Rights and Obligations of Medical Institutions

 

BRACE Law Firm ©

Anna Ivanova, Attorney at BRACE Law Firm June 10, 2022

 

According to Art. 2 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ" or the "Law on the Fundamentals of Health Protection"), a medical organization is a legal entity, regardless of its organizational and legal form, whose primary (chartered) activity is medical activity conducted under a license granted in accordance with Russian legislation on the licensing of specific types of activities.

Within the framework of this article, the terms "medical institutions" and "medical organizations" are used as synonyms. However, a narrower interpretation of the term "medical institution" may also exist in the context of the organizational and legal form of a legal entity—the "institution" (Articles 123.21 – 123.23 of the Civil Code of the Russian Federation).

The provisions of the Law on the Fundamentals of Health Protection regulating the activities of medical organizations extend to other legal entities, regardless of their organizational and legal form, that conduct medical activities alongside their primary (chartered) activities, and apply to such organizations regarding their medical activities. Furthermore, individual entrepreneurs conducting medical activities are equivalent to medical organizations. In practice, medical organizations may be categorized by their field of activity (e.g., dental, anti-tuberculosis, etc.).

Another classification of medical organizations is based on the method of patient treatment (inpatient or outpatient). Specific types of medical organizations also include medical organizations in the sphere of compulsory medical insurance. The latter include organizations entitled to conduct medical activities and included in the Unified Register of Medical Organizations Operating in the Sphere of Compulsory Medical Insurance in accordance with Federal Law No. 326-FZ dated November 29, 2010, On Compulsory Medical Insurance in the Russian Federation. This register includes information on medical organizations subordinate to federal executive bodies that provide medical care financed in accordance with the uniform requirements of the basic compulsory medical insurance program, as well as registers of medical organizations operating in the sphere of compulsory medical insurance under territorial compulsory medical insurance programs.

Despite these classifications, all medical organizations must obtain a license to conduct medical activities and comply with licensee requirements. In accordance with Decree of the Government of the Russian Federation No. 852 dated June 1, 2021, On Licensing Medical Activities (with the Exception of Said Activities Conducted by Medical Organizations and Other Organizations Part of the Private Healthcare System on the Territory of the Skolkovo Innovation Center) and the Repeal of Certain Acts of the Government of the Russian Federation, such requirements include:

• compliance with medical care procedures, rules for conducting laboratory, instrumental, pathological-anatomical, and other types of diagnostic studies, regulations on organizing the provision of medical care by type, procedures for organizing medical rehabilitation and health resort treatment, procedures for conducting medical examinations, health screenings, dispensaries, medical check-ups, and medical certifications approved in accordance with the Law on the Fundamentals of Health Protection;
• compliance with requirements for internal quality control and safety of medical activities;
• compliance with the procedure for providing paid medical services;
• compliance with the rules for registering operations related to the circulation of medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting;
• professional development for specialists performing the declared medical services at least once every 5 years.

In addition to the requirements above, medical organizations also have a significant number of rights and obligations, which are discussed below.

Obligations of Medical Organizations (Institutions)

According to Art. 79 of the Law on the Fundamentals of Health Protection, medical organizations have the following obligations:

• to provide medical care to citizens in an emergency form;
• to organize and conduct medical activities in accordance with the legislative and other regulatory legal acts of the Russian Federation, including medical care procedures, and taking into account medical care standards;
• to ensure that medical workers provide medical care based on clinical recommendations and to create conditions ensuring that the medical care provided meets medical care quality assessment criteria;
• to inform citizens of the possibility of receiving medical care within the framework of the state guarantee program for the free provision of medical care to citizens and territorial state guarantee programs for the free provision of medical care to citizens;
• to observe medical secrecy, including the confidentiality of personal data used in medical information systems;
• to ensure the use of medicinal products, specialized therapeutic food products, medical devices, and disinfection, disinfestation, and deratization agents authorized for use in the Russian Federation;
• to provide patients with reliable information about the medical care being provided, the effectiveness of treatment methods, and the medicinal products and medical devices used;
• to inform citizens in an accessible form, including via the Internet, about the medical activities conducted and the medical workers of the medical organizations, their level of education, and their qualifications, and to provide other information determined by the authorized federal executive body necessary for an independent assessment of the quality of service conditions provided by medical organizations;
• to ensure the professional training, retraining, and professional development of medical workers in accordance with the labor legislation of the Russian Federation;
• to inform internal affairs authorities (regarding the admission of a patient where there are sufficient grounds to believe that the harm to their health was caused by unlawful actions; the admission of a patient who, due to their health, age, or other reasons, cannot provide their identity; or the death of a patient whose identity has not been established);
• to maintain insurance for cases of harm to the life and/or health of a patient during the provision of medical care in accordance with federal law;
• to maintain medical documentation in the established procedure and submit reports by type, form, deadline, and volume as established by the authorized federal executive body;
• to ensure the accounting and storage of medical documentation, including strict reporting forms;
• to conduct measures to reduce the risk of injury and occupational diseases, implement safe methods for collecting medical waste, and ensure protection from injury by medical device components;
• to ensure conditions for conducting an independent assessment of service quality;
• to allow relatives, other family members, or legal representatives of the patient to visit the patient in the medical organization, including its structural unit intended for intensive care and resuscitation measures;
• to ensure the provision of information to the Unified State Health Information System in the Sphere of Healthcare (EGISZ) in accordance with the legislation of the Russian Federation.

In the context of the obligations of medical institutions, we will primarily focus on those obligations whose non-compliance may lead to serious legal consequences for the organization, as well as other problematic issues.

First and foremost is the obligation of a medical organization (medical institution) to provide emergency medical care. In accordance with Art. 11 of the Law No. 323-FZ, it must be provided free of charge and immediately, regardless of whether the organization is state-owned or private. Non-compliance with this provision entails liability for the physician under Art. 124 of the Criminal Code of the Russian Federation. However, a question may arise as to whether there are any limits to the obligation to provide emergency care. Specifically, practice has not fully resolved the question of the legality of a medical organization’s refusal to provide care to a patient due to the absence of the necessary equipment for providing qualified assistance.

There are valid reasons why medical care may not be provided:

• the presence of insurmountable circumstances, such as a natural disaster or military action, as a result of which the physician cannot reach the sick or injured person;
• the illness of the medical worker themselves;
• physical or psychological coercion;
• the absence of conditions for providing care, such as the unavailability of necessary special instruments or pharmacological agents;
• the lack of consent from the patient (victim) or their close relatives to receive care.

In such a situation, there is an important nuance: if emergency care is necessary and the patient (or victim) is unconscious, and no legal representatives of this citizen are present, then medical care must be provided even without obtaining anyone's consent.[1]

Thus, according to Art. 124 of the Criminal Code of the Russian Federation, the failure to provide assistance to a patient without valid reasons by a person obligated to provide it in accordance with the law or a special rule, if this resulted by negligence in the infliction of moderate harm to the patient’s health, is punishable by a fine of up to 40,000 rubles or in the amount of the wages or other income of the convicted person for a period of up to 3 months, or by compulsory labor for a term of up to 360 hours, or by correctional labor for a term of up to 1 year, or by arrest for a term of up to 4 months.

The same act, if it resulted by negligence in the death of the patient or the infliction of serious harm to their health, is punishable by forced labor for a term of up to 4 years with the deprivation of the right to hold certain positions or engage in certain activities for a term of up to 3 years or without such, or by deprivation of liberty for a term of up to 4 years with the deprivation of the right to hold certain positions or engage in certain activities for a term of up to three years or without such.

It is important to note that in this case, the medical worker who failed to provide care is directly held criminally liable.

For instance, in one case, a physician was found guilty and convicted for failing to provide assistance to a patient without valid reasons, being a person obligated to provide such assistance by law, which resulted by negligence in the patient’s death. In the appellate court, the prosecutor attempted to reclassify the charge as intentional murder (Art. 105 of the Criminal Code of the Russian Federation), as the prosecutor believed that recordings of medical staff conversations implied the defendant was instructed to record the child as stillborn. The prosecutor believed the defendant had a motive to kill the child—to avoid an increase in child mortality rates, for which she was responsible as the head of the department. Contrary to these arguments, the Judicial Chamber concluded that the court's findings regarding the absence of the crime of murder were justified. According to the forensic experts' conclusion, although the child was born alive, it was non-viable; its gestational age and degree of organ immaturity prevented independent survival outside the mother's body. The cause of death was hypoxia (asphyxia) caused by several diseases. The duration of its extrauterine life was measured in seconds or minutes.[2] It is important to note that in cases of this category, medical expert reviews are most common, and courts base their decisions on them. Despite the complexity of investigating these cases, it is crucial to observe the interests of patients while simultaneously detailing the presence of a crime on the part of the medical worker to avoid unjust conviction.

A medical institution may also be held liable for the improper provision of medical care. For example, a court awarded the relative of a deceased patient compensation for moral harm because an inspection established that during the patient’s entire stay in the hospital, no consultation with an infectious disease specialist was conducted, which the patient needed; there was a late diagnosis and, as a consequence, delayed surgical treatment.[3]

In addition to the specified obligation to provide medical care, there are certain requirements for its provision. Since January 1, 2022, medical organizations are obligated to ensure that medical workers provide medical care based on clinical recommendations and to create conditions ensuring that the medical care provided meets medical care quality assessment criteria. Clinical recommendations approved by the Scientific and Practical Council of the Ministry of Health of Russia and approved by medical professional non-profit organizations are posted on the official website of the Ministry of Health of Russia in the Rubricator of Clinical Recommendations.[4]

Regarding the obligation to inform patients of the possibility of receiving medical care within the framework of the state guarantee program for the free provision of medical care to citizens, failure to comply entails administrative liability. According to Art. 6.30 of the Code of Administrative Offenses of the Russian Federation (the "CAO RF"), a medical organization’s failure to fulfill the obligation to inform citizens of the possibility of receiving medical care under state and territorial guarantee programs for free care entails an administrative fine on officials in the amount of 5,000 to 7,000 rubles and on legal entities from 10,000 to 20,000 rubles. A medical organization participating in the implementation of the state guarantee program that fails to provide patients with information on the procedure, volume, and conditions for providing medical care in accordance with the program entails an administrative fine on officials in the amount of 10,000 to 15,000 rubles and on legal entities from 20,000 to 30,000 rubles.

For the most effective coverage of issues related to informing citizens about the procedure and conditions for the free provision of medical care, the Ministry of Health of Russia recommends implementing the following measures:

• posting relevant information on the websites of the regional health management body and on the websites of medical organizations subordinate to the regional executive bodies of state power;
• providing the population with printed reference materials on the organization and conditions for the free provision of medical care to citizens (leaflets, booklets, banners);
• conducting thematic PR campaigns;
• conducting thematic exhibitions, conferences, and seminars;
• discussing issues regarding the organization of the procedure and conditions for the free provision of medical care at meetings of the public council formed under the regional executive body in the sphere of healthcare;
• installing information stands in medical organizations subordinate to the regional executive bodies of state power;
• organizing a hotline for citizens' questions regarding the provision of medical care and preferential drug provision;
• regularly conducting thematic consultations for citizens by employees of the regional health management body, including by telephone and via the Internet.[5]

It is important to note that courts recognize the failure to take the above measures as a violation. For instance, in one case, a court established that a medical unit failed to inform citizens of the possibility of receiving medical care under state and territorial guarantee programs for free medical care. According to the court, the medical organization’s arguments that the legal entity’s website contained a link to the official website of the Territorial Compulsory Medical Insurance Fund of the Kursk Region did not refute the fact of the violation established by existing legislation.[6]

Furthermore, in the sphere of informing citizens, the medical organization is also obligated to inform citizens about the medical activities it conducts and to post information about its employees, including their level of qualification and education. In this regard, it should be noted that a medical organization does not need to obtain the consent of physicians to post information about them on the Internet (usually on the organization’s website). Specifically, the Constitutional Court of the Russian Federation clarified that the public interest in such information is of fundamental importance for deciding the legality of publishing information about a person's private life without their consent. Such cases include the medical organization's obligation to inform citizens in an accessible form about its activities and employees. By choosing this activity and profession, the medical worker expressed their consent to the openness of such information. The distribution of such information does not violate the rights and freedoms of the physician.[7]

In addition to the specified obligations, existing legislation pays special attention to medical secrecy, which medical organizations, medical workers, and other persons must observe. According to Art. 13 of Law No. 323-FZ, medical secrecy consists of information regarding the fact of a citizen's request for medical care, their health status and diagnosis, and other information obtained during their medical examination and treatment. It is worth noting that medical secrecy also effectively includes personal data, which is not subject to disclosure and which, by virtue of the Federal Law No. 152-FZ dated July 27, 2006, On Personal Data, means any information relating directly or indirectly to an identified or identifiable physical person.

It is important to remember that a request to a government body for the purpose of receiving assistance in realizing the rights of citizens cannot be considered the distribution (disclosure) of information, even taking into account the potential risk of harm to the rights and freedoms of the persons associated with the information contained in the request.[8]

The Constitutional Court of the Russian Federation also clarified that a physician's complaint to the prosecutor's office regarding abuses by the medical institution's management against patients (specifying patient data) does not constitute a disclosure of medical secrecy, whereas the medical institution demanded that the physician be held liable under Art. 137 of the Criminal Code of the Russian Federation for violating the privacy of private life using their official position.[9]

Thus, the disclosure of medical secrecy may lead to both administrative and criminal liability. Criminal liability provides for a fine in the amount of 100,000 to 300,000 rubles or in the amount of the wages or other income of the convicted person for a period of 1 to 2 years, or the deprivation of the right to hold certain positions or engage in certain activities for a term of two to 5 years, or forced labor for a term of up to 4 years with the deprivation of the right to hold certain positions or engage in certain activities for a term of up to 5 years or without such, or arrest for a term of up to six months, or deprivation of liberty for a term of up to 4 years with the deprivation of the right to hold certain positions or engage in certain activities for a term of up to 5 years.

The obligation of medical organizations to ensure the use of medicinal products, specialized therapeutic food products, medical devices, and disinfection, disinfestation, and deratization agents authorized for use in the Russian Federation is directly related to the quality of medical care and the procurement of such medicinal products. For example, according to a decision by the Chelyabinsk FAS Russia, a complaint against procurement documentation was recognized as groundless because the Customer, in the requirements for the second part of the bid, required the bidder to provide a decision on the inclusion of the pharmaceutical substance in the state register of medicinal products. According to Clause 5, Part 1, Art. 37 of the Law on the Fundamentals of Health Protection, a medical organization is obligated to ensure the use of medicinal products, specialized therapeutic food products, medical devices, and disinfection, disinfestation, and deratization agents authorized for use in the Russian Federation.[10]

Another important obligation of a medical organization is ensuring the professional retraining of medical workers. Courts have concluded that an employer is obligated to provide additional professional education for employees if it is a condition for the employees to perform certain types of activities. In this case, the employer will be denied the recovery of funds spent on the worker’s training, even if the employment contract contained a condition that after 5 years of work at the organization, the employer would send the physician for professional development on the condition that the employee agrees to work at the organization for 3 years and, in the event of early resignation, agrees to return the cost of the professional development. The court found such a condition in the employment contract to be unlawful.[11]

Another significant innovation is the obligation of medical institutions to allow relatives, other family members, or legal representatives of the patient to visit the patient in the medical organization, including its structural unit intended for intensive care and resuscitation measures, which was introduced on June 9, 2019.

According to the general requirements for organizing visits to a patient by relatives and other family members or legal representatives in a medical organization, including its structural units intended for intensive care and resuscitation measures, during the provision of inpatient medical care, approved by Order of the Ministry of Health of Russia No. 869n dated August 19, 2020, an employee responsible for organizing patient visits is appointed in the medical organization (or its structural unit).

Patient visits are conducted taking into account the patient’s condition, compliance with anti-epidemic regimes, and the interests of other persons working and/or present in the medical organization, with the patient’s consent.

A patient visit is conducted with the permission of the head of the structural unit of the medical organization where the patient is receiving inpatient medical care, the duty physician, or the responsible person in the event:

• the patient’s condition does not allow them to express consent for a visit and/or legal representatives are absent;
• a visit to a patient in serious condition in a ward, including one intended for intensive care and resuscitation measures.

When visiting a patient in a resuscitation and intensive care ward, a maximum of two visitors per patient are allowed simultaneously.

At the same time, visits are not conducted for patients in infectious disease box departments and infectious disease box wards, nor during the introduction of restrictive measures (quarantine) in the medical organization (or its structural unit). This requirement is particularly relevant during a pandemic, as in practice medical institutions did not allow patient visits, organizing only the transfer of necessary items through an authorized employee.

The main obligations of medical organizations are reviewed above. Nevertheless, it is important to note that medical organizations are endowed with many additional obligations. Specifically, medical organizations participating in the implementation of the state guarantee program for the free provision of medical care are obligated:

• to provide patients with information on the procedure, volume, and conditions for providing medical care in accordance with the state guarantee program for the free provision of medical care;
• to ensure the provision of medical care to citizens within the framework of state and territorial guarantee programs for the free provision of medical care;
• to ensure the conduct of preventive measures aimed at preventing disease risk factors and their early detection;
• to promote a healthy lifestyle and provide sanitary and hygienic education to the population.

Additional obligations are imposed on medical organizations regarding the performance of any contractual relations with both the patient and partners (including suppliers of medicinal products and medical devices). In this regard, medical organizations, in addition to the specific obligations established by Law No. 323-FZ, must also comply with general requirements of civil legislation, procurement legislation, fire safety rules, etc.

Rights of Medical Organizations (Institutions)

Article 78 of Law No. 323-FZ establishes that a medical organization has the right:

• to submit proposals to the founder on optimizing the provision of medical care to citizens;
• to participate in the provision of medical care to citizens of the Russian Federation in accordance with the state guarantee program for the free provision of medical care, which includes the basic compulsory medical insurance program;
• to issue medical reports, certificates, and prescriptions for medicinal products and medical devices in hard copy and/or, with the consent of the patient or their legal representative, in the form of electronic documents using an Enhanced Qualified Electronic Signature (UK(E)P) of the medical worker in the procedure established by the authorized federal executive body;
• to generate sick leave certificates in the form of an electronic document or, in certain cases, in hard copy, in the procedure established in accordance with the legislation of the Russian Federation on compulsory social insurance for temporary disability and in connection with maternity;
• to conduct scientific and/or research activities, including fundamental and applied scientific research;
• to create medical information systems containing data on patients, the medical care provided to them, and the medical activities of medical organizations in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data and medical secrecy.

For example, the Law on the Fundamentals of Health Protection provides for the existence of state, municipal, and private healthcare systems. Private medical organizations generally provide medical services for a fee based on a contract for the provision of medical services for consideration or a voluntary medical insurance contract. However, the Law on the Fundamentals of Health Protection does not exclude the possibility of private medical organizations participating in the implementation of the State Guarantee Program for the free provision of medical care (including primary health care, specialized medical care, including high-tech care; emergency medical care, including specialized emergency care; and palliative medical care in medical organizations).[12]

According to Decree of the Government of the Russian Federation No. 2505 dated December 28, 2021, within the framework of the basic compulsory medical insurance program, citizens (insured persons) are provided with primary health care, including preventive care, emergency medical care (except for air medical evacuation), specialized medical care, including high-tech medical care included in the list of types of high-tech medical care financed by compulsory medical insurance funds, except for sexually transmitted diseases, diseases caused by human immunodeficiency virus, acquired immunodeficiency syndrome, tuberculosis, mental disorders, and behavioral disorders; preventive measures are also conducted, including health screenings and dispensary observation. Citizens who have recovered from the new coronavirus infection (COVID-19) are entitled to undergo in-depth health screenings, including studies and other medical interventions.

It should also be noted that the exercise of rights to conduct scientific activities at medical organizations that perform practical work with patients is an important component for the development of science and the improvement of medical practice.

When exercising the right to create medical information systems containing data on patients, the medical care provided to them, and the medical activities of medical organizations, compliance with restrictions on the distribution of patients' personal data is necessary, whereas providing information about the physicians of a medical institution is simultaneously an obligation of the medical organization.

In this article, the main rights and obligations of medical organizations (institutions) have been reviewed with an analysis of the most common law enforcement practice. Based on the analysis conducted, it can be concluded that the specified rights of medical organizations are realized while mandatory compliance with all established obligations and the rights of patients is observed.

 

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References

[1] Liability for Unlawful Refusal to Provide Medical Care. Clarifications of the Stavropol Territory Prosecutor's Office. September 22, 2020.

[2] Appeal Determination of the Supreme Court of the Russian Federation dated March 6, 2019, No. 85-APU19-1.

[3] Decision of the Nefteyugansk District Court of the Khanty-Mansi Autonomous Okrug dated May 20, 2020, in Case No. 2-1034/2020.

[4] Letter of the Ministry of Health of Russia dated May 20, 2021, No. 17-4/I/1-7530, On the Transition of Medical Organizations to Work in Accordance with Clinical Recommendations from January 1, 2022.

[5] Letter of the Ministry of Health of Russia dated April 29, 2015, No. 21-3/839.

[6] Decision of the Kurchatov City Court of the Kursk Region dated July 2, 2019, in Case No. 12-41/2019.

[7] Resolution of the Constitutional Court of the Russian Federation dated May 25, 2021, No. 22-P.

[8] Determination of the Constitutional Court of the Russian Federation dated December 5, 2019, No. 3272-O.

[9] Determination of the Constitutional Court of the Russian Federation dated March 26, 2020, No. 540-O.

[10] Decision of the Chelyabinsk FAS Russia dated January 19, 2018, in Case No. 48-zh/2018.

[11] Review of Judicial Practice of the Kaliningrad Regional District (City) Courts in Civil Cases for the First Half of 2018.

[12] Bugaenko N.V., Kratenko M.V. Judicial Practice in Civil Cases. Consumer Rights Protection Disputes: Scientific and Practical Guide. Moscow: Yustitsinform, 2013. 392 p.