Informed voluntary consent of the patient is. Informed voluntary consent of the patient to medical intervention - in all seriousness. Patient informed consent model in dentistry

1. A necessary precondition for medical intervention is the giving of informed voluntary consent of a citizen or his legal representative to medical intervention on the basis of complete information provided by a medical worker in an accessible form about the goals, methods of providing medical care the risks associated with them, possible options for medical intervention, its consequences, as well as the expected results of medical care.

2. Informed voluntary consent to medical intervention is given by one of the parents or other legal representative in relation to:

1) a person who has not reached the age established by paragraph 5 of Article 47 and paragraph 2 of Article 54 of this federal law, or a person recognized in the manner prescribed by law as legally incompetent, if such a person, due to his condition, is not able to give consent to medical intervention;

2) a minor addicted to drug addiction when providing him with drug treatment or when medical examination minor in order to establish the state of narcotic or other toxic intoxication (with the exception of those established by law Russian Federation cases of acquisition by minors of full legal capacity before they reach the age of eighteen).

3. A citizen, one of the parents or other legal representative of the person specified in part 2 of this article shall have the right to refuse medical intervention or demand its termination, except for the cases provided for by part 9 of this article. The legal representative of a person who has been recognized legally incompetent in accordance with the procedure established by law shall exercise this right if such a person, due to his condition, is not able to refuse medical intervention.

4. In case of refusal of medical intervention to a citizen, one of the parents or other legal representative of the person specified in part 2 of this article, the possible consequences of such a refusal must be explained in an accessible form to him.

5. If one of the parents or other legal representative of the person specified in part 2 of this article, or the legal representative of the person recognized as incapacitated in accordance with the procedure established by law, refuses from the medical intervention necessary to save his life, the medical organization has the right to apply to the court for protect the interests of such person. The legal representative of a person recognized in the manner prescribed by law as legally incompetent notifies the guardianship and guardianship authority at the place of residence of the ward of the refusal of medical intervention necessary to save the life of the ward, no later than the day following the day of this refusal.

6. The persons specified in parts 1 and this article, in order to receive primary health care, when choosing a doctor and a medical organization for the period of their choice, give informed voluntary consent to certain types of medical intervention, which are included in the list established by the authorized federal executive body .

7. Informed voluntary consent to medical intervention or refusal of medical intervention is contained in the medical records of a citizen and is drawn up in the form of a document for hard copy, signed by a citizen, one of the parents or other legal representative, medical worker, or is formed in the form electronic document signed by a citizen, one of the parents or other legal representative using an enhanced qualified electronic signature or a simple electronic signature by applying unified system identification and authentication, as well as by a medical worker using an enhanced qualified electronic signature. Informed voluntary consent to medical intervention or refusal of medical intervention by one of the parents or other legal representative of the person specified in Part 2 of this Article may be formed in the form of an electronic document if the patient's medical records contain information about his legal representative.

8. The procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention, including in relation to certain types of medical intervention, the form of informed voluntary consent to medical intervention and the form of refusal of medical intervention are approved by the authorized federal executive body.

(see text in previous edition)

9. Medical intervention without the consent of a citizen, one of the parents or other legal representative is allowed:

1) if medical intervention is necessary for emergency reasons to eliminate the threat to a person’s life and if his condition does not allow him to express his will or there are no legal representatives (in relation to the persons specified in part 2 of this article);

3) in relation to persons suffering from severe mental disorders;

4) in relation to persons who have committed socially dangerous acts (crimes);

5) when conducting a forensic medical examination and (or) a forensic psychiatric examination;

6) in the provision of palliative care, if the citizen's condition does not allow him to express his will and there is no legal representative.

10. The decision on medical intervention without the consent of a citizen, one of the parents or other legal representative is made:

Receipt informed consent treatment seems like an obvious and easily achievable goal. In reality, everything happens quite differently. Over the past thirty years, achieving this goal has been perhaps the most time-consuming problem to solve, both medically and legally. Ideally, the patient should receive as much information as possible about specific treatment plans and expected results, positive or negative. This recommendation seems simple, however, in practice it is not always easy to determine what specific information should be discussed. There are, however, guidelines developed at the state level regarding the appropriate amount of information required by a physician to negotiate consent with a patient.

Legislative acts of a number of states determine what information must be provided to the patient before the doctor performs any invasive examination or procedure or prescribes a course of treatment. The doctor should be aware of the requirements set out in his state's informed consent law - as, of course, other health-related laws - and be aware of any changes or additions to the wording of the law. All states post their laws online, and anyone can quickly access and search any state's database of laws.

New York state law requires the physician to be more proactive in matters of informed consent, obliging the physician to discuss the risks and benefits of the proposed treatment in much greater detail, whether or not the patient requests Additional information. New York State defines "lack of informed consent" as "the failure by a professional treatment or diagnostic provider to provide such information about available alternatives and possible reasonable risks and benefits as a reasonable medical professional, dentist, or orthopedist would provide in similar circumstances, thus so that the patient can assess the situation based on the information received.

In addition to requirement about disclosing in advance all information about the risk and positive results, the law also establishes that in the case of filing a claim against a doctor, the plaintiff must prove the absence of informed consent. The plaintiff must "prove that a reasonably prudent person in the patient's shoes would not consent to treatment or diagnosis if they had full information, and that the lack of informed consent is the direct cause of injury or harm to health." The law goes on to list what a doctor can say in his defense: the risk is so well known to the general public that there was no need to explain it; the patient assured the doctor that he agrees to undergo treatment, regardless of the risks associated with it; there was not sufficient opportunity to obtain consent, or the physician decided that obtaining information about the risks was not in the interests of the patient, because such information "would have a significant adverse effect on the patient's condition." Full compliance with such instructions before the recommended major surgery would require detailed explanations from the field of anatomy, physiology, pathology and postoperative complications. It is clear that this level of informed consent is a model that is never put into practice. Thus, acceptable agreement is based on incomplete information. Even a doctor who has undergone many years of training in a non-surgical specialty does not fully understand all the possible risks of a complex operation.

In the article Bitterman provides an excellent overview of such legal dilemmas. As noted above, consent has four elements: it must describe the patient's problems, define the proposed solution, explain less effective alternatives, and summarize the possible risks of treatment or refusal of treatment. If a friend or family member of the patient is asked to sign the consent form—although the consent in this case may not be valid—the surgeon must choose between immediate care and the risk of harming the injured patient through delay. In fact, if urgently needed treatment is delayed in order to obtain informed consent, this situation in itself may give rise to legal liability.

Elderly Patients or incapacitated patients living in nursing homes may delegate decision-making authority to a specific person, or may have documents indicating that there should not be cardiopulmonary resuscitation in the event that they have an attack of acute cardiac or lung failure. However, even these instructions become useless if such a patient suffers an acute injury and a new set of instructions takes effect. This is true, for example, if the patient receives gunshot wound, which is life-threatening if not treated immediately. The responsible surgeon must treat life-threatening injuries resulting from a single incident; the conditions under which a meeting with a person with decision-making authority was required do not apply to such a situation.

The same way, psychotic patient with a life-threatening injury, life-saving assistance should be provided, even if the patient refuses surgery. Of course, the surgeon will feel more confident if the hospital lawyer assists him. Courts are reluctant to accept that the patient was in fact informed if the subject of the litigation is a standardized consent form written in formulaic language, the content of which was neither understood nor explained to the patient. Thus, in the case of a patient who had to sign an arbitration agreement before she could begin treatment in medical clinic, the court held that the patient did not consent to arbitration because the clinic's policy was only to answer the patient's questions about the agreement, and not to provide this information on its own initiative.

In a similar situations When it was standard practice for the thoracic surgeon to advise the patient that with every procedure "there is morbidity ... and there is mortality", but not to use specific facts about a particular procedure to explain these terms, the court ruled that the surgeon did not provide information to his patient , sufficient for her informed consent to the puncture of the pericardium.

Principle " implied» legal consent is applicable when delaying treatment in order to obtain formal consent could be harmful, although courts are not always unanimous in defining what constitutes a 'condition requiring emergency assistance". When it comes to a patient with acute injury who lacks the legal capacity to accept or refuse treatment because the patient is a minor, mentally incompetent, or whose best interests, in the opinion of the surgeon and the hospital, are not being served by those who have been entrusted with representing his legal rights, then a solution must be chosen, which is designed to help prolong the life of the patient. However, every conscious patient has the legal right to refuse treatment. When documenting a patient's refusal to be treated for life-threatening conditions, the surgeon must know that the patient is competent and not under the influence of mind-altering drugs or illegal substances.

The patient must be informed what are the risks of treatment compared to the risks of refusing treatment, and this should be documented. Ideally, the patient will sign a waiver form, although it is much more common for the patient to refuse to sign anything. Confirmation of this denial by the patient's friends or relatives can help if there are any legal issues later on. Thus, a patient with suspected intestinal rupture as a result of blunt trauma the abdomen may have a legal right to refuse surgery - as long as severe sepsis does not affect its ability to make informed decisions; surgery can be performed at this point, however, both the associated and legal risks will be very high. A more complex situation arises when a conscious patient refuses treatment, such as monitoring his condition with a digital monitor and then surgical intervention to eliminate active external bleeding with a knife wound in the femoral artery. Faced with a similar dilemma in the case of a fully conscious patient with active bleeding, one of the authors of this chapter turned off pressure maintenance, so that the patient went into hemorrhagic shock from rebleeding; he was immediately taken to the operating room without further resuscitation until he was completely under anesthesia.

This decision was based on assumption that the patient by this point would have changed his mind about the operation needed to save his life. All patients treated with a similar episode expressed their gratitude to the doctor after the operation. There were no legal complications. When it comes to a severely injured patient who is unable to provide fully informed consent, the trauma team should be guided by the “Golden Rule” that you should treat the patient the way you would like to be treated under the same circumstances. This principle applies to an unaccompanied minor patient, a minor patient accompanied by a guardian who persistently obstructs treatment necessary to save the patient's life, and an incapacitated or insane adult. In the case of an insane state of the patient, one must not forget that its cause may be the abuse of any substances. Prisoners also have the right to refuse surgery or any other treatment, even if their other rights have been suspended for the duration of their imprisonment.

A more difficult problem arises when a patient jeopardizes an ideal religious treatment by refusing blood or blood products. The authors of this chapter have had occasion to show their respect for such beliefs in their planned surgical operations for example, performing an anatomically correct liver resection for metastatic colon cancer with a preoperative hemoglobin of 11 g/dl in one patient and a splenectomy for idiopathic thrombocytopenic purpura with a preoperative hemoglobin of 5.5 g/dl and a platelet count of 10,000/ml in another patient. The courts have traditionally upheld the patient's right to refuse treatment, especially if the refusal is based on religious beliefs. Therefore, according to the court decision, the patient, who considers herself a Jehovah's Witness, had the right to refuse a blood transfusion.

Compliance with these religious dogmas does not apply to cases where the patient is under the influence of psychoactive substances or when the injury was the result of a suicide attempt. If an injured patient is insane but is known to belong to a religious sect that traditionally rejects blood and blood products, such a patient will be managed according to his medical needs. If the patient has a card in his wallet stating that he is prohibited from blood products, such treatment should be avoided. Although laws vary from state to state, Michigan law, for example, prohibits the use of blood products if the patient is in possession of a similar card that contains the date and is properly attested or signed with a second signature.

In September 1992, the 44th World Medical Assembly, held in the city of Marbella (Spain), adopted a special appeal to the National Medical Associations of the countries members of the World Health Organization, dedicated to the educational work of doctors with patients. It pointed out the expediency of developing various forms of activity aimed at ensuring parity between the doctor and the patient. The urgent need to create educational programs that inform the general public about the risks associated with modern methods of treatment was noted. Attention was drawn to the need to develop medical educational programs that reveal the essence of informed voluntary informed consent (IDS) and teach methods for obtaining it.

In the Fundamentals of the USSR Legislation on Health Protection, there was a rule obliging the doctor to obtain the written consent of the patient for a surgical operation and complex diagnostic procedures. Since the first half of the 1990s, Russian legislation has been harmonized with international legislation, in particular, in the implementation of the patient's key right in practice - the right to informed voluntary consent. Legal provision establishing the requirement to obtain informed voluntary consent from the patient for every medical intervention, appeared in the legislation on healthcare in Russia in 1993 (clause 7 of article 30 and article 32 of the Fundamentals). Until now, the domestic regulatory framework does not provide clarifications about what is medical intervention, and also does not formulate specific ideas about how the fact of receiving the patient's IDS should be documented. These two questions have to be answered in international law. Definition medical intervention given in 1994 in the WHO document " Principles of the Rights of Patients in Europe: A Common Framework)»: m medical intervention is any examination, treatment or other action of a preventive, diagnostic, therapeutic, rehabilitative or research nature, performed by a doctor or other medical professional in relation to a particular patient. The answer to the question of how the patient's IDS should be formalized stems from what, in its legal essence, this consent represents. And it is a two-way transaction, in the process of which one party (a medical worker), due to the requirements of Art. 30 and 32 of the Fundamentals gives the patient the necessary information about the medical intervention, and the second party (the patient) gives his consent (or disagreement) to its implementation. From the moment the patient makes a positive decision, the other party has the legal right to carry out medical intervention. What is a medical intervention from a legal standpoint? Getting an answer to this question is necessary due to the fact that the above definition of intervention has a descriptive and medical (technological) character. From a legal point of view medical intervention is a violation of the physical and (or) mental integrity of a person, which occurs as a result of interference in the structure and (or) functioning of the body (psyche), carried out by a special subject of law (medical worker) with the help of medical means. The implementation of medical intervention without the consent of a person, even if it is carried out by a medical worker, has legal signs of a violation of the inviolability of the person in the form of violence and, accordingly, falls under all protective legal norms, including those established by the Criminal Code. Due to the fact that all transactions individuals with legal entities must be carried out in writing (the requirement of Article 161 of the Civil Code), the fact that the patient has received informed voluntary consent to medical intervention must also be recorded in writing.

The legislation has established the following requirements for the procedure for obtaining an IDS:

This is a prerequisite for any medical intervention;

The consent of the patient must be recorded in writing;

It must be obtained before the onset of medical intervention;

It should be obtained after providing the patient with all the information that he needs to make an informed decision;

The will (consent) must be voluntary (that is, it cannot be obtained as a result of delusion, deceit, violence, or as a result of a combination of difficult life circumstances);

The subject giving informed voluntary consent may be a capable person over the age of 15 years. Cases concerning the receipt of IDS by persons under the age of 15, persons whose condition does not allow them to give IDS, while the situation requires medical intervention, as well as cases of incapacity of the patient are specifically stipulated in the law (Article 34 of the Fundamentals);

The provision of medical care (medical examination, hospitalization, observation and isolation) without the consent of citizens or their legal representatives is allowed in relation to persons suffering from diseases that pose a danger to others, persons suffering from severe mental disorders, or persons who have committed socially dangerous acts, on the grounds and in the manner prescribed by the legislation of the Russian Federation.

It requires clarification of the amount of information, the provision of which to the patient provides the conditions for the awareness of his decision. In accordance with article 31 of the Fundamentals, the patient must be provided with information:

About the results of the examination;

About the presence of the disease, its diagnosis and prognosis;

About methods of treatment;

About the risk of different treatments;

About possible options for medical intervention;

About their possible positive and negative consequences.

Defects in obtaining informed voluntary consent that occur in practice generally correspond to the classic defects of transactions, that is, they represent the following options:

IDS with a defect in form (the fact that the doctor received the patient's IDS was not recorded in writing);

IDS with the defect of content (the information provided to the patient about the upcoming medical intervention does not meet the requirements for informing the patient established by the current legislation);

IDS with a vice of will patient (consent was obtained as a result of incorrect information, or incorrect perception of information, or delusion, violence, deceit, threat, or forced, due to a difficult combination of life circumstances);

IDS with the vice of the subject (an incompetent patient, or the IDS was not received by the person who will carry out the medical intervention, or was not obtained from the patient, but from another person not authorized to give such consent).

Possible situations where there is a specificity of the subject giving IDS, the legislator in Article 32 of the Fundamentals specifies as follows:

“In cases where the condition of a citizen does not allow him to express his will, and medical intervention is urgent, the issue of its implementation in the interests of the citizen is decided by a council, and if it is impossible to convene a council, the attending (duty) doctor directly, followed by notification of officials of the medical institution .

Consent to medical intervention in respect of persons under the age of 15 years, and citizens recognized in the manner prescribed by law as legally incompetent, is given by their legal representatives after informing them of the information provided for in part one of Article 31 of these Fundamentals. In the absence of legal representatives, the decision on medical intervention is made by a council, and if it is impossible to convene a council - directly by the attending (duty) doctor, followed by notification of officials of the medical institution and legal representatives.

The most frequently discussed topic when discussing the problems of obtaining IDS in patients is the question of how much a patient (non-specialist) should be given medical information to obtain a full-fledged IDS from him.

Today, there are three models of informing the patient in the world, and in the last decade there has been a clear movement from the first option to the third:

“Professional” informing model – the doctor determines the amount of information provided to the patient, focusing on how his colleagues usually do it. This approach operates as widely as possible in Russia, leading to the fact that with the same medical interventions, the amount of information given to patients differs significantly, varying from ignoring this procedure to detailed and well-formed protocols for obtaining IDS.

Model of "reasonable subject". The information is given in the amount that seems sufficient for a reasonable person who needs information to make the right decision. This approach makes it possible to create fairly universal IDS protocols, especially in the context of specialized medical interventions. In Russia, this model is implemented mainly in specialized clinics.

subjective model. Means that information is given to the patient in a form understandable to a particular person, taking into account his age, intellectual level, desire to have information. It is this approach in obtaining an IDS that the legislator assumes, formulating in Art. 31 basic requirement about the accessible form of providing information. However, this option makes it difficult to record in writing the actual amount of information provided to the patient in the process of obtaining his IDS. Rare in Russia. It is difficult to verify this option, because a detailed written fixation of the received IDS is not carried out, and usually the doctor is limited to several typical phrases in the medical record. However, this model for obtaining CID in the world is considered the most civilized.

Modern ideas about the amount of information that should be provided to the patient when receiving an IDS from him are reflected in the documents of the standardization system (Order of the Ministry of Health of the Russian Federation dated August 3, 1999 N 303 "On the introduction of the Industry standard" Patient management protocols. General requirements "). In accordance with this industry standard (Section 03.02.10 “Informed consent form of the patient during the implementation of the protocol and additional information for the patient and his family members”), the IDS form for medical intervention should include information about:

etiology and pathogenesis,

diagnostic methods,

treatment methods,

rehabilitation methods,

methods of primary and secondary prevention,

prospects and results of medical intervention,

possible complications, methods and results of their correction,

impact of medical intervention on quality of life.

Informed voluntary consent of a patient to medical intervention is a rather complex medical and legal phenomenon that reflects the general processes of transition to contractual regulation of the most complex types relationships in healthcare. Obtaining and fixing IDS is of particular relevance in connection with the rapid development of technologies for medical interventions, which have both a high therapeutic and diagnostic potential and iatrogenic potential. In this regard, the volume of obligations of the service provider to the patient in the field of information support for the possibility of making a reasonable and informed decision by the consumer increases. It should be noted that the full implementation by the doctor of the procedure for obtaining the patient's IDS can give a number of beneficial effects, since it is positive for the patient and for the doctor affects:

formation of therapeutic cooperation between doctor and patient;

the frequency of anxiety-depressive disorders;

the frequency of unreasonable claims of patients to the quality medical services;

increase in medical literacy of patients;

assessment of the quality of the doctor's work by the employer and external expert services;

development of consumer and legal culture of patients and doctors in general.

At the end of this section, it is worth giving answers to 5 frequently asked questions on the problem of "doctor and patient's rights".

Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1177n "On approval of the procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention in relation to certain types of medical interventions, forms of informed voluntary consent to medical intervention and forms of refusal of medical intervention" ( with changes and additions)

Annex N 1. The procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention in relation to certain types of medical interventions when choosing a doctor and a medical organization to receive primary health care help

Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1177n
"On approval of the procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention in relation to certain types of medical interventions, forms of informed voluntary consent to medical intervention and forms of refusal of medical intervention"

With changes and additions from:

a form of informed voluntary consent to the types of medical interventions included in the List of Appendix No. 2;

a form of refusal of the type of medical intervention included in the List of certain types of medical interventions, to which citizens give informed voluntary consent when choosing a doctor and medical organization for receiving primary health care, in accordance with Appendix N 3.

Registration N 28924

In order to receive primary health care, when choosing a doctor and medical organization, citizens (their legal representatives) give informed voluntary consent to medical intervention.

Forms of consent to medical intervention and refusal from it are given.

Consent is issued at the first contact with the medical organization. Before receiving it, the patient is provided with an accessible full information about the goals and methods of providing medical care, about the risk associated with it, possible options for medical intervention, about its consequences, including the likelihood of complications. The expected results of medical care are also reported.

If a citizen refuses medical intervention, he is explained the possible consequences of such a decision, including the likelihood of developing complications of the disease (condition).

Informed voluntary consent is filed into the patient's medical documentation and is valid for the entire period of primary health care in the selected medical organization.

Citizens have the right to refuse one or more types of medical interventions or demand their termination (with the exception of certain cases: for example, this does not apply to people suffering from severe mental disorders and criminals).

Informed voluntary consent (hereinafter referred to as IDC) is an important and necessary prerequisite for medical intervention. In other words, according to the legislation, medical intervention cannot be carried out without first obtaining an IDS. This requirement is mandatory for execution by both state, municipal and private medical organizations. Meanwhile, in practice this requirement is not always observed, and if it is observed, then formally with significant violations.

Below we consider the main features of the design of the IDS.

The need for IDS is dictated by the requirements of the Constitution of the Russian Federation and the Federal Law “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation” No. 323-FZ of November 21, 2011.

IDS is directly related to the constitutional right of everyone (Article 41 of the Constitution of the Russian Federation; Part 2 of Article 18, Part 5 of Article 19, Part 1 of Article 22 of Law No. 323-FZ of November 21, 2011):

for the protection of life and health;

to information about facts posing a threat to life and health;

to provide quality medical care;

to information about the state of health, including the methods of providing medical care, the risks associated with them, possible types of medical intervention, its consequences and the results of the provision of medical care;

to refuse medical intervention.

Parts 9-11 of Law No. 323-FZ dated November 21, 2011 list cases where medical intervention can be performed without the consent of a citizen, one of the parents or other legal representative. The law also provides the right to refuse medical intervention at any subsequent stage. However, the subject of this material will be the specifics of obtaining consent.

The IDS is drawn up by the employees of the medical organization in writing in the form of a separate document. This document is filed into the patient's medical records and stored in it.

Currently, the Ministry of Health of the Russian Federation has developed forms of IDS for individual cases of medical intervention.

For example

for cases of preventive vaccinations for children (Appendix to the Order of the Ministry of Health and Social Development No. 19n dated January 26, 2009);

for cases of applying for primary health care when choosing a doctor and medical organization (Appendix No. 2 to the Order of the Ministry of Health of the Russian Federation of December 20, 2012 No. 1177n);

for cases of the use of assisted reproductive technologies (Appendix to the Order of the Ministry of Health of the Russian Federation No. 107n dated August 30, 2012);

for cases of medical care within the framework of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation (Appendix No. 2 to the Order of the Ministry of Health of the Russian Federation No. 474n dated July 21, 2015);

for cases of artificial termination of pregnancy at the request of a woman (Appendix to the Order of the Ministry of Health of Russia No. 216n of 04/07/2016).

The forms developed by the Ministry of Health of the Russian Federation are mandatory for use.

However, they are not universal. The legislation does not prohibit the use of IDS forms prepared by a medical organization independently. This document can be developed for any special cases of medical intervention, taking into account the specifics of the activity, the workflow of a particular medical organization, as well as the interests medical worker and the patient. In particular, the additionally prepared forms will ensure that the patient's right to complete and reliable information about the methods of providing medical care, the risks associated with them, the consequences and results of providing medical care in a particular case is respected. The number of IDS is not limited by law. The forms developed by the Ministry of Health of the Russian Federation can be taken as a basis.

In paragraph 6 of Art. 20 Law No. 323-FZ dated November 21, 2011 strictly prescribes giving CID for the types of medical interventions included in the list approved by Order of the Ministry of Health and Social Development of the Russian Federation No. 390 dated April 23, 2012, when receiving primary health care when choosing a doctor and medical organizations. The law also says that the IDS is given in the form approved by the Order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1177n. However, this requirement applies only to cases of implementation of the program of state guarantees.

As for the content of the IDS, as indicated above, it is drawn up in relation to medical intervention, that is various kinds medical examinations and (or) medical manipulations in relation to the patient, which:

are carried out by a medical worker and other worker who has the right to carry out medical activities;

affect the physical or mental condition person;

have a preventive, research, diagnostic, therapeutic, rehabilitation orientation;

aimed at artificial termination of pregnancy (part 5 of article 2 of Law No. 323-FZ of November 21, 2011).

According to the requirements of the legislation of the Russian Federation, the content of this document must always be complete and reliable information:

about the purposes of medical care;

on the methods of providing medical care;

about the risk associated with the methods of providing medical care;

about possible options for medical intervention;

about possible consequences medical intervention;

about the expected results of medical care.

According to the form of presentation, the information in the IDS should be simple, accessible and understandable to a person who does not have special medical knowledge.

In a separate line in the IDS, it is necessary to inform the patient about his right to refuse medical intervention, the right to terminate it at any stage. The document should contain information about the possible consequences of such actions.

In addition, it is necessary to explicitly indicate in the IDS that the consent is given by the patient voluntarily without coercion, the form of presentation of information is accessible, and the volume of information is complete and sufficient for making a positive decision.

An important requisite of this document is the date.

In the IDS, taking into account the specifics of medical intervention, other important provisions may be included in the interests of the patient, medical worker and medical organization.

IDS signing.

The legislation establishes the possibility of signing an IDS:

by the citizen in respect of whom medical intervention is being carried out;

one of the parents or other legal representative of the citizen in respect of whom the medical intervention is being carried out.

In most cases, the signature on the IDS is affixed by the citizen himself, in respect of whom the medical intervention is being carried out.

One of the parents or another legal representative signs the document in exceptional cases established by law (part 2 of article 20, article 47 of the LAW No. 323-FZ of November 21, 2011):

in relation to a person under the age of 15 years or a person recognized as incapacitated in accordance with the procedure established by law, if such a person, due to his condition, is not able to give consent to medical intervention;

in relation to a person under the age of 18, in case of transplantation (transplantation) of organs and tissues;

in relation to a minor drug addict when providing him with drug treatment or during a medical examination of a minor in order to establish the state of narcotic or other toxic intoxication (with the exception of cases established by law).

The signature of the healthcare worker is always affixed next to the signature of the patient or his parent/legal guardian.

Responsibility for the absence of IDS.

The presence of an IDS in a medical organization is a licensing requirement that must be observed.

The absence of this document, as well as shortcomings in its execution, are assessed by law enforcement agencies as an administrative offense and apply liability under Parts 3, 4 of Art. 14.1 of the Code of Administrative Offenses of the Russian Federation.

Below are examples of the law enforcement practice of arbitration courts.

Resolution of the Fourth Arbitration Court of Appeal dated November 19, 2012 in case N A58-2579 / 2012.

“From the extract it follows that 02/22/2012 - 02/23/2012 gr. Kosmach V.D. provided medical (dental) care. Evidence of obtaining the informed voluntary consent of the said patient was not presented in the case file.

The presented extract, the outpatient card does not contain an indication that Kosmach V.D. gave informed voluntary consent to medical intervention.

By virtue of the above, the court of first instance came to the conclusion that these actions were reasonably qualified by the administrative body as a violation of the rules for the provision of paid medical services, which form the objective side of an administrative offense under part 3 of article 14.1 of the Code of Administrative Offenses of the Russian Federation.

Decree of the Federal Antimonopoly Service of the Volga District dated March 3, 2016 No. Ф06-6352/2016:

“In the course of the audit, facts of violation by the company of licensing requirements and conditions in the implementation of medical activities were established:

... in violation of Article 20 of the Federal Law of November 21, 2011 No. 323-FZ "On the Basics of Protecting the Health of Citizens in the Russian Federation" - in the medical record of an outpatient N 587, individual cards pregnant women No. 24, 26, 2, 21, 20 - there is no informed voluntary consent of a citizen or his legal representative for medical intervention ...

The Arbitration Court of the Astrakhan Region, having examined the evidence presented by the administrative body in accordance with Article 71 of the Arbitration Procedure Code of the Russian Federation, brought the company to administrative responsibility under Part 4 of Article 14.1 of the Code of Administrative Offenses of the Russian Federation.

Decree of the Federal Antimonopoly Service of the Urals District dated October 29, 2015 No. F09-7712 / 15:

"…in medical records of a dental patient, there are no informed voluntary consents for dental treatment ... (Shevkoplyas T.V., Ermalova A.A.) ...

The violations listed above are among the gross violations of licensing requirements, the fact of their commission is documented and is not disputed by the company. In this regard, the courts correctly established the presence in the actions of the company of an event of an administrative offense under Part 4 of Art. 14.1 of the Code".

Resolution of the Thirteenth Arbitration Court of Appeal dated October 2, 2015 in case No. А56-31485/2015:

“Based on the results of the identified violations ... a protocol on an administrative offense was drawn up ... under part 3 of Article 14.1 of the Code of Administrative Offenses of the Russian Federation. A protocol on an administrative offense ... in the course of medical activities, the Company was charged with gross violations of the licensing requirements stipulated by the license, the Regulations on the licensing of medical activities, approved by the Decree of the Government of the Russian Federation dated 16.04.2012 No. 291 (hereinafter referred to as the Regulation), namely:

the submitted informed voluntary consent dated 08.23.2012 does not contain data: from which citizen it was received (the surname, name, patronymic of the citizen are missing), which is a violation of paragraph 28 of the Rules for the provision of paid medical services by medical organizations, approved by the Decree of the Government of the Russian Federation of 04.10.2012 No. 1006".

Decree of the Federal Antimonopoly Service of the Far Eastern District of January 20, 2016 No. Ф03-6005/2015:

“In the course of the audit, the administrative body established that the hematologist performed medical manipulations on the patient without his consent, which gave rise to the initiation of an administrative offense case on the grounds of Part 4 of Article 14.1 of the Code of Administrative Offenses of the Russian Federation. that the medical intervention in relation to the patient was performed according to emergency indications by decision of a council of doctors, that is, it is a case of permissible medical intervention without the consent of the patient in accordance with parts 9 and 10 of Article 20 of the Law on Fundamentals of Health Protection. No evidence to the contrary has been presented by the administrative authority.”

Similar conclusions were made by the Eleventh Arbitration Court of Appeal in its ruling dated January 15, 2015 in case No. А55-20037/2014.