2023
  • 2023 № 7 Review of the regulatory framework regarding the use of multifocal IOLs for cataract surgery.

    Considering the increasing requirements for the quality of postoperative vision, the number of requests from patients for the implantation of a multifocal IOL is increasing, which makes it relevant to analyze the existing regulatory framework for the possibility and obligation to use this medical device in the provision of specialized medical care – surgical treatment of cataract within the framework of the state guarantees program. An analysis of the current regulatory framework showed that the existing regulatory framework allows the use of multifocal IOLs in the provision of medical services under the state guarantees program, however, it does not give the patient the right to choose, and makes considering the patient’s desire to implant this particular type of medical device is not mandatory when planning
    surgery. Considering the requirements of mandatory informed voluntary consent when receiving a medical service, the patient must be informed about the implantation or refusal to implant this type of medical device when providing him with specialized medical care. Most of the analyzed medical devices – IOLs with multifocal properties – are registered in the Russian Federation as “Intraocular lens for the posterior chamber of the eye, pseudophakic”, and not “Intraocular lens for the posterior chamber of the eye, pseudophakic, with increased depth of focus”. There is both a clinical need for changes (Clinical guidelines), and an organizational need to identify a group of operations, including with the application of additional coefficients to the tariff as part of the payment for medical services included in the program of state guarantees.

    Authors: Chuprov A. D. [4] Lositsky A. O. [2] Zhediale N. A. [1]

    Tags: cataract treatment1 cost of medical services2 multifocal iols1 quality of life8 state  guarantee  program4 tariff setting1

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  • 2023 № 6 Regulatory and legal regulation of medical care in day hospitals.

    The program of state guarantees provides for a reduction in the amount of inpatient care due to the development of inpatient forms and planning an increase in part of the state’s expenses for outpatient care. The correct organization of medical care using hospital replacement technologies is possible only if the requirements of regulatory documents are met. This will allow faster implementation of the main provisions of the Health Concept for the development of hospital replacement forms. Day hospitals are organized in order to improve the organization and improve the quality of medical care in outpatient settings, as well as to increase the economic efficiency of medical organizations through the introduction and widespread use of modern resource-saving medical technologies for prevention, diagnosis,
    treatment and rehabilitation, which is achieved by following the regulatory documents discussed in the article.

    Authors: Demyankov K. B. [1] Yakushev D. Yu. [1]

    Tags: day hospital4 hospital replacement forms1 regulatory documents2

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  • 2023 № 2 A new methodology of medical and legal aspects of compensation for moral damage in disputes with patients.

    The authors consider the explanations of the Supreme Court of the Russian Federation contained in the new Resolution on compensation for moral damage, including items affecting compensatory aspects in the provision of medical care and harm to the health of patients.
    Changes in the policy of the Supreme Court of the Russian Federation on the problem under consideration are shown.
    An assessment of the possible consequences of the explanations of the Supreme Court of the Russian Federation in relation to citizens (patients) and medical organizations, prospects of law enforcement practice based on the provisions of the new Resolution is given.

    Authors: Kadyrov F. N. [123] Sveredyuk M. G. [2] Stupak V. S. [3]

    Tags: compensation for moral damage1 medical care13 patient13 statement of claim1

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  • 2022
  • 2022 № 10 Evolution of regional regulatory and legal acts concerning the organization and financings of high-tech medical care

    Article represents the review of regulatory-legal base of the devoted organization of rendering and financial maintenance of high-tech medical care. Acts accepted both at a level of the Russian Federation as a whole, and in separately taken region are considered. Dynamics of variation of volumes and sources of financing of the given type of the help is traced. Data as about the solved problems in the organization of high-tech medical care, and about legal blanks in the legislation cite. The major factor preventing an increase of availability of high-tech medical care, it is considered deficiency of financing and imperfection of mechanisms of planning of volumes. Rendering of high-tech medical care due to the state sources of financing, requires perfection, especially concerning absence of the precise rules of a level co-financing. The decision of the given questions will assist as a result to growth of security of the population of Russia by high-tech medical care.

    Authors: Naberezhnaya I. B. [2]

    Tags: co-financing3 federal budget9 high-tech medical care11 review2 state task1

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  • 2022 № 8 Organizational and legal issues of examination of minors in a gynecological hospital

    The organizational and legal aspects of gynecological care for minors remain a matter of debate, and the indicated topic requires further detailed study. Due to the limited scope of work, not all relevant aspects on the issue under consideration are considered, but only issues of providing information about a minor to law enforcement agencies without the consent of the patient and her legal representative. The relevance of the study is largely due to the fact that the answer to the indicated questions causes difficulties not only among medical professionals, but also among lawyers.
    The authors set out to substantiate the main features of the organization of gynecological care for minor patients, as well as provisions for the observance of their rights. To achieve the goal, the authors set the tasks of determining the legal status of minor patients of the gynecological hospital, the accompanying duties of medical workers and medical organizations, development of practical recommendations on the actions of a medical organization when examining a minor and establishing the fact of pregnancy, as well as interaction with law enforcement agencies.
    The study materials were the provisions of regulatory legal acts in the field of health protection and ensuring the rights of minors, as well as judicial practice on the issue under study.
    When conducting the study, the authors used general scientific and private scientific methods of cognition, such as analysis and synthesis, formal and legal, interpretations.
    During the examination of a minor in a gynecological hospital, doctors face the need to ensure the rights of minor patients both to sexual inviolability, sexual freedom and the normal moral and physical development of the minor’s personality, as well as to ensure the protection of personal data and medical secrets. I correspond to these rights the obligations of medical workers and medical organizations not only to transfer information about the patient to law enforcement agencies in cases established by law, but also to comply with the requirements of the law on the protection of information constituting a secret protected by law.
    As a result of the study, the authors came to the following conclusions. When establishing the fact of pregnancy of a minor or the entry of a minor into sexual intercourse (other sexual acts), if there are no sufficient grounds to believe that harm to her health was caused as a result of illegal actions, the medical professional (doctor) must explain to the minor (her legal representative) the possibility of transmitting relevant information to the internal affairs body; obtain written consent to the transfer of relevant information to the internal affairs body, which is stored in a medical organization; transfer relevant information to the medical officer responsible for timely informing the internal affairs bodies.
    The results of the study can be used by gynecological hospitals and other medical institutions in organizing the provision of gynecological care to minor patients, interaction with the internal affairs bodies to protect the rights and legitimate interests of minors.

    Authors: Samoilova Yu. B. [1] Paikov A. Yu. [1] Miroshnikova E. M. [1]

    Tags: doctor2 gynecological department1 informing1 internal affairs body1 medical organization52 minor1 patient13 pregnancy4

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  • 2021
  • 2021 № 9 Legal and regulatory framework of the system for ensuring an accessible environment for people with disabilities and other low-mobility groups of the population on the example of an ophthalmological medical organization

    The article analyzes the existing regulatory framework governing the formation of an accessible environment for people with disabilities and other low-mobility groups of the population. The experience of a republican-level clinic providing medical care in the field of “ophthalmology” when organizing visits to low-mobility groups of the adult population in the Republic of Tatarstan is presented. The forms of work of an ophthalmological medical organization to provide an accessible living environment for the specified category of patients are considered. The types of responsibility of officials and legal entities for violations in the field of providing an accessible environment for people with disabilities and low-mobility groups of the population are determined.

    Authors: Khusainova D. K. [3] Stein E. V. [1] Zigangareeva G. G. [3]

    Tags: accessible environment1 disabled people2 people with limited mobility1

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  • 2020
  • 2020 № 7 On the issue of legal protection of adolescent girls ‘ reproduc tive health

    The article presents an overview of modern approaches to legal protection of reproductive health of adolescent girls
    in the Russian Federation. The system aspects of health protection of girls and adolescent girls, as well as prevention of violations
    of reproductive health formation, are taken into account. The research was based on Federal laws, regulatory and legislative acts
    of individual subjects of the Russian Federation, and relevant scientific publications. The legal priority in ensuring the reproductive
    health of girls and adolescent girls is determined by the availability and quality of specific medical care, as well as relevant sections of the main legal documents.

    Authors: Mingazova E. N. [29] Zhelezova P. V. [3] Samojlova A. V. [1] Zagorujchenko A. A. [1] Shigabutdinova T. N. [2]

    Tags: adolescent girls1 eproductive health1 health4 health protection4 legal regulation1 legislation4 prevention24 regulatory framework1

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  • 2020 № 6 Regulatory aspects of the organisation of medicine provision for welfare beneficiaries

    A legal basis has been established to regulate the issue of pharmacological support of special patient groups. It consists of several individual categories, diseases and drug lists. Nowadays pharmacological support is divided into federal and regional levels. However, some rules and regulations are duplicated in both of them. This fact can lead to organizational problems and also influence the negative budget issues. The analysis of the current legal basis will allow to determine the directions for further improve- ment of pharmacological support legislation

    Authors: Nagibin О. А. [3] Selyavina  O.  N. [1] Karausheva  L.  E. [1]

    Tags: clinical-economy  analysis2 edl2 essential  drug  list2 federal  law2 government  order  8902 healthcare  system2 high  cost  nosologies2 legal  acts2 life-threatening  committee2 onlp2 orphan  diseases2 pharmaceu- tical product1 pharmacological support1 regional  procurement2 russian  regions2 special  patient  groups2 state  guarantee  program4

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  • 2020 № 3 Improving the regulatory and legal framework for delivering primary health care to the population in the field of non-communicable diseases prevention and the implementation of a healthy lifestyle standardization

    In order to prevent non-communicable diseases and carry out measures to model a healthy lifestyle, the article proposes changes to the regulatory and legal framework for delivering primary health care and primary specialized health care, including the introduction of a position of a physician for common hygiene in medical organizations. It is proposed to introduce additions to the nomenclature of medical services provided. There was developed a section of occupational standards program “Specialist in hygiene”, on the job functions of a physician for common hygiene. It is proposed to include in the job functions of a physician for common hygiene the diagnostic testing in health centers in order to assess the functional reserves and adaptive capabilities of a person affected by adverse environmental factors, and the prescribing appropriate curative and preventive measures. Implementation of the proposed activities in the health centers will improve the efficiency of medical and preventive work of medical organizations and reduce the level of uncertainty of preventive activities carried out, and of the expected results of preventive work carried out by a therapist and a general practitioner (family doctor). The proposed changes will help to identify causal relationships between the health status of the population and the impact of adverse environmental factors, to form risk groups among adult population in accordance with diagnostic criteria of risk factors and other pathological conditions and diseases associated with the impact of adverse environmental factors that increase the likelihood of developing of chronic non-communicable diseases in risk groups, if there are diagnostic criteria of risk factors to send the indigent to health organization for in-depth examination and carrying out the necessary medical and preventive measures, to prepare research and information materials and to participate in hygiene education, to promote healthy lifestyles and to improve health literacy of population.

    Authors: Prilipko N. S. [4] Turbinsky V. V. [2] Bobrovnitsky I. P. [2]

    Tags: job  functions.1 normative  legal  documents1 physician  for  common  hygiene1 primary health care19

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  • 2019
  • 2019 № 6 Legal issues of non-conformity of payment medical services to expectations of the patient

    The article is devoted to the problems arising in the course of inconsistency with the patient’s expectations in the context of providing paid medical services. The legal regulation of this service sector needs to be improved, so the paper analyzes the documentation of the legal relationship between the medical organization and the patient, considers the basic conditions that are mandatory for implementation and determines the specific nature of the medical service within the framework of delineating patient information when provided for payment and free medical care.

    Authors: Perepelova O. V. [3] Grishina N. K. [6] Gridnev O. V. [2] Pesennikova E. V. [2]

    Tags: informed  voluntary  consent  to  medical  intervention1 paid medical services21 paid  medical  services  contract1

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  • 2019 № 5 Current organization of drug maintenance for certain patient groups. Role of drug lists

    Nowadays there is established legal basis for drug maintenance of certain patient groups. Based on it there are several individual categories, diseases and drug lists. Despite the division on federal and regional levels, some rules and regulations are duplicated that lead to organizational problems and also influence the negative budget issues. In order to determine directions for improvement, one should analyze current legal basis in Russian healthcare.

    Authors: I.  A.  Komarov [1] O. Yu.  Aleksandrova [1] O.  A.  Nagibin [1]

    Tags: clinical-economy  analysis2 drugs2 drug  maintenance1 edl2 essential  drug  list2 federal  law2 government  order  8902 healthcare  system2 high  cost  nosologies2 legal  acts2 life-threatening  committee2 onlp2 orphan  diseases2 pharmacoeconomics1 regional  procurement2 russian  regions2 special  patient  groups2 state  guarantee  program4

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  • 2018
  • 2018 № 10 Problems of normative support of health care institutions in the context of structural reforms

    The results of the analysis of the effectiveness of structural reforms in health care, their validity, compliance with the Program of state guarantees of free medical care to citizens of the Russian Federation, adequate provision of medical organizations with resources. It is proved that the formation of a network of medical organizations should be justified by the objective needs of the population in medical care, confirmed by the data of monitoring the health status of the population and the study of consumer demand. It is also necessary to take into account the forecast of changes in the needs of the population in the volumes and types of care, as well as to scientifically justify the profiling, typing and staffing of medical organizations.

    Authors: Son I. M. [40] Starodubov V. I. [40] Rugol L. V. [2]

    Tags: a network of medical organizations1 regulatory support1 structural reforms1 the program of state guarantees of free medical care to citizens of the russian federation1

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  • 2018 № 3 Topical issues of arbitration practice in the CHI system (the experience of Saint-Petersburg)

    The current legislation in the system of compulsory health insurance has opened wide opportunities for participation in this system of medical organizations of any organizational and legal form. However, this has led to an increase in the number of economic disputes in the compulsory health insurance system. In particular, the number of lawsuits is increasing on new grounds: the amount of medical care; payment for medical care provided in excess of these volumes. The defendants in the claims are not only the insurance medical organizations and territorial funds of the MLA, but also the Commission, which develop territorial programs of compulsory medical insurance and are not legal entities. Court practice in many cases violates the logic of legislation on compulsory health insurance. This article is devoted to the consideration of these problems for recommendations to improve the legislation

    Authors: Gordeev A. E. [1]

    Tags: commission  on  the  elaboration  of  territorial  programmes1 compulsory medical insurance18 health  insurance  organizations3 litigation1 the  volume  of  medical  care2

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  • 2017
  • 2017 № 6 Regulatory framework for providing high-technology ophthalmological medical care under outpatient treatment

    The article analyzes the existing legal basis for providing high-technology ophthalmological medical care through a systematic review of regulatory enactments that directly regulate this type of activity (14 regulatory enactments, including 2 federal laws).
    High-technology medical care is a separately licensed type of medical activity carried out by approved federal or regional medical organizations, financed by subsidy or directly from federal budget, provided for approved types of medical care in a hospital. The source of funding for healthcare determines essential conditions. The existing legal framework creates significant restrictions for providing high-technology ophthalmological medical care under outpatient treatment in the case of healthcare covered by Compulsory Health Insurance or an appropriate budget. The article outlines the ways of solving this problem proposed by the authors, including for a medical institution, without violating the current legislation. Healthcare covered by other sources of funding can be provided in any conditions, including outpatient

    Authors: Borshchuk E. L. [4] Chuprov A. D. [4] Lositskiy A. O. [1]

    Tags: compulsory medical insurance fund1 medical organization52 quality and safety of medical activity12 quality of medical care20 regulatory body of public health service1

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  • 2016
  • 2016 № 10 Administrative penalty applicable to protection of citizens from exposure to tobacco smoke

    Annotation. The integrated policy of dealing with the harm caused due to tobacco use is administrative penalty for the violating the restrictions. The article provides analysis of the regulatory and enforcement issues of administrative sanctions for violation of the «anti-smoking legislation» (Art. 6.24 and 6.25 of the Administrative Code of the Russian Federation).

    Authors: Roshchin D. O. [5] Plutnitsky A. N. [4]

    Tags: an administrative offense1 protection from tobacco smoke1 smoking bans1

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  • 2016 № 9 Administrative suspension of activities of the health care institution

    Annotation. The analysis of the legal nature of the administrative penalty of business interruption of activities assigned by the courts, a temporary suspension of activities applied by officials of the government authorities in relation to health care organizations, as well as the proscription in a civil lawsuit is performed. The criteria for the use of these measures is performed. Law enforcement practice outcomes in the different regions of the Russian Federation are presented in the article.

    Authors: Roshchin D. O. [5]

    Tags: administrative penalty1 administrative suspension of activities1 health care institution1

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  • 2016 № 8 Guarantee citizens‘ rights while using medical devices

    The article shows that in recent years the requirements in the sphere of medical products circulation not only increased in volume but also become more stringent. So it requires that medical organizations has to do targeting actions to improve the work to ensure the rights of citizens to use medical devices. It is proved that the rights of citizens in the use of medical devices has certain specifics. The proposed measures aimed at improving the provision of these rights of citizens and safety monitoring of medical devices.

    Authors: Piven D. V. [58] Kitsul I. S. [58] Ivanov I. V. [29]

    Tags: medical devices2 medical organization52 quality and safety of medical devices1 quality control and safety of medical practice1 rights of citizens2 safety monitoring of medical devices1

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  • 2016 № 5 Legal regulation of internal control of the quality and safety of medical activity

    The article shows and proves what the Federal legislation should be analyzed and used in medical organization in the field of internal control of the quality and safety of medical activity. Presents directions for internal control of quality and safety of medical activities with regard to regulation of each Federal legislation.

    Authors: Piven D. V. [58] Kitsul I. S. [58] Ivanov I. V. [29]

    Tags: internal control7 legislation4 medical organization52 quality and safety of medical activities9

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  • 2016 № 4 The legitimacy of the audio and video recording during a medical examination

    In the article analysis of legislation in an attempt to answer the question of the legality of the audio and video recordings is performed for the performing of the quality of medical care as well as using in civil court as evidence. The practice of applying the law demonstrated by the judgments which were presented as evidence to the court audio and video recordings.

    Authors: Roshchin D. O. [5] Sayapina S. M. [1]

    Tags: audio recording1 civil process1 health care quality control1 medical service2 video recording1

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  • 2016 № 2 Analysis of the official regulation documents on organization of outpatient care for patients with chronic complications of diabetes mellitus

    Diabetes mellitus (DM) is a socially important chronic disease with the disabling and economically significant complications. Organization of specialized structures for interdisciplinary out-patient care for patients with chronic complications of diabetes (affecting kidneys, eyes, the lower extremities) is an important task. We analyzed existing National clinical expert recommendations and orders of Ministry of Health concerning standards of care for patients with DM and its complications. Conclusions are drawn on necessary development of the regulatory documentary base for out-patient multidisciplinary care for this kind of patients.

    Authors: Udovichenko O. V. [2] Berseneva E. A. [5] Meshkov D. O. [4]

    Tags: definitions2 diabetes mellitus6 diabetic foot2 diabetic nephropathy2 diabetic retinopathy3 legal base1 organization of care1 standard of care1

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  • 2015
  • 2015 № 9 The history of establishment of the service of anesthesiology and intensive care in the Russian Federation in the orders

    In the present study analyzes the formation and development of the service of anesthesiology and intensive care in our country in the regulatory documents. Reflected changes in staffing groups and departments of anesthesiology and intensive care, as well as the functional responsibilities of these offices.

    Authors: Gorbachev V. I. [4] Netesin E. S. [2]

    Tags: anesthesia2 anesthesiology and reanimation1 nurse anesthetist1 orders4 physician anesthesiologist1 staffing ratios1

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