Healthcare Interoperability Standards Compliance Handbook - Conformance and Testing of Healthcare Data Exchange Standards

Foreword

Preface

Trademarks and Disclaimer

Copy-Editor

Contributors

Reviewers

HL7 Conformance Working Group

Robert Snelick Acknowledgments

Frank Oemig Acknowledgments

Dedication

Contents

About the Authors

Acronyms

List of Figures

List of Tables

Healthcare Information Technology

1 Introduction

1.1 The Case for Common Understanding

1.1.1 The Need for Consistency

1.2 Information Cycle

1.3 Motivation for Cooperation

1.4 Definition of Key Terms and Concepts

1.4.1 Conformance

1.4.2 Interoperability

1.5 Interoperability Levels

1.6 Standards Development Life-Cycle

1.7 ISO/OSI Stack

1.8 Reference Model for Open Distributed Processing (RM-ODP)

1.9 Concept Relationships

1.10 Approaches to Standards Development

1.11 Testing

1.12 Scope and Purpose

1.13 Commonly Used Terms and Definitions

1.14 Intended Audience

1.15 Keywords for Use

1.16 Summary

References

2 Architecture

2.1 Interface

2.1.1 Types of Interfaces

2.1.1.1 Functional (Local + Remote)

2.1.1.2 Message-Based Data Exchange

2.1.1.3 Document Exchange

2.1.2 Communication Paradigms

2.1.3 Protocol Layer

2.1.4 Levels for Interoperability

2.2 Interfacing

2.2.1 Impact on Interfaces

2.3 Serving Interfaces with Data

2.3.1 General “Capability” of a System

2.3.2 Relevance for Interfaces

2.4 Dynamic Behavior

2.4.1 Message Pairs

2.4.2 Timing

2.4.3 Message Identification

2.4.4 Routing to Multiple Destinations

2.4.5 Responsibility of a System

2.4.6 Event Handling

2.4.7 Delayed Message Handling (Sender)

2.4.8 Handling of Outdated Data (Receiver)

2.5 Intermediate Message Handling

2.6 Message Population

2.7 Information Transmission

2.8 Delete Indication

2.8.1 Legal Requirements for Data Persistence

2.8.2 Receiver Responsibility

2.8.3 Data Granularity

2.8.4 Impact of Order of Messages

2.8.5 Sender Responsibility: Impact to System Design

2.9 Null Flavors

2.10 Snapshot Mode Versus Update Mode

2.11 Considerations in Application Development

2.11.1 Introducing Functional Requirements

2.11.2 Conformance Discussion

2.12 Summary

References

3 Healthcare Standards Landscape

3.1 Introduction

3.2 Standards Developing Organizations

3.2.1 UNECE

3.2.2 ASC (US)

3.2.3 ASTM (US)

3.2.4 HL7

3.2.4.1 Affiliates

3.2.5 DICOM

3.2.6 KBV, ZI and QMS (Germany)

3.2.7 KV-Telematik (Germany)

3.2.8 NCPDP (USA)

3.2.9 OASIS

3.3 Profile Development Organizations

3.3.1 IHE

3.3.2 ELGA (Austria)

3.3.3 eHealth Suisse (Switzerland)

3.3.4 HITSP (US)

3.3.5 S&I Framework (US)

3.3.6 Standards Collaborative (Canada)

3.3.7 Interop’Santé (France)

3.3.8 ASIP Santé (France)

3.3.9 Phast (France)

3.3.10 eSanté (Luxembourg)

3.3.11 Interoperability Forum (Germany)

3.3.12 NHS (UK)

3.3.13 SMART Health IT on FHIR® (US)

3.3.13.1 Profiles

3.4 Overview of Widely Used Standards

3.4.1 HL7

3.4.1.1 Version 2.x and 3.0

3.4.1.2 CDA

3.4.1.3 CCOW

3.4.1.4 FHIR

3.4.1.5 More HL7 Family Members

3.4.2 Other Standards

3.5 Summary

References

4 Healthcare Data Exchange Standards

4.1 Introduction

4.2 HL7 Version 2.X

4.2.1 Versions

4.2.2 Information Model

4.2.3 Message Structure

4.2.4 Optionality

4.2.5 Encoding

4.2.6 Delimiters

4.2.7 Delete Requests

4.2.8 Null-Flavors

4.2.9 Data Types

4.2.10 Events

4.2.11 Dynamic Behavior

4.2.12 Transmission Protocols

4.2.13 Tables and Table Values

4.2.14 Conformance Methodology

4.3 FHIR (HL7)

4.3.1 Introduction and Overview

4.3.2 Element Hierarchy

4.3.3 References

4.3.4 Bundling

4.3.5 Retrieval and Queries

4.3.6 Extensibility

4.3.7 Use of Vocabulary

4.3.8 Data Types

4.3.9 Representation/Encoding

4.3.10 Maturity Model

4.3.11 Versions

4.3.12 Profiling by “Slicing”

4.3.13 Conformance

4.3.13.1 Conformance Resource

4.3.13.2 DataElement Resource

4.3.13.3 Structure Definition Resource

4.3.13.4 Operation Definition Resource

4.3.13.5 Search Parameter Resource

4.3.14 Conformance Methodology

4.4 UN/EDIFACT

4.4.1 Introduction and Overview

4.4.2 Message Structure

4.4.3 Delimiter

4.4.4 Data Types Format Notation

4.4.5 Tables

4.4.6 Conformance Methodology

4.5 ebXML

4.5.1 ebRIM

4.5.2 Data Types

4.5.3 Classes and Attributes

4.5.4 Methods

4.5.5 Conformance Methodology

4.6 CTS2 (HL7)

4.6.1 Information Model

4.6.2 Conformance Methodology

4.7 ClaML (ISO)

4.7.1 Information Model

4.7.2 Conformance Methodology

4.8 Technical Compatibility Matrix

4.9 Summary

References

Conformance (and Tools)

5 Conformance Constructs

5.1 Overview

5.1.1 Conformance Constructs Overview

5.1.2 Related Conformance Concepts

5.1.3 Example Specifications

5.1.4 Summary

5.2 Data Structures and Data Types

5.2.1 Binding to Elements

5.2.2 Atomic Versus Complex Information

5.2.3 Representation/Formats

5.2.4 Precision in Representation

5.2.5 Precision in Meaning

5.2.6 Collections of Data Types

5.2.7 Promotion/Demotion (in HL7 V3)

5.3 Usage (Optionality)

5.3.1 Example Application Discussion

5.3.2 Support for an Element

5.3.3 Implementation Support Versus Presence in Instances

5.3.4 Conditional Usage

5.3.5 Case Study: HL7 v2.x Conditional Usage

5.3.6 “Required” Versus “Mandatory”

5.3.7 Binding of Elements

5.3.8 Interface Design Choices

5.3.9 Sender and Receiver Perspectives

5.4 Cardinality

5.4.1 Limitations

5.4.2 Delimiters

5.4.3 Alternate Terms for Cardinality

5.4.4 Notation for Cardinality

5.4.5 Use of Cardinality

5.4.6 Relationship of Optionality and Cardinality

5.5 Length

5.5.1 Sender/Receiver Role

5.5.2 Truncation

5.5.3 Padding

5.5.4 Conformance Length

5.6 Content

5.6.1 Vocabulary

5.6.1.1 Vocabulary Mechanics

5.6.1.2 Value Set Definition and Value Set Expansion

5.6.1.3 Value Sets Using Multiple Code Systems

5.6.1.4 Coded Elements with Text Exceptions

5.6.1.5 Explicit Binding Strength Specification

5.6.1.6 Types of Bindings Used in Standards

5.6.2 Null Flavors (Values)

5.6.3 Fixed Value (Constant)

5.6.4 Default Values

5.6.5 Placeholder Values

5.7 Conformance Statements

5.8 Data Semantics

5.8.1 Models

5.9 Encoding

5.9.1 Display-Oriented Encoding Concepts

5.9.1.1 Escaping

5.9.1.2 Text Formatting

5.9.1.3 Character Sets

5.9.1.4 HL7 v2.x XML Encoding

5.9.2 Presence/Absence of an Element

5.9.2.1 Summary of Presence/Absence Capabilities

5.9.3 Parsing

5.9.3.1 Message Substructures

5.9.3.2 HL7 v2.x: Implicit Segment Structures

5.9.3.3 HL7 v2.x: Explicit Message Structures/BNF

5.9.3.4 HL7 v3 Message Structures

5.10 Summary

References

6 Principles of Specifying Conformance

6.1 Introduction

6.2 Overloaded Terms

6.2.1 Declaring Requirements and Conformance

6.2.2 Requirement Documents

6.3 Conformance Keywords

6.3.1 Impact of Keywords on Requirements

6.3.2 Nested Requirements

6.3.3 Normative and Informative Statements

6.4 Conformance Clause

6.4.1 Conformance Claim

6.5 Specifying Conformance Requirements

6.5.1 Implicit Definitions with Conformance Constructs

6.5.2 Explicit Definition with Normative Statements

6.5.3 Principles for Writing Conformance Requirements

6.6 Scope of Conformance Specifications

6.7 Summary

References

7 Principles of Effective Profiling

7.1 Introduction

7.2 Profiling: Definition of Terms

7.2.1 Profile Components

7.2.2 Annotations

7.3 Refinement of a Standard

7.3.1 Profiling Methodology Summary

7.3.2 Constraints

7.3.2.1 Usage (Optionality) Constraint

7.3.2.2 Cardinality Constraint

7.3.2.3 Data Type Constraint

7.3.2.4 Content (Value Set) Constraint

7.3.2.5 Length Constraint

7.3.2.6 Conformance Statement (Predicate Constraint)

7.3.2.7 Co-constraints

7.3.3 Allowable Constraints

7.3.4 Extensions

7.3.5 Conformance Approaches: Constraints Versus Extensions

7.4 Profile Hierarchy

7.4.1 Profile Hierarchy in Use

7.4.2 Profile Hierarchies for Standard Specifications

7.4.3 Non-compliant Profiles

7.5 Profiling Case Study: HL7 v2

7.5.1 HL7 v2.x Profiles: Background and Motivation

7.5.2 HL7 v2 Conformance Profile Defined

7.5.3 Message Profile Components Defined

7.6 Vocabulary Profiling

7.6.1 Vocabulary Binding and Profiling

7.6.2 Use of Extensibility and Stability

7.6.3 Profiling at the Code Level

7.6.4 Summary

7.7 Vocabulary Management

7.7.1 Managing Code Systems

7.7.2 Value Set Definition and Expansion

7.7.3 Managing Dynamic Value Sets

7.8 Uses of Conformance Profiles

7.9 Profile Design and Management

7.9.1 Profile Identification Management

7.9.2 Publishing the Specification

7.10 Pairing Sender and Receiver Profiles for Use

7.10.1 One-to-One Profile Pairing

7.10.2 One-to-Many Profile Pairing

7.10.3 Many-to-One Profile Pairing

7.10.4 Design Considerations: Profiling Pairing

7.11 Case Studies

7.11.1 Localization Using Profile Components

7.11.2 IHE Integration Profile

7.11.3 Laboratory Orders, Results, and Public Health

7.11.4 HL7 v2.x Message Profiles (in Germany)

7.12 Documenting Interfaces

7.12.1 Profile and Implementation Relationships

7.12.2 Documentation Quality

7.13 Summary

References

8 Profile Relationships

8.1 Introduction

8.2 Specialization of Profiles

8.2.1 Usage (Optionality) Compliance Rules

8.2.1.1 Conditional Usage

8.2.1.2 Withdrawn Usage

8.2.2 Cardinality Compliance Rules

8.2.3 Length Compliance Rules

8.2.3.1 Maximum Length

8.2.3.2 Minimum Length

8.2.3.3 Conformance Length

8.2.4 Vocabulary Compliance Rules

8.2.4.1 Constraining Vocabulary

8.3 Versioning of Profiles

8.3.1 Example

8.4 Creating New Profiles

8.5 Compatibility of (Sender and Receiver) Profiles

8.5.1 Usage

8.5.2 Cardinality

8.5.3 Length

8.5.4 Vocabulary

8.6 Summary

References

9 Conformance Profiling Tools

9.1 Introduction

9.2 Messaging Workbench

9.3 IGAMT

9.4 MDHT

9.5 ART-DECOR

9.6 Lantana Template Repository: Trifolia

9.7 Forge

9.8 Summary

References

Testing (and Tools)

10 Testing Models

10.1 Introduction

10.2 Testing Objectives

10.3 Definition of Terms

10.4 Test Organization Hierarchy

10.5 Test Evaluation Types

10.6 Testing Models

10.6.1 Data Instance Testing Model

10.6.2 Isolated System Testing Model

10.6.3 Peer-to-Peer System Testing Model

10.7 Additional Testing Considerations

10.8 Summary

References

11 Principles of Conformance Testing

11.1 Overview

11.2 Conformance and Interoperability Testing

11.2.1 Conformance Testing

11.2.2 Interoperability Testing

11.2.3 Conformance and Interoperability Testing Relationship

11.2.4 Periodic Testing

11.2.5 Conformance Testing in Operational Environments

11.3 Standards Development Life-Cycle

11.4 Test Methodology Framework

11.4.1 System-Under-Test (SUT)

11.4.2 Anatomy of a Test Suite

11.4.3 Anatomy of a Test Plan

11.4.4 Anatomy of a Test Case

11.4.5 Anatomy of a Test Step

11.4.6 Test Data

11.4.7 Test Script

11.4.8 Inspection Documents

11.4.9 Test Artifact

11.4.10 Test Assertion

11.4.11 Test Tool

11.4.12 Configuration Information

11.4.13 Test Report

11.5 Testing in Practice

11.5.1 Testing Sending Applications

11.5.1.1 Context-Free Testing Versus Context-Based Testing

11.5.2 Case Study: Laboratory Results

11.5.2.1 Test Procedure Workflow

11.5.3 Testing Receiving Applications

11.5.3.1 Inspection Testing Approach

11.5.3.2 Use of Acknowledgements Approach

11.5.3.3 Query and Response Approach

11.5.3.4 Extended Workflow Approach

11.5.3.5 Artificial System Capability Approach

11.5.3.6 Combining Approaches

11.5.4 Case Study: Incorporation of Laboratory Results

11.5.4.1 Juror Document Interpretation and Use

11.6 Context-Based Test Data Categorizations

11.6.1 Data Content Conformity Assessment Examples

11.6.2 Testing Cardinality and Other Conformance Constructs

11.7 Strategies and Best Practices for Test Case Development

11.8 Capability, Site, and Interoperability Testing

11.9 Negative Testing

11.9.1 Message and Document Incorporation

11.9.2 Boundary Testing

11.9.3 False Positive and False Negative Test Results

11.10 Other Types of Testing

11.10.1 Smoke Testing

11.10.2 Communication Testing

11.10.3 Application Functional Testing

11.10.4 Data Quality Testing

11.10.5 Usability Testing

11.10.6 Load Testing

11.11 Summary

References

12 Conformity Assessment

12.1 Overview

12.2 Processing Aspects (for Receiving Applications)

12.3 Usage/Optionality

12.3.1 Sender Usage Conformity Assessments

12.3.2 Receiver Usage Conformity Assessment

12.4 Cardinality

12.4.1 Sender Cardinality Conformity Assessment

12.4.2 Receiver Cardinality Conformance Assessment

12.5 Vocabulary Conformance and Assessment

12.5.1 Vocabulary Conformance

12.5.2 Vocabulary Conformity Assessment

12.5.2.1 Conformity Assessment for Senders

12.5.2.2 Conformity Assessment for Receivers

12.6 Summary

References

13 Testing Architectures

13.1 Introduction

13.2 Testing Infrastructure

13.2.1 Key Objectives of a Testing Infrastructure

13.2.2 Resource Repository

13.2.3 Test Harness

13.2.4 Services

13.2.4.1 Generation Services

13.2.4.2 Validation Services

13.2.4.3 Test Agents

13.2.4.4 Registry/Repository Services

13.2.4.5 Test Data Services

13.2.4.6 Report Services

13.2.4.7 Consistent Time Service

13.2.4.8 Proxy Service

13.2.4.9 Communication Infrastructure

13.2.4.10 Terminology Service

13.2.4.11 Aggregated Services

13.2.4.12 Other Services

13.2.5 Infrastructure Components

13.2.6 Testing Infrastructure—A Broader Context

13.2.6.1 Test Management Systems

13.2.6.2 Tool Access and Delivery

13.2.6.3 External Tools and Services

13.2.6.4 Development Components

13.2.7 Testing Infrastructure Observations

13.3 A Test Scenario

13.4 Testing Frameworks

13.4.1 Data Instance Test Framework

13.4.2 Isolated System Test Framework

13.4.3 Peer-to-Peer Testing Framework

13.5 Instantiation of Test Tools

13.5.1 Data Instance Testing Test Tool

13.5.2 Isolated System Testing Test Tool

13.5.3 Interoperability Test Bed

13.5.3.1 Operational Functions

13.5.3.1.1ƒSimulating a Vendor System

13.5.3.2 Test Flow

13.5.3.2.1ƒScheduling and Configuration

13.5.3.2.2ƒTest Execution Status Evaluation and Progress Display

13.5.3.2.3ƒOrchestration of Events

13.5.3.2.4ƒAnalysis and Results Reporting

13.5.3.2.5ƒDiscussion

13.5.3.3 Need for the ITB

13.5.3.4 Multiple Domain Test Scenarios and Testing

13.6 Summary

References

14 Testing Tools

14.1 Introduction

14.2 NIST HL7 v2.x Test Tools

14.2.1 NIST Immunization Test Suite

14.2.1.1 General Tool Capabilities

14.2.1.2 Testing Sending Applications in the Tool

14.2.1.3 Testing Receiving Applications in the Tool

14.2.2 Testing Functional Requirements with the Tool

14.2.3 NIST HL7 v2.x Testing Web Services API

14.3 Message Workbench (MWB)

14.3.1 Message Instance Validation

14.3.2 Message Validation via a Proxy-Server

14.3.3 MWB Validation Server

14.4 CDC Message Quality Framework

14.5 AHML-Australian Healthcare Messaging Laboratory

14.5.1 Message Testing Process

14.5.2 Reporting

14.6 CDA Test Tools

14.6.1 ART-DECOR

14.6.2 Lantana Trifolia

14.6.3 NIST CDA Testing

14.6.4 eHealth Suisse

14.6.5 IHE Gazelle Object Checker

14.7 IHE Conformance and Interoperability Test Tools

14.8 e-Prescribing (e-Rx) Tools

14.8.1 NIST e-Prescribing Test Tool

14.9 DVTk—DICOM Validation Toolkit

14.9.1 History

14.9.2 Functionality

14.10 Related Tools

14.10.1 HAPI

14.10.2 MDHT

14.10.3 IPF (by Open eHealth Foundation)

14.10.4 eHealth Connector (by eHealth Suisse)

14.11 Table of Tools and Access Points

14.12 Summary

References

15 Testing and Certification Programs

15.1 Introduction

15.2 Certification Perspectives

15.3 IHE Testing Programs

15.3.1 IHE Technical Framework Overview

15.3.2 IHE Testing Process

15.3.2.1 Pre-connect-a-Thon

15.3.2.2 Virtual Connect-a-Thon

15.3.2.3 Connect-a-Thon

15.3.3 IHE Product Registry

15.3.4 Gazelle

15.4 EHR Certification and Meaningful Use Programs

15.4.1 Patient Safety and Federal EHR Technology Programs

15.4.2 The Federal HIT Certification Program

15.4.3 The Role of NIST

15.4.4 Reaction in the Market to the Federal EHR Programs

15.4.5 The Interoperability Factor

15.4.6 Summary and Conclusions

15.5 Other Programs

15.5.1 Surescripts

15.5.2 Certification in Australia

15.5.3 Certification in Germany

15.6 Scope of Certification Testing

15.7 Summary

References

Appendix A: Additional Healthcare Data Exchange Standards

A.1 HL7 Version 3

A.1.1 Reference Information Model (RIM)

A.1.2 Structural Attributes

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A.1.2.1 Mood Code

A.1.2.2 Class Code

A.1.3 Null-Flavors

A.1.4 Required and Mandatory Values

A.1.5 State Transitions

A.1.6 Application Roles

A.1.7 Data Types

A.1.8 ITS

A.1.9 Recursive Relationships

A.2 CDA

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A.2.1 Levels

A.2.2 Releases

A.2.3 Templates

A.2.4 Implementation Guides

A.2.5 SDA—Structured Document Architecture

A.3 ASTM

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A.3.1 Message Structure and Segments

A.3.2 Chapters

A.3.3 Conformance Methodology

A.4 DICOM

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A.4.1 Introduction and Overview

A.4.2 Information Model

A.4.3 Information Object

A.4.4 Data Element

A.4.5 Value Representation

A.4.6 Conformance Methodology

A.4.7 Proprietary Extensions

A.5 XDT (Germany)

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A.5.1 Introduction and Overview

A.5.2 Information Model

A.5.3 Data Exchange

A.5.4 Encoding and Parsing

A.5.5 Explanation of Segment Structure

A.5.6 Overall Structure (Message Structure)

A.5.7 “Datenpaket” (Data Package/Message)

A.5.8 “Satz” (Segment)

A.5.8.1 “Feldarten” (Optionality)

A.5.9 “Bedingung” (Condition/Rules)

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A.5.10 Feldtabelle (Data Element Table)

A.5.11 Feldtypen (Data Types)

A.5.12 Vocabulary

A.5.13 Character Sets

A.5.14 Example

A.5.15 Conformance Methodology

A.6 Hprim Santé (France)

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A.6.1 Introduction and Overview

A.6.2 Segments

A.6.2.1 Properties

A.6.3 Message Types

A.6.4 Message Structure

A.6.4.1 Comparison to HL7 V2.X

A.6.5 Data Types

A.6.6 Vocabulary

A.6.7 Encoding

A.6.8 Conformance Methodology

A.7 PN13 (France)

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A.7.1 Introduction and Overview

A.7.2 Message Types

A.7.3 Data Elements

A.7.4 Data Type

A.7.5 Optionality and Cardinality

A.7.6 Representation

A.7.7 Conformance Methodology

A.8 Summary

References

Appendix B: Trademark Information

Index