Based on the accumulation of medical big data, advances in medical artificial intelligence technology facilitate the timely treatment of disease through the reading the medical images and the increase of prediction speed and accuracy of diagnoses. In addition, these advances are expected to spark significant innovations in reducing medical costs and improving care quality. There are already approximately 40 FDA approved products in the US, and more than 10 products with K-FDA approval in Korea. Medical applications and services based on artificial intelligence are expected to spread rapidly in the future. Furthermore, the evolution of medical artificial intelligence technology is expanding the boundaries or limits of various related issues such as reference standards and specifications, ethical and clinical validation issues, and the harmonization of international regulatory systems.
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