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Risultati finali
The DIABCARD patient card is a tool which allows the patient to carry his medical record. It is based on the PC/SC and OpenCard standards. DIABCARD was implemented on an IBM MFC, but the DIABCARD data interface also makes possible the use of other cards and card operating systems. PC/SC, however, is a prerequisite.
The DIABCARD data is represented in ASN.1 BER (ISO 8825 Specification of Basic Encoding Rules - Abstract Syntax Notation One). The file structure on the DIABCARD chip card is according to the ISO 7816-4 file system. The EU/G7 interoperable data - a prerequisite for the interoperability to Cardlink - are stored in three elementary files (EF):
- EU/G7 card data.
- EU/G7 administrative data.
- EU/G7 medical emergency data.
DIABCARD medical data, not contained within the three interoperability data sets, is stored in one single EF. The data has been organised via item groups. An item group represents a set of logically related items of the DCDS, which can only be written as a whole to the chip card. Each item group on the card has a reference to its recorder. The recorder fixes the health care professional who stored the medical data and the time of storage on the chip card. The recorder ID will be provided by the DIABCARD Access Card. Data item groups can be stored in multiple occurrences on the card. For speeding up the access to the data an internal directory was created for this EF. The contents of these data sets are defined within the DIABCARD Data Set. The DIABCARD Data Interface provides access to the contents of these files via pre-defined tags.
The data on the card can only be accessed by a Professional Card. Additionally, the user has to type in his PIN - only emergency data can be accessed without any PIN.
The card has been validated in Austria, France, Germany, Greece, Italy and Spain. The validations showed that for a diabetes speciality record the capacity and functionality of the chip card is sufficient.
The DIABCARD Core System is a sophisticated application system for the care of diabetes patients. It handles administrative and medical data, data import and export, patient record administration (creation, editing, search etc.), browsing of the patient record, and document administration, user defined reporting, chip card I/O and user management. There are administrator-oriented functions (e.g. document generation) and user oriented functions. Both are secured by passwords.
A simple-to-use tool enables every site to design its own documents out of the DIABCARD Data Set by 'drag-and-drop'. Reports are automatically created along with each document. It is possible to add data items to the system's local database and to include them in new documents. Any document can be hidden. Thus a system cut to personal needs can be created.
Every document is described by the date and time that it was created, the date and time that it was last modified and by the user that performed the last modification.
The data are stored in a Paradox database. For the database-handling layer, Borland Database Engine was used. The developing tool is Delphi. All the interfaces are standardised and can thus easily be connected to or be incorporated into other medical record systems. The system was implemented in English. German and Spanish versions are being prepared. A User Manual is available.
Though the number of application systems for diabetes care has increased in the past couple of years, to our knowledge, a system covering such a wide range of standardised medical documents at the same time being applicable all over Europe is not available anywhere. It stands good market chances especially in Germany because the system is being adapted to meet the requirements of the 'Strukturverträge'.
Risultati sfruttabili
DIABCARD Chip Card based Medical Information System (CCMIS) framework is a sophisticated medical documentation and communication system for chronic diseases in ambulatory and hospital care applying the state-of-the-art technology. The new requirements resulting from the rapidly changing technological and political situation were taken into account during development. It is based on user requirements. Standardisation and interoperability were main issues to be covered.
The architecture of the DIABCARD CCMIS is based on ISO 7816, and on the up-to-date technologies (PC/SC, OpenCard, Java) and complies a layered architecture. As laid out above the Chip Card, Server including the Data Interface and the Core System are ready. The Browser has been implemented in the Core System. It is foreseen to specify and develop a Browser in combination with a data update facility.
Its layered architecture allows the complete system or single modules of the system - described below - to be easily integrated into existing systems. The other systems will benefit from the additional functions. This will facilitate the use of the DIABCARD CCMIS, but it will also promote the use of telematic services all over Europe. The system works on any WINDOWS-platform (3.1 and higher).
On the application level the use of the DIABCARD CCMIS will improve the services for persons with diabetes. It may be integrated in a diabetes clinic routine care since it can be used both for easy routine based data archiving and reporting. Thus enhancing diabetes care (less secondary diseases, less repeated examinations, less leave due to the disease - to name but a few of the effects) will contribute to reducing the vast budget spent in this sector. The data either on the CCMIS's database or on the card could be used for epidemiological research projects and/or quality assessment.
Each DIABCARD site has evaluated the system in respect to functionality, usefulness, usability and acceptance by patient and physician. It was recognised as a singular and valuable tool.
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