Several European countries already have nationwide card systems in place, some even containing medical data. Some of those which are merely administrative are going to be replaced during the coming years, for example, in Germany.
The only health card project funded currently in the European program is NETC@RDS. The objectives of this project are mainly of an administrative nature, using cards in a European-wide network for healthcare entitlement when travelling. This activity also has to be seen in the context of the European Council's decision in March 2002 in Barcelona to introduce a European health insurance card, which will replace the current paper forms needed for health treatment in another member state. New cards will somehow "contain" the information needed, and existing cards will be enhanced to prove entitlement all over Europe. This will lead to Europe-wide implementation and use of cards, different in content and technique.
However, which health insurance cards, and respectively which projects, already exist in Europe?
The objective of the European Commission's efforts is not the harmonisation of the health systems but the achieving more cooperation and more convergence among the health systems and the finding answers to the open questions concerning cross border healthcare according to increasing patients mobility in Europe.
Being aware of these challenges, the EU health ministers in 2002 had agreed on adopting a common approach to increasingly deal with community questions of cross-border healthcare--for example, covering cross-border healthcare in border regions and healthcare for patients staying abroad for a longer period of time, like pensioners in Spain.
The increasing mobility of the citizens, as mentioned, and the increasing cross-border use of health services also mean that quality-assured health information must be made available beyond national borders. This will mean, for example, the exchange of treatment data, the simplification of cross-border billing procedures and also the use of patient information systems across Europe by mobile citizens and patients.
The recent action plan eEurope 2005 "Information Society for All," adopted in May 2002, highlights priorities for the introduction of cross-border and telematics-based health services.
Most important is the introduction of the European health insurance card that will replace paper-based forms like the E111 "Certificate of Entitlement to Benefits in Kind During A Stay in a Member State," which are presently required for using health services in another Member State. The new card will allow simplified healthcare utilisation and billing in another European country. The eEurope 2005 action plan explicitly mentions the crucial role of an Electronic health card and the synergies in the use of cards to access networked electronic patient records. Furthermore, the European Commission intends to support a common approach to patient identifiers and electronic health record architecture through standardisation.
The history of large scale deployment of health cards in the healthcare sector goes back to the late eighties/early nineties, when France and Germany each started national programs on the nationwide introduction of health insurance cards. Since then, other nations, such as Slovenia and Belgium, have also introduced health cards, and various projects have been started all over Europe.
The European Commission funded several projects to gain experience in the use of such cards and to stimulate their introduction in Europe. The best known in this series are DIABCARD, CARDLINK, and NETLINK, all dealing with different aspects of health cards. These projects are finished and had huge impact on several national projects in Europe.
Most of the smart card and IT network software applications deployed in the scheme of local or national health information systems are available only in the context of national regulation; they were designed for the national or local healthcare information system. Most of the services provided by such systems are not available abroad, and many may not even be interoperable between different regions within the same country.
Administrative procedures for international cases, therefore, still rely on paper in the Member States even where smart cards are used and administrative procedures computerised. In the Member States where patient clinical data are, or will be, electronically available (on smart cards or through networks), health professionals still cannot in international cases have access to the patient clinical data, even in an emergency situation. Interoperable solutions at trans-European level could dramatically improve the quality of services provided to citizens in social security and health applications.
Standards will help to gain that desired interoperability. There is an eight-part standard under development in the ISO TC 215 "Health Informatics" Working Group 5 "Cards" on "Patient Healthcard Data":
Health informatics - Patient healthcard data - Part 1: General structure
Health informatics - Patient healthcard data - Part 2: Common objects
Health informatics - Patient healthcard data - Part 3: Limited clinical data
Health informatics - Patient healthcard data - Part 4: Extended clinical data
Health informatics - Patient healthcard data - Part 5: Identification data
Health informatics - Patient healthcard data - Part 6: Administrative data
Health informatics - Patient healthcard data - Part 7: Electronic prescription
Health informatics - Patient healthcard data - Part 8: Links
Parts 1 to 3 have been published officially as ISO - Standards ISO/IS 21549 1-3 on May 15, 2004, including definitions of a limited emergency data set, immunisation, and blood transfusion details. This will be extremely helpful for all countries planning to introduce cards with medical content.
The other parts are in different stages of development inside the standardisation process.
Presently, there are card systems or pilots implemented in 10 European countries, namely in Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Norway, and Slovenia. Some countries have gained experience in several pilots; four systems run on a nationwide basis and will be briefly presented in the following. All three systems consist of two cards: a patient data card (PDC) and a health professional card (HPC).
Belgium SIS Card
The Belgian Health Coverage's (Mutualités Belges) Social Identity System (SIS) requires smart cards for patients and doctors, pharmacists, and hospitals (where the third party paying system applies).
The SIS health insurance card became mandatory for all social insured citizens (about 10.5 million) in the beginning of the year 2000 and contains a microchip with information about the person's health insurance.
It should enable more rational management of the health sector and also help to simplify reimbursement.
The SIS card is personal and stores two types of data in its memory chip.
Unprotected data, visibly indicated on the card, is keyed in electronically using a reader. These data are surname, first forename and first letter of the second forename, date of birth, sex, social security number, card number, a unique 10-figure combination, which is the identification number of the social identity card, card validity start date and end date. These data are freely accessible and write protected.
Protected data can be accessed only by key holders with a professional health service card called SAM and PIN verification. These data are version number (indicating last change to the entitlements to reimbursement of healthcare) and period of insurability (this period is bounded by a start date and an end date, including insurance organisation identification).
French Vitale Card
France was one of the first countries in the world to introduce the large-scale use of smart cards in the health insurance system. The pioneering SESAM-VITALE system was the first fully automatic system in which microprocessor cards were used in the health sector. The system was initiated by the French Ministry of Health.
Today's Vitale card is a microprocessor card containing roughly eight pages of text and replacing the standard paper individual health insurance card. The first, family version (Vitale 1) of the card contains administrative data, available to physicians for the immediate printout of a health claim form during the visit. Visibly printed on the card are s urname, forename, and social security number (NIR) on the front and the card serial number on the reverse of the card. The data stored in the chip are separated in two zones and comprise NIR (Social Security number), health insurance system code, branch, entitlement start date, proof of entitlement, presence of permanent entitlement , s urname, forename, date of birth, status of beneficiary, information specific to the health insurance system, entitlement end date etc.
The card is intended to help track healthcare spending better and to enable the electronic transfer of medical records and prescriptions to healthcare funds responsible for reimbursement. It shall also optimise healthcare costs with the best quality of service and provide the same healthcare service quality and access for all citizens. The Sesame-Vitale card is the heart of the health network (Reseau Sante-Social - RSS), aiming to link through a secured computer network each individual patient with all kinds of healthcare providers: public hospitals, private clinics, general practitioners, specialised doctors, nurses, etc. Already more than 45 million of these cards have been issued.
The second card generation (Vitale 2), an individual health card, will include medical information--for example, a patient's medical history, treatment history, an emergency data set, and possibly other medical parameters that will only be available to health professionals using a health professional card for identification. Sixty-five million of these cards will be rolled out.
Parallel to the Vitale 1 card, France introduced a Health Professional Card (CPS--Carte de Professionnel de Santé.) It identifies the health professional and also provides authentication, digital signature, and data encryption. Pharmacists and medical staff also receive a card, which can easily be recognised by its colour.
More than 425,000 cards have already been issued to healthcare professionals, more than 90,000 of these to physicians.
German Statutory Health Insurance Card
In 1992, a law was enacted that ordered the introduction of smart cards for all statutory health insurances. The actual introduction of these Health Insurance Cards (HICs) was then postponed until after another field test in 1993, where 256-byte RAM cards were issued in Wiesbaden, Böblingen, and Weimar. In the following year, 1994, over 80 million cards were issued throughout all 16 German states in five steps. In addition, over 147,000 card readers and dot-matrix printers were issued to all licensed statutory physicians as well as ambulatory centers and old people's homes.
The focus of these cards was naturally the administrative data of the statutory health insurance system, comprising name, address, date of birth, name and number of the insurer, insurance status, and end of validity. All of these data were placed in a simple random access memory module in ASN-1 notation, and printer interfaces were developed so that the card readers were able to print the data directly on insurance forms, in addition to serially transmitting this data to attached computer systems. At the time, this was deemed sufficient in terms of a return on investment.
Two years later in 1996, the private health insurance companies in Germany were finally able to reach an agreement with the statutory health insurances for use of the reader and printer infrastructure and then issued their own analogous and interoperable insurance cards. These basically contained the same data as statutory health insurance cards. Some data fields were, however, modified for the purposes of private health insurance. The handling of these private cards by healthcare providers and related organisational implications remained unchanged.
So to this day, almost all German citizens have and use one of these cards.
German Health Professional Card
The official German Physicians' ID implements five different functions, which are specific to the user as a person.
First, this card is a classic visual identification card with a personalisation, including a picture, so that it can be used for general proof of ID in various medical settings, for example, in a pharmacy, should the holder wish to purchase a prescription drug.
A second, similar function is in the electronic chip where a base certificate electronically signed by the issuing Medical Association identifies the holder by name and digitised picture and specifies his role as a physician. This function is intentionally not PIN-protected and is intended for easy and simple use in an already secure environment. As such, it is a direct counterpart of the visual ID function.
All other functions, specifically three private keys from asymmetric key pairs, are protected by a PIN and have to be explicitly activated. Each of these keys is dedicated to a specific purpose. The first key is for secure client/server authentication within a medical application system using strong encryption. The second key is used for transport encryption using a hybrid symmetric asymmetric encoding scheme. The third key is used for the generation of a personal electronic signature, which according to current German law has to have legally binding characteristics. A set of specific attribute certificates issued by the state Medical Association or the state Administration of Office Based Physicians can be appended to this signature by the signer. In 2003, the specification version 2.0 had been finalised, officially approved and made available for pilot projects.
New German Health Passport
With the last healthcare reform, effective since January 2004, the so-called Statutory Health Insurance Modernisation Law, a comprehensive legal basis for implementing health telematics in the German health system has been set up within the German Social Code V.
The new legislation for the first time supports the priority of electronic communication within the Health System. Further regulations allow the financing of personal electronic health records by the Statutory Health Insurance Funds and modify the data stored on the Health Insurance Card, such as copayment and picture of holder.
Of special importance are the regulations for the new health insurance, like the electronic prescription as obligatory application, access using qualified electronic signature and a comprehensive infrastructure for health telematics applications like the electronic health record.
Based on the legislation of the information, communication, and security infrastructure, the organisations of the self-governing system have meanwhile established a task force to prepare the necessary steps.
The Federal Ministry for Health and Social Security has issued a roll-out plan, which is based on the results of the bIT4health project. The sequence of events has been consented by the self-governing organizations and the German Länder; yet, there are some controversies with regard to the exact time schedule of these events.
Following the finalization of the so called " solution architecture," due in the middle of 2004, there will be laboratory tests and "mini" tests in late autumn.
Slovenian Health Insurance Card
Following a four-year period of design and development, the introduction of the health insurance card in Slovene healthcare was completed in October 2000. Through this project, the entire Slovene healthcare system relies on electronic documents certifying health insurance (the health insurance card--HIC), with a virtual network interconnecting health insurers and all healthcare service providers. The HIC system, which effectively combines smart card technology and network services, consists of the following technological components: insured person's cards, health professional cards, healthcare service providers' data processing environment, and an online network of self-service terminals.
The system has been up and running in all regions since its introduction. The evaluation results of monitoring this new mode of work have demonstrated that the card has been accepted by the insured, healthcare professionals, and the staff of insurance providers as a normal mode of routine work. Empirical measurements of acceptance, conducted in September 2000, demonstrate high rates of satisfaction with the system among insured and healthcare professionals (the substitution of the healthcare booklet for the card was "strongly approved" or "approved" by 82.6 percent of the insured population). The degree of satisfaction and recognition of system benefits for the healthcare professionals has been growing as the system is used.
The goals set for the project's first phase have been achieved. The insured, physicians, pharmacists, healthcare professionals, and the insurance providers are interconnected by an electronic system providing fast and user-friendly communication, as well as a higher degree of identification and accountability. The system offers opportunities for advanced organisation of operations, as well as neat and controlled individualisation of services in the healthcare sector; these are preconditions for well-regulated and transparent operation.
Business benefits brought by the HIC system are reliable insured person identification at all healthcare points, facilitated communications between all actors (insured person, health service provider, insurance company), simplification and speed of administrative procedures, enhanced data security, promotion of the insured persons responsibility and care for her/his own health, and raising of IT literacy among healthcare staff through system use. All these benefits combine to advance the quality, efficiency, and transparency of the healthcare services.
With the introduction of the card, the old "healthcare booklet" has lost its applicability as a document to verify the validity of health insurance. The card has relieved the insured of the need to update the validity of insurance with their employers' personnel departments; instead, they are assigned responsibility for the currency of their health insurance data and given autonomy to update the card data through self-service terminals. The updating of insurance validity also updates other card data (except visual data such as name, date of birth, etc.) from data servers connected to the network of self-service terminals. As indicated by the statistics for card updating and application in day-to-day circumstances, the insured have accepted and successfully mastered the new modes of operation.
The decision of the European Commission to replace paper forms in the healthcare sector by cards European-wide will lead to the issuing of a variety of different cards across Europe, ranging from simple plastic cards with just printed data on the front and the back, up to smart cards with the data stored on the chip. Experiences from card pilots throughout the world of existing nationwide implementations, as presented above, will stimulate discussions among the users of benefits and further functionalities of those cards. From that perspective the process started in Europe, it is only the beginning of a development towards an electronic health record with a card as only one component of an overall telematic infrastructure.
eEurope Smartcards Initiative Trailblazer 11 "Health Cards." White Paper: Smart Cards as Enabling Technology for Future-Proof Healthcare: A Requirements Survey.
About the Author
Jürgen Sembritzki is Managing Director, Centre for Health Telematics Ltd., Germany.
|Source: 2004 IFHRO Congress & AHIMA Convention Proceedings, October 2004|