我国诊疗规范制定的法治化研究  

Research on the Legalization of the Formulation of Diagnostic and Treatment Standards in China

作　　者：王启辉 黄天秋 刘武[2] WANG Qihui(School of Law,Hohai University,Nanjing,Jiangsu,211100,China)

机构地区：[1]河海大学法学院,江苏南京211100 [2]南京医科大学第一附属医院,江苏南京210029

出　　处：《医学与社会》2023年第8期110-115,共6页Medicine and Society

基　　金：司法部法治建设与法学理论研究部级科研项目,编号为20SFB4023。

摘　　要：《中华人民共和国基本医疗卫生与健康促进法》等法律要求医务人员遵循诊疗规范,但首要问题在于,医务人员所遵循的诊疗规范本身是否“应当”被遵循。这种“应当”指向两个维度:诊疗规范的外在的形式规范性(诊疗规范制定的规范化、制定出来的诊疗规范内在协调统一)和内在的实质正当性(符合医学科学规律、符合医学伦理)。《医疗机构管理条例实施细则》第八十八条规定诊疗规范由国家卫生健康主管部门“制定”和“认可”,但如何“制定”和“认可”,其具体规范要求阙如。为保证诊疗规范的形式规范性和实质正当性,建议确立基于循证医学证据的科学性审查规则和基于独立机构的伦理审查规则,构建诊疗规范制定的基本程序,从而实现诊疗规范制定的法治化。The Law on Basic Medical and Health Care and Health Promotion and other laws require medical and health care personnel to follow diagnostic and treatment standards.However,the first question to be answered is whether the diagnostic and treatment standards followed by medical personnel should be"mandatory"in the first place.This"mandatory"aspect can be understood from two dimensions:the external formal standardization of diagnostic and treatment standards(the standardization of their formulation and the internal coordination and unity of the diagnostic and treatment standards)and the internal substantive legitimacy(compliance with medical scientific principles and medical ethics).Article 88 of the"Implementation Regulations for the Management of Medical Institutions"stipulates that diagnostic and treatment standards are"formulated"and"recognized"by the competent health authorities.However,the specific requirements for how to"formulate"and"recognize"these standards are lacking.To ensure the formal standardization and substantive legitimacy of diagnostic and treatment standards,it is recommended to establish scientific review rules based on evidence-based medicine,ethical review rules based on independent institutions,and establish basic procedures for the formulation of diagnostic and treatment standards,thereby achieving the legalization of their formulation.

关 键 词：诊疗规范 制定 法治化 规范性 正当性 

分 类 号：R195-019[医药卫生—卫生统计学]