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
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).
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
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.
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.