医疗技术临床应用管理立法进程及其特征分析

Analysis on the Legislative Process and Characteristics of Medical Technology Clinical Application Management

本文对医疗技术管理立法进程进行了梳理,并分析总结了其演变特征。本文指出,医疗技术临床应用管理由许可制转变为备案制,医疗机构已成为责任主体;伦理审查、规范培训和信息化在医疗技术临床应用管理中的重要性日益突显。为进一步规范医疗技术临床应用,建议提高医疗技术临床应用管理的立法层级,细化法规内容,同时加大违法成本,充分发挥法律的指引与威慑作用。

This study sorted out the medical technology management legislation process, analyzed and summarized the evolution characteristics. The clinical application management of medical technology has changed from a licensing system to a filing system, medical institutions have assumed the main responsibility. The importance of technical ethics review, standardized training, and informationization in management has become increasingly prominent. In order to further standardize the clinical application of medical technology, it is recommended to improve the legislative level of clinical application management of medical technology, refine the content of regulations, increase the cost of illegal activities, and play the role of legal guidance and deterrence.