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목차 1
주요국 디지털 치료기기의 보건의료기술평가 현황과 시사점 : 독일, 영국, 미국 발전과정을 중심으로 ＝ Health technology assessment of digital therapeutics : developments in Germany, the United Kingdom, and the United States, and implications for Korea / 송인명 ; 김동숙 1
[요약] 1
서론 1
연구방법 2
연구결과 2
고찰 및 시사점 6
결론 7
REFERENCES 7
권호기사
참고문헌 (32건) : 자료제공( 네이버학술정보 )
| 번호 | 참고문헌 | 국회도서관 소장유무 |
|---|---|---|
| 1 | Pear Therapeutics. Pear Therapeutics obtains FDA clearance of the first prescription digital therapeutic to treat disease [Internet]. Boston:Pear Therapeutics [cited 2024 Feb 23]. Available from: https://www.prnewswire.com/news-releases/pear-therapeutics-obtains-fdaclearance-of-the-first-prescription-digital-therapeutic-to-treat-disease-300520068.html. | 미소장 |
| 2 | Federal Institute for Drugs and Medical Devices. The fast-track process for digital health applications (DiGA) according to section 139e SGB V. A guide for manufacturers, service providers and users [Internet]. Bonn: Federal Institute for Drugs and Medical Devices [cited 2024 Feb 23]. Available from: https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.html. | 미소장 |
| 3 | Digital Health Global. Digital Health Global Market report 2023:ease of access, shorter development timelines and decreased cost of treatment bolster demand - ResearchAndMarkets.com [Internet]. EVERSANA [cited 2024 Feb 23]. Available from: https://www.digitalhealthglobal. com/digital-health-global-market-report-2023-easeof-access-shorter-development-timelines-and-decreased-cost-oftreatment-bolster-demand-researchandmarkets-com. | 미소장 |
| 4 | Korea Health Industry Development Institute. [Regulatory cases and issues responding to technological innovation Ⅱ: reimbursement for newly emerging medical technologies in digital health]. Cheongju:Korea Health Industry Development Institute;2023. Korean | 미소장 |
| 5 | European Data Protection Supervisor. Digital therapeutics (DTx)[Internet]. Brussels: European Data Protection Supervisor [cited 2024 Jan 9]. Available from: https://edps.europa.eu/press-publications/publications/techsonar/digital-therapeutics-dtx. | 미소장 |
| 6 | Digital Therapeutics Alliance. Understanding DTx [Internet]. Washington, DC: Digital Therapeutics Alliance [cited 2024 Jan 9]. Available from: https://dtxalliance.org/understanding-dtx. | 미소장 |
| 7 | Phan P, Mitragotri S, Zhao Z. Digital therapeutics in the clinic. Bioeng Transl Med 2023;8:e10536. | 미소장 |
| 8 | Wang W, Gellings Lowe N, Jalali A, Murphy SM. Economic modeling of reSET-O, a prescription digital therapeutic for patients with opioid use disorder. J Med Econ 2021;24:61-68. | 미소장 |
| 9 | Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K. Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic. Expert Rev Pharmacoecon Outcomes Res 2021;21:69-76. | 미소장 |
| 10 | Sapanel Y, Tadeo X, Brenna CTA, Remus A, Koerber F, Cloutier LM, et al. Economic evaluation associated with clinical-grade mobile app-based digital therapeutic interventions: systematic review. J Med Internet Res 2023;25:e47094. | 미소장 |
| 11 | van Kessel R, Roman-Urrestarazu A, Anderson M, Kyriopoulos I, Field S, Monti G, et al. Mapping factors that affect the uptake of digital therapeutics within health systems: scoping review. J Med Internet Res 2023;25:e48000. | 미소장 |
| 12 | Prodan A, Deimel L, Ahlqvist J, Birov S, Thiel R, Toivanen M, et al. Success factors for scaling up the adoption of digital therapeutics towards the realization of P5 medicine. Front Med (Lausanne) 2022;9:854665. | 미소장 |
| 13 | Federal Ministry of Health. Driving the digital transformation of Germany’s healthcare system for the good of patients [Internet]. Berlin:Federal Ministry of Health [cited 2024 Jan 10]. Available from:https://www.bundesgesundheitsministerium.de/en/digital-healthcareact. | 미소장 |
| 14 | Fürstenau D, Gersch M, Schreiter S. Digital therapeutics (DTx). Bus Inf Syst Eng 2023;65:349-360. | 미소장 |
| 15 | Brönneke JB, Herr A, Reif S, Stern AD. Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation. Int J Technol Assess Health Care 2023;39:e72. | 미소장 |
| 16 | Lauer W, Löbker W, Höfgen B. [Digital health applications (DiGA):assessment of reimbursability by means of the “DiGA Fast Track”procedure at the Federal Institute for Drugs and Medical Devices (BfArM)]. Bundesgesundheitsbl 2021;64:1232-1240. German | 미소장 |
| 17 | Gerke S, Stern AD, Minssen T. Germany’s digital health reforms in the COVID-19 era: lessons and opportunities for other countries. NPJ Digit Med 2020;3:94. | 미소장 |
| 18 | Dittrich F, Mielitz A, Pustozerov E, Lawin D, von Jan U, Albrecht UV. Digital health applications from a government-regulated directory of reimbursable health apps in Germany-a systematic review for evidence and bias. Mhealth 2023;9:35. | 미소장 |
| 19 | Digital Therapeutics Alliance. Digital therapeutics in the United Kingdom [Internet]. Washington, DC: Digital Therapeutics Alliance [cited 2024 Feb 10]. Available from: https://dtxalliance.org/wp-content/uploads/2021/06/DTA_DTx-Overview_UK.pdf. | 미소장 |
| 20 | Unsworth H, Dillon B, Collinson L, Powell H, Salmon M, Oladapo T, et al. The NICE evidence standards framework for digital health and care technologies – Developing and maintaining an innovative evidence framework with global impact. Digit Health 2021;7:20552076211018617. | 미소장 |
| 21 | Yan K, Balijepalli C, Druyts E. The impact of digital therapeutics on current health technology assessment frameworks. Front Digit Health 2021;3:667016. | 미소장 |
| 22 | National Institute for Health and Care Excellence. Evidence standards framework for digital health technologies [Internet]. London:National Institute for Health and Care Excellence [cited 2024 Jan 9]. Available from: https://www.nice.org.uk/corporate/ecd7. | 미소장 |
| 23 | National Institute for Health and Care Excellence. Evidence standards framework for digital health technologies. Section C: evidence standards tables [Internet]. London: National Institute for Health and Care Excellence [cited 2024 Jan 11]. Available from: https://www.nice. org.uk/corporate/ecd7/chapter/section-c-evidence-standards-tables. | 미소장 |
| 24 | NICE recommends offering app-based treatment for people with insomnia instead of sleeping pills | News | News. NICE. NICE, 2022[cited 2024 Feb 26]. Available from: https://www.neuroscience. ox.ac.uk/news/nice-recommends-offering-app-based-treatment-forpeople-with-insomnia-instead-of-sleeping-pills. | 미소장 |
| 25 | Thompson M. 117th Congress (2021-2022): H.R.7051 - access to prescription digital therapeutics act of 2022 [Internet]. Washington, DC: United States Congress [cited 2024 Jan 10]. Available from:https://www.congress.gov/bill/117th-congress/house-bill/7051/related-bills. | 미소장 |
| 26 | Patel NA, Butte AJ. Characteristics and challenges of the clinical pipeline of digital therapeutics. NPJ Digit Med 2020;3:159. | 미소장 |
| 27 | 보건복지부, 식품의약품안전처. [의료기기산업 육성 및 혁신의료기기 지원법(시행 2020. 5. 1.) (법률 제16405호, 2019. 4. 30., 제정)]. Korean | 미소장 |
| 28 | 식품의약품안전처. [디지털치료기기 허가·심사 가이드라인]. 청주: 식품의약품안전처;2020. Korean | 미소장 |
| 29 | 식품의약품안전처. [디지털의료제품법(시행 2025. 1. 24.) (법률 제20139호, 2024. 1. 23., 제정)]. Korean | 미소장 |
| 30 | 보건복지부, 건강보험심사평가원. [디지털치료기기 건강보험 등재가이드라인]. 세종, 원주: 보건복지부, 건강보험심사평가원;2023. Korean | 미소장 |
| 31 | 보건복지부. [2023년 제13차 건강보험정책심의위원회: 디지털치료기기·인공지능 임시등재 방안]. 세종: 보건복지부;2023. Korean | 미소장 |
| 32 | Huh KY, Oh J, Lee S, Yu KS. Clinical evaluation of digital therapeutics:present and future. Healthc Inform Res 2022;28:188-197. | 미소장 |
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