Blockchain-Enabled Biomedical Data Governance: A Review of Genomic Privacy, Consent Automation, and Clinical Interoperability
Main article
Abstract
Biomedical data—genomic sequences, clinical records, multi-omics measurements—are produced today at a scale and pace that strain conventional centralised governance. Although institutional databases protected by role-based access control remain the dominant pattern, they expose collaborators to single points of failure, opaque consent enforcement, fragmented audit trails, and weak interoperability across jurisdictions. Blockchain technology has been proposed as a substrate that can ameliorate these limitations through tamper-evident replication, programmable consent, and decentralised verification. This article synthesises the evidence base by systematically reviewing 67 peer-reviewed studies published between 2017 and 2025, retrieved from Scopus, IEEE Xplore, ScienceDirect, SpringerLink, and the ACM Digital Library and screened against an explicit five-question quality rubric. Building on the synthesis, we propose a six-layer reference architecture that combines a permissioned consortium ledger, smart-contract-based consent automation, privacy-preserving cryptography (zero-knowledge proofs, homomorphic encryption, differential privacy), W3C decentralised identity, off-chain storage on the InterPlanetary File System, and native interoperability with HL7 FHIR-compliant clinical systems. A multi-axis comparison shows that the proposed framework outperforms traditional centralised baselines on tamper resistance, provenance, consent automation, outage resilience, and interoperability, while the centralised baseline retains advantages in raw throughput, read latency, and confidentiality unless dedicated cryptographic primitives are deployed. The framework offers a practical roadmap for biomedical data stewardship and highlights open questions around energy efficiency, regulatory alignment, and post-quantum cryptography.
