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A Permissioned Blockchain Network for Security and Sharing of De-identified Tuberculosis Research Data in Brazil.

BACKGROUND
 Tuberculosis (TB) is an infectious disease and is among the top 10 causes of death in the world, and Brazil is part of the top 30 high TB burden countries. Data collection is an essential practice in health studies, and the adoption of electronic data capture (EDC) systems can positively increase the experience of data acquisition and analysis. Also, data-sharing capabilities are crucial to the construction of efficient and effective evidence-based decision-making tools for managerial and operational actions in TB services. Data must be held secure and traceable, as well as available and understandable, for authorized parties.


OBJECTIVES
 In this sense, this work aims to propose a blockchain-based approach to build a reusable, decentralized, and de-identified dataset of TB research data, while increasing transparency, accountability, availability, and integrity of raw data collected in EDC systems.


METHODS
 After identifying challenges and gaps, a solution was proposed to tackle them, considering its relevance for TB studies. Data security issues are being addressed by a blockchain network and a lightweight and practical governance model. Research Electronic Data Capture (REDCap) and KoBoToolbox are used as EDC systems in TB research. Mechanisms to de-identify data and aggregate semantics to data are also available.


RESULTS
 A permissioned blockchain network was built using Kaleido platform. An integration engine integrates the EDC systems with the blockchain network, performing de-identification and aggregating meaning to data. A governance model addresses operational and legal issues for the proper use of data. Finally, a management system facilitates the handling of necessary metadata, and additional applications are available to explore the blockchain and export data.


CONCLUSIONS
 Research data are an important asset not only for the research where it was generated, but also to underpin studies replication and support further investigations. The proposed solution allows the delivery of de-identified databases built in real time by storing data in transactions of a permissioned network, including semantic annotations, as data are being collected in TB research. The governance model promotes the correct use of the solution.