Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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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

빅데이터 및 인공지능을 이용한 혁신의료기기 발전 방향: 한국, 미국, 유럽의 사례중심

  • Yun Hee Song (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University) ;
  • Gyu Ha Ryu (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Research Institute for Future Medicine, Samsung Medical Center)
  • 송윤희 (성균관대학교 삼성융합의과학원 의료기기산업학과) ;
  • 류규하 (성균관대학교 삼성융합의과학원 의료기기산업학과, 삼성서울병원 미래의학연구원)
  • Received : 2023.07.03
  • Accepted : 2023.08.18
  • Published : 2023.08.31
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Abstract

Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international 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 investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization 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 coverage 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.

Keywords

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