Zhuang Yu, Sheets Lincoln, Shae Zonyin, Tsai Jeffrey J P, Shyu Chi-Ren
Informatics Institute.
School of Medicine, University of Missouri, Columbia, MO, USA.
AMIA Annu Symp Proc. 2018 Dec 5;2018:1167-1175. eCollection 2018.
"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 private 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. Keywords: Blockchain, Smart Contract, Health Information Exchange, Clinical Trial, Persistent Monitoring.
“区块链”是一种最初应用于金融领域的分布式账本技术。该技术无需第三方验证即可确保交易的完整性。其去中心化交易验证、数据溯源、数据共享和数据集成功能非常适合健康信息交换和临床试验的需求。我们研究了健康信息交换和临床试验的当前工作流程；与临床医生、试验管理人员、信息专家和区块链专业人员进行了设计思维流程；并实施了一个私有区块链模型来解决已知问题。我们使用编码的智能合约规则来模拟医疗保健流程中的几种场景。这项概念验证工作为跨不同普查区域持续监测临床试验的潜在解决方案提供了可行的模拟。已设计了各种级别的数据访问权限，以利用一套定制的智能合约设置。这些设置模拟了监测实体、试验申办者、临床申办者和参与受试者的工作流程协议。关键词：区块链、智能合约、健康信息交换、临床试验、持续监测。
