For better life, medical and IT technology are converging and data plays a key role in this convergence. Data in the medical field is information about humans, and these data are sensitive. Because this type of data is frequently accessed by multiple users, a high degree of caution is required during handling. In addition, systematic security precautions must be followed to prevent data from being used outside of the intended purpose, even in clinical research. In this paper, we propose a human-centric framework for clinical environments based on the standards, procedures, and methods outlined in guidelines published in the United States and Korea. This study provides a more balanced approach to the utilization and security of personal information as compared to that in the two previously published guidelines. For the secure clinical studies, this framework makes it possible to provide utility and security in a balanced manner, depending on the forms of provision. As a result, the proposed framework extends the usability of the clinical study, and support secure usage of clinical research data.

中文翻译：

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设计以人类为中心的去识别框架，以利用各种临床研究数据

为了改善生活，医疗和IT技术正在融合，数据在这种融合中起着关键作用。医学领域的数据是关于人类的信息，这些数据是敏感的。由于此类数据经常被多个用户访问，因此在处理过程中需要高度注意。此外，必须遵循系统的安全预防措施，以防止数据被用于预期目的之外，甚至在临床研究中也是如此。在本文中，我们基于在美国和韩国发布的指南中概述的标准，程序和方法，提出了一种以人为中心的临床环境框架。与之前发布的两个指南相比，该研究为个人信息的使用和安全提供了一种更加平衡的方法。为了进行安全的临床研究，该框架使得有可能根据提供的形式以平衡的方式提供实用程序和安全性。结果，提出的框架扩展了临床研究的可用性，并支持临床研究数据的安全使用。