Role and Regulatory Status of Digital Therapeutics

Digital therapeutics have emerged as a new treatment method due to ICT advancements, offering evidence-based interventions for disease prevention and treatment. The Ministry of Food and Drug Safety (MFDS) has proactively supported the development and approval of digital therapeutics by publishing guidelines since August 2020. This has led to the approval of various products aimed at improving conditions such as insomnia. However, there are still barriers to entry and a need for improvements in the reimbursement system. Digital therapeutics represent a promising technology that can be directly used by patients. Monitoring clinical efficacy and expanding accessibility are crucial for creating a sustainable ecosystem. The government should improve regulatory frameworks to help domestic companies compete globally.