The event was the second edition of the BBMRI-ERIC ELSI Academy Symposium, this time under the brief of “Ethical, Legal, and Societal Aspects in View of Recent EU Legislation”. It was jointly co-organised by BBMRI-ERIC, the University of the Basque Country (UPV/EHU), the University of Milano-Bicocca (UNIMIB) and the BBMRI Spanish national node: Platform ISCIII Biomodels and Biobanks (BBMRI.es).
The Department of Innovation and Digitalisation in Law (ID Law) as BBMRI.at’s representative for ELSI talso attended and was present at the previous edition of the Symposium in Lyon, in June 2024. You can read more about that event, and UNIVIE’s participation, here.
The extensive programme for the event included a focus on the European Health Data Space (EHDS) Regulation, as one of the most prominent recent developments in EU legislation that is due to greatly affect scientific research, especially in what concerns availability of electronic health data for research pursuits and other processing purposes that are different to those purposes for which the data was initially collected or produced. In line with the theme of the event, the ID Law team working for the BBMRI.at project had a presentation on the topic of Incidental findings under the European Health Data Space (EHDS) Regulation. The presentation delved on the concepts of general and individual research results and the legal concerns that incidental findings pose to biobanks. The concept of ‘significant findings’ contained, but not defined, in the Regulation, and the obligations created by the Regulation to report such findings were the main focus of the presentation, which was based on research by the BBMRI.at UNIVIE team members Catarina Almeida and Klaudia Kwiatkowska, led by Univ.-Prof. Dr. Nikolaus Forgó.
UNIVIE’s participation in this event is part of UNIVIE’s tasks in BBMRI.at, under Work Package 2 (WP2) ‘Legal and Regulatory Challenges and Opportunities’ and supported by the Austrian Federal Ministry of Women, Science and Research funded project BBMRI.at [grant number 2023-0.752.780].
