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临床研究中慢性病患者数据隐私和安全保护的伦理共识 被引量:3

Ethical consensus on privacy and security protection of data for patients with chronic diseases in clinical research
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摘要 在慢性病防治及临床研究中,大数据技术的应用不仅能够促进研究,而且能够降低医疗成本,为国家医疗预防和保健工作提供积极的决策参考,但医疗健康大数据也面临巨大的隐私和安全风险。为了保障慢性病患者的数据隐私安全和权益,也为相关从业者和管理者提供行动指南和决策参考,十分有必要制定临床研究中慢性病患者数据隐私和安全保护的伦理共识。针对慢性病患者数据隐私和安全保护的特殊性,共识在申明基本伦理原则的基础上,将基于数据全生命周期理论对慢性病患者数据隐私和安全保护措施做出阶段性划分,对具体的技术手段和要求提供详细说明,并就相关的管理制度提供具体建议。 In the prevention,control and clinical research of chronic disease,the application of big data technology can not only benefit the research,but also reduce medical cost and provide effective decision reference for the work of medical care and healthcare in China.However,there are substantial privacy and security risks facing big data in medical care and healthcare.In order to protect the patients’data privacy,data security and their rights and interests as well as to provide guide to action and decision-making reference for medical care and healthcare practitioners and decision-makers,it is highly necessary to establish ethical consensus on the protection of data privacy and security for patients living with chronic diseases in clinical research.With consideration of the particularity of the protection of data privacy and security for patients with chronic diseases,this study will embark on establishing consensus by a declaration of the basic ethical principles.The consensus draws on the theory of the Lifecycle of Data to suggest protection measures for data privacy and security by stage before providing detailed instructions on technical means and requirements and giving suggestions for the management systems optimization.
作者 韩晓晓 刘迅 崇雨田 文贤庆 孙保学 胡晓萌 HAN Xiaoxiao;LIU Xun;CHONG Yutian;WEN Xianqing;SUN Baoxue;HU Xiaomeng(The Third Affiliated Hospital of Sun Yat-sen University,Guangzhou 510000,China;不详)
出处 《现代医院》 2021年第6期898-902,906,共6页 Modern Hospitals
基金 国家重点研发计划课题(2018YFC1315403)。
关键词 慢性病 数据隐私 数据安全 伦理原则 伦理共识 Chronic disease Data privacy Data security Ethical principles Ethical consensus
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