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Gdpr Requirements For Biobanking Activities Across Europe
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Book Synopsis GDPR Requirements for Biobanking Activities Across Europe by : Valentina Colcelli
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.
Book Synopsis GDPR Requirements for Biobanking Activities Across Europe by : Valentina Colcelli
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.
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 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.
Book Synopsis Protecting Genetic Privacy in Biobanking through Data Protection Law by : Dara Hallinan
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.
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 Building Continents of Knowledge in Oceans of Data: The Future of Co-Created EHealth by : A. Ugon
Download or read book Building Continents of Knowledge in Oceans of Data: The Future of Co-Created EHealth written by A. Ugon and published by IOS Press. This book was released on 2018-05-18 with total page 996 pages. Available in PDF, EPUB and Kindle. Book excerpt: The domain of eHealth faces ongoing challenges to deliver 21st century healthcare. Digitalization, capacity building and user engagement with truly interdisciplinary and cross-domain collaboration are just a few of the areas which must be addressed. This book presents 190 full papers from the Medical Informatics Europe (MIE 2018) conference, held in Gothenburg, Sweden, in April 2018. The MIE conferences aim to enable close interaction and networking between an international audience of academics, health professionals, patients and industry partners. The title of this year’s conference is: Building Continents of Knowledge in Oceans of Data – The Future of Co-Created eHealth, and contributions cover a broad range of topics related to the digitalization of healthcare, citizen participation, data science, and changing health systems, addressed from the perspectives of citizens, patients and their families, healthcare professionals, service providers, developers and policy makers. The second part of the title in particular has attracted a large number of papers describing strategies to create, evaluate, adjust or deliver tools and services for improvements in healthcare organizations or to enable citizens to respond to the challenges of dealing with health systems. Papers are grouped under the headings: standards and interoperability, implementation and evaluation, knowledge management, decision support, modeling and analytics, health informatics education and learning systems, and patient-centered services. Attention is also given to development for sustainable use, educational strategies and workforce development, and the book will be of interest to both developers and practitioners of healthcare services.
Book Synopsis Biobanking of Human Biospecimens by : Pierre Hainaut
Download or read book Biobanking of Human Biospecimens written by Pierre Hainaut and published by Springer Nature. This book was released on 2021-08-25 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Transnational Securities Regulation by : Antonio Marcacci
Download or read book Transnational Securities Regulation written by Antonio Marcacci and published by Springer Nature. This book was released on 2022-11-25 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Ethics of Medical Data Donation by : Luciano Floridi
Download or read book The Ethics of Medical Data Donation written by Luciano Floridi and published by . This book was released on 2020-10-08 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. Today, it is easy to donate blood or even organs, but it is virtually impossible to donate one's own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.
Book Synopsis Ethics, Law and Governance of Biobanking by : Deborah Mascalzoni
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 275 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 :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :030948247X Total Pages :103 pages Book Rating :4.3/5 (94 download)
Book Synopsis Data Matters by : National Academies of Sciences, Engineering, and Medicine
Download or read book Data Matters written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-28 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an increasingly interconnected world, perhaps it should come as no surprise that international collaboration in science and technology research is growing at a remarkable rate. As science and technology capabilities grow around the world, U.S.-based organizations are finding that international collaborations and partnerships provide unique opportunities to enhance research and training. International research agreements can serve many purposes, but data are always involved in these collaborations. The kinds of data in play within international research agreements varies widely and may range from financial and consumer data, to Earth and space data, to population behavior and health data, to specific project-generated dataâ€"this is just a narrow set of examples of research data but illustrates the breadth of possibilities. The uses of these data are various and require accounting for the effects of data access, use, and sharing on many different parties. Cultural, legal, policy, and technical concerns are also important determinants of what can be done in the realms of maintaining privacy, confidentiality, and security, and ethics is a lens through which the issues of data, data sharing, and research agreements can be viewed as well. A workshop held on March 14-16, 2018, in Washington, DC explored the changing opportunities and risks of data management and use across disciplinary domains. The third workshop in a series, participants gathered to examine advisory principles for consideration when developing international research agreements, in the pursuit of highlighting promising practices for sustaining and enabling international research collaborations at the highest ethical level possible. The intent of the workshop was to explore, through an ethical lens, the changing opportunities and risks associated with data management and use across disciplinary domainsâ€"all within the context of international research agreements. This publication summarizes the presentations and discussions from the workshop.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :396 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309475171 Total Pages :399 pages Book Rating :4.3/5 (94 download)
Book Synopsis Returning Individual Research Results to Participants by : National Academies of Sciences, Engineering, and Medicine
Download or read book Returning Individual Research Results to Participants written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-09-23 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Download or read book Health in the 21st Century written by and published by . This book was released on 2019 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report explores how data and digital technology can help achieve policy objectives and drive positive transformation in the health sector while managing new risks such as privacy, equity and implementation costs. It examines the following topics: improving service delivery models; empowering people to take an active role in their health and their care; improving public health; managing biomedical technologies; enabling better collaboration across borders; and improving health system governance and stewardship. It also examines how health workforces should be equipped to make the most of digital technology. The report contains findings from surveys of OECD countries and shares a range of examples that illustrate the potential benefits as well as challenges of the digital transformation in the health sector. Findings and recommendations are relevant for policymakers, health care providers, payers, industry as well as patients, citizens and civil society.
Book Synopsis Artificial Intelligence in Medical Imaging by : Erik R. Ranschaert
Download or read book Artificial Intelligence in Medical Imaging written by Erik R. Ranschaert and published by Springer. This book was released on 2019-01-29 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a thorough overview of the ongoing evolution in the application of artificial intelligence (AI) within healthcare and radiology, enabling readers to gain a deeper insight into the technological background of AI and the impacts of new and emerging technologies on medical imaging. After an introduction on game changers in radiology, such as deep learning technology, the technological evolution of AI in computing science and medical image computing is described, with explanation of basic principles and the types and subtypes of AI. Subsequent sections address the use of imaging biomarkers, the development and validation of AI applications, and various aspects and issues relating to the growing role of big data in radiology. Diverse real-life clinical applications of AI are then outlined for different body parts, demonstrating their ability to add value to daily radiology practices. The concluding section focuses on the impact of AI on radiology and the implications for radiologists, for example with respect to training. Written by radiologists and IT professionals, the book will be of high value for radiologists, medical/clinical physicists, IT specialists, and imaging informatics professionals.
Book Synopsis Global Genes, Local Concerns by : Timo Minssen
Download or read book Global Genes, Local Concerns written by Timo Minssen and published by Edward Elgar Publishing. This book was released on 2019 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
