title: The Effect of the General Data Protection Regulation on Medical Research.
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.
authors.affiliation: Faculty of Science, Engineering and Computing, Kingston University London, Kingston upon Thames, United Kingdom.
authors.forename: John Mark Michael
authors.identifier: 0000-0002-3308-711X
authors.initials: JM
authors.lastname: Rumbold
authors.affiliation: School of Science and Technology, 50 Shakespeare Street, Nottingham Trent University, Nottingham NG1 4FQ, United Kingdom.|Faculty of Science, Engineering and Computing, Penrhyn Road, Kingston University London, Kingston upon Thames KT1 2EE, United Kingdom.
authors.forename: Barbara
authors.identifier: 0000-0002-8661-6353
authors.initials: B
authors.lastname: Pierscionek
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000379:methods*; D016494:Computer Security; D006801:Humans; D048088:Informatics / Q000379:methods* / Q000592:standards; D012107:Research Design
keywords: anonymity; data protection; data reporting; informatics; privacy-preserving protocols; pseudonymity; research ethics; untraceability