基于HB-HTA的医疗新技术准入评估体系研究

Research on Access Evaluation System of New Medical Technology Based on HB-HTA

医疗新技术准入评估是医疗技术纳入临床应用前的重要一环,对保证医疗服务质量和医疗安全具有关键性作用。但在准入评估具体实践过程中,还存在着准入理论框架不完善、评估指标体系不健全等问题。以卫生政策及法律法规为战略支撑,借鉴医院卫生技术评估(Hospital-based Health Technology Assessment,HB-HTA)的理论和方法,综合考虑评估主体、评估客体、评估内容等核心要素,从技术特性、安全性、有效性、经济性、适用性等维度进行指标体系设计,构建引进型医疗新技术准入评估框架,以期为医疗机构医疗技术准入管理提供理论框架和循证基础。

The access evaluation of new medical technology is an important part of the preclinical application of medical technology and plays a vital role in ensuring the quality and safety of medical services.However,in the concrete practice of access evaluation,there are still some problems such as imperfect access theoretical framework,imperfect evaluation index system.With the strategic support of health policies,laws,and regulations,the theory and method of HB-HTA are used for reference,core elements such as assessment subject,assessment object,and assessment content are comprehensively considered,the index system is designed from the dimensions of technical characteristics,safety,effectiveness,economy and applicability,and the access evaluation framework of imported medical new technologies is constructed.To offer a theoretical framework and evidence-based basis for medical facility medical technology access management.