Blockchain for Digital Health Governance: Evidence Gap Map and Scoping Review.

چکیده اصلی

BACKGROUND: Digital health increasingly depends on data exchange across institutions, technologies, and jurisdictions, creating persistent challenges for the governance of access, consent, interoperability, provenance, and accountability. Blockchain and distributed ledger technology (DLT) systems have been proposed as mechanisms for coordinating and verifying governance processes across distributed actors. However, existing research has examined individual applications or technical domains, leaving unclear how blockchain/DLT systems function as governance infrastructure across health care, and whether these systems have progressed toward real-world implementation. OBJECTIVE: This evidence gap map and scoping review aim to characterize how blockchain/DLT systems are applied to health data governance, identify the health care application domains, and governance functions addressed by these systems, and assess their evidence maturity. METHODS: We searched PubMed/MEDLINE, Embase, Scopus, and Dimensions (Digital Science), and conducted backward and forward citation searching to identify peer-reviewed studies reporting blockchain/DLT systems in health care with an implemented artifact, technical evaluation, simulation, benchmark, pilot/usability assessment, or operational deployment, published between January 1, 2010, and February 28, 2026. Conceptual or architecture-only papers were excluded. Studies were charted by application domain, governance function, and evidence maturity (proof-of-concept/prototype, simulated/benchmarked evaluation, pilot/usability-tested implementation, or operational/real-world deployment). A focused narrative synthesis was conducted for studies reporting pilot/usability-tested implementation or operational/real-world deployment. RESULTS: Of 892 included studies, the evidence base was dominated by proof-of-concept/prototype (n=418) and simulated/benchmarked evaluation (n=455) work; only 18 reported pilot/usability-tested implementation, and 1 reported operational/real-world deployment. Studies were concentrated in electronic health record management/health information exchange (n=372) and telemedicine/distributed care/Internet of Things (IoT)-enabled remote monitoring (n=250), followed by clinical decision support/smart health care (n=82), public health surveillance/certification (n=72), clinical trials/research governance (n=67), and health data marketplace/monetization (n=49). Across 3273 nonmutually exclusive governance-function codes, the most frequent functions were privacy/security, interoperability/data sharing, access control, data/model integrity, and identity/authentication. Publication activity increased over time, with the highest annual volumes in 2022 and 2025. This growth was not accompanied by a shift toward higher-maturity evidence. Privacy/security and interoperability/data sharing remained prominent across publication years, while other governance functions varied over time. Higher-maturity evidence was unevenly distributed across application domains, particularly clinical trials/research governance and electronic health record management/health information exchange. Within the 19 higher-maturity studies, evidence remained limited by small-scale evaluations, short follow-up, and a lack of sustained routine use beyond the evaluation period. CONCLUSIONS: Across digital health, blockchain/DLT systems were positioned as governance infrastructure for verifiable access, consent, provenance, identity, and audit trails, rather than as repositories for health data. Despite a growing literature, real-world implementation evidence remained limited. Whether blockchain/DLT systems improve governance outcomes over conventional architectures remains largely untested. Future research should prioritize comparative, implementation-focused evaluation of whether these systems can be integrated, sustained, and shown to provide governance benefits in real-world settings.

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