{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T22:01:57Z","timestamp":1792620117941,"version":"4.5.0"},"reference-count":30,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2024,12,1]],"date-time":"2024-12-01T00:00:00Z","timestamp":1733011200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Scand J Public Health"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Aims:<\/jats:title>\n                    <jats:p>Personalised medicine in chronic complex diseases such as rheumatoid arthritis (RA) is within reach but requires international multi-stakeholder collaboration. We exemplify how national implementations of the General Data Protection Regulation (GDPR) have introduced administrative delays and created disincentives for data sharing and collaborative research.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Our Danish\/Swedish\/Norwegian research collaboration (the 3-year NordForsk-funded \u201cNORA\u201d project) aims to develop a personalised medicine approach for the management of RA, built on the exploitation of unique existing data sources: longitudinal data from clinical rheumatology registries, research cohorts, nationwide health care registries, and biobank material from &gt;20 sample collections. Data and results are shared and accessed remotely by collaborators at secure servers. New biomarker assays and patient-centric implementations of the results are to be explored, validated, and disseminated to patients and health care via the development of digital tools.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Following the advice of legal experts at the involved academic or public institutions and private companies, GDPR compliance resulted in &gt;20 legal documents to govern the collaboration (consortium-, joint controller-, research collaboration-, data sharing-, and a series of unique two-way data processing-, and material transfer agreements). Lack of agreed-upon templates, policies, procedures, and a shortage of legal resources have caused considerable delays. Thus, our research consortium has spent more time ensuring GDPR compliance than on actual research activities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>\n                      <jats:bold>The current interpretation and implementation of the legal premises (rather than the GDPR per se) for research collaborations caused unnecessary barriers and delays. Our experiences call for Nordic trust-based code-of-conduct-like framework agreements, and for harmonisation of procedures and templates, lest the Nordic advantage in research be lost.<\/jats:bold>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/14034948231212711","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T06:54:25Z","timestamp":1733727265000},"page":"1019-1025","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Legal obstacles jeopardise research in personalised medicine \u2013 experiences from a Nordic collaboration within rheumatology"],"prefix":"10.1177","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8931-8482","authenticated-orcid":false,"given":"Bente","family":"Glintborg","sequence":"first","affiliation":[{"name":"DANBIO, The Danish Rheumatologic Biobank and Copenhagen Center for Arthritis Research (COPECARE), Centre of Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mats","family":"Hansson","sequence":"additional","affiliation":[{"name":"Centre for Research Ethics &amp; Bioethics, Department of Public Health and Caring Sciences, Uppsala University, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilde Berner","family":"Hammer","sequence":"additional","affiliation":[{"name":"Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway"},{"name":"Faculty of Medicine, University of Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Klareskog","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden"},{"name":"Centrum for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saedis","family":"Saevarsdottir","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden"},{"name":"Faculty of Medicine, School of Health Sciences, University of Iceland, Reykjavik, Iceland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helga","family":"Westerlind","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"R\u00f6nnelid","sequence":"additional","affiliation":[{"name":"Department of Immunology, Genetics and Pathology, Uppsala University, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"Gehring","sequence":"additional","affiliation":[{"name":"Thermo Fisher Scientific, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikael","family":"Benson","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Link\u00f6ping University, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bente Appel","family":"Esbensen","sequence":"additional","affiliation":[{"name":"DANBIO, The Danish Rheumatologic Biobank and Copenhagen Center for Arthritis Research (COPECARE), Centre of Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merete Lund","family":"Hetland","sequence":"additional","affiliation":[{"name":"DANBIO, The Danish Rheumatologic Biobank and Copenhagen Center for Arthritis Research (COPECARE), Centre of Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonid","family":"Padyukov","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden"},{"name":"Centrum for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tue Wenzel","family":"Kragstrup","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Aarhus University Hospital, Denmark"},{"name":"Department of Biomedicine, Aarhus University, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen-Margrethe","family":"Hauge","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Aarhus University Hospital, Denmark"},{"name":"Department of Biomedicine, Aarhus University, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara Bislawska","family":"Axn\u00c4s","sequence":"additional","affiliation":[{"name":"Elsa Science, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels Steen","family":"Krogh","sequence":"additional","affiliation":[{"name":"ZiteLab ApS, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Johannesson","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"Askling","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Rheumatology, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,12,9]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-216846"},{"key":"e_1_3_2_3_2","unstructured":"US Food and Drug Administration. Precision medicine https:\/\/www.fda.gov\/medical-devices\/in-vitro-diagnostics\/precision-medicine (2018 accessed November 2023)."},{"key":"e_1_3_2_4_2","unstructured":"Toward precision medicine: building a knowledge network for biomedical research and a new taxonomy of disease. 2012; 16;1\u2013128."},{"key":"e_1_3_2_5_2","unstructured":"En indgang til sundhedsdata. Research Health Data Gateway https:\/\/www.enindgangtilsundhedsdata.dk\/en\/AboutUs (2021 accessed November 2023)."},{"key":"e_1_3_2_6_2","unstructured":"NordForsk. A vision of a Nordic secure digital infrastructure for health data: the Nordic Commons www.nordforsk.org (2019 accessed November 2023)."},{"key":"e_1_3_2_7_2","unstructured":"NordForsk. Joint nordic registers and biobanks \u2013 a goldmine for health and welfare research www.nordforsk.org (2014 accessed November 2023)."},{"key":"e_1_3_2_8_2","unstructured":"Indenrigs- og sundhedsministeriat [Danish Ministry of Health Danish Regions]. Personalised medicine for the benefit of the patients 2021\u20132022 https:\/\/sum.dk\/publikationer-sundhed\/2021\/juli\/personalised-medicine-for-the-benefit-of-the-patients (2021 accessed November 2023)."},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-221754"},{"key":"e_1_3_2_10_2","unstructured":"GDPR.EU. Complete guide to GDPR compliance https:\/\/gdpr.eu\/ (2020 accessed November 2023)."},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13690-022-00866-7"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v23.i28.5045"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-221996"},{"key":"e_1_3_2_14_2","article-title":"Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial","volume":"371","author":"Hetland ML","year":"2020","unstructured":"Hetland ML, Haavardsholm EA, Rudin A, et al. Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial. BMJ 2020;371:m4328.","journal-title":"BMJ"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.phrs.2019.104410"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S99490"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2018-000655"},{"key":"e_1_3_2_18_2","unstructured":"NordForsk. Personalized medicine in RA by combining genomics biomarkers clinical and patient-derived data from the Nordic countries https:\/\/www.nordforsk.org\/projects\/personalized-medicine-ra-combining-genomics-biomarkers-clinical-and-patient-derived-data (2021 accessed November 2023)."},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41431-020-0596-x"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11845-021-02789-8"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1089\/big.2018.0176"},{"key":"e_1_3_2_22_2","unstructured":"intersoft consulting. Art. 46 GDPR. Transfers subject to appropriate safeguards https:\/\/gdpr-info.eu\/art-46-gdpr\/ (accessed November 2023)."},{"key":"e_1_3_2_23_2","unstructured":"intersoft consulting. Art. 45 GDPR. Transfers on the basis of an adequacy decision https:\/\/gdpr-info.eu\/art-45-gdpr\/ (accessed November 2023)."},{"key":"e_1_3_2_24_2","unstructured":"EU Monitor. Decision 2004\/915 \u2013 2004\/915\/EC: Commission Decision of 27 December 2004 amending Decision 2001\/497\/EC as regards the introduction of an alternative set of standard contractual clauses for the transfer of personal data to third countries (notified under document number C(2004) 5271) https:\/\/www.eumonitor.eu\/9353000\/1\/j9vvik7m1c3gyxp\/vi8rm2z4lvxu (2004 accessed November 2023)."},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1038\/d41586-020-00082-9"},{"key":"e_1_3_2_26_2","unstructured":"European Data Protection Board. Guidelines 1\/2019 on codes of conduct and monitoring bodies under Regulation 2016\/679 https:\/\/edpb.europa.eu\/our-work-tools\/our-documents\/guidelines\/guidelines-12019-codes-conduct-and-monitoring-bodies-0_en (2019 accessed November 2023)."},{"key":"e_1_3_2_27_2","unstructured":"The Biobanking and BioMolecular resources Research Infrastructure. Summary report following the BBMRI-ERIC working meeting on health and life sciences GDPR code of conduct https:\/\/www.bbmri-eric.eu\/wp-content\/uploads\/2016\/07\/Summary-Report_BBMRI-ERIC_CoC_Meeting_FINAL.pdf (2017 accessed November 2023)."},{"key":"e_1_3_2_28_2","volume-title":"Establishing precompetitive collaborations to stimulate genomics-driven product development: workshop summary","author":"Institute of Medicine (US) Roundtable on Translating Genomic-Based Research for Health","year":"2011","unstructured":"Institute of Medicine (US) Roundtable on Translating Genomic-Based Research for Health. Establishing precompetitive collaborations to stimulate genomics-driven product development: workshop summary. Washington, DC: National Academies Press, 2011."},{"key":"e_1_3_2_29_2","unstructured":"European Commission. Proposal for a regulation \u2013 the European Health Data Space https:\/\/health.ec.europa.eu\/publications\/proposal-regulation-european-health-data-space_en (2022 accessed November 2023)."},{"key":"e_1_3_2_30_2","article-title":"Increasing value and reducing waste in biomedical research regulation and management","volume":"383","author":"Al-Shahi Salman R","year":"2014","unstructured":"Al-Shahi Salman R, Beller E, Kagan J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet 2014;383:176\u201385.","journal-title":"Lancet"},{"key":"e_1_3_2_31_2","first-page":"1","article-title":"Rheumatoid arthritis","volume":"4","author":"Smolen JS","year":"2018","unstructured":"Smolen JS, Aletaha D, Barton A, et al. Rheumatoid arthritis. Nat Rev Dis Prim 2018;4:1\u201323.","journal-title":"Nat Rev Dis Prim"}],"container-title":["Scandinavian Journal of Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/14034948231212711","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/14034948231212711","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/14034948231212711","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T04:18:41Z","timestamp":1777695521000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/14034948231212711"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12]]},"references-count":30,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1177\/14034948231212711"],"URL":"https:\/\/doi.org\/10.1177\/14034948231212711","relation":{},"ISSN":["1403-4948","1651-1905"],"issn-type":[{"value":"1403-4948","type":"print"},{"value":"1651-1905","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12]]}}}