The European Commission has started an ambitious project
with its presentation of the draft regulation for the EHDS (European Health
Data Space). The aim is to improve medical care for people in the EU through
using larger quantities of data and ensuring greater data availability.
We have already taken a look at EHDS in the current magazine ed* and it shows which challenges lie
ahead for the member states and for us as social insurance institutions.
Access to health data – primary data use
Patients should have the right to access
their treatment data electronically anywhere in the EU and it should also be
made available to the doctors treating them. In order to make this possible the
service providers involved must be connected to an interoperable data infrastructure
that will allow accessing and exchanging of ePrescriptions and digital patient summaries. Harmonisation should not only reduce the costs of health data traffic
within the EU but also strengthen cross-border mobility in Europe.
Merging the health data – secondary data use
The second major section to be regulated by
the EHDS is the secondary use of health data. The aim is for member states to
make their health data available across the EU for research, innovation,
policy-making, AI development and personalised medicine purposes. The EHDS
should control which data they can access, where as well as at what quality
level. Important medical advances for treating diseases should then become
possible through the pooling of large quantities of data.
Differences within the member states
A key challenge here will be ensuring that
the EHDS fits well into existing national health and social structures. They
vary greatly throughout the member states, especially with regard to
digitisation levels, technical governance structures and data protection
interoperable data infrastructure already exists in principle in the
MyHealth@EU project for primary data use. It has also been tested by some
member states, so the EHDS can build on this structure. This data
infrastructure must first be created so that it will be available for secondary
data use. The relevant national infrastructures that already exist in the
member states for exchanging health data differ considerably in some cases.
This also includes the data quality and formats as well as official
responsibilities. Different national regulations covering health and research
data must also be monitored from a legal perspective in addition to the GDPR.
You can find out more in our magazine ed*.