# C_2009302EN.01001201.xml

| 12.12.2009 | EN | Official Journal of the European Union | C 302/12 |
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Council conclusions of 1 December 2009 on a safe and efficient healthcare through eHealth

2009/C 302/06

THE COUNCIL OF THE EUROPEAN UNION,

| 1. | RECALLS that Article 152 of the Treaty states that a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities, and that the Community shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action. Any action at Community level shall fully respect the Member States’ responsibility to organise and deliver healthcare; |
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| 2. | RECALLS that one of the objectives of the Community health strategy (2008-2013)( 1 ) is to support dynamic health systems and new technologies, recognising that new technologies can improve disease prevention, diagnosis and treatment, facilitate patient safety and improve health systems’ coordination, use of resources and sustainability; |
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| 3. | RECALLS that European Union Member States’ representatives issued a Declaration (20 February 2009) at the Prague 2009 eHealth Ministerial Conference( 2 ), recognising the benefits of eHealth for a safer and more efficient health sector, calling for action on building an eHealth area for European citizens, and initiating a process for coordinated action and governance in the field of eHealth; |
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| 4. | RECALLS European Union initiatives relevant to eHealth, including:
(a)
eHealth — making healthcare better for European citizens: an action plan for a European eHealth Area( 3 ); (b)
Council conclusions on eHealth( 4 ) of 27 May 2004; (c)
Commission communication on a lead market initiative for Europe( 5 ), with special emphasis on the need to remove the barriers of market fragmentation and a lack of interoperability of eHealth systems in order to accelerate the development of the market; (d)
Commission Recommendation on cross-border interoperability of electronic health record systems( 6 ); (e)
Commission communication on telemedicine for the benefit of patients, healthcare systems and the economy( 7 ); | (a) | eHealth — making healthcare better for European citizens: an action plan for a European eHealth Area( 3 ); | (b) | Council conclusions on eHealth( 4 ) of 27 May 2004; | (c) | Commission communication on a lead market initiative for Europe( 5 ), with special emphasis on the need to remove the barriers of market fragmentation and a lack of interoperability of eHealth systems in order to accelerate the development of the market; | (d) | Commission Recommendation on cross-border interoperability of electronic health record systems( 6 ); | (e) | Commission communication on telemedicine for the benefit of patients, healthcare systems and the economy( 7 ); |
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| (a) | eHealth — making healthcare better for European citizens: an action plan for a European eHealth Area( 3 ); | | | | | | | | | | |
| (b) | Council conclusions on eHealth( 4 ) of 27 May 2004; | | | | | | | | | | |
| (c) | Commission communication on a lead market initiative for Europe( 5 ), with special emphasis on the need to remove the barriers of market fragmentation and a lack of interoperability of eHealth systems in order to accelerate the development of the market; | | | | | | | | | | |
| (d) | Commission Recommendation on cross-border interoperability of electronic health record systems( 6 ); | | | | | | | | | | |
| (e) | Commission communication on telemedicine for the benefit of patients, healthcare systems and the economy( 7 ); | | | | | | | | | | |

| 5. | WELCOMES recent collaboration between a number of Member States:
(a)
in the epSOS large scale pilot project( 8 ), which seeks to develop cross-border interoperability of summaries of electronic health records and ePrescriptions, and in the Calliope thematic network( 9 ), which aims at developing a roadmap for eHealth interoperability in Europe and create the necessary consensus for its implementation; (b)
in the ongoing cooperation in the field of eHealth standardisation in response to the European Commission’s Mandate 403 for eHealth( 10 ); | (a) | in the epSOS large scale pilot project( 8 ), which seeks to develop cross-border interoperability of summaries of electronic health records and ePrescriptions, and in the Calliope thematic network( 9 ), which aims at developing a roadmap for eHealth interoperability in Europe and create the necessary consensus for its implementation; | (b) | in the ongoing cooperation in the field of eHealth standardisation in response to the European Commission’s Mandate 403 for eHealth( 10 ); |
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| (a) | in the epSOS large scale pilot project( 8 ), which seeks to develop cross-border interoperability of summaries of electronic health records and ePrescriptions, and in the Calliope thematic network( 9 ), which aims at developing a roadmap for eHealth interoperability in Europe and create the necessary consensus for its implementation; | | | | |
| (b) | in the ongoing cooperation in the field of eHealth standardisation in response to the European Commission’s Mandate 403 for eHealth( 10 ); | | | | |

| 6. | WELCOMES the Swedish Presidency’s Report eHealth for a Healthier Europe( 11 ), presented at the informal meeting of Ministers for Health in Jönköping on 6 and 7 July 2009, which gives an example of how political goals for healthcare can be realised through eHealth investments; |
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| 7. | RECOGNISES the importance of eHealth as a tool to improve quality and patient safety, to modernise national healthcare systems, to increase their effectiveness and make them more accessible to all and better adapted to meet the individual needs of patients, health professionals and the challenges of an ageing society; |
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| 8. | RECOGNISES the need for further political leadership and to integrate eHealth into health policy in order to develop eHealth services on the basis of public health needs; |
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| 9. | CALLS UPON the Member States to conceive and implement initiatives aimed at enabling the deployment and use of eHealth services, in particular to:
1.
commit politically and strategically to eHealth as one of the main instruments to enhance quality, access and safety in healthcare:
(a)
setting eHealth in the context of healthcare reform programmes and consider the creation of specific financial incentive mechanisms for deployment; (b)
addressing, in a coordinated manner, barriers hampering the deployment of eHealth services; 2.
build confidence in and acceptance of eHealth services:
(a)
ensuring the highest standards of patient safety, data protection and privacy; (b)
promoting awareness, confidence and acceptance by health authorities, professionals, patients and their relatives; (c)
ensuring, for both patients and health professionals, adequate needs assessment and training action; 3.
bring legal clarity and ensure protection of health data:
(a)
examining their current provisions for licensing, accreditation and the regulation of eHealth services and advising on any improvements; (b)
examining current practices for identification and authentication of professional health staff accessing and using personal health data; (c)
addressing legal constraints for the safe exchange of medical data across national borders, respecting the need to protect health data and the personal integrity of the patient, and therefore the rights of patients to give a consent to use of their medical data; 4.
solve technical issues and facilitate market development:
(a)
ensuring that the aim of the interoperability of eHealth services across organisational and national boundaries is taken into account in national, regional and local health strategies and investment plans; (b)
ensuring the adoption and implementation of common medical terminologies and technical standards, in particular for medical data that are subject to exchange between Member States; (c)
using public procurement, in full respect of the existing legislation, to support the deployment of interoperable eHealth services; | 1. | commit politically and strategically to eHealth as one of the main instruments to enhance quality, access and safety in healthcare:
(a)
setting eHealth in the context of healthcare reform programmes and consider the creation of specific financial incentive mechanisms for deployment; (b)
addressing, in a coordinated manner, barriers hampering the deployment of eHealth services; | (a) | setting eHealth in the context of healthcare reform programmes and consider the creation of specific financial incentive mechanisms for deployment; | (b) | addressing, in a coordinated manner, barriers hampering the deployment of eHealth services; | 2. | build confidence in and acceptance of eHealth services:
(a)
ensuring the highest standards of patient safety, data protection and privacy; (b)
promoting awareness, confidence and acceptance by health authorities, professionals, patients and their relatives; (c)
ensuring, for both patients and health professionals, adequate needs assessment and training action; | (a) | ensuring the highest standards of patient safety, data protection and privacy; | (b) | promoting awareness, confidence and acceptance by health authorities, professionals, patients and their relatives; | (c) | ensuring, for both patients and health professionals, adequate needs assessment and training action; | 3. | bring legal clarity and ensure protection of health data:
(a)
examining their current provisions for licensing, accreditation and the regulation of eHealth services and advising on any improvements; (b)
examining current practices for identification and authentication of professional health staff accessing and using personal health data; (c)
addressing legal constraints for the safe exchange of medical data across national borders, respecting the need to protect health data and the personal integrity of the patient, and therefore the rights of patients to give a consent to use of their medical data; | (a) | examining their current provisions for licensing, accreditation and the regulation of eHealth services and advising on any improvements; | (b) | examining current practices for identification and authentication of professional health staff accessing and using personal health data; | (c) | addressing legal constraints for the safe exchange of medical data across national borders, respecting the need to protect health data and the personal integrity of the patient, and therefore the rights of patients to give a consent to use of their medical data; | 4. | solve technical issues and facilitate market development:
(a)
ensuring that the aim of the interoperability of eHealth services across organisational and national boundaries is taken into account in national, regional and local health strategies and investment plans; (b)
ensuring the adoption and implementation of common medical terminologies and technical standards, in particular for medical data that are subject to exchange between Member States; (c)
using public procurement, in full respect of the existing legislation, to support the deployment of interoperable eHealth services; | (a) | ensuring that the aim of the interoperability of eHealth services across organisational and national boundaries is taken into account in national, regional and local health strategies and investment plans; | (b) | ensuring the adoption and implementation of common medical terminologies and technical standards, in particular for medical data that are subject to exchange between Member States; | (c) | using public procurement, in full respect of the existing legislation, to support the deployment of interoperable eHealth services; |
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| 1. | commit politically and strategically to eHealth as one of the main instruments to enhance quality, access and safety in healthcare:
(a)
setting eHealth in the context of healthcare reform programmes and consider the creation of specific financial incentive mechanisms for deployment; (b)
addressing, in a coordinated manner, barriers hampering the deployment of eHealth services; | (a) | setting eHealth in the context of healthcare reform programmes and consider the creation of specific financial incentive mechanisms for deployment; | (b) | addressing, in a coordinated manner, barriers hampering the deployment of eHealth services; | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (a) | setting eHealth in the context of healthcare reform programmes and consider the creation of specific financial incentive mechanisms for deployment; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (b) | addressing, in a coordinated manner, barriers hampering the deployment of eHealth services; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2. | build confidence in and acceptance of eHealth services:
(a)
ensuring the highest standards of patient safety, data protection and privacy; (b)
promoting awareness, confidence and acceptance by health authorities, professionals, patients and their relatives; (c)
ensuring, for both patients and health professionals, adequate needs assessment and training action; | (a) | ensuring the highest standards of patient safety, data protection and privacy; | (b) | promoting awareness, confidence and acceptance by health authorities, professionals, patients and their relatives; | (c) | ensuring, for both patients and health professionals, adequate needs assessment and training action; | | | | | | | | | | | | | | | | | | | | | | | | |
| (a) | ensuring the highest standards of patient safety, data protection and privacy; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (b) | promoting awareness, confidence and acceptance by health authorities, professionals, patients and their relatives; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (c) | ensuring, for both patients and health professionals, adequate needs assessment and training action; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3. | bring legal clarity and ensure protection of health data:
(a)
examining their current provisions for licensing, accreditation and the regulation of eHealth services and advising on any improvements; (b)
examining current practices for identification and authentication of professional health staff accessing and using personal health data; (c)
addressing legal constraints for the safe exchange of medical data across national borders, respecting the need to protect health data and the personal integrity of the patient, and therefore the rights of patients to give a consent to use of their medical data; | (a) | examining their current provisions for licensing, accreditation and the regulation of eHealth services and advising on any improvements; | (b) | examining current practices for identification and authentication of professional health staff accessing and using personal health data; | (c) | addressing legal constraints for the safe exchange of medical data across national borders, respecting the need to protect health data and the personal integrity of the patient, and therefore the rights of patients to give a consent to use of their medical data; | | | | | | | | | | | | | | | | | | | | | | | | |
| (a) | examining their current provisions for licensing, accreditation and the regulation of eHealth services and advising on any improvements; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (b) | examining current practices for identification and authentication of professional health staff accessing and using personal health data; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (c) | addressing legal constraints for the safe exchange of medical data across national borders, respecting the need to protect health data and the personal integrity of the patient, and therefore the rights of patients to give a consent to use of their medical data; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 4. | solve technical issues and facilitate market development:
(a)
ensuring that the aim of the interoperability of eHealth services across organisational and national boundaries is taken into account in national, regional and local health strategies and investment plans; (b)
ensuring the adoption and implementation of common medical terminologies and technical standards, in particular for medical data that are subject to exchange between Member States; (c)
using public procurement, in full respect of the existing legislation, to support the deployment of interoperable eHealth services; | (a) | ensuring that the aim of the interoperability of eHealth services across organisational and national boundaries is taken into account in national, regional and local health strategies and investment plans; | (b) | ensuring the adoption and implementation of common medical terminologies and technical standards, in particular for medical data that are subject to exchange between Member States; | (c) | using public procurement, in full respect of the existing legislation, to support the deployment of interoperable eHealth services; | | | | | | | | | | | | | | | | | | | | | | | | |
| (a) | ensuring that the aim of the interoperability of eHealth services across organisational and national boundaries is taken into account in national, regional and local health strategies and investment plans; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (b) | ensuring the adoption and implementation of common medical terminologies and technical standards, in particular for medical data that are subject to exchange between Member States; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| (c) | using public procurement, in full respect of the existing legislation, to support the deployment of interoperable eHealth services; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| 10. | CALLS UPON the Commission to:
1.
update the European Action Plan on eHealth; 2.
produce a report on the development of existing EU policies and actions regarding electronic identification management in related areas in order to benefit from possible synergies; 3.
organise an evaluation, at appropriate intervals, of the health benefits and cost-effectiveness of the use of different eHealth services, building on knowledge accumulated at EU and national levels; | 1. | update the European Action Plan on eHealth; | 2. | produce a report on the development of existing EU policies and actions regarding electronic identification management in related areas in order to benefit from possible synergies; | 3. | organise an evaluation, at appropriate intervals, of the health benefits and cost-effectiveness of the use of different eHealth services, building on knowledge accumulated at EU and national levels; |
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| 1. | update the European Action Plan on eHealth; | | | | | | |
| 2. | produce a report on the development of existing EU policies and actions regarding electronic identification management in related areas in order to benefit from possible synergies; | | | | | | |
| 3. | organise an evaluation, at appropriate intervals, of the health benefits and cost-effectiveness of the use of different eHealth services, building on knowledge accumulated at EU and national levels; | | | | | | |

| 11. | CALLS UPON Member States and the Commission to:
1.
build upon the political momentum created by the existing informal meetings of State Secretaries and their equivalents, in order to develop, via the most efficient and suitable Member State led high-level mechanism, the governance, coordination and consolidation of ongoing activities in the field of eHealth, in liaison with the European Commission, to bring forward eHealth deployment and actual use of interoperable eHealth services within and between national healthcare systems; 2.
ensure that the main aims of this mechanism are to:
(a)
bring together and coordinate groups, projects and institutions at EU level; (b)
promote an alignment of eHealth with health strategies and needs at EU and national levels through the direct involvement of national health authorities; (c)
disseminate scientific evidence of the cost-effectiveness and socio-economic benefits of eHealth services based on research at national and Community levels; (d)
report regularly on its activities to the relevant Council meetings; 3.
apply this mechanism in the following areas in particular:
(a)
working together to address common issues and challenges related to bringing forward eHealth services for achieving health objectives; (b)
supporting Member States by the development of a roadmap including decision support and guidelines for the deployment, acceptance and use of eHealth services; (c)
working together with stakeholders, in particular patients and health professionals, to ensure that eHealth tools and services well reflect clinical needs and overall health system objectives. | 1. | build upon the political momentum created by the existing informal meetings of State Secretaries and their equivalents, in order to develop, via the most efficient and suitable Member State led high-level mechanism, the governance, coordination and consolidation of ongoing activities in the field of eHealth, in liaison with the European Commission, to bring forward eHealth deployment and actual use of interoperable eHealth services within and between national healthcare systems; | 2. | ensure that the main aims of this mechanism are to:
(a)
bring together and coordinate groups, projects and institutions at EU level; (b)
promote an alignment of eHealth with health strategies and needs at EU and national levels through the direct involvement of national health authorities; (c)
disseminate scientific evidence of the cost-effectiveness and socio-economic benefits of eHealth services based on research at national and Community levels; (d)
report regularly on its activities to the relevant Council meetings; | (a) | bring together and coordinate groups, projects and institutions at EU level; | (b) | promote an alignment of eHealth with health strategies and needs at EU and national levels through the direct involvement of national health authorities; | (c) | disseminate scientific evidence of the cost-effectiveness and socio-economic benefits of eHealth services based on research at national and Community levels; | (d) | report regularly on its activities to the relevant Council meetings; | 3. | apply this mechanism in the following areas in particular:
(a)
working together to address common issues and challenges related to bringing forward eHealth services for achieving health objectives; (b)
supporting Member States by the development of a roadmap including decision support and guidelines for the deployment, acceptance and use of eHealth services; (c)
working together with stakeholders, in particular patients and health professionals, to ensure that eHealth tools and services well reflect clinical needs and overall health system objectives. | (a) | working together to address common issues and challenges related to bringing forward eHealth services for achieving health objectives; | (b) | supporting Member States by the development of a roadmap including decision support and guidelines for the deployment, acceptance and use of eHealth services; | (c) | working together with stakeholders, in particular patients and health professionals, to ensure that eHealth tools and services well reflect clinical needs and overall health system objectives. |
| --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --- | --------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | -------------------------------------------------------------------- | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | -------------------------------------------------------------------------------------------------------------------------------------- | --- | -------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 1. | build upon the political momentum created by the existing informal meetings of State Secretaries and their equivalents, in order to develop, via the most efficient and suitable Member State led high-level mechanism, the governance, coordination and consolidation of ongoing activities in the field of eHealth, in liaison with the European Commission, to bring forward eHealth deployment and actual use of interoperable eHealth services within and between national healthcare systems; | | | | | | | | | | | | | | | | | | | | |
| 2. | ensure that the main aims of this mechanism are to:
(a)
bring together and coordinate groups, projects and institutions at EU level; (b)
promote an alignment of eHealth with health strategies and needs at EU and national levels through the direct involvement of national health authorities; (c)
disseminate scientific evidence of the cost-effectiveness and socio-economic benefits of eHealth services based on research at national and Community levels; (d)
report regularly on its activities to the relevant Council meetings; | (a) | bring together and coordinate groups, projects and institutions at EU level; | (b) | promote an alignment of eHealth with health strategies and needs at EU and national levels through the direct involvement of national health authorities; | (c) | disseminate scientific evidence of the cost-effectiveness and socio-economic benefits of eHealth services based on research at national and Community levels; | (d) | report regularly on its activities to the relevant Council meetings; | | | | | | | | | | | | |
| (a) | bring together and coordinate groups, projects and institutions at EU level; | | | | | | | | | | | | | | | | | | | | |
| (b) | promote an alignment of eHealth with health strategies and needs at EU and national levels through the direct involvement of national health authorities; | | | | | | | | | | | | | | | | | | | | |
| (c) | disseminate scientific evidence of the cost-effectiveness and socio-economic benefits of eHealth services based on research at national and Community levels; | | | | | | | | | | | | | | | | | | | | |
| (d) | report regularly on its activities to the relevant Council meetings; | | | | | | | | | | | | | | | | | | | | |
| 3. | apply this mechanism in the following areas in particular:
(a)
working together to address common issues and challenges related to bringing forward eHealth services for achieving health objectives; (b)
supporting Member States by the development of a roadmap including decision support and guidelines for the deployment, acceptance and use of eHealth services; (c)
working together with stakeholders, in particular patients and health professionals, to ensure that eHealth tools and services well reflect clinical needs and overall health system objectives. | (a) | working together to address common issues and challenges related to bringing forward eHealth services for achieving health objectives; | (b) | supporting Member States by the development of a roadmap including decision support and guidelines for the deployment, acceptance and use of eHealth services; | (c) | working together with stakeholders, in particular patients and health professionals, to ensure that eHealth tools and services well reflect clinical needs and overall health system objectives. | | | | | | | | | | | | | | |
| (a) | working together to address common issues and challenges related to bringing forward eHealth services for achieving health objectives; | | | | | | | | | | | | | | | | | | | | |
| (b) | supporting Member States by the development of a roadmap including decision support and guidelines for the deployment, acceptance and use of eHealth services; | | | | | | | | | | | | | | | | | | | | |
| (c) | working together with stakeholders, in particular patients and health professionals, to ensure that eHealth tools and services well reflect clinical needs and overall health system objectives. | | | | | | | | | | | | | | | | | | | | |

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( 1 )  White paper — Together for health: a strategic approach for the EU 2008-2013 (COM(2007) 630).

( 2 )  http://www.ehealth2009.cz/Pages/108-Prague-Declaration.html

( 3 )  COM(2004) 356.

( 4 )  9628/04.

( 5 )  COM(2007) 860.

( 6 )  COM(2008) 3282.

( 7 )  COM(2008) 689.

( 8 )  Smart Open Services for European Patients — co-funded by the EC under the Competitiveness and Innovation Programme (CIP) ICT PSP: http://www.epsos.eu

( 9 )  Call for Interoperability, funded by the EC under the CIP ICT PSP: http://www.calliope-network.eu

( 10 )  eHealth Interoperability Standards Mandate (M/403): http://www.ehealth-interop.nen.nl

( 11 )  eHealth for a Healthier Europe — opportunities for a better use of healthcare resources http://www.se2009.eu

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