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KMID : 1137820230440040264
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의공학회지
2023 Volume.44 No. 4 p.264 ~ p.274
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The Innovative Medical Devices Using Big Data and Artificial Intelligence: Focusing on the cases of Korea, the United States, and Europe
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Song Yun-Hee
Ryu Gyu-Ha
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Abstract
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The objective is to extract insights that can contribute to the formulation of harmonized inter- national policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investi- gates technological advancements, regulatory approval systems, insurance policies, and successful com- mercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance cov- erage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.
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KEYWORD
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Digital healthcare, Software as a medical device (SaMD), Breakthrough device, Digital ther- apeutics
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