Normalization of deviance in neuromodulation for epilepsy

The rapid expansion of neuromodulation therapies for drug resistant epilepsy has introduced a growing risk of normalization of deviance (NoD). This occurs when incremental deviations from established procedures are iteratively reinterpreted as the care standard in the absence of immediate adverse outcomes. While motivated by an urgent need to develop novel therapies to improve the quality-of-life of persons with epilepsy, NoD risks harm to the very individuals these neurotechnologies are designed to help. In this commentary, we borrow from organizational safety research to highlight systemic, institutional, and cultural factors that enable NoD in the pursuit of neuromodulation for epilepsy. We highlight the dual imperative of driving forward innovations in neurotechnologies while prioritizing patient safety. Finally, we propose safeguards against NoD including institutional review, centralized data collection, and cultural shifts that prioritize safety and mitigate risk.