Synthetic electronic health record (EHR) data generation has emerged as a potential solution to balancing clinical data accessibility with patient privacy, using generative artificial intelligence to simulate tabular, longitudinal, and textual health records without exposing identifiable patient information. This critical review, informed by PRISMA-ScR methodology, examines studies published between 2017 and 2025 focusing on generative models for synthetic EHR creation, with particular attention to privacy risks, data fidelity, downstream task utility, and ethical or regulatory considerations. A total of 67 studies were included after systematic screening, showing a dominance of GAN-based approaches alongside growing use of diffusion models and large language models in recent years, although privacy assessment and benchmarking practices remain inconsistent. Overall, the evidence suggests that while synthetic EHR data can facilitate data sharing, research, and model development, achieving a balance between realism, utility, and privacy remains challenging, as high statistical fidelity does not necessarily translate into clinical usefulness and strong downstream performance does not ensure adequate privacy protection.
Rare pediatric tumors like sarcomas, neuroblastoma, medulloblastoma, and retinoblastoma pose a challenge for developing deep learning models due to the limited availability of histopathology images, which are distributed across multiple institutions. This scarcity is compounded by privacy concerns, as whole-slide images often contain sensitive clinical and genomic data, and generative adversarial networks (GANs) risk memorizing and leaking training samples. To address this, a differentially private GAN framework is proposed for synthesizing high-resolution histopathology patches of rare pediatric cancers. The framework incorporates a generator for image synthesis, a discriminator for realism assessment, per-sample gradient clipping, Gaussian noise injection, and a privacy accountant, ensuring provable privacy guarantees during the training process. The synthetic images generated can aid in data augmentation, model pre-training, and benchmarking without exposing identifiable pathology data, offering a privacy-preserving solution for dataset augmentation while emphasizing the importance of clinical validation.
Clinical Intelligence Research Press