The Data Protection and Medical Research in Europe: PRIVIREAL series focuses on the 'Privacy in Research Ethics and Law' EC-funded project examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development of the PRIVIREAL project.
This volume relates to the first stage of the project regarding the implementation of the Data Protection Directive, in particular in the area of medical research. It contains an introduction and overview of this topic, keynote papers addressing specific questions on the subject, and a report on both the general implementation of the Directive and the implementation in relation to medical research in 26 European countries.
The book will be invaluable for those people with an interest in data protection, medical research and their implications for each other. It lays open the actual situation across Europe, including both New Member States and Newly Associated Member States.
Contents: Introduction And Keynote Papers: Introduction, Deryck Beyleveld, Ségolène Rouillé-Mirza, David Townend and Jessica Wright; An overview of Directive 95/46/EC in relation to medical research, Deryck Beyleveld; The concept of privacy: an analysis of the EU directive on the protection of personal data, Mette Hartlev; Anonymization and pseudonymization: the legal framework at an European level, Carlos María Romeo-Casabona; The scope for exemptions for medical research, Herman Nys; The duty to provide information to the data subject: articles 10 and 11 of Directive 95/46/EC, Deryck Beyleveld; Overriding data subjects' rights in the public interest, David Townend; Genetic information and the data protection directive of the European union, Lasse A. Lehtonen. Report Framework And Comparative Studies: EU, Norway and the NAS law report framework, Deryck Beyleveld and David Townend; Comparative study on the implementation and effect of Directive 95/46/EC on data protection in Europe: general standards, Ségolène Rouillé-Mirza and Jessica Wright; Comparative study on the implementation and effect of Directive 95/46/EC on data protection in Europe: medical research, Ségolène Rouillé-Mirza and Jessica Wright; Index; List of cases.
About the Editor: Deryck Beyleveld, Professor of Law, PRIVIREAL Director and founder of the Sheffield Institute of Biotechnological Law and Ethics, David Townend, Maastricht University, The Netherlands. Ségolène Rouillé-Mirza and Jessica Wright, PRIVIREAL Co-ordinating Co-Workers, Sheffield Institute of Biotechnological Law and Ethics, Department of Law, University of Sheffield, UK.
Reviews: 'Up until now there has been a notable absence of sustained comparative analysis to assess the impact of the [EU Data Protection] Directive [95/46/EC] across the member states of the EU – this book fills that void. It is an invaluable resource providing detailed information regarding the comparative perspective to this issue…This book is likely to prove an invaluable source to those interested in the impact of the EU Data Protection Directive in the research practice at member states.' Jean V. McHale, University of Leicester, UK
'This book…will appeal to experts in the field because of the detailed analysis but it could also give someone new to this field a sense of how this directive operates and its implications for the use of medical data.' SCRIPT-ed
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