Synthetic electronic health records (EHRs) that are both realistic and preserve privacy can serve as an alternative to real EHRs for machine learning (ML) modeling and statistical analysis. However, generating high-fidelity and granular electronic health record (EHR) data in its original, highly-dimensional form poses challenges for existing methods due to the complexities inherent in high-dimensional data. In this paper, we propose Hierarchical Autoregressive Language mOdel (HALO) for generating longitudinal high-dimensional EHR, which preserve the statistical properties of real EHR and can be used to train accurate ML models without privacy concerns. Our HALO method, designed as a hierarchical autoregressive model, generates a probability density function of medical codes, clinical visits, and patient records, allowing for the generation of realistic EHR data in its original, unaggregated form without the need for variable selection or aggregation. Additionally, our model also produces high-quality continuous variables in a longitudinal and probabilistic manner. We conducted extensive experiments and demonstrate that HALO can generate high-fidelity EHR data with high-dimensional disease code probabilities (d ≈ 10,000), disease code co-occurrence probabilities within a visit (d ≈ 1,000,000), and conditional probabilities across consecutive visits (d ≈ 5,000,000) and achieve above 0.9 R2 correlation in comparison to real EHR data. In comparison to the leading baseline, HALO improves predictive modeling by over 17% in its predictive accuracy and perplexity on a hold-off test set of real EHR data. This performance then enables downstream ML models trained on its synthetic data to achieve comparable accuracy to models trained on real data (0.938 area under the ROC curve with HALO data vs. 0.943 with real data). Finally, using a combination of real and synthetic data enhances the accuracy of ML models beyond that achieved by using only real EHR data.

The ongoing pandemic has highlighted the importance of reliable and efficient clinical trials in healthcare. Trial sites, where the trials are conducted, are chosen mainly based on feasibility in terms of medical expertise and access to a large group of patients. More recently, the issue of diversity and inclusion in clinical trials is gaining importance. Different patient groups may experience the effects of a medical drug/ treatment differently and hence need to be included in the clinical trials. These groups could be based on ethnicity, co-morbidities, age, or economic factors. Thus, designing a method for trial site selection that accounts for both feasibility and diversity is a crucial and urgent goal. In this paper, we formulate this problem as a ranking problem with fairness constraints. Using principles of fairness in machine learning, we learn a model that maps a clinical trial description to a ranked list of potential trial sites. Unlike existing fairness frameworks, the group membership of each trial site is non-binary: each trial site may have access to patients from multiple groups. We propose fairness criteria based on demographic parity to address such a multi-group membership scenario. We test our method on 480 real-world clinical trials and show that our model results in a list of potential trial sites that provides access to a diverse set of patients while also ensuing a high number of enrolled patients. * This work was conducted while author was an employee of IQVIA Inc. Correspondence email: rakshith.sharma.s[at]gmail.com 2 All clinical trials specify certain inclusion criteria which describe a set of conditions to be met by patients to be enrolled in the trial and exclusion criteria, which describe conditions that determine patients who cannot be enrolled in the study.