This volume relates to the first stage of the PRIVIREAL project regarding the implementation of the Data Protection Directive. It includes 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.

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.

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.

Hallinan argues that the substantive framework presented by the GDPR offers an admirable base-line level of protection for the range of genetic privacy rights engaged by biobanking.

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.

This book explores the emerging economic reality of health data pools from the perspective of European Union policy and law. The contractual sharing of health data for research purposes is giving rise to a free movement of research data, which is strongly encouraged at European policy level within the Digital Single Market Strategy. However, it has also a strong impact on data subjects' fundamental right to data protection and smaller businesses and research entities ability to carry out research and compete in innovation markets. Accordingly the work questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the work addresses the following sub-questions: i) which is the emerging innovation paradigm in digital health research?; ii) how are health data pools addressed at European policy level?; iii) do European data protection and competition law promote health data-driven innovation objectives, and how?; iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the work is that both branches of European Union law are key regulatory tools for the creation of a common European health data space as envisaged in the Commissions 2020 European strategy for data. It thus demonstrates that both European data protection law, as defined under the General Data Protection Regulation, and European competition law and policy set research enabling regimes regarding health data, provided specific normative conditions are met. From a further perspective, both regulatory frameworks place external limits to the freedom to share (or not share) research valuable data.

This book presents cutting edge research on the new ethical challenges posed by biomedical Big Data technologies and practices. ‘Biomedical Big Data’ refers to the analysis of aggregated, very large datasets to improve medical knowledge and clinical care. The book describes the ethical problems posed by aggregation of biomedical datasets and re-use/re-purposing of data, in areas such as privacy, consent, professionalism, power relationships, and ethical governance of Big Data platforms. Approaches and methods are discussed that can be used to address these problems to achieve the appropriate balance between the social goods of biomedical Big Data research and the safety and privacy of individuals. Seventeen original contributions analyse the ethical, social and related policy implications of the analysis and curation of biomedical Big Data, written by leading experts in the areas of biomedical research, medical and technology ethics, privacy, governance and data protection. The book advances our understanding of the ethical conundrums posed by biomedical Big Data, and shows how practitioners and policy-makers can address these issues going forward.

The goal of the book is to present the latest research on the new challenges of data technologies. It will offer an overview of the social, ethical and legal problems posed by group profiling, big data and predictive analysis and of the different approaches and methods that can be used to address them. In doing so, it will help the reader to gain a better grasp of the ethical and legal conundrums posed by group profiling. The volume first maps the current and emerging uses of new data technologies and clarifies the promises and dangers of group profiling in real life situations. It then balances this with an analysis of how far the current legal paradigm grants group rights to privacy and data protection, and discusses possible routes to addressing these problems. Finally, an afterword gathers the conclusions reached by the different authors and discuss future perspectives on regulating new data technologies.

Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks. Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn’t only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills.