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- Fåhraeus, David, et al.
(författare)
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The European Health Data Space : Challenges and Opportunities
- 2024
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- In her 2020 State of the Union address, the European Commission President Ursula von der Leyen announced a new legislative proposal to create a European Health Data Space. Its aim is to make electronic health data accessible in order to support healthcare delivery, health research, innovation, effective policymaking and regulation, and personalised medicine. This European Policy Analysis examines the Commission’s proposal and its implications for patients, healthcare providers, market actors and national administrations.The analysis shows that the Commission’s Proposal has significant potential benefits for a wide range of stakeholders. However, concerns still remain regarding aspects such as the empowerment of individuals in relation to their data, adjustments that will need to be made by the healthcare sector, incentives for innovation, and trust in EU governance. At the time of writing, the European Parliament and the Council have adopted their negotiating positions. However, a number of changes are likely to be introduced before the Commission’s Proposal is agreed and can be implemented in the Member States.
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| 2. |
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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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| 3. |
- Slokenberga, Santa, et al.
(författare)
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EU data transfer rules and African legal realities : is data exchange for biobank research realistic?
- 2019
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Ingår i: International data privacy law. - : Oxford University Press (OUP). - 2044-3994 .- 2044-4001. ; 9:1, s. 30-48
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Tidskriftsartikel (refereegranskat)abstract
- Key PointsTo effectively collaborate in biobanking and build capacity in low and middle-income countries, data transfer from European Union (EU) Member States to states in Africa is crucial.Although under the General Data Protection Regulation (GDPR) avenues for data transfer exist, the ones feasible for transcontinental data exchange for biobank research rely on EU enforcement which in essence means limited oversight possibilities and, consequently, considerable risks to the EU data subject’s privacy.To ensure effective data protection for data subjects in biobanking, raising the data protection bar in data recipient countries is crucial. Although Kenya, Nigeria, South Africa, and Uganda have taken considerable steps towards developing data protection frameworks, only that of South Africa and Nigeria’s Protection of Personal Information Bill seem to be such to meet the protection level set out by the GDPR. The legislative initiatives in Kenya and Uganda require revisions to ensure that protection of privacy is not undermined when data are being sent to these countries.Currently, considerable responsibility is placed in the hands of the legislatures in the countries of concern—and notably in Kenya, and Uganda—to set foundations for ending research and research integrity-harming practices. In Nigeria, these foundations are defined in the Protection of Personal Information Bill, but not adopted yet. South Africa, however, has taken a big step towards building routes for genuine biobank capacity-building in the country and collaboration in that regard.
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| 4. |
- Klingström, Tomas, et al.
(författare)
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Legal & ethical compliance when sharing biospecimen
- 2018
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Ingår i: Briefings in Functional Genomics & Proteomics. - Oxford : Oxford University Press. - 2041-2649 .- 2041-2657. ; 17:1, s. 1-7
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Forskningsöversikt (refereegranskat)abstract
- When obtaining samples from biobanks, resolving ethical and legal concerns is a time-consuming task where researchers need to balance the needs of privacy, trust and scientific progress. The Biobanking and Biomolecular Resources Research Infrastructure-large Prospective Cohorts project has resolved numerous such issues through intense ommunication between involved researchers and experts in its mission to unite large rospective study sets in Europe. To facilitate efficient communication, it is useful for onexperts to have an at least basic understanding of the regulatory systemformanaging biological samples. Laws regulating research oversight are based on national law and normally share core principles founded on international charters. In interview studies among donors, chief concerns are privacy, efficient sample utilization and access to information generated fromtheir samples. Despite a lack of clear evidence regarding which concern takes precedence, scientific as well as public discourse has largely focused on privacy concerns and the right of donors to control the usage of their samples. It is therefore important to roactively deal with ethical and legal issues to avoid complications that delay or prevent samples from being accessed. To help biobank professionals avoid making unnecessary mistakes, we have developed this basic primer covering the relationship between ethics and law, the concept of informed consent and considerations for returning findings to donors.
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| 8. |
- Reichel, Jane, 1971-
(författare)
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EU governance for research and ethics in biobanks
- 2015
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Ingår i: <em>Ethics, Law and Governance of Biobanking: National, European and International Profiles</em>. - Dordrecht, the Netherlands : Springer. - 9789401795739
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Bokkapitel (refereegranskat)
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