Opinion of the Committee of the Regions on the Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions eHealth — making healthcare better for European citizens: An action plan for a European eHealth Area
Date: 2004-11-17
Institutions: European Committee of the Regions
Subjects: action programme, data protection, health policy, information system, information technology, medical data, telemedicine, transmission network

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Opinion of the Committee of the Regions on the Communication from the Commission to the
Council,
the European Economic and Social Committee and the
Committee of the Regions eHealth — making healthcare better for European citizens: An action
plan for a European eHealth Area

the European Parliament,

(2005/C 71/08)

THE COMMITTEE OF THE REGIONS,

Having regard to the Communication from the Commission to the Council, the European Parliament, the
European Economic and Social Committee and the Committee of the Regions on eHealth – making health-
care better for European citizens: An action plan for a European e-Health Area (COM(2004) 356 final),

Having regard to the decision of the European Commission of 30 April 2004 to consult it on this subject,
under the first paragraph of Article 265 of the Treaty establishing the European Community,

Having regard to the decision of its President of 8 September 2004 to instruct its Commission for Culture
and Education to draw up an Opinion on this subject,

Having regard to its Draft Opinion 256/2004 rev. 1 adopted on 22 September 2004 by its Commission
for Culture and Education, (Rapporteur: Mr Olivier Bertrand, Maire de Saint-Silvain-Bellegarde (FR/EPP),

unanimously adopted the following opinion at its 57th plenary session, held on 17-18 November
2004 (meeting of 17 November).

1. The Committee of the Regions' views

Introduction

establishing and maintaining public confidence. Establishment
of confidence should be recognised as a key issue in encoura-
ging citizens to use sources that provide sound, balanced and
impartial
instead of those that offer
poor, or even dangerous,
information, often for commercial
purposes (1).

information and advice,

1.1
e-Health, widely interpreted as in the Introduction to the
to deliver
Commission's Communication, has the potential
improved healthcare, effectively and economically. However,
the key to success will be securing the confidence of citizens
that all aspects of e-Health that have implications for them, are
designed giving first priority to their interests. The involvement
of representatives of organisations representing patients and
citizens,
in the design of e-Health products, systems and
services, will thus be very important. For systems designed for
specific groups of patients representatives of
the relevant
patient support groups should be involved. The issue of confi-
dentiality of personal medical records will be a major concern
for citizens.

The designation ‘citizen centred health service’ must
implementation of policies

1.2
be seen to apply in the practical
and not merely as a description of intent in policy documents.

1.3
Experience of the introduction of e-Health systems has
also clearly demonstrated the need to involve health profes-
sionals from the very outset of discussions on any e-Health
project designed for their use.

1.4
The issue of quality assurance of (Webseal) validated e-
Health information systems will also be of vital importance in

2. Challenges and Expectations facing Europe's Health

Sectors and the Role of e-Health

Accessibility of services: The Communication states
2.1
that by 2051, nearly 40 % of the Union's population will be
over 65. The younger segments of
this age-group will be
people who have lived and worked in an electronic environ-
ment, and are likely to be familiar and to be comfortable with
e-Health provided the necessary quality controls have been in
place throughout their experience. However in early years of
the 21st century many of those in older age groups may have
little experience of e-Health and some may lack IT skills neces-
sary to gain maximum benefit from e-Health developments.

(1) A recent survey of 32 of the most popular alternative and comple-
mentary therapy websites, said to attract tens of thousands of ‘visi-
tors’ each day, offered 118 different ‘cures’ for cancer, and 59 so-
called preventative treatments, none of which could be demon-
strated to have the effect claimed. And one fifth of the websites
either actively or indirectly discouraged patients from using conven-
tional treatments for cancer (study published in the Journal ‘Annals
of Oncology’, cited on BBC News 15 April 2004)

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These are the very people who are most likely to require
increasing access to healthcare services. Systems must be in
place to ensure that their interests are not prejudiced. For some
years there will be a need to provide other channels of commu-
nications for citizens to access services, for example by tele-
phone. Printed information should also be available.

2.2
It is understood that a Committee convened under the
auspices of DG Employment and Social Affairs is examining e-
Health including the ‘digital divide’, urban and rural differences
and questions about education and training for health profes-
sionals and citizens. Resolution of these issues is essential for
successful implementation of e-Health.

2.3
Technology infrastructure: Reference is made in the
Communication of the need for action on the ‘roll out of
broadband networks in telecommunications’. Some current
broadband connections to the Internet in some geographical
areas, are currently not sufficiently robust. This has important
implications for hospitals and primary care professionals in
such areas. Some facets of telemedicine such as the transmis-
sion of x-ray results, would be extremely uncertain,
if not
In the rural or sparsely populated areas where
impossible.
current broadband connections are
the
distances between healthcare facilities are likely to be greater
than in other areas, and thus the potential benefits of e-Health
applications greater. In addition, if local healthcare providers
wish to make information available on-line for local residents,
it is essential that these residents have a reliable technological
infrastructure to provide ready access.

relatively fragile,

2.4
There is therefore a need for investment in the necessary
equipment to ensure that the appropriate technological infra-
structure is in place for all concerned to have ready access to e-
Health services. The investment could come from EU cohesion
and/or structural
funds and possibly through the European
Investment Bank.

- patients

Empowering health consumers

2.5
and
healthy citizens: Reference is made to the support people
now need in managing their own diseases, risks and lifestyles
and to the fact that people are looking proactively for informa-
tion on their medical conditions. In brief, people nowadays
wish to be partners with health professionals in decisions on
treatment.

should be strongly encouraged to use the EMA database as
their priority source because the information provided will be
objective, reliable and scientifically proven.

All

2.7
‘validated’ websites on medicinal products and
medical treatments should contain explicit advice to people to
discuss the information, or any medication difficulties with
their doctor or pharmacist. The 2003 WHO Report ‘Adherence
to long term therapies – evidence for action’, emphasised the major
problems that arise through non-adherence to courses of long
term medication for chronic medical conditions. This repre-
sents not only a waste of resources, but also a threat to the
future health of the individual.

Recent research (2) has indicated that people often take
2.8
positive decisions to cease taking their medicines, rather than
just forgetting. The WHO report indicated that the reasons for
non-adherence vary but often encountering an unpleasant side
effect can be a trigger. This should be taken into account in all
e-Health initiatives providing information about medicines and
medical treatments, with a positive approach to encouraging
adherence.

2.9
A conclusion in the WHO report was that ‘increasing
the effectiveness of adherence interventions may have a far
greater impact on the health of
the population than any
improvements in specific medical treatments.’ In time of pres-
sure on resources for healthcare appropriate e-Health initiatives
should focus on improving adherence.

2.10
The Communication emphasises the improvements in
quality of care and patient safety that can result from access to
‘comprehensive and secure electronic health records’. The
dilemma is how to maintain patient confidence in the security
and confidentiality of medical records, while at the same time
ensuring that all necessary information is available to all health
professionals providing health care to an individual, enabling
them to provide the best possible quality of care. The problem
of maintaining public confidence on confidentiality of data is
likely to be made more difficult with increasing cross border
provision of health care. The Communication opens up the
possibility of a study specific to data protection in the context
of e-Health. This should be a priority.

2.6
The use of medication is by far the most common inter-
vention in the treatment of illness and to safeguard citizens
against suffering serious medical
incidents such as coronary
heart disease or stroke. The published proposals for the ‘road
map’ of the European Medicines Agency (EMA) indicates the
wish to have an EMA database covering all the medicines for
which marketing authorisations have been granted in any EU
Member State and under
the centralised procedure. This
proposal should be implemented as soon as practicable. People
who wish to seek information on medicines via the Internet

2.11
Supporting health authorities and health managers:
The Communication suggests that e-Health opens up new
opportunities for people who live in remote areas with only
limited healthcare services, as well as ‘marginalised groups’
such as people with varying degrees of disability. This will only
be true if the necessary investment is made in the technology
infrastructure in remote areas, where needed. Training for citi-
zens will also be vital.

(2) Barber N, Parsons J, Clifford S, Darracott R, Horne R,

‘Patients'
problems with new medication for chronic diseases’ Quality and
Safety in Healthcare, No 13, June 2004

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3. State of Play

tatives of the medical, dental and pharmaceutical professions
should be invited to cooperate with such an initiative.

3.1 Major challenges for wider implementation: As the
Communication makes clear, interoperability is a key issue
that, if it is to be achieved, will require a much more positive
approach than has been demonstrated up to now. User-friend-
liness should be less difficult to achieve, given the necessary
investment. Confidentiality and security issues have already
been covered in this Opinion.

3.1.1
The provision within the general data protection direc-
tive to create a code of conduct for special domains such as
health should be taken forward as a matter of urgency espe-
cially to address issues of confidentiality and security.

to cross-border provision of services,

3.1.2
Apart from assurance about confidentiality, citizens
will be concerned to be confident that, if problems arise subse-
quent
their rights to
compensation will be protected. The discussions on the
proposal for a Directive on Services in the Internal Market
(COM(2004) 2 final) show that professional indemnity cover
differs widely between Member States. Insurers have suggested
that a requirement
indemnity
cover for health professionals could make it impossible for
some health professions to obtain affordable cover. They would
then be faced with withdrawing services or acting illegally. This
problem must be resolved if citizens are to have confidence in
using cross border e-Health services.

for compulsory professional

3.2
The question of the qualifications of those offering
health services cross border is also an issue for citizens, as the
debates on the proposed Directive on the mutual recognition
of professional qualifications (COM(2002) 119 final), have
clearly demonstrated. It is essential that e-health services are
not used to bypass national regulations, which means that the
regulatory authority in the host Member State must know that
a service is being offered by a health professional from another
Member State and be satisfied that the professional concerned
is properly qualified, licensed to practise their profession, and
not subject
to be
certain that health professionals from other Member States
providing services to them meet the same standards required in
their Member State. A solution must be found in the text of the
Directive concerned,
if citizens are to be confident using e-
Health services.

to disciplinary sanctions. Citizens want

throughout

3.3
An example, which would help enhance security and
legal certainty, would be the standardisation of e-prescription
forms. There is currently no standardisation of format of paper
prescriptions
the EU, which is an additional
element leading to difficulties for patients seeking to have a
prescription dispensed in a Member State other than the one in
which it was issued. It seems appropriate therefore to investi-
gate the standardisation of e-prescription formats while e-
prescription services are in their infancy, rather than wait until
systems are in place in individual Member States. EU represen-

3.4
As the Communication states, citizens prefer services
tailored to their needs and requirements, while knowing that
their right to privacy is protected. It is agreed that the take-up
of e-Health systems and services would take place more rapidly
were the needs and interests of the user communities (health
professionals, patients and citizens)
to be taken on board.
Representatives of user groups should therefore be integrated
into the development of e-Health projects. These communities
will then be much more likely to be users and promoters of e-
Health. The fact that each stakeholder group has the ability to
veto implementation of any project if not considered beneficial
should be uppermost in the mind of those planning these
projects.

3.5
The risk that the sections of the community mentioned
under the subheading Access for all to e-Health might be
excluded from the possibilities offered by e-Health, must be
tackled as a priority issue if people in these already disadvan-
taged groups are not to feel further excluded. e-Health, appro-
priately provided, could be a major element in the delivery of
improved health care to them;

4. Towards a European e-Health Area: Issues and Actions

4.1
The objectives listed on issues raised earlier in the
Communication will only be achieved if there is full commit-
ment on the part of Member States,
if all stakeholders,
including representatives of patients, citizens and the profes-
sions are closely involved from the outset at both national and
Community level, if there is careful and consistent monitoring
of achievement of the targets set out and if there is the neces-
sary investment in technology infrastructure. This will assist
greatly in encouraging citizens to be confident in using e-
Health services and in supporting their further development.
Without their support little will be achieved.

The Committee of the Regions has not commented on every
subheading in this section of the Communication.

4.2
Issue 1: Addressing common challenges: (Communi-
cation point 4.2.1) It is important that Member States and the
Commission study the matter of the reimbursement of services
It is possible to imagine a situation
provided cross border.
where a patient living close to a border might find that the
nearest and apparently most suitable specialist for providing a
second opinion, by teleconsultation - as set out
in point
4.3.2 - is in a hospital in a Member State other than that of
residence of the patient. For such people an absence of regu-
lation on this matter would be difficult to understand, and any
regulation introduced should be adapted to the regulations
applying in each Member State.

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4.2.1
(Communication point 4.2.3) In relation to mobility of
patients, the achievement of a common approach to patient
identifiers as envisaged in section 4.2.2.1 and confidence that
strict controls are in place for assurance of the competence of
health professionals, offering services in Member States, will be
very important.

reiterates

4.2.2
(Communication point 4.2.4) Here the Committee of
financial
its earlier
the Regions
support from the Community will be essential in accelerating
the roll out of broadband communications in some under-
served localities.

statement

that

(Communication point 4.2.7) The Commission's
4.2.3
Communication states that certainty of e-Health product and
service liability ‘would be beneficial’. The Committee of the
Regions considers that these words should be replaced by ‘is
essential’ if patient confidence in using e-Health services is to
be stimulated and maintained. An earlier date than 2009
should be set
in collaboration with
Member States, to provide the necessary framework for greater
legal certainty in this regard.

the Commission,

for

4.3 Issue 2: Pilot actions: accelerating beneficial implementation

4.3.1
(Communication point 4.3.1) The Committee of the
Regions welcomes the co-funding by the Commission for the
development of a set of quality criteria for health related
websites. There should be long-term campaigns by govern-
ments and health professionals to encourage citizens to use
sites with a ‘webseal’, in preference to others. Formal, constant
monitoring of such sites to ensure continuing compliance with
the quality criteria will be essential.

4.3.2
(Communication point 4.3.3) The Committee of the
Regions welcomes the introduction of the European health
insurance card. The proposed European health card should, on
its introduction,
incorporate the information on the health
insurance card together with the essential health data should
the patient so wish. The patient should then be able to permit
individual health professionals to access relevant data to ensure
that they can provide the best possible quality of healthcare.
This again points to the importance of ensuring interoperability
of electronic technology. Care should be taken that certain
medical data that could be used for ‘cherry picking’ is not made
available to health insurance organisations.

4.3.3
(Communication point 4.4.1) The establishment of the
high level e-Health forum, to support the Commission will
provide the ideal opportunity to establish confidence by
confirming that all necessary stakeholders will be involved
from the outset. It is understood that the forum will be able to
set up working groups on specific topics, one of which should
obviously be interoperability. There should be close liaison
between the e-Health forum and the high level reflection group

Brussels, 17 November 2004

on healthcare and medical services to be established under the
Commission's Communication on patient mobility.

5. The Committee of the Regions' recommendations

THE COMMITTEE OF THE REGIONS,

5.1
recommends that financial support be provided via EU
structural/cohesion funds or from the European Investment
Bank to ensure the required effectiveness of broadband
communications in localities that would otherwise be under-
served;

recommends that the problem of maintaining public
5.2
confidence on confidentiality of personal medical data, while
explaining the benefits of the sharing of relevant information
by health professionals involved in their treatment, be tackled
as a priority by the Commission in cooperation with Member
States;

5.3
recommends that representatives of patients, citizens
and the health professions be involved from the outset in all
proposals relating to e-Health projects;

5.4
recommends that positive steps be taken to ensure that
the interests of those in older age groups and other vulnerable
groups, are specifically addressed in relation to all e-Health
projects and that for some years, alternative means for seeking
information and advice are provided;

5.5
recommends that a much earlier date than 2009 be set
for the Commission, in cooperation with Member States, to
provide the necessary framework for greater legal certainty on
e-Health product and service liability;

recommends that

5.6
services provided cross border be given priority;

the issue of

reimbursement

for

recommends that the benefits of using ‘webseal’ sites
5.7
rather than others be promoted to citizens, on a long term
basis, by governments of Member States and health profes-
sionals;

recommends that a system be established to ensure
5.8
that ‘webseal’ sites consistently adhere to the established quality
criteria;

recommends that e-Health services associated with
serious

5.9
treatments by medication, positively address
problem of non-adherence to medication regimens;

the

5.10
recommends that there be close liaison between the
e-Health forum and the high level refection group on health-
care and medical services to be established under the Commis-
sion's communication on patient mobility.

The President

of the Committee of the Regions

Peter STRAUB