Download or read book The Data Protection Directive and Medical Research Across Europe written by D. Townend and published by Routledge. This book was released on 2017-07-05 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Implementation of the Data Protection Directive in Relation to Medical Research in Europe written by D. Townend and published by Routledge. This book was released on 2017-11-28 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Implementation of the Data Protection Directive in Relation to Medical Research in Europe written by D. Townend and published by Routledge. This book was released on 2022 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book European Data Protection In Good Health written by Serge Gutwirth and published by Springer Science & Business Media. This book was released on 2012-02-23 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Research Ethics Committees Data Protection and Medical Research in European Countries written by D. Townend and published by Routledge. This book was released on 2017-05-15 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Foundations of EU Data Protection Law written by Orla Lynskey and published by Oxford University Press. This book was released on 2015-11-26 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nearly two decades after the EU first enacted data protection rules, key questions about the nature and scope of this EU policy, and the harms it seeks to prevent, remain unanswered. The inclusion of a Right to Data Protection in the EU Charter has increased the salience of these questions, which must be addressed in order to ensure the legitimacy, effectiveness and development of this Charter right and the EU data protection regime more generally. The Foundations of EU Data Protection Law is a timely and important work which sheds new light on this neglected area of law, challenging the widespread assumption that data protection is merely a subset of the right to privacy. By positioning EU data protection law within a comprehensive conceptual framework, it argues that data protection has evolved from a regulatory instrument into a fundamental right in the EU legal order and that this right grants individuals more control over more forms of data than the right to privacy. It suggests that this dimension of the right to data protection should be explicitly recognised, while identifying the practical and conceptual limits of individual control over personal data. At a time when EU data protection law is sitting firmly in the international spotlight, this book offers academics, policy-makers, and practitioners a coherent vision for the future of this key policy and fundamental right in the EU legal order, and how best to realise it.

Download or read book Consent in European Data Protection Law written by Eleni Kosta and published by Martinus Nijhoff Publishers. This book was released on 2013-03-21 with total page 461 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Research Ethics Committees Data Protection and Medical Research in Europe key Issues written by Deryck Beyleveld and published by Ashgate Publishing Company. This book was released on 2006 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Open Data Protection written by Andreas Wiebe and published by Göttingen University Press. This book was released on 2017 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben and published by Springer. This book was released on 2018-12-21 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

Download or read book Data Privacy in European Medical Research A Contemporary Legal Opinion written by Christian Dierks and published by Medizinisch Wissenschaftliche Verlagsgesellschaft mbH & Co. KG. This book was released on 2021-02-12 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: The European Data Protection Regulation applies since May 25th, 2018. It creates a uniform data protection legal framework within the EU. National and international medical research projects, regardless of whether they were started before or after the introduction of the GDPR, are obliged to follow this new regulation and implement it promptly. This raises various challenges for a large number of medical research projects. The University Medicine Greifswald commissioned this legal report, that was prepared by DIERKS+COMPANY. Two real-world research projects, the Baltic Fracture Competence Centre (BFCC) as well as the German Centre for Cardiovascular Research (DZHK) provide use cases, questions, and context for this legal report. It addresses questions regarding all steps of data processing. The report provides practical answers to a wide array of technical and organisational questions in the area of data protection-compliant processing of research data. A comprehensive guide to GDPR-compliant data processing has been developed, which both summarises the broad legal environment and provides specific assistance in the design and implementation of GDPR-compliant data management processes, including Informed Consent, Legal Consequences of Withdrawal, and Privacy by Design.

Download or read book Reinventing Data Protection written by Serge Gutwirth and published by Springer Science & Business Media. This book was released on 2009-05-24 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: data. Furthermore, the European Union established clear basic principles for the collection, storage and use of personal data by governments, businesses and other organizations or individuals in Directive 95/46/EC and Directive 2002/58/EC on Privacy and Electronic communications. Nonetheless, the twenty-?rst century citizen – utilizing the full potential of what ICT-technology has to offer – seems to develop a digital persona that becomes increasingly part of his individual social identity. From this perspective, control over personal information is control over an aspect of the identity one projects in the world. The right to privacy is the freedom from unreasonable constraints on one’s own identity. Transactiondata–bothtraf?candlocationdata–deserveourparticularattention. As we make phone calls, send e-mails or SMS messages, data trails are generated within public networks that we use for these communications. While traf?c data are necessary for the provision of communication services, they are also very sensitive data. They can give a complete picture of a person’s contacts, habits, interests, act- ities and whereabouts. Location data, especially if very precise, can be used for the provision of services such as route guidance, location of stolen or missing property, tourist information, etc. In case of emergency, they can be helpful in dispatching assistance and rescue teams to the location of a person in distress. However, p- cessing location data in mobile communication networks also creates the possibility of permanent surveillance.

Download or read book Protection of Natural Persons with Regard to Automated Individual Decision Making in the GDPR written by Aleksandra Drożdż and published by Kluwer Law International B.V.. This book was released on 2020-03-09 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Increasingly, algorithms regulate our lives. Personal data is routinely processed on an unprecedented scale in both private and public sectors. This shift from more subjective and less structured human decision-making processes to automated ones has provoked numerous concerns with regard to the rights and freedoms of natural persons affected. In particular, those attached to profiling that can lead to discrimination influencing crucial opportunities of individuals, such as the ability to obtain credit, insurance, education, a job or even medical treatment. To the extent that automated individual decision-making is based on personal data, in the European Union it is subject to the General Data Protection Regulation. The author examines whether this legislative act affords sufficient protection of natural persons with regard to such processing, identifying the loopholes that hinder or prevent its efficacy and the de lege lata rules and de lege ferenda postulates that could provide individuals with effective protection in relation to automated individual decision-making. She provides an in-depth analysis of such aspects as the following: the GDPR’s background, terminology and material and territorial scope of application; key concerns regarding automated individual decision-making; specific and general provisions of the GDPR relevant to protection of natural persons with regard to automated individual decision-making; special and general rights of the data subject relevant to automated individual decision-making provided for in the GDPR; key limitations to algorithmic transparency; how profiling can create special categories of personal data by inference from ‘ordinary’ personal data; and how the version of reality derived from personal data is often at least partially inaccurate. To interpret the rules of the GDPR, the analysis draws on the travaux préparatoires, case law of the Court of Justice of the European Union and national courts that concerns the previous Data Protection Directive, guidelines and opinions of the Article 29 Working Party and the European Data Protection Board, various reports and recommendations and numerous academic writings. In its consideration of some of the most controversial issues in the realm of personal data protection – issues whose role in the information society will grow rapidly – this book represents a major contribution to research and legal guidance at the confluence of law and new technologies concerning algorithmic accountability. Policymakers, regulators and lawyers active in the ongoing development of personal data protection law will become knowledgeable about interpretations and guidelines formulated by European data protection authorities, as well as examples and best practices in the field. Moreover practitioners will find the implementation of automated individual decision-making systems in accordance with the GDPR greatly facilitated. The analysis will assist data protection authorities and judicature in assessing such systems and interpreting the GDPR framework with regard to protection of natural persons in the years to come.

Download or read book GDPR and Biobanking written by Jane Reichel and published by Springer Nature. This book was released on 2021 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .

Download or read book The EU General Data Protection Regulation GDPR written by Christopher Kuner and published by Oxford University Press, USA. This book was released on 2019-06-13 with total page 1360 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new book provides an article-by-article commentary on the new EU General Data Protection Regulation. Adopted in April 2016 and applicable from May 2018, the GDPR is the centrepiece of the recent reform of the EU regulatory framework for protection of personal data. It replaces the 1995 EU Data Protection Directive and has become the most significant piece of data protection legislation anywhere in the world. The book is edited by three leading authorities and written by a team of expert specialists in the field from around the EU and representing different sectors (including academia, the EU institutions, data protection authorities, and the private sector), thus providing a pan-European analysis of the GDPR. It examines each article of the GDPR in sequential order and explains how its provisions work, thus allowing the reader to easily and quickly elucidate the meaning of individual articles. An introductory chapter provides an overview of the background to the GDPR and its place in the greater structure of EU law and human rights law. Account is also taken of closely linked legal instruments, such as the Directive on Data Protection and Law Enforcement that was adopted concurrently with the GDPR, and of the ongoing work on the proposed new E-Privacy Regulation.

Download or read book G3P Good Privacy Protection Practice in Clinical Research written by Karl-Heinz Schriever and published by Walter de Gruyter GmbH & Co KG. This book was released on 2014-10-02 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection. The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented. Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.

Download or read book Health Data Pools Under European Data Protection and Competition Law written by Giulia Schneider and published by Springer Nature. This book was released on 2022-04-13 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.