guide
Query for Existing Data (QED) CAP123 SC113
Immunization Content (IC) CAP119 CAP133 SC112
Request for Clinical Guidance
CAP133
(IC payload) 12 13
Original Standard V2
V3 Patient Admin messaging
V3 Care Record messaging
V3 Care Record CDA

24. Immunization Use Case Within HL7 SAEAF ECCF Specification Stack#
Patient Identification
Data Retrieval and Update
Decision Support 1
Enterprise View (Service Functional Models) 2
Identification Service Functional Model
Retrieve, Locate, Update SFM
Decision Support SFM 3
Computational View (Service Definitions) 4
Identification Service Specification
Retrieve, Locate, Update Spec
Decision Support Service Spec 5
Information View (Payloads) 6
PIX/PDQ SC110
Future Draft: 2.5 Impl Guide
Query for Existing Data (QED) CAP123 SC113
Immunization Content (IC) CAP119 CAP133 SC112
Request for Clinical Guidance
CAP133
(IC payload) 7
Implementation View (Vendor Implementations) 8
Base Standard 9 V2
V3 Patient Admin msg
V3 Care Record msg
V3 Care Record CDA
V3 Care Record mesg

25. Service Definition Ref: A Service-Oriented Architecture (SOA) View of IHE Profiles IHE 2009

26. Meet in the Middle* *Anna Orlova, Josh Painter, Alean Kirnak, “A SOA View of IHE Profiles” working drafts
Copyright 2009 Software Partners LLC

27. Cost Effectiveness Proposition
Target cost function of healthcare IT connectivity
# of service consumers * # of services

28. Cost Effectiveness Proposition
Target cost function of healthcare IT connectivity
# of service consumers * # of services

29. Point to Point Messaging Economics
Approximately 75 U.S. Immunization Information Systems (IISs)
Completely connected point-to-point IIS network: 74 * 75 / 2 = 2775 connections
Assume 200 regional provider EHRs per IIS:
200 * 75 = 15,000 connections
Each connection costs $10K-$30K per side
$40K each * 17,775 =$711,000,000
Copyright 2009 Software Partners

30. Expand to Multiple Domains
Labs
Meds
Allergies
Cancer Registries
Joint Replacement Registries
Chronic Disease Registries
Adverse Event Reporting
…etc.
Intra-enterprise communication
Provider-to-Provider communication
...
100 domains increases cost to $71,100,000,000
Copyright 2009 Software Partners

31. Growth of Points of Care
Schools
Drug stores
Airports …
Copyright 2009 Software Partners

32. Growth of Personal Health Records
Tethered
Untethered
Wireless devices …
Copyright 2009 Software Partners

33. How to Solve? Bus architecture Plug-and-play connections
Common information model
Copyright 2009 Software Partners

34. Cost Reduction Opportunities
Bus architecture
Build common carrier once
hide routing, translation
Plug and play connections
Eliminates cost on one side of each connection
Common information model
Allows multiple platform-specific models for a single platform-independent model
Copyright 2009 Software Partners

35. Cost Reduction Opportunities
75 IISs each accessing one service
15,000 EHRs, installations ea = 500 connections
is per service consumer only
$20K * ( ) =$11,500,000
+ cost of carrier
Drive down the $20K
Copyright 2009 Software Partners

36. Meaningful Use Rules and Regs#
Capability
Patient Identification
Data Retrieval and Update
Decision Support 1
Standards Org
HL7 2
Service Specification
Identification Service Functional Model
Retrieve, Locate, Update SFM
Decision Support SFM 3
OMG 4
Identification Service Specification
Retrieve, Locate, Update Spec
Decision Support Service Spec 5
Profile Org
IHE 6
SOA Profile
SOA White Paper 7 8
Immunization Profile
PIX/PDQ SC110
Query for Existing Data (QED) CAP123 SC113
Immunization Content (IC) CAP119 CAP133 SC112
Request for Clinical Guidance CAP133 (IC payload) 9
American Immunization Registry Association/CDC 10
Draft: 2.5 Impl Guide 11
2.3.1 Impl Guide CAP131 CAP132 SC115
2.3.1 Impl Guide CAP131 CAP132 SCII5 12 13
Original Standard V2
V3 Patient Admin msg
V3 Care Record msg
V3 (POIZ) Immunization msg
V3 Care Record CDA
V3 Care Record messaging
V3 POIZ messaging

37. Proposed Meaningful Use Comments
Propose use of service interfaces to satisfy need for transport layer standards for immunizations
Fill gaps in immunization standards
Include immunizations in medical summary
Use CAP133 Immunization Content in Table 2A
Include immunizations in decision support clauses
Note the immunization use case includes patient identification

38. Proposed 2.5.1 Immunization Guide Changes
Clarify use of HITSP and IHE constructs
Consider a service definition that combines PIX/PDQ and IZ data retrieval and update into a composed service

39. Topics for Discussion

40. RED indicates where HL7 and HITSP artifacts can be used
Business Capability Lifecycle (BCL)
KEY PROCESS
RED indicates where HL7 and HITSP artifacts can be used

41. RED indicates where HL7 and HITSP artifacts can be used
BCL Develop/ Update Reference Architecture
RED indicates where HL7 and HITSP artifacts can be used

42. Requirements Management Process
Slide 42

43. Prototype Vaccination and Adverse Event Reporting Prototype
AHIC Use Cases
EHR-S FM
HITSP Capabilities
Information Model

44. EHR-SD RM Prototype Requirements from 2008 AHIC Use Cases
Use Case 1: Immunization and Response Management (IRM) and
Use Case 2: Public Health Case Reporting (PHCR)
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
The Public Health Case Reporting AHIC Use Case and HITSP Interoperability Specification supports the bi-directional information exchanges of the Public Health Case Reporting process
The Public Health Case Reporting Use Case addresses numerous domains which have similar content and processes at a high level, but which also are dissimilar in report content details and case management processes when considering any specific report

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

46. EXAMPLE ARTIFACT Vaccine and Drug Administration and Reporting Use Case Full use case available at:

47. Blue Italics indicates IERs, which are common to 1-IRM and 2-PHCR
EHR-SD RM Prototype Information Exchange Requirements (IERs) Use Case 1: Immunization and Response Management (IRM)
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
Blue Italics indicates IERs, which are common to 1-IRM and 2-PHCR
For details, see HITSP IS 10 Immunization and Response Management, available at

48. Blue Italics indicates common across IRM and PHCR
EHR-SD RM Prototype Data Requirements (DRs) Use Case 1: Immunization and Response Management (IRM)
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
Blue Italics indicates common across IRM and PHCR
For details, see HITSP IS 10 Immunization and Response Management, available at

49. Blue Italics indicates common across 1-IRM and 2-PHCR
EHR-SD RM Prototype IRM Information Exchange Requirements (IERs) Use Case 2: Public Health Case Reporting (PHCR)
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
IER29 Send/receive electronic form for data capture
IER40 Query for existing data
IER42 Request/receive medical concept knowledge
IER49 Report confirmation
Blue Italics indicates common across 1-IRM and 2-PHCR
For details, see HITSP IS 10 Immunization and Response Management, available at

50. Blue Italics indicates common across IRM and PHCR
EHR-SD RM Prototype Data Requirements (DRs) Use Case 2: Public Health Case Reporting (PHCR)
DR08 Unstructured Data
DR17 Decision Support Data
DR21 Terminology Data
DR24 Case Report Pre-populate Data
DR22 Generic Alert Data
DR23 Consumer Vaccination View
DR25 Case Report Content
DR26 Reporting Criteria Content
DR59 Generic Alert Data
Blue Italics indicates common across IRM and PHCR
For details, see HITSP IS 10 Immunization and Response Management, available at

51. Blue Italics indicates common across IRM and PHCR
EHR-SD RM Prototype Information Exchange Requirements (IERs) HITSP Security and Privacy
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
Blue Italics indicates common across IRM and PHCR
For details, see HITSP IS 10 Immunization and Response Management, available at

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

53. EXAMPLE ARTIFACT EHR-S Requirements

54. EXAMPLE ARTIFACT EHR-S FM Dependencies

55. EXAMPLE ARTIFACT HITSP Interoperability Design Specifications

56. HITSP Data Element Identifier and Name Additional Specification
Sample HITSP C83 Data Modules Immunizations Data Mapping Table – Requirements
CDA Data Location
HITSP Data Element Identifier and Name
O/R[1]
Additional Specification =
' ']
Immunization Event Entry
See Below[2]
@negationInd
Refusal
R/N
cda:effectiveTime
Administered Date
O/N
cda:entryRelationship cda:observation/cda:value
Medication Series Number
’ ’]
Reaction
O/Y
cda:performer/cda:assignedEntity
Performer
cda:consumable/cda:manufacturedProduct
Medication Information
R/Y
Coded Product Name
R2/Y
cda:originalText
Free Text Product Name
cda:manufacturerOrganization
Drug Manufacturer
cda:manufacturedMaterial/ cda:lotNumberText
Lot Number
R2/N
’ ’]
Refusal Reason

57. Sample of Standards used within HITSP Components within IS10
Standard: HITSP Construct
Accredited Standards Committee (ASC) X12 Standards Release HITSP/C80 - Clinical Document and Message Terminology
American Medical Association (AMA) Current Procedural Terminology (CPT®) Fourth Edition (CPT-4); CPT Evaluation and Management Codes HITSP/C80 - Clinical Document and Message Terminology
ASTM International Standard Guide for Electronic Authentication of Health Care Information: # E (2003) HITSP/C26 - Nonrepudiation of Origin
CDC Race and Ethnicity Code Sets HITSP/C80 - Clinical Document and Message Terminology
Center for Disease Control and Prevention Implementation Guide for Immunizations Data Transaction using Version of the Health Level Seven (HL7) Standard Protocol. Implementation Guide Version 2.2 June 2006 HITSP/C70 - Immunization Query and Response, HITSP/C72 - Immunization Message, HITSP/C80 - Clinical Document and Message Terminology
Digital Imaging and Communications in Medicine (DICOM) Part 3.12: Media Formats and Physical Media for Media Interchange HITSP/T33 - Transfer of Documents on Media
European Telecommunications Standards Institute (ETSI) Technical Specification TS : XML Advanced Electronic Signatures (XadES) HITSP/C26 - Nonrepudiation of Origin
Federal Information Processing Standards (FIPS) Codes for the Identification of the States, the District of Columbia and the Outlying Areas of the United States, and Associated Areas Publication # 5-2, May, HITSP/C80 - Clinical Document and Message Terminology
Food and Drug Administration (FDA) - Unique Ingredient Identifier (UNII) HITSP/C80 - Clinical Document and Message Terminology
Food and Drug Administration (FDA) - National Drug Code (NDC) HITSP/C80 - Clinical Document and Message Terminology
Health Care Provider Taxonomy HITSP/C80 - Clinical Document and Message Terminology
Health Level Seven (HL7) Clinical Document Architecture (CDA) Release HITSP/C78 - Immunization Document, HITSPC83 - CDA Content Modules
Health Level Seven (HL7) Common Terminology Services (CTS) Release 1 HITSP/T66 - Retrieve Value Set
Health Level Seven (HL7) Implementation Guide for CDA Release 2: History and Physical (H&P) Notes HITSP/C83 - CDA Content Modules
Health Level Seven (HL7) Implementation Guide for CDA Release 2: Consultation Note HITSP/C83 - CDA Content Modules
Health Level Seven (HL7) Implementation Guide: CDA Release 2 – Continuity of Care Document (CCD), April 01, 2007 HITSP/C83 - CDA Content Modules
Health Level Seven (HL7) Standard Code Set CVX - Vaccines Administered HITSP/C80 - Clinical Document and Message Terminology
Health Level Seven (HL7) Standard Code Set MVX - Manufacturers of Vaccines HITSP/C80 - Clinical Document and Message Terminology
Health Level Seven (HL7) V3 RBAC, R1-2008, HL7 Version 3 Standard: Role Based Access Control (RBAC) Healthcare Permissions Catalog, Release 1, February 2008, HITSP/TP20 - Access Control
Health Level Seven (HL7) Version HITSP/C70 - Immunization Query and Response
Health Level Seven (HL7) Version Chapter 2 – Control, Chapter 3 – Patient Administration HITSP/TP22 - Patient ID Cross-Referencing
Health Level Seven (HL7) Version 2.5, Chapter 2 – Control, Chapter 3 – Patient Administration, Chapter 5 – Query HITSP/TP22 - Patient ID Cross-Referencing
Health Level Seven (HL7) Version 2.5, Chapter 2 – Control, Chapter 3 – Patient Administration, Chapter 5 - Query HITSP/T23 - Patient Demographics Query
Health Level Seven (HL7) Version HITSP/C80 - Clinical Document and Message Terminology
Health Level Seven (HL7) Version Vocabularies and Value Sets HITSP/C80 - Clinical Document and Message Terminology
Health Level Seven (HL7) Version 3.0 Context-Aware Information Retrieval Specification: URL Implementation Guide HITSP/T81 - Retrieval of Medical Knowledge

58. Basic UML Legend

59. 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