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Data Privacy In European Medical Research A Contemporary Legal Opinion
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Book Synopsis Data Privacy in European Medical Research by : Christian Dierks
Download or read book Data Privacy in European Medical Research written by Christian Dierks and published by . This book was released on 2021 with total page 1 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.
Book Synopsis Data Privacy in European Medical Research: A Contemporary Legal Opinion by : Christian Dierks
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.
Book Synopsis Research Handbook on EU Data Protection Law by : Kosta, Eleni
Download or read book Research Handbook on EU Data Protection Law written by Kosta, Eleni and published by Edward Elgar Publishing. This book was released on 2022-04-19 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bringing together leading European scholars, this thought-provoking Research Handbook provides a state-of-the-art overview of the scope of research and current thinking in the area of European data protection. Offering critical insights on prominent strands of research, it examines key challenges and potential solutions in the field. Chapters explore the fundamental right to personal data protection, government-to-business data sharing, data protection as performance-based regulation, privacy and marketing in data-driven business models, data protection and judicial automation, and the role of consent in an algorithmic society.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Book Synopsis Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law by : Daria Kim
Download or read book Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law written by Daria Kim and published by Springer Nature. This book was released on 2021-10-19 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trial data should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors’ control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.
Book Synopsis Personal Data Protection and Legal Developments in the European Union by : Tzanou, Maria
Download or read book Personal Data Protection and Legal Developments in the European Union written by Tzanou, Maria and published by IGI Global. This book was released on 2020-06-12 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the age of technological advancement, including the emergence of artificial intelligence, big data, and the internet of things, the need for privacy and protection has risen massively. This phenomenon has led to the enforcement of two major legal directives in the European Union (EU) that aim to provide vigorous protection of personal data. There is a need for research on the repercussions and developments that have materialized with these recent regulations and how the rest of the world has been affected. Personal Data Protection and Legal Developments in the European Union is an essential reference source that critically discusses different aspects of the GDPR and the Law Enforcement Directive as well as recent jurisprudential developments concerning data privacy in the EU and its member states. It also addresses relevant recent case law of the Court of Justice of the EU, the European Court of Human Rights, and national courts. Featuring research on topics such as public transparency, medical research data, and automated decision making, this book is ideally designed for law practitioners, data scientists, policymakers, IT professionals, politicians, researchers, analysts, academicians, and students working in the areas of privacy, data protection, big data, information technology, and human rights law.
Book Synopsis Research Ethics Committees, Data Protection and Medical Research in European Countries by : D. Townend
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.
Book Synopsis Implementation of the Data Protection Directive in Relation to Medical Research in Europe by : D. Townend
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.
Book Synopsis GDPR and Biobanking by : Jane Reichel
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. .
Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Book Synopsis Handbook on European data protection law by : Council of Europe
Download or read book Handbook on European data protection law written by Council of Europe and published by Council of Europe. This book was released on 2018-04-15 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid development of information technology has exacerbated the need for robust personal data protection, the right to which is safeguarded by both European Union (EU) and Council of Europe (CoE) instruments. Safeguarding this important right entails new and significant challenges as technological advances expand the frontiers of areas such as surveillance, communication interception and data storage. This handbook is designed to familiarise legal practitioners not specialised in data protection with this emerging area of the law. It provides an overview of the EU’s and the CoE’s applicable legal frameworks. It also explains key case law, summarising major rulings of both the Court of Justice of the European Union and the European Court of Human Rights. In addition, it presents hypothetical scenarios that serve as practical illustrations of the diverse issues encountered in this ever-evolving field.
Book Synopsis Data Protection on the Move by : Serge Gutwirth
Download or read book Data Protection on the Move written by Serge Gutwirth and published by Springer. This book was released on 2016-01-09 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume brings together papers that offer methodologies, conceptual analyses, highlight issues, propose solutions, and discuss practices regarding privacy and data protection. It is one of the results of the eight annual International Conference on Computers, Privacy, and Data Protection, CPDP 2015, held in Brussels in January 2015. The book explores core concepts, rights and values in (upcoming) data protection regulation and their (in)adequacy in view of developments such as Big and Open Data, including the right to be forgotten, metadata, and anonymity. It discusses privacy promoting methods and tools such as a formal systems modeling methodology, privacy by design in various forms (robotics, anonymous payment), the opportunities and burdens of privacy self management, the differentiating role privacy can play in innovation. The book also discusses EU policies with respect to Big and Open Data and provides advice to policy makers regarding these topics. Also attention is being paid to regulation and its effects, for instance in case of the so-called ‘EU-cookie law’ and groundbreaking cases, such as Europe v. Facebook. This interdisciplinary book was written during what may turn out to be the final stages of the process of the fundamental revision of the current EU data protection law by the Data Protection Package proposed by the European Commission. It discusses open issues and daring and prospective approaches. It will serve as an insightful resource for readers with an interest in privacy and data protection.
Book Synopsis The EU General Data Protection Regulation (GDPR) by : Paul Voigt
Download or read book The EU General Data Protection Regulation (GDPR) written by Paul Voigt and published by Springer. This book was released on 2017-08-07 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides expert advice on the practical implementation of the European Union’s General Data Protection Regulation (GDPR) and systematically analyses its various provisions. Examples, tables, a checklist etc. showcase the practical consequences of the new legislation. The handbook examines the GDPR’s scope of application, the organizational and material requirements for data protection, the rights of data subjects, the role of the Supervisory Authorities, enforcement and fines under the GDPR, and national particularities. In addition, it supplies a brief outlook on the legal consequences for seminal data processing areas, such as Cloud Computing, Big Data and the Internet of Things.Adopted in 2016, the General Data Protection Regulation will come into force in May 2018. It provides for numerous new and intensified data protection obligations, as well as a significant increase in fines (up to 20 million euros). As a result, not only companies located within the European Union will have to change their approach to data security; due to the GDPR’s broad, transnational scope of application, it will affect numerous companies worldwide.
Book Synopsis The Emergence of Personal Data Protection as a Fundamental Right of the EU by : Gloria González Fuster
Download or read book The Emergence of Personal Data Protection as a Fundamental Right of the EU written by Gloria González Fuster and published by Springer Science & Business. This book was released on 2014-04-28 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the coming into being in European Union (EU) law of the fundamental right to personal data protection. Approaching legal evolution through the lens of law as text, it unearths the steps that led to the emergence of this new right. It throws light on the right’s significance, and reveals the intricacies of its relationship with privacy. The right to personal data protection is now officially recognised as an EU fundamental right. As such, it is expected to play a critical role in the future European personal data protection legal landscape, seemingly displacing the right to privacy. This volume is based on the premise that an accurate understanding of the right’s emergence is crucial to ensure its correct interpretation and development. Key questions addressed include: How did the new right surface in EU law? How could the EU Charter of Fundamental Rights claim to render ‘more visible’ an invisible right? And how did EU law allow for the creation of a new right while ensuring consistency with existing legal instruments and case law? The book first investigates the roots of personal data protection, studying the redefinition of privacy in the United States in the 1960s, as well as pioneering developments in European countries and in international organisations. It then analyses the EU’s involvement since the 1970s up to the introduction of legislative proposals in 2012. It grants particular attention to changes triggered in law by language and, specifically, by the coexistence of languages and legal systems that determine meaning in EU law. Embracing simultaneously EU law’s multilingualism and the challenging notion of the untranslatability of words, this work opens up an inspiring way of understanding legal change. This book will appeal to legal scholars, policy makers, legal practitioners, privacy and personal data protection activists, and philosophers of law, as well as, more generally, anyone interested in how law works.
Book Synopsis Reinventing Data Protection? by : Serge Gutwirth
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.
Book Synopsis Data Protection and Privacy: (In)visibilities and Infrastructures by : Ronald Leenes
Download or read book Data Protection and Privacy: (In)visibilities and Infrastructures written by Ronald Leenes and published by Springer. This book was released on 2017-02-07 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book features peer reviewed contributions from across the disciplines on themes relating to protection of data and to privacy protection. The authors explore fundamental and legal questions, investigate case studies and consider concepts and tools such as privacy by design, the risks of surveillance and fostering trust. Readers may trace both technological and legal evolution as chapters examine current developments in ICT such as cloud computing and the Internet of Things. Written during the process of the fundamental revision of revision of EU data protection law (the 1995 Data Protection Directive), this volume is highly topical. Since the European Parliament has adopted the General Data Protection Regulation (Regulation 2016/679), which will apply from 25 May 2018, there are many details to be sorted out. This volume identifies and exemplifies key, contemporary issues. From fundamental rights and offline alternatives, through transparency requirements to health data breaches, the reader is provided with a rich and detailed picture, including some daring approaches to privacy and data protection. The book will inform and inspire all stakeholders. Researchers with an interest in the philosophy of law and philosophy of technology, in computers and society, and in European and International law will all find something of value in this stimulating and engaging work.
Book Synopsis Solidarity in Biomedicine and Beyond by : Barbara Prainsack
Download or read book Solidarity in Biomedicine and Beyond written by Barbara Prainsack and published by Cambridge University Press. This book was released on 2017-01-19 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: In times of global economic and political crises, the notion of solidarity is gaining new currency. This book argues that a solidarity-based perspective can help us to find new ways to address pressing problems. Exemplified by three case studies from the field of biomedicine: databases for health and disease research, personalised healthcare, and organ donation, it explores how solidarity can make a difference in how we frame problems, and in the policy solutions that we can offer.
