Blockchain Technology for Enhancing Clinical Data Management in Healthcare: A Systematic Literature Review
Keywords:
audit trail, blockchain, clinical data management, consent management, healthcare, HL7 FHIR, interoperability, smart contractsAbstract
This systematic review examines how blockchain is applied in clinical data management and what currently prevents its adoption in healthcare. A structured search in Scopus and Web of Science retrieved 554 records; after applying inclusion/exclusion criteria and quality assessment, 32 studies published between 2018 and 2024 were included. The analysis was guided by five research questions: how blockchain supports clinical data workflows; its role in data security and privacy; key technical challenges; commonly used technologies; and integration with other healthcare technologies. Findings show that blockchain can support consent management, secure data sharing, traceability, and tamper-resistant audit trails using smart contracts and decentralized access control. It is also positioned as a trust layer for electronic health records (EHRs), the Internet of Medical Things (IoMT), artificial intelligence (AI), and telemedicine by ensuring integrity and controlled access to sensitive clinical data. However, several barriers limit real-world deployment. Reported challenges include limited scalability and throughput, difficulty integrating with legacy EHR systems, heterogeneous regulatory requirements, and the complexity of encoding privacy, consent, and compliance into smart contracts. Ethereum and Hyperledger Fabric are the most frequently implemented platforms, often combined with off-chain storage and interoperability standards such as FHIR/SMART-on-FHIR. Overall, blockchain shows strong potential to improve security, transparency, and cross-institution exchange in clinical data management, but its viability depends on addressing scalability, interoperability, and governance constraints.
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Copyright (c) 2026 Khaoula Chafik, MS Computer Science, PhD(c), Mohamed Hanine, PhD, Abdellah Ouaguid, PhD, ENSET (École Normale Supérieure de l’Enseignement Technique), Sulieman Alshuhri, PhD
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