Successful event “New Era for Health Data” on secondary use of data in EHDS and DGA

EHDS – DGA – secondary use of data

In 2025, the European Health Data Space (EHDS) Regulation was formally adopted by the Council of the European Union. This law aims to make it easier to exchange and access health data at EU level. The EHDS shall empower individuals’ access to and control over their personal electronic health data resulting from healthcare (primary use of data). It shall also enable certain data to be reused in a secure and trustworthy manner for research and innovation purposes for the benefit of European patients (secondary use of data).[1]

The European Data Governance Act (DGA) is another regulation that entered into force in June 2022. It shall facilitate data sharing across sectors and EU countries, in order to leverage the potential of data for EU countries.

Both regulations are important for the digital transformation of healthcare in Europe which is a key priority for the European Commission and the secondary use of data.

Panel discussion

Around 70 participants attended the event in the Aula of the University of Vienna (UNIVIE) or joined through the online stream, which is available on YouTube. The comprehensive programme begun with a panel discussion with respected Austrian experts from the fields of health, law, ethics and policymaking. Panel discussion topic was “Europe and Austria in the midst of new data-related regulations. Status quo and the future of the EHDS and DGA implementation and its impact on secondary health data use”.

The invited speakers – guided in their discussion by Nikolaus Forgó (leader of BBMRI.at WP2 on legal issues) – covered topics such as Austria’s current state of readiness in implementing the EHDS and DGA, including the opportunities and challenges that these legal acts bring to the secondary use of health data for research, innovation, and public health. Further issues discussed were for example the opt out option in the EHDS and the chances and drawbacks. People (data providers) have an opt out right and can object to the “secondary use” if their health data. Experts stressed the strong need for and the importance of good communication to the public in order to build trust and to prevent misunderstandings and misconceptions.

Workshops

Three interactive workshops offered valuable insights into the secondary use of health data (moderated by BBMRI.at),  data altruism (moderated by Smart FOX), and EHDS implementation in hospitals (moderated by CD-Laboratory), fostering interdisciplinary discussions among participants.

The BBMRI.at workshop was co-moderated by Helmuth Haslacher, coordinator of the biobank of the Med Uni Wien a BBMRI.at Consortium Partner. Helmuth Haslacher who leads the BBMRI.at Work Package on Quality received valuable support in moderating the workshop from UNIVIE colleagues from BBMRI.at Work Package 2 on Legal Issues.

The event – organized in collaboration of BBMRI.at with the research projects Smart FOX and CD Laboratory for Machine Learning Driven Precision Imaging – concluded with a networking session, fostering collaboration between researchers, policymakers, and stakeholders.

BBMRI.at thanks all speakers, moderators, and the organizers for their contributions to this successful initiative.