of November 21, 2011 No. 323-FZ
About bases of protection of public health in the Russian Federation
Accepted by the State Duma of the Russian Federation on November 1, 2011
Approved by Council of the Russian Federation on November 9, 2011
This Federal Law governs the relations arising in the sphere of protection of public health in the Russian Federation (further - in the sphere of health protection), and determines:
1) legal, organizational and economic basis of protection of public health;
2) the rights and obligations of man and citizen, separate national groups in the sphere of health protection, the sales warranty of these rights;
3) powers and responsibility of public authorities of the Russian Federation, public authorities of subjects of the Russian Federation and local government bodies in the sphere of health protection;
4) the rights and obligations of the medical organizations, other organizations, individual entrepreneurs when implementing activities in the sphere of health protection;
5) rights and obligations of health workers and pharmaceutical workers.
1. For the purposes of this Federal Law the following basic concepts are used:
1) health - condition of physical, mental and social wellbeing of the person in case of which there are no diseases, and also disorders of functions of bodies and systems of organism;
2) protection of public health (further - health protection) - system of measures political, economic, legal, social, scientific, medical, including sanitary and anti-epidemic (preventive), nature, the subjects of the Russian Federation performed by public authorities of the Russian Federation, public authorities, local government bodies, the organizations, their officials and other persons, citizens for the purpose of prevention of diseases, preserving and strengthening of physical and mental health of each person, maintenance of his long active life, provision to it medical care;
3) medical care - complex of the actions directed to maintenance and (or) recovery of health and including provision of medical services;
4) medical service - medical intervention or complex of the medical interventions directed to prevention, diagnostics and treatment of diseases, medical rehabilitation and having the independent finished value;
5) medical intervention - carried out by the health worker and other worker having the right to implementation of medical activities, in relation to the patient, the types of physical examinations and (or) medical manipulations mentioning physical or mental condition of the person and having preventive, research, diagnostic, medical, rehabilitation orientation, and also abortion;
6) prevention - complex of the actions directed to preservation and promotion of health and including forming of healthy lifestyle, the prevention of origin and (or) spread of diseases, their early identification, identification of the reasons and conditions of their origin and development, and also directed to elimination of adverse effect on health of the person of factors of the circle of its dwelling;
7) diagnostics - complex of the medical interventions directed to recognition of conditions or factual determination of availability or absence of the diseases performed by means of collection and the analysis of claims of the patient, data of its anamnesis and survey, carrying out laboratory, tool, pathoanatomical and other researches for the purpose of determination of the diagnosis, the choice of actions for treatment of the patient and (or) control of implementation of these actions;
8) treatment - complex of the medical interventions which are carried out to destination the health worker which purpose is elimination or simplification of displays of disease or diseases or the patient's conditions, recovery or improvement of his health, working capacity and quality of life;
9) the patient - physical person to which medical care is provided or which addressed for delivery of health care irrespective of availability at it of disease and from its condition;
10) medical activities - professional activity on delivery of health care, conducting medical examinations, medical examinations and medical surveys, sanitary and anti-epidemic (preventive) actions and the professional activity connected with transplantation (change) of bodies and (or) fabrics, the address of donor blood and (or) its components in the medical purposes;
11) the medical organization - the legal entity irrespective of form of business performing as the main (authorized) type of activity medical activities based on the license provided according to the procedure, the established legislation of the Russian Federation on licensing of separate types of activity. The provisions of this Federal Law regulating activities of the medical organizations extend on other legal entities irrespective of form of business performing medical activities along with the main (authorized) activities and are applied to such organizations in the part concerning medical activities. For the purpose of this Federal Law the individual entrepreneurs performing medical activities are equated to the medical organizations;
12) the pharmaceutical organization - the legal entity irrespective of form of business performing pharmaceutical activities (the organization of wholesale trade by medicines, the pharmaceutical organization). For the purpose of this Federal Law the individual entrepreneurs performing pharmaceutical activities are equated to the pharmaceutical organizations;
13) the health worker - the physical person which has medical or other education works in the medical organization for the position included in the nomenclature of positions of health workers and pharmaceutical workers and which labor (official) obligations include implementation of medical activities, or the physical person who is the individual entrepreneur who is directly performing medical activities;
14) the pharmaceutical worker - the physical person which has pharmaceutical education works in the pharmaceutical organization and to which labor duties wholesale trade by medicines, their storage, transportation and (or) retail trade by medicines for medical application belong (further - medicines), their production, leave, storage and transportation;
15) the attending physician - the doctor to whom functions on the organization and direct rendering medical care to the patient during observation of it and its treatment are assigned;
16) disease - the business disruption of organism, working capacity, capability arising in connection with impact of pathogenic factors to adapt to the changing conditions of external and internal environment in case of simultaneous change of protective and compensatory and protective and adaptive reactions and mechanisms of organism;
17) condition - the changes of organism arising in connection with impact of pathogenic and (or) physiological factors and requiring delivery of health care;
18) the main disease - the disease which in itself or in connection with complications causes the first-priority necessity of delivery of health care in connection with the greatest threat of working capacity, life and to health or results in disability, or becomes cause of death;
19) associated disease - the disease which has no cause and effect relationship with the main disease yields it in degree of need of delivery of health care, influence on working capacity, danger to life and health and is not cause of death;
20) disease severity or conditions - the criterion determining the extent of defeat of bodies and (or) systems of human body or violation of their functions caused by disease or condition or their complication;
21) quality of medical care - set of the characteristics reflecting timeliness of delivery of health care, correctness of the choice of methods of prevention, diagnostics, treatment and rehabilitation in case of delivery of health care, extent of achievement of the planned result;
22) telemedicine technologies - the information technologies providing remote interaction of health workers among themselves with patients and (or) their legal representatives, identification and authentication of specified persons, documentation of the actions made by them when carrying out consultations, consultations, remote medical observation of the state of health of the patient;
23) clinical recommendations - the documents containing the structured information on questions of prevention, diagnostics, treatment and rehabilitation based on scientific proofs, including protocols of maintaining (protocols of treatment) the patient, options of medical intervention and the description of the sequence of actions of the health worker taking into account the course of disease, availability of complications and associated diseases, other factors influencing results of delivery of health care.
2. The concepts specified in this Article can be specified according to the program of experimental legal regime in the sphere of digital innovations approved according to the Federal Law of July 31, 2020 No. 258-FZ "About experimental legal regimes in the sphere of digital innovations in the Russian Federation".
1. The legislation in the sphere of health protection is based on the Constitution of the Russian Federation and consists of this Federal Law, other Federal Laws accepted according to it, other regulatory legal acts of the Russian Federation, the laws and other regulatory legal acts of subjects of the Russian Federation.
2. The regulations about health protection containing in other Federal Laws, other regulatory legal acts of the Russian Federation, the laws and other regulatory legal acts of subjects of the Russian Federation shall not contradict regulations of this Federal Law.
3. In case of discrepancy of the regulations about health protection containing in other Federal Laws, other regulatory legal acts of the Russian Federation, the laws and other regulatory legal acts of subjects of the Russian Federation, to regulations of this Federal Law regulations of this Federal Law are applied.
4. Local government bodies within the competence have the right to publish the municipal legal acts containing regulations about health protection according to this Federal Law, other Federal Laws, other regulatory legal acts of the Russian Federation, the laws and other regulatory legal acts of subjects of the Russian Federation.
5. If the international treaty of the Russian Federation establishes other rules, than provided by this Federal Law of the rule in the sphere of health protection rules of the international treaty are applied.
5.1. The decisions of interstate bodies made based on provisions of international treaties of the Russian Federation in their interpretation contradicting the Constitution of the Russian Federation are not subject to execution in the Russian Federation. Such contradiction can be established according to the procedure, determined by the Federal constitutional Law.
6. The legislation in the sphere of health protection is applied to the organizations performing medical activities in the territories of the advancing development taking into account the features established by the Federal Law "About the Territories of the Advancing Social and Economic Development in the Russian Federation".
7. The legislation in the sphere of health protection is applied to the organizations located in the territory of the international medical cluster and performing medical activities taking into account the features established by the Federal Law "About the International Medical Cluster and Modification of Separate Legal Acts of the Russian Federation".
8. The legislation in the sphere of health protection is applied to the organizations performing medical activities in the territory of the free port of Vladivostok taking into account the features established by the Federal Law "About the Free Port of Vladivostok".
9. The legislation in the sphere of health protection is applied to the organizations performing medical activities in the territories of the innovative scientific and technological centers taking into account the features established by the Federal Law "About the Innovative Scientific and Technological Centers and about Modification of Separate Legal Acts of the Russian Federation".
10. The regulatory legal acts adopted according to this Federal Law and establishing mandatory requirements (except for standards and procedures for delivery of health care, clinical recommendations), become effective in the terms provided by the Federal Law of July 31, 2020 No. 247-FZ "About mandatory requirements in the Russian Federation". The regulatory legal acts establishing mandatory requirements in regulations on the organization of delivery of health care by types of medical care in rules of conducting examinations, laboratory, tool, pathoanatomical and other diagnostic testings in case of detection of need of carrying out the specified researches for the purpose of prevention of threat of life and to health of citizens, and also in procedures for performing routine medical examinations and medical examination, can provide other terms of the introduction them in force.
11. According to the Federal Law of July 31, 2020 No. 258-FZ "About experimental legal regimes in the sphere of digital innovations in the Russian Federation" in the field of the legislation in the sphere of health protection can be established the special regulation different from the regulation provided by provisions of this Federal Law. Such special regulation is established by the program of experimental legal regime in the sphere of digital innovations approved by the Government of the Russian Federation according to the Federal Law of July 31, 2020 No. 258-FZ "About experimental legal regimes in the sphere of digital innovations in the Russian Federation". The provisions of this program establishing conditions of experimental legal regime in the sphere of digital innovations can change or exclude action of provisions of this Federal Law if it is directly provided by this Federal Law, and shall contain including list of services, including the services rendered using telemedicine technologies concerning which special regulation, and also type of the responsibility applied to subjects of experimental legal regime in the sphere of digital innovations with indication of conditions of its approach will be established.
The basic principles of health protection are:
1) observance of the rights of citizens in the sphere of health protection and providing the state guarantees connected with these rights;
2) priority of interests of the patient in case of delivery of health care;
3) priority of health protection of children;
4) social security of citizens in case of loss of health;
5) responsibility of public authorities and local government bodies, officials of the organizations for providing the rights of citizens in the sphere of health protection;
6) availability and quality of medical care;
7) inadmissibility of refusal in delivery of health care;
8) prevention priority in the sphere of health protection;
9) observance of medical secret.
1. Events for health protection shall be held on the basis of recognition, observance and protection of the rights of citizens and according to the conventional principles and rules of international law.
2. The state provides to citizens health protection irrespective of floor, race, age, nationality, language, availability of diseases, conditions, origin, property and official capacity, the residence, the relation to religion, beliefs, belonging to public associations and from other circumstances.
3. The state guarantees to citizens protection against any forms of the discrimination caused by availability at them any diseases.
1. The priority of interests of the patient in case of delivery of health care is implemented by way:
1) respect for ethical and moral standards, and also the valid and humane relation from health workers and other employees of the medical organization;
2) delivery of health care to the patient taking into account its physical condition and with respect for whenever possible cultural and religious traditions of the patient;
3) ensuring leaving in case of delivery of health care;
4) the organizations of delivery of health care to the patient taking into account rational use of its time;
5) establishments of requirements to designing and placement of the medical organizations taking into account observance of sanitary and hygienic regulations and providing comfortable conditions of stay of patients in the medical organizations;
6) creations of the conditions providing possibility of visit of the patient and stay of relatives with it in the medical organization taking into account condition of the patient, observance of the anti-epidemic mode and interests of the other persons working and (or) being in the medical organization.
2. For the purpose of realization of the principle of priority of interests of the patient in case of delivery of health care the public authorities of the Russian Federation, public authorities of subjects of the Russian Federation, local government bodies performing powers in the sphere of health protection and the medical organizations within the competence interact with the public associations, other non-profit organizations performing the activities in the sphere of health protection.
1. The state recognizes health protection of children as one of the most important and necessary conditions of physical and mental development of children.
2. Children irrespective of their family and social wellbeing are subject to special protection, including care about their health and proper legal protection in the sphere of health protection, and have the priority rights in case of delivery of health care.
3. The medical organizations, the organizations performing educational activities public associations and other organizations shall recognize and observe the rights of children in the sphere of health protection.
4. Public authorities of the Russian Federation, public authorities of subjects of the Russian Federation and local government bodies according to the powers are developed and realize the programs directed to prevention, early detection and treatment of diseases, decrease in maternal and infantile death rate, forming at children and their parents to motivation to healthy lifestyle and take adequate measures on the organization of providing children with the medicines specialized by products of clinical nutrition, medical products.
5. Public authorities of the Russian Federation and public authorities of subjects of the Russian Federation according to the powers create and develop the medical organizations providing medical care to children taking into account providing favorable conditions for stay in them of children, including handicapped children, and possibilities of stay with them of parents and (or) other family members, and also the social infrastructure oriented to organized rest, improvement of children and recovery of their health.
Social security of citizens in case of loss of health is provided by establishment and realization of the legal, economic, organizational, medico-social and other measures guaranteeing social security including at the expense of means of compulsory social insurance, determination of need of the citizen for social protection in accordance with the legislation of the Russian Federation, in rehabilitation and leaving in case (condition), establishment of temporary disability, disability or in other cases determined by the legislation of the Russian Federation.
1. Public authorities and local government bodies, the medical organizations, the organizations of social servicing and other organizations perform interaction for the purpose of providing the rights of citizens in the sphere of health protection.
2. Public authorities and local government bodies, officials of the organizations bear responsibility for providing the guarantees in the sphere of health protection established by the legislation of the Russian Federation within the powers.
Availability and quality of medical care are provided:
1) the organization of delivery of health care for the principle of nearness to the residence, place of employment or training;
2) availability of necessary number of health workers and level of their qualification;
3) possibility of the choice of the medical organization and the doctor according to this Federal Law;
4) application of procedures for delivery of health care, clinical recommendations and standards of medical care;
5) provision by the medical organization of the guaranteed amount of medical care according to the program of the state guarantees of free rendering medical care to citizens;
6) establishment in accordance with the legislation of the Russian Federation requirements to placement of the medical organizations of the state health care system and municipal health care system and other infrastructure facilities in health sector proceeding from requirements of the population;
7) transport availability of the medical organizations to all national groups, including disabled people and other national groups with limited traficabilities;
8) possibility of free and free use by the health worker of means of communication or vehicles for transportation of the patient in the nearest medical organization in the cases threatening his life and health;
9) equipment of the medical organizations by the equipment for delivery of health care taking into account special needs of disabled people and other national groups with limited opportunities of health;
10) use of telemedicine technologies.
1. Refusal in delivery of health care according to the program of the state guarantees of free rendering medical care to citizens and collection of payment for its rendering by the medical organization participating in implementation of this program, and health workers of such medical organization do not allow.
2. Medical care in the emergency form appears the medical organization and the health worker to the citizen instantly and free of charge. The refusal in its rendering is not allowed.
3. The medical organizations and health workers bear responsibility for violation of the requirements provided by parts 1 and 2 of this Article in accordance with the legislation of the Russian Federation.
The prevention priority in the sphere of health protection is provided in the way:
1) developments and program implementations of forming of healthy lifestyle, including programs of decrease in consumption of alcohol, consumption of tobacco or consumption of nikotinsoderzhashchy products, prevention and fight against not medical consumption of drugs and psychotropic substances;
2) implementation of sanitary and anti-epidemic (preventive) actions;
3) implementation of actions for the prevention and early detection of diseases, including to the prevention of socially important diseases and fight against them;
4) performing routine and other medical examinations, medical examinations, dispensary observation in accordance with the legislation of the Russian Federation;
5) implementation of actions for preserving life and health of citizens in the course of their training and labor activity in accordance with the legislation of the Russian Federation.
1. Data on the fact of the request of the citizen for delivery of health care, state of his health and the diagnosis, other data received in case of its physical examination and treatment are medical secret.
2. Disclosure of the data which are medical secret including after the death of the person, persons to whom they became known during the training, execution of the labor, job, service and other responsibilities, except as specified, established by parts 3 and 4 of this Article is not allowed.
3. Disclosure of the data which are medical secret, to other citizens, including officials for the purpose of physical examination and treatment of the patient, carrying out scientific research, their publications in scientific publications, uses in educational process and in other purposes is allowed from written consent of the citizen or his legal representative. Consent to disclosure of the data which are medical secret can be expressed also in the informed voluntary consent to medical intervention.
3.1. After the death of the citizen disclosure of the data which are medical secret, the spouse (spouse), to close relatives (to the children, parents adopted to adoptive parents, brothers and sisters, grandsons, grandfathers, grandmothers) or to the other persons specified by the citizen or his legal representative in the written consent to disclosure of the data which are medical secret or the informed voluntary consent to medical intervention on their request is allowed if the citizen or his legal representative did not forbid disclosure of the data which are medical secret.
4. Provision of the data which are medical secret without the consent of the citizen or his legal representative is allowed:
1) for the purpose of carrying out physical examination and treatment of the citizen who as a result of the condition is not capable to express the will, taking into account provisions of Item 1 of part 9 of article 20 of this Federal Law;
2) in case of threat of spread of infectious diseases, mass poisonings and defeats;
3) at the request of bodies of inquiry and investigation, court in connection with conducting investigation or legal proceedings, at the request of bodies of prosecutor's office in connection with implementation of public prosecutor's supervision by them, at the request of body of criminal executive system in connection with execution of criminal penalty and control of behavior conditionally of the convict, the convict concerning whom serving sentence is delayed, and person exempted conditional ahead of schedule and also in connection with the execution condemned obligations to undergo treatment for drug addiction and medical and (or) social resettlement;
3. 1) for the purpose of implementation by the persons authorized by the federal executive bodies of control of execution recognized by patients with drug addiction or consuming drugs or psychotropic substances without appointment of the doctor or new potentially dangerous psychoactive agents assigned to them in case of purpose of administrative punishment of obligation by court to undergo treatment for drug addiction, diagnostics, preventive actions and (or) medical rehabilitation;
4) in case of delivery of health care to the minor according to Item 2 of part 2 of article 20 of this Federal Law, and also to the minor who did not reach the age established by part 2 of article 54 of this Federal Law for informing one of his parents or other legal representative;
5) for the purpose of informing law-enforcement bodies:
a) about arrival of the patient concerning which good reasons to believe are had that harm to his health is done as a result of illegal actions;
b) about arrival of the patient who for health reasons, cannot report to age or other reasons data on the personality;
c) about the death of the patient whose personality is not identified;
6) for the purpose of conducting military-medical examination on requests of military commissariats, personnel services and military-medical (medical and flight) commissions of federal executive bodies and federal state bodies in which the Federal Law provides the military and equated to it service;
7) for the purpose of investigation of labor accident and occupational disease, and also accident with the student during stay in the organization performing educational activities and according to part 6 of article 34.1 of the Federal Law of December 4, 2007 No. 329-FZ "About physical culture and sport in the Russian Federation" accident with the person having sports training and not consisting in employment relationships with the sports organization which is not performing sports preparation and being the customer of services in sports preparation during passing by such person of the sports preparation to the organizations performing sports preparation including during its participation in the sports competitions provided by implementable programs of sports preparation;
8) in case of exchange of information by the medical organizations, including placed in medical information systems, for the purpose of delivery of health care taking into account requirements of the legislation of the Russian Federation about personal data;
9) for the purpose of implementation of accounting and control in system of compulsory social insurance;
10) for the purpose of control of quality and safety of medical activities according to this Federal Law.
11) ceased to be valid according to the Federal Law of the Russian Federation of 25.11.2013 No. 317-FZ
1. In the sphere of health protection treat powers of federal bodies of the government:
1) carrying out single state policy in the sphere of health protection;
2) protection of rights and freedoms of man and citizen in the sphere of health protection;
3) management of the federal state-owned property used in the sphere of health protection;
4) organization of system of sanitary protection of the territory of the Russian Federation;
5) organization, providing and implementation of federal state sanitary and epidemiological surveillance;
6) implementation of actions, directed to rescuing of life and preserving human health in case of emergency situations, liquidation of medical and sanitary consequences of emergency situations, informing the population on medical and sanitary situation in zone of emergency situation and about the taken measures;
7) licensing of separate types of activity in the sphere of health protection, except for licensing which is performed according to part 1 of article 15 of this Federal Law public authorities of subjects of the Russian Federation;
8) the organization and control in the sphere of health protection, including behind observance of requirements of technical regulations in the sphere of health protection;
9) maintaining federal information systems, federal databases in health sector, including ensuring confidentiality of the personal data containing in them in accordance with the legislation of the Russian Federation;
10) establishment of procedure of medical activities on the principles of public-private partnership in the sphere of health protection;
11) organization of rendering to citizens of primary health care, specialized, including high-technology, medical care, fast, including fast specialized, medical care and palliative medical care by the medical organizations subordinated to federal executive bodies;
11. 1) the organization of conducting medical examinations, medical examinations and medical surveys in the medical organizations subordinated to federal executive bodies;
11. 2) the organization of delivery of health care within clinical approbation of methods of prevention, diagnostics, treatment and rehabilitation (further - clinical approbation) the medical organizations subordinated to federal executive bodies;
11. 3) the organization of the medical activities connected with transplantation (change) of bodies and tissues of the person, including with organ donation and fabrics for the purpose of transplantation (change) in the medical organizations subordinated to federal executive bodies;
12) the organization of non-paid providing with donor blood and (or) its components, and also the organization of providing with the medicines specialized by products of clinical nutrition, medical products, means for disinfection, disinsection and deratization in case of delivery of health care, conducting medical examinations, medical examinations and medical surveys according to Items 6, 11 both 11.1 these parts and Item 17 of part 2 of this Article;
13) organization of biomedical support of athletes of sports national teams of the Russian Federation;
14) the organization and control of reliability of primary statistical data provided by the medical organizations;
15) monitoring of safety of medical products, registration of the side effects which are not specified in the instruction for application or the operation manual on medical product, undesirable reactions in case of its application, features of interaction of medical products among themselves, the facts and circumstances creating threat of life and to health of citizens and health workers in case of application and operation of medical products (further - unfavorable events);
16) ensuring development and program implementation of scientific research in the sphere of health protection, their coordination;
17) international cooperation of the Russian Federation in the sphere of health protection, including the conclusion of international treaties of the Russian Federation.
18) preparation and representation to chambers of Federal Assembly of the Russian Federation no later than June 1 of the year following after accounting year, the annual state report on realization of state policy in the sphere of health protection according to the procedure, established by the Government of the Russian Federation.
19) the organization of providing persons infected with human immunodeficiency virus including in combination with the viruses of the hepatitises B and C, anti-virus medicines for medical application included in the list of vital and essential drugs according to the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation";
20) the organization of providing persons, TB patients with the multiple medicinal stability of the activator, antibacterial and antitubercular medicines for medical application included in the list of vital and essential drugs according to the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation";
21) approval of cases and procedure for the organization of rendering primary health care and specialized, including high-technology, medical care by health workers of the medical organizations subordinated to federal executive bodies, out of such medical organizations.
2. To powers of the federal executive body performing functions on development and realization of state policy and normative legal regulation in health sector (further - authorized federal executive body), belong:
1) carrying out single state policy in health sector, development and program implementation of forming of healthy lifestyle and other programs in the sphere of health protection, implementation of measures for health care development, prevention of diseases, sanitary and epidemiologic wellbeing of the population, delivery of health care, the organization of the medical activities connected with transplantation (change) of bodies and tissues of the person, including with organ donation and fabrics for the purpose of transplantation (change), to sanitary and hygienic education;
2) establishment of requirements to placement of the medical organizations of the state health care system and municipal health care system, other infrastructure facilities in health sector proceeding from requirements of the population;
3) coordination of activities in the sphere of health protection of federal executive bodies, executive bodies of subjects of the Russian Federation, local government bodies, subjects of the state health care system, municipal health care system and private health care system;
3. 1) coordination in the procedure for position assignment of the head of executive body of the subject of the Russian Federation established by the Government of the Russian Federation in the sphere of health protection;
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