Putting the GDPR into Practice: Difficulties and Uncertainties Experienced in the Conduct of Big Data Health Research

Wouters, Birgit; Shaw, David; Sun, Chang; Ippel, Lianne; Soest, Johan van; Berg, Bob van den; Mussmann, Ole; Koster, Annemarie; Kallen, C. van der; Oppen, Claudia van; Dekker, André; Dumontier, Michel; Townend, David

doi:10.21552/edpl/2021/2/9

Cited by 7 publications

(3 citation statements)

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“…[11] Minimality is a core concept in the General Data Protection Regulation and POPIA because it protects the freedom and autonomy of data subjects. On the other hand, Wouters et al [12] point out that '… the principle of data minimization seems to conflict with the usage of big data analytics in health and research' .…”

Section: Correspondencementioning

confidence: 99%

Building coherence in the regulation of health research: A reply to Thaldar

Bronstein,

Nyachowe

2023

S Afr Med J

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Section: Correspondencementioning

confidence: 99%

Building coherence in the regulation of health research: A reply to Thaldar

Bronstein,

Nyachowe

2023

S Afr Med J

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“…China Dereli [55] Understanding risk, uncertainty, and ignorance in big data and ethics reviews for health systems research in low-income countries. Turkey Wouters [56] Recognizing the challenges and uncertainties faced when conducting big data health research. The Netherlands Bag [57] Investigate the influence of innovation leadership on big data analytics (BDA) on healthcare supply chain (HSC) innovation, responsiveness, and resilience in the context of the COVID-19 pandemic.…”

Section: Authorsmentioning

confidence: 99%

A Systematic Review of Literature on Sustaining Decision-Making in Healthcare Organizations Amid Imperfect Information in the Big Data Era

Orlu,

Abdullah,

Zaremohzzabieh

et al. 2023

Sustainability

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The significance of big data analytics (BDA) has benefited the health sector by leveraging the potential insights and capabilities of big data in decision making. However, every implementation of BDA within the healthcare field faces difficulties due to incomplete or flawed information that necessitates attention and resolution. The purpose of this systematic literature review is to accomplish two main objectives. Firstly, it aims to synthesize the various elements that contribute to imperfect information in BDA and their impact on decision-making processes within the healthcare sector. This involves identifying and analyzing the factors that can result in imperfect information in BDA applications. Secondly, the review intends to create a taxonomy specifically focused on imperfect information within the context of BDA in the health sector. The study conducted a systematic review of the literature, specifically focusing on studies written in English and published up until February 2023. We also screened and retrieved the titles, abstracts, and potentially relevant studies to determine if they met the criteria for inclusion. As a result, they obtained a total of 58 primary studies. The findings displayed that the presence of uncertainty, imprecision, vagueness, incompleteness, and complexity factors in BDA significantly impacts the ability to sustain effective decision-making in the healthcare sector. Additionally, the study highlighted that the taxonomy for imperfect information in BDA provides healthcare managers with the means to utilize suitable strategies essential for successful implementation when dealing with incomplete information in big data. These findings have practical implications for BDA service providers, as they can leverage the findings to attract and promote the adoption of BDA within the healthcare sector.

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“…These difficulties also arise relative to prior legislation. However, the high costs of non-compliance with the GDPR, and the requirement to ensure compliance with multiple competing national data protection laws have heightened pre-existing challenges [ 1 – 4 ]. The court-initiated adoption of new procedural requirements as preconditions to outbound transfers from the European Economic Area (EEA) to third countries outside the EEA has also exacerbated difficulties in performing outbound transfers of data from the EEA.…”

Section: Introductionmentioning

confidence: 99%

Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory

Bernier,

Molnár-Gábor,

Knoppers

et al. 2023

Eur J Hum Genet

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The coming-into-force of the EU General Data Protection Regulation (GDPR) is a watershed moment in the legal recognition of enforceable rights to informational self-determination. The rapid evolution of legal requirements applicable to data use, however, has the potential to outstrip the capabilities of networks of biomedical data users to respond to the shifting norms. It can also delegitimate established institutional bodies that are responsible for assessing and authorising the downstream use of data, including research ethics committees and institutional data custodians. These burdens are especially pronounced for clinical and research networks that are of transnational scale, because the legal compliance burden for outbound international data transfers from the EEA is especially high. Legislatures, courts, and regulators in the EU should therefore implement the following three legal changes. First, the responsibilities of particular actors in a data sharing network should be delimited through the contractual allocation of responsibilities between collaborators. Second, the use of data through secure data processing environments should not trigger the international transfer provisions of the GDPR. Third, the use of federated data analysis methodologies that do not provide analysis nodes or downstream users access to identifiable personal data as part of the outputs of those analyses should not be considered circumstances of joint controllership, nor lead to the users of non-identifiable data to be considered controllers or processors. These small clarifications of, or modifications to, the GDPR would facilitate the exchange of biomedical data amongst clinicians and researchers.

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Putting the GDPR into Practice: Difficulties and Uncertainties Experienced in the Conduct of Big Data Health Research

Cited by 7 publications

References 0 publications

Building coherence in the regulation of health research: A reply to Thaldar

Building coherence in the regulation of health research: A reply to Thaldar

A Systematic Review of Literature on Sustaining Decision-Making in Healthcare Organizations Amid Imperfect Information in the Big Data Era

Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory

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