Applying Blockchain Technology for Health Information Exchange and Persistent Monitoring for Clinical Trials

“Blockchain” is a distributed ledger technology originally applied in the financial sector. This technology ensures the integrity of transactions without third-party validation. Its functions of decentralized transaction validation, data provenance, data sharing, and data integration are a good fit for the needs of health information exchange and clinical trials. We investigated the current workflow of Health Information Exchange and clinical trials; conducted design thinking processes with clinicians, trial managers, informaticians, and blockchain professionals; and implemented a blockchain model to tackle known issues. We used coded Smart Contract regulations to simulate several scenarios in healthcare processes. This proof-of-concept work provides a feasible simulation for potential solutions to monitor clinical trials across different census regions persistently. Various levels of data access privileges have been designed to utilize a suite of customized Smart Contract settings. These settings emulate the workflow protocols for the monitoring entities, trial sponsors, clinical sponsors and participating subjects.