Balancing Protection and Free Movement of Personal Data: The New European Union General Data Protection Regulation
Authors: Heidi Beate Bentzen, Njål Høstmælingen
Journal: Annals of Internal Medicine (2019)

Ideas and Opinions5 March 2019Balancing Protection and Free Movement of Personal Data: The New European Union General Data Protection RegulationHeidi Beate Bentzen, LLM and Njål Høstmælingen, LLMHeidi Beate Bentzen, LLMThe Norwegian Research Center for Computers and Law and Centre for Medical Ethics, University of Oslo, Oslo, Norway (H.B.B.) and Njål Høstmælingen, LLMClinical Effectiveness Research Group, Oslo University Hospital, Oslo, Norway (N.H.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-2782 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The General Data Protection Regulation (GDPR), the European Union's (EU's) new data privacy law, aims to strike a balance between an individual's rights to the protection of personal data and, among other factors, the research and business sectors' need to process these data (1). This regulation has led to concerns and uncertainty in the biomedical industry and research community across Europe and the United States. Here, we examine what is new with the GDPR and whether it poses concerns.The GDPR contributes to harmonization among existing rules and establishes some new rules. Its introduction has garnered much attention and debate ...References1. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). 27 April 2016. Accessed at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0679 on 16 December 2018. Google Scholar2. Haug CJ. Turning the tables—the new European General Data Protection Regulation. N Engl J Med. 2018;379:207-9. [PMID: 29874143] doi:10.1056/NEJMp1806637 CrossrefMedlineGoogle Scholar3. General Data Protection Regulation, art. 83, para. 5 (2016). Google Scholar4. Consolidated versions of the Treaty on the European Union and the Treaty on the Functioning of the European Union, C326, art. 179, Oct. 26, 2012. Google Scholar5. Charter of Fundamental Rights of the European Union, C364, art. 8. 18 December 2000. Google Scholar6. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 24 October 1995. Accessed at https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A31995L0046 on 16 December 2018. Google Scholar7. General Data Protection Regulation, arts. 3, 4, paras. 2, 7, 8 (2016). Google Scholar8. General Data Protection Regulation, art. 4, paras. 1, 2, 5, recital 26 (2016). Google Scholar9. General Data Protection Regulation, art. 4, paras. 1, 13, 15, recitals 34, 35 (2016). Google Scholar10. General Data Protection Regulation, art. 1 (2016). Google Scholar Author, Article, and Disclosure InformationAffiliations: The Norwegian Research Center for Computers and Law and Centre for Medical Ethics, University of Oslo, Oslo, Norway (H.B.B.)Clinical Effectiveness Research Group, Oslo University Hospital, Oslo, Norway (N.H.)Disclaimer: The funding sources had no role in the study design, data collection or analysis, decision to publish, or preparation of the manuscript.Financial Support: By NordForsk (grant 81105; Ms. Bentzen), The Research Council of Norway (grant 238999; Ms. Bentzen), and the Clinical Effectiveness Research Group and Frontier Science and Technology Research Foundation (Mr. Høstmælingen).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-2782.Corresponding Author: Heidi Beate Bentzen, LLM, The Norwegian Research Center for Computers and Law, University of Oslo, PO Box 6706, St. Olavs plass, 0130 Oslo, Norway; e-mail, h.b.[email protected]uio.no.Current Author Addresses: Ms. Bentzen: The Norwegian Research Center for Computers and Law, Faculty of Law, University of Oslo, PO Box 6706, St. Olavs plass, 0130 Oslo, Norway.Mr. Høstmælingen: Clinical Effectiveness Research Group, Oslo University Hospital, Sognsvannsveien 21 Bygg 20, 0372 Oslo, Norway.Author Contributions: Conception and design: H.B. Bentzen, N. Høstmælingen.Drafting of the article: H.B. Bentzen, N. Høstmælingen.Critical revision of the article for important intellectual content: H.B. Bentzen, N. Høstmælingen.Final approval of the article: H.B. Bentzen, N. Høstmælingen.This article was published at Annals.org on 19 February 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoAre Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation? Deborah Mascalzoni , Heidi Beate Bentzen , Isabelle Budin-Ljøsne , Lee Andrew Bygrave , Jessica Bell , Edward S. Dove , Christian Fuchsberger , Kristian Hveem , Michaela Th. Mayrhofer , Viviana Meraviglia , David R. O'Brien , Cristian Pattaro , Peter P. Pramstaller , Vojin Rakić , Alessandra Rossini , Mahsa Shabani , Dan Jerker B. Svantesson , Marta Tomasi , Lars Ursin , Matthias Wjst , and Jane Kaye Metrics Cited byData Sharing Under the General Data Protection RegulationSpecial Section on Ethics in Health InformaticsPEDIA: prioritization of exome data by image analysis 5 March 2019Volume 170, Issue 5Page: 335-337KeywordsBloodComputersDecision analysisDisclosureHealth careInformation storage and retrievalResearch facilitiesResearch laboratoriesSalivaUrine ePublished: 19 February 2019 Issue Published: 5 March 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...