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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.

Design of a human-centric de-identification framework for utilizing various clinical research data