Opportunities and challenges for member states and social insurance institutions

CC – 10/2022

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 conventions.

An 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*.