GDPR and Biobanking PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download GDPR and Biobanking PDF full book. Access full book title GDPR and Biobanking by Jane Reichel. Download full books in PDF and EPUB format.
Author: Jane Reichel
Publisher: Springer Nature
ISBN: 3030493881
Category : Biobanks
Languages : en
Pages : 432
Get Book Here
Book Description
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. .
Author: Jane Reichel
Publisher: Springer Nature
ISBN: 3030493881
Category : Biobanks
Languages : en
Pages : 432
Get Book Here
Book Description
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. .
Author: Valentina Colcelli
Publisher: Springer Nature
ISBN: 3031429443
Category : Law
Languages : en
Pages : 627
Get Book Here
Book Description
The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality. Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.
Author: Valentina Colcelli
Publisher: Springer
ISBN: 9783031429439
Category : Law
Languages : en
Pages : 0
Get Book Here
Book Description
The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality. Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.
Author: Pieter Kubben
Publisher: Springer
ISBN: 3319997130
Category : Medical
Languages : en
Pages : 218
Get Book Here
Book Description
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.
Author: Antonio Marcacci
Publisher: Springer Nature
ISBN: 3031180631
Category : Law
Languages : en
Pages : 518
Get Book Here
Book Description
The book provides an analysis of the emergence, evolution, and transformation of transnational securities regulation and of the influences from and the interactions between global regulatory powers in the field. Combining insights from law and political science, the work employs a two-tier complementary "on-the-books" and "in-action” approach. The more classical "on-the-books" approach draws on scholarship in United States and European Union securities regulation; transnational regulation and global administrative law; regime complexity; global governance studies; and the regulatory production of the International Organisation of Securities Commissions (IOSCO). The law in-action approach leverages the author’s experience as Compliance senior professional in a multinational financial institution as well as research interviews with senior IOSCO staff. The author’s findings enable the reader to develop an original understanding of IOSCO, its standards, and its unique place in the transnational regulatory arena. They also challenge the doxa that the US are the only driving regulatory power in the securities area when in fact, other regulatory powers are emerging – for the time being, the EU. The balance has shifted and regulatory compromises are achieved at different points in the rule making process.
Author: Nils Hoppe
Publisher: Universitätsverlag Göttingen
ISBN: 3863950313
Category : Medical
Languages : en
Pages : 183
Get Book Here
Book Description
"Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss.EU project ('Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union--an Evidence-Based Impact Analysis') to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results"--Publisher's description
Author: Council of Europe
Publisher: Council of Europe
ISBN: 9287198497
Category : Political Science
Languages : en
Pages : 402
Get Book Here
Book Description
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.
Author: Raphaël Gellert
Publisher:
ISBN: 0198837712
Category : Law
Languages : en
Pages : 305
Get Book Here
Book Description
This title provides an extensive analysis of the risk-based approach taken to data protection. It also considers risk management methodologies and provides discussions at the intersection of data protection law scholarship, regulation theory, and risk and risk management literature.
Author: Orla Lynskey
Publisher: Oxford University Press
ISBN: 0191028061
Category : Law
Languages : en
Pages : 337
Get Book Here
Book Description
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.
Author: Pierre Hainaut
Publisher: Springer Nature
ISBN: 3030559017
Category : Medical
Languages : en
Pages : 210
Get Book Here
Book Description
Over the past 25 years, biobanks of human specimens have become a cornerstone for research on human health and have empowered the “omics “revolution that characterizes biomedical science in the XXIst Century. Today, biobanking of human specimens is a critical component of the interface between clinical practice and translational research, supporting the discovery and validation of new biomarkers of disease etiology, risk, early detection, diagnosis, prognosis, prediction and relapse. With the development of personalized medicine, biobanking of cryopreserved specimens has become standard practice in order to investigate genetic, transcriptomic, proteomic, metabolomics and immunological biomarkers useful to inform caregivers for therapeutic decisions. Data generated from biobanked specimens represent a rapidly growing and highly valuable resource, participating in the emergence of Big Data Medicine. With the development of large computing capabilities and artificial intelligence, data associated with biobanked specimens constitute a unique resource for the discovery and validation of new biomarkers and therapeutically actionable targets. Interconnecting, interoperating and sharing this data have become major issues for national health systems, raising enormous stakes as well as major societal, legal and cybersecurity challenges in terms of compliance with the protection of personal sensitive information. This book project is the second part of an initiative launched in 2012 to produce a published corpus of knowledge encompassing all aspects of human biobanking as a central practice for research and medicine. The first volume, published in 2017, is entitled: Human Biobanking: Principles and Practice. This first volume compiled a series of high level contributions overseeing the main developments that carried the progression of human biobanking as a research and biotechnological field over the past two decades. This new book project will constitute de facto Volume 2 of the same initiative, under the title: Biobanking of Human Biospecimens: lessons from 25 years of biobanking experience. Hence, the two volumes will share the same generic title (Biobanking of Human Biospecimens), with different subtitles, making clear that the two volumes are interrelated while highlighting their specificities in terms of what they actually cover. As a result, the two books are “twins” but can also be used independently of each other. The overarching aim of the two volumes of Biobanking of Human Biospecimens is to provide a published “one-stop shop” for state-of-the-art information on what constitutes the field of human biobanking, from conception of a biobank, standard operating procedures, ethical and societal aspects, governance, networking, interoperability and economic sustainability. This inclusive publication concept meets the needs of a vast readership, including scientists, doctors and technical staffs who are directly involved in biobanking operations, scientists in other disciplines that heavily rely on biobanking (such as genomics or proteomics), stakeholders and policy makers, and of course students for whom biobanking is becoming an important part of the training curriculum. So far, there has been a lack of major textbooks on biobanking. Documentation for biobanking is widely available through numerous publications, regulatory documents published by International or Governmental Agencies, and sets of recommendations essentially accessible through the Internet. However, it is difficult to access a single, top-of-the shelf reference that provides at a glance a large coverage of all aspects of human biobanking. Fulfilling this need is the main origin of the concept for this back-to-back publication project. To our knowledge, there is currently no other publication project with the same breath and scope as this one in the field of biobanking.
