The Ministry of Health and Welfare (MOHW) is moving to bridge the "Death Valley" that has blocked artificial intelligence (AI) digital medical devices from entering the market. The plan is to accelerate the adoption of medical AI products by supporting the entire commercialization process — from clinical validation to real-world data (RWD) and real-world evidence (RWE) collection, and insurance listing.
The ministry announced on the 31st that it will launch the "Rapid Commercialization Support Program for AI Application Products." The core of the initiative lies in shifting away from the existing research and development-focused support to directly backing the commercialization stage. Until now, AI medical devices faced structural limitations: even after obtaining approval from the Ministry of Food and Drug Safety, the path to actual hospital adoption and market entry required lengthy procedures including clinical validation, cost-effectiveness evaluation and insurance listing.
To address these bottlenecks, the ministry will operate the program through consortiums in which hospitals and companies participate together. Selected consortiums will receive multi-year support (2026–2027) covering multi-center clinical validation, accumulation of RWD and RWE based on actual clinical data, and cost-effectiveness evaluations. The ministry also plans to provide package support that includes marketing expenses for hospital adoption and market expansion.
The program particularly focuses on raising the likelihood of insurance listing by verifying clinical efficacy and cost-effectiveness of products that can be used in actual clinical settings. This is seen as an expansion of policy support beyond the "technology verification" stage to the "market establishment" stage for AI medical devices.
The ministry aims to build a "commercialization highway" that enables AI technologies developed through this program to be applied in real medical settings within a short period. The plan is to promote digital transformation at medical institutions and lay the groundwork for expanding AI-based medical services.
"Promising digital medical device companies have long faced difficulties in the market entry process after obtaining regulatory approval," Minister of Health and Welfare Jeong Eun-gyeong said. "Through this program, we will resolve institutional barriers such as clinical trials and insurance listing, and support the rapid adoption of excellent AI medical devices in clinical settings."