A Validation Study for Medical Research Based on Synthetic Hospital Data (Preprint)

BACKGROUND Privacy restrictions limit access to protected patient-derived health information for research purposes. Consequently, data anonymization is required to allow researchers data access for initial analysis before granting Institutional Review Board approval. A system implemented in our institution enables synthetic data generation that mimics data from real electronic medical records, wherein only fictitious patients are listed. OBJECTIVE This paper studies the validity of results obtained when analyzing synthetic data for medical research. A comprehensive validation process concerning meaningful clinical questions and various types of data was conducted to assess the accuracy and precision of statistical estimates derived from synthetic patient data. METHODS A cross-hospital project was conducted to validate results obtained from synthetic data produced for five contemporary studies on various topics. For each study, results derived from synthetic data were compared to those based on real data. In addition, repeatedly generated synthetic data sets were used to estimate the bias and stability of results obtained from synthetic data. RESULTS This study demonstrated that results derived from synthetic data were predictive of results from real data. When the number of patients was large relative to the number of variables used, highly accurate and strongly consistent results were observed between synthetic and real data. When small populations were accounted for, prediction was of moderate accuracy. CONCLUSIONS The use of synthetic data provides a close estimate to real data results and is thus a powerful tool in shaping research hypotheses and accessing estimated analyses, without risking patient privacy. Synthetic data enables broad access to data, including for out-of-organization researchers, and rapid, safe, and repeatable analysis of data in hospitals or other health organizations where patient privacy is a primary value.