Blockchain as an Audit Layer in EU Healthcare

Trust, Governance, and Evidence Artifacts aligned with the GDPR, EHDS, and NIS2
Erscheinungsjahr 2026
ISBN: 978-981-9246-91-5
Verlag: Springer

Buch, Englisch, 283 Seiten, Format (B × H): 155 mm x 235 mm

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.

Zielgruppe

Professional/practitioner

Autoren/Hrsg.

Fitzek, Sebastian

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
• Mathematik | Informatik EDV | Informatik Technische Informatik Computersicherheit Kryptographie, Datenverschlüsselung
• Mathematik | Informatik EDV | Informatik Informatik Künstliche Intelligenz
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Public Health, Gesundheitsmanagement, Gesundheitsökonomie, Gesundheitspolitik
• Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
• Mathematik | Informatik EDV | Informatik Daten / Datenbanken

Inhaltsverzeichnis

Chapter 1: The necessity of trust: blockchain as an audit layer in EU Healthcare.- Chapter 2: Building the Ledger: Fundamentals of Blockchain Technology.- Chapter 3: The Trust Gap in Practice: Challenges and Opportunities.- Chapter 4: Choosing the Right Ledger: Architectures and Platforms for Healthcare.- Chapter 5: Architecture to Operations: Applied Use Cases, EHR Consent and Integrity, Pharmaceutical Provenance, and Telemedicine/IoMT Data Trust.- Chapter 6: Training AI Without Moving Data: Verifiable, Privacy-Preserving, and Explainable Intelligence.- Chapter 7: Legal, Ethical, and Regulatory Aspects (EU Focus).- Chapter 8: Empirical case studies (European), from pilots to policy-aligned patterns.- Chapter 9: China’s blockchain strategy for healthcare: Policy, infrastructure, and transferable lessons.- Chapter 10: Comparative Analysis and Implementation Pathway.- Chapter 11: Engineering Trust at Scale: Performance, Security, and Sustainability Chapter 12: Closing the Loop (2025--2035): From Prototype to Infrastructure.

Über Autor(innen)

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.