# C_2016013EN.01001401.xml

| 15.1.2016 | EN | Official Journal of the European Union | C 13/14 |
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15.1.2016

EN

Official Journal of the European Union

C 13/14

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Opinion of the European Economic and Social Committee on ‘Towards digital health — electronic information for safe use of medicinal products’

(own-initiative opinion)

(2016/C 013/04)

| Rapporteur: | Renate HEINISCH |
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Rapporteur:

Rapporteur:

Renate HEINISCH

Renate HEINISCH

On 22 January 2015, the European Economic and Social Committee, acting under Rule 29(2) of its Rules of Procedure, decided to draw up an own-initiative opinion on:

Towards digital health — electronic information for safe use of medicinal products

Towards digital health — electronic information for safe use of medicinal products

(own-initiative opinion).

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee’s work on the subject, adopted its opinion on 14 July 2015.

At its 510th plenary session, held on 16 and 17 September (meeting of 16 September), the European Economic and Social Committee adopted the following opinion by 212 votes with 6 abstentions:

1.   Conclusions and recommendations

Conclusions and recommendations

| 1.1. | The European Economic and Social Committee (EESC) endorses the European Commission’s efforts to make eHealth a high priority within the Digital Agenda. |
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1.1.

The European Economic and Social Committee (EESC) endorses the European Commission’s efforts to make eHealth a high priority within the Digital Agenda.

| 1.2. | The Committee notes that people seeking information, patients and healthcare professionals have repeatedly stressed the need for full, accurate and up-to-date information on medicinal products and for a single digital market. |
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1.2.

The Committee notes that people seeking information, patients and healthcare professionals have repeatedly stressed the need for full, accurate and up-to-date information on medicinal products and for a single digital market.

people seeking information

| 1.3. | This officially approved information must, in the EESC’s view, be available without discrimination or obstacle so as to afford access for the deaf and the visually or otherwise physically impaired. It must be capable of being tailored to the needs of individual citizens, patients and healthcare professionals so that it is pitched at the right level for the safest and most effective use of medicinal products. |
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1.3.

This officially approved information must, in the EESC’s view, be available without discrimination or obstacle so as to afford access for the deaf and the visually or otherwise physically impaired. It must be capable of being tailored to the needs of individual citizens, patients and healthcare professionals so that it is pitched at the right level for the safest and most effective use of medicinal products.

| 1.4. | The EESC believes electronic distribution of product information approved by drug licensing authorities will further improve access. An electronic database of patient information leaflets (PILs) and technical information approved by health authorities (Summary of Product Characteristics — SPCs) can ensure the availability of up-to-date and targeted information on medicinal products. |
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1.4.

The EESC believes electronic distribution of product information approved by drug licensing authorities will further improve access. An electronic database of patient information leaflets (PILs) and technical information approved by health authorities (Summary of Product Characteristics — SPCs) can ensure the availability of up-to-date and targeted information on medicinal products.

Summary of Product Characteristics — SPCs

| 1.5. | The EESC proposes that information for the visually impaired be made available in the way most appropriate, for example in larger print or as audio data. Videos, possibly with sign language, could be produced to demonstrate the proper use of medical appliances (such as asthma sprays) to the deaf. ‘Simplified language’ versions offer further possibilities to reduce barriers to communication. These allow people with learning disabilities to access information targeting them and compensate for educational shortcomings. |
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1.5.

The EESC proposes that information for the visually impaired be made available in the way most appropriate, for example in larger print or as audio data. Videos, possibly with sign language, could be produced to demonstrate the proper use of medical appliances (such as asthma sprays) to the deaf. ‘Simplified language’ versions offer further possibilities to reduce barriers to communication. These allow people with learning disabilities to access information targeting them and compensate for educational shortcomings.

| 1.6. | The EESC also points out that having all this on a single portal means there is a trustworthy and in many ways easily accessible source of officially authorised information that meets disability-access criteria. This means that patients and healthcare professionals can compare any information available elsewhere with the basic authorised information. |
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1.6.

The EESC also points out that having all this on a single portal means there is a trustworthy and in many ways easily accessible source of officially authorised information that meets disability-access criteria. This means that patients and healthcare professionals can compare any information available elsewhere with the basic authorised information.

| 1.7. | To ensure overall suitability for use, development should be supported by both users and web-designers with expertise in accessibility for the disabled. Open format solutions should be created so that users can access the information with any device (PC, tablet, smartphone, etc.) they want or have available to them. |
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1.7.

To ensure overall suitability for use, development should be supported by both users and web-designers with expertise in accessibility for the disabled. Open format solutions should be created so that users can access the information with any device (PC, tablet, smartphone, etc.) they want or have available to them.

| 1.8. | The EESC thinks that the website/portal for officially approved information should be developed in close collaboration with all major stakeholders — the pharmaceutical industry, which should operate and finance it, as well as patient associations, organisations representing people with disabilities and healthcare professionals — in order to best meet requirements. |
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1.8.

The EESC thinks that the website/portal for officially approved information should be developed in close collaboration with all major stakeholders — the pharmaceutical industry, which should operate and finance it, as well as patient associations, organisations representing people with disabilities and healthcare professionals — in order to best meet requirements.

| 1.9. | The EESC thinks it important to find user-centred solutions to make sure people with lower levels of education and infrequent internet users can also have access to information. |
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1.9.

The EESC thinks it important to find user-centred solutions to make sure people with lower levels of education and infrequent internet users can also have access to information.

| 1.10. | Even though electronic access to information is considered to be important, it should be stressed that doctors (particularly GPs) and other healthcare professionals, such as pharmacists and nurses, are the first point of contact for patients, providing them with recommendations regarding their ailments and treatment options. |
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1.10.

Even though electronic access to information is considered to be important, it should be stressed that doctors (particularly GPs) and other healthcare professionals, such as pharmacists and nurses, are the first point of contact for patients, providing them with recommendations regarding their ailments and treatment options.

| 1.11. | The EESC asks the European Commission to support the proposal for the IMI2 project on electronic product information. Member States are invited to join the effort to coordinate existing databases. |
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1.11.

The EESC asks the European Commission to support the proposal for the IMI2 project on electronic product information. Member States are invited to join the effort to coordinate existing databases.

2.   Introduction

Introduction

| 2.1. | In 2012, the European Commission published an action plan that set out the obstacles to the full use of digital solutions in Europe’s healthcare systems. This plan is now being implemented under the title ‘eHealth Action Plan 2012-2020 — Innovative healthcare for the 21st century’ (1). |
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2.1.

In 2012, the European Commission published an action plan that set out the obstacles to the full use of digital solutions in Europe’s healthcare systems. This plan is now being implemented under the title ‘eHealth Action Plan 2012-2020 — Innovative healthcare for the 21st century’ (1).

eHealth

1

| 2.2. | The aim, the Commission states, is to improve health care for the benefit of patients, to give them more control over their treatment and to cut costs. While patients, the public and healthcare professionals are using telemedicine applications with great enthusiasm and millions of Europeans have downloaded smartphone apps to monitor their health and wellbeing, eHealth has yet to fulfil its great potential to improve healthcare systems and make savings through efficiency. In this connection, the EESC would point out the need to take account of data protection issues. |
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2.2.

The aim, the Commission states, is to improve health care for the benefit of patients, to give them more control over their treatment and to cut costs. While patients, the public and healthcare professionals are using telemedicine applications with great enthusiasm and millions of Europeans have downloaded smartphone apps to monitor their health and wellbeing, eHealth has yet to fulfil its great potential to improve healthcare systems and make savings through efficiency. In this connection, the EESC would point out the need to take account of data protection issues.

| 2.3. | eHealth, which includes telemedicine and mHealth, is defined as follows by the WHO: eHealth is the transfer of health resources and health care by electronic means. It encompasses three main areas:






  — | The delivery of health information, for health professionals and health consumers, through the internet and telecommunications. |
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2.3.

eHealth, which includes telemedicine and mHealth, is defined as follows by the WHO: eHealth is the transfer of health resources and health care by electronic means. It encompasses three main areas:

eHealth

mHealth

eHealth

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The delivery of health information, for health professionals and health consumers, through the internet and telecommunications.

| — | Using the power of IT and ecommerce to improve public health services, e.g. through the education and training of health workers. |
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Using the power of IT and ecommerce to improve public health services, e.g. through the education and training of health workers.

ecommerce

| — | The use of ecommerce and ebusiness practices in health systems management. |
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The use of ecommerce and ebusiness practices in health systems management.

ecommerce

ebusiness

| 2.4. | The European Commission has produced a Green Paper on mobile Health (‘mHealth’) (2)
  . mHealth is a sub-segment of eHealth and covers medical and public health practice supported by mobile devices. In particular, it includes the use of mobile communication devices for health and well-being services and information purposes, as well as mobile health applications. |
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2.4.

The European Commission has produced a Green Paper on mobile Health (‘mHealth’) (2)
  . mHealth is a sub-segment of eHealth and covers medical and public health practice supported by mobile devices. In particular, it includes the use of mobile communication devices for health and well-being services and information purposes, as well as mobile health applications.

mHealth’

2

. mHealth

eHealth

| 2.5. | An increasing number of people of all ages use the steadily growing amount of electronic health information and applications. |
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2.5.

An increasing number of people of all ages use the steadily growing amount of electronic health information and applications.

| 2.6. | However, the quality of these sources of information varies greatly and search engines usually do not distinguish between reliable, officially approved sources and less reliable ones. |
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2.6.

However, the quality of these sources of information varies greatly and search engines usually do not distinguish between reliable, officially approved sources and less reliable ones.

| 2.7. | There is a range of certified information systems for healthcare professionals. These professionals, particularly GPs and pharmacists, play a key role in healthcare systems and high-quality information is essential if we want to have well-informed medical professionals who can meet the healthcare needs of the EU population. |
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2.7.

There is a range of certified information systems for healthcare professionals. These professionals, particularly GPs and pharmacists, play a key role in healthcare systems and high-quality information is essential if we want to have well-informed medical professionals who can meet the healthcare needs of the EU population.

| 2.8. | The EESC believes that all patients need equally easy access to reliable information so they can better manage and participate in their own health care — something that is also mirrored in greater patient adherence. The details on training needs and inclusion of all groups (including the elderly and people with disabilities) have been set out in previous opinions (3). |
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2.8.

The EESC believes that all patients need equally easy access to reliable information so they can better manage and participate in their own health care — something that is also mirrored in greater patient adherence. The details on training needs and inclusion of all groups (including the elderly and people with disabilities) have been set out in previous opinions (3).

3

| 2.9. | The increased workload of healthcare personnel and the various opportunities for people to get involved as patients or members of the public in healthcare organisations — such as national licensing authorities and committees of the European Medicines Agency (EMA) — and ethics committees requires knowledge to be widely shared. |
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2.9.

The increased workload of healthcare personnel and the various opportunities for people to get involved as patients or members of the public in healthcare organisations — such as national licensing authorities and committees of the European Medicines Agency (EMA) — and ethics committees requires knowledge to be widely shared.

| 2.10. | The European Patients’ Academy on Therapeutic Innovation (EUPATI) offers patients the opportunity to educate themselves on health issues. This consortium is financed by the Innovative Medicines Initiative, a public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). |
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2.10.

The European Patients’ Academy on Therapeutic Innovation (EUPATI) offers patients the opportunity to educate themselves on health issues. This consortium is financed by the Innovative Medicines Initiative, a public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

| 2.11. | EUPATI is a consortium of 29 organisations led by the European Patients’ Forum (EPF). It is a unique amalgam of pan-European patient associations and academic and voluntary organisations that lead the field as experts in patient-focused and social engagement, and EFPIA member companies. EUPATI informs patients, as laypeople in the healthcare system, and difficult-to-reach patient groups by fostering public awareness of the development of new therapies. With the help of EUPATI, training courses — or corresponding educational programmes — can also be organised for better understanding of information on medicinal products. |
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2.11.

EUPATI is a consortium of 29 organisations led by the European Patients’ Forum (EPF). It is a unique amalgam of pan-European patient associations and academic and voluntary organisations that lead the field as experts in patient-focused and social engagement, and EFPIA member companies. EUPATI informs patients, as laypeople in the healthcare system, and difficult-to-reach patient groups by fostering public awareness of the development of new therapies. With the help of EUPATI, training courses — or corresponding educational programmes — can also be organised for better understanding of information on medicinal products.

| 2.12. | Some EU Member States already have information on medicinal products available electronically. The most highly developed database, FASS (4), is run by the Swedish Pharma Association LIF, but there are others in, for example, Germany, the UK, Finland and Denmark. These databases are either not normally accessible to the visually impaired or do not contain the full range of medicines. |
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2.12.

Some EU Member States already have information on medicinal products available electronically. The most highly developed database, FASS (4), is run by the Swedish Pharma Association LIF, but there are others in, for example, Germany, the UK, Finland and Denmark. These databases are either not normally accessible to the visually impaired or do not contain the full range of medicines.

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| 2.13. | Some, moreover, are not regularly updated. |
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2.13.

Some, moreover, are not regularly updated.

| 2.14. | In addition, drug licensing authorities have allowed the inclusion in package leaflets of codes (QR codes) that link to package leaflets on the company website. Here, again, there is often no access for the disabled. |
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2.14.

In addition, drug licensing authorities have allowed the inclusion in package leaflets of codes (QR codes) that link to package leaflets on the company website. Here, again, there is often no access for the disabled.

| 2.15. | These initiatives show that a harmonised approach is still needed to provide access for all social groups to information through these new technologies. |
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2.15.

These initiatives show that a harmonised approach is still needed to provide access for all social groups to information through these new technologies.

3.   General comments

General comments

3.1.   
  Infrastructure

Infrastructure

| 3.1.1. | The EESC holds the pharmaceutical industry responsible for accurate and up-to-date information on its products. Any technological solution should come about in close collaboration with the industry in order to make use of existing technical solutions and ensure supervision by drug licensing authorities. |
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3.1.1.

The EESC holds the pharmaceutical industry responsible for accurate and up-to-date information on its products. Any technological solution should come about in close collaboration with the industry in order to make use of existing technical solutions and ensure supervision by drug licensing authorities.

| 3.1.2. | The EESC stresses that how officially approved information is presented and can be accessed must be agreed with the relevant stakeholders (licensing authorities, patient associations, health professionals). |
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3.1.2.

The EESC stresses that how officially approved information is presented and can be accessed must be agreed with the relevant stakeholders (licensing authorities, patient associations, health professionals).

| 3.1.3. | A consortium responsible for coordinating development of the database/portal could be established and financed under the IMI initiative. |
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3.1.3.

A consortium responsible for coordinating development of the database/portal could be established and financed under the IMI initiative.

| 3.1.4. | The creation of the proposed portal will take account of existing databases (such as the EMA). |
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3.1.4.

The creation of the proposed portal will take account of existing databases (such as the EMA).

3.2.   
  Need for further research

Need for further research

3.2.1.   Technical research and technical development

Technical research and technical development

| — | The designs of national databases are available. An additional prototype has also been developed to demonstrate a user-friendly and widely accessible database that also includes options for audio and video data. A technical solution that is freely available should be developed that makes the most effective use of existing sources. |
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The designs of national databases are available. An additional prototype has also been developed to demonstrate a user-friendly and widely accessible database that also includes options for audio and video data. A technical solution that is freely available should be developed that makes the most effective use of existing sources.

| — | This solution should also take into account the fact that citizens/patients do not want to use too many scanning applications on their smartphones. The database/portal should therefore be accessible using conventional scanner technologies, for example. |
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This solution should also take into account the fact that citizens/patients do not want to use too many scanning applications on their smartphones. The database/portal should therefore be accessible using conventional scanner technologies, for example.

| — | Open format solutions should be sought to increase take-up. It must be possible to request and view information using any kind of device (PC, tablet, smartphone, etc.). |
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Open format solutions should be sought to increase take-up. It must be possible to request and view information using any kind of device (PC, tablet, smartphone, etc.).

| — | Comparisons of technical solutions should be made and include matters related to parts of the healthcare system (such as Member State initiatives to reach people via television connections or ATMs and initiatives proposed by the European Commission (5)). |
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Comparisons of technical solutions should be made and include matters related to parts of the healthcare system (such as Member State initiatives to reach people via television connections or ATMs and initiatives proposed by the European Commission (5)).

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| — | In Italy, pharmacies are required by law to print out updated package leaflets that the pharmaceutical industry has put on a database. Such printing — either by the pharmacist or by patients (using ATM-like terminals) — is a further complementary option and could cater for those who do not use the internet. |
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In Italy, pharmacies are required by law to print out updated package leaflets that the pharmaceutical industry has put on a database. Such printing — either by the pharmacist or by patients (using ATM-like terminals) — is a further complementary option and could cater for those who do not use the internet.

3.2.2.   Testing and presentation of content

Testing and presentation of content

Public receptiveness to the various options must be analysed and technical solutions tested by users to check that they work.

| — | Research must include structural questions about the testing of technical solutions in order to increase acceptance. |
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Research must include structural questions about the testing of technical solutions in order to increase acceptance.

| — | How do licensing authorities check content? |
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How do licensing authorities check content?

| — | Content must be presented in a way that enables adaptation to the individual needs of patients/citizens and must comprise all the information required by the relevant licensing documents or by law. |
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Content must be presented in a way that enables adaptation to the individual needs of patients/citizens and must comprise all the information required by the relevant licensing documents or by law.

| — | To enable rapid feedback for all those involved, a possibility for users to evaluate the information (above all in terms of understandabiity) could be incorporated. Social media elements for presentation, dissemination and exchange could be used for this. |
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To enable rapid feedback for all those involved, a possibility for users to evaluate the information (above all in terms of understandabiity) could be incorporated. Social media elements for presentation, dissemination and exchange could be used for this.

Social media

3.2.3.   Education and training

Education and training

Internet usage varies greatly between different social groups. Many use social networks but do not make use of the information available. A small group (an estimated 10 % according to Germany’s Federal Statistical Office) never use the internet at all. Research should be launched to answer the following questions:

| — | How can active learning be encouraged so that existing sources of information can be used to disseminate information (including that in digital form) on health? |
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How can active learning be encouraged so that existing sources of information can be used to disseminate information (including that in digital form) on health?

| — | Learning to learn (life-long learning) is one of the eight key competences listed in the Recommendation of the European Parliament and of the Council of 18 December 2006 (6), which calls on the Member States to implement national measures. The ‘European agenda for adult learning’ proposes measures Member States can take to encourage active adult learning. ‘Digital health literacy’ could become a criterion to assess adult learning under the PIAAC. |
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Learning to learn (life-long learning) is one of the eight key competences listed in the Recommendation of the European Parliament and of the Council of 18 December 2006 (6), which calls on the Member States to implement national measures. The ‘European agenda for adult learning’ proposes measures Member States can take to encourage active adult learning. ‘Digital health literacy’ could become a criterion to assess adult learning under the PIAAC.

6

| — | What role can the various educational institutions (universities, adult education centres, etc.) and health care facilities play in strengthening the many skills involved — e.g., working with new technologies, getting involved and managing one’s health in a socially beneficial way, and imparting social and technical expertise? |
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What role can the various educational institutions (universities, adult education centres, etc.) and health care facilities play in strengthening the many skills involved — e.g., working with new technologies, getting involved and managing one’s health in a socially beneficial way, and imparting social and technical expertise?

| — | Health professionals should receive the relevant training as part of their academic studies. Adult education centres could offer attractive courses tailored to the users of the system. In order to reach the target group, adult education centres could cooperate with professionals (especially doctors), local pharmacies and local health and social welfare facilities. This is especially important in rural areas, where people are more isolated. Inter-generational learning, in particular, could help to share knowledge on content and technical skills. |
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Health professionals should receive the relevant training as part of their academic studies. Adult education centres could offer attractive courses tailored to the users of the system. In order to reach the target group, adult education centres could cooperate with professionals (especially doctors), local pharmacies and local health and social welfare facilities. This is especially important in rural areas, where people are more isolated. Inter-generational learning, in particular, could help to share knowledge on content and technical skills.

Brussels, 16 September 2015.

The President of the European Economic and Social Committee

Henri MALOSSE

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(1)  COM(2012) 736 final.

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(2)  COM(2014) 219 final, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014DC0219&from=EN

2

(3)  EESC Opinion on ‘The digital society: access, education, training, employment, tools for equality’ (OJ C 451, 16.12.2014, p. 25).

3

(4)  http://www.fass.se/LIF/startpage?userType=2

4

(5)  http://www.mobilehealthglobal.com/in-the-news/interviews/46/interview-with-peteris-zilgalvis

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(6)  OJ L 394, 30.12.2006, p. 10.

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