An AI-based SaMD has completed provisional insurance registration for the first time in Korea through an integrated assessment for innovative medical device/technology. The name of the determined technology is “AI-based Ischemic Stroke Detection using MR Image (implemented on December 26, 2023)”, and as non-reimbursable (100% payment by patient), the fee can be decided by adding the designated add-on payment (maximum 18,100 KRW as “AI analysis and utilization fee”) to the existing treatment fee.

For reference, the add-on payment decision was made based on the assessment result for the product’s potential by the integrated review board, which led the add-on payment to fall under the type 1 with maximum 18,100 KRW only. If the potential had been evaluated high enough, type 2 with maximum 54,300 KRW could have been applied.

In the meantime, the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service (HIRA) have established operating guidelines for the temporary registration pilot project for DTx and AI-based medical technology.

If you have any inquiries about integrated assessment and temporary registration of innovative medical device/technology, please contact MDREX (pro@mdrex.co.kr) at any time.

Thank you