1st Workshop: Bridging the Interoperability Gap in ECG Devices 10-12 October 2002, KNOSSOS Royal Village, Hersonissos, Greece

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A. Lymberis
European Commission, Information Society Directorate-General*, Brussels, Belgium

Information Society Technologies R&D in Personal Health Monitoring: EU achievements and future challenges

An evolution is underway in healthcare and health delivery in Europe and world-wide. This evolution is driven by three main factors: Major societal changes, progress in sciences and technologies and increase of medical knowledge.

More and more people are eager to take an active role in managing their own health, patient becomes "health consumer" asking for better health and life style management, including healthcare, rehabilitation, nutrition, fitness, sport, etc, ageing population and chronic diseases increase steadily in Europe, while better and cost-efficient disease management, non-invasive diagnosis and therapy and faster recovery become requirements.

From the other hand, micro and nanotechnologies offer, for the first time, a number of new possibilities and solutions bringing intelligence, miniaturisation reduced power consumption, speed and new materials (e.g. smart textiles integrating the possibilities of electrical, optical, chemical and mechanical sensors and flexible technologies particularly adapted to the human body) at low cost. In addition huge progresses occurred in mobile and wireless telecommunications (device to device, inside the house, long distance) as well as in signal processing (artificial intelligence, data mining), human-computer interface technologies, tools for retrieving and combining information from different type of sources.

The new means and new tasks imply new responsibilities, from the medical device manufacturer to the patient/citizen, via the health practitioner. Given the ambulatory (and decentralised) instrumentation, e.g. home telecare and surgery assisted by robotics, the "catching area" of each actor become less clear. All health Telematics (e-Health) applications have to comply with user authentication restrictions as well as with personal data protection lows and regulations [Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data]. The same applies for standardisation and certification procedures. In addition, a risk analysis relating, to the technological platform (sensors, processing, transmission, communication) and to the medical error (due to the remote procedure) have to be defined, probability of risk occurrence has to be estimated and countermeasures have to be scheduled for each specific e-Health application. The concept of Total Quality Management associated to the tracability has to be applied as a whole.

In Europe, Health Telematics contributes, since early 90's, to major changes in healthcare delivery. Development of Telemedicine and health Telematics networks enable healthcare delivery across regional and national borders [EC, 4TH FP, Health Telematics Programme, 1994-1998]. During the last 5 years, the Information Society Technologies (IST) strive to provide new generation systems and applications to ensure "continuity of care" i.e. better and timely access, better quality of care and cost-effective care at all stages, from prevention to rehabilitation. The developments in remote monitoring and personal telemedicine could enable significantly reducing the total cost of care by avoiding unnecessary hospitalisations and ensuring that those who need urgent care get it sooner. The use of intelligent-based systems provide to physicians the data to timely detect and manage health risks, early illness diagnose or injury, recommend treatment that would prevent further deterioration and, finally, to make confident professional decisions based on objective information - all in a reasonably short time. A large number of patient groups, e.g. people with heart and respiratory diseases, elderly, rehabilitation and high risk patients, as well as healthy sport users can greatly benefit from wearable monitoring systems.

The European Union is being supporting research and development activities in continuous healthcare monitoring (and management) through the 5th Framework Programme of Research and Development of the European Commission. Roughly 50 million Euro have been spent since 1999 to fund more than 30 projects in the area of Telemedicine/homecare and "care at the point of need". In homecare, projects like @Home, Chronic, Daphne, Doc@home, E-remedy, Telemedicare, Telecare have developed and validated systems and applications to support chronic diseases, children care, neurological disorders and rehabilitation. Other projects develop integrated wearable platforms with advanced sensing and embedded intelligent processing, for remote patient care and alert monitoring (e.g. AMON, a wrist multisensor), for early detection and interpretation of cardiological symptoms (e.g. Epi-Medics, a portable ECG monitor) as well as for monitoring of health condition and sport performance of athletes and real time prevention of sport injuries (e.g. Dromeas). Future research and development on biomedical clothing, where sensing, processing and communications are integrated in a woven structure to monitor biomechanical variables and physiological signals is also supported by the European Commission in the 5th Framework Programme, IST programme. WEALTHY aims at developing a health monitoring system based on a new multifunctional fabric, integrating smart sensors (in fiber and yarn form) advanced signal processing and wireless telecommunication and decision support unit.

Technology is progressing very fast but this is not enough to meet all challenges of a health-world in transition. Telemedicine operational doctrine is founded on the principle of interoperability. This concept requires that systems are able to operate together in order to achieve a task. The key is compatibility and compliance with industry equipment and software standards. The European Commission has strongly supported standardisation activities in Health Telematics through CEN TC251but also through RTD projects (OEDIPE, GEHR, etc). Currently, it is under preparation a recommendation on the co-ordination of Notified Bodies Medical Devices (NB-MED) on directives 90/385/EEC, 93/42/EEC and 98/79/EC. The objective is to provide guidance to Notified Bodies and manufacturers on the application of all the provisions which apply to software within the scope of the Medical Device Directives.

The use of standardised communication protocols e.g., DICOM-3.0 communication for Teleradiology, SCP-ECG communication for Computer-Assisted Electrocardiography and HTML/XML for mark-up text/object processing, rather than proprietary protocols, is also a requirement for Telemedicine and telehealth.

Especially in the domain of cardiology, with an increasing number of citizens suffering from cardiac problems, it is extremely important to promote and disseminate standards for storage and data exchange between medical devices such as ECGs, RT-Monitoring, Holter, and Stress ECG. In addition, compatibility with the Electronic Health Record has to be ensured. Given that SCP-ECG protocol, the only existing European standard, has still not been implemented by most manufacturers of computerized cardiology appliances (including portable and wearable) there is an ever pressing need to raise public awareness, disseminate open source viewing and translation tools and provide certification services that ensures interoperability among different implementations of the standard. The European Commission supports strongly standardisation activities in healthcare for two main reasons: improve the quality of care and develop further the market in Europe.