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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Vydané v:Journal of medical Internet research Ročník 19; číslo 2; s. e47
Hlavní autori: Rumbold, John Mark Michael, Pierscionek, Barbara
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Canada Journal of Medical Internet Research 24.02.2017
Gunther Eysenbach MD MPH, Associate Professor
JMIR Publications
Predmet:
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
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Abstract 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.
AbstractList Background 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. Objective Our objective is to explain the changes in data protection laws that apply to medical research and to discuss their potential impact. Methods Analysis of ethicolegal requirements imposed by the GDPR. Results 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. Conclusions 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.
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.BACKGROUNDThe 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.OBJECTIVEOur 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.METHODSAnalysis 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.RESULTSThe 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.CONCLUSIONSThe GDPR introduces protections for data subjects that aim for consistency across the EU. The proposed changes will make little impact on biomedical data 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 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.
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.
Audience Academic
Author Pierscionek, Barbara
Rumbold, John Mark Michael
AuthorAffiliation 3 Faculty of Science, Engineering and Computing Penrhyn Road Kingston University London Kingston upon Thames KT1 2EE United Kingdom
2 School of Science and Technology 50 Shakespeare Street Nottingham Trent University Nottingham NG1 4FQ United Kingdom
1 Faculty of Science, Engineering and Computing Kingston University London Kingston upon Thames United Kingdom
AuthorAffiliation_xml – name: 1 Faculty of Science, Engineering and Computing Kingston University London Kingston upon Thames United Kingdom
– name: 2 School of Science and Technology 50 Shakespeare Street Nottingham Trent University Nottingham NG1 4FQ United Kingdom
– name: 3 Faculty of Science, Engineering and Computing Penrhyn Road Kingston University London Kingston upon Thames KT1 2EE United Kingdom
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/28235748$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Copyright John Mark Michael Rumbold, Barbara Pierscionek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.02.2017.
COPYRIGHT 2017 Journal of Medical Internet Research
Copyright Gunther Eysenbach MD MPH, Associate Professor Feb 2017
John Mark Michael Rumbold, Barbara Pierscionek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.02.2017. 2017
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– notice: John Mark Michael Rumbold, Barbara Pierscionek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.02.2017. 2017
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Keywords data reporting
pseudonymity
data protection
anonymity
informatics
research ethics
privacy-preserving protocols
untraceability
Language English
License John Mark Michael Rumbold, Barbara Pierscionek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.02.2017.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
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Snippet The enactment of the General Data Protection Regulation (GDPR) will impact on European data science. Particular concerns relating to consent requirements that...
Background The enactment of the General Data Protection Regulation (GDPR) will impact on European data science. Particular concerns relating to consent...
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StartPage e47
SubjectTerms 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
Title The Effect of the General Data Protection Regulation on Medical Research
URI https://www.ncbi.nlm.nih.gov/pubmed/28235748
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