Resolution on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society

2019/2804(RSP)

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.