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DataSHIELD: mitigating disclosure risk in a multi-site federated analysis platform.

Bioinformatics advances

Authors: Demetris Avraam, Rebecca C Wilson, Noemi Aguirre Chan, Soumya Banerjee, Tom R P Bishop, Olly Butters, Tim Cadman, Luise Cederkvist, Liesbeth Duijts, Xavier Escribà Montagut, Hugh Garner, Gonçalo Gonçalves, Juan R González, Sido Haakma, Mette Hartlev, Jan Hasenauer, Manuel Huth, Eleanor Hyde, Vincent W V Jaddoe, Yannick Marcon, Michaela Th Mayrhofer, Fruzsina Molnar-Gabor, Andrei Scott Morgan, Madeleine Murtagh, Marc Nestor, Anne-Marie Nybo Andersen, Simon Parker, Angela Pinot de Moira, Florian Schwarz, Katrine Strandberg-Larsen, Morris A Swertz, Marieke Welten, Stuart Wheater, Paul Burton

MOTIVATION: The validity of epidemiologic findings can be increased using triangulation, i.e. comparison of findings across contexts, and by having sufficiently large amounts of relevant data to analyse. However, access to data is often constrained by practical considerations and by ethico-legal and data governance restrictions. Gaining access to such data can be time-consuming due to the governance requirements associated with data access requests to institutions in different jurisdictions.

RESULTS: DataSHIELD is a software solution that enables remote analysis without the need for data transfer (federated analysis). DataSHIELD is a scientifically mature, open-source data access and analysis platform aligned with the 'Five Safes' framework, the international framework governing safe research access to data. It allows real-time analysis while mitigating disclosure risk through an active multi-layer system of disclosure-preventing mechanisms. This combination of real-time remote statistical analysis, disclosure prevention mechanisms, and federation capabilities makes DataSHIELD a solution for addressing many of the technical and regulatory challenges in performing the large-scale statistical analysis of health and biomedical data. This paper describes the key components that comprise the disclosure protection system of DataSHIELD. These broadly fall into three classes: (i) system protection elements, (ii) analysis protection elements, and (iii) governance protection elements.

AVAILABILITY AND IMPLEMENTATION: Information about the DataSHIELD software is available in https://datashield.org/ and https://github.com/datashield.

© The Author(s) 2025. Published by Oxford University Press.

PMID: 40191546

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