586 results on '"Genetic Privacy legislation & jurisprudence"'
Search Results
2. The Legal Status and Improvement Path of Human Genetic Data in Gene Therapy in China.
- Author
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Chen J and Li W
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- Humans, China, Genetic Privacy legislation & jurisprudence, Informed Consent legislation & jurisprudence, Confidentiality legislation & jurisprudence, Genetic Therapy legislation & jurisprudence, Genetic Therapy methods
- Abstract
In the legal context of Chinese law, genetic data are an object of complex rights. At the level of private law, genetic data contain personal information, thus being protected by the Civil Code and the Personal Information Protection Law. At the level of public law, genetic data are important genetic resource that embody both public and national interests, which should also be regulated by public laws such as the Biosecurity Law and the Data Security Law. The recently issued Regulation on the Administration of Human Genetic Resources have refined the approval and record procedure, in order to promote the utilization of genetic data in China. At present, China still lacks sufficient protection for genetic data privacy, and the "informed consent" and "anonymization" system cannot work effectively. On the path of improvement, we should break constraints of individualism and start from the following three levels to strengthen genetic data privacy protection: formulating specialized legislation and leveraging the functions of group organizations and public interest litigation systems.
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- 2024
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3. A proposal for an inclusive working definition of genetic discrimination to promote a more coherent debate.
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Kaiser B, Uberoi D, Raven-Adams MC, Cheung K, Bruns A, Chandrasekharan S, Otlowski M, Prince AER, Tiller J, Ahmed A, Bombard Y, Dupras C, Moreno PG, Ryan R, Valderrama-Aguirre A, and Joly Y
- Subjects
- Humans, Social Discrimination, Genetic Privacy legislation & jurisprudence, Prejudice, Human Rights
- Abstract
Genetic discrimination is an evolving phenomenon that impacts fundamental human rights such as dignity, justice and equity. Although, in the past, various definitions to better conceptualize genetic discrimination have been proposed, these have been unable to capture several key facets of the phenomenon. In this Perspective, we explore definitions of genetic discrimination across disciplines, consider criticisms of such definitions and show how other forms of discrimination and stigmatization can compound genetic discrimination in a way that affects individuals, groups and systems. We propose a nuanced and inclusive definition of genetic discrimination, which reflects its multifaceted impact that should remain relevant in the face of an evolving social context and advancing science. We argue that our definition should be adopted as a guiding academic framework to facilitate scientific and policy discussions about genetic discrimination and support the development of laws and industry policies seeking to address the phenomenon., (© 2024. Springer Nature America, Inc.)
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- 2024
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4. Legal aspects of privacy-enhancing technologies in genome-wide association studies and their impact on performance and feasibility.
- Author
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Brauneck A, Schmalhorst L, Weiss S, Baumbach L, Völker U, Ellinghaus D, Baumbach J, and Buchholtz G
- Subjects
- Humans, Genetic Privacy legislation & jurisprudence, Genome-Wide Association Study, Computer Security legislation & jurisprudence
- Abstract
Genomic data holds huge potential for medical progress but requires strict safety measures due to its sensitive nature to comply with data protection laws. This conflict is especially pronounced in genome-wide association studies (GWAS) which rely on vast amounts of genomic data to improve medical diagnoses. To ensure both their benefits and sufficient data security, we propose a federated approach in combination with privacy-enhancing technologies utilising the findings from a systematic review on federated learning and legal regulations in general and applying these to GWAS., (© 2024. The Author(s).)
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- 2024
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5. Moving Genomics into the Clinic: Platforms for Implementing Clinical Genomic Data-Sharing in Ways That Address Ethical, Legal and Social Implications.
- Author
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Nicol D, Otlowski M, Reade K, Thorne N, and Gaff C
- Subjects
- Humans, Australia, Informed Consent legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Confidentiality legislation & jurisprudence, Genomics legislation & jurisprudence, Genomics ethics, Information Dissemination legislation & jurisprudence, Information Dissemination ethics
- Abstract
This section explores the challenges involved in translating genomic research into genomic medicine. A number of priorities have been identified in the Australian National Health Genomics Framework for addressing these challenges. Responsible collection, storage, use and management of genomic data is one of these priorities, and is the primary theme of this section. The recent release of Genomical, an Australian data-sharing platform, is used as a case study to illustrate the type of assistance that can be provided to the health care sector in addressing this priority. The section first describes the National Framework and other drivers involved in the move towards genomic medicine. The section then examines key ethical, legal and social factors at play in genomics, with particular focus on privacy and consent. Finally, the section examines how Genomical is being used to help ensure that the move towards genomic medicine is ethically, legally and socially sound and that it optimises advances in both genomic and information technology., Competing Interests: Nicol and Otlowski are supported by a grant from the Australian Research Council, DP180100269. The Melbourne Genomics Health Alliance is supported are supported by the Victorian Government Department of Health and Human Services (www.dhhs.vic.gov.au/).
- Published
- 2024
6. How Indigenous communities in New Zealand are protecting their data.
- Author
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Kukutai T
- Subjects
- Artificial Intelligence, New Zealand, Humans, Human Rights legislation & jurisprudence, Maori People legislation & jurisprudence, Information Dissemination legislation & jurisprudence, Genetic Privacy legislation & jurisprudence
- Abstract
Concerns about the ethical use of data, privacy, and data harms are front of mind in many jurisdictions as regulators move to impose tighter controls on data privacy and protection, and the use of artificial intelligence (AI). Although efforts to hold corporations to account for their deployment of data and data-driven technologies have been largely welcomed by academics and civil society, there is a growing recognition of the limits to individual data rights, given the capacity of tech giants to link, surveil, target, and make inferences about groups. Questions about whether collective data rights exist, and how they can be recognized and protected, have provided fertile ground for researchers but have yet to penetrate the broader discourse on data rights and regulation.
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- 2024
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7. The Genetic Information Privacy Act: Drawbacks and Limitations.
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Prince AER
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- Confidentiality, Prejudice, Privacy, United States, Genetic Privacy legislation & jurisprudence, Genetic Testing legislation & jurisprudence
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- 2023
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8. Anti-Selection is Only the Beginning.
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Blake VK and Roberts JL
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- Genetic Testing legislation & jurisprudence, Humans, Genetic Privacy legislation & jurisprudence, Insurance
- Abstract
This commentary proposes the need for greater normative debate about when, if ever, it is appropriate for insurers to access genetic information of insureds to combat anti-selection.
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- 2022
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9. Looking back: three key lessons from 20 years of shaping Japanese genome research regulations.
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Minari J, Yokono M, Takashima K, Kokado M, Ida R, and Hishiyama Y
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- Biomedical Research ethics, Biomedical Research history, Biomedical Research standards, Computer Security ethics, Computer Security history, Computer Security legislation & jurisprudence, Ethicists history, Ethicists legislation & jurisprudence, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Healthy Volunteers, History, 21st Century, Human Genetics ethics, Human Genetics history, Human Genetics standards, Humans, Japan, Biomedical Research legislation & jurisprudence, Genome, Human physiology, Government Regulation history, Human Genetics legislation & jurisprudence, Practice Guidelines as Topic standards
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- 2021
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10. HIPAA at 25 - A Work in Progress.
- Author
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Allen AL
- Subjects
- Confidentiality history, Genetic Privacy legislation & jurisprudence, Government Regulation history, Health Insurance Portability and Accountability Act legislation & jurisprudence, History, 20th Century, History, 21st Century, Information Dissemination legislation & jurisprudence, United States, United States Dept. of Health and Human Services, Confidentiality legislation & jurisprudence, Health Insurance Portability and Accountability Act history
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- 2021
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11. Direct-to-consumer personal genomic tests need better regulation.
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Moneer O, Miller JE, Shah ND, and Ross JS
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- Humans, Genetic Privacy legislation & jurisprudence, Genetic Testing legislation & jurisprudence, Genome, Human genetics, Genomics legislation & jurisprudence
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- 2021
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12. Genetics and COVID-19: How to Protect the Susceptible.
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Field RI, Orlando AW, and Rosoff AJ
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- COVID-19 prevention & control, COVID-19 virology, Genetic Markers genetics, Genetic Testing legislation & jurisprudence, Humans, COVID-19 genetics, Genetic Predisposition to Disease genetics, Genetic Privacy legislation & jurisprudence, SARS-CoV-2 physiology
- Abstract
Along with the potential for breakthroughs in care and prevention, the search for genetic mechanisms underlying the spread and severity of coronavirus disease 2019 (COVID-19) introduces the risk of discrimination against those found to have markers for susceptibility. We propose new legal protections to mitigate gaps in protections under existing laws., (Copyright © 2020 Elsevier Ltd. All rights reserved.)
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- 2021
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13. Disclosing genetic information to family members without consent: Five Australian case studies.
- Author
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Tiller J, Bilkey G, Macintosh R, O'Sullivan S, Groube S, Palover M, Pachter N, Rothstein M, Lacaze P, and Otlowski M
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- Australia, Duty to Warn ethics, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Humans, Informed Consent ethics, Informed Consent legislation & jurisprudence, Duty to Warn legislation & jurisprudence, Family, Genetic Predisposition to Disease
- Abstract
Genetic risk information is relevant to individual patients and also their blood relatives. Health practitioners (HPs) routinely advise patients of the importance of sharing genetic information with family members, especially for clinically actionable conditions where prevention is possible. However, some patients refuse to share genetic results with at-risk relatives, and HPs must choose whether to use or disclose genetic information without consent. This requires an understanding of their legal and ethical obligations, which research shows many HPs do not have. A recent UK case held that HPs have a duty to a patient's relatives where there is a proximate relationship, to conduct a balancing exercise of the benefit of disclosure of the genetic risk information to the relative against the interest of the patient in maintaining confidentiality. In Australia, there is currently no legal duty to disclose genetic information to a patient's at-risk relatives, but there are laws and guidelines governing unconsented use/disclosure of genetic information. These laws are inconsistent across different Australian states and health contexts, requiring greater harmonisation. Here we provide an up-to-date and clinically accessible resource summarising the laws applying to HPs across Australia, and outline five Australian case studies which have arisen in clinical genetics services, regarding the disclosure of genetic results to relatives without consent. The issues addressed here are relevant to any Australian HP with access to genetic information, as well as HPs and policy-makers in other jurisdictions considering these issues., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)
- Published
- 2020
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14. Operationalising forensic genetic genealogy in an Australian context.
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Scudder N, Daniel R, Raymond J, and Sears A
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- Australia, Confidentiality legislation & jurisprudence, DNA Fingerprinting, Forensic Genetics, Genetic Privacy legislation & jurisprudence, Humans, Quality Control, Trust, Databases, Nucleic Acid legislation & jurisprudence, Pedigree
- Abstract
Forensic genetic genealogy, a technique leveraging new DNA capabilities and public genetic databases to identify suspects, raises specific considerations in a law enforcement context. Use of this technique requires consideration of its scientific and technical limitations, including the composition of current online datasets, and consideration of its scientific validity. Additionally, forensic genetic genealogy needs to be considered in the relevant legal context to determine the best way in which to make use of its potential to generate investigative leads while minimising its impact on individual privacy. This article presents these issues from an Australian perspective, with the observations and conclusions likely to be applicable to other jurisdictions., Competing Interests: Declaraion of Competing Interest No potential conflicts of interest are reported by the authors., (Copyright © 2020 Elsevier B.V. All rights reserved.)
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- 2020
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15. Professional duties are now considered legal duties of care within genomic medicine.
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Anna M, Christine P, Jonathan R, Richard M, Alessia C, Lauren R, and Jerome A
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- Genetic Privacy ethics, Genetics, Medical ethics, Health Personnel ethics, Humans, Informed Consent ethics, United Kingdom, Genetic Privacy legislation & jurisprudence, Genetics, Medical legislation & jurisprudence, Health Personnel legislation & jurisprudence, Informed Consent legislation & jurisprudence
- Abstract
The legal duty to protect patient confidentiality is common knowledge amongst healthcare professionals. However, what may not be widely known, is that this duty is not always absolute. In the United Kingdom, both the General Medical Council governing the practice of all doctors, as well as many other professional codes of practice recognise that, under certain circumstances, it may be appropriate to break confidentiality. This arises when there is a wider duty to protect the health of others, and when the risk of non-disclosure outweighs the potential harm from breaking confidentiality. We discuss this situation specifically in relation to genomic medicine where relatives in a family may have differing views on the sharing of familial genetic information. Overruling a patient's wishes is predicated on balancing the duty of care towards the patient versus protecting their relative from serious harm. We discuss the practice implications of a pivotal legal case that concluded recently in the High Court of Justice in England and Wales, ABC v St Georges Healthcare NHS Trust & Ors. Professional guidance is already clear that genetic healthcare professionals must undertake a balancing exercise to weigh up contradictory duties of care. However, the judge has provided a new legal weighting to these professional duties: 'The scope of the duty extends not only to conducting the necessary balancing exercise but also to acting in accordance with its outcome' [1: 189]. In the context of genomic medicine, this has important consequences for clinical practice.
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- 2020
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16. Predictive Health Information and Employment Discrimination under the ADA and GINA.
- Author
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Rothstein MA
- Subjects
- Humans, Public Policy, Risk Assessment trends, United States, Civil Rights legislation & jurisprudence, Disabled Persons legislation & jurisprudence, Employment legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Health Status, Risk Assessment methods
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- 2020
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17. Looking Beyond GINA: Policy Approaches to Address Genetic Discrimination.
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Joly Y, Dupras C, Pinkesz M, Tovino SA, and Rothstein MA
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- Humans, Legislation, Medical, Prejudice, Genetic Privacy legislation & jurisprudence, Genetic Testing legislation & jurisprudence, Genomics ethics, Genomics legislation & jurisprudence, Public Policy
- Abstract
Concerns about genetic discrimination (GD) often surface when discussing research and innovation in genetics. Over recent decades, countries around the world have attempted to address GD using various policy measures. In this article, we survey these approaches and provide a critical commentary on their advantages and disadvantages. Our examination begins with regions featuring extensive policy-making activities (North America and Europe), followed by regions with moderate policy-making activities (Australia, Asia, and South America) and regions with minimal policy-making activities (the Middle East and Africa). Our analysis then turns to emerging issues regarding genetic testing and GD, including the expansion of multiomics sciences and direct-to-consumer genetic tests outside the health context. We additionally survey the shortcomings of current normative approaches addressing GD. Finally, we conclude by highlighting the evolving nature of GD and the need for more innovative policy-making in this area.
- Published
- 2020
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18. Consent and Privacy in the Era of Precision Medicine and Biobanking Genomic Data.
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Conboy C
- Subjects
- Decision Making, Humans, Biological Specimen Banks legislation & jurisprudence, Confidentiality legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Human Experimentation legislation & jurisprudence, Informed Consent legislation & jurisprudence, Precision Medicine ethics, Whole Genome Sequencing ethics
- Abstract
"Big Data represents a challenge that points to the need for collective and political approaches to self-protection rather than solely individual, atomistic approaches."- Anita Allen, "Protecting One's Own Privacy in a Big Data Economy".
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- 2020
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19. Genetic Discrimination: The Genetic Information Nondiscrimination Act's Impact on Practice and Research.
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Underhill-Blazey M and Klehm MR
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- Female, Humans, Middle Aged, Neoplasms genetics, Oncology Nursing, Prejudice, United States, Genetic Privacy legislation & jurisprudence, Genetic Testing legislation & jurisprudence
- Abstract
The Genetic Information Nondiscrimination Act of 2008 (GINA) provides federal safeguards to prohibit employer or insurance discrimination based on personal or familial genetic information or conditions. Awareness of the implications of genetic testing in individuals and families and of state and federal legislation in place for their protection is an essential component of oncology nursing practice. This article discusses the critical role of the oncology nurse in interacting with and providing information about GINA to patients in a cancer care setting engaged in genetic assessment.
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- 2020
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20. Ensuring privacy and security of genomic data and functionalities.
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Mohammed Yakubu A and Chen YP
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- Genome, Human, Genome-Wide Association Study, Humans, Computer Security, Genetic Privacy legislation & jurisprudence, Genomics methods
- Abstract
In recent times, the reduced cost of DNA sequencing has resulted in a plethora of genomic data that is being used to advance biomedical research and improve clinical procedures and healthcare delivery. These advances are revolutionizing areas in genome-wide association studies (GWASs), diagnostic testing, personalized medicine and drug discovery. This, however, comes with security and privacy challenges as the human genome is sensitive in nature and uniquely identifies an individual. In this article, we discuss the genome privacy problem and review relevant privacy attacks, classified into identity tracing, attribute disclosure and completion attacks, which have been used to breach the privacy of an individual. We then classify state-of-the-art genomic privacy-preserving solutions based on their application and computational domains (genomic aggregation, GWASs and statistical analysis, sequence comparison and genetic testing) that have been proposed to mitigate these attacks and compare them in terms of their underlining cryptographic primitives, security goals and complexities-computation and transmission overheads. Finally, we identify and discuss the open issues, research challenges and future directions in the field of genomic privacy. We believe this article will provide researchers with the current trends and insights on the importance and challenges of privacy and security issues in the area of genomics., (© The Author(s) 2019. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
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- 2020
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21. Review of policies of companies and databases regarding access to customers' genealogy data for law enforcement purposes.
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Skeva S, Larmuseau MH, and Shabani M
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- Databases, Factual ethics, Databases, Factual legislation & jurisprudence, Direct-To-Consumer Screening and Testing ethics, Direct-To-Consumer Screening and Testing legislation & jurisprudence, Genetic Privacy ethics, Genetic Testing legislation & jurisprudence, Health Policy, Humans, Pedigree, Genetic Privacy legislation & jurisprudence, Genetic Testing ethics
- Abstract
The rapidly evolving popularity of direct-to-consumer genetic genealogy companies has made it possible to retrieve genomic information for unintended reasons by third parties, including the emerging use for law enforcement purposes. The question remains whether users of direct-to-consumer genetic genealogy companies and genealogical databases are aware that their genetic and/or genealogical data could be used as means to solving forensic cases. Our review of 22 companies' and databases' policies showed that only four companies have provided additional information on how law enforcement agencies should request permission to use their services for law enforcement purposes. Moreover, two databases have adopted a different approach by providing a special service for law enforcement. Although all companies and databases included in the study provide at least some provisions about police access, there is an ongoing debate over the ethics of these practices, and how to balance users' privacy with law enforcement requests.
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- 2020
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22. Genomic research and privacy: A response to Staunton et al.
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Thaldar DW and Townsend B
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- Genomics, Humans, South Africa, Confidentiality legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Genetic Research legislation & jurisprudence
- Abstract
The Protection of Personal Information Act No. 4 of 2013 (POPIA) promises a new dispensation of privacy protection for research participants in South Africa. In a recent article, Staunton et al. proposed that a purposive interpretation of POPIA would allow for the retention of the status quo of broad consent in the context of genomic research. In this response article, we analyse the argument presented by Staunton et al., and conclude that it fails to convince: firstly, because Staunton et al. do not present empirical data for their factual assumption that moving up the consent benchmark is likely to stymie research; secondly, because genomic research does not have a monopoly on the public interest, but shares it with the privacy rights of research participants; and thirdly, because POPIA was designed to promote the protection of privacy, not simply to preserve the status quo as found in existing policy instruments. In contrast to the position advocated by Staunton et al., we suggest that a purposive interpretation of POPIA is aligned with the plain meaning of the statute - namely that specific (not broad) consent is a prerequisite for research on genomic information.This article, which comments on an article by Staunton et al. (Staunton C, Adams R, Botes M, et al. Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. S Afr Med J 2019;109(7):468-470. https://doi.org/10.7196/SAMJ.2019.v109i7.14148), is followed by a letter by Thaldar and Townsend (Privacy rights of human research participants in South Africa must be taken seriously. S Afr Med J 2020;110(3):175-176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450); and a response to the article and letter by Staunton et al. (S Afr Med J 2020;110(3):175-176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450).
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- 2020
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23. Disclosure to genetic relatives without consent - Australian genetic professionals' awareness of the health privacy law.
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Meggiolaro N, Barlow-Stewart K, Dunlop K, Newson AJ, and Fleming J
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- Awareness, Duty to Warn ethics, Duty to Warn legislation & jurisprudence, Humans, Informed Consent, Moral Obligations, New South Wales, Disclosure ethics, Disclosure legislation & jurisprudence, Family, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence
- Abstract
Background: When a genetic mutation is identified in a family member (proband), internationally, it is usually the proband's or another responsible family member's role to disclose the information to at-risk relatives. However, both active and passive non-disclosure in families occurs: choosing not to communicate the information or failing to communicate the information despite intention to do so, respectively. The ethical obligations to prevent harm to at-risk relatives and promote the duty of care by genetic health professionals (GHPs) is in conflict with Privacy laws and professional regulations that prohibits disclosure of information to a third party without the consent of the proband (duty of confidentiality). In New South Wales (NSW), Australia, amendments to Privacy legislation permits such disclosure to living genetic relatives with the process defined under guidelines although there is no legal duty to warn. This study assessed NSW GHP's awareness and experience of the legislation and guidelines., Methods: An online survey collected demographics; theoretical knowledge; clinical scenarios to assess application knowledge; attitudes; confidence; experience with active non-disclosure. A link to correct answers was provided after completion. Knowledge scores above the median for non-parametric data or above the mean for parametric data were classified as 'good' or 'poor'. Chi square tests assessed associations between confidence and knowledge scores., Results: While many of the 37 participants reported reading the guidelines, there was limited awareness of their scope and clinical application; that there is no legal duty to warn; and that the threat does not need to be imminent to warrant disclosure. No association between confidence and 'good' theoretical or applied clinical knowledge was identified. Uncertainty of their professional responsibility was identified and in the several case examples of active non-disclosure that were reported this uncertainty reflected the need for further understanding of the guidelines in regard to the processes required before disclosure was initiated., Conclusions: There is a need for further education and training about the guidelines associated with the legislation that would be relevant to support disclosure. The findings may inform future strategies to support introduction of policy changes in other jurisdictions where similar regulatory regimes are introduced.
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- 2020
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24. ESHG PPPC Comments on postmortem use of genetic data for research purposes.
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Fellmann F, Rial-Sebbag E, Patch C, Hentze S, Stefandottir V, Mendes Á, van El CG, Cornel MC, and Forzano F
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- Autopsy, Europe, Expert Testimony, Genetic Privacy legislation & jurisprudence, Humans, Public Policy, Societies, Medical, Biological Specimen Banks ethics, Genetic Privacy ethics, Human Genetics ethics
- Published
- 2020
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25. Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis.
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Schickhardt C, Fleischer H, and Winkler EC
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- Confidentiality ethics, Confidentiality legislation & jurisprudence, Ethical Analysis, Europe, Humans, Informed Consent ethics, Informed Consent legislation & jurisprudence, Research Personnel ethics, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Genetic Research ethics, Genetic Research legislation & jurisprudence, Genomics ethics, Patients, Research Subjects
- Abstract
Background: As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice., Methods: In a first step we clarify some central concepts such as "raw data"; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one's raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data., Results: In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom., Conclusion: Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects' legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.
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- 2020
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26. Return of raw data in genomic testing and research: ownership, partnership, and risk-benefit.
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May T, Nakano-Okuno M, Kelley WV, East K, Moss IP, Sodeke S, Korf B, and Barsh G
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- Alabama, Direct-To-Consumer Screening and Testing legislation & jurisprudence, Direct-To-Consumer Screening and Testing organization & administration, Genetic Testing legislation & jurisprudence, Humans, Ownership, Genetic Privacy legislation & jurisprudence, Patient Access to Records legislation & jurisprudence
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- 2020
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27. Crack down on genomic surveillance.
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Moreau Y
- Subjects
- Biometric Identification methods, China, DNA Fingerprinting ethics, Federal Government, Genetic Privacy standards, Human Rights ethics, Human Rights standards, Humans, Internationality, Pedigree, Population Surveillance methods, Biometric Identification ethics, Databases, Genetic ethics, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Genome, Human genetics, Human Rights legislation & jurisprudence, Sequence Analysis, DNA ethics
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- 2019
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28. Opportunities and Challenges in Interpreting and Sharing Personal Genomes.
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Rubin IR and Glusman G
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- Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Humans, Information Dissemination, Genetic Privacy standards, Genome, Human
- Abstract
The 2019 "Personal Genomes: Accessing, Sharing and Interpretation" conference (Hinxton, UK, 11-12 April 2019) brought together geneticists, bioinformaticians, clinicians and ethicists to promote openness and ethical sharing of personal genome data while protecting the privacy of individuals. The talks at the conference focused on two main topic areas: (1) Technologies and Applications, with emphasis on personal genomics in the context of healthcare. The issues discussed ranged from new technologies impacting and enabling the field, to the interpretation of personal genomes and their integration with other data types. There was particular emphasis and wide discussion on the use of polygenic risk scores to inform precision medicine. (2) Ethical, Legal, and Social Implications, with emphasis on genetic privacy: How to maintain it, how much privacy is possible, and how much privacy do people want? Talks covered the full range of genomic data visibility, from open access to tight control, and diverse aspects of balancing benefits and risks, data ownership, working with individuals and with populations, and promoting citizen science. Both topic areas were illustrated and informed by reports from a wide variety of ongoing projects, which highlighted the need to diversify global databases by increasing representation of understudied populations.
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- 2019
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29. The GDPR and the research exemption: considerations on the necessary safeguards for research biobanks.
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Staunton C, Slokenberga S, and Mascalzoni D
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- Biomedical Research ethics, Biomedical Research legislation & jurisprudence, Biomedical Research methods, European Union, Health Records, Personal ethics, Humans, International Cooperation, Biological Specimen Banks legislation & jurisprudence, Computer Security legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Human Genetics legislation & jurisprudence
- Abstract
The General Data Protection Regulation (GDPR) came into force in May 2018. The aspiration of providing for a high level of protection to individuals' personal data risked placing considerable constraints on scientific research, which was contrary to various research traditions across the EU. Therefore, along with the set of carefully outlined data subjects' rights, the GDPR provides for a two-level framework to enable derogations from these rights when scientific research is concerned. First, by directly invoking provisions of the GDPR on a condition that safeguards that must include 'technical and organisational measures' are in place and second, through the Member State law. Although these derogations are allowed in the name of scientific research, they can simultaneously be challenging in light of the ethical requirements and well-established standards in biobanking that have been set forth in various research-related soft legal tools, international treaties and other legal instruments. In this article, we review such soft legal tools, international treaties and other legal instruments that regulate the use of health research data. We report on the results of this review, and analyse the rights contained within the GDPR and Article 89 of the GDPR vis-à-vis these instruments. These instruments were also reviewed to provide guidance on possible safeguards that should be followed when implementing any derogations. To conclude, we will offer some commentary on limits of the derogations under the GDPR and appropriate safeguards to ensure compliance with standard ethical requirements.
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- 2019
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30. Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013.
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Staunton C, Adams R, Botes M, Dove ES, Horn L, Labuschaigne M, Loots G, Mahomed S, Makuba J, Olckers A, Pepper MS, Pope A, Ramsay M, Loideain NN, and De Vries J
- Subjects
- Electronic Data Processing legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Humans, South Africa, Confidentiality legislation & jurisprudence, Genetic Research, Genomics, Information Dissemination legislation & jurisprudence, Informed Consent legislation & jurisprudence
- Abstract
Genomic research has been identified in South Africa (SA) as important in developing a strong bio-economy that has the potential to improve human health, drive job creation and offer potential solutions to the disease burden harboured by low- and middle-income countries. Central to the success of genomic research is the wide sharing of biological samples and data, but the true value of data can only be unlocked if there are laws and policies in place that foster the legal and ethical sharing of genomic data. The introduction and entry into force of SA's Protection of Personal Information Act (POPIA) No. 4 of 2013 is to be welcomed, but the wording of POPIA as it pertains to consent for the processing of personal information for research purposes has sparked a debate about the legal status of broad consent. We argue that a purposive interpretation of the legislation would permit broad consent for the processing of personal information for research. Although there are ongoing debates surrounding the ethical use of broad consent in Africa, the objective of this article is not to engage with the ethics of broad consent itself, but rather to focus on the legal status of broad consent for genomic data sharing under POPIA.
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- 2019
- Full Text
- View/download PDF
31. Direct-to-Consumer Genetic Testing and Potential Loopholes in Protecting Consumer Privacy and Nondiscrimination.
- Author
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Hendricks-Sturrup RM, Prince AER, and Lu CY
- Subjects
- Direct-To-Consumer Screening and Testing ethics, Genetic Testing ethics, Health Insurance Portability and Accountability Act, Humans, United States, Direct-To-Consumer Screening and Testing legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Genetic Testing legislation & jurisprudence, Law Enforcement
- Published
- 2019
- Full Text
- View/download PDF
32. Cases in Precision Medicine: Concerns About Privacy and Discrimination After Genomic Sequencing.
- Author
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Stiles D and Appelbaum PS
- Subjects
- Genetic Predisposition to Disease, Humans, United States, Genetic Counseling legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Genetic Testing legislation & jurisprudence, Genomics legislation & jurisprudence, Precision Medicine, Prejudice legislation & jurisprudence
- Abstract
Patients and research participants have indicated that privacy of their genetic test results is an important concern, particularly with respect to insurance coverage. Internists and other physicians whose patients ask about legal protections for information generated by genome sequencing for clinical purposes can provide both reassurance and caution. Protections for medical information in general, as well as laws in some states that provide additional safeguards for genetic data, should reassure patients that this information will remain private. Patients themselves will need to weigh the risks versus the benefits of generating genomic data in deciding whether to undergo exome sequencing.
- Published
- 2019
- Full Text
- View/download PDF
33. Thought Leader Perspectives on Participant Protections in Precision Medicine Research.
- Author
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Hammack CM, Brelsford KM, and Beskow LM
- Subjects
- Confidentiality legislation & jurisprudence, Female, Genetic Privacy legislation & jurisprudence, Humans, Male, Computer Security legislation & jurisprudence, Human Experimentation legislation & jurisprudence, Interviews as Topic, Precision Medicine ethics
- Abstract
Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current "web" of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research.
- Published
- 2019
- Full Text
- View/download PDF
34. Comparative perspectives: regulating insurer use of genetic information.
- Author
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Prince AER
- Subjects
- Australia, Canada, Genetic Privacy economics, Genetic Privacy legislation & jurisprudence, Genetic Privacy trends, Genetic Testing economics, Genetic Testing legislation & jurisprudence, Humans, Public Opinion, United Kingdom, Genetic Privacy ethics, Genetic Testing ethics, Insurance Carriers
- Abstract
Fear of genetic discrimination has led individuals worldwide to avoid medically recommended genetic testing and participation in genomics research, causing potential health effects as research and clinical care are stymied. In response, many countries have adopted policies that regulate how insurers, such as life, disability, or critical illness insurers, can underwrite using genetic test results. This article presents a comparison of policies in the United Kingdom, Canada, and Australia, through analysis of interviews with 59 key stakeholders representing insurance, government, advocacy, academia, and genetics. While the ultimate policy of each country is different, the policy motivations and issues raised share commonalities across the countries, particularly around themes of fairness, usefulness of genetic information, and the determination of actuarial fairness.
- Published
- 2019
- Full Text
- View/download PDF
35. Shadow health records meet new data privacy laws.
- Author
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Price WN 2nd, Kaminski ME, Minssen T, and Spector-Bagdady K
- Subjects
- Big Data, European Union, Health Insurance Portability and Accountability Act, Humans, United States, Confidentiality legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Health Records, Personal, Information Dissemination legislation & jurisprudence
- Published
- 2019
- Full Text
- View/download PDF
36. Prohibiting Genetic Discrimination to Promote Science, Health, and Fairness.
- Subjects
- Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Humans, Prejudice ethics, Genetics, Medical ethics, Genetics, Medical legislation & jurisprudence, Health, Prejudice legislation & jurisprudence, Prejudice prevention & control, Social Justice legislation & jurisprudence
- Abstract
Protections against genetic discrimination advance genetics research and the clinical use of genetics, as well as ensure the ethical use of genetic data. Ten years after the passage of the Genetic Information Nondiscrimination Act (GINA), the American Society of Human Genetics remains a staunch advocate for GINA's strong implementation and for other laws that enhance protections for the public., (Copyright © 2018. Published by Elsevier Inc.)
- Published
- 2019
- Full Text
- View/download PDF
37. Genomic Privacy.
- Author
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Schwab AP, Luu HS, Wang J, and Park JY
- Subjects
- Computer Security ethics, Computer Security legislation & jurisprudence, Databases, Factual, Forensic Genetics ethics, Forensic Genetics legislation & jurisprudence, Genome, Human, Government Regulation, Humans, Information Dissemination, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Genetic Testing ethics, Genetic Testing legislation & jurisprudence, Genetic Testing methods
- Abstract
Background: Genetic information is unique among all laboratory data because it not only informs the current health of the specific person tested but may also be predictive of the future health of the individual and, to varying degrees, all biological relatives., Content: As DNA sequencing has become ubiquitous with decreasing cost, large repositories of genomic data have emerged from the domains of research, healthcare, law enforcement, international security, and recreational consumer interest (i.e., genealogy). Broadly shared genomic data are believed to be a key element for future discoveries in human disease. For example, the National Cancer Institute's Genomic Data Commons is designed to promote cancer research discoveries by providing free access to the genome data sets of 12000 cancer patients. However, in parallel with the promise of curing diseases, genomic data also have the potential for harm. Genomic data that are deidentified by standard healthcare practices (e.g., removal of name, date of birth) can be reidentified by methods that combine genomic software with publicly available demographic databases (e.g., phone book). Recent law enforcement cases (i.e., Bear Brook Murders, Golden State Killer) in the US have demonstrated the power of combining DNA profiles with genealogy databases., Summary: We examine the current environment of genomic privacy and confidentiality in the US and describe current and future risks to genomic privacy. Reidentification and inference of genetic information of biological relatives will become more important as larger databases of clinical, criminal, and recreational genomic information are developed over the next decade., (© 2018 American Association for Clinical Chemistry.)
- Published
- 2018
- Full Text
- View/download PDF
38. China's crackdown on genetics breaches could deter data sharing.
- Author
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Cyranoski D
- Subjects
- Breast Neoplasms diagnosis, Breast Neoplasms genetics, China, DNA genetics, Genome, Human genetics, Genomics legislation & jurisprudence, Humans, Publishing legislation & jurisprudence, Drug Industry legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Information Dissemination legislation & jurisprudence
- Published
- 2018
- Full Text
- View/download PDF
39. Law and policy oversight of familial searches in recreational genealogy databases.
- Author
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Murphy E
- Subjects
- DNA Fingerprinting legislation & jurisprudence, Data Mining, Humans, Microsatellite Repeats, Polymorphism, Single Nucleotide, Databases, Nucleic Acid legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Police
- Published
- 2018
- Full Text
- View/download PDF
40. Should police have access to genetic genealogy databases? Capturing the Golden State Killer and other criminals using a controversial new forensic technique.
- Author
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Guerrini CJ, Robinson JO, Petersen D, and McGuire AL
- Subjects
- Adolescent, Adult, California, Databases, Nucleic Acid ethics, Databases, Nucleic Acid legislation & jurisprudence, Female, Forensic Genetics ethics, Forensic Genetics legislation & jurisprudence, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Humans, Male, Pedigree, Surveys and Questionnaires, Young Adult, Criminals legislation & jurisprudence, Forensic Genetics methods, Genealogy and Heraldry, Police ethics, Police legislation & jurisprudence
- Abstract
On April 24, 2018, a suspect in California's notorious Golden State Killer cases was arrested after decades of eluding the police. Using a novel forensic approach, investigators identified the suspect by first identifying his relatives using a free, online genetic database populated by individuals researching their family trees. In the wake of the case, media outlets reported privacy concerns with police access to personal genetic data generated by or shared with genealogy services. Recent data from 1,587 survey respondents, however, provide preliminary reason to question whether such concerns have been overstated. Still, limitations on police access to genetic genealogy databases in particular may be desirable for reasons other than current public demand for them., Competing Interests: The authors have declared that no competing interests exist.
- Published
- 2018
- Full Text
- View/download PDF
41. Genes wide open: Data sharing and the social gradient of genomic privacy.
- Author
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Haeusermann T, Fadda M, Blasimme A, Tzovaras BG, and Vayena E
- Subjects
- Computer Security ethics, Computer Security legislation & jurisprudence, Electronic Health Records ethics, Electronic Health Records legislation & jurisprudence, Follow-Up Studies, Genetic Privacy legislation & jurisprudence, Genetic Research legislation & jurisprudence, Genomics, Humans, Information Dissemination legislation & jurisprudence, Qualitative Research, Social Responsibility, Direct-To-Consumer Screening and Testing ethics, Genetic Privacy ethics, Genetic Research ethics, Information Dissemination ethics
- Abstract
This study reports on 13 semistructured in-depth interviews to qualitatively explore the experiences of individuals who publicly shared their direct-to-consumer genetic testing results on the platform openSNP. In particular, we focused on interviewees' understanding of privacy. Participants reported that the likelihood and the magnitude of privacy harms depend on gender, ethnicity, sexual orientation, the stigma associated with certain clinical conditions, the existence of adequate legislation, and the nature of national health care systems. Some participants expressed the view that those who enjoy higher socioeconomic status or are better protected by their country's legislation have a responsibility to share their genetic data. Our study shows that people who share their genetic data publicly online-far from being insensitive to privacy risks-have a complex understanding of the social, relational, and contextual nature of genetic privacy.
- Published
- 2018
- Full Text
- View/download PDF
42. A response to the forensic genetics policy initiative's report "Establishing Best Practice for Forensic DNA Databases".
- Author
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Samuel G, Howard HC, Cornel M, van El C, Hall A, Forzano F, and Prainsack B
- Subjects
- Access to Information ethics, Access to Information legislation & jurisprudence, Big Data, Commerce ethics, Computer Security legislation & jurisprudence, DNA Fingerprinting, Data Mining ethics, Data Mining legislation & jurisprudence, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, High-Throughput Nucleotide Sequencing, Humans, Information Dissemination legislation & jurisprudence, Informed Consent ethics, Informed Consent legislation & jurisprudence, International Cooperation, Phenotype, Databases, Nucleic Acid ethics, Databases, Nucleic Acid legislation & jurisprudence, Forensic Genetics ethics, Forensic Genetics legislation & jurisprudence
- Published
- 2018
- Full Text
- View/download PDF
43. Canada: will privacy rules continue to favour open science?
- Author
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Thorogood A
- Subjects
- Canada, Humans, Computer Security legislation & jurisprudence, Computer Security standards, Databases, Genetic legislation & jurisprudence, Databases, Genetic standards, Genetic Privacy legislation & jurisprudence, Genetic Privacy standards, Genetic Research legislation & jurisprudence, Personally Identifiable Information legislation & jurisprudence, Personally Identifiable Information standards
- Abstract
Canada's regulatory frameworks governing privacy and research are generally permissive of genomic data sharing, though they may soon be tightened in response to public concerns over commercial data handling practices and the strengthening of influential European privacy laws. Regulation can seem complex and uncertain, in part because of the constitutional division of power between federal and provincial governments over both privacy and health care. Broad consent is commonly practiced in genomic research, but without explicit regulatory recognition, it is often scrutinized by research or privacy oversight bodies. Secondary use of health-care data is legally permissible under limited circumstances. A new federal law prohibits genetic discrimination, but is subject to a constitutional challenge. Privacy laws require security safeguards proportionate to the data sensitivity, including breach notification. Special categories of data are not defined a priori. With some exceptions, Canadian researchers are permitted to share personal information internationally but are held accountable for safeguarding the privacy and security of these data. Cloud computing to store and share large scale data sets is permitted, if shared responsibilities for access, responsible use, and security are carefully articulated. For the moment, Canada's commercial sector is recognized as "adequate" by Europe, facilitating import of European data. Maintaining adequacy status under the new European General Data Protection Regulation (GDPR) is a concern because of Canada's weaker individual rights, privacy protections, and regulatory enforcement. Researchers must stay attuned to shifting international and national regulations to ensure a sustainable future for responsible genomic data sharing.
- Published
- 2018
- Full Text
- View/download PDF
44. Conclusion: harmonisation in genomic and health data sharing for research: an impossible dream?
- Author
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Townend D
- Subjects
- Humans, Artificial Intelligence ethics, Artificial Intelligence legislation & jurisprudence, Artificial Intelligence standards, Bioethics, Computer Security ethics, Computer Security legislation & jurisprudence, Computer Security standards, Genetic Privacy ethics, Genetic Privacy legislation & jurisprudence, Genetic Privacy standards, Genetic Research ethics, Genetic Research legislation & jurisprudence, Information Dissemination legislation & jurisprudence
- Abstract
There are clear benefits from genomics and health data sharing in research and in therapy for individuals across societies. At the same time, citizens have different expectations and fears about that data sharing. International legislation in relation with research ethics and practice and, particularly, data protection create a particular environment that, as is seen in the articles in part two of this special issue, are crying out for harmonisation both at a procedural but at fundamental conceptual levels. The law of data sharing is pulling in different directions. This paper poses the question, 'harmonisation, an impossible dream?' and the answer is a qualified 'no'. The paper reflects on what can be seen in the papers in part two of the special issue. It then identifies three major areas of conceptual uncertainty in the new EU General Data Protection Regulation (not because it has superiority over other jurisdictions, but because it is a recent revision of data protection law that leaves universal conceptual questions unclear). Thereafter, the potential for Artificial Intelligence to meet some of the shortcomings is discussed. The paper ends with a consideration of the conditions under which data sharing harmonisation might be achieved: an understanding of a human rights approach and citizen sensitivities in considering the 'public interest'; social liberalism as a basis of solidarity; and the profession of 'researcher'.
- Published
- 2018
- Full Text
- View/download PDF
45. South Korea: in the midst of a privacy reform centered on data sharing.
- Author
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Kim H, Kim SY, and Joly Y
- Subjects
- Humans, Republic of Korea, Databases, Genetic legislation & jurisprudence, Databases, Genetic standards, Genetic Privacy legislation & jurisprudence, Genetic Privacy standards, Genome, Human, Information Dissemination legislation & jurisprudence
- Abstract
With rapid developments in genomic and digital technologies, genomic data sharing has become a key issue for the achievement of precision medicine in South Korea. The legal and administrative framework for data sharing and protection in this country is currently under intense scrutiny from national and international stakeholders. Policymakers are assessing the relevance of specific restrictions in national laws and guidelines for better alignment with international approaches. This manuscript will consider key issues in international genome data sharing in South Korea, including consent, privacy, security measures, compatible adequacy and oversight, and map out an approach to genomic data sharing that recognizes the importance of patient engagement and responsible use of data in South Korea.
- Published
- 2018
- Full Text
- View/download PDF
46. Germany: a fair balance between scientific freedom and data subjects' rights?
- Author
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Molnár-Gábor F
- Subjects
- Germany, Humans, Computer Security legislation & jurisprudence, Computer Security standards, Databases, Genetic legislation & jurisprudence, Databases, Genetic standards, Genetic Privacy legislation & jurisprudence, Genetic Privacy standards, Genetic Research legislation & jurisprudence, Information Dissemination legislation & jurisprudence
- Abstract
With the German Bundestag's adoption of the Data Protection Adaptation and Implementation Act EU (DSAnpUG-EU) on 30 June 2017, the adaptation of German law to the General Data Protection Regulation (GDPR) has begun (Gesetz zur Anpassung des Datenschutzrechts an die Verordnung (EU) 2016/679 und zur Umsetzung der Richtlinie (EU) 2016/680 (Datenschutz-Anpassungs- und -Umsetzungsgesetz-DSAnpUG-EU) v. 30. Juni 2017, BGBl. 2017 I p. 2097 et seq.). Despite being directly binding on all EU member states, the GDPR does not render national data protection provision obsolete-they are covered by the GDPR's opening clauses which include regulatory mandates and room for derogation. This creates considerable need for national legislative adaptation. Art. 1 DSAnpUG-EU contains the necessary amendments to the Federal Data Protection Law (BDSG(neu)), thus creating the second major building block of future German data protection alongside the GDPR itself. Nevertheless, there are still numerous sector-specific regulations in other federal laws and the data protection laws of the 16 states also need amendments. Adjustment in Germany is well on its way, but implementation in general is still ongoing, with further consequences for data processing and sharing.
- Published
- 2018
- Full Text
- View/download PDF
47. United States: law and policy concerning transfer of genomic data to third countries.
- Author
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Majumder MA
- Subjects
- Humans, Computer Security legislation & jurisprudence, Databases, Genetic legislation & jurisprudence, Databases, Genetic standards, Genetic Privacy legislation & jurisprudence, Genetic Privacy standards, Genetic Research legislation & jurisprudence, Information Dissemination legislation & jurisprudence, Personally Identifiable Information legislation & jurisprudence, Personally Identifiable Information standards
- Abstract
This paper provides an overview of US laws and related guidance documents affecting transfer of genomic data to third countries, addressing the domains of consent, privacy, security, compatible processing/adequacy, and oversight. In general, US laws governing research and disclosure and use of data generated within the health care system do not impose different requirements on transfers to researchers and service providers based in third countries compared with US-based researchers or service providers. Of note, the US lacks a comprehensive data protection regime. Data protections are piecemeal, spread across bodies of law that target specific kinds of research or data generated or held by specific kinds of actors involved in the delivery of health care. Oversight is also distributed across a range of bodies, including institutional review boards and data access committees. The conclusion to this paper examines future directions in US law and policy, including proposals for more comprehensive protections for personal data.
- Published
- 2018
- Full Text
- View/download PDF
48. China: concurring regulation of cross-border genomic data sharing for statist control and individual protection.
- Author
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Chen Y and Song L
- Subjects
- China, Humans, Computer Security legislation & jurisprudence, Computer Security standards, Genetic Privacy legislation & jurisprudence, Genetic Privacy standards, Genetic Research legislation & jurisprudence, Personally Identifiable Information legislation & jurisprudence, Personally Identifiable Information standards
- Abstract
This paper reviews the major legal instruments and self-regulations that bear heavily on the cross-border sharing of genomic data in China. It first maps out three overlapping frameworks on genomic data and analyzes their underpinning policy goals. Subsequent sections examine the regulatory approaches with respect to five aspects of responsible use and sharing of genomic data, namely, consent, privacy, security, compatible processing, and oversight. It argues that substantial centralised control exerted by the state is, and would probably remain, the dominant feature of genomic data governance in China, though concerns of individual protection are gaining momentum. Rather than revolving around a simplistic antinomy between privacy preservation and open science, the regulatory landscape is mainly shaped by the tension between government desires for national security, state competitiveness, and public health benefits.
- Published
- 2018
- Full Text
- View/download PDF
49. United Kingdom: transfers of genomic data to third countries.
- Author
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Taylor MJ, Wallace SE, and Prictor M
- Subjects
- Humans, United Kingdom, Databases, Genetic legislation & jurisprudence, Databases, Genetic standards, Genetic Privacy legislation & jurisprudence, Genetic Privacy standards, Genetic Research legislation & jurisprudence, Information Dissemination legislation & jurisprudence, Personally Identifiable Information legislation & jurisprudence, Personally Identifiable Information standards
- Abstract
In the United Kingdom (UK), transfer of genomic data to third countries is regulated by data protection legislation. This is a composite of domestic and European Union (EU) law, with EU law to be adopted as domestic law when Brexit takes place. In this paper we consider the content of data protection legislation and the likely impact of Brexit on transfers of genomic data from the UK to other countries. We examine the advice by regulators not to rely upon consent as a lawful basis for processing under data protection law, at least not when personal data are used for research purposes, and consider some of the other ways in which the research context can qualify an individual's ability to exercise control over processing operations. We explain how the process of pseudonymization is to be understood in the context of transfer of genomic data to third parties, as well as how adequacy of data protection in a third country is to be determined in general terms. We conclude with reflections on the future direction of UK data protection law post Brexit with the reclassification of the UK itself as a third country.
- Published
- 2018
- Full Text
- View/download PDF
50. Using a genetic test result in the care of family members: how does the duty of confidentiality apply?
- Author
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Parker M and Lucassen A
- Subjects
- Confidentiality legislation & jurisprudence, Genomics trends, Health Personnel, Humans, Family, Genetic Counseling legislation & jurisprudence, Genetic Privacy legislation & jurisprudence, Genetic Testing legislation & jurisprudence
- Abstract
The use of genetic and genomic testing is becoming more widespread in healthcare and more inherited explanations for family history of diseases or conditions are being uncovered. Currently, relevant genetic information is not always used in the care of family members who might benefit from it, because of health professionals' fears of inappropriately breaching another family member's confidence. Such examples are likely to increase as testing possibilities expand. Here we present the case for use of familial information in the care and treatment of family members. We argue that whilst a clinical diagnosis in person A is confidential, the discovery of a familial factor that led to this diagnosis should be available for use in depersonalised form by health professionals to inform the testing and clinical care of other family members. The possibility of such use should be made clear in clinical practice at the time of initial testing, but should not require consent from the person in whom the familial factor was first identified. We call for further debate on these questions in the wake of high profile non-disclosure of genetic information cases, and forthcoming Data Protection legislation changes.
- Published
- 2018
- Full Text
- View/download PDF
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