London, Smart Card Europe Conference - 13 December 1995

**[International Harmonisation of use of data cards in
healthcare]{.smallcaps}**

*Antonio Pernice (1) and Hervé Doaré(2)*

*(1) European Commission, Brussels - (2) CSIH, Paris*

The administrative benefits of using cards containing information for
patient identification, social security, health care insurance, etc. are
already proven enough for some countries in Europe, like Germany and
France which are moving or considering to move towards national
large-scale implementations. The (smart) 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 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.

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. Further applications
of cards 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. Other on-going
experiments of patient data cards are within specific subsets of the
patients population (some chronic diseases like diabetes, cardiac risks,
pregnant women, newborns, 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 already
outlined can form a substantial basis on which the use of cards in
healthcare can be implemented. For instance, it is now widely accepted
that the decision to use a card containing personal medical information
should remain with the individual citizen on a voluntary personal basis.

Due to the concerns for confidentiality, the suggestion coming from the
development models is to separate the content of clinical data into a
basic medical data set which can be accessed in emergency situations
directly by all healthcare professionals, and an extended medical data
set, with the essential patient medical history, or the necessary
information to access and retrieve it from remote institutions or
practitioners, protected by a security mechanism. The doctor\'s right to
access these data is demonstrated by the combined use of the
professional card and of the patient\'s card.

An analysis conducted by the European Commission (EUROCARDS action) has
shown that in many European countries that are considering the
introduction of data (smart) 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 implementation model in Europe for value-added services and
interoperable applications in healthcare relies on the availability of a
telematic infrastructure (physical connections) and of a basic set of
services, such as access to the network, e-mail or data transfer. On top
of that, a layer of specific value-added services will be tailored or
developed for each application area, and as the last layer on top,
common or interoperable applications are developed.

In this model telematics and data cards are not competitors, but
synergical. A co-ordinated development and implementation of the two
technologies is needed for two main reasons:

1.  the card is a carrier of data: where the telematic infrastructure is
    not available, the patient, moving from one point of care to the
    other, and carrying in a card his/her own data and pointers to
    remote databases, actually makes a sort of \"virtual\" flexible
    infrastructure that can substitute and complement a more "physical"
    infrastructure (cabled or wireless).

2.  the card is a key to access the network: both the patient\'s card,
    containing the pointers to federate remote data bases, and the
    doctor\'s professional card, containing the profile of the user and
    the associated rights to access the system and its services,
    constitute essential elements for the overall networked system.

Technology and patents of smart data cards are essentially European.
Gemplus, Schlumberger, Siemens, Bull are some of the major developers
and manufacturers of cards. An analysis of the developments in the
European Member States has shown that two countries in Europe, namely
France and Germany, have traditionally been leading the development of
technology and the pilot phase, and Germany is now actively moving into
nation-wide implementation. Other European countries have plans to
follow a similar direction. Outside the European Union, it is worthwhile
mentioning the role that the proposed healthcare reform of President
Clinton has given to the patient security card for entitlement to care
and for access to the networked healthcare system in USA.

The EC action EUROCARDS has also explored why the market of cards, while
showing a success story in the banking and telecommunication sectors, is
much underdeveloped for the healthcare applications. This is mainly due
to lack of standardisation and interoperability of applications, which
are normally developed for a very restricted market, and to the lack of
data from larger scale experiments demonstrating the cost-effectiveness
of the solution for the healthcare authorities to decide on investments.
In fact, many experiments have been on-going for a while, but only
recently Germany has decided to issue a basic administrative card to all
citizens (about 70 millions cards being issued) on the basis of a
cost-effectiveness study and France has decided to co-ordinate its
efforts on the establishment of a professional card and of its social
security card.

***The role of the European Commission***

The European Commission has been active in this field with the above
mentioned Concerted Action EUROCARDS and with some R&D and pilot
activities.

EUROCARDS was established to investigate the subject of data card
applications in the healthcare system and to reach consensus on the most
suitable strategic approach. It has gathered the various relevant
experiences in Europe and elsewhere, and has developed a technical,
social, and legal framework for data card applications. It has also
established itself as the forum in which 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.

In addition, the European Commission has funded some pilot
implementation in programmes such as ESPRIT, AIM DGXIII, and in DG XII
and DGV. A substantial pilot activity, also demonstrating in practical
terms the principles of interoperability and harmonisation of data sets,
has been prepared in the Third Framework by the two European R&D
projects CARDLINK and DIABCARD, and is now the goal in the Fourth
Framework (1995-98), where the same two projects have been granted
substantial additional resources. Moreover, a new project, TRUSTHEALTH,
is considering the harmonized application of the professional card in
the medical context. Recently these projects have reached an agreement
to jointly develop the basic elements that would insure technical and
functional interoperability of the applications that make use of data
cards.

***Main conclusions and recommendations of the European Concerted Action
EUROCARDS***

[Expected economic and organisational benefits of the introduction of
cards in the healthcare systems]{.underline}

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. The
use of data cards in healthcare should reduce the number of unnecessary
laboratory and radiological investigations. In Germany, a financial
analysis of the administrative card has shown that even substancial
initial investments, if calculated over a 5 year period per insured
citizen, are only as high as running the paper system used at present
(ca. 2.2 DM/year/person).

[Benefits for the patient]{.underline}

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.

As the patient is very often the weakest actor in the healthcare system,
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. The introduction of PDCs provides
a good opportunity to redefine the relationship between patients and
healthcare professionals that in many cases today can be considered as
unbalanced. The introduction of PDCs should not cause discrimination
against patients or health care professionals who do not use them.

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]{.underline}

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.

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.

To fully benefit from the all the advantages and opportunities which
data cards system can bring, there should be a coordinated
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.

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,
convergence towards common technical approaches to similar problems
should be promoted.

[Technologies for healthcare cards]{.underline}

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.
However, the storage on portable devices of full grown case histories
and high resolution images requires mass memory. For applications
requiring mass storage, alternative solutions to be considered are
optical cards, magneto-optical disks or cards, PCMCIA cards, and
networking. The request for more memory may lead to an important market
for future card generations only after corresponding difficult legal and
documentation problems have been solved. In the long run, reliability,
userfriendliness, and access time will be the key success factors for
any technology or specific type of device.

[Modularity and smart card information system]{.underline}

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]{.underline}

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\. Specialty medical data (e.g. diabetes).

iii\. Additional medical information for general practice.

Data may be stored either as text or in coded format. Where coded format
is used, the coding system employed should be indicated. Access
possibilities should depend on the sensitivity of the data and on its
use, general recommendations are:

-   *[Administrative data]{.underline}:* easy access (this means a large
    number of unidentified health professionals) justified to fulfill 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]{.underline}:* 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 authorization 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.

[Data cards and telematic networks]{.underline}

Patient data cards and networks are two complementary technologies to be
used with their specific advantages to meet the requirements of the
health care domain. Both carry patient information in relation to a
health care process. Both approaches have their specific advantages and
disadvantages with respect to the legal, economical, and infrastructural
capacity of a country or a region. Both may be cost-effective. However,
investment in a card infrastructure ensures a few distinct advantages
within the context of the European data protection regulations:

1.  The role of the citizen/patient as an equal partner in relation to
    health care professionals is supported;

2.  The degree of possible system abuse is lower than in existing paper
    and pencil documentations (reference Rimouski publications);

3.  Easy to handle and secure documentation is possible especially in
    shared care environments.

If professional cards are introduced, patient and professional cards
become the key security mechanism within all information processing in
health care. Both cards could also be access keys to telematic services.
In this perspective cards and networks are not competiting but synergic;
especially the use of professional cards that may enhance the security
of the health data in networks.

[Strategic areas for implementation]{.underline}

EUROCARDS recommends the following priority levels for implementation:

1.  *Administrative cards* for administration purposes (creation of an
    infrastucture i.e. reader, workstation, etc.).

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* also having the capacity to host the
    administrative data for national and international administrative
    purposes (including E111).

4.  *Patient cards* containing medical and pharmaceutical information or
    pointers to it. Cards of this type may initially be introduced by
    particular medical specialties. However, any specialty
    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)
    cooperative 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 specialty applications,
cross-border interoperability remains an objective to be reached at
mid-term but higher priority should be given to interoperability across
specialties in national applications.

*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*

A Health Care Professional card (HCP card) can be a key element for the
security functionality that will be required for patient card
applications and for telematic health care applications particularily
when widespread interoperability at a European level is desirable.

The major use of smart cards for health care professionals are to
provide:

-   Identification information in machine readable form;

-   Access control to information systems, i.e. to local systems like
    PCs as well as to local servers and remote computer systems;

-   Signatures for electronic documents to be stored locally and/or to
    be transmitted.

An additional use, that may be of particular importance in some health
care systems, is to provide access to patient data cards based on the
possession of cryptographic class keys indicating a certain professional
status.

Security requirements for HCP cards are very high and are strongly
influenced by the structure of the national health care system, existing
health information systems (in particular patient card systems) and
legal requirements. Requirements on the technology are central. However,
it is equally important to establish organisations, «trust centers», and
to give them control of the personalisation and the issuing of cards,
cryptographic keys and certificates. The issuing of HCP cards has to be
authorised by the relevant registration bodies for the professional
group concerned.

*3. Emergency cards*

Essential medical information, available through a data card voluntarily
carried by the patient, can improve the effectiveness of immediate care.
Emergency cards must operate in vital emergencies or in situations which
risk lapsing into an emergency when the healthcare supplier must
intervene on the basis of little or no knowledge of the patient
situation and background.

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.

The implementation of the emergency card must ensure transnational
interoperability, so that basic medical information is made available
irrespective of the country of origin of the card holder, issuer and of
the actors involved. Possible implementation strategies could be: (1)
emergency medical data added voluntarily on an existing administrative
card which is compulsory. (2) two separate cards benefiting from the
same infrastructure (readers). In this case it is recommended that the
administrative data feature also on the emergency card. The choice
between these two strategies should be made keeping in mind that the
healthcare organisation of each country has to guarantee freedom for the
patient to produce or refrain from producing his emergency medical data
without it incurring any discrimination. It is expected that the
advantages of this type of application may immediately be understood by
most citizens, and may have a high social impact.

*4. Specialty medical applications*

Effective medical data communication may increase the quality of life
and provide benefits for patients suffering from chronic diseases or
specific pathologies such as kidney insufficiency or diabetes which
require long and extensive treatment. Clinical cards issued to such
patients may help them to manage their disease better. They may also
improve the mobility of such patients and alleviate their anxiety about
treatment whilst away from home. This depends on a wide availability of
appropriate applications that are capable of accessing these cards.

There may be some attraction in issuing cards to patients who require
frequent medical treatment and check-ups. This may facilitate the
initial development of clinical card systems. However, such developments
should be seen as parts of a migration path towards more general
clinical cards. Otherwise, the cost of developing the infrastructure to
provide card access at a wide range of healthcare locations may not be
justified by the amount of use and the resulting benefits.

[Obstacles to overcome]{.underline}

-   *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.

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-   *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.

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-   *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.

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-   *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.

***From the European concerted action EUROCARDS to the G-7 sub-project
6***

The European Commission has promoted a special session of the G-7 - the
group of the most industrialised nations in the world - in Brussels in
February 1995, with the participation of the telecommunications
ministers of the seven countries and of representatives of industry, to
discuss the issue of the "Global Information Society".

A special meeting was devoted to the linking up of the
telecommunications networks at a global level and to the identification
of services that would be developed on such a global infrastructure. In
an accompanying G-7 Showcase, companies and institutions from the G-7
countries have demonstrated practically to the public what kind of
revolution would affect our lives at home, at the school, in the office,
in the factory, in the hospital, in the streets, etc. The decision was
then taken by the G-7 governments to promote the follow-up of some ideas
that had been presented and partially demonstrated in the Showcase,
encouraging the establishment of 11 global pilot projects in selected
areas that would further demonstrate the committment of the G-7
countries in joint actions.

The selected projects aim at demonstrating the potential of the
Information Society, at contributing to solve various basic issues and
at stimulating its growth. The projects, initially based on the core
group of the G-7 countries, are open to all actors concerned at all
levels and in any country. They range from a global inventory of
projects on Information Society, to cross-cultural education and
examples of electronic libraries and museums, to the global management
of natural resources, environment and emergencies, to the establishment
of connections amongst national administrations, to the development of
global healthcare applications.

***The G-7 Global Healthcare Application project***

A special position is assigned to this last G-7 pilot action, the Global
Healthcare Application Project, with six sub-projects aimed at
demonstrating the potential of telematics in the field of medicine. The
sub-projects are largely based on the strong tradition of international
co-operation in the field of healthcare. This includes for instance
intergovernmental co-operation activities in the framework of WHO for
the monitoring and control of infectious diseases, and co-ordinated
international actions in case of major accidents or catastrophes. It is
also exemplified by the world-wide co-operation of researchers in fields
such as cancer or cardiovascular diseases, where the pooling of
information and knowledge at a global level allows an increase in the
efficiency of both epidemiological or clinical studies and in the
diagnosis and treatment of these major scourges.

The sub-project 1, "Towards a Global Public Health Network\" is aimed at
facilitating the work of public health authorities, notably in their
fight against infectious diseases or major health hazards. The
sub-project will investigate the feasibility of linking existing and
emerging public health data telematic networks in Canada, Europe, Japan,
the USA, the WHO, and other international health-related organizations.
Two sub-projects are designed to help health professionals to increase
the efficiency of epidemiological and clinical studies and to access to
best medical practice regardless of location; Sub-project 2,
\"*Improving Prevention, Early Detection and Treatment of Cancer*\", and
Sub-project 3, \"*Improving the Prevention, Diagnosis and Treatment of
Major Cardiovascular Diseases*\" address two major causes of death,
disability and health costs in the industrialised countries. Their aim
is to strenghten international collaborative efforts in order to create
databases and tele-consultation services which will make it possible for
health professionals across the world to access the best possible
information and expertise. The objective of the sub-project 4, \"*A
24-hour Multilingual Telemedicine Surveillance and Emergency System
Around the World*\", would be the establishment of a global
teleconsultation system for health emergencies. A telematic network,
linking major public and private emergency centres around the world and
the relevant medical supporting institutions, should be the basis for
delivering a 24-hour multilingual emergency teleconsultation service to
people at sea or travelling and working in isolated places and in
regions with less developed healthcare services. Sub-project 5
\"*Enabling mechanisms for global healthcare network*\" deals with
nomenclature, coding and standards, with tools for navigation and access
to the networks, with linguistic aspects (including on-line
translation), and with the harmonisation of security standards for
patient related data exchange. The key issue of protection of personal
data while they are accessed and transmitted across the global networks
is of paramount importance for the acceptance of this type of
applications by the society.

The sub-project 6 \"*International harmonisation of use of data cards in
healthcare*\" deals with the development of a framework for
co-ordination within the G-7 countries and beyond, to meet the
principles of data harmonisation and application interoperability of
health cards.

It is designed on the model of the "concerted action" EUROCARDS funded
by the Europen Commission, where relevant partners from interested
countries meet regularly to exchange results of studies and share
difficulties and successes met in implementing health cards.

The objectives of the G-7 sub-project 6 \"International harmonisation of
use of data cards in healthcare\" are those of continuing and extending
the activities of the "concerted action" EUROCARDS by means of its
successor project G7-HEALTHCARDS, to extend the European collaboration
to USA, Canada and Japan.

The issues to be addressed in this wider context are:

1.  the harmonisation of data sets and the interoperability of
    applications and services by complying with relevant international
    standards at all system layers;

2.  the complementary nature and synergy between data cards and
    telematics networks;

3.  the acceptability of data cards through fulfilling demands for
    privacy and security.

The focus will be on the development and piloting of an international
emergency card that would provide the essential medical information that
is vital for an emergency situation, as well as an international
harmonized administrative data set, and of an international professional
card that will allow the secure identification of healthcare
professionals when accessing medical data and network services.

It is also expected that the experience coming from the implementation
in the above mentioned European projects and others in USA, Canada and
Japan will facilitate the transition from the large number of local
pilot experiments that take place in many countries, to a co-ordinated
implementation of data cards in healthcare worldwide. The practical
demonstration of the concept of interoperability will also provide input
to the national and international standardisation bodies for
consideration.

*Antonio Pernice*

*European Commission*

*DG XIII C-4 - Healthcare Telematics*

*rue de la Loi 200*

*B-1049 Brussels Belgium*

*tel. (+32) 2 2963508 fax (+32) 2 2960181*

*e-mail apern@dg13.cec.be*