JMIR Publications

ABSTRACT

Background:

Digital health systems increasingly rely on large-scale data exchange across fragmented, multi-institutional environments, creating persistent challenges for data governance. Blockchain and distributed ledger technologies have been proposed as infrastructures to improve transparency, coordination, and trust in these settings. However, existing research is often organized within specific application domains, limiting cross-domain understanding of blockchain’s broader role in digital health systems.

Objective:

This scoping review aimed to map and synthesize literature on blockchain applications in digital health, with a focus on governance-related functions across domains including telemedicine, clinical research, artificial intelligence (AI), and health data exchange.

Methods:

PubMed, Scopus, and Dimensions were searched for peer-reviewed studies published between January 1, 2010 and February 28, 2026. Eligible studies were screened and charted using a standardized data extraction framework. Findings were synthesized thematically across four domains: telemedicine and distributed care delivery, clinical trial transparency and research governance, AI–integrated data ecosystems, and health data monetization and value exchange. Cross-cutting governance and coordination challenges were identified across domains.

Results:

A total of 58 studies were included. Literature consisted primarily of conceptual frameworks, system design studies, pilot implementations, and systematic reviews, with limited large-scale empirical evaluation. Across domains, blockchain was most commonly described as a distributed ledger for recording governance-related metadata, including consent, access permissions, identity, and data provenance, while primary clinical data remained off-chain, indicating a consistent governance role rather than a clinical data function. Recurring challenges included interoperability limitations, fragmented data stewardship, and limited auditability. Blockchain-based approaches were most frequently proposed in contexts requiring multi-organizational coordination, dynamic consent management, and verifiable transaction histories. Governance models, incentive structures, and regulatory alignment varied substantially across use cases.

Conclusions:

Blockchain in digital health was most consistently conceptualized as a governance-layer infrastructure rather than a system for storing or processing clinical data. Its potential value is context-dependent, particularly in settings requiring coordination across multiple actors without centralized trust. However, it does not address foundational challenges including data quality, regulatory compliance, or institutional accountability. Further empirical evaluation is needed to assess its implementation and real-world impact. Clinical Trial: -