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Blockchain-enabled digital twin systems in healthcare: a systematic scoping review of architectural integration; privacy; governance; ethical challenges; and regulatory solutions under GDPR and HIPAA
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DOI：10.3389/fdgth.2026.1898383.png)
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Abstract
En 中文
Background and objectiveThe integration of blockchain and digital twin (DT) technologies is increasingly recognised as a promising approach for improving healthcare data integrity; interoperability; privacy; and clinical decision support. While digital twins enable dynamic patient modelling and predictive healthcare applications; blockchain provides secure data governance through decentralised trust; auditability; and access control. However; existing research remains fragmented; with limited synthesis of the architectural integration; regulatory readiness; ethical governance; and interoperability of blockchain-enabled healthcare digital twin systems. This systematic scoping review addresses these gaps by providing a comprehensive architectural and compliance-oriented analysis of the current evidence.MethodsA systematic scoping review was conducted following PRISMA 2020 guidelines using Scopus; PubMed; and Web of Science. From 148 identified records; 55 eligible studies published between 2020 and 2025 were included after duplicate removal and eligibility screening. Data were extracted on digital twin functionality; blockchain architecture; healthcare application domains; consensus mechanisms; privacy-preserving strategies; and regulatory and ethical alignment. Structured Python-based visual mapping and comparative analyses were performed to identify architectural; governance; and compliance patterns across the literature.ResultsThe findings demonstrate that blockchain is predominantly employed to provide access control; audit logging; data integrity; consent management; and secure data provenance within healthcare digital twin ecosystems. Patient-level and EHR-centred digital twins represented the most mature application areas; whereas cross-domain and infrastructure-level frameworks dominated early architectural exploration. The review identifies recurring compliance-oriented architectural patterns while revealing substantial gaps in clinically validated deployments; interoperability with established healthcare standards; decentralised governance models; and formal implementation of GDPR- and HIPAA-compliant engineering practices. Comparative heatmap analyses further highlight the uneven maturity of ethical governance and regulatory integration across blockchain functionalities.ConclusionThis review provides the first comprehensive compliance-oriented architectural synthesis of blockchain-enabled healthcare digital twin systems by integrating technical architecture; regulatory readiness; ethical governance; and privacy-preserving design patterns within a unified analytical framework. The proposed architectural mapping identifies critical research gaps in interoperability; governance engineering; consensus optimisation; and real-world clinical validation; providing a foundation for the development of trustworthy; GDPR/HIPAA-aligned; FHIR-compatible; and clinically interoperable healthcare digital twin ecosystems.
Keywords:
blockchain
healthcare
ethics
digital twin
clinical decision support
federated learning
data integrity
healthcare architecture
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