Privacy Concerns Related to Data Sharing for European Diabetes Devices

Background: 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. 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. Methods: A document analysis was conducted on the ToS and Privacy Policy documents of diabetes medical equipment and software applications approved in Norway. 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). 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

M.: Legally compatible design of digital dactyloscopy in future surveillance scenarios

ABSTRACT Innovation in multimedia systems impacts on our society. For example surveillance camera systems combine video and audio information. Currently a new sensor for capturing fingerprint traces is being researched. It combines greyscale images to determine the intensity of the image signal, on one hand, and topographic information to determine fingerprint texture on a variety of surface materials, on the other. This research proposes new application areas which will be analyzed from a technical-legal view point. It assesses how technology design can promote legal criteria of German and European privacy and data protection. For this we focus on one technology goal as an example