Objective

The creation and exchange of patients’ Electronic Healthcare Records have developed significantly in the last decade. Patients’ records are however distributed in data silos across multiple healthcare facilities, posing technical and clinical challenges that may endanger patients’ safety. Current healthcare sharing systems ensure interoperability of patients’ records across facilities, but they have limits in presenting doctors with the clinical context of the data in the records. We design and implement a platform for managing provenance tracking of Electronic Healthcare Records based on blockchain technology, compliant with the latest healthcare standards and following the patient-informed consent preferences.

Methods

The platform leverages two pillars: the use of international standards such as Integrating the Healthcare Enterprise (IHE), Health Level Seven International (HL7) and Fast Healthcare Interoperability Resources (FHIR) to achieve interoperability, and the use of a provenance creation process that by-design, avoids personal data storage within the blockchain. The platform consists of: (1) a smart contract implemented within the Hyperledger Fabric blockchain that manages provenance according to the W3C PROV for medical document in standardised formats (e.g. a CDA document, a FHIR resource, a DICOM study, etc.); (2) a Java Proxy that intercepts all the document submissions and retrievals for which provenance shall be evaluated; (3) a service used to retrieve the PROV document.

Results

We integrated our decentralised platform with the SpiritEHR engine, an enterprise-grade healthcare system, and we stored and retrieved the available documents in the Mandel's sample CDA repository,¹ which contained no protected health information. Using a cloud-based blockchain solution, we observed that the overhead added to the typical processing time of reading and writing medical data is in the order of milliseconds. Moreover, the integration of the Proxy at the level of exchanged messages in EHR systems allows transparent usage of provenance data in multiple health computing domains such as decision making, data reconciliation, and patient consent auditing.

Conclusions

By using international healthcare standards and a cloud-based blockchain deployment, we delivered a solution that can manage provenance of patients’ records via transparent integration within the routine operations on healthcare data.

中文翻译：

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医疗数据分散来源。

目的

在过去的十年中，患者电子医疗记录的创建和交换取得了长足的发展。但是，患者的记录分布在多个医疗机构的数据孤岛中，构成了可能危害患者安全的技术和临床挑战。当前的医疗保健共享系统可确保患者记录在各个机构之间的互操作性，但是它们在向医生提供记录中数据的临床背景方面存在局限性。我们设计和实施一个平台，用于基于区块链技术，符合最新医疗保健标准并遵循患者知情同意的偏好来管理电子医疗记录的出处跟踪。

方法

该平台利用了两个支柱：使用国际标准，例如集成医疗保健企业（IHE），七级卫生国际（HL7）和快速医疗保健互操作性资源（FHIR）以实现互操作性，以及使用通过-design，避免在区块链内存储个人数据。该平台包括：（1）在Hyperledger Fabric区块链中实施的智能合约，该合约根据W3C PROV管理标准化格式的医学文档的来源（例如CDA文档，FHIR资源，DICOM研究等）；（2）一个Java代理，它拦截所有应评估其来源的文档提交和检索；（3）用于检索PROV文档的服务。

结果

我们将分散式平台与SpiritEHR引擎（企业级医疗保健系统）集成在一起，并在Mandel的示例CDA存储库¹中存储和检索了可用文档，其中没有受保护的健康信息。使用基于云的区块链解决方案，我们观察到读取和写入医疗数据的典型处理时间所增加的开销约为毫秒。此外，在EHR系统中在已交换消息级别集成代理，可以在多个健康计算域中透明使用出处数据，例如决策，数据对账和患者同意审核。

结论

通过使用国际医疗保健标准和基于云的区块链部署，我们提供了一种解决方案，可以通过在医疗保健数据的常规操作中进行透明集成来管理患者记录的出处。