IHE Global Collaborative Strategy for Testing and Tools Cor Loef/Chris Carr IHE International Testing and Tools Committee

Contents 1.IHE: Use Case-driven, Standards-based Development Process 2.Testing Tools Business Strategy 3.Testing Tools Technical Strategy 4.Collaborative Strategy with Certification Bodies 5.Proposed Actions

IHE 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 Process Patient Centric Information Flow

Document Use Case Requirements Identify available standards ( e.g. HL7, DICOM, IETF, OASIS) Develop technical specifications Testing at Connectathons IHE Demonstrations Products with IHE Timely access to information Easy to integrate products IHE Development Process

An Integration Profile :  A Set of Actors  Exchanging Transactions Use cases Process Flows For each transaction:  Std referenced  Options specified  Mapping required ActorsTransactions IHE Development Process

Testing 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 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) 1999 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 world-wideDemonstrations at major conferences world-wide Each domain serves part of the hospital IT interoperability Veterinary Endoscopy Pharmacy Quality Testing and Tools Business Strategy Growth in Domain Profiles

Testing and Tools Business Strategy National Extensions Technical Framework National/Regional Extension Test Tools Test Plan National Specifications Test Tools Identification, Codification, Regulation Other needs Test Plan Test Tools Technical Framework International Development Committee International Test &Tools Committee National certification

Testing and Tools Technical Strategy Hitting the Wall Explosive growth of Connectathon systems and Integration Profiles requires a redesign of testing toolkit.

Testing and Tools Technical Strategy 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 Gazelle Architecture

Testing and Tools Technical Strategy Gazelle Deployment Configurations 1.Stand-alone testing (local or remote) 2.Face-to-face Connectathons 3.Virtual Connectathons

Gazelle - Core Library Gazelle API IHE Testing Used Plug-In Test Data Used by a plug-in for IHE testing Test Data Core related Optional Plug-In Test Data Used by a Plug-in for additional testing Testing and Tools Technical Strategy Gazelle Functional Structure

IHE’s Collaborative Strategy for Testing Tools Testing and Tools Governance

Testing & Tool Committee IHE International WHAT Testing & Tool Committee IHE SponsorsOrganizations WHO IHE DomainCommittee ExecutiveStaff Non -IHE SponsorsOrganizations Gazelle Mesa QualityAssurance Projects IHE’s Collaborative Strategy for Testing Tools Testing 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 Tools Gazelle Development

IHE’s Collaborative Strategy for Testing Tools Stakeholders’ 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 Tools 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 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 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 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 Challenge Contact: Chris Carr,