Issue Unsettled regulation, safety evidence and data privacy for brain stimulation and BCI therapies

Summary

Korea has a basic framework for digital therapeutics and AI medical devices through safety and performance evaluation guidelines and a proposed digital medical products act. Detailed rules for combination products that merge electroceuticals, brain stimulation and AI, such as how to classify them and what clinical evidence to demand, are still being set. Because mental disorders vary widely in symptoms and causes, there is little consensus on optimal stimulation targets and parameters for each condition, and long-term follow-up data are scarce. Transcranial focused ultrasound still lacks sufficient safety verification regarding skull penetration, temperature rise and unintended tissue damage. The use of extremely sensitive mental and behavioural data also raises strong concerns about privacy violations and stigma.