Motohashi Tomomitsu, Hirano Tomonobu, Okumura Kosuke, Kashiyama Makiko, Ichikawa Daisuke, Ueno Taro
SUSMED, Inc, Tokyo, Japan.
J Med Internet Res. 2019 May 16;21(5):e13385. doi: 10.2196/13385.
Blockchain is emerging as an innovative technology for secure data management in many areas, including medical practice. A distributed blockchain network is tolerant against network fault, and the registered data are resistant to tampering and revision. The technology has a high affinity with digital medicine like mobile health (mHealth) and provides reliability to the medical data without labor-intensive third-party contributions. On the other hand, the reliability of the medical data is not insured before registration to the blockchain network. Furthermore, there are issues with regard to how the clients' mobile devices should be dealt with and authenticated in the blockchain network in order to avoid impersonation.
The aim of the study was to design and validate an mHealth system that enables the compatibility of the security and scalability of the medical data using blockchain technology.
We designed an mHealth system that sends medical data to the blockchain network via relay servers. The architecture provides scalability and convenience of operation of the system. In order to ensure the reliability of the data from clients' mobile devices, hash values with chain structure (client hashchain) were calculated in the clients' devices and the results were registered on the blockchain network.
The system was applied and deployed in mHealth for insomnia treatment. Clinical trials for mHealth were conducted with insomnia patients. Medical data of the recruited patients were successfully registered with the blockchain network via relay servers along with the hashchain calculated on the clients' mobile devices. The correctness of the data was validated by identifying illegal data, which were made by simulating fraudulent access.
Our proposed mHealth system, blockchain combined with client hashchain, ensures compatibility of security and scalability in the data management of mHealth medical practice.
UMIN Clinical Trials Registry UMIN000032951; https://upload.umin.ac.jp/cgi-open- bin/ctr_e/ctr_view.cgi?recptno=R000037564 (Archived by WebCite at http://www.webcitation.org/78HP5iFIw).
区块链正作为一种创新技术出现在包括医疗实践在内的许多领域，用于安全的数据管理。分布式区块链网络能够容忍网络故障，且注册的数据抗篡改和修订。该技术与移动健康（mHealth）等数字医学具有高度亲和力，无需第三方大量投入人力即可为医疗数据提供可靠性。另一方面，在将医疗数据注册到区块链网络之前，其可靠性无法得到保证。此外，关于如何在区块链网络中处理和认证客户端移动设备以避免身份冒用，还存在一些问题。
本研究旨在设计并验证一个移动健康系统，该系统利用区块链技术实现医疗数据安全性与可扩展性的兼容。
我们设计了一个移动健康系统，该系统通过中继服务器将医疗数据发送到区块链网络。该架构提供了系统操作的可扩展性和便利性。为确保来自客户端移动设备的数据的可靠性，在客户端设备中计算具有链式结构的哈希值（客户端哈希链），并将结果注册到区块链网络上。
该系统已应用并部署于用于失眠治疗的移动健康领域。对失眠患者进行了移动健康临床试验。招募患者的医疗数据通过中继服务器与在客户端移动设备上计算的哈希链一起成功注册到区块链网络。通过识别模拟欺诈性访问产生的非法数据，验证了数据的正确性。
我们提出的移动健康系统，即区块链与客户端哈希链相结合，确保了移动健康医疗实践数据管理中安全性与可扩展性的兼容性。
日本大学医学情报网临床试验注册中心UMIN000032951；https://upload.umin.ac.jp/cgi-open- bin/ctr_e/ctr_view.cgi?recptno=R000037564（由WebCite存档于http://www.webcitation.org/78HP5iFIw）
