IHE Global Collaborative Strategy for

Testing and ToolsCor Loef/Chris CarrCor Loef/Chris Carr

IHE International Testing and Tools IHE International Testing and Tools CommitteeCommittee

ContentsContents

1. IHE: Use Case-driven, Standards-based Development Process

2. Testing Tools Business Strategy3. Testing Tools Technical Strategy4. Collaborative Strategy with

Certification Bodies5. Proposed Actions

IHE Development ProcessIHE Development Process

Mission:

Integrating the Healthcare Enterprise (IHE) is a multi-stakeholder organization of users, vendors and others, whose mission is to encourage the adoption of standards-based approaches to information sharing and interoperability in healthcare.

IHE Development ProcessIHE Development ProcessPatient Centric Information FlowPatient Centric Information Flow

Document Document Use Case Use Case RequirementsRequirements

Document Document Use Case Use Case RequirementsRequirements

Identify available Identify available standards (standards (e.g. HL7, e.g. HL7, DICOM, IETF, OASIS)DICOM, IETF, OASIS)

Identify available Identify available standards (standards (e.g. HL7, e.g. HL7, DICOM, IETF, OASIS)DICOM, IETF, OASIS)

Develop Develop technical technical

specificationsspecifications

Develop Develop technical technical

specificationsspecifications

Testing at Testing at ConnectathonsConnectathonsTesting at Testing at ConnectathonsConnectathons

IHE IHE DemonstrationsDemonstrationsIHE IHE DemonstrationsDemonstrations

Products Products with IHEwith IHEProducts Products with IHEwith IHE

Timely access to Timely access to informationinformationTimely access to Timely access to informationinformation

Easy to integrate Easy to integrate productsproductsEasy to integrate Easy to integrate productsproducts

IHE Development ProcessIHE Development Process

An Integration Profile :An Integration Profile : A Set ofA Set of ActorsActors Exchanging Exchanging TransactionsTransactions

Query Modality Worklist [RAD-5]

ADT Order Placer

Register J.Doe

AcquisitionModality

Placer OrderManagement –New [RAD-2]

Patient Reconciliation

Department System Scheduler/Order Filler

Schedule Procedure

Procedure Scheduled [RAD-4]

Modality Procedure Step Completed [RAD-7]J.Doe ->

J.Smith

Patient Update/Merge [RAD-12]

Modality Procedure Step Completed [RAD-7]

PatientRegistration [RAD-1]

Patient Update/

Merge [RAD-12]

Modality Procedure Step In Progress [CARD-1]

Modality Procedure Step In Progress [CARD-1]

Perform Acquisition

Filler Order Mgmt - Status Update [RAD-3]

Filler Order Mgmt - Status Update [RAD-3]

ImageManager/

PPS Manager

Filler Order Management -New [RAD-3]

One or the other methods of creating an order is used

Query Modality Worklist [RAD-5]

ADT Order Placer

Register J.Doe

AcquisitionModality

Placer OrderManagement –New [RAD-2]

Patient Reconciliation

Department System Scheduler/Order Filler

Schedule Procedure

Procedure Scheduled [RAD-4]

Modality Procedure Step Completed [RAD-7]J.Doe ->

J.Smith

Patient Update/Merge [RAD-12]

Modality Procedure Step Completed [RAD-7]

PatientRegistration [RAD-1]

Patient Update/

Merge [RAD-12]

Modality Procedure Step In Progress [CARD-1]

Modality Procedure Step In Progress [CARD-1]

Perform Acquisition

Filler Order Mgmt - Status Update [RAD-3]

Filler Order Mgmt - Status Update [RAD-3]

ImageManager/

PPS Manager

Filler Order Management -New [RAD-3]

One or the other methods of creating an order is used

Use casesUse casesProcess FlowsProcess Flows

For each transaction:For each transaction: Std referencedStd referenced Options specifiedOptions specified Mapping requiredMapping required

Pt. Registration [RAD-1] Patient Update [RAD-12]

Pt. Registration [RAD-1] Patient Update [RAD-12]

Placer Order Management [RAD-2] Filler Order Management [RAD-3]

ADT

Query Images [RAD-14] Retrieve Images/Evidence [CARD-4]

Image Display

Modality Image/Evidence Stored [CARD-2]

Storage Commitment

[CARD-3]

Procedure Scheduled [RAD-4]

Procedure Updated [RAD-13]

Query Modality Worklist [RAD-5]

Performed Procedure

Step Manager

Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]

Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]

Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]

Order Placer

Acquisition Modality

ImageManager

ImageArchive

DSS/ Order Filler

Patient Update [RAD-12]

Modality Image/Evidence Stored [CARD-2]

Storage Commitment

[CARD-3]

Evidence Creator Modality PS in Progress [CARD-1]

Modality PS Completed [RAD-7]

Instance Availability Notification [RAD-49]

Pt. Registration [RAD-1] Patient Update [RAD-12]

Pt. Registration [RAD-1] Patient Update [RAD-12]

Placer Order Management [RAD-2] Filler Order Management [RAD-3]

ADT

Query Images [RAD-14] Retrieve Images/Evidence [CARD-4]

Image Display

Modality Image/Evidence Stored [CARD-2]

Storage Commitment

[CARD-3]

Procedure Scheduled [RAD-4]

Procedure Updated [RAD-13]

Query Modality Worklist [RAD-5]

Performed Procedure

Step Manager

Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]

Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]

Modality PS in Progress [CARD-1] Modality PS Completed [RAD-7]

Order Placer

Acquisition Modality

ImageManager

ImageArchive

DSS/ Order Filler

Patient Update [RAD-12]

Modality Image/Evidence Stored [CARD-2]

Storage Commitment

[CARD-3]

Evidence Creator Modality PS in Progress [CARD-1]

Modality PS Completed [RAD-7]

Instance Availability Notification [RAD-49]

ActorsActors TransactionsTransactions

IHE Development ProcessIHE Development Process

Testing and Tools Business StrategyTesting and Tools Business Strategy

Mission:

Create the Test Platform and Quality Assurance Process needed to foster the delivery of interoperable HIT products,which conform to the IHE Technical Framework and its National Extensions, to healthcare provider and health delivery organizations.

Testing and Tools Business StrategyTesting and Tools Business Strategy

• The testing tools (MESA/KUDU) and methods developed by IHE over the course of 10 years of testing represent valuable intellectual property and proven track record:

• 25 Connectathon testing events

• Over 300 vendors’ products conformance tested

• The sponsors of IHE and developers have made their test tools available under Open Source licensing terms, initially to Connectathon participants and subsequently to all users.

Radiology (18 profiles)

IT Infrastructure for Healthcare (20 profiles)

Cardiology (7 profiles)

Laboratory (6 profiles)

Radiation Oncology (3 profiles)

Patient Care Coord. (5 profiles)

Patient Care Devices (3 profiles)

Pathology

Eye Care (4 profiles)

19

99

• Over 200 vendors involved world-wideOver 200 vendors involved world-wide• 8 Technical Frameworks8 Technical Frameworks• 64 Integration Profiles64 Integration Profiles

• Testing at “Connectathons” world-wideTesting at “Connectathons” world-wide• Demonstrations at major conferences Demonstrations at major conferences

world-wideworld-wide

Each domain serves part of theEach domain serves part of thehospital IT interoperabilityhospital IT interoperability

VeterinaryEndoscopyPharmacy

Quality

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20

01

20

02

20

03

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20

05

20

06

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07

20

08

Testing and Tools Business StrategyTesting and Tools Business StrategyGrowth in Domain ProfilesGrowth in Domain Profiles

Testing and Tools Business StrategyTesting and Tools Business StrategyNational ExtensionsNational Extensions

Technical Framework Technical Framework National/Regional Extension

Test ToolsTest Tools

Test Plan

National Specifications

Test ToolsTest Tools

Identification, Codification,Regulation

Other needs

Test Plan

Test PlanTest PlanTest ToolsTest Tools

Technical Framework Technical Framework

International Development Committee

International Test &Tools Committee

National certification

Testing and Tools Technical StrategyTesting and Tools Technical StrategyHitting the WallHitting the Wall

2001 2002 2003 2004 2005 2006 20070

50

100

150

200

250

300

11

3343 46

7563

0

18

57

74 79

99

120

0

35

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135

180

250

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DomainsIntegration profilActorsCompaniesSystemsParticipants

2001 2002 2003 2004 2005 2006 2007

Explosive growth of Connectathon systems and Integration Profiles requires a redesign of testing toolkit.

Testing and Tools Technical StrategyTesting and Tools Technical StrategyNext Generation: Gazelle Next Generation: Gazelle

Gazelle is the successor of MESA and KUDU Toolkit Gazelle is a more advanced set of tools that better

integrates existing tools on a common platform, uses Web Services, provides new functions and a single, cohesive overview on the user interface.

Gazelle is designed to support on demand interoperability testing of a single application or network as well as to enhance face to face testing and inspection of multiple systems in a Connectathon setting.

Gazelle is composed of: a testing management platform, to manage the testing process

and results, and a set of testing modules used to validate specific profile

conformance of systems to the IHE Technical Framework and its underlying base standards.

Testing and Tools Technical Strategy Testing and Tools Technical Strategy Gazelle ArchitectureGazelle Architecture

Testing and Tools Technical Strategy Testing and Tools Technical Strategy Gazelle Deployment ConfigurationsGazelle Deployment Configurations

1. Stand-alone testing (local or remote)

2. Face-to-face Connectathons

3. Virtual Connectathons

Gazelle - Core

Library Library Library

Gazelle API

IHE Testing Used

Plug-In

Test Data Used by a plug-in for IHE testing

Test DataCore related

Optional

Plug-In

Test DataUsed by a Plug-in for additional testing

Testing and Tools Technical Strategy Testing and Tools Technical Strategy Gazelle Functional StructureGazelle Functional Structure

IHE’s Collaborative Strategy for Testing ToolsIHE’s Collaborative Strategy for Testing ToolsTesting and Tools GovernanceTesting and Tools Governance

Testing & Tool Committee

IHE International

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IHE’s Collaborative Strategy for Testing ToolsIHE’s Collaborative Strategy for Testing ToolsTesting and Tools GovernanceTesting and Tools Governance

How

Collaborative effort on global scale• IHE NA, IHE-Europe, IHE-Japan, NIST,

DVTk consortium, Tiani Spirit, OFFIS, David Clunie• The project has a permanent development team and

2 Managers: Steve Moore (MIR/North America) and Eric Poiseau (INRIA/Europe)

• Leverage contributors with competence in HL7, DICOM, Web Services

Open Source Software model• The terms of the new Gazelle conformance test tool

license will allow unlimited use, copying, distribution and creation of derivative works. They will require only that such works include a copyright credit statement acknowledging IHE International and other contributors to their development.

IHE’s Collaborative Strategy for Testing ToolsIHE’s Collaborative Strategy for Testing ToolsGazelle DevelopmentGazelle Development

IHE’s Collaborative Strategy for Testing ToolsIHE’s Collaborative Strategy for Testing ToolsStakeholders’ InterestStakeholders’ Interest

The IHE open source approach will allow all health information stakeholders, including certification bodies, to use these assets to meet their particular conformance testing needs. Gazelle parts already used at IHE NA Connectathon 08.

IHE proposes that sharing a common conformance testing platforms and modules for functional and interoperability testing is in the best interests of all stakeholders:

– For users, it assures systems are in compliance with contractual, professional or regulatory requirements.

– For vendors, it reduces the costs and complexity of developing systems having to meet duplicative and overlapping testing requirements.

– For health information exchanges, it reduces the technical challenges of insuring interoperability of diverse node systems.

IHE’s Collaborative Strategy for Testing ToolsIHE’s Collaborative Strategy for Testing ToolsStakeholders’ Interest (Continued)Stakeholders’ Interest (Continued)

– For national and regional authorities use of common certification testing can reduce their overhead and increase the pool of potential systems available for their respective users.

– For certification bodies, it reduces the technical efforts of developing their own conformance testing platforms while allowing them to configure testing to meet national or regional requirements.

Collaborative Strategy with Certification BodiesCollaborative Strategy with Certification Bodies

Certification is the process of labeling and confirming conformance of test results and other guarantees to the user of interoperability features. IHE currently does not intend to become a certifying body nor develop a certification process.

IHE proposes to provide the actual conformance testing services to certification bodies, including tailoring IHE testing processes to the specific needs of a certification body’s administrative processes.

Collaborative Strategy with Certification BodiesCollaborative Strategy with Certification Bodies

The IHE conformance testing tools and process are intended to be used in two types of certification programs:

– By neutral third party (which may not be a governmental entity) to manage the program and require that a sample of a product/implementation be tested for conformance. The weakness of this approach is that is assumes that the sample IT software being tested is consistent with the products being shipped.

– Based on an audited quality system of the vendor including the conformance testing process followed by the vendor to test each instance of product shipped. This is the process that has proven to be effective and is widely used in many industries, including some parts healthcare. Only a quality system auditing body is required.

Proposed ActionsProposed Actions

Reach out to all major organizations worldwide with testing tools and certification initiatives relevant to IHE and Gazelle:

– Explore common business interests and technical needs

– Offer collaboration for tool development to avoid duplication of tools and waste of development resources

– Offer conformance testing processes and services adequate to support certification processes.

– Negotiate terms for sharing and collaboration

The Open Source Collaboration ChallengeThe Open Source Collaboration Challenge

Contact: Chris Carr, ihe@rsna.org