临床科研场景下医疗数据安全开放共享平台设计

Design and Exploration of Medical Data Security Opening Sharing Platform for Clinical Research Scenarios

目的:基于真实世界数据的临床研究面临患者隐私及敏感数据泄漏等问题,旨在设计一套临床科研数据安全共享平台,保障临床科研数据安全共享与计算。方法:梳理基于真实世界数据的临床研究面临的数据安全问题,制定临床科研场景下数据安全共享管理流程,设计一套临床科研场景下医疗数据安全共享平台。结果:从制度流程和技术管控两个维度,探索形成临床科研场景下医疗数据安全共享和开发利用模式,规范临床科研场景下临床数据安全管理。结论:针对临床科研场景,提出的临床数据安全共享管理流程和安全共享平台可以为今后规范临床科研数据安全合理利用,构建跨机构多中心的临床科研数据安全开放共享模式提供有益参考。

Objective:Clinical research based on real world data is faced with the problems of patient privacy and sensitive data leakage.The purpose of this study is to design a clinical research data security sharing platform to ensure the safe sharing and calculation of clinical research data.Methods:Sort out the data security issues in clinical research based on real-world data,formulate data security sharing management procedures in clinical scientific research scenarios,and design a set of medical data security sharing platforms in clinical scientific research scenarios.Results:From the two dimensions of institutional process and technical control,explore the formation of a safe sharing and development and utilization model of medical data in clinical scientific research scenarios,and standardize the safe management of clinical scientific research data.Conclusion:Facing the clinical research scenario,the paper formulated the clinical data security sharing management process specification,explored the construction of a clinical research data security sharing platform,it provides a useful reference for the construction of cross institution and multi center clinical research data security open sharing mode and the promotion of clinical data security utilization.