Presentation (CTI)

OBJECTIVES: As digital therapeutics expand globally, designing effective regulatory frameworks has become a major policy concern. Germany’s DiGA system is a notable example, ensuring the reliability of digital health applications through patient-centered design, data protection, and accessibility. This study examines the operational features and policy structure of Germany’s DiGA system and suggests directions for improving post-market evaluation framework for digital health technologies.
METHODS: Publicly available sources, including official websites and policy documents, were reviewed to analyze DiGA’s eligibility criteria, Early Access Evaluation Criteria, and Reimbursement System. These components were compared with South Korea’s current digital health policies and assessment procedures.
RESULTS: • Eligibility Criteria: DiGA includes CE-certified Class I or IIa digital health apps that support patient self-management and clinical outcomes. South Korea’s system covers MFDS-approved technologies, including digital therapeutics, AI diagnostics, and robotic systems. • Conditional Reimbursement Period: Germany’s DiGA system allows conditional reimbursement for an initial period of up to 12 months, with the possibility of a one-time extension, making the maximum provisional duration 24 months. In contrast, South Korea permits conditional reimbursement for up to four years. • Early Access Evaluation Criteria: In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) evaluates aspects such as patient-centeredness, real-world data collection plans, and data protection. In South Korea, the New Health Technology Assessment Committee assesses criteria including patient-centeredness and safety. • DiGA’s post-market evaluation occurs within 12 months of conditional listing and is based on clinical evidence from RCTs and real-world data to assess effectiveness and quality-of-life outcomes.
CONCLUSIONS: While some evaluation criteria are common across countries, differences arise due to variations in healthcare systems and regulatory structures. Therefore, it is necessary to develop globally applicable standardized indicators or establish context-specific evaluation frameworks tailored to each country’s healthcare environment.