Blockchain as an Audit Layer in EU Healthcare - Trust, Governance, and Evidence Artifacts aligned with the GDPR, EHDS, and NIS2

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.