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