The Effect of the General Data Protection Regulation on Medical Research

The enactment of the General Data Protection Regulation (GDPR) will impact on European data science. Particular concerns relating to consent requirements that would severely restrict medical data research have been raised. Our objective is to explain the changes in data protection laws that apply to...

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Veröffentlicht in:Journal of medical Internet research Jg. 19; H. 2; S. e47
Hauptverfasser: Rumbold, John Mark Michael, Pierscionek, Barbara
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Canada Journal of Medical Internet Research 24.02.2017
Gunther Eysenbach MD MPH, Associate Professor
JMIR Publications
Schlagworte:
Analysis
Biomedical research
Biomedical Research - ethics
Biomedical Research - methods
Biomedicine
Classification
Computer privacy
Computer Security
Consent
Data
Data integrity
Data security
Enactment
Ethics
Humans
Informatics - methods
Informatics - standards
Informed consent
Laws, regulations and rules
Medical advice systems
Medical law
Medical research
Medicine, Experimental
Political aspects
Protection
Public interest
Regulation
Research Design
Viewpoint
United Kingdom
data reporting
pseudonymity
data protection
anonymity
informatics
research ethics
privacy-preserving protocols
untraceability
ISSN:1438-8871, 1439-4456, 1438-8871
Online-Zugang:Volltext
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Beschreibung
Zusammenfassung:The enactment of the General Data Protection Regulation (GDPR) will impact on European data science. Particular concerns relating to consent requirements that would severely restrict medical data research have been raised. Our objective is to explain the changes in data protection laws that apply to medical research and to discuss their potential impact. Analysis of ethicolegal requirements imposed by the GDPR. The GDPR makes the classification of pseudonymised data as personal data clearer, although it has not been entirely resolved. Biomedical research on personal data where consent has not been obtained must be of substantial public interest. The GDPR introduces protections for data subjects that aim for consistency across the EU. The proposed changes will make little impact on biomedical data research.
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ISSN:1438-8871
1439-4456
1438-8871
DOI:10.2196/jmir.7108