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| 2. |
- Chassang, Gauthier, et al.
(författare)
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Data Portability in Health Research and Biobanking
- 2018
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Ingår i: European Data Protection Law Review. - : Lexxion Verlag. - 2364-2831 .- 2364-284X. ; 4:3, s. 296-307
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Tidskriftsartikel (refereegranskat)abstract
- This article examines the content of data portability right (II), operationalisation of data portability in health research context and related challenges (III) by considering both GDPR provisions and special Guidelines from the European Data Protection Board (ex-Article 29 Data Protection Working Party). We provide in depth analysis of the provisions and tables for easing the identification of potential implementation of data portability in health research contexts.
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| 3. |
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GDPR and Biobanking : Individual Rights, Public Interest and Research Regulation across Europe
- 2021
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Samlingsverk (redaktörskap) (refereegranskat)abstract
- 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.
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| 4. |
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| 5. |
- Matar, Amal, et al.
(författare)
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A proposal for an international Code of Conduct for data sharing in genomics
- 2022
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Ingår i: Developing World Bioethics. - : John Wiley & Sons. - 1471-8731 .- 1471-8847. ; 23:4, s. 344-357
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Tidskriftsartikel (refereegranskat)abstract
- As genomic research becomes commonplace across the world, there is an increased need to coordinate practices among researchers, especially with regard to data sharing. One such way is an international code of conduct. In September 2020, an expert panel consisting of representatives from various fields convened to discuss a draft proposal formed via a synthesis of existing professional codes and other recommendations. This article presents an overview and analysis of the main issues related to international genomic research that were discussed by the expert panel, and the results of the discussion and follow up responses by the experts. As a result, the article presents as an annex a proposal for an international code of conduct for data sharing in genomics that is meant to establish best practices.
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| 6. |
- Molnar-Gabor, Fruzsina, et al.
(författare)
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Harmonization after the GDPR? Divergences in the rules for genetic and health data sharing in four member states and ways to overcome them by EU measures: insights from Germany, Greece, Latvia and Sweden
- 2022
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Ingår i: Seminars in Cancer Biology. - : Elsevier. - 1044-579X .- 1096-3650. ; 84, s. 271-283
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Tidskriftsartikel (refereegranskat)abstract
- The EU member states’ healthcare and health-related research sectors are both characterized by an emerging infrastructural coalescence on a national and European level. The culmination of this coalescence is the planned creation of a European Health Data Space, an EU-wide infrastructure for the processing of personal data for healthcare and for secondary uses such as scientific research. In contrast to growing technical interoperability, the legal framework for such integration is not yet defined in detail, particularly with regard to data protection law. Its development is accompanied by discussions about divergent member state implementations of the EU General Data Protection Regulation (GDPR) that affect data sharing between healthcare and scientific research actors and across various sectors driven by divergent processing purposes.The article presents four member states’ main rules on data sharing based on the respective provision of the GDPR in six health-related contexts regarding data sharing across the healthcare and research sector and between the main actors of those sectors. The striking differences are then evaluated from the perspective of their factual effect on European data sharing depending on the legal characteristics of the GDPR provisions they rely on. Against this backdrop, the planned regulatory measures for the setup of the European Health Data Space are introduced and evaluated with regard to further harmonization between member states’ laws and possibilities to overcome divergences in data protection rules relevant for European data sharing.The results of the analysis point to the conclusion that the destructive effect of divergent member state rules depends on the legal qualification of the EU provisions they rely on and that this qualification also determines which further EU regulatory measure would be the most effective to set the framework for the European Health Data Space.
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| 7. |
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| 8. |
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| 9. |
- Slokenberga, Santa, et al.
(författare)
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Introduction
- 2021
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Ingår i: GDPR and Biobanking. - Cham : Springer. - 9783030493882 - 9783030493875 ; , s. 1-7
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Bokkapitel (övrigt vetenskapligt/konstnärligt)abstract
- The General Data Protection Regulation (GDPR) is already four years old legal instrument, with over two years of practical experience, yet, several central questions on its application, its importance in scientific research, rights of the data subjects, and obligations on the controllers and processors remain uncharted. In this edited volume, questions ranging from the meaning of the GDPR provisions for a particular research project to impact of the GDPR on long term collaborations, when the UK is leaving the EU are is discussed. This chapter sets out the aim of this book and provides an overview of how various contributions interplay to shed light on how the GDPR shapes the research regimes on the use of personal data in biobanking by EU Member States.
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| 10. |
- Slokenberga, Santa, et al.
(författare)
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Setting the foundations: Individual rights, public interest, scientific research and biobanking
- 2020
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Ingår i: Individual rights, public interest and biobanking. Article 89 GDPR and European legal responses.
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Bokkapitel (övrigt vetenskapligt/konstnärligt)abstract
- The EU lacks competence to regulate research in a comprehensive manner, yet furthering research is one of its aspirations. Data protection, however, is an area within which the EU has legislated extensively. During the development of the General Data Protection Regulation (GDPR), an important issue to tackle was how to balance the EU aspirations, on the one hand, with limited competences in research regulation, on the other, as well as how to determine the extent to which data protection can be used as a means to further scientific research in the EU legal order. The outcome is the GDPR multifaceted research regime that sets forth EU policy and opens up for further regulations from the Member States as well as the EU. The research regime that the GDPR has created poses numerous questions, which it is hoped this book will answer. Key among these is, what are the implications of operationalisation of the Article 89 GDPR research regime in biobanking? This chapter introduces the tensions and also sets forth some conceptual foundations for the book. It provides insights into the EU’s interests in the area of biobanking and maps out the research regime that has been built around the GDPR. Thereafter, it analyses the key concepts used in the book: biobank, biorepository, biobanking, scientific research as undertaken under the GDPR, individual rights and public interest. Lastly, it shares some preliminary reflections as starting points for the analysis to come.
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