Introduction . Design of medical institutions in the Russian Federation is carried out taking into account requirements of the Federal law of 30 December 2009 No. 384 “Technical regulations on safety of buildings and constructions”, and also the Federal law of 22 July 2008 No. 123 “Technical regulations on requirements of fire safety”. In Italy, the technical regulations on fire safety in the design, construction and operation of public and private medical institutions were approved by Decree No. 227 of 18 September 2002 of the Ministry of Internal. The purpose of this article is to study the Italian design standards of medical institutions for comparative analysis with the Russian regulatory framework in terms of fire safety of health facilities. Methods . A comparative analysis of the main provisions and objectives of the documents of technical regulation in the field of fire safety and general principles of fire safety in Italy and Russia. Results . It should be noted that the fire safety regulations approved by Decree No. 227 do not contain a specific concept of “evacuation” and do not describe its characteristics. In Federal law No. 123, both the concept of evacuation and its characteristics are disclosed in sufficient detail. The requirements established by the Italian building codes for fire resistance of building structures, practically coincide with the domestic fire safety requirements for fire resistance. Conclusion. Despite the complex nature of the system of fire safety of buildings, including fire prevention system, fire protection system and organizational and technical measures, it should be noted the similarity of principles and approaches in ensuring fire safety both in Russian standards and in the Italian design rules. The differences are due, in the authors’ opinion, to climatic, socio-economic and, possibly, scientific and cultural aspects that influence the decision-making of standard-setting organizations and associations.