Health Telematics (AIM) Final Report
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Updated: Feb 1, 97 

DIABCARD I & II

Improved Communication in Diabetes Care Based on Chip Card Technology

Project Codes:   A2004, A2051
Project value:  1453 + 846 = 2299 KECU
EC contribution:  595 + 348 = 943 KECU
No of partners:  9
No of countries:  4
Duration:  24 + 24 months
Contact:
Dr. Rolf Engelbrecht
GSF - medis
Neuherberg
Postfach 1129
D-85758 Oberschleiáheim
Germany
Tel.: +49-89-31.87.41.38/9
Fax: +49-89-31.87.30.08
E-mail: engel@gsf.de

Overview

DIABCARD has developed the core of a chip card based medical information system (CCMIS) for patients with chronic diseases exemplified on Diabetes mellitus. The DIABCARD dataset was defined, a first prototype has been developed and implemented, and a pilot was run for three months. The results of the evaluation were presented in a Consensus Workshop.

Purposes, Goals, Objectives

The long term goal of the project is to improve medical documentation and the quality of care for patients with chronic diseases. To have a portable electronic medical record on a smart card will vitally improve the communication between the different healthcare personnel and between different institutions. At the same time this will promote shared care. The DIABCARD CCMIS will offer controlled access to the necessary and up-to-date patient record to everybody involved in the patient's treatment and it will help reduce the constantly rising health care expenditure.

The medical paper record which is often held in different places makes efficient patient management difficult. When compared to paper records, electronic medical records are more easily accessible for health care providers, they contain less mistakes, they provide better privacy protection and they are more suitable to support medical research. The smart card seems an ideal carrier for an electronic medical record. It is small, easy-to-handle and patient based. Chips with 32 KBytes EEPROM will be available in the near future and thus smart cards will be able to store besides the patient's actual state-of-health-data, his/her medical history and even biosignals and images. The patient carries the card and is thus actively involved in the health care process. The introduction of the patient data card does not require any vital modification of existing structures and practices.

The project is being exemplified on diabetes mellitus to eventually be extended to other chronic diseases, e.g. Cardiovascular Diseases, Chronic Renal Failure, Cancer Diseases. Diabetes mellitus can be considered a typical chronic disease including nearly all aspects of chronic health care. Besides, this disease concerns about 30 mil people in Europe and consumes about 10% of the total health care budget.

In 1989 is the "St. Vincent Declaration", an initiative to improve the life and health of diabetic people started under the aegis of WHO Regional Office of Europe and the International Diabetes Federation. Its main emphasis is on monitoring the diabetic's state-of-health and it describes goals and targets for prevention, identification and treatment of diabetes to be performed on a local, regional, national and European level. Quality assurance in diabetes care is a major part of the St. Vincent Declaration. Quality indicators were for this purpose designed and constitute the DiabCare dataset, laid down in the Basic Information Sheet (BIS). DIABCARD has integrated the BIS for quality assurance. DIABCARD will improve the quality of diabetes care and help reduce costs in health care.

Results

The project team has developed a health smart card for Diabetic patients. The card has to be seen as part of a chip card based medical information system (CCMIS). Specific functions deduced from the requirement analysis were implemented into a prototype. A pilot of this system was run for 3 months and evaluated. The results were presented and discussed in a Consensus Workshop.

The DIABCARD chip card and its supporting and operating environment is flexible and adaptable to different needs. The DIABCARD architecture can be implemented into existing information systems and into different networking environments. It can be adapted to technological advancements of the chip card. Its specification is not limited to Diabetes and adaptable to general health care data and other chronic diseases. The DIABCARD architecture is covered by standards and pre-standards defined within ISO and ETSI.

A flexible interface for the use of different smart cards and smart card readers was built in DIABCARD. The interface additionally allows the use of the BDT format or of other clinical interfaces. By having integrated high security levels, the project makes sure that the medical data is safe and protected from misuse.

A common European basic diabetes data set based on approved data sets was produced and validated. It defines the data items that will be necessary for good treatment of a diabetes patient. Main emphasis is, as required by the final goals of DIABCARD on the aspect of quality assurance according to DiabCare and on communication. Most medical items, are widely agreed and have been validated in the first DIABCARD pilot, that took place in Barcelona, October December, 1995. The DIABCARD data set will be further evaluated in the various pilots to be performed within DIABCARD 3. The results from the pilots and from the interoperability activities that DIABCARD is involved in will constitute the next version.

A first prototype was developed, field-tested in Barcelona for 3 months and evaluated. The prototype itself consists of a computer-based medical record system and the DIABCARD smart card enhancements. It is based on the Diabcare-system and was enhanced with medical content and management, report and card functions. The system contains different categories of data, i.e. administrative data and medical data (the data of the BIS; pregnancy data; nephrology data; endocrinology data; ophthalmology data) and emergency data. The most recent values are kept on the card.

The results of the pilot indicate that a smart card in the case of the patient with chronic diseases - where care is provided by different people and/or several institutions and where frequent updating is necessary - is feasible. Additional pilots and evaluations are scheduled for all the European countries under DiabCard 3.

Exploitation of results

The project's results - specification, analysis and design of DIABCARD - clearly demonstrate that the technology of today's chip cards and their components is advanced enough to support advanced medical information systems based on chip card technology. Future developments can thus be better aligned to user and market oriented strategies.

The medical smart card offers a good alternative to scattered paper records. DIABCARD contains the adequate information to support high level quality and continuity in treatment. Continuous documentation on the patient's illness becomes possible.

DIABCARD is a future oriented but simple-to-use technology which can be used everywhere and which presents the communication standard of tomorrow. Once implemented DIABCARD will be the first chip card based information system with an agreed diabetes data set and stands a good chance for commercial introduction.

All medical, informatic and industrial partners of this project are highly motivated to implement DIABCARD actively and undertake all measures for a successful launching.

72 million heath insurance cards and 100.000-150.000 card readers have been distributed in Germany. The combination of the KVK-card and DIABCARD ensures that, concerning the development of an information system suitable to be used for insurance cards, special attention will be paid to the requirements of patient data cards in Germany. The patient data card is the follow-up model of an administrative-oriented insurance card. At the same time, the use of patient data cards is an essential prerequisite for the introduction of a data network into public health care.

Industrial, social and health impact

The project has important and wide-ranging implications in health care. The DIABCARD Project offers a solution for standardised diabetes documentation. Its implementation will improve the quality of diabetes care in Europe in conjunction with the progress derived from the Euro-DiabCare initiative under the auspices of WHO-IDF, Europe. This, on the other hand, will create more confidence of patients and physicians and lead to a close co-operation between the professionals, institutions and levels. Europe wide usage coupled with the technically easy-to-solve data security aspects for the patients makes DIABCARD an ideal tool to establish a high standard of European diabetes care.

DIABCARD considerably contributed to gain knowledge about defining appropriate systems in the field of health care. The use of smart cards in health care has now become an important issue in all member states of the EU. Germany (insurance card, already introduced) and France (social security card, first test sites) spearhead the development. The DIABCARD project has definitely stimulated the international discussions and played its part in fertilising the potential market for smart cards.

The provision of healthcare is very different in the various European countries and very much dependent on regional characteristics. The DIABCARD-approach is based on the user needs, that means the system has to adjust to the user needs or not- as is often the case - to get the user used to the system. By providing a basic system that can be adapted according to regional requirements and by leaving the co-ordination, management and validation of the test site up to a local team, which includes local users, acceptance and use of the system can be stimulated.

The system is inter-operable, which means that the various installation sites can communicate across regions and even across borders. Step-by step the infrastructure will grow. DIABCARD will be integrated into existing networks which will benefit from the additional use. Telematic services offered by the network can be utilised on.

The project had to overcome some difficulties, obstacles in dissemination. The lack of relevant European and international standards causes delay to ongoing work in DIABCARD. At the same time, legal requirements are necessary as e.g. the legal status of the electronic signature or the protection of confidentiality. Problems like "prevention of data tempering" and "maintenance of backup data" have to be solved.

There is a high need for the market to get this DIABCARD solution real. A market strategy is based on the acceptance of the product or of the concept of a evolving product. Therefore, the acceptance activities followed by prototype development and field test are an absolute necessity. Successful field testing will produce a concept which will via the appropriate industry and institutions lead to a successful market strategy and product.

List of Deliverables

List of Participants

Dr. Joachim Thiery
Boehringer Mannheim GmbH
Central Marketing
Sandhofer Str. 116
D-68398 Mannheim, Germany
Tel.: +49-621-759.31.42 / 38.18
Fax: +49-621-759.41.79
Dr. Dr. Klaus Piwernetz
DIABCARE
Kobellstr. 3
D-80336 München, Germany
Tel.: +49-89-74.71.91.00
Fax: +49-89-74.71.91.80
Mr. Arno Reith
Siemens AG
HLSTVK1 CC
Postfach 801709
D-81617 München, Germany
Tel.: +49-89-41.44.20.58
Fax: +49-89-41.44.23.60
Dr. Rolf Engelbrecht
GSF-Medis
Neuherberg
Postfach 1129
D-85758 Oberschleiáheim, Germany
Tel.: +49-89-31.87.41.38 / 9
Fax: +49-89-31.87.30.08
E-mail: engel@gsf.de
Dr. Reli Mechtler
Johannes Kepler Universitat
Institut für Pflege- und Gesundheitssystemforschung
Altenberger Str. 69
A-4040 Linz Auhof, Austria
Tel.: +43-732-24.68.93.83 / 93.89
Fax: +43-732-246.85.94
E-mail: reli.mechtler@jk.uni-linz.ac.at
Prof. Massimo Massi-Benedetti
Universita di Perugia
Istituto di Med. Int. e Scienze Endocr. Metab.
Via E. dal pozzo
I-6100 Perugia, Italy
Tel.: +39-75-578.34.76 / 278.60
Fax: +39-75-573.08.55
E-mail: mabe@unipg.it
Prof. Dr. Alberto de Leiva
Hosp. de la Santa Cruz y San Pablo
Servicio de Endocrinologia y Nutrition
Autonomous University
Avinguda S. Antoni M. Claret, 167
E-08025 Barcelona, Spain
Tel.: +34-3-291.90.42
Fax: +34-3-291.92.70
E-mail: hsp.endocri@bcn.servicom.es
Dr. Gerhard Brenner
ZI f. d. kassenärztliche Versorgung
in der Bundesrepublik Deutschland
Herbert-Lewin-Str. 5
D-50931 Köln, Germany
Tel.: +49-221-400.51.24 / 125
Fax: +49-221-40.80.55
Dr.-Ing. H. Henn
SC Smart Card Software
Schoenaicher Str. 220
D-71032 Boeblingen, Germany
Tel.: +49-7031-16.43.36
Fax: +49-7031-16.48.88
E-mail: hhenn@boevm4.vnet.ibm.com

[ DIABCARD 3 (4 FW, 1994-1998) ]

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