Data exchange should be encouraged.

WN – 09/2020

The EU Commission is planning a bill for 2021 to create a framework for a freer exchange of health data within the EU. This is currently being drafted by the Directorate-General for Health and Food Safety (DG Sante) and is intended to propose administrative structures to the Member States that will allow access to health data and exchange thereof in accordance with the basic EU General Data Protection Regulation (GDPR). This will promote the existing initiatives under the European Data Strategy.

European Data Strategy

As early as February 2020, the Commission presented the so-called "European Data Strategy" as part of one of the six priorities of its work for the period 2019-2024.

The strategy aims to create a single market for data with a total of nine European data spaces. The following priorities are planned for the Health Data Space:

  • progress in prevention,
  • detection and cure of diseases and
  • informed, evidence-based decisions to improve the accessibility, effectiveness and sustainability of health systems.

In the case of social security, and in particular health insurance, European cooperation at many levels can have a positive impact on health care. These include, in particular joint evaluation of medical devices and medicinal products, electronic health records or prescriptions in cross-border care or the sharing of big data applications and artificial intelligence (AI).

Current priorities

The topic of data protection is particularly in focus: The currently differing legal interpretations of the GDPR by the Member States, as well as within themselves, e.g. by different state authorities, make it difficult to draft overarching data protection regulations or corresponding proposals. This is the starting point for the Commission's initiative.

A further focus of the current technical debate on the topic is to identify the already existing fragments of health data and, as far as possible, to make them usable throughout Europe, for example by clarifying the question under which framework conditions billing or treatment data can be made usable. Such pooling of data is considered particularly important in the treatment of cancer or rare diseases. Here, opportunities can be created to set joint research priorities, to pool corresponding data from a wide variety of sources and to reuse the knowledge gained in the care system.

The consultation phase on the Common European Data Spaces has reached completion. The Commission proposal is expected in October, the roadmap on this topic can be found here.