Ms. Heidi Beate Bentzen
Title of Presentation
Human Biological Samples versus Personal Data
Date and Place
Heidi Beate Bentzen is a PhD Candidate in law at The Centre for Medical Ethics at The Faculty of Medicine and The Norwegian Research Center for Computers and Law at The Faculty of Law, University of Oslo, Norway. She collaborates with The Norwegian Cancer Genomics Consortium. Ms. Bentzen holds a Master of Laws degree from The University of Oslo, with specialization in data privacy law and medical law, and a master’s thesis on the legal regulation of personalized medicine and the clinical use of whole genome sequencing. For her PhD, Ms. Bentzen researches the legal regulation of the information flow pertaining to personalized cancer medicine, i.e. the legal regulation of genetic testing, and the processing of human biological samples and DNA data, including sample reuse and DNA data sharing. Ms. Bentzen co-chairs COST Action IS 1303 CHIP ME working group 1 on research ethics, which focuses on the ethical and legal issues of research biobanks.
The European Union Data Protection Directive 95/46/EC (DPD) is interpreted and implemented differently in the member states. One area where there is a difference in interpretation relates to the definition of personal data: Are human biological samples considered personal data? The member states are split in their answers. The upcoming European Union General Data Protection Regulation (EU) 2016/679 (GDPR) that will replace the DPD, seeks to harmonize data protection law in the member states. A new definition of personal data where the relationship to human biological samples is clarified is part of this harmonization. The legal background for the distinction between human biological samples and personal data will be presented, as will the GDPR’s new definition of personal data and the implications for biobanks.