在韩国建立一个使用大规模数据库的积极疫苗安全监测系统:全球应用的教训和可扩展的见解
Jin Gu Yoon1,2, Eliel Nham1,2, Yu Jung Choi1,2
1Division of Infectious Diseases, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
Journal of Korean medical science
|January 6, 2026
概括
韩国需要一个强大的系统来监测罕见的疫苗不良事件 (AEFI). 这项研究提出了一个使用现有健康数据的联合数据库架构,以改善许可后的疫苗安全监测.
科学领域:
- 公共卫生 公共卫生
- 流行病学 流行病学
- 医疗信息学 医疗信息学
背景情况:
- 授权后监测对于检测免疫接种后罕见不良事件 (AEFI) 至关重要.
- 韩国现有的健康数据基础设施包括索赔数据库和免疫注册表,但缺乏全面的,积极的监测框架.
- 医院越来越多地提供标准化的电子健康记录.
研究的目的:
- 提出一个联合的,代码到数据架构,用于在韩国对AEFI的积极,基于数据库的监控.
- 利用现有的国家健康数据资产,加强疫苗安全监测.
- 建立一个可扩展的系统来检测罕见的AEFI,并支持基于证据的沟通和补偿.
主要方法:
- 提出一个联合架构,在全国索赔数据库 (NHIS/HIRA),免疫注册表 (KDCA IRIS) 和医院电子健康记录之间进行数据链接.
- 采用通用数据模型 (CDM),标准化案例定义,延迟会计和透明报告.
- 解决诸如行政批准,不完整的成年人疫苗接种数据,数据异质性和隐私限制等挑战.
主要成果:
- 拟议的架构旨在整合不同的数据源,以进行全面的AEFI监控.
- 主要优先事项包括简化行政流程,改善成年人疫苗接种数据的捕获,并加强数据的互操作性.
- 开发安全的集成输出中心对于实际实施至关重要.
结论:
- 在韩国建立一个可扩展的主动监控系统需要制定战略优先级,克服重大挑战.
- 拟议的系统将加强罕见AEFI的检测,促进透明的沟通,并确保公平的损害赔偿.
- 成功实施将使韩国能够利用国内数据主动管理疫苗安全.
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