Please use this identifier to cite or link to this item: https://hdl.handle.net/10419/338078 
Year of Publication: 
2026
Series/Report no.: 
Discussion Paper No. 2026/5
Publisher: 
Freie Universität Berlin, School of Business & Economics, Berlin
Abstract: 
This thesis operationalises the European Health Data Space (EHDS) notion of a Secure Processing Environment (SPE) by translating technology-neutral regulatory obligations into implementable and testable platform requirements. Following a Design Science Research approach, it introduces a traceability-centred translation mechanism that incrementally refines legal clauses into role-specific requirements and consolidates them in a traceability matrix, keeping interpretations, responsibilities and control points explicit along the EHDS secondary-use journey. Based on this requirements baseline, the thesis designs and implements Badger, a cloud-native SPE prototype on Kubernetes that supports end-to-end workflows, from identity and access management to permit-bound workspaces and controlled result export via an airlock. Evaluation using EHDS-aligned scenarios and a traceability-matrix cross-check indicates strong coverage where obligations can be mapped to enforceable workflow steps and isolation boundaries, while exposing open challenges in enforcing permit conditions and providing a complete end-to-end audit trail. The thesis contributes a reusable method for regulatory grounding under legal uncertainty. For practitioners, it offers a checklist-style traceability matrix and a modular blueprint for realising EHDS-compliant SPE workflows.
Subjects: 
EHDS
Secure Processing Environment
Regulatory Traceability
Design Science Research
Trusted Research Environments
Persistent Identifier of the first edition: 
Document Type: 
Working Paper

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