临床新技术管理中的法律缺位

基于我国临床新技术管理的立法现状,从临床新技术的管理范畴、知情同意、时限性、风险承担等方面进行分析,阐述我国新技术管理在以上方面的立法盲点与缺陷,探索进一步完善、细化和规范新技术管理的必要性、迫切性,强调新技术管理中应特别注重全过程质量控制及环节质量管理,呼吁进行新技术管理的特别立法.

Absence of law in the management of new clinical technologies

Based on the current situation of legislation on new clinical technologies management in China,the paper analyzes the legal absence or defect on management of new clinical technologies on such aspects as management category,informed consent,time limit,and risk taking,explores the necessity and urgency tO further improve,refine and standardize the management of new technologies,emphasizes that particular attention should be paid to the whole course quality control and link quality management, and appeals for special legislation on the management of new technologies.