A critique of the regulation of data science in healthcare research in the European Union
Open accessAbstract
The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.
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Preventing re-identification of individuals has challenges in preserving data utility.
“Challenges in preserving data utility”
From AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications (2023) · cites this paper as [243]
Preventing re-identification of individuals minimizes risk of data breaches.
“Minimizes risk of data breaches”
From AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications (2023) · cites this paper as [243]
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AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications
Chen, P., Wu, L., & Wang, L. (2023) · Applied Sciences · doi:10.3390/app131810258 · Cited by 155 · see citing works
- Authors
- Rumbold, J. M. M., & Pierscionek, B. K.
- Affiliations
- Kingston University London (GB)
- Nottingham Trent University (GB)
- Corresponding author
- Pierscionek, Barbara K.
- Venue
- BMC Medical Ethics
- Published
- 2017-04-08
- Volume
- 18
- Issue
- 1
- Pages
- 27-27
- ISSN
- 1472-6939 (ISSN-L)
- PMC
- PMC5385067
- OpenAlex
- W2604701281
- Cited by
- 33
- References
- 37
- Citations by year
- 2025: 4 · 2024: 5 · 2023: 3 · 2022: 3 · 2021: 6 · 2020: 2 · 2019: 6 · 2018: 4
- FWCI
- 3.08
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMC Medical Ethics (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Repository (Kingston University London) (acceptedVersion)
- Nottingham Trent University's Institutional Repository (Nottingham Trent Repository) (acceptedVersion)
- Anglia Ruskin Research Online (Anglia Ruskin University) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Zenodo (CERN European Organization for Nuclear Research) (submittedVersion, cc-by)
- Funders
- EU H2020 (H2020 ICT/2014/1)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Law › Digitalization, Law, and Regulation
- Physical Sciences › Computer Science › Information Systems › Thoreau and American Literature
- Keywords
- European Union, data protection law, re-identification risk, data anonymization, informed consent, biobanks, research ethics, data sharing
- MeSH terms
- Confidentiality, Data Collection, European Union, Health Services Research, Humans, Informed Consent, International Cooperation, Medical Records, Social Control, Formal, Computer Security, Privacy, Ethics, Research, Information Dissemination
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