Commission Recommendation of 2 July 2008 on cross-border interoperability of electronic health record systems (notified under document number C(2008) 3282)
Date: 2008-07-02
Institutions: European Commission
Subjects: data protection, harmonisation of standards, health service, information system, information technology, medical data, standardisation

18.7.2008

EN

Official Journal of the European Union

L 190/37

RECOMMENDATIONS

COMMISSION RECOMMENDATION

of 2 July 2008

on cross-border interoperability of electronic health record systems

(notified under document number C(2008) 3282)

(2008/594/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community, and in particular Article 211 thereof,

establishing the European

Whereas:

and economic benefits of
fragmentation

Lack of
interoperability of electronic health record
systems is one of the major obstacles for realising the
eHealth in the
social
Community. Market
is
eHealth
in
aggravated by the lack of technical and semantic inter­
operability. The health information and communication
systems and standards currently used in Member States
are often incompatible and do not facilitate access to
vital information for provision of safe and good quality
healthcare across different Member States.

(1)

(2)

(3)

The strategic initiative i2010, which is an initiative for
growth and employment, builds on information and
communication technology policies, research and inno­
vation to help achieve the goals of the Lisbon Strategy.
The i2010 initiative promotes the building of European
information society and encourages provision of better
public services, including eHealth.

Resolving existing and future challenges to European
healthcare systems is possible, at least partly, through
deployment of proven information and communication
technology-enabled
(eHealth). A major
requirement to use benefits of eHealth is improved coop­
eration regarding interoperability of Member States’
eHealth systems
and applications. Electronic health
record systems form a fundamental part of eHealth
systems.

solutions

Electronic health record systems have the potential to
achieve greater quality and security in health information
than the traditional forms of health records. Interoper­
ability of electronic health record systems should make
access easier, and enhance the quality and safety of
patient care throughout the Community by providing
patients and health professionals with relevant and up-
to-date information while ensuring the highest standards
of protection of personal data
and confidentiality.
Enhancing cross-border cooperation in the domain of
providers,
cooperation
eHealth
purchasers and regulators of healthcare services
in
different Member States. At the same time any measure
relating to interoperability need not necessarily lead to
the harmonisation of laws and regulations of the organ­
isation and delivery of healthcare in Member States.

between

requires

(5)

(6)

(7)

the

the

European

Parliament,

The Communication from the Commission to the
Council,
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’, presented on 30 April 2004 (1), outlines
the potential of eHealth systems and major challenges for
its wide deployment. The Action Plan outlined in this
Communication calls for joint Community and Member
States action on interoperability of electronic health
record systems.

The Declaration of the High Level eHealth Conference in
2007 acknowledged the importance of starting joint
initiatives among Member States by strengthening a
range of activities related to interoperability of electronic
health record systems.

The Commission responded to the report ‘Creating an
Innovative Europe’ of
the independent expert group
with the Communication ‘A Lead Market Initiative for
Europe’ (2) that aims at the creation and marketing of
innovative products and services in lead industrial and
social areas, including eHealth. One of the main targets
of the proposed initiatives to boost the interoperability of
electronic health record systems, since the health infor­
mation and communication systems
and standards
currently used in Member States are often incompatible
and thus present a barrier to the emergence of cost-
effective
technology
and
solutions for healthcare.

information

innovative

(1) COM(2004) 356 final.
(2) COM(2007) 860 final.

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Official Journal of the European Union

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(8)

in the

The European Parliament, on 23 May 2007, passed a
Resolution on the impact and consequences of
the
exclusion of health services
from the Directive on
internal market (1). The Resolution
services
invites the Commission to encourage Member States to
actively support the introduction of eHealth and teleme­
dicine, particularly by developing interoperable systems
allowing the exchange of patient information between
healthcare providers in different Member States.

(9)

The purpose of the Recommendation is to contribute to
development of overall European eHealth interoperability
by the end of 2015.

(10)

This Recommendation respects and observes the prin­
ciples recognised by the Charter of Fundamental Rights
of the European Union,
in particular Article 7 on the
right to respect for private and family life and Article 8
on the right of every individual to the protection of his
or her personal data.

(11) Health records are among the most sensitive records
available containing information concerning an indi­
a medical
vidual. The unauthorised disclosure of
condition or diagnosis could negatively impact an indi­
vidual’s personal and professional life. Maintaining health
records in an electronic form increases the risk that
patients’
information could be accidentally exposed or
easily distributed to unauthorised parties.

(12)

Interoperability of electronic health records
involves
transfer of personal data concerning a patient’s health.
These data should be able to flow freely from one
Member State to another, but at
the same time the
fundamental rights of
the individual should be safe­
guarded. This Recommendation should therefore be
without prejudice to the Community provisions on the
protection of personal data consisting in particular of
Directive 95/46/EC of the European Parliament and of
the Council of 24 October 1995 on the protection of
individuals with regard to the processing of personal data
and on the free movement of such data (2), and Directive
2002/58/EC of
the
Council of 12 July 2002 concerning the processing of
personal data and the protection of privacy in the elec­
tronic communications sector (Directive on privacy and
electronic communications) (3).

the European Parliament and of

(13)

The Commission considers that Privacy Enhancing Tech­
nologies (PETs) should be developed and more widely
used where personal data is processed through ICT
networks in relevant fields such as eHealth (4),

(1) (2006/2275 (INI)).
(2) OJ L 281, 23.11.1995, p. 31. Directive modified by Regulation (EC)

No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

HEREBY RECOMMENDS:

1. This Recommendation provides a set of guidelines for
developing and deploying interoperable electronic health
record systems, allowing for cross-border exchange of
patient data within the Community so far as necessary
for a legitimate medical or healthcare purpose. Such elec­
tronic health record systems
should enable healthcare
providers to ensure that a patient receives care more effec­
tively and efficiently by having timely and secure access to
basic, and possibly vital, health information, if so needed
and in conformity with the patient’s fundamental rights to
privacy and data protection.

2. This Recommendation provides guidance for
electronic health record systems,
emergency data

ability of
patient
records facilitating ePrescription solutions.

summaries,

interoper­
including
sets, medication

3. For the purposes of this Recommendation the following

definitions are applied:

(a)

‘patient’ means any natural person who receives or
wishes to receive health care in a Member State;

(b) ‘health professional’ means a doctor of medicine or a
nurse responsible for general care or a dental practi­
tioner or a midwife or a pharmacist within the meaning
of Directive 2005/36/EC of the European Parliament
and of the Council of 7 September 2005 on the recog­
nition of professional qualifications (5) or another
professional
in the healthcare
sector which are restricted to a regulated profession
as defined in Article 3(1)(a) of Directive 2005/36/EC;

exercising activities

(c)

a

‘electronic health record’ means
comprehensive
medical record or similar documentation of the past
and present physical and mental state of health of an
individual in electronic form, and providing for ready
availability of
treatment and
these data for medical
other closely related purposes;

(d)

‘electronic health record system’ means a system for
recording, retrieving and manipulating information in
electronic health records;

(e)

‘patient’s summary, emergency data set, medication
record’ mean subsets of electronic health records that
contain information for a particular application and
particular purpose of use, such as an unscheduled
care event or ePrescription;

(3) OJ L 201, 31.7.2002, p. 37. Directive modified by Directive

(5) OJ L 255, 30.9.2005, p. 22. Directive as

(EC) No 1430/2007 (OJ

last amended by
L 320,

2006/24/EC (OJ L 105, 13.4.2006, p. 54)

(4) COM(2007) 228 final.

Commission Regulation
6.12.2007, p. 3).

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Official Journal of the European Union

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(f)

‘ePrescription’ means
as
defined by Article 1(19) of Directive 2001/83/EC of
the European Parliament and of the Council (1), issued
and transmitted electronically;

a medicinal prescription,

The political

level of cross-border

interoperability of electronic

health record systems

5. At the level of political feasibility and commitment to elec­
it is recom­

tronic health record systems interoperability,
mended that Member States:

(g)

‘interoperability of electronic health record systems’
means the ability of
two or more electronic health
inter­
record systems
pretable data and human interpretable information
and knowledge;

to exchange both computer

(h) ‘cross-border

interoperability’ means
interoperability
between neighbouring and non-neighbouring Member
States and their entire territories;

(i)

‘semantic interoperability’ means ensuring that
the
precise meaning of exchanged information is under­
standable by any other system or application not
initially developed for this purpose.

4. Achieving and maintaining cross-border interoperability of
electronic health record systems
implies managing a
continuous process of change and the adaptation of a
multitude of elements and issues within and across elec­
tronic infrastructures in Member States. These electronic
infrastructures are necessary to exchange information,
interact cooperate in order to ensure the highest possible
levels of quality and safety in healthcare provision to
patients. Implementing interoperability of electronic health
record systems will require a complex set of framework
conditions, organisational structures and implementation
procedures involving all relevant stakeholders.

(a) To achieve this, Member States are invited to undertake
actions at five levels, namely the overall political, the
organisational, the technical, the semantic and the level
of education and awareness raising.

for

and

confidentiality

(b) Underpinning these activities will be full compliance
with national as well as Community legal instruments,
the protection of personal data,
in particular
including
security. The
data
necessary legal safeguards should be ensured, together
with the embedding of data protection safeguards in
the design and implementation of electronic health
record systems. Furthermore,
is indispensable to
develop mechanisms for education of both patients
and professionals as well as for the evaluation and
monitoring of activities necessary for ensuring the
interoperability of electronic health record systems.

it

(1) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive

2008/29/EC (OJ L 81, 20.3.2008, p. 51).

(a) commit politically and strategically to the implemen­
tation at local, regional and national level of electronic
health record systems that are capable also of intero­
perating with electronic health record systems in other
Member States;

(b) engage in active cooperation with other Member States
and relevant stakeholders to ensure the adoption and
that make the cross-
implementation of
border
electronic health record
interoperability of
systems feasible and; secure

standards

(c)

implement interoperability of electronic health record
systems as an integral part of regional and national
eHealth strategies;

(d) consider

the inclusion of eHealth in national and
regional strategies for territorial cohesion and develop­
ment and analyse the results of already deployed elec­
tronic health record systems at the level of eHealth
policy and financing possibilities. For
the period
2007-2013 the support for developing eHealth inter­
operability through investments in eHealth and trans-
national and cross-border activities is provided within
the framework of cohesion policy;

(e) analyse the risks, barriers or missing elements

in
relation to achieving cross-border interoperability of
electronic health record systems, and identify the
necessary preconditions and relevant
to
solve the problems;

incentives

(f)

reserve adequate resources, for example by means of
direct incentives, to invest in electronic health record
systems;

(g) recognise that

in both technical and
investments
in the
semantic interoperability can be beneficial
shorter term, applying a step-by-step approach and
examples of best practice, drawing on priorities and
expertise of Member States;

(h) consider

the

creation of other

indirect
incentive mechanisms to enable the adoption, acqui­
sition and/or modernisation of interoperable electronic
health record systems;

financial

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(i) plan the activities directed to ensure the interoperability
of electronic health record systems ahead for at least
five years. Such a timescale is deemed appropriate to
ensure policy consistency — which is often a precon­
dition for increasing investment and innovation;

systems

supporting cross-border
implementation of
healthcare and the provision of healthcare services
throughout the Community, especially those related to
electronic health records and exchange of information;

(j) accompany implementation of electronic health record
systems by strong involvement of users and other
governance,
stakeholders
management,
public
procurement, planning,
evaluation,
training, information and education;

in establishing
public-private

adequate
partnerships,

implementation,

(k) raise awareness among relevant stakeholders such as
local and regional authorities, health professionals,
patients and industry of the benefits and need for inter­
operability of electronic health record systems.

The

organisational

level

of

cross-border

interoperability

of

electronic health record systems

6. It is essential to create an organisational framework and
process that will enable cross-border interoperability of
electronic health record systems. This should be based on
a roadmap, developed by Member States, which covers a
five-year period and provides details with regard to the
following milestones:

(a) agree on a European governance process to establish
guidelines for developing, implementing and sustaining
cross-border interoperability of electronic health record
systems covering management for reliable identification
of patients and authentication of health professionals as
well as other relevant issues as described in points 7, 8,
9 and 14;

(b) consider policies and incentives to increase demand for
procuring eHealth services to enable interoperability of
electronic health record systems;

(c) analyse the factors which render the standardisation
processes leading to higher levels of
interoperability
such a long,
of electronic health record systems
complex and expensive activity, and devise measures
to speed up these processes.

Technical interoperability of electronic health record systems

7. Compatibility of electronic health record systems at the
technical level is the essential prerequisite for interoperable
electronic health record systems. Member States should:

(a) undertake a comprehensive survey of existing technical
standards and infrastructures that may facilitate the

(b) analyse the use of standardised information models and
standards-based profiles when developing and imple­
menting interoperable electronic health record systems
and services solutions. Consider standardised infor­
mation models and standards-based profiles
to be
part of national or regional specific interoperability
specifications. Where appropriate,
these information
should make use of existing
models and profiles
European and international standards, and be based
on the approaches
relevant
industrial initiatives;

and achievements of

(c) commit to the development of any necessary additional
standards, preferably open standards on a global scale,
involving the relevant European and international stan­
dardisation bodies in the key areas where shortcomings
have been identified;

(d) analyse the achievements of

the Mandate M 403:
‘Mandate to the European Standardisation Organi­
sations CEN, Cenelec and ETSI in the field of Infor­
mation and Communication Technologies, applied to
the domain of eHealth’
in order to provide optimal
technological
safety and
regulatory integration in Europe and within global
markets.

infrastructure,

foundations,

Semantic interoperability of electronic health record systems

8. Semantic interoperability is an essential factor in achieving
the benefits of electronic health records to improve the
quality and safety of patient care, public health, clinical
research, and health service management. The Member
States should:

(a) establish an appropriate mechanism in cooperation
with the relevant standards development organisations,
the Commission and the World Health Organisation, to
involve national research centres, relevant
industries
and stakeholders
in the development of health
semantics to advance in implementation efforts of
interoperable electronic health record systems;

(b) wherever possible, consider the suitability of interna­
terminologies, nomenclatures
tional medical-clinical
and classifications of diseases, including those for phar­
macovigilance and clinical trials; the establishment of
competence centres for multilingual and multicultural
adaptation
and
terminologies should also be encouraged;

classifications

international

of

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the

(c) agree on standards for semantic interoperability to
represent
a
particular application through data structures (such as
archetypes and templates), and subsets of terminology
systems and ontologies responsive to local user needs;

relevant health information for

(d) consider the need for a sustainable reference system of
concepts (ontology) as a basis for mapping multilingual
lexicons that take into account the difference between
professional healthcare languages, lay terminologies and
traditional coding schemes;

(e) support the widespread availability of methodologies
and tools for incorporating the semantic content into
practical applications as well as the development of
relevant human capacity and skills in this domain;

(f) demonstrate
current
sound evaluation and assessment.

the benefits

and future

systems

and/or

shortcomings of
through scientifically

Certification of electronic health record systems

procedures

9. There is a need for a mutually recognisable conformity
testing
the
are
Community or which serve as a basis for each Member
State’s certification mechanism. Therefore Member States
should:

throughout

valid

that

(a) apply properly the existing eHealth standards and
profiles, namely those related to interoperability of elec­
tronic health record systems, in order to enhance users’
confidence in those standards;

(b) put

a

into place

joint or mutually

recognised
mechanism for conformity testing and certification of
interoperable
and other
electronic health records
eHealth applications, such as the techniques and meth­
odologies offered by various industry consortia;

(c) consider

the

industry

and/or
conformity testing activities as a mechanism to reduce
delays in bringing interoperable eHealth solutions to
the market;

self-certification

(d) take into account national and international practices,

including those which exist outside Europe.

Protection of personal data

in conformity with Community
health record systems,
provisions on the protection of personal data, in particular
Directives 95/46/EC and 2002/58/EC.

11. Directive 95/46/EC applies to personal data processed in
application of this Recommendation. Processing of personal
data contained in the electronic health records and their
systems is particularly sensitive and therefore subject to the
special data protection rules on the processing of sensitive
data. Article 8 of Directive 95/46/EC prohibits in principle
the processing of sensitive data concerning health. Limited
exemptions to this prohibition principle are laid down in
the Directive,
in particular if processing is required for
specified medical and healthcare purposes.

12. Member States should be aware that interoperable elec­
risk that
tronic health record systems
personal data concerning health could be accidentally
exposed or easily distributed to unauthorised parties, by
enabling greater access to a compilation of the personal
data
and
throughout a lifetime.

concerning health,

from different

increase

sources,

the

13. Member States should follow the guidance on electronic
health record systems provided for by the Working Party
set up under Article 29 of Directive 95/46/EC (1).

interoperable

14. Member States should lay down a comprehensive legal
electronic health record
framework for
systems. Such a legal
framework should recognise and
address the sensitive nature of personal data concerning
health and provide for specific and suitable safeguards so
to protection of
as
personal data of the individual concerned.

the fundamental

to protect

right

This legal framework should in particular:

(a) analyse different personal data protection impacts of
organisational alternatives for storing personal data
organisational
concerning
structures for electronic health record systems in view
of the specific risks for the rights and freedoms of data
subjects, which best reflect the national, regional and
local specifications and practices;

establish

health

and

and

freely

the patient’s

(b) guarantee the patient’s self-determination by allowing
for
taken
autonomous
decision, supported by means of user-friendly tech­
nology, as to which personal data concerning health
are to be stored and disclosed to whom in his or her
electronic health record unless expressly required by
national law. This decision shall be without prejudice
to the possibility for the relevant healthcare body or
doctor to store this data for treatment purposes;

10. Member States should ensure that the fundamental right to
protection of personal data is fully and effectively protected
in interoperable eHealth systems, in particular in electronic

(1) See at present Working Document 131 of 15 February 2007 on the
processing of personal data relating to health in electronic health
records.

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(c) establish that electronic health record systems are
designed and selected in accordance with the aim of
collecting, processing or using no personal data or as
little personal data as possible. In particular, use is to be
for pseudonymisation or
made of
rendering persons
is
possible and the effort
reasonable in
relation to the desired level of protection;

the possibilities

anonymous,

involved is

insofar

this

as

(d) provide for an assessment of the information security
risks and personal data protection impacts prior to the
implementation of an electronic health record system,
in view of the specific risks for the rights and freedoms
of data subjects;

(e) clarify the extent to which categories of personal data
concerning health should be made available in elec­
tronic form or online. In particular, certain categories
of personal data concerning health such as genetic or
psychiatric data may have to be excluded from online
processing altogether or at least be subject to especially
strict access controls;

(f) prescribe that processing of personal data in electronic
health records and their systems must be required and
carried out only by a health professional subject under
national law or rules established by national competent
bodies to the obligation of professional secrecy or by
another person subject to an equivalent obligation of
secrecy; ensure a reliable identification of patients and
health professionals;

(g) determine the conditions under which health data
contained in electronic health record systems can be
lawfully accessed and processed by persons other than
the individual concerned, and for what predefined
health purposes, including the security that should be
assured while processing health data; specify these
issues as policies that can be practically applied, tech­
nically implemented and enforced,
inter alia, by the
national data protection supervisory authorities;

(h) ensure that patients are fully informed on the nature of
the electronic health
the data and the structure of
record containing them. Patients should have alternative
data
(conventional) means
to
concerning health related to him or her.
In this
information
context
provided to data subjects uses language and a layout
that is easy to understand and is given in an appro­
priate manner
(e.g.
children or elderly persons);

to persons with special needs

to ensure that

is important

personal

access

it

(i) provide for special measures to prevent patients from
being illegally induced to disclose their personal data
contained in electronic health record systems;

(j) make sure that any processing — especially the storage
— of personal data in electronic health record systems
takes place within jurisdictions applying Directive
95/46/EC or those with an adequate level of protection
of personal data;.

(k)

for

lay down detailed auditing requirements
the
purpose of ensuring compliance with data protection
obligations, such as reliable system of electronic identi­
fication and authentication, data access logging, docu­
mentation of all processing steps, duration of main­
taining the auditing information, effective back up
and recovery systems, and enforce the adoption of
these requirements or
solutions according to best
practices for information handling;

(l) guarantee the confidentiality of electronic health record
systems as well as provide for appropriate technical and
including rules on incident
organisational measures,
detection and management processes,
in case of a
breach of security or identity mechanisms leading to
the accidental or unlawful destruction, loss, alteration,
unauthorised disclosure of or access to personal data
transmitted, stored or otherwise processed in electronic
health record systems. Incidents or violations should be
identified promptly and effectively and measures or
solutions should be put
in place to manage such
incidents, including informing and involving the indi­
viduals concerned, the national data protection super­
visory authorities, and other appropriate stakeholders.

15. Member States should furthermore:

(a) stimulate

the

security-enhancing
products, processes and services to prevent and fight
identity theft and other privacy-intrusive attacks;

deployment

of

(b) ensure that data protection safeguards are embedded in
electronic health record systems, including through the
widest possible use of Privacy Enhancing Technologies
(PETs) in their design and implementation.

Monitoring and evaluation

16. In order to ensure monitoring and evaluation of cross-
border interoperability of electronic health record systems,
Member States should:

(a) consider the possibilities for setting up a monitoring
interoperability of electronic health
observatory for
record systems
to monitor,
in the Community
benchmark and assess progress on technical and
semantic interoperability for successful implementation
of electronic health record systems;

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(b) undertake a number of assessment activities. These
could include defining the quantitative and qualitative
criteria for measuring the eventual benefits and risks
(including economic benefits and cost-effectiveness) of
interoperable electronic health record systems and
assessing the benefits and risks achieved by the
systems and services developed by such practical
demonstrators as the Large Scale Pilot projects (Pilot
Actions A) that are incorporated within the Competi­
tiveness and Innovation Programme ICT Policy Support
Programme.

Education and awareness raising

17. In terms of education,

training and awareness raising,

Member States should:

(a)

increase awareness about the benefits of and need for
standards in electronic health record systems and their
interoperability among producers and vendors of infor­
mation and communication technologies, healthcare
and
providers, public health institutions,
other stakeholders;

insurers

information
recording, storing and processing clinical
as well as in gaining informed consent of the patient
and lawfully sharing patient’s personal data;

(d) provide parallel

raising,

for all

individuals,

information and training,

including
awareness
in particular
patients. Such an approach would make for more
effective use of health information as patients move
between a variety of healthcare providers, along the
continuum of care, and receive whenever possible
treatment, care and data in their own homes.

18. Member States are invited to report, on a yearly basis, to
the Commission on the measures they have taken in
relation to the implementation of cross-border interoper­
ability of electronic health record systems. The first report
should be presented by Member States one year following
the day of publication of this Recommendation.

19. The Recommendation is addressed to Member States.

(b) consider requirements for education and training with
regard to health policy-makers and health professionals;

Done at Brussels, 2 July 2008.

(c) pay particular attention to education,

dissemination of

good practices

training and
in electronically

For the Commission

Viviane REDING
Member of the Commission