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dc.contributor.authorRandine, Pietro
dc.contributor.authorPocs, Matthias
dc.contributor.authorCooper, John Graham
dc.contributor.authorTsolovos, Dimitrios
dc.contributor.authorMuzny, Miroslav
dc.contributor.authorBesters, Rouven
dc.contributor.authorÅrsand, Eirik
dc.date.accessioned2023-11-17T14:00:00Z
dc.date.available2023-11-17T14:00:00Z
dc.date.issued2023-11-13
dc.description.abstractBackground: Individuals with diabetes rely on medical equipment (eg, continuous glucose monitoring (CGM), hybrid closed-loop systems) and mobile applications to manage their condition, providing valuable data to health care providers. Data sharing from this equipment is regulated via Terms of Service (ToS) and Privacy Policy documents. The introduction of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Union has established updated rules for medical devices, including software.<p> <p>Objective: This study examines how data sharing is regulated by the ToS and Privacy Policy documents of approved diabetes medical equipment and associated software. It focuses on the equipment approved by the Norwegian Regional Health Authorities.<p> <p>Methods: A document analysis was conducted on the ToS and Privacy Policy documents of diabetes medical equipment and software applications approved in Norway.<p> <p>Results: The analysis identified 11 medical equipment and 12 software applications used for diabetes data transfer and analysis in Norway. Only 3 medical equipment (OmniPod Dash, Accu-Chek Insight, and Accu-Chek Solo) were registered in the European Database on Medical Devices (EUDAMED) database, whereas none of their respective software applications were registered. Compliance with General Data Protection Regulation (GDPR) security requirements varied, with some software relying on adequacy decisions (8/12), whereas others did not (4/12).<p> <p>Conclusions: The study highlights the dominance of non-European Economic Area (EEA) companies in medical device technology development. It also identifies the lack of registration for medical equipment and software in the EUDAMED database, which is currently not mandatory. These findings underscore the need for further attention to ensure regulatory compliance and improve data-sharing practices in the context of diabetes management.en_US
dc.identifier.citationRandine, Pocs, Cooper, Tsolovos, Muzny, Besters, Årsand. Privacy Concerns Related to Data Sharing for European Diabetes Devices. Journal of Diabetes Science and Technology. 2023en_US
dc.identifier.cristinIDFRIDAID 2196739
dc.identifier.doi10.1177/19322968231210548
dc.identifier.issn1932-2968
dc.identifier.urihttps://hdl.handle.net/10037/31813
dc.language.isoengen_US
dc.publisherSAGE Publicationsen_US
dc.relation.ispartofRandine, P. (2024). Dia-Continua: An Information System for Type 1 Diabetes Consultation. (Interoperability, Privacy, and Information Quality on a FHIR-Based Information System for Type 1 Diabetes Consultations based on Patient-Generated Health Data). (Doctoral thesis). <a href=https://hdl.handle.net/10037/33508>https://hdl.handle.net/10037/33508</a>
dc.relation.journalJournal of Diabetes Science and Technology
dc.relation.projectIDinfo:eu-repo/grantAgreement/EC/H2020/883275/Norway/New cybersecurity system to protect medical devices/HEIR/en_US
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titlePrivacy Concerns Related to Data Sharing for European Diabetes Devicesen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution 4.0 International (CC BY 4.0)
Except where otherwise noted, this item's license is described as Attribution 4.0 International (CC BY 4.0)