Clinical Data Extraction During Public Health Emergencies: A Blockchain Technology Assessment.

Q4 Medicine

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI:10.2345/0890-8205-55.3.103

Joan C. Brown, Manas Bhatnagar, Hugh Gordon, K. Lutrick, Jared Goodner, James Blum, Raquel R Bartz, D. Uslan, Ernesto David-DiMarino, A. Sorbello, Gregory H. Jackson, Jeremy Walsh, Lauren Neal, Marek Cyran, H. Francis, J. Cobb

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引用次数: 1

Abstract

OBJECTIVE We sought to explore the technical and legal readiness of healthcare institutions for novel data-sharing methods that allow clinical information to be extracted from electronic health records (EHRs) and submitted securely to the Food and Drug Administration's (FDA's) blockchain through a secure data broker (SDB). MATERIALS AND METHODS This assessment was divided into four sections: an institutional EHR readiness assessment, legal consultation, institutional review board application submission, and a test of healthcare data transmission over a blockchain infrastructure. RESULTS All participating institutions reported the ability to electronically extract data from EHRs for research. Formal legal agreements were deemed unnecessary to the project but would be needed in future tests of real patient data exchange. Data transmission to the FDA blockchain met the success criteria of data connection from within the four institutions' firewalls, externally to the FDA blockchain via a SDB. DISCUSSION The readiness survey indicated advanced analytic capability in hospital institutions and highlighted inconsistency in Fast Healthcare Interoperability Resources format utilitzation across institutions, despite requirements of the 21st Century Cures Act. Further testing across more institutions and annual exercises leveraging the application of data exchange over a blockchain infrastructure are recommended actions for determining the feasibility of this approach during a public health emergency and broaden the understanding of technical requirements for multisite data extraction. CONCLUSION The FDA's RAPID (Real-Time Application for Portable Interactive Devices) program, in collaboration with Discovery, the Critical Care Research Network's PREP (Program for Resilience and Emergency Preparedness), identified the technical and legal challenges and requirements for rapid data exchange to a government entity using the FDA blockchain infrastructure.

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突发公共卫生事件中的临床数据提取：区块链技术评估。

目的：我们试图探索医疗机构对新的数据共享方法的技术和法律准备情况，这些方法允许从电子健康记录（EHR）中提取临床信息，并通过安全数据代理（SDB）安全地提交给美国食品药品监督管理局（FDA）的区块链。材料和方法本评估分为四个部分：机构EHR准备情况评估、法律咨询、机构审查委员会申请提交，以及区块链基础设施上的医疗数据传输测试。结果所有参与机构都报告了从EHR中以电子方式提取数据进行研究的能力。正式的法律协议被认为对该项目没有必要，但在未来的真实患者数据交换测试中需要。向美国食品药品监督管理局区块链的数据传输符合四个机构防火墙内数据连接的成功标准，通过SDB.讨论从外部连接到美国食品药品监管局区块链。准备情况调查表明，医院机构具有先进的分析能力，并强调了各机构之间快速医疗互操作性资源格式使用的不一致性，尽管有《21世纪治愈法》的要求。建议在更多机构进行进一步测试，并利用区块链基础设施上的数据交换应用进行年度演习，以确定这种方法在公共卫生紧急情况下的可行性，并扩大对多站点数据提取技术要求的理解。结论美国食品药品监督管理局的RAPID（便携式互动设备实时应用程序）计划与重症监护研究网络的PREP（恢复力和应急准备计划）Discovery合作，确定了使用美国食品药品管理局区块链基础设施向政府实体快速交换数据的技术和法律挑战及要求。

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来源期刊

Biomedical Instrumentation and Technology Computer Science-Computer Networks and Communications

CiteScore

1.10

自引率

0.00%

发文量

期刊介绍： AAMI publishes Biomedical Instrumentation & Technology (BI&T) a bi-monthly peer-reviewed journal dedicated to the developers, managers, and users of medical instrumentation and technology.