BETA


2019/2804(RSP) Resolution on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI ARŁUKOWICZ Bartosz (icon: EPP EPP), CERDAS Sara (icon: S&D S&D), RIES Frédérique (icon: Renew Renew), AUKEN Margrete (icon: Verts/ALE Verts/ALE), REGIMENTI Luisa (icon: ID ID), KOPCIŃSKA Joanna (icon: ECR ECR), KONEČNÁ Kateřina (icon: GUE/NGL GUE/NGL)
Lead committee dossier:
Legal Basis:
RoP 136-p5

Events

2020/04/29
   EC - Commission response to text adopted in plenary
Documents
2019/12/18
   EP - Results of vote in Parliament
2019/12/18
   EP - Decision by Parliament
Details

The European Parliament adopted a resolution tabled by the Committee on Environment, Public Health and Food Safety on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society.

Europe’s health and care systems face serious challenges in the context of an ageing society. The emergence of new technologies creates both opportunities and challenges for the development of better healthcare.

Spending on healthcare is growing fast and accounts for 9.6 % of GDP in the EU as a whole. Innovative digital solutions for health and care can boost the prevention of diseases and improve citizens’ quality of life. Healthcare digitalisation will not be limited to greater use of mobile health apps, but will also include data mining, i.e. the analysis of large data sets that serve as a foundation for artificial intelligence (AI) and machine learning.

The progressive digitalisation of society will increasingly lead patients, caregivers, healthcare professionals and potentially all the actors in the healthcare chain to face the challenges of using information technology and the digital infrastructure of patient records, raising questions of personal data security and privacy.

Members welcomed the Commission communication on enabling the digital transformation of health and care in the Digital Single Market, which aims at the promotion of health and the prevention and control of disease, and at helping address citizens’ unmet needs, as well as representing an opportunity to improve the sustainability of health systems and make it easier for citizens to enjoy equal and affordable access to high quality care through the meaningful use of digital innovations. Compliance with EU legislation on data protection should be a precondition of the digital transformation of health and care in the Digital Single Market.

Access and sharing personal health data

The resolution stressed that citizens have the right to access and share their personal health data in accordance with the General Data Protection Regulation in order to obtain better healthcare, and should be able to expect that this data be available in a timely manner and in a format that is layperson-friendly. Citizens should have secure access to a comprehensive electronic record of their health data, and should remain in control of and be able to share their personal health data securely with authorised parties, while unauthorised access should be prohibited in accordance with the data protection legislation.

The Commission is called on to:

continue improving cybersecurity and thus reducing the risk of privacy breaches and the unauthorised use of health data across the Union; continue promoting cooperation between Member States’ health authorities in order to connect to a public eHealth digital infrastructure; develop guidance to promote the secondary use of data for research and to ensure fair, transparent and non-discriminatory access to data throughout Europe; launch a broad European reflection on the ethical aspects of the digital transformation of health and care; launch an EU-wide educational campaign on the benefits of and mechanisms for health data sharing in order to break down misconceptions and support the actions put forward in its communication on enabling the digital transformation of health and care in the Digital Single Market.

Improved health data

Parliament called on the Commission to:

set up a platform for competent authorities, notified bodies and the pharmaceutical and medical technology industries on the application of the Medical Devices Regulation to digital therapeutics and combination products, with specific attention to the needs of start-ups and SMEs; step up European coordinated action to support the secure exchange and linkage in practice of genomic and other health data in order to advance the progress of researchers and personalised medicine, and thereby identify the best treatments; proceed with the testing of specific applications for high-security cross-border health data exchange for research and health policy, in order to improve the prevention, diagnosis and treatment of diseases so as to help health systems to meet current and future challenges.

Better digital tools

Members considered that digital healthcare tools, such as portable patient information cards, could address the challenges of accessibility regarding health information and health literacy, both of which are essential for health promotion, better disease prevention and more effective disease management. Patients should benefit from the most up-to-date information about their medicines. Therefore the Commission is urged to develop further electronic product information, including use of e-leaflets, in order to improve regulatory efficiency and empower patients with up-to-date information on medicines.

The Commission is called on to examine the possibility of setting up a European smart health innovation hub to assess and promote smart health initiatives and provide a platform for all actors in the health chain to establish consortia to realise ambitious large-scale projects.

Policy Learning Platform

The Commission is called on to:

continuously monitor, benchmark and promote the sharing of best practices; assist Member States in creating and implementing contingency strategies to address any potential temporary or permanent unavailability of health data resulting from an accident or attack on the infrastructure, systems or software used for the collection, processing or storage of such data; establish a clear timetable for the changes planned in order to create a digital health Europe, with mid-term assessments and the setting of targets.

Documents
2019/12/18
   EP - End of procedure in Parliament
2019/12/17
   EP - Motion for a resolution
Documents
2019/12/17
   EP - Debate in Parliament
2019/12/16
   EP - Oral question/interpellation by Parliament
Documents
2019/11/18
   EP - Amendments tabled in committee
Documents
2019/09/09
   EP - ARŁUKOWICZ Bartosz (EPP) appointed as rapporteur in ENVI
2019/09/09
   EP - CERDAS Sara (S&D) appointed as rapporteur in ENVI
2019/09/09
   EP - RIES Frédérique (Renew) appointed as rapporteur in ENVI
2019/09/09
   EP - AUKEN Margrete (Verts/ALE) appointed as rapporteur in ENVI
2019/09/09
   EP - REGIMENTI Luisa (ID) appointed as rapporteur in ENVI
2019/09/09
   EP - KOPCIŃSKA Joanna (ECR) appointed as rapporteur in ENVI
2019/09/09
   EP - KONEČNÁ Kateřina (GUE/NGL) appointed as rapporteur in ENVI

Documents

Activities

Votes

B9-0239/2019 - § 11/2 #

2019/12/18 Outcome: -: 589, +: 77, 0: 14
EE MT LV CY LU FI SI HR SK LT IE IT BE DK FR HU EL BG AT CZ SE PT NL RO ES PL GB DE
Total
6
6
7
6
6
12
8
10
12
10
10
68
20
13
67
16
19
15
18
21
18
20
25
29
46
48
57
87
icon: ID ID
70

Estonia ID

Abstain (1)

1

Finland ID

2

Denmark ID

Abstain (1)

1

Austria ID

3

Czechia ID

For (1)

Abstain (1)

2
icon: GUE/NGL GUE/NGL
37

Cyprus GUE/NGL

2

Finland GUE/NGL

Against (1)

1

Ireland GUE/NGL

3

Belgium GUE/NGL

Against (1)

1

Denmark GUE/NGL

Against (1)

1

Czechia GUE/NGL

Against (1)

1

Portugal GUE/NGL

4

Netherlands GUE/NGL

Against (1)

1
icon: NI NI
41

Croatia NI

Abstain (1)

1

Slovakia NI

1

Hungary NI

1

Germany NI

Against (1)

1
icon: ECR ECR
58

Latvia ECR

Against (1)

Abstain (1)

2

Croatia ECR

Against (1)

1

Slovakia ECR

2

Lithuania ECR

Against (1)

1

Bulgaria ECR

2
3

Netherlands ECR

4

United Kingdom ECR

2

Germany ECR

Against (1)

1
icon: Verts/ALE Verts/ALE
69

Latvia Verts/ALE

Against (1)

1

Luxembourg Verts/ALE

Against (1)

1

Finland Verts/ALE

2

Lithuania Verts/ALE

2

Ireland Verts/ALE

2

Belgium Verts/ALE

3

Denmark Verts/ALE

2

Austria Verts/ALE

Against (2)

2

Czechia Verts/ALE

3

Sweden Verts/ALE

2

Portugal Verts/ALE

Against (1)

1

Netherlands Verts/ALE

3

Spain Verts/ALE

2
icon: Renew Renew
104

Estonia Renew

3

Latvia Renew

Against (1)

1

Luxembourg Renew

2

Finland Renew

3

Slovenia Renew

2

Croatia Renew

Against (1)

1

Slovakia Renew

2

Lithuania Renew

2

Ireland Renew

Against (1)

1

Hungary Renew

Against (1)

1

Bulgaria Renew

3

Austria Renew

Against (1)

1

Sweden Renew

3
icon: S&D S&D
142

Estonia S&D

Against (1)

Abstain (1)

2

Malta S&D

Abstain (1)

4

Latvia S&D

2

Cyprus S&D

2

Luxembourg S&D

Against (1)

1

Finland S&D

1

Slovenia S&D

Against (2)

2
3

Slovakia S&D

3

Lithuania S&D

2

Belgium S&D

3

Greece S&D

2

Bulgaria S&D

3
icon: PPE PPE
159

Malta PPE

2

Latvia PPE

Against (1)

1

Cyprus PPE

2

Luxembourg PPE

2

Slovenia PPE

4

Lithuania PPE

3

Belgium PPE

For (1)

3

Denmark PPE

Against (1)

1
AmendmentsDossier
130 2019/2804(RSP)
2019/11/18 ENVI 130 amendments...
source: 643.214

History

(these mark the time of scraping, not the official date of the change)

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New
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type
Text adopted by Parliament, single reading
body
EP
events/1/summary
  • The European Parliament adopted a resolution tabled by the Committee on Environment, Public Health and Food Safety on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society.
  • Europe’s health and care systems face serious challenges in the context of an ageing society. The emergence of new technologies creates both opportunities and challenges for the development of better healthcare.
  • Spending on healthcare is growing fast and accounts for 9.6 % of GDP in the EU as a whole. Innovative digital solutions for health and care can boost the prevention of diseases and improve citizens’ quality of life. Healthcare digitalisation will not be limited to greater use of mobile health apps, but will also include data mining, i.e. the analysis of large data sets that serve as a foundation for artificial intelligence (AI) and machine learning.
  • The progressive digitalisation of society will increasingly lead patients, caregivers, healthcare professionals and potentially all the actors in the healthcare chain to face the challenges of using information technology and the digital infrastructure of patient records, raising questions of personal data security and privacy.
  • Members welcomed the Commission communication on enabling the digital transformation of health and care in the Digital Single Market, which aims at the promotion of health and the prevention and control of disease, and at helping address citizens’ unmet needs, as well as representing an opportunity to improve the sustainability of health systems and make it easier for citizens to enjoy equal and affordable access to high quality care through the meaningful use of digital innovations. Compliance with EU legislation on data protection should be a precondition of the digital transformation of health and care in the Digital Single Market.
  • Access and sharing personal health data
  • The resolution stressed that citizens have the right to access and share their personal health data in accordance with the General Data Protection Regulation in order to obtain better healthcare, and should be able to expect that this data be available in a timely manner and in a format that is layperson-friendly. Citizens should have secure access to a comprehensive electronic record of their health data, and should remain in control of and be able to share their personal health data securely with authorised parties, while unauthorised access should be prohibited in accordance with the data protection legislation.
  • The Commission is called on to:
  • continue improving cybersecurity and thus reducing the risk of privacy breaches and the unauthorised use of health data across the Union; continue promoting cooperation between Member States’ health authorities in order to connect to a public eHealth digital infrastructure; develop guidance to promote the secondary use of data for research and to ensure fair, transparent and non-discriminatory access to data throughout Europe; launch a broad European reflection on the ethical aspects of the digital transformation of health and care; launch an EU-wide educational campaign on the benefits of and mechanisms for health data sharing in order to break down misconceptions and support the actions put forward in its communication on enabling the digital transformation of health and care in the Digital Single Market.
  • Improved health data
  • Parliament called on the Commission to:
  • set up a platform for competent authorities, notified bodies and the pharmaceutical and medical technology industries on the application of the Medical Devices Regulation to digital therapeutics and combination products, with specific attention to the needs of start-ups and SMEs; step up European coordinated action to support the secure exchange and linkage in practice of genomic and other health data in order to advance the progress of researchers and personalised medicine, and thereby identify the best treatments; proceed with the testing of specific applications for high-security cross-border health data exchange for research and health policy, in order to improve the prevention, diagnosis and treatment of diseases so as to help health systems to meet current and future challenges.
  • Better digital tools
  • Members considered that digital healthcare tools, such as portable patient information cards, could address the challenges of accessibility regarding health information and health literacy, both of which are essential for health promotion, better disease prevention and more effective disease management. Patients should benefit from the most up-to-date information about their medicines. Therefore the Commission is urged to develop further electronic product information, including use of e-leaflets, in order to improve regulatory efficiency and empower patients with up-to-date information on medicines.
  • The Commission is called on to examine the possibility of setting up a European smart health innovation hub to assess and promote smart health initiatives and provide a platform for all actors in the health chain to establish consortia to realise ambitious large-scale projects.
  • Policy Learning Platform
  • The Commission is called on to:
  • continuously monitor, benchmark and promote the sharing of best practices; assist Member States in creating and implementing contingency strategies to address any potential temporary or permanent unavailability of health data resulting from an accident or attack on the infrastructure, systems or software used for the collection, processing or storage of such data; establish a clear timetable for the changes planned in order to create a digital health Europe, with mid-term assessments and the setting of targets.