In spring 2020, the EU Commission presented
its European data strategy. In the area of health, it announced the
establishment of an European Health Data Space (EHDS). The purpose of the EHDS
is to use the health data available in the EU for
- high-quality health care in Europe
- improved access to healthcare and
- improved access to health data for research and
A legal framework enabling the collecting,
accessing, storing, primary use as well as the secondary processing of health
data in the interest of citizens and also ensuring that sensitive personal
data remains protected will be proposed during the 4th quarter of 2021.
Cross-border data exchange and digital services
Until now, the cross-border exchange of
health data (e.g. e-patient files, e-prescriptions) has been made possible
through voluntary cooperation between member states who participate in the
The view of the EU Commission is that the
continued lack of interoperability of e-patient records and fragmented
implementation of the e-health network guidelines or the recommendations for a European Electronic Health Record
Exchange Format (EHRxF) restrict EU-wide circulation of digital products and
The lack of mandatory action to implement
the initiatives affects the availability and use of health data. The resulting
lack of access to data and its exchanging hinders scientific research and
innovation (secondary data processing), according to the EU Commission.
Research, innovation and AI
According to the EU Commission, with the
increasing availability of health data, there is also the need to make data
accessible for scientific research and development, AI and innovations in
addition to the primary use of health data in care.
In the White paper covering AI, which describes a cross-sector
strategy, the EC pointed out possible special requirements for the health
sector that exceed a horizontal approach. A legislative proposal to this effect
has been announced for the first quarter of 2021.
For example, specific requirements will
include non-discrimination of datasets, training, testing and validation of AI
systems as well as the related rights, obligations and liabilities.
Shaping the European Health Data Space
The EC’s present combined roadmap and impact assessment focuses on two application areas. First,
more binding cooperation to coordinate the cross-border exchanging of health
data. Second, making data available for secondary use via the data governance structure. The following objectives have
- Access, sharing and optimised use of health data for providing
health services as well as the secondary use of data for research and
innovation, policy-making and regulatory action should be made possible.
Health data made available across borders must be subject to data
protection and data security requirements and it should be provided in a
prompt, reliable and transparent way through an institutionalised
- The common single market for digital health, digital health
services and products such as tele-health, tele-monitoring and
mobile-health should be strengthened.
- The development, provision and application of reliable digital
health services and products, including AI applications, should be
The consultation process for an EHDS began
in the first quarter of 2021. The draft legislative text is expected to be
presented during the fourth quarter of 2021.