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A chip card for patients with diabetes
computer methods and programs in biomedicine ELSEVIER
Computer Methods and Programs in Biomedicine 45 (1994) 33-35
A chip card for patients with diabetes R . E n g e l b r e c h t *d, C. H i l d e b r a n d d, E. K f i h n e l d, G . B r e n n e r ~, R . C o r c o y ~', G . E b e r h a r d h, C. G a p p u, G . K l e p s e r ~, A. d e L e i v a a, M . M a s s i - B e n e d e t t i g, R . M e c h t l e r f, K . P i w e r n e t z ~, J. S e m b r i t z k i i, J. T h i e r y b "Autonomous University, Barcelona, Spain, 6Boehringer, Mannheim, Germany, "Diabetes Center Bogenhausen, Miinchen, German),, aGSF Research Center, Medis-lnstitute, Miinehen, Germany, "IBM Informationssysteme Deutschland GmbH, Germany. /Univ. J. Kepler. Linz, Germany gUniv. Perugia, Perugia, Itah' /'Siemens AG, Miinehen, Germany. ~Z1 Zentralinstitut fiir die Kassendrztl. Versotzgung, K6ln, Germany
Abstract
DIABCARD provides the specification for the core of a Chip Card Based Medical Information System (CCMIS) for the treatment of patients with chronic diseases. It will provide an instrument for assessing health care services, improve the links between health care providers and set up communication between the different levels of health care. It will therefore improve the quality of care and thus the life of patients with chronic diseases. DIABCARD concentrates on diabetes at the moment, the concept of the diabetes chip card will, however, be extendable to other chronic diseases. Key words: DIABCARD: Health care services: CCMIS
I. Introduction
Most European health care systems are oriented towards the treatment of acute complications; the overall quality of care of chronic diseases, e.g., diabetes mellitus needs improving. Representatives from European governments, patient organizations and Diabetes experts met un-
* Corresponding author.
der the auspices of the WHO-Europe and the IDF (International Diabetes Federation) in October 1989 and launched the St. Vincent Declaration. This defines a series of five-year goals in respect to quality indicators to improve the life of people suffering from diabetes. Quality of health care depends to a great deal on the availability of the patient's data. People with chronic diseases are very often treated in various institutions due to the multitude and severeness of their diseases. This means that the
0169-2607/94/$07.00 ,c 1994 Elsevier Science Ireland Ltd. All rights reserved SSD1 0169-2607( 94)01538-Q
34
R. Engelbrecht et al. / Comput. Methods Programs Biomed. 45 (1994) 3 3 - 3 5
patient's data is scattered across several locations. A portable personal medical record (PPMR), the chip card, as for example the DIABCARD for patients with diabetes, would save costs and provide health care personnel and patient with the necessary and up-to-date medical information at all times.
• defining the DIABCARD system with special regard to the chip card; • object oriented modelling of the clinical environment by object oriented analysis and design; and by • modelling typical applications.
2. Development of the DIABCARD CCMIS
The results of the object oriented analysis and design are described in the DIABCARD repository [5]. First results have been implemented in the DIABCARD Demonstrator, which shows the functionality of the DIABCARD chip card.
2.1. Scenario technique The specification for the core of the CCMIS DIABCARD have been developed [1]. The User Centered Design (USD) method established in the AIM-PRECISE-Project [2] was adapted. A continuous spiral of requirement analysis, prototype development, test and evaluation in small workshops with users leads to new and more advanced specifications. The user is at the center of the development. At the start of the project the medical partners, acting as potential users, described 'typical' situations of patients with diabetes, e.g., first consultation, routine check-up, etc. in narrative scenarios. These scenarios describe: • the information exchange; • the communication between patient, health care professional and the various health care institutions; • the security requirements; and helped defining • the possible use and benefits of a chip card; • the data (medical, managerial, socio-demographic, self-monitoring and emergency data) and its structure; • the administrative processes/tasks necessary to provide a good overall quality of care for patients with diabetics. The DIABCARD data set is based on approved diabetes data sets, e.g., the one of the International CareCard.
2.2. Information model The information model of the DIABCARD CCMIS was developed using the object- oriented approach of Coach/Yourdan [3,4] by:
2.3. System architecture The basic communication model consists of different types of workstations for the different environments. Communication channel is the card. An open architecture which integrates the different views of the information model was developed for the chip card [6]. It allows a bandwidth of different security levels, depending on the requirements. It can easily be implemented into existing information systems and into different networking environments. The architecture of the DIABCARD will be adaptable to technological advancements of the smart card. The specifications are not limited to diabetes and adaptable to general health care data and other chronic diseases. The DIABCARD architecture is covered by standards defined within ISO (International Standardization Organisation) and ETSI (European Telecommunication Standards Institute). 2.4. Security and privacy Two types of cards are to be used: • the Health Care Professional Card for identification and access to the system; and • the Patient Card, which contains the medical data of the patients. Specific safeguards including rights of access and control of insertion and deletion have been taken care of. The access authorization is controlled by different security keys attributed either to the role of the user or to the individual himself. The DIABCARD concept is based on the latest development of chip cards and their specific security features [7,8]. It enforces:
R. Engelbrecht et al. / Comput. Methods Programs Biomed. 45 (1994) 33 35
• • • •
confidential data exchange/communication; data protection: true authentication of the card; and identification of the card holder.
It has, however, to be stressed that the patient is the owner of the card and its data and that the use of the card is voluntary. Legal, ethical, and economical implications need further investigation. 2.5. Evahlation The overall concept of the evaluation is based on the UCD (User Centred Design) [9] and is an integral part of the development. At the present stage of the project the acceptance of the concept of a medical chip card and of the D I A B C A R D itself is tested by a survey of patients and physicians in all participating countries. To demonstrate the use and potential of D I A B C A R D a video and demonstrators have been developed. They show different situations a doctor and a person with diabetes might encounter. They also demonstrate possible security and access levels. A consensus activity involving patients, health care personnel and health care administrators took place in Munich this October. The participants took a positive attitude on the concept of the patient data card and on DIABCARD. Patients, nurses and physicians felt that the card could bring vital advantages. Considerations were posed concerning the infrastructure. In the coming year D I A B C A R D will concentrate on the prototype development and its evaluation. Small scale fieldtests with restricted functionalities are scheduled for the beginning of next year to take place in Perugia and Barcelona. 3. Conclusions
The D I A B C A R D project offers a neat solution for standardised diabetes documentation and communication between specialised hospital units, GPs and specialists in primary care. A first stage specification for the CCMIS DIAB C A R D is ready. Next step will be to demonstrate its usefulness and usability. The results of
35
the evaluation of the consensus activity and the questionnaires will be integrated into the pilot CCMIS. The approach used will provide the basis for broader application, including the extension to other chronic diseases. Three main groups of chronic diseases seem suitable to starl with: • cardiovascular diseases; • renal insuffiency and failure; • cancer. The long-term success of approaches like DIABC A R D will depend on the provision of the required infrastructure. The introduction of insurance health cards is well on ils way; the infrastructure for a broader implementation of D I A B C A R D will in quite a few European countries be ready in time. References [1] R. Engelbrecht, C. Hildebrand, E. Kiihnel et al., Smart Card for Diabetes Care the DIABCARD Project, in Conference Proceedings 11 th International Congress of the European Federation for Medical lnformatics, eds. A. Reichert, and B.A. Sadan, pp. 600 603, (Jerusalem, 1993). [2] A. Rector, User Centred Design of a Human Computer Environment for Chronic Disease Care. Diab. Nutr. Metab. 4 (Suppl.1), Editrice Kurtis s.r.l., Milano (1991) 29 32. [3] P. Coad and E. Yourdan, Object-Oriented Analysis, (Yourdan Press, Prentice Hall. New Jersey, 1991). [4] P. Coad and E. Yourdan. Object-Oriented Design, (Yourdan Press, Prentice Hall. New Jersey 1991). [5] R. Engelbrecht, C. Hildebrand, E. Kiihnel et al., Deliverable l: Implementation Strategy for Clinical Diabetes Documentation. (Medis, Miinchen 1993). [6] R. Engelbrecht, C. Hildebrand, E. Kiihnel et al., Deliverable 2: Report on Functional Specification t\)r Chip Card Documentation, (Medis, Mfinchen 1993). [7] J. Brigth, Smart Solutions Telecommunications, P30, Feb. (1992) 75-76. [8] B. Struif, Smart Cards Technik yon Menschen lflr Menschen, oder Methoden der Automatisierung, Pseudonymisierung und Autorisierung. in: Proceedings GMD-Smart Card Workshop. (Darmstadt, 1993). [9] R. Engelbrecht, M. Fitter, J. Schneider et al., EUROD1ABETA, Del. 12: Report on Validation and Verification Requirements and Operational Criteria, (Medis. Mfinchen, 1990).
Computer Methods and Programs in Biomedicine 45 (1994) 33-35
A chip card for patients with diabetes R . E n g e l b r e c h t *d, C. H i l d e b r a n d d, E. K f i h n e l d, G . B r e n n e r ~, R . C o r c o y ~', G . E b e r h a r d h, C. G a p p u, G . K l e p s e r ~, A. d e L e i v a a, M . M a s s i - B e n e d e t t i g, R . M e c h t l e r f, K . P i w e r n e t z ~, J. S e m b r i t z k i i, J. T h i e r y b "Autonomous University, Barcelona, Spain, 6Boehringer, Mannheim, Germany, "Diabetes Center Bogenhausen, Miinchen, German),, aGSF Research Center, Medis-lnstitute, Miinehen, Germany, "IBM Informationssysteme Deutschland GmbH, Germany. /Univ. J. Kepler. Linz, Germany gUniv. Perugia, Perugia, Itah' /'Siemens AG, Miinehen, Germany. ~Z1 Zentralinstitut fiir die Kassendrztl. Versotzgung, K6ln, Germany
Abstract
DIABCARD provides the specification for the core of a Chip Card Based Medical Information System (CCMIS) for the treatment of patients with chronic diseases. It will provide an instrument for assessing health care services, improve the links between health care providers and set up communication between the different levels of health care. It will therefore improve the quality of care and thus the life of patients with chronic diseases. DIABCARD concentrates on diabetes at the moment, the concept of the diabetes chip card will, however, be extendable to other chronic diseases. Key words: DIABCARD: Health care services: CCMIS
I. Introduction
Most European health care systems are oriented towards the treatment of acute complications; the overall quality of care of chronic diseases, e.g., diabetes mellitus needs improving. Representatives from European governments, patient organizations and Diabetes experts met un-
* Corresponding author.
der the auspices of the WHO-Europe and the IDF (International Diabetes Federation) in October 1989 and launched the St. Vincent Declaration. This defines a series of five-year goals in respect to quality indicators to improve the life of people suffering from diabetes. Quality of health care depends to a great deal on the availability of the patient's data. People with chronic diseases are very often treated in various institutions due to the multitude and severeness of their diseases. This means that the
0169-2607/94/$07.00 ,c 1994 Elsevier Science Ireland Ltd. All rights reserved SSD1 0169-2607( 94)01538-Q
34
R. Engelbrecht et al. / Comput. Methods Programs Biomed. 45 (1994) 3 3 - 3 5
patient's data is scattered across several locations. A portable personal medical record (PPMR), the chip card, as for example the DIABCARD for patients with diabetes, would save costs and provide health care personnel and patient with the necessary and up-to-date medical information at all times.
• defining the DIABCARD system with special regard to the chip card; • object oriented modelling of the clinical environment by object oriented analysis and design; and by • modelling typical applications.
2. Development of the DIABCARD CCMIS
The results of the object oriented analysis and design are described in the DIABCARD repository [5]. First results have been implemented in the DIABCARD Demonstrator, which shows the functionality of the DIABCARD chip card.
2.1. Scenario technique The specification for the core of the CCMIS DIABCARD have been developed [1]. The User Centered Design (USD) method established in the AIM-PRECISE-Project [2] was adapted. A continuous spiral of requirement analysis, prototype development, test and evaluation in small workshops with users leads to new and more advanced specifications. The user is at the center of the development. At the start of the project the medical partners, acting as potential users, described 'typical' situations of patients with diabetes, e.g., first consultation, routine check-up, etc. in narrative scenarios. These scenarios describe: • the information exchange; • the communication between patient, health care professional and the various health care institutions; • the security requirements; and helped defining • the possible use and benefits of a chip card; • the data (medical, managerial, socio-demographic, self-monitoring and emergency data) and its structure; • the administrative processes/tasks necessary to provide a good overall quality of care for patients with diabetics. The DIABCARD data set is based on approved diabetes data sets, e.g., the one of the International CareCard.
2.2. Information model The information model of the DIABCARD CCMIS was developed using the object- oriented approach of Coach/Yourdan [3,4] by:
2.3. System architecture The basic communication model consists of different types of workstations for the different environments. Communication channel is the card. An open architecture which integrates the different views of the information model was developed for the chip card [6]. It allows a bandwidth of different security levels, depending on the requirements. It can easily be implemented into existing information systems and into different networking environments. The architecture of the DIABCARD will be adaptable to technological advancements of the smart card. The specifications are not limited to diabetes and adaptable to general health care data and other chronic diseases. The DIABCARD architecture is covered by standards defined within ISO (International Standardization Organisation) and ETSI (European Telecommunication Standards Institute). 2.4. Security and privacy Two types of cards are to be used: • the Health Care Professional Card for identification and access to the system; and • the Patient Card, which contains the medical data of the patients. Specific safeguards including rights of access and control of insertion and deletion have been taken care of. The access authorization is controlled by different security keys attributed either to the role of the user or to the individual himself. The DIABCARD concept is based on the latest development of chip cards and their specific security features [7,8]. It enforces:
R. Engelbrecht et al. / Comput. Methods Programs Biomed. 45 (1994) 33 35
• • • •
confidential data exchange/communication; data protection: true authentication of the card; and identification of the card holder.
It has, however, to be stressed that the patient is the owner of the card and its data and that the use of the card is voluntary. Legal, ethical, and economical implications need further investigation. 2.5. Evahlation The overall concept of the evaluation is based on the UCD (User Centred Design) [9] and is an integral part of the development. At the present stage of the project the acceptance of the concept of a medical chip card and of the D I A B C A R D itself is tested by a survey of patients and physicians in all participating countries. To demonstrate the use and potential of D I A B C A R D a video and demonstrators have been developed. They show different situations a doctor and a person with diabetes might encounter. They also demonstrate possible security and access levels. A consensus activity involving patients, health care personnel and health care administrators took place in Munich this October. The participants took a positive attitude on the concept of the patient data card and on DIABCARD. Patients, nurses and physicians felt that the card could bring vital advantages. Considerations were posed concerning the infrastructure. In the coming year D I A B C A R D will concentrate on the prototype development and its evaluation. Small scale fieldtests with restricted functionalities are scheduled for the beginning of next year to take place in Perugia and Barcelona. 3. Conclusions
The D I A B C A R D project offers a neat solution for standardised diabetes documentation and communication between specialised hospital units, GPs and specialists in primary care. A first stage specification for the CCMIS DIAB C A R D is ready. Next step will be to demonstrate its usefulness and usability. The results of
35
the evaluation of the consensus activity and the questionnaires will be integrated into the pilot CCMIS. The approach used will provide the basis for broader application, including the extension to other chronic diseases. Three main groups of chronic diseases seem suitable to starl with: • cardiovascular diseases; • renal insuffiency and failure; • cancer. The long-term success of approaches like DIABC A R D will depend on the provision of the required infrastructure. The introduction of insurance health cards is well on ils way; the infrastructure for a broader implementation of D I A B C A R D will in quite a few European countries be ready in time. References [1] R. Engelbrecht, C. Hildebrand, E. Kiihnel et al., Smart Card for Diabetes Care the DIABCARD Project, in Conference Proceedings 11 th International Congress of the European Federation for Medical lnformatics, eds. A. Reichert, and B.A. Sadan, pp. 600 603, (Jerusalem, 1993). [2] A. Rector, User Centred Design of a Human Computer Environment for Chronic Disease Care. Diab. Nutr. Metab. 4 (Suppl.1), Editrice Kurtis s.r.l., Milano (1991) 29 32. [3] P. Coad and E. Yourdan, Object-Oriented Analysis, (Yourdan Press, Prentice Hall. New Jersey, 1991). [4] P. Coad and E. Yourdan. Object-Oriented Design, (Yourdan Press, Prentice Hall. New Jersey 1991). [5] R. Engelbrecht, C. Hildebrand, E. Kiihnel et al., Deliverable l: Implementation Strategy for Clinical Diabetes Documentation. (Medis, Miinchen 1993). [6] R. Engelbrecht, C. Hildebrand, E. Kiihnel et al., Deliverable 2: Report on Functional Specification t\)r Chip Card Documentation, (Medis, Mfinchen 1993). [7] J. Brigth, Smart Solutions Telecommunications, P30, Feb. (1992) 75-76. [8] B. Struif, Smart Cards Technik yon Menschen lflr Menschen, oder Methoden der Automatisierung, Pseudonymisierung und Autorisierung. in: Proceedings GMD-Smart Card Workshop. (Darmstadt, 1993). [9] R. Engelbrecht, M. Fitter, J. Schneider et al., EUROD1ABETA, Del. 12: Report on Validation and Verification Requirements and Operational Criteria, (Medis. Mfinchen, 1990).