Protecting patient privacy in tabular synthetic health data: a regulatory perspective.

Pilgram, Lisa; Ko, Haksoo; Tung, Adeline; El Emam, Khaled · NPJ Digit Med · 2025

review · Level V

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Abstract

Synthetic tabular data generation (SDG) is increasingly important in healthcare research and innovation while preserving patients' privacy. However, ethical concerns remain, primarily over residual privacy vulnerability and insufficient oversight. This review analyzes the only published SDG regulatory guidelines to date, from United Kingdom, Singapore, and South Korea. All emphasize privacy, acknowledging synthetic data is not inherently free from disclosure risks. Thresholds for sufficiently low risk are yet to be determined.