Commission and Germany’s Presidency of the Council of the EU underline importance of the European Health Data Space

This article is brought to you in association with the European Commission.

Today at the virtual High-Level Conference “Digital Health 2020 – EU on the Move”, the Commission and Germany’s Presidency of the Council of the EU announced their intention to work closely together on a secure and patient-oriented use of health data for Europe, and EU-wide collaboration in this area, through a European Health Data Space for better healthcare, better research and better health policy making. The set-up of the European Health Data Space will be an integral part of building a European Health Union, a process launched by the Commission today with a first set of proposals to reinforce preparedness and response during health crisis. This  is also a direct follow up of the Data strategy adopted by the Commission in February this year, where the Commission had already stressed the importance of creating European data spaces, including on health.

Jens Spahn, Germany’s Federal Minister of Health, said: “Health data is paramount, for health care in general, but especially to fight cross-border health threats such as the COVID-19 pandemic. Citizens in the EU should be in control of their health data, have trust in transparent and legally sound data processing and be empowered to share their data on a voluntary basis. Therefore we need to set up a cross-country framework. We will kick off the process next year with a first concrete European use-case. By 2025 we want to have an interoperable data access infrastructure in place to facilitate secure cross-border analysis of health data.”

Stella Kyriakides, Commissioner for Health and Food Safety, said: “The European Health Data Space will be a crucial component of a strong European Health Union. Data saves lives – and we have all seen this during the COVID-19 crisis. It will allow access to health data under a trusted governance and clear rules and support the free movement of digital health services. By 2025, patients from all Member States should be able to share their data with healthcare professionals of their choice when traveling abroad. Together, we can empower millions of citizens, to digitally increase their access to healthcare, and improve their well-being.”

Commissioner for Internal Market Thierry Breton said: “With the upcoming Data Governance Act, we will establish a horizontal framework for the use and reuse of sensitive and valuable data in areas such as health. This will facilitate the creation of sectoral European data spaces, including a common European Health Data Space. Strengthening and extending the use and re-use of health data is critical for an innovative and competitive EU healthcare sector, and will help make Europe more resilient to weather challenges such as the current pandemic.”

The Minister and the Commissioners agreed that it is now necessary and urgent to galvanise EU-wide collaboration.

In this perspective, as part of the implementation of the Data strategy, a data governance act is set to be presented still this year, which will support the reuse of public sensitive data such as health data. A dedicated legislative proposal on a European health data space is planned for next year, as set out in the 2021 Commission work programme.

As first steps, the following activities starting in 2021 will pave the way for better data-driven health care in Europe:

• The Commission proposes a European Health Data Space in 2021;
• A Joint Action with 22 Member States to propose options on governance, infrastructure, data quality and data solidarity and empowering citizens with regards to secondary health data use in the EU;
• Investments to support the European Health Data Space under the EU4Health programme, as well as common data spaces and digital health related innovation under Horizon Europe and the Digital Europe programmes;
• Engagement with relevant actors to develop targeted Codes of Conduct for secondary health data use;
• A pilot project, to demonstrate the feasibility of cross border analysis for healthcare improvement, regulation and innovation;
• Other EU funding opportunities for digital transformation of health and care will be available for Member States as of 2021 under Recovery and Resilience Facility, European Regional Development Fund, European Social Fund+, InvestEU.

The set of proposals adopted by the Commission today to strengthen the EU’s crisis preparedness and response, taking the first steps towards a European Health Union, also pave the way for the participation of the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) in the future European Health Data Space infrastructure, along with research institutes, public health bodies, and data permit authorities in the Member States.