24/07/2026
📌HIRA Publishes Research on Pathways for Insurance Listing of Digital Medical Technologies (AI + DTx)
The Health Insurance Review & Assessment Service (HIRA) released the findings of a study commissioned to CHA University Industry-Academic Cooperation Foundation on July 1, 2026, titled "Development of Reimbursement Evaluation Criteria and Listing Pathways for AI-Based Medical Technologies." The study was conducted to establish a reimbursement classification framework applicable when AI-based medical technologies and digital therapeutics (DTx) – currently listed under temporary coverage or the nHTA Deferral Program – proceed to formal health insurance listing following New Health Technology Assessment (nHTA).
The study proposes classifying AI-based medical technologies into four categories based on the nature of their function and output: Category 1 for interpretation support technologies, Category 2 for measurement-based technologies, Category 3 for disease or risk prediction technologies, and Category 4 for technologies used in conjunction with specific medical equipment. Each technology would then be evaluated on diagnostic accuracy, clinical utility, and clinical significance, and reclassified into Group A (eligible for reimbursement) or Group B (not eligible for reimbursement).
Technologies classified under Group A would be further stratified by technology level – high, medium, and low – and assigned to one of four reimbursement grades (Grade 1, Grade 2, Grade 3, and a Baseline Grade) for differentiated compensation. In cases where both covered and non-covered services are provided in combination, only the amount corresponding to the Baseline Grade would be reimbursed under the national health insurance, while the difference above the Baseline Grade amount would be charged as a non-reimbursable out-of-pocket expense. The proposed reimbursement amount ranges from approximately KRW 1,000 to KRW 16,000, with selective reimbursement coverage applying patient co-payment rates of 50%, 80%, or 90%. The study also proposes establishing a periodic re-evaluation mechanism that would allow delisting or reimbursement reduction if a technology fails to demonstrate sufficient clinical value. A policy improvement measure allowing temporary listing for technologies currently designated under the nHTA Deferral Program was also proposed.
Separately, HIRA also released findings from the study "Development of Reimbursement Evaluation Criteria and Formal Listing Pathways for Digital Therapeutics." Recognizing that patients directly experience the therapeutic effects of digital therapeutics, the study emphasizes that a reimbursement framework is needed which can simultaneously enable objective effectiveness evaluation and incentivize broader adoption of high-quality products. Under the proposed formal listing model, physician fees would be divided into prescription fee and treatment effectiveness evaluation fee, with the effectiveness evaluation fee further subdivided into cognitive behavioral therapy (CBT) and biofeedback categories. For biofeedback in particular, a reimbursement level approximately KRW 10,000 higher than that for CBT was proposed, reflecting the greater workload and evaluation burden on physicians. A temporary fee add-on of 50% or 100% for a defined initial implementation period was also examined as a measure to accelerate early adoption and encourage active clinical use — intended to allow both patients and physicians to experience real-world product effectiveness and to sustain a viable digital therapeutics industry ecosystem that delivers public benefit. Device usage fees were proposed to be set as fixed amounts by product type, following the reimbursement model adopted in Germany, and an exit mechanism was included whereby products undergoing re-evaluation at the four-year mark post-listing may be delisted if clinical effectiveness or utilization value is found to be insufficient.
These studies are significant in that they move beyond temporary listing arrangements to propose a concrete classification framework and reimbursement direction for the formal health insurance listing of AI-based medical technologies and digital therapeutics under the Korean national health insurance system. Going forward, securing formal reimbursement listing is expected to require comprehensive evidence not only of technical performance, but also of diagnostic accuracy, clinical utility, patient benefit, and physician workload impact. Furthermore, given that the proposed framework allows for reimbursement reduction or delisting through periodic post-listing re-evaluation, companies will need to prepare not only for initial reimbursement listing but also for long-term clinical evidence accumulation and post-market management strategies.
MDREX provides integrated support across the full pathway for AI-based medical devices and digital therapeutics, spanning regulatory approval, new health technology assessment, temporary and formal reimbursement listing strategies. If your organization requires review of market entry pathways, clinical evidence preparation, or reimbursement strategy for relevant products, please contact MDREX at [email protected].
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