Blockchain as an Audit Layer in EU Healthcare

This book offers a comprehensive technical and regulatory framework for implementing blockchain technology as a dedicated audit layer within the European healthcare ecosystem. As healthcare systems transition toward the European Health Data Space (EHDS) and comply with the NIS2 Directive, the challenge of maintaining data integrity while respecting patient privacy has become paramount.The work moves away from speculative "on-chain" storage models, instead proposing a pragmatic "Audit Layer" architecture. This model utilizes blockchain to store integrity anchors, consent receipts, and evidence artifacts, ensuring that all clinical and administrative actions are verifiable and legally defensible. By bridging the gap between decentralized ledger technology (DLT) and the General Data Protection Regulation (GDPR), the author provides a roadmap for achieving "Privacy-by-Design" in complex medical environments.

Dr. Sebastian Fitzek is a researcher at the Research Centre for Medical Image Analysis & Artificial Intelligence (MIAAI), within the Faculty of Medicine and Dentistry at Danube Private University (DPU), Austria. His current research focus lies at the intersection of Health Services Research and emerging technologies, with a specific emphasis on the implementation of decentralized systems and Data Science in clinical environments. He is actively involved in developing frameworks that bridge the gap between technical innovation and the stringent requirements of modern healthcare systems.