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面向数字临床试验初期保障数据隐私和效用的架构。

Towards an Architecture to Guarantee Both Data Privacy and Utility in the First Phases of Digital Clinical Trials.

机构信息

Department of Computer, Control, and Management Engineering "Antonio Ruberti", Sapienza University of Rome, 00185 Rome, Italy.

出版信息

Sensors (Basel). 2018 Nov 28;18(12):4175. doi: 10.3390/s18124175.

DOI:10.3390/s18124175
PMID:30487435
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6308650/
Abstract

In the era of the Internet of Things (IoT), drug developers can potentially access a wealth of real-world, participant-generated data that enable better insights and streamlined clinical trial processes. Protection of confidential data is of primary interest when it comes to health data, as medical condition influences daily, professional, and social life. Current approaches in digital trials entail that private user data are provisioned to the trial investigator that is considered a trusted party. The aim of this paper is to present the technical requirements and the research challenges to secure the flow and control of personal data and to protect the interests of all the involved parties during the first phases of a clinical trial, namely the of the potential patients and their possible . The proposed architecture will let the individuals keep their data private during these phases while providing a useful sketch of their data to the . Proof-of-concept implementations are evaluated in terms of performances achieved in real-world environments.

摘要

在物联网(IoT)时代,药物开发者可以潜在地访问大量真实的、参与者生成的数据,从而获得更好的洞察力并简化临床试验流程。在涉及健康数据时,保护机密数据是首要关注点,因为医疗状况会影响日常生活、职业和社交生活。当前的数字试验方法需要将私人用户数据提供给被认为是可信方的试验研究者。本文旨在介绍技术要求和研究挑战,以确保在临床试验的第一阶段(即潜在患者及其可能的 )中个人数据的流动和控制,并保护所有相关方的利益。所提出的架构将允许个人在这些阶段保持其数据的隐私性,同时向 提供其数据的有用概述。根据在真实环境中实现的性能来评估概念验证的实现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/ec1945535fc4/sensors-18-04175-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/7d50cee8c0b6/sensors-18-04175-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/9a9fd35ca4e5/sensors-18-04175-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/438450a99952/sensors-18-04175-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/3ad9c5aff2d9/sensors-18-04175-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/f3d3a7a17838/sensors-18-04175-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/b13a27acd4fe/sensors-18-04175-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/ec1945535fc4/sensors-18-04175-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/7d50cee8c0b6/sensors-18-04175-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/9a9fd35ca4e5/sensors-18-04175-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/438450a99952/sensors-18-04175-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/3ad9c5aff2d9/sensors-18-04175-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/f3d3a7a17838/sensors-18-04175-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/b13a27acd4fe/sensors-18-04175-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b3c/6308650/ec1945535fc4/sensors-18-04175-g007.jpg

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