Current Status of Digital Therapeutic Devices in Cognitive Intervention in South Korea

With the rapid aging of the global population, early intervention in cognitive decline has become increasingly important.Digital cognitive intervention therapies have emerged as scalable and accessible alternatives to traditional face-to-face approaches, especially with the acceleration of digital health technologies during the coronavirus disease 2019 (COVID-19) pandemic.These interventions-delivered via mobile or virtual platforms-hold promise for enhancing cognitive function and delaying progression to dementia, particularly among individuals with mild cognitive impairment.In South Korea, the growing demand for digital healthcare solutions has prompted the enactment of the Digital Healthcare Products Act, which addresses regulatory limitations of conventional medical devices.Under this framework, digital cognitive therapeutic devices must undergo rigorous evaluation, including medical device approval and new health technology assessment, to be integrated into clinical practice and considered for reimbursement.Despite clinical demand, conventional cognitive therapies remain uncovered by national insurance, limiting patient access.However, recent advancements-such as VIVID Brain, a digital therapeutic approved for visual field restoration following brain injury-demonstrate the feasibility and potential impact of digital interventions.To advance this field, robust clinical evidence, streamlined regulatory processes, and financial support are essential.Furthermore, rKorean digital health companies must enhance their global competitiveness through innovation and evidencebased development.With continued support from government and regulatory agencies, digital cognitive interventions are expected to play a key role in the future landscape of dementia prevention and cognitive healthcare.