The European data strategy


The European data strategy
Over the last few years, digital technologies have transformed the economy and society, affecting all sectors of activity and the daily lives of all Europeans. 

Data is at the centre of this transformation and more is to come.  In a society where individuals will generate ever increasing amounts of data, the way in which the data are collected and used must place the interests of the individual first, in accordance with European values, fundamental rights and rules, it is stated in European Commission’s European Data Strategy. Citizens will trust and embrace data-driven innovations only if they are confident that any personal data sharing in the EU will be subject to full compliance with the EU’s strict data protection rules. 

The EU can become a leading role model for a society empowered by data. The creation of a single data market will enable their smooth flow within the EU and through various sectors for the benefit of medicine, the economy, research, science and public administration. By enabling people, businesses and organizations to use relevant data, it will directly influence better decision-making that will encourage their greater competitiveness in the market.

The EU will create a single market for data where

  • data can flow within the EU and across sectors, for the benefit of all
  • European rules, in particular privacy and data protection, as well as competition law, are fully respected
  • the rules for access and use of data are fair, practical and clear

The current regulatory and research models rely on access to health data, including individual level data from patients. Strengthening and extending the use and re-use of health data is critical for innovation in the healthcare sector. It also helps healthcare authorities to take evidence-based decisions to improve the accessibility, effectiveness and sustainability of the healthcare systems. It also contributes to the competitiveness of the EU’s industry. Better access to health data can significantly support the work of regulatory bodies in the healthcare system, the assessment of medical products and demonstration of their safety and efficacy.

Citizens have the right in particular to access and control their personal health data and to request their portability, but implementation of this right is fragmented. Working towards making sure that every citizen has secure access to their Electronic Health Record (EHR) and can ensure the portability of his/her data – within and across borders – will improve access to and quality of care, cost effectiveness of care delivery and contribute to the modernisation of health systems.

Citizens also need to be reassured that, once they have given consent for their data to be shared, the healthcare systems uses such data in an ethical manner and ensure that the given consent can be withdrawn at any time. 

The Commission will: 

  • Develop sector-specific legislative or non-legislative measures for the European health data space, complementing the horizontal framework of the common data space.
  • Take measures to strengthen citizens’ access to health data and portability of these data 
  • Undertakes all measures to support and to encourage the development of national electronic health records and the interoperability of health data by applying a format for the exchange of electronic health records.
  • Increase cross-border exchange of health data
  • Link and make available through secure, pooled repositories, special types of health information, such as electronic health records, genomic information (for at least 10 million people by 2025) and digital health recordings, in line with the GDPR.
  • Enable the exchange of electronic patient health records and e-prescriptions between 22 Member States using the digital eHealth Infrastructure (eHDSI) infrastructure by 2022.
  • Start cross-border electronic exchanges of medical recordings, laboratory findings and discharge lists via eHDSI and improve the virtual consultation model and registers of European reference networks;
  • Support projects with a large amount of data used by networks of regulatory bodies.

These activities will improve prevention, diagnosis and treatment (especially of oncology patients, those suffering from rare diseases and common, complex chronic diseases), research and innovation, health policy-making and regulatory activities of Member States in the field of public health.

Such a digital Europe should reflect the best of Europe and be open, fair, diverse and democratic.