Blockchain Technology to Enhance Clinical Data Management in Healthcare: A Systematic Literature Review

Area of Science:

• Health Informatics
• Computer Science
• Blockchain Technology

Background:

• Clinical data management (CDM) faces challenges in security, privacy, and interoperability.
• Emerging technologies like blockchain offer potential solutions for these issues.
• A systematic review is needed to understand blockchain's current role and adoption barriers in CDM.

Purpose of the Study:

• To systematically review the application of blockchain in clinical data management.
• To identify how blockchain supports clinical data workflows, security, and privacy.
• To explore technical challenges, integration with other technologies, and barriers to adoption.

Main Methods:

• Systematic literature search conducted in Scopus and Web of Science.
• Inclusion/exclusion criteria and quality assessment applied to retrieved records.
• Analysis guided by five research questions focusing on blockchain's role, challenges, and integration.

Main Results:

• Blockchain facilitates consent management, secure data sharing, traceability, and tamper-resistant audit trails via smart contracts.
• It acts as a trust layer for electronic health records, IoT, AI, and telemedicine.
• Key challenges include limited scalability, integration difficulties with legacy systems, regulatory hurdles, and smart contract complexity.

Conclusions:

• Blockchain demonstrates significant potential to enhance security, transparency, and data exchange in CDM.
• Addressing scalability, interoperability, and governance is crucial for real-world deployment.
• Further research with quantitative benchmarks and real-world deployments is needed to improve comparability and generalizability.