23.12.2016   

EN

Official Journal of the European Union

C 482/14

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having regard to the Commission Communication of 6 December 2012 entitled ‘eHealth Action Plan 2012-2020 — Innovative healthcare for the 21st century’ (COM(2012)0736),

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having regard to the Commission Communication of 30 April 2004 entitled ‘e-Health — making healthcare better for European citizens: an action plan for a European e-Health Area’ (COM(2004)0356),

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having regard to the Commission Recommendation of 2 July 2008 on cross-border interoperability of electronic health record systems (2008/594/EC),

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having regard to the Commission Communication of 4 November 2008 entitled ‘Telemedicine for the benefit of patients, healthcare systems and society’ (COM(2008)0689),

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having regard to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the applications of patients’ rights in cross-border healthcare,

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having regard to the Commission’s eHealth Strategies Report of January 2011 entitled ‘European countries on their journey towards national eHealth infrastructures’ (1),

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having regard to Rule 48 of its Rules of Procedure,

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having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on the Internal Market and Consumer Protection, the Committee on Regional Development and the Committee on Women’s Rights and Gender Equality (A7-0443/2013),

A.

whereas equal access to high-quality universal healthcare is internationally recognised — especially within the EU — as a fundamental right;

B.

whereas access to a healthcare system is in many cases restricted as a result of either financial or regional constraints (e.g. in sparsely populated areas), and eHealth systems can play an important role in improving these health inequalities;

C.

whereas the trust of patients in the healthcare services provided to them is crucial in order to guarantee high-quality healthcare;

D.

whereas Article 168 of the Treaty on the Functioning of the European Union stipulates that Union action must complement national policies and be directed towards improving public health, preventing physical and mental illness and diseases and obviating sources of danger to physical and mental health;

E.

whereas, therefore, Union action in the field of eHealth consists of helping all competent authorities at local, regional, national or state level to coordinate their efforts at national and cross-border levels and supporting their actions in fields where EU intervention can provide added value, the aim being to improve the quality of life of citizens;

F.

whereas the economic downturn implies cuts in national healthcare budgets, which implies that solutions must be found to increase the efficiency of healthcare systems and, hence, ensure their sustainability;

G.

whereas eHealth should be a cost-effective and efficient way of providing healthcare to patients while aiming to reducing their medical expenses without placing undue burden on current national healthcare systems;

H.

whereas inequalities resulting from the digital divide will extend to healthcare inequalities if access to high-speed internet connections is not improved as eHealth services are expanded;

I.

whereas the organisational and cultural approaches to the way healthcare is delivered vary from one Member State to another, which is of significant value, in particular for encouraging innovation;

J.

whereas we are facing multiple cross-border health concerns;

K.

whereas there has been an increase in the mobility of the general public within the healthcare systems of their own countries, and whereas it is now more common for some patients to undergo medical treatment outside their country of residence;

L.

whereas article 4(5) of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare stipulates that Union action shall not affect laws and regulations in Member States on the use of languages;

M.

whereas there is little benefit to patients in unnecessarily repeating clinical tests when the results of these already exist in their medical records and can be accessed by healthcare professionals treating them in other places;

N.

whereas information and communication technology (ICT) has developed to such a point that it can be applied in eHealth systems, and whereas this has met with success in various Member States and in countries around the world, entailing numerous benefits at national level, in particular as a means of strengthening patient safety, facilitating a holistic approach to patient care, fostering the development of personalised medicine and increasing the efficiency — and thereby sustainability — of healthcare systems;

O.

whereas, however, further investment in research, development, evaluation and monitoring is required to ensure that eHealth systems (including mobile applications) lead to positive outcomes;

P.

whereas there is a need for ICT specialists, consumers, patients, informal carers, healthcare professionals in general — and doctors in particular — and the public health authorities to work together in this field;

Q.

whereas successful eHealth initiatives and projects like epSOS or the Virtual Physiological Human initiative have demonstrated the great value of eHealth solutions;

R.

whereas importance should be given to databases (such as cloud computing) and to the matter of where and how they are kept, and whereas the security of such databases must be a priority;

S.

whereas priority should be given to legal and data protection considerations relating to eHealth, and, as patients’ health data is of an extremely sensitive nature, there is a need to balance data protection with access to data and to establish clarity regarding liability;

T.

whereas there is a need for regulatory frameworks regarding eHealth in all Member States;

U.

whereas EU guidelines for health professionals on how to use patients’ data correctly are needed;

V.

whereas it is necessary to foster EU-wide use of standards in the design of eHealth systems, and to make the latter interoperable in the various Member States in order to guarantee their effectiveness on a European, cross-border scale, while also ensuring that standardisation actions only seek to ensure interoperability and do not result in a single player having a monopolistic position;

W.

whereas not all citizens and healthcare professionals have the opportunity to use IT tools or the skills needed to take advantage of eHealth services;

X.

whereas, as a consequence, and in order to provide all the actors with the necessary knowledge and skills to engage in eHealth,

Y.

whereas, due to longer life expectancy and the gender sensitivity of certain diseases, women are affected by chronic and disabling diseases to a greater extent than men;

Z.

whereas patients with chronic disease need a multidisciplinary approach;

AA.

whereas eHealth solutions have the potential to increase the well-being of — especially chronic — patients because it is easier to treat them at home;

1.

Welcomes the Commission Communication entitled ‘eHealth Action Plan 2012-2020: Innovative healthcare for the 21st century’, which updates the eHealth Action Plan adopted in 2004 by putting in place further actions, especially as regards improving access to health services, reducing health costs and ensuring greater equality among European citizens; urges the Commission to continue working towards the wholesale adoption of eHealth throughout the EU;

2.

Considers that, for all its shortcomings, eHealth has great potential and could be of benefit to the professionals involved in healthcare, to patients and informal carers and to the competent authorities themselves;

3.

Points to the possibilities of eHealth applications that allow for decentralised healthcare policies at regional or local level and for adapting healthcare policies to local needs and differences;

4.

Considers that providing the tools necessary for harnessing public, real-time data will facilitate a better understanding of benefit-risk, the prediction of adverse events and improvements in the efficiency of health technology assessments;

5.

Emphasises that eHealth applications must be accessible to everyone and that, when developing any product or software application, accessibility should be a mandatory condition, in order to prevent any inequality with regard to access;

6.

Recommends that the necessary steps be taken to close the digital gap between the different regions of the Member States and to ensure that having access to and use of eHealth services does not become a source of social or territorial inequality, in order that they benefit all EU citizens equally, reaching patients who are not familiar with ICT technologies as well as those who otherwise would be excluded or underserviced by national healthcare systems;

7.

Asks the Commission and the Member States to ensure equal access for women to the field of eHealth, not only as patients but also as caregivers (professional or not), ICT specialists and policymakers; highlights the fact that women are involved at all levels of the health sector throughout their lives;

8.

Calls on the Commission to encourage and promote eHealth services designed for (informal) family carers so as to support them in their often heavy caring tasks and to enable them to provide the best care possible;

9.

Points out that adoption of a ‘eHealth culture’ by healthcare professionals is paramount, as is the creation of conditions that lead to patients being empowered by and having trust in eHealth;

10.

Emphasises, in this respect, the importance of strengthening the role of healthcare professionals, and of patients and patient organisations, in the development and implementation of the eHealth Action Plan;

11.

Stresses, in particular, the need to ensure that patients have the possibility of consulting and using information concerning their health, and asks, therefore, the Commission and the Member States to ensure patients’ health literacy in order to enable effective implementation of eHealth tools;

12.

Asks the Commission and the Members States to pay particular attention to digital literacy and to technical training in order to ensure that eHealth tools, especially telemedicine, are genuinely effective and accessible for the whole population;

13.

Considers the proposed cuts to the Connecting Europe facility for broadband and digital services deeply regrettable, especially given the current crisis of competitiveness in the Union; hopes that financing for this area under Horizon 2020 will be maintained; encourages local and regional authorities to make effective use of EU funds to finance eHealth — without thereby reducing funding for traditional health services, such as by closing down community-owned hospitals — and to share health literacy knowledge;

14.

Urges the Commission and the Member States to provide the economic, human and material resources necessary to ensure that access to and use of eHealth services will not add to the territorial inequalities already affecting access to existing ICT services;

15.

Urges in particular the competent authorities within the Member States to make full use of the EU structural funds to improve internet connectivity and reduce the digital divide;

16.

Calls on the Commission to support these efforts through the Digital Agenda for Europe, to facilitate the use of these funds for this purpose, while providing clear guidelines regarding funding in order to directly support the ICT and health sectors, and to engage further with telecom operators to encourage broadband mapping.

17.

Calls on the Commission and the Member States to develop new eHealth tools that are accessible to and user-friendly for the elderly and for persons with disabilities;

18.

Calls on the Commission to encourage eHealth solutions for isolated women, not only those living in remote areas but also home-bound women lacking the mobility and/or (social) support network they need in order to maintain their health and well-being;

19.

Calls on the Commission and the Member States to play a major part in bringing different stakeholders together to share experience and best practices;

20.

Calls, in the light of these considerations, for the establishment of a platform for collaboration in research between patients, academia, industry and professionals in order to ensure the delivery of an effective and all-inclusive eHealth policy.

21.

Points out that the development of eHealth applications, including the use and re-use of health data, requires measures concerning confidentiality, data protection, liability and reimbursement in order to ensure that sensitive data are protected from hacking, illegal data selling or other forms of abuse; welcomes, in this respect, the Commission’s intention to launch a study regarding the legal aspects of eHealth services;

22.

Calls on the Commission and the Member States to bring forward guidelines and legislative proposals to fill the legal gaps that currently exist, in particular in the field of responsibilities and liability, and to ensure effective implementation of the eHealth system across the EU;

23.

Urges in particular the Commission and the Member States to proceed with guidelines and legislation on the legal and data protection considerations relating to eHealth, in particular legislation enabling secure sharing, processing and analysis of data, in order to balance data protection with data access.

24.

Calls on the Commission and the Member States to ensure good governance of operations related to health information on the internet;

25.

Stresses the need for doctors, other professionals involved in healthcare, patients and informal carers to be provided with continuous and specialised assistance and training in eHealth so as to help them develop their digital literacy and, hence, make the most of eHealth services without exacerbating social or territorial inequalities;

26.

Believes that assistance and training should prioritise

27.

Recommends that the opinions of doctors and other professionals involved in healthcare, along with those of patients associations, be taken into account, not only in the development of eHealth applications but also in their evaluation and monitoring;

28.

Points to the importance of preserving a human dimension in healthcare, especially in view of the fact that the population is ageing and that it is therefore increasingly difficult to distinguish between medical and social aspects; calls, therefore, on the Commission to make sure that eHealth technologies will not become a substitute for the trusting relationship between patients and their (health)care professionals;

29.

Calls on the Member States and the Commission to run eHealth awareness and IT literacy training campaigns (taking into account social and territorial inequalities) aimed at overcoming the lack of knowledge and trust among patients, the general public and healthcare professionals; believes that these campaigns should be tailored to suit each of the social groups targeted, since public information and active public participation are key to the effective development of new healthcare delivery models;

30.

Urges the Member States to step up cooperation on eHealth at national and regional level, but also at cross-border level so that countries further advanced in this field can communicate what they have learned to those with less experience;

31.

Calls on the Member States to share their experiences, knowledge and good practices, and to work among themselves, with the Commission and with stakeholders, to increase the effectiveness of patient-centred eHealth systems;

32.

Stresses that, to this end, the Member States should continue to collaborate by means of electronic platforms that allow them to share good practices regarding eHealth systems and solutions, and that and both the Commission and the Member States should support the connection between the different eHealth projects in the EU;

33.

Underlines the potential of apps for mobile devices for patients, especially for those with chronic diseases, and encourages the development of helpful, specifically health-oriented apps with medically verified content;

34.

Urges the Commission to come forward with an ‘mHealth action plan’ for mobile devices, which should include guidelines on market surveillance of mHealth apps in order to ensure data protection and the reliability of the provided health information, as well as to guarantee that these apps are developed under appropriate medical scrutiny;

35.

Urges the Commission and the Member States to adopt standards for health-related mobile apps so as to ensure that the information transmitted is accurate, and to remedy the lack of legal clarity and transparency regarding the use of the data collected by such apps;

36.

Urges the Commission and the Member States to continue working through pilot projects, such as epSOS and ‘Renewing health’, and/or the Virtual Physiological Human initiative in order to develop pan-European interoperability, and to continue to support innovative solutions for person-centred care, including advanced modelling and simulations, needed to achieve the aims of predictive and personalised medicine;

37.

Stresses that the organisation of healthcare systems falls under the competence of authorities in the Member States; urges, nevertheless, the Commission to continue to work with healthcare professionals, patients’ associations, other key stakeholders and the competent authorities when framing its policies and addressing the conflicting priorities in eHealth, keeping in mind that the main priority is the access of patients to an effective and affordable healthcare system;

38.

Stresses that eHealth creates new jobs in medicine, research and health-related services, and, in this regard, calls on the Commission to encourage national authorities to make use of EU funds to finance programmes for eHealth and cross-border health threats;

39.

Calls on the Member States — given that the eHealth Action Plan is aimed at creating new job opportunities in the research, health, medicine and ICT sectors — to pay particular attention to the gender balance in education, training and recruitment in all these sectors;

40.

Urges the Commission and the Member States to work together to develop sustainable funding models for eHealth services within national health budgets, and to consult other stakeholders, such as health insurance funds, national health institutions, healthcare professionals and patients organisations, when doing so;

41.

Underlines the fact that innovations in the field of eHealth create business opportunities and contribute to future growth;

42.

Stresses the need to step up research into eHealth systems, but to do so in a way that research expenditure does not impact directly on the cost of the service provided;

43.

Urges the Commission to dedicate resources within future research and development framework programmes to eHealth;

44.

Emphasises the need to guarantee that appropriate support is given to SMEs, in order to ensure a level playing field in the eHealth sector, boost SMEs’ market access in this domain and ensure that they contribute to social and territorial cohesion;

45.

Calls, therefore, on the Commission to support and facilitate SME eHealth projects by setting guidelines on the eHealth market and improving cooperation between SMEs, on the one hand, and stakeholders, research bodies and health insurance schemes, on the other, to create innovation for healthcare providers.

46.

Stresses that, when it comes to SMEs developing ICT tools, there is a need for transparency and competition in order to ensure affordable prices for eHealth tools.

47.

Calls on the Commission and the Member States to develop data standards for collecting, sharing and reporting on cross-border, health-related issues;

48.

Urges the Commission and the Member States to work together with patients, and with other relevant stakeholders, to pinpoint eHealth tools and models to support the implementation and development of Article 12 of Directive 2011/24/EU, which deals with the development of European reference networks between healthcare providers and centres of expertise;

49.

Urges the Commission and the Member States to continue their efforts to implement Article 14 of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare, which is aimed at establishing an eHealth network;

50.

Calls on the Commission to allow membership of all regional authorities that are competent for eHealth applications in the eHealth Network set up through Directive 2011/24/EU;

51.

Stresses the need of an ethical code of practice for cross-border activities that is without prejudice to the principle of subsidiarity;

52.

Underlines that it is essential for patients to be able to access their own personal health data; stresses that patients, having given prior consent to the use of this data, should always be informed, in a clear and transparent manner, of how it is being processed;

53.

Urges the Commission and the Member States to apply the processing standards for health-related personal data laid down in the proposal for a regulation on the protection of individuals with regard to the processing of personal data and on the free movement of such data, once that regulation has entered into force;

54.

Points to the need to use international standards both in the modelling of information and in its exchange in all Member States, to develop international codes for eHealth professions and to harmonise the relevant definitions;

55.

Welcomes, in this respect, the ongoing international collaboration with the WHO and the OECD;

56.

Welcomes the EU-US cooperation on eHealth, characterised by on-going collaboration such as that developed in the context of the Memorandum of Understanding on cooperation surrounding health information and communication technologies, and including, notably, the jointly developed EC-HHS roadmap for the development of internationally recognised interoperability standards and interoperability implementation specifications for electronic health information systems;

57.

Emphasises the need to ensure the technical standardisation and interoperability of ICT-enabled solutions and of data exchange at all levels of European healthcare systems, while developing guidelines for the EU-wide interoperability of these systems;

58.

Stresses the importance of assuring interoperability between software applications used by patients and doctors, respectively, in order to attain better results and improve communication;

59.

Welcomes the Commission’s intention to propose an eHealth Interoperability Framework by 2015, and sees this as a very important step towards patient empowerment in eHealth; regards it important that this Framework includes the creation of standardised reporting in medical records as well as support for the development of medical devices, including a feature for the automatic electronic storage of medical records;

60.

Emphasises the need to ensure that the cultural and linguistic diversity of the European Union is fully respected with regard to the technical standardisation and interoperability of European healthcare systems;

61.

Calls for eHealth tools to be developed not only on the basis of technological and financial considerations, but also on their effectiveness and their worth in terms of improving health outcomes and quality of life, stressing that the overriding aim of the development of such tools should be the best interests of the patients, including the elderly and patients with disabilities;

62.

Calls on the Member States, when promoting the plan, to stress the importance of the gender balance;

63.

Urges the Commission and the Member States to promote a gender-balanced approach to healthcare and medicine and, when implementing the eHealth Action Plan, to take into consideration the specific needs of women and girls as healthcare beneficiaries;

64.

Stresses the importance of global surveys in eHealth evidence-building;

65.

Recommends that the Member States and the Commission, with the help of the European Institute for Gender Equality (EIGE), collect gender-disaggregated data on initial findings as regards the accessibility and impact of eHealth systems and tools, and calls for steps to be taken to share best practices in eHealth implementation;

66.

Recalls the need for the future eHealth Action Plan to guarantee the following key principles:

67.

Calls on the Commission to publish every other year a progress review as regards the implementation of the eHealth Action Plan in the individual Member States, showing how this tool has been modified in innovative ways to provide citizens with high-quality and efficient healthcare systems, and, in the light of this, to set effective indicators at national and Union levels to measure the progress and impact of the actions planned, paying particular attention to potential discrimination or to access inequalities that could affect consumers and patients.

68.

Instructs its President to forward this resolution to the Council and the Commission, to the Committee of the Regions and to the Member States.