Date: 29th August
Venue: Zoom, link will be sent to all registered participants shortly before the event
Time: 13:00 - 14:30 CET
How to register:
Please email email@example.com to register until 26th August 2022.
On May 3, 2022, the European Commission adopted a proposal for a new regulation governing health data, the European Health Data Space Regulation (proposed EHDS Regulation). One of the central issues the EHDS Regulation aims to capture is data access for scientific research purposes, innovation, and product development. The mechanisms set up within the proposed regulation raise several questions, including, regarding their intended functioning, as well as opportunities and implications for scientific research, responsibilities of researchers, and co-existence of different EU and national laws, including the General Data Protection Regulation, the Data Governance Act Regulation as well as the proposal for an EU Data Act Regulation.
In this webinar, we will examine the opportunities and implications that the proposed EHDS Regulation promises to bring along for scientific research.
Moderator: Katharina Ó Cathaoir, Associate Professor, Faculty of Law, University of Copenhagen and Pro Futura Scientia Fellow at the Swedish Collegium for Advanced Study
Santa Slokenberga, Senior Lecturer in Administrative Law at Uppsala University.
The proposed European Health Data Space regulation seeks to facilitate the secondary use of electronic health data for scientific research purposes. It will co-exist with the scientific research regime that has been established under the General Data Protection Regulation. In this presentation, I will highlight how the proposed EHDS regulation promises to transform the EU scientific research regime and what implications it brings along for the research participant, researcher and research institution, as well as research governance.
Marjut Salokannel, Research Director, Faculty of Law, University of Helsinki, Finland.
EU commission gave its proposal for the European Health Data Space Regulation in May 2022. In Article 33.5 it is stated that “Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.” The Data Governance Act provides a rule for altruistic consent which can also be utilised in the context of the EHDS. EU Clinical Trial Regulation also provides explicit rules for the use of consent in the context of clinical trials and subsequent scientific research. The Oviedo Convention for its part provides for consent with regard to biomedical research, including for research utilising biobank samples and genetic data. This presentation will discuss the interaction of these different regulations and raise issues as to where further clarification is needed.
Ana Nordberg, Associate Professor, Faculty of Law, Lund University, Sweden.
During the covid-19 pandemic the scientific community and public policy makers experienced difficulties in accessing data held by private actors. In order to solve such issue, the EHDS Regulation proposal develops a framework also aimed at private actors and determined to overrule IP or trade secret objections to make health, health related and wellness data available for reuse for a variety of purposes.
This presentation will focus on Article 33 and the intersection of the proposed limitation to IP and trade secret rights with IP law.