HIRA

의료기기 통합정보를 활용한 건강보험심사평가원과 식품의약품안전처의 정보 연계 방안

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Type
Review Article
Author(s)
임수연정현주권병주
Issued Date
2024-05-31
Keyword
Medical deviceMinistry of Food and Drug SafetyHealth Insurance Review & Assessment ServiceUnique device identificationData integration
Abstract
With the expansion of the medical device market, the efficient distribution and post-management of therapeutic materials have become increasingly important. Because of the transfer of the management system to the Ministry of Health and Welfare, inefficiencies arise from unlinked data between the Ministry of Food and Drug Safety (MFDS) and the Health Insurance Review & Assessment Service (HIRA). To solve this problem, we analyzed the phenomena that occur when linking information from the Therapeutic Materials Guide Map with information from the MFDS. Furthermore, we analyzed the roadmap for the “EDI (electronic data interchange) Standard Code Model Name Transition” and the Medical Device Supply Reporting System to propose improvement methods to enhance the reliability of data provided by the Integrated Medical Device Information System and integrate unlinked data of the MFDS and HIRA. When reporting medical device supply, errors can occur in the EDI codes because the EDI code data are registered directly by the manufacturers. The HIRA must be able to manage and verify the EDI code data entered by the manufacturers in the Integrated Medical Device Information System. The usage and linkage of UDI (unique device identifier) and EDI codes hold promise, particularly when using the Medical Device Supply Reporting System. Integrating medical device information from the MFDS and HIRA will enhance the efficiency of medical device management and contribute to the effective operation of health insurance systems. The Medical Device Supply Reporting System, which is unique to Korea, should be actively used for system improvements to strengthen the competitiveness of the domestic medical device industry and contribute to public health protection.
Publisher
심사평가연구소
DOI
10.52937/hira.24.4.1.e8
URI
https://repository.hira.or.kr/handle/2019.oak/3255
Alternative Title
Strategy for Linking Data between the Health Insurance Review & Assessment Service and the Ministry of Food and Drug Safety Using the Integrated Medical Device Information System
Publisher
심사평가연구소
Location
KOR
Citation
임수연. (2024-05-31). 의료기기 통합정보를 활용한 건강보험심사평가원과 식품의약품안전처의 정보 연계 방안. HIRA Research, 4(1), 34–48. doi: 10.52937/hira.24.4.1.e8
p-ISSN
2765-6764
e-ISSN
2765-7353
Appears in Collections:
HIRA 발간 > 1. HIRA Research
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