Federated electronic health records for the European Health Data Space.

The European Commission's draft for the European Health Data Space (EHDS) aims to empower citizens to access their personal health data and share it with physicians and other health-care providers. It further defines procedures for the secondary use of electronic health data for research and development. Although this planned legislation is undoubtedly a step in the right direction, implementation approaches could potentially result in centralised data silos that pose data privacy and security risks for individuals. To address this concern, we propose federated personal health data spaces, a novel architecture for storing, managing, and sharing personal electronic health records that puts citizens at the centre-both conceptually and technologically. The proposed architecture puts citizens in control by storing personal health data on a combination of personal devices rather than in centralised data silos. We describe how this federated architecture fits within the EHDS and can enable the same features as centralised systems while protecting the privacy of citizens. We further argue that increased privacy and control do not contradict the use of electronic health data for research and development. Instead, data sovereignty and transparency encourage active participation in studies and data sharing. This combination of privacy-by-design and transparent, privacy-preserving data sharing can enable health-care leaders to break the privacy-exploitation barrier, which currently limits the secondary use of health data in many cases.

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Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests AK declares funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement number 820820. ADS declares that she serves as a member of the Scientific Advisory Board of the German Society for Digital Medicine and the Strategic Advisory Board of HumanFirst. JK declares grants from the EU (for projects MobiliseD and DigiPD) and from the Bavarian Ministry of Economics (for project dHealthSolutions); payment for lectures from Roche/RoxHealth, Desitin, and Bial and for education from StreamedUP; support from Novartis for travel related to lecturing; a patent on gait assessment; a role as scientific advisor for Medical Valley Digital Health Application Center, Germany; membership in the patient-advisory board of EverPharma; an unpaid role in the European Taskforce for Digital Medical Devices; an unpaid advisory role in the Lux Taskforce for Health Technology Assessment for Digital Medical Devices; and has shares in Portabiles and Portabiles Healthcare Technologies. DR declares grants from the Alexander Humboldt Foundation, the European Research Council, the British Heart Foundation, Engineering and Physical Sciences Research Council, InnovateUK, Wellcome Trust, Horizon 2020, and German Federal Ministry of Education and Research; and a research contract with Roche. RE declares a grant from the Federal Ministry of Research and Education for the HiGHmed consortium in the Medical Informatics Initiative. BME declares consulting fees from Adidas, Siemens Healthineers, Portabiles Healthcare Technologies, and Sivantos; payment from AbbVie Deutschland and AGAPLESION; and a patent application EP 16174268.9 (gait assessment) with Portabiles HealthCare Technologies. All other authors declare no competing interests.