Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

Mostert, Menno; Bredenoord, Annelien L.; Biesaart, Monique C I H; Delden, Johannes J. M. van

doi:10.1038/ejhg.2015.239

Cited by 117 publications

(117 citation statements)

References 64 publications

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“…member states implement these rules). 93 Important differences between the United States and the European Union, as well as other regions, warrant further investigation along this line.…”

Section: Resultsmentioning

confidence: 99%

Genome privacy: challenges, technical approaches to mitigate risk, and ethical considerations in the United States

Wang

Jiang

Singh

et al. 2016

Annals of the New York Academy of Sciences

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Accessing and integrating human genomic data with phenotypes is important for biomedical research. Making genomic data accessible for research purposes, however, must be handled carefully to avoid leakage of sensitive individual information to unauthorized parties and improper use of data. In this article, we focus on data sharing within the scope of data accessibility for research. Current common practices to gain biomedical data access are strictly rule based, without a clear and quantitative measurement of the risk of privacy breaches. In addition, several types of studies require privacy-preserving linkage of genotype and phenotype information across different locations (e.g., genotypes stored in a sequencing facility and phenotypes stored in an electronic health record) to accelerate discoveries. The computer science community has developed a spectrum of techniques for data privacy and confidentiality protection, many of which have yet to be tested on real-world problems. In this article, we discuss clinical, technical, and ethical aspects of genome data privacy and confidentiality in the United States, as well as potential solutions for privacy-preserving genotype–phenotype linkage in biomedical research.

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“…member states implement these rules). 93 Important differences between the United States and the European Union, as well as other regions, warrant further investigation along this line.…”

Section: Resultsmentioning

confidence: 99%

Genome privacy: challenges, technical approaches to mitigate risk, and ethical considerations in the United States

Wang

Jiang

Singh

et al. 2016

Annals of the New York Academy of Sciences

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show abstract

“…There are many possibilities for personal health and medical data to be exploited by Internet and data mining companies and to be implicated in data breaches, hacking, and other cybercriminal activities (Libert, 2014;Sarasohn-Kahn, 2014). Some information ethicists have begun to discuss personal health data ethics in the context of medical practice (Mittelstadt & Floridi, 2016;Mostert, Bredenoord, Biesaart, & van Delden, 2016). This type of discussion is almost entirely absent in public health ethics literature, or indeed the wider literature on public health (Lupton, 2015b).…”

Section: Discussionmentioning

confidence: 99%

“For Me, the Biggest Benefit Is Being Ahead of the Game”:The Use of Social Media in Health Work

Lupton

Michael

2017

Social Media + Society

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Using social media in the workplace raises a number of issues for any occupation. In this article, we report the findings of a study that investigated how social media are used in a field of health work. The study uses semi-structured interviews conducted by telephone with 15 participants working in communicable disease in Australia. We identified several key features shaping the use of social media. These included the sociomaterial aspects of the workplace (to what extent employees were provided with access to and allowed to use the Internet), the affordances of social media technologies (fast and real-time communication and sharing, opportunities to easily connect with peers as well as the public, and the casual tone of interactions), tacit norms and assumptions about professional behavior and social media (whether social media are considered to be appropriate tools to use for work and how they should best be used), the specific nature of people’s work (how sensitive, stigmatized, contentious, or political were the diseases they focused on), and the nature of people’s own experiences (how other social media users responded to them, what value they perceived they gained from using social media for work, and the types of networks they were able to establish). The findings of this study highlight the importance of context when considering how people use social media in the workplace.

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“…In this era of genomics and big data analytics, the traceability of donors is generally increased 43. Certain types of organoids could be extra privacy-sensitive.…”

Section: Exchange Of Organoids: Questioning the Two Dichotomiesmentioning

confidence: 99%

“…Precision medicine applications of organoids are most advanced in the field of CF (online supplementary file 1); however, initiatives in cancer research and cerebral organoids are progressing 12 16 20 21 44 45. In addition to these informational benefits, the use of organoids can generate informational harms such as the yield of unsolicited findings or privacy concerns 43. In the case of future organoid transplantation, organoids can have short-term and long-term effects on the well-being of the recipient, being either the donor or another patient, both in terms of clinical improvement and safety risks 16 17…”

Section: Exchange Of Organoids: Questioning the Two Dichotomiesmentioning

confidence: 99%

Organoids as hybrids: ethical implications for the exchange of human tissues

2018

Self Cite

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Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of ‘mini-organs’ in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a ‘consent for governance’ model that contributes to responsible innovation and clinical translation in this exciting field.

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Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

Cited by 117 publications

References 64 publications

Genome privacy: challenges, technical approaches to mitigate risk, and ethical considerations in the United States

Genome privacy: challenges, technical approaches to mitigate risk, and ethical considerations in the United States

“For Me, the Biggest Benefit Is Being Ahead of the Game”:The Use of Social Media in Health Work

Organoids as hybrids: ethical implications for the exchange of human tissues

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