突发公共卫生事件中的临床数据提取：区块链技术评估。

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

出版信息

Biomed Instrum Technol. 2021 Jul 1;55(3):103-111. doi: 10.2345/0899-8205-55.3.103.

DOI:10.2345/0899-8205-55.3.103

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8657842/

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.

摘要

目的

我们旨在探讨医疗机构在新型数据共享方法方面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）安全地提交给食品和药物管理局（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在区块链基础设施上测试医疗保健数据传输。

结果

所有参与机构都报告了能够从 EHR 中提取数据进行研究的能力。正式的法律协议被认为对项目不必要，但在未来对真实患者数据交换的测试中需要。数据传输到 FDA 区块链符合从四个机构防火墙内部到通过 SDB 到 FDA 区块链的外部数据连接的成功标准。

讨论

准备情况调查表明医疗机构具有先进的分析能力，并强调了尽管 21 世纪治愈法案有要求，但各机构之间 Fast Healthcare Interoperability Resources 格式利用的不一致性。建议在更多机构进行进一步测试，并利用区块链基础设施进行数据交换的年度演练，以确定在公共卫生紧急情况下采用这种方法的可行性，并更广泛地了解多站点数据提取的技术要求。