Updated: Feb 1, 97
EUROCARDS

Project Code:   A2108 Project value:   6025 KECU EC contribution:   537 KECU No of partners:   6 No of countries:   3 Duration:   15 months

Contact: Herve Doare CAP SESA I.H. 129 rue de l'Universite F-75007 Paris, France Tel.: +33-1-49.55.96.80 Fax: +33-1-49.55.96.96 E-mail: hdoare@ecom.cgs.fr

Project overview

Purpose and objectives

The administrative specifications are based on two main requirements:

• to identify the patient and his/her entitlement to care: a basic set of administrative data is stored within the card and/or embossed on its surface;
• to identify the medical professional and his/her entitlement to access and/or process the medical data of an individual patient, either locally on the personal card of the patient, or through a telematic connection with a remote data base. Another possible application is that of accessing specific information or services reserved to the medical profession (information on drugs, adverse reactions, etc.), while for the general public this applies to the possibility of receiving information and advice for prevention, compliance to therapy, etc.

With reference to the medical data, some countries are considering to develop an electronic patient record as a portable medical file, whose essential information can be stored on a card, together with pointers to the more extended records that are available in remote databases for telematic access. Other applications are aimed at providing essential information about the patient in emergency situations, or to keep track of the history of medications and of compliance to treatment are also considered. Finally, several on-going experiments of patient data cards deal with specific subsets of the patients population (some chronic diseases like diabetes, cardiac risks, pregnant women, new-borns, etc).

The issues of confidentiality and security of patient records are a major concern for the Authorities involved and for the general public. There are different Data Protection Acts within European States and different interpretations on the ownership of data, as well as different sensibilities to ethical issues. But some broad principles can form a substantial basis on which the use of cards in healthcare can be implemented.

An analysis conducted by the EUROCARDS action has shown that in many European countries that are considering the introduction of data cards in their healthcare systems, the card is not seen as a stand-alone element, but as an enabling component of a more global communication system. The card is seen both as a key used to access the existing telematic infrastructure, providing the necessary user identification and security requirements, and as a medium able to supplement and integrate the existing physical infrastructure for data transfer, where the carrier of information is the same person holding the card and moving from one point of service to another.

The ten Working Groups of Eurocards have taken as one of the starting points for their work the Council Resolution of 1986 and have developed a comprehensive approach to the use of cards for administrative, emergency and clinical purposes, specifying recommendations for data architectures, data sets and application rules. The theoretical approach has been conducted in co-ordination with CEN and has been tested in the R&D project Cardlink in the 3rd Framework Program and is now going to be validated extensively in the 4th Framework Program by Cardlink II, where 10 regions in 9 Member States are going to test and validated a common interoperable emergency card and other projects that may share the common interoperability concept. A new project is considering the harmonised application of the professional card in the medical context.

Recently all European manufacturers involved in the pilot projects have reached an agreement to jointly develop the basic software elements that would insure technical and functional interoperability of the applications that make use of data cards. These specifications form the basis for a wider interoperability agreement that is currently being discussed with partners from North-America and Japan in the G-7 context.

The concerted action Eurocards has established itself as the forum in the European Union where all actors and Member States are working for the harmonisation and interoperability of solutions. The Concerted Action includes official representatives from all European countries and representatives from industry, insurance company, policy makers, healthcare authorities, researchers, system integrators, etc.

The organisation of Eurocards has now been enlarged to include connections with East Europe, North-America and Japan.

Results

Expected economic and organisational benefits of the introduction

of cards in the healthcare systems

They come mainly from the replacement of paper flow by electronic technology. The introduction of data cards in the banking and telecommunication sectors has already produced significant savings due to reduced paper flow. It is likely that similar benefits would apply to the health care sector with the introduction of patient data cards[1].

Benefits for the patient

The perspective of the patient, his acceptance and confidence in the stored information and in the use of the card for his benefit, will be key success factors for its widespread use. The agreement of the patient is always necessary when a card contains medical data.

All possible steps should be taken through legislation or other appropriate means to protect the patient's interest in relation to information systems and patient cards. Cards applications should comply with the existing national regulations (ownership of medical data, privacy and security for health information, etc.). According to regulations, and particularly those laid down by the Council of Europe for automated medical data bases, individual health records have to be structured in such a way that access rights to various segments may be differently defined. Patient and professional cards offer solutions that could effectively address this requirement.

The European dimension: harmonisation and interoperability to favour the mobility of citizens

A target of the European Union is to enhance the mobility of European citizens and to allow healthcare to be provided to all, regardless of the location of the healthcare facility or of the patient's nationality. If patient data cards are to facilitate the transfer of medical data across Europe, then the cards and the applications making use of them must be interoperable.

To fully benefit from the all the advantages and opportunities which data cards system can bring, there should be a co-ordinated implementation effort at a European level. The objective will be that any healthcare card officially issued by a Member State must be readable and accepted in all healthcare institutions across Europe. From the citizen/patient point of view the data held in the card should be accessed on a transparent basis, overcoming language barriers and compatibility problems between different administrative and medical data structures and coding systems.

For the national healthcare systems, the administrative benefits of using cards containing information for patient identification, social security, health insurance, etc. have already been demonstrated in some countries in Europe. Applications aimed at providing essential information in emergency situations, or at keeping track of medications and compliance to treatment are also being considered.

Those designing, developing and implementing Patient Card Systems should adopt and comply with relevant European and international standards. To ensure interoperability, the use of standards is necessary at all system layers from hardware to data content. There are standardisation activities at a European level organised by the European Standardisation Body: Comité Européen de Normalisation (CEN) in TC 251 Medical Informatics and TC 224 on Cards. Where standards do not exist, Eurocards has promoted convergence towards common technical approaches to similar problems.

Technologies for healthcare cards

The technology assessment study performed by EUROCARDS concludes that smart card technology because of its security functions is suitable for all currently relevant types of applications of portable, computer-readable data storage devices in the health care sector. Applications requiring mass storage for full grown case histories and high resolution images may lead to future developments in this direction. Alternative solutions such as optical cards, magneto-optical disks or cards, PCMCIA cards, etc. may have an important market only after corresponding difficult legal and documentation problems have been solved. In the long run, reliability, user friendliness, and access time will be the key success factors for any technology or specific type of device.

Modularity and smart card information system

The smart card applied to health care is only one component of a more comprehensive computer based information system including professional workstations, printers, readers, networks, etc. Modularity in this context means that smart card systems are kept open and interfaceable horizontally regarding all system components. Vertical modularity refers to hardware, software, interfaces and documentation and coding systems (medical nomenclatures). Systems which are modular and open may experience a rapid growth in the European market.

The logical architecture of patient data card content: a layered approach

It is recommended that the implementation of a patient data card in healthcare starts with a modular and layered approach to the design of its data structure. The following layers of data (and corresponding functions) are identified:

1. Administrative data (patient identification, etc.)
2. Medical data:
   • i. Emergency data.
   • ii. Speciality medical data (e.g. diabetes).
   • iii. Additional medical information for general practice.

• Administrative data: easy access (this means a large number of unidentified health professionals) justified to fulfil a specific function through a specific simple device (reader). In some countries, components of the administrative data set are considered sensitive information and need a security device.
• Medical data: some of this data can also be considered as justifying easy access as above (e.g. emergency data). Access to most of the data will need additional authorisation such as by a Health Care Professional Card (HCPC). In the case of an implementation of medical data cards in a country without HCPC, alternative solutions (e.g. security systems located in the application software) are required.

EUROCARDS recommends the following priority levels for implementation:

1. Administrative cards: the proposed core administrative data set should be supported by all patient card systems in which cards are used for healthcare administration purposes. Administrative data cards should support the functions of the current E111 form which indicates entitlement to the provision of immediate care during temporary stay in other Member States.
2. Healthcare professional cards should be considered as a valuable means of enhancing the security of healthcare telematic systems used with or without patient cards. Security mechanisms of this type become vital if clinical information is stored on patient cards.
3. Emergency cards: essential medical information, available through a data card voluntarily carried by the patient, can improve the effectiveness of immediate care. The recommended content of the European emergency data set is based on the European medical passport (resolution 86/C/184/03 of the European Council), and includes an identification layer, information about the usual physician and next of kin, a basic clinical data set, pointers to medical records, a health insurance payment provision (E111 data set for migrant workers). Additional medical data may also be present in the card as an open-ended data set in order to facilitate the handling of the case by professionals.
4. Patient cards containing medical and pharmaceutical information or pointers to it. Cards of this type may initially be introduced by particular medical specialities. However, any speciality implementation should be designed to facilitate expansion towards a more general use.

In addition to the emergency data card and speciality medical application cards, data card technology could also apply to other topics: (i) location of the complete medical record or parts of it not stored in the card (pointers), (ii) drug prescriptions, result of medical procedures (means of conveying the information), (iii) co-operative cards facilitating patient communication within the medical community and across levels of care.

It is recommended that transnational harmonisation and interoperability be introduced from the very beginning of the implementation phase for administrative cards and emergency cards whilst leaving space for specific national functions. For medical speciality applications, cross-border interoperability remains an objective to be reached at mid-term but higher priority should be given to interoperability across specialities in national applications.

Obstacles to overcome

• The wide variety of clinical information and physician office systems currently in use: To work towards an agreement between medical associations both on a national and a European level concerning a common interface between patient data cards and computerised patient information systems.
• The absence of a standard interface which would allow cards manufactured by different suppliers to be read/written to by any card reader. To promote collaboration between different European smart card users, and communication between users and suppliers in order to motivate suppliers to solve these problems.
• The lack of multilingual translations for all the coding systems for diseases, procedures or drugs which are currently in use. To take appropriate steps so that European scientific networks produce conversion tables and language translation which will allow patient data to be transferred readily between existing coding systems.
• The high initial costs involved in the implementation process. To work towards the involvement of governments and large insurance companies thus producing economies of scale which in turn will reduce the unit cost of introducing patient data cards.
• Different legislations in different countries. To achieve a European consensus on security and data protection for electronic health care records.
• Uncertainty as regards the acceptability of cards to patients and health care professionals. To promote and set up studies to identify psychological and political barriers to the use of cards and to suggest solutions.

List of Deliverables

• Intermediate report on user's acceptance (WG5A)
• Intermediate report on evaluation methodology (WG5B)
• Draft final report on User Acceptance
• Draft Booklet "User Acceptance"
• Draft final report on Evaluation Methodology
• Draft Booklet "Implementation Guidelines"
• Final Reports of WG5A & B and Booklets

List of Participants

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