Implementation Of The Data Protection Directive In Relation To Medical Research In Europe

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Implementation of the Data Protection Directive in Relation to Medical Research in Europe

Author : D. Townend
Publisher : Routledge
ISBN 13 : 1351155946
Total Pages : 547 pages
Book Rating : 4.3/5 (511 download)

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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.

The Data Protection Directive and Medical Research Across Europe

Author : D. Townend
Publisher : Taylor & Francis
ISBN 13 : 1351891804
Total Pages : 264 pages
Book Rating : 4.3/5 (518 download)

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Book Synopsis The Data Protection Directive and Medical Research Across Europe by : D. Townend

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

Implementation of the Data Protection Directive in Relation to Medical Research in Europe

Author : D. Townend
Publisher : Routledge
ISBN 13 : 9781138356061
Total Pages : pages
Book Rating : 4.3/5 (56 download)

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Book Synopsis Implementation of the Data Protection Directive in Relation to Medical Research in Europe by : D. Townend

Implementation of the Data Protection Directive in Relation to Medical Research in Europe

Author :
Publisher :
ISBN 13 : 9780754624172
Total Pages : 473 pages
Book Rating : 4.6/5 (241 download)

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Book Synopsis Implementation of the Data Protection Directive in Relation to Medical Research in Europe by :

Download or read book Implementation of the Data Protection Directive in Relation to Medical Research in Europe written by and published by . This book was released on 2004 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Research Ethics Committees, Data Protection and Medical Research in European Countries

Author : D. Townend
Publisher : Routledge
ISBN 13 : 1351903977
Total Pages : 328 pages
Book Rating : 4.3/5 (519 download)

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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.

Research Ethics Committees, Data Protection, and Medical Research in Europe--key Issues

Author : Deryck Beyleveld
Publisher : Ashgate Publishing Company
ISBN 13 : 9780754623748
Total Pages : 188 pages
Book Rating : 4.6/5 (237 download)

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Book Synopsis Research Ethics Committees, Data Protection, and Medical Research in Europe--key Issues by : Deryck Beyleveld

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.

Fundamentals of Clinical Data Science

Author : Pieter Kubben
Publisher : Springer
ISBN 13 : 3319997130
Total Pages : 219 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Fundamentals of Clinical Data Science by : Pieter Kubben

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.

The Data Protection Directive and Medical Research Across Europe

Author : D. Townend
Publisher : Routledge
ISBN 13 : 1351891790
Total Pages : 372 pages
Book Rating : 4.3/5 (518 download)

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Book Synopsis The Data Protection Directive and Medical Research Across Europe by : D. Townend

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 372 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.

GDPR and Biobanking

Author : Jane Reichel
Publisher : Springer Nature
ISBN 13 : 3030493881
Total Pages : 432 pages
Book Rating : 4.0/5 (34 download)

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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. .

Open Data Protection

Author : Andreas Wiebe
Publisher : Göttingen University Press
ISBN 13 : 3863953347
Total Pages : 263 pages
Book Rating : 4.8/5 (639 download)

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Book Synopsis Open Data Protection by : Andreas Wiebe

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.

Personal Data Protection and Legal Developments in the European Union

Author : Tzanou, Maria
Publisher : IGI Global
ISBN 13 : 1522594914
Total Pages : 375 pages
Book Rating : 4.5/5 (225 download)

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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.

European Data Protection: In Good Health?

Author : Serge Gutwirth
Publisher : Springer Science & Business Media
ISBN 13 : 9400729022
Total Pages : 368 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis European Data Protection: In Good Health? by : Serge Gutwirth

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.

Data Privacy in European Medical Research: A Contemporary Legal Opinion

Author : Christian Dierks
Publisher : Medizinisch Wissenschaftliche Verlagsgesellschaft mbH & Co. KG
ISBN 13 : 3954665921
Total Pages : 136 pages
Book Rating : 4.9/5 (546 download)

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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.

Privireal

Author : David Townend
Publisher :
ISBN 13 : 9780754643517
Total Pages : 500 pages
Book Rating : 4.6/5 (435 download)

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Book Synopsis Privireal by : David Townend

Download or read book Privireal written by David Townend and published by . This book was released on 2005 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: PRIVIREAL IS A EUROPEAN COMMISSION FUNDED PROJECT EXAMINING THE IMPLEMENTATION OF DIRECTIVE 95/46/EC ON DATA PROTECTION IN RELATION TO MEDICAL RESEARCH AND THE ROLE OF ETHICS COMMITTEES. THIS VOLUME RELATES TO THE THIRD STAGE OF THIS PROJECT ON RECOMMENDATIONS AND SUGGESTIONS TO BE MADE TO THE EC ON THE IMPLEMENTATION OF THE DIRECTIVE AND THE REMIT TO BE GIVEN TO RECS TO PROTECT RESEARCH PARTICIPANTs' RIGHTS. THIS VOLUME COMBINES BOTH INTRODUCTIONS TO THE TOPIC, REPORTS FROM MANY OF THE 26 EUROPEAN COUNTRIES PARTICIPATING IN PRIVIREAL, AND THE OVERALL RECOMMENDATIONS DEVELOPED BY THE SERIES EDITORS FOR SUBMISSION TO THE EC. THESE RECOMMENDATIONS CONCERN ISSUES SURROUNDING THE IMPLEMENTATION OF THE DIRECTIVE, LAWS IN COUNTRIES WHERE THE DIRECTIVE IS NOT YET IMPLEMENTED, THE REQUIREMENTS AND PRACTICE OF RESEARCH ETHICS COMMITTEES IN RELATION TO DATA PROTECTION, AND ANY OTHER MATTERS DEEMED RELEVANT.

Data Privacy in European Medical Research

Author : Christian Dierks
Publisher :
ISBN 13 : 9783954666034
Total Pages : 1 pages
Book Rating : 4.6/5 (66 download)

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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.

The EU General Data Protection Regulation (GDPR)

Author : Paul Voigt
Publisher : Springer
ISBN 13 : 3319579592
Total Pages : 385 pages
Book Rating : 4.3/5 (195 download)

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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.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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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.