1. |
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2. |
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3. |
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4. |
- 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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5. |
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6. |
- Axmin, Martina, et al.
(författare)
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Gränsöverskridande vård
- 2020
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Ingår i: Medicinsk rätt. - 9789139117148
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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7. |
- Barkane, Irena, et al.
(författare)
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The legal implications of covid-19 vaccination certificates : Implementation experiences from Nordic and Baltic region
- 2022
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Ingår i: New legal reality. - Riga : University of Latvia Press. - 9789934188251 - 9789934188268 ; , s. 209-223
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Konferensbidrag (refereegranskat)abstract
- EU Digital green certificates were initially envisaged as a joint EU initiative to facilitate free movement during the pandemic. However, many countries rapidly extended their use in different contexts at the national level, raising serious ethical and legal concerns and questions, in particular, on how to strike a right balance between the interests of the individual and the interests of society. The paper aims to explore the legal implications of using vaccination certificates at the national level, in particular by exploring and comparing practices in selected Nordic and Baltic countries. The article emphasises that, despite COVID-19 crises, the governments should protect fundamental rights and values and when deciding on new restrictions carefully assess their necessity and proportionality. National responses call for a new regulatory framework to ensure responsible use of digital technologies in public interests.
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8. |
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9. |
- 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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10. |
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11. |
- 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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12. |
- Garland, Jameson, et al.
(författare)
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Protecting the Rights of Children with Intersex Conditions from Nonconsensual Gender-Conforming Medical Interventions : The View from Europe
- 2019
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Ingår i: Medical Law Review. - : Oxford University Press. - 0967-0742 .- 1464-3790. ; 27:3, s. 482-508
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Tidskriftsartikel (refereegranskat)abstract
- Nonconsensual gender-conforming interventions on children with intersex conditions have recently come under sharp criticism from human rights authorities within the United Nations, the Council of Europe, and the European Union, which have identified these interventions as violating children’s rights to bodily integrity, privacy, and protection from violence, torture, and degrading treatment. Responding largely to requests for intervention from nongovernmental organizations, these authorities have called upon nations to reform their legal frameworks, both to prevent these rights violations and to redress them. To date, however, few nations have endeavored to prohibit nonconsensual gender-conforming procedures on children with intersex conditions, and none have enacted significant reforms of their frameworks to redress rights violations. This particular ‘compliance gap’ between human rights recommendations and law reform stems from a failure of national legal orders to formally recognize the scope of rights that are threatened by nonconsensual gender-conforming interventions—rights that are well-established as part of states’ positive obligations to prevent physical and psychological harm to children. This article, therefore, analyzes the nature of the rights at stake and the importance of reporting human rights violations to generate direct calls for reform wherever violations occur. The article further analyzes how developments in Europe may have special significance for legal framework reforms—particularly if they facilitate judicial actions against national authorities through the European Convention of Human Rights, which may serve as a model for litigation elsewhere.
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14. |
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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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15. |
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Governing, Protecting, and Regulating the Future of Genome Editing : The Significance of ELSPI Perspectives
- 2023
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Samlingsverk (redaktörskap) (refereegranskat)abstract
- This book brings together several outstanding authors in the field and covers questions relating to the fundamental milestones in technology development and governance (Judit Sandor), an analysis of disability questions and empowerment of the community (Pin Lean Lau), right to health opportunities and challenges (Anne Kjersti Befring), the protection of the right to private life and life (Merel M. Spaander), and preconditions for the use of technology for heritable changes in the human genome (Noemi Conditi), and the intersection of genome editing and artificial intelligence (Anastasiya Kiseleva). It also examines the rules relating to the early access of gene therapy medicinal products (Vera Lucia Raposo) and the adequacy of the rules on safety and application of the technology in healthcare within the EU (Michal Koščík and Eliška Vladíková). Moreover, it looks into the availability and accessibility of the technology. The special issue examines the values behind the prohibitions of germline interventions in Europe and explores the feasibility of lifting these bans (Santa Slokenberga, gold OA); it looks at the social justice in the field and the need to ensure better access to biotechnological innovations (Oliver Feeney) as well as examines the morality clauses in patent legislation and their impact on the technology governance (Duncan Matthews, Timo Minssen and Ana Nordberg). At times, even the best technology governance tools fail in ensuring adequate access to the technology and the market actors risk behaving in a way that could undermine the right to health. Here, competition law perspectives come into play and offer tools for ensuring a minimum level of competition in the field (Vladimir Bastidas Venegas, gold OA). The book is an outcome of the Nordic Permed Law Symposium on Human Genome Editing, held online on November 3-4, 2021, and is expected to be published open access, latest September 2022.
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17. |
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18. |
- Kalokairinou, L, et al.
(författare)
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Legislation of direct-to-consumer genetic testing in Europe: : a fragmented regulatory landscape
- 2018
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Ingår i: Journal of Community Genetics. - : Springer Science and Business Media LLC. - 1868-310X .- 1868-6001. ; 9:2, s. 117-132
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Forskningsöversikt (refereegranskat)abstract
- Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients’ rights.
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19. |
- Litins'ka, Yana, et al.
(författare)
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An Ounce of Prevention for a Pound of Cure? Infection Disease Testing at the Border
- 2023
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Ingår i: Festskrift till Elisabeth Rynning: Integritet och rättssäkerhet inom och bortom den medicinska rätten. - 9789177372356 ; , s. 251-263
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Bokkapitel (refereegranskat)abstract
- On 5 January 2023, the Swedish Government announced the decision to introduce new restrictions to enter Sweden: due to the spread of Covid-19 in China, travellers from this direction need to show negative Covid-test results. In cases when there is no possibility of showing the results, the travellers are not allowed to enter Sweden. Governmental Ordinance (2023:2) was temporary and lasted from 7 January until 19 February 2023.Although the Ordinance is no longer in force, the fact of its enaction raises several public law concerns. Firstly, the concerns about the rule of law and the legal nature of such testing within the Swedish legal order must be addressed. Chapter 2 Article 6 of the Instrument of Government (hereinafter – IoG) prohibits forced bodily interventions; the right can be limited only by Parliament and, if necessary, in a democratic society. Governmental Ordinance 2023:2 raises the question of whether it limits the freedom from bodily interventions in the constitutional meaning. Secondly, if it will be concluded that the decisions about testing for infectious disease are the exclusive competence of Parliament, the central questions of legislative preparedness to prevent epidemic outbreaks in Sweden via testing those who arrive from the countries where such outbreaks occur must be raised. This contribution analyses the possibilities and hindrances for introducing compulsory testing to enter Sweden, such as the one established under Ordinance 2023:2. The analysis focuses on national constitutional and administrative law norms.
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20. |
- Litins'ka, Yana, et al.
(författare)
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Samtycke och beslutskompetens i vården
- 2020. - 1
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Ingår i: Medicinsk rätt. - Stockholm : Norstedts Juridik AB. - 9789139117148 ; , s. 85-99
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Bokkapitel (refereegranskat)
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21. |
- Litins'ka, Yana, et al.
(författare)
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Samtycke och beslutskompetens i vården
- 2022. - 2
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Ingår i: Medicinsk rätt. - Visby : Norstedts Juridik AB. - 9789139025269 ; , s. 119-134
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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22. |
- Litins'ka, Yana, et al.
(författare)
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Smittskydd
- 2022. - 2
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Ingår i: Medicinsk rätt. - 9789139025269 ; , s. 203-218
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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23. |
- Martin, Sylvia, et al.
(författare)
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A comparative ethical analysis of the Egyptian clinical research law
- 2024
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Ingår i: BMC Medical Ethics. - : BioMed Central (BMC). - 1472-6939. ; 25:1
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundIn this study, we examined the ethical implications of Egypt’s new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients.MethodsWe conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws.ResultsOn the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones.ConclusionThe analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.
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24. |
- 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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25. |
- Mattsson, Titti, et al.
(författare)
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E-hälsa
- 2020
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Ingår i: Medicinsk rätt. - 9789139117148 ; , s. 119-133
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Bokkapitel (refereegranskat)
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26. |
- Mattsson, Titti, et al.
(författare)
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E-hälsa
- 2022. - 2
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Ingår i: Medicinsk rätt. - 9789139025269 ; , s. 153-168
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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27. |
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28. |
- Mattsson, Titti, et al.
(författare)
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Vård i livets slutskede
- 2020
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Ingår i: Medicinsk rätt. - 9789139117148
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Bokkapitel (populärvet., debatt m.m.)
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29. |
- Mattsson, Titti, et al.
(författare)
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Vård i livets slutskede
- 2022. - 2
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Ingår i: Medicinsk rätt. - 9789139025269 ; , s. 307-320
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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30. |
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Medical Law
- 2015
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Samlingsverk (redaktörskap) (övrigt vetenskapligt/konstnärligt)
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31. |
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Medicīnas tiesības
- 2022. - 2
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Samlingsverk (redaktörskap) (övrigt vetenskapligt/konstnärligt)
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32. |
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Medicinsk rätt
- 2020
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Samlingsverk (redaktörskap) (övrigt vetenskapligt/konstnärligt)
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33. |
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Medicinsk rätt
- 2022. - 2
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Samlingsverk (redaktörskap) (övrigt vetenskapligt/konstnärligt)abstract
- Området för medicin och hälsa skapar dagligen nyhetsuppslag rörande dess kvalitet, tillgång, ansvar och konsekvenser för människors liv. De frågor som behandlas inom den medicinska rätten ligger i gränslandet mellan medicin och juridik, där även etiska, sociala och policydimensioner spelar in. De medicinrättsliga reglerna berör och påverkar flera aktörer på området för hälsa och medicin, såsom hälso- och sjukvårdspersonal, vårdgivare, patienter, forskare och olika beslutsfattare på myndigheter.Medicinsk rätt behandlar vissa kärnområden inom den medicinskarätten, bl.a. följande:• Hälso- och sjukvårdens rättsliga ansvar och patientens ställning.• Hälso- och sjukvårdssekretess.• Psykiatrisk tvångsvård.• Smittskydd.• Läkemedelsrätt, det rättsliga området för genetiska ingrepp och klinisk forskning.Medicinsk rätt är en lärobok som riktar sig till juriststudenter och studenter inom området för medicin, vård och omsorg samt verksamma inom samma områden. Det är även en värdefull bok för andra som behöver en fördjupad kunskap om de rättsliga ramarna för svenskhälso- och sjukvård och annan medicinsk verksamhet.I denna andra upplaga av boken har grundkapitlen reviderats och fyra nya kapitel tillkommit som alla berör olika relevanta och aktuella delar av den medicinska rätten.Bokens författare har särskilda sakkunskaper inom området för medicinsk rätt, där många har gedigen forskningserfarenhet och/eller stor erfarenhet av juridiskt och praktiskt arbete inom området.
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34. |
- 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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35. |
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36. |
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37. |
- Nordberg, Ana, et al.
(författare)
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Biobank and Biomedical Research: Responsibilities of Controllers and Processors under the EU General Data Protection Regulation
- 2021
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Ingår i: GDPR and biobanking : Individual rights, public interest and research regulation across Europe - Individual rights, public interest and research regulation across Europe. - Cham : Springer International Publishing. - 9783030493875 - 9783030493882 ; , s. 61-89
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Bokkapitel (refereegranskat)abstract
- Biobanks are essential infrastructures in current health and biomedical research. Advanced scientific research increasingly relies on processing and correlating large amounts of genetic, clinical and behavioural data. These data are particularly sensitive in nature and the risk for privacy invasion and misuse is high. The EU General Data Protection Regulation (GDPR) developed and increased harmonization, resulting in a framework defining specific duties and obligations of entities processing personal data – controllers and processors. Biobanks, in the exercise of their functions assume the role of controllers and/or processors and as such need to comply with a number of complex rules. This chapter analyses these rules, in light of Article 89 GDPR, which creates safeguards and derrogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. It identifies key compliance challenges faced by biobanks as data controllers and processors, such as determining whether the GDPR is applicable and its intersection with other regulations; when should a biobank be considered controller and processor; what are the main duties of biobanks as data controllers and processors and options for compliance.
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38. |
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40. |
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41. |
- Pagil, Sophie, et al.
(författare)
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Etik som rättsligt verktyg? Etikprövning av forskning som rättslig skyddsåtgärd för enskilda
- 2022
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Ingår i: Nordisk socialrättslig tidskrift. - : Stockholm Law Faculty's Trust Fund for Publications. - 2000-6500. ; 31-32, s. 39-70
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Tidskriftsartikel (refereegranskat)abstract
- Ethical review has in recent decades played an increasingly prominent role in the research community. In addition to the main function of the ethics review – to assess the benefits and risks of a planned research project – a further function has become increasingly important, namely ethical review as a tool for legal protection. International, European and Swedish fundamental rights documents entail a right to privacy (both physical and personal integrity) and the right to data protection. There are two internationally recognized safeguards to implement these rights in the field of scientific research: the requirement for informed consent and ethical review. The article analyzes the legal structure for ethical review in Swedish law, taking its departure in a matter decided by the Ethics Review Authority and the Board of Appeal for Ethics Review in 2020, where a research project was considered to fall outside the scope of the Ethics Review Act, after a narrow interpretation of relevant legal concepts. Based on an analysis of the phenomenon of juridification, the question is asked whether the Swedish ethics review is designed to provide adequate access to ethical review for research, while at the same time providing effective legal protection for research participants. The conclusion drawn is that the ethical review ought to be handled as an ethical tool, rather than a legal one. Focus ought to be placed on the ethical balancing of the benefits of a planned research project against the welfare of the research participants in the individual case, rather than a review of legal particularities.
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42. |
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43. |
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44. |
- Siemaszko, Konrad, et al.
(författare)
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D5.6: Recommendations for the enhancement of the existing legal frameworks for genomics, human enhancement, and AI and robotics
- 2020
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- This report identifies potential changes needed in the existing legal and human rights frameworks (international, EU and national) that might be necessary or desirable to create an environment in which the SIENNA proposals for ethical human genetics and genomics, human enhancement technologies and AI and robotics could be implemented most effectively. It also includes recommendations to improve enforcement and promote the uptake and effectiveness of the existing legislation in thesefields. The desired or necessary changes advanced are specified in the report along with related actions, actors responsible for implementing them, their priority levels, implementation challenges and how these could be addressed. The report also discusses the interrelations between ethics and law from the perspective of policymakers.
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45. |
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46. |
- Slokenberga, Santa, et al.
(författare)
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Ārstniecība cilvēka dzīves nogalē
- 2022. - 2
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Ingår i: Medicīnas tiesības. - : Tiesu namu aģentūra. - 9789934621017 ; , s. 485-514
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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47. |
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48. |
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49. |
- Slokenberga, Santa
(författare)
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Biobanking between the EU and Third Countries - Can Data Sharing Be Facilitated via Soft Regulatory Tools?
- 2018
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Ingår i: European Journal of Health Law. - : BRILL ACADEMIC PUBLISHERS. - 0929-0273 .- 1571-8093. ; 25:5, s. 517-536
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Tidskriftsartikel (refereegranskat)abstract
- In biobanking, collaboration and data sharing contribute to building genomic research capacity, and have the potential to further scientific advances that ultimately can result in advances in clinical care. However, in the absence of common applicable legal frameworks that enable collaboration, capacity building is hindered. With the applicability of the General Data Protection Regulation, the obstacles to data sharing which involve export of data from European Union Member States to third countries are expected to grow, rendering the collaboration between the EU and third countries even more challenging. This article examines how, if at all, data sharing in biobank research between the EU and third countries could be facilitated via the use of soft regulatory tools. It argues that although the existing soft tools might not in itself be suitable for meeting all the GDPR requirements, they could be the basis on which to raise the area-specific data protection bar globally.
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50. |
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