Access and Reimbursement for Artificial Intelligence in Radiology: A Japanese Perspective

Artificial intelligence (AI) is reshaping radiology by improving image reconstruction, workflow efficiency, and decision support.Yet, technological excellence alone does not guarantee clinical adoption.The equation often cited by healthcare economists-value = outcome/cost-captures the essence of why reimbursement matters: innovations must demonstrate measurable improvements in safety, quality, or timeliness of care while remaining economically feasible [1].In Japan, the relationship between regulatory approval and reimbursement is distinctive.Both processes fall under the Ministry of Health, Labor and Welfare (MHLW), with technical evaluation by the Pharmaceuticals and Medical Devices Agency (PMDA).This unified system allows rapid alignment between approval and reimbursement but limits flexibility for post-market evidence evaluation or price revision.