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practice Healthcare Interoperability Testing and Conformance Harmonisation

Healthcare Interoperability Testing and Conformance Harmonisation

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Acronym of the case:

HITCH

Web address of the case:

Country of the case:

Belgium , Denmark , France , Germany

Posting Date:

15 June 2011

Last Edited Date:

27 June 2011

Author:

Onken Michael (OFFIS - Institute for Information Technology)
Healthcare Interoperability Testing and Conformance Harmonisation Logohitchproject's picture
Editor's Choice 2011

Type of initiative

  • Project or service-imgProject or service

Case Abstract

HITCH is an EC-funded research project for developing the European Union's roadmap for Interoperability Conformance Testing of information systems in the field of Healthcare. The project started in January 2010 and is running for 18 months. The project is realized by partners being already at the heart of eHealth testing: IHE Europe and EuroRec from Belgium, INRIA and ETSI from France as well as MedCom from Denmark and OFFIS from Germany.

HITCH sketches a vision of how interoperability and conformance testing of eHealth systems should be organized in Europe and beyond. This includes

  • Analysis of existing eHealth testing tools and identification of tools still missing
  • Conception of a Quality Management System for cross-vendor and in-house interoperability testing
  • Comprehensive eHealth certification and quality labelling scenarios for Europe

Description of the case

Domain
Date
January 2010 to June 2011
Target Users
Add Patients | Health authorities | Health professionals
Target Users Description

Vendors directly benefit from enhanced interoperability testing in eHealth as proposed by HITCH. By joining cross-vendor testing events, establishing interoperability quality management systems in-house and utilising a multitude of available eHealth testing tools, they deliver products with significant higher quality and therefore highly reduce costs of fixing live systems and providing expensive hours of support to their customers.

Patients are only indirectly involved into interoperability testing, of course. However, they are the ones finally targeted and who should receive the greatest benefit from it in the end. From seamless integration of involved eHealth systems results better care, since errors like doubled examinations or adverse drug abuse can be reduced only if all information is transmitted and interpreted correctly.

Authorities: Optimal health delivery supported by seamless eHealth system integration obviously helps patients to stay or become healthy. This is of course also in the interest of national authorities since today the health budget of countries is becoming larger and larger, and yet not being seen as sufficient at all. Besides this indirect benefit coming from interoperability testing, HITCH will describe quality labelling and certification scenarios for the world of eHealth, thus enabling authorities to establish quality labelling or certification programs, again leading to better and safer health care.

Certifiers: By the labelling/certification scenarios that will be described by HITCH, certifiers are guided on how such quality programs can be organised and performed. The HITCH Quality Management System for interoperability testing provides comprehensive information on the processes, actors and other issues needed to offer certification services.

Scope
International | Local (city or municipality) | National | Pan-European | Regional (sub-national)
Status
Operation
Language(s)
English

Policy Context and Legal Framework

Today, delivering healthcare to patients includes a multitude of computer systems that collaborate with each other by exchanging patient data.  This is necessary, since often many different devices, departments, institutions or even nations are engaged in the treatment of a single patient. All the collected information like medical images (X-Rays, Ultrasound, etc), and medical reports should be available to the patient's physicians in order to permit optimum treatment, therefore avoiding redundant examinations or adverse drug reactions. Also the current trend of having all patient-related data ubiquitously available (e.g. in the patient's holiday resort) requires high interaction between the computer systems involved.

The underlying communication of images, reports and other information is highly complex. Why is this? There are many communication standards and protocols used in medicine that in the best case complement but also sometimes compete with each other. Together these standards (should) cover everything that is needed to express medical knowledge, thus including ways to express medical terms (e.g. anatomical regions, diseases, physical units, medications, pharmaceutics and many more) in a unique and ultimately defined way as well as communication protocols for transmitting medical data for example into an electronic health record. The final goal would be to have all information shared in a way, so that a computer system may "understand" and evaluate it. Also it should be able to provide an understandable presentation to the user utilising the system, e.g. to a physician or the patient themselves.

This only works if all involved systems communicate in an internationally designed, well-known, standardised way. If two systems can talk to each other, then there is "interoperability" between those systems. According to the IEEE Standard Computer Directory Interoperability can be defined as the ability of two or more systems or components to

  • exchange data and to use the information that has been exchanged;
  • among linguistically and culturally disparate health professionals, patients and other actors and organisations;
  • within and across health system jurisdictions in a collaborative manner.

First, this must be achieved by the conformance harmonisation of eHealth products, i.e. making sure that different systems implement the same standards and communication measures to talk with each other. This is sometimes also referred to as profiling, i.e. selecting (subsets of) standards and options in order to uniquely identify the communication measures to be used. As described, these standards are fairly complex, e.g. the DICOM standard describing the content and communication of medical images spans over 4 000 pages of technical documentation. So, besides describing how the communication should work, it has to be ensured that the different software products actually do what is defined. In this context, two different testing methods are known. On the one hand, testing whether a system conforms to a set of standards is called conformance testing. On the other hand, interoperability testing "just" tests whether two systems are able to exchange information with each other, i.e. aims at testing whether the communication goal is reached regardless of whether both are also conformant to the standards they implement. However, in order to pass interoperability tests usually a fair amount of conformance testing is also required and involved.

HITCH is about to provide a roadmap to the European Commission that aims at different goals within this context:

  • Quality Management for eHealth Interoperability Testing
  • eHealth Test Tools
  • Labelling and Certification of eHealth Systems

Project Size and Implementation

Type of initiative
IT infrastructures and products
Overall Implementation approach
Partnerships between administration and/or private sector and/or non-profit sector
Technology choice
Not applicable/not available
Funding source
Public funding EU
Project size
Implementation: Not applicable/not available

Implementation and Management Approach

HITCH is about developing a vision of how interoperability and conformance testing of eHealth systems should be organised in Europe and beyond. This ranges from the analysis of eHealth testing tools, over quality management in interoperability testing, to complete labelling/certification scenarios.

HITCH does not aim at developing new eHealth communication standards and HITCH does not do Profiling of existing standards. HITCH instead focuses on the organisation, performance and quality management of eHealth interoperability testing.

HITCH analyses different aspects of interoperability testing and for each of them on how they should develop in the future to be more complete and effective:

  • Interoperability testing tools: Which kind of (mostly free open source) tools are available for eHealth testing?
  • Interoperability Quality Management Systems (QMS): How should interoperability testing be organised and performed in a quality way within and cross organisations?
  • Interoperability testing-based labelling/certification of eHealth products: What are the current players in eHealth labelling/certification in Europe and how can it be organised in the future?
  • Relationship between functional audit and interoperability testing and definition of a common process in order to label/certify a product by combining the two approaches
  • Evaluate first HITCH results in a real world interoperability testing event: the European IHE (Integrating the Healthcare Enterprise) Connectathon

Spread expert knowledge on interoperability testing by organising a workshop on the topic in April 2011

Impact, innovation and results

Impact

The interoperability definition from IEEE quoted above does not talk about eHealth systems in particular but primarily addresses human's which, finally, are the receivers and beneficiaries of the information. However, this of course presumes that the underlying eHealth systems are interoperable. Thus, HITCH focuses on interoperability testing of eHealth systems, finally aiming at the interoperability between all stakeholders of the medical context.

Interoperability testing in eHealth means that different implementations (practically, different products or other eHealth systems) are tested whether they can successfully communicate with each other, i.e. whether they are interoperable in the sense of above definition. Since delivering health is a critical application area and non-interoperability of eHealth systems might lead to serious damage or even death of patients, interoperability testing must take place even before systems are distributed on the market. Vendors themselves are, of course, very interested in offering high quality products. The problem is that developing a product isolated in a vendor's lab cannot guarantee that the system is interoperable when it goes live in real world environment since it first is nearly impossible to build bug-free software but second it also common that other vendors might interpret the underlying standards a another way and therefore implement their products slightly different and therefore maybe incompatibly.

Also, if a vendor would actually create a bug-free product, it is common that in a real world scenario there might be actually products that are not. In those cases, being able (where safe) to cope and communicate with buggy systems makes a product much more robust and increases chances to successfully communicate with each other. As a result, systems must undergo interoperability testing in order to provide high quality and value to their customers and therefore, to physicians and finally patients.

 

HITCH defines the European  roadmap on eHealth interoperability testing and therefore will provide recommendations to institutions and authorities interested in establishing conformance testing session and cross-vendor interoperability testing (and events) but also to vendors that like to implement an in-house interoperability testing Quality Management System. Additionally, HITCH provides a vision on how future eHealth labelling/certification could be deployed in Europe at the project level. The quality of the roadmap should be guaranteed by the HITCH partners that are already deeply involved in those topics. Clear recommendations were deployed for developing a consistent market over Europe, based on four main topics:

  • Recognition of standard profiles already used in Europe
  • Establishment and improvement of Quality Management Systems for testing
  • Development of new tools and features, especially in the areas of test case development and other test management tasks
  • Development of testing tools that can be use both, European and project level

Track record of sharing

Of course, there are other European projects working on issues being connected to HITCH. HITCH keeps in touch with these projects (e. g. epSOS and Calliope), ensuring that HITCH aligns to the other projects' efforts and vice versa. The same is true for health organisations and Standard Developing Organisations (SDOs) which all are linked to eHealth interoperability testing.

eHealth markets and their vendors, but also customers are of course highly affected by the results of the HITCH project. Therefore, HITCH communicates with them and makes sure that all results will be practically relevant. This is also achieved by evaluating HITCH results directly in the IHE European Connectathon which involves dozens of companies of all sizes and usually is run by neutral "monitors" that verify the Connectathon tests, coming from different health organisations world-wide. Furthermore, feedback on the roadmap and the processes initiated by HITCH is discussed with stakeholders during dedicated workshops and leads to better understanding of testing processes for everybody, thus offering chances for discussion and future improvement.

Lessons learnt

  • eHealth testing initiatives will benefit from Quality Management. The Quality Management System for eHealth testing developed in HITCH was evaluated at the European Connectathon 2011 and showed that defined Quality Management processes are important to ensure and improve high quality testing. Quality Management in the area of eHealth testing is new and not well known: Before HITCH, no serious efforts in this area existed but, as shown, highly needed.
  • eHealth tools that can be used for testing are widely available. However, their quality significantly differs and not all areas where tools are needed are sufficiently covered. HITCH has shown that freely accessible and stable standards usually convey the development and existence of quality tools in that area. Also, there is a need for a tool ecosystem, meaning that there should be driving projects that implement international standards and corresponding test tools. Further, it must be assured that those tools are updated as the standards evolve which may require funding schemes. The re-usability of tools should be ensured by using open source licenses in order to permit broad tool distribution, and by agreeing on international standard profiles that exactly define the parts and specializations of the standards to be tested. Also, common interfaces that help interconnecting tools (e.g. in order to run as part of a Test Management System at an interoperability test event like the IHE Connectathon) will ease testing and therefore save time and efforts.
  • Three labelling/certification scenarios were analysed and the results show that they are not in opposition to each other: Each scenario has offers clear benefits depending of the maturity of the market. For new and innovative standard profiles, labelling/certification is the best way to quickly harmonise and deploy new features. When the profiles and specifications become more stable, self-assessment with external reference is a more appropriate choice. When a market becomes very mature, testing tools are available and engineers are well educated, self-assessment without external reference is sufficient in order to rapidly deploy products providing a high level of interoperability.

Overall, the HITCH project provides its partners and relevant stakeholders with a better vision of the necessary steps in order to gain a higher level of interoperability between eHealth products in Europe. The HITCH roadmap will be published in June 2011 and lists three main phases on the road to European eHealth interoperability:

  • "Get Ready": Develop a common testing approach including detailed labelling/certification processes, using a well-defined Quality Management System. Further, start with the development of missing test tools and features.
  • "Operationalise": Improve the results of the first phase. Make the defined processes and tools ready for roll-out by defining all necessary details.
  • "Deploy": Launch and perform the whole testing framework (labelling/certification, QMS and tools) in Europe.

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