빅데이터 및 인공지능을 이용한 혁신의료기기 발전 방향 : 한국 , 미국 , 유럽의 사례중심
The Innovative Medical Devices Using Big Data and Artificial Intelligence: Focusing on the cases of Korea, the United States, and Europe
1
조회
0
다운로드
3
인용
0
참고문헌
키워드
초록
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.
Abstract
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.
참고문헌 (38)
- Snijders CCP, ""Big Data" : big gaps of knowledge in the field of internet science", International Journal of Internet Science, 7(1), pp.1~5 (2012)
- Raine L, "Networked. The new social operating system", International Journal of E-Politics, 4(2), pp.64~66 (2012)
- "Big data : The next frontier for innovation, competition"[URL]
- Neelamani Samal, "Big Data Processing : Big Challenges and Opportunities", Journal of Computer Sciences and Applications, 3(6), pp.177~180 (2015)
- Davis A, "Artificial Intelligence and Echocardiography : A Primer for Cardiac Sonographers", J Am Soc Echocardiogr, 33(9), pp.1061~1066 (2020)
- "Machine Learning-enabled Medical Devices: Key Terms and Definitions"[URL]
- "Breakthrough Devices Program"[URL]
- "Software as a Medical Device (SaMD): Key Definitions"[URL]
- "Understanding DTx"[URL]
- "Guidance on Qualification and Classification of Software in Regulation(EU)2017/745 – MDR and Regulation(EU)2017/746 – IVDR"[URL]
- Urs J Muehlematter, "Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe(2015–20) : a comparative analysis", Lancet Digit Health, 3, pp.e195~e203 (2021)
- "DiGA Bfarm - conception & consulting"[URL]
- "Ministry of Food and Drug Safety"[URL]
- "Social Security Code (SGB V)"[URL]
- "Long Term Plan Implementation Framework"[URL]
- "Digital medical devices: preparing your file for the HAS assessment"[URL]
- "Evaluation of Health Innovation Experiments (Article 51)"[URL]
- "Early Charge Prize"[URL]
- "Announcement on new medical technology for postponement of evaluation"[URL]
- "Artificial intelligence funding"[URL]
- "Medicare Program-Prospective Payment System for Hospital Outpatient Services: Criteria for Establishing Additional Pass-Through Categories for Medical Devices"[URL]
- "Medicare Program; Changes to the Hospital Outpatient Prospective Payment System for Calendar Year 2002"[URL]
- Morey JR, "Adoption and Trends in the Medicare New Technology Add-On Payment Program", J Gen Intern Med, 36(7), pp.2174~2176 (2021)
- "New Medical Services and New Technologies"[URL]
- "Access to Prescription Digital Therapeutics Act of 2022"[URL]
- "Pear Therapeutics"[URL]
- "FDA Clears First Prescription-Based ‘Digital Therapeutic’"[URL]
- 김기영, "독일 디지털 헬스케어법의 주요 내용과 정책적 시사점", 법제, 696, pp.103~129 (2022), 법제처[DOI]
- "Digital Health Applications Ordinance – DiGAV"[URL]
- "DiGA Report 2022"[URL]
- "Cara Care for Doctors"[URL]
- "Sleepio to treat insomnia and insomnia symptoms"[URL]
- "Digital therapeutics : at an inflection point"[URL]
- Nam Hye-jin, "France’s medical device reimbursement management system", National Medical Center Policy Trends, 9(2), pp.85~ (2015)
- "How to get your digital health app reimbursed in Europe? Start with Germany, Belgium and France"[URL]
- "French Ministry of the health and prevention"[URL]
- "Adel sante"[URL]