Privacy Challenges in the Health Sector through Emerging Technologies
The GDPR and biomedical research: the state of the art and a possible code of conduct.
The lecture explores the regulatory framework that is in force in the EU for processing and sharing biomedical and genetic data for research purposes.
Firstly, it offers an overview of the provisions of the General Data Protection Regulation (GDPR) concerning biomedical and genetic data, their processing and their sharing for scientific research purposes.
Secondly, a critical analysis of the GDPR norms is developed, in particular regarding its shortcomings, its fuzzy definitions, the lack of effective harmonization of data protection rules in the context of research and the broad margin of maneuver and interpretation left to Member States.
Thirdly, it questions if an instrument of soft law, such as a bottom-up code of conduct, could be a proper instrument for simplifying the implementation of the GDPR and boosting biomedical and genetic research in Europe, as well as international data sharing.
Ilaria Colussi is an Italian qualified lawyer and holds a Ph. D. in Public Law/Biolaw from the University of Trento, Italy. She has worked both as a counselor in law firms in Udine and Milan, Italy, in the areas of administrative law and international trade law, and as an academic researcher in the areas of law and new technologies (genetics and synthetic biology). She has been a Marie Curie Post-Doctoral Fellow at the University of Liège, Belgium, in the European Studies Unit, where she focused on dual-use items, export control issues and European restrictive measures. She has served as a legal trainee at the European Ombudsman in Brussels (Belgium), and through the years she has been a visiting researcher and professor at St. Hugh’s College-University of Oxford (UK), Interuniversity Chair of Law and the Human Genome -Bilbao (Spain), European Studies Unit-University of Concepciòn (Chile) and Constitutional Law Chair-University of Paranà (Argentina). She has also worked as a Legal Specialist in a private company, focusing on compliance with the European Data Protection Regulation (GDPR). As a legal expert on privacy issues, she has joined BBMRI-ERIC, with the role of dealing with the implementation of a Code of Conduct for Health Research.