Published on 05.11.2021 05.11.2021

European health projects and initiatives meet to solve challenges around European Health Data Space

TEHDAS has identified the main challenges to overcome concerning the European Health Data Space. The project forum convened European health data specialists to solve them.

The second TEHDAS project forum, held online, 29 October, gathered over 110 European health data specialists representing more than 50 projects and initiatives. The event aimed to bring together representatives of European projects to discuss challenges concerning General Data Protection Regulation (GDPR) interpretations, data quality assurance, linking data from different sectors and countries, and public engagement.

Four parallel sessions focused on different aspects of building the European Health Data Space (EHDS). The results of these discussions will be included in further work on TEHDAS.

EHDS can resolve shared challenge of legal uncertainty

During the session on the harmonisation of GDPR interpretations in the Member States, Vanja Pajić of X-eHealth outlined the challenges caused by national derogations to the regulation. He highlighted the recent rise in awareness among member states of the problems and limitations that these derogations cause, as well as of the need to harmonise interpretations, starting from finding a common definition for secondary use of health data.

All projects struggle with legal uncertainty. No project is unaffected. This is a shared challenge for us.

Irene Schlünder, TMF, umrella organisation for networked medical research in Germany

The session on governance of data quality included a presentation by Petr Holub of BBMRI on the solutions to the data quality assurance challenges.

The main discussion concerned different incentives for data quality assurance. They include reimbursements for the hospital sector, collecting high quality data and the development of coding skills among clinicians and researchers. On auditing data sources, forum participants found mutual understanding that in EHDS it would be better to audit data procedures rather than data sources.

Difficulties in combining data across sectors and regions

In the discussion about combining data from various domains, such as health services and data registries and linking data among regions and states, Niklas Bloomberg from ELIXIR presented the EGA example of a federated repository.

This is a network of distributed data repositories, where the aim is to link genomic data with clinical data. He highlighted the importance of building on existing standards (such as HL7 FHIR and OMOP) and the need for implementing open references to increase the transparency on the standards used by data infrastructures. The rare diseases network was presented as a successful example of using common standards across member states.

The EHDS legal act should be seen as an enabler and not a restriction for secondary use of data. Technology alone cannot overcome limitations that we currently face, but it is an important factor and will increase trust when properly implemented.

Jaakko Lähteenmäki, VTT Technical Research Centre of Finland

Preference for opt-out model in health data use

The issue of public engagement came up in all sessions. This especially concerned the use of consent methods to make their data available to benefit research and policymaking. Most participants preferred the opt-out model rather than the patient consent model. This means that individuals would need to indicate that their data cannot be used for secondary use.

The fourth session focused specifically on this topic, starting with a presentation of Attila Wohlbrandt from the Smart4Health project. The discussion covered the obstacles with ensuring that data remains anonymous with emerging technologies, and the right to be forgotten. A key point of discussion was the importance of the public receiving feedback on how their data is used, to demonstrate the value of the use of their data and ensuring their consent for its secondary use.

The forum provided a chance for the work package leaders to present the initial achievements of the joint action and establish connections with European projects. For example, the TEHDAS work package focusing on citizens found synergies with the activities of the diabetes diary project in Finland.

The discussions will be taken forward in the next project forum, in May 2022, when a more concrete response to the legislative proposal on the EHDS will be discussed in relation to TEHDAS. TEHDAS initiative will hold a total of four project forums.

Meeting agenda

For further information, please contact: TEHDAS.sciensano@sciensano.be