The Data Protection Directive And Medical Research Across Europe

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.

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 this project concerning the implementation of the Data Protection Directive, in particular in the area of medical research. It contains reports from 26 European countries on the implementation of the Directive, or the data protection regime, all with a specific focus on issues and questions relating to medical research. Presenting a unique resource for all those involved in data protection, medical research and their implications for each other, this title provides a valuable insight into the actual workings across Europe, including both the New Member States and the Newly Associated Member States.

The Data Protection and Medical Research in Europe: PRIVIREAL series represents the results of this 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 second stage of this project and is concerned with the setting up and role of research ethics committees. It assesses their legal responsibilities, especially with regard to data protection matters and contains reports from more than 20 European countries on these issues. Focusing on the theoretical role and practical operation of research ethics committees and the impact of relevant international and national instruments, this volume will be an essential resource for all those concerned with data protection issues in medical research.

Although Europe has a significant legal data protection framework, built up around EU Directive 95/46/EC and the Charter of Fundamental Rights, the question of whether data protection and its legal framework are ‘in good health’ is increasingly being posed. Advanced technologies raise fundamental issues regarding key concepts of data protection. Falling storage prices, increasing chips performance, the fact that technology is becoming increasingly embedded and ubiquitous, the convergence of technologies and other technological developments are broadening the scope and possibilities of applications rapidly. Society however, is also changing, affecting the privacy and data protection landscape. The ‘demand’ for free services, security, convenience, governance, etc, changes the mindsets of all the stakeholders involved. Privacy is being proclaimed dead or at least worthy of dying by the captains of industry; governments and policy makers are having to manoeuvre between competing and incompatible aims; and citizens and customers are considered to be indifferent. In the year in which the plans for the revision of the Data Protection Directive will be revealed, the current volume brings together a number of chapters highlighting issues, describing and discussing practices, and offering conceptual analysis of core concepts within the domain of privacy and data protection. The book’s first part focuses on surveillance, profiling and prediction; the second on regulation, enforcement, and security; and the third on some of the fundamental concepts in the area of privacy and data protection. Reading the various chapters it appears that the ‘patient’ needs to be cured of quite some weak spots, illnesses and malformations. European data protection is at a turning point and the new challenges are not only accentuating the existing flaws and the anticipated difficulties, but also, more positively, the merits and the need for strong and accurate data protection practices and rules in Europe, and elsewhere.

The Data Protection and Medical Research in Europe: PRIVIREAL series represents the results of the 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 second stage of this project, and is concerned with the role of research ethics committees across Europe in ensuring that participants in medical research gain the protection of the Directive. The work examines the specific provision of each Member State. It provides an overview of the European position through a comparative analysis of the domestic positions, and through a series of papers addressing key issues in the area. This book presents a valuable guide to the role and operation of research ethics committees and will be essential reading for all those involved with data protection issues in medical research.

This study analyses legal barriers to data sharing in the context of the Open Research Data Pilot, which the European Commission is running within its research framework programme Horizon2020. In the first part of the study, data protection issues are analysed. The main focus is on the Data Protection Directive (95/46/EC) and its implementation in selected EU Member States. Additionally, the upcoming General Data Protection Regulation (2016/679/EU) and relevant changes are described. Special focus is placed on leading data protection principles. Next, the study describes the use of research data in the Open Research Data Pilot and how data protection principles influence such use. The experiences of the European Commission in running the Open Research Data Pilot so far, as well as basic examples of repository use forms, are considered. The second part of the study analyses the extent to which legislation on public sector information (PSI) influences access to and re-use of research data. The PSI Directive (2003/98/EC) and the impact of its revision in 2013 (2013/37/EU) are described. There is a special focus on the application of PSI legislation to public libraries, including university and research libraries, and its practical implications. In the final part of the study the results are critically evaluated and core recommendations are made to improve the legal situation in relation to research data.

Today, consent is a fundamental concept in the European legal framework on data protection. The analysis of the historical and theoretical context carried out in this book reveals that consent was not an intrinsic notion in the birth of data protection. The concept of consent was included in data protection legislation in order to enhance the role of the data subject in the data protection arena, and to allow the data subject to have more control over the collection and processing of his/her personal information. This book examines the concept of consent and its requirements in the Data Protection Directive, taking into account contemporary considerations on bioethics and medical ethics, as well as recent developments in the framework of the review of the Directive. It further studies issues of consent in electronic communications, carrying out an analysis of the consent-related provisions of the ePrivacy Directive.