Gdpr And Biobanking

Author : Jane Reichel
Publisher : Springer Nature
ISBN 13 : 3030493881
Total Pages : 432 pages
Book Rating : 4.82/5 ( download)

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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. .

Author : Santa Slokenberga
Publisher : Springer
ISBN 13 : 9783030493905
Total Pages : 444 pages
Book Rating : 4.03/5 ( download)

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Download or read book GDPR and Biobanking written by Santa Slokenberga and published by Springer. This book was released on 2022-01-09 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book focuses on the discrepancies in biobank research regulations that are among the most significant hurdles to effective research collaboration. The General Data Protection Regulation (GDPR) has established stringent requirements for the processing of health and genetic data, while simultaneously allowing considerable multi-level exceptions for the purposes of scientific research. In addition to directly applicable exceptions, the GDPR places the regulatory responsibility for further defining how the Member States strike a balance between the individuals' rights and the public interest in research within their national legal orders. Since Member States' approaches to the trade-off between data subjects' rights on the one hand, and appropriate safeguards on the other, differ according to their ethical and legal traditions, their data protection requirements for research also differ considerably. This study takes a comprehensive approach to determine how the GDPR affects regulatory regimes on the use of personal data in biobanking research, with a particular focus on the balance between individuals' rights, public interest and scientific research. In this regard, it has two main goals: first, to scrutinize the GDPR research regime, its objective and constitutive elements, the impact it has on biobanking, and its role in a changing EU landscape post-Brexit; and second, to examine how various exceptions have been operationalized nationally, and what challenges and opportunities this diversification entails. The book not only captures the complexity GDPR creates for biobanking, but also sheds light on various approaches to tackling the corresponding challenges. It offers the first comprehensive analysis of GDPR for biobanking, and the most up-to-date overview of the national biobank regulatory frameworks in Europe.

Author : Dara Hallinan
Publisher :
ISBN 13 : 0192896474
Total Pages : 305 pages
Book Rating : 4.76/5 ( download)

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Download or read book Protecting Genetic Privacy in Biobanking Through Data Protection Law written by Dara Hallinan and published by . This book was released on 2021-03 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Dara Hallinan
Publisher : Oxford University Press
ISBN 13 : 0192650394
Total Pages : 305 pages
Book Rating : 4.99/5 ( download)

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Download or read book Protecting Genetic Privacy in Biobanking through Data Protection Law written by Dara Hallinan and published by Oxford University Press. This book was released on 2021-03-11 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biobanks are critical infrastructure for medical research but they are also the subject of considerable ethical and legal uncertainty. Given that biobanks process large quantities of genomic data, questions have emerged as to how genetic privacy should be protected. What types of genetic privacy rights and rights holders should be protected and to what extent? Since 25th May 2018 the General Data Protection Regulation (GDPR) has applied and now occupies a key position in the European legal framework for the regulation of biobanking. This book takes an in-depth look at the function, problems, and opportunities presented by European data protection law under the GDPR as a framework for the protection of genetic privacy in biobanking in Europe. Hallinan argues that the substantive framework presented by the GDPR already offers an admirable base-line level of protection for the range of genetic privacy rights engaged by biobanking. The book further argues that, whilst numerous problems with this standard of protection are indeed identifiable, the GDPR offers the flexibility to accommodate solutions to these problems, as well as the procedural mechanisms to realise these solutions.

Author : Valentina Colcelli
Publisher : Springer Nature
ISBN 13 : 3031429443
Total Pages : 627 pages
Book Rating : 4.46/5 ( download)

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Download or read book GDPR Requirements for Biobanking Activities Across Europe written by Valentina Colcelli and published by Springer Nature. This book was released on 2024-01-27 with total page 627 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 3319997130
Total Pages : 219 pages
Book Rating : 4.31/5 ( download)

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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.

Author : Council of Europe
Publisher : Council of Europe
ISBN 13 : 9287198497
Total Pages : 402 pages
Book Rating : 4.95/5 ( download)

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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.

Author : Valentina Colcelli
Publisher : Springer
ISBN 13 : 9783031429439
Total Pages : 0 pages
Book Rating : 4.35/5 ( download)

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Download or read book GDPR Requirements for Biobanking Activities Across Europe written by Valentina Colcelli and published by Springer. This book was released on 2023-12-25 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Deborah Mascalzoni
Publisher : Springer
ISBN 13 : 9401795738
Total Pages : 277 pages
Book Rating : 4.39/5 ( download)

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Download or read book Ethics, Law and Governance of Biobanking written by Deborah Mascalzoni and published by Springer. This book was released on 2015-01-22 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.38/5 ( download)

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Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.