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Research Article Open Access
Objectives: The aim of this study was to design frameworks for the use of unlisted health technologies in emergency and quasi-emergency situations. Methods: We interviewed the representatives of patient organizations and analyzed related press releases from the main internet news portals in Korea to investigate the needs of patients. In addition, a literature review was conducted on the emergency use of unapproved drugs and medical devices in Korea. Results: Due to the current reimbursement listing system in Korea, there have been constant demands for unlisted technologies prior to their listing. Thus, we created two frameworks that allow for the use of those technologies in quasi-emergency and emergency situations. For quasi-emergencies, the MOHW must issue approval prior to use; in emergencies, unlisted technologies can be used without pre-approval. In both cases, however, implementing institutions have to report the results and the Committee for nHTA must review them for appropriateness. Conclusions: This paper will be the first attempt to develop frameworks for the emergency and quasi-emergency use of unlisted health technology. It will be a critical new tool to fulfill the need for timely and practical medical treatment or diagnosis that is currently unlisted in Korea.
Unlisted health technology, Emergency use, Quasi-emergency use, Framework, Review process., Health Technology