医院部署GCP远程监查的多级安全防护设计与实践

Design and Practice of Multi-level Security Protection for GCP Remote Monitoring in Hospitals

目的 解决医院远程监查业务过程中可能面临的安全风险,实现患者隐私保护,以提高药物临床试验质量管理规范(GCP)相关业务的便捷性与工作效率。方法 从GCP业务需求出发,综合考虑通信网络、主机系统、Web应用、数据管理、业务权限等5个方面的信息安全要求,设计和部署了一套多级安全防护方案。结果 此方案能够满足医院拓展GCP远程业务的安全技术要求,保证了GCP远程监查系统的应用效果。该系统上线1年内,业务效率大幅提升且未发生安全事故。结论 本方案能够满足互联网环境下医院GCP远程业务拓展的安全需求,可为同类系统构建提供参考。

Objective To solve the problem of potential security risks that hospitals may face in the process of remote monitoring,achieve patient privacy protection,and increase the convenience of clinical drug testing(GCP) business and improve work efficiency.Methods By designing and deploying a multi-level security protection scheme,based on the GCP business requirements and comprehensively considered the information security requirements of communication networks,host systems,web applications,data management,and business permissions.Results This solution can meet the security technical requirements for hospitals to expand GCP remote services.Since the GCP remote monitoring system was launched one year ago,business efficiency has significantly improved and there have been no incidents of safety.Conclusion This solution can satisfy the security requirements for remote business expansion of hospital GCP under the environment of the Internet,which can provide reference for the construction of similar systems.