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["在应用“监管断头台”情况下质量管理和医疗活动安全的规范性法律规定"]

[The normative legal regulation of quality management and medical activities security in conditions of application "regulatory guillotine"].

作者信息

Palevskaya S A, Badma-Garyaev M S, Blashentsev M K

机构信息

The Federal State Budget Educational Institution of Higher Education "The Samara State Medical University" of Minzdrav of Russia, 443001, Samara, Russia,

N. A. Semashko National Research Institute of Public Health, 105064, Moscow, Russia.

出版信息

Probl Sotsialnoi Gig Zdravookhranenniiai Istor Med. 2021 Jan;29(1):125-129. doi: 10.32687/0869-866X-2021-29-1-125-129.

DOI:10.32687/0869-866X-2021-29-1-125-129
PMID:33591668
Abstract

The term "regulatory guillotine" means analysis of all existing normative legal acts in order to understand their compliance with modern requirements. If these regulations meet the requirements, then the rules remain; if not, they must either be canceled and new regulation to be elaborated or corresponding changes must be implemented to current regulation. To resolve this problem, the government of the Russian Federation decided to implement the "regulatory guillotine" procedure. The main task of this procedure is to completely replace the entire array of norms that establish mandatory requirements with new ones by January 1, 2021. This will reduce administrative burden on business and increase level of security for consumers of various services. The same work is applied to the standards regulating management of quality and safety of medical activities. The article analyzes normative legal acts that regulate quality and safety management of medical activities, as well as new normative legal acts that are already accepted but still are not entered into force.

摘要

“监管断头台”一词是指对所有现行规范性法律文件进行分析,以了解它们是否符合现代要求。如果这些法规符合要求,那么规则将保留;如果不符合,则必须要么予以废除并制定新的法规,要么对现行法规进行相应修改。为解决这一问题,俄罗斯联邦政府决定实施“监管断头台”程序。该程序的主要任务是在2021年1月1日前用新的规范完全取代确立强制性要求的整套规范。这将减轻企业的行政负担,并提高各类服务消费者的安全水平。同样的工作也适用于规范医疗活动质量和安全管理的标准。本文分析了规范医疗活动质量和安全管理的规范性法律文件,以及已获批准但尚未生效的新规范性法律文件。

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