Law on the introduction of telemedicine. Federal Law "On Amendments to Certain Legislative Acts of the Russian Federation on the Application of Information Technologies in the Sphere of Health" - Rossiyskaya Gazeta. President of the Russian Federation

On the territory Russian Federation Starting from January 1, 2018, changes are in effect providing for the introduction of telemedicine in the field of health care. They do not cancel the right and necessity of citizens for face-to-face consultations, but they make it possible to increase the availability and efficiency of medical care and relieve clinics of queues through the use of telemedicine technologies.

The concept of “telemedicine” implies a complex of any services in the field of healthcare based on the use of digital and communication technologies for remote consultations or provision of medical care.

In Russia there has long been an opportunity electronic recording see a doctor, and there are also online services with medical consultations from specialists, but until 2018 their activities were considered “informational”, and they did not have the legislative right to choose treatment tactics, write prescriptions, etc. But in July 2017, changes were approved to the Federal Law “On the Fundamentals of Protecting the Health of Citizens,” which introduce the concept of telemedicine technologies and their use in the country legally.

Note! According to a study by the NAFI Analytical Center, 61% of Russian residents are ready to use telemedicine. At the same time, the most popular services include issuing certificates (44%), the possibility of emergency consultations (39%), issuing prescriptions (38%) and conducting scheduled consultations (22%).

  • Regulation of telecommunication contacts between patients, doctors and healthcare institutions with compliance with the requirements of confidentiality of personal information and medical confidentiality.
  • Formation of a communication network through the implementation of the Unified State Information System in the field of healthcare (Uniform State Health Information System). The Ministry of Health has been working on the development of the latter for more than 5 years, so that as a result it will connect into a single network all regional departments of clinics and hospitals with federal specialized centers to be able to receive consultations 24 hours a day and 7 days a week.
  • Transition to an electronic form of medical document flow, including the issuance of prescriptions in electronic form, and the development of telemedicine services for the interaction of doctors, which will be introduced in 2019.

But in at the moment There are no by-laws that should regulate the implementation of the law on telemedicine. So far, the Ministry of Health has developed and put forward for public discussion the Draft Order “On the procedure for providing medical care using telemedicine technologies,” which reflects the rules for filling out electronic documentation, identifying and authenticating patients and health workers, etc.

New opportunities for doctors and patients

According to Art. 36.2 doctors can conduct remote consultations for patients/their legal representatives in order to:

  • recommend preventive measures;
  • collect and analyze patient complaints;
  • monitor health status;
  • evaluate the effectiveness or adjust the prescribed treatment;
  • determine the need for an in-person consultation.

Important! Establishing a diagnosis and prescribing initial treatment recommendations is permitted only during a face-to-face consultation.

Thus, after an initial in-person appointment, patients may not come for repeat appointments, and doctors will use remote consultations to monitor the effectiveness of treatment and adjust prescriptions, which is primarily important for citizens with chronic diseases.

To be able to work remotely, you will need to undergo special registration:

  • for medical institutions - in the Federal Register of Medical Organizations of the Unified State Health Information System;
  • for doctors - in the Federal Register of Medical Workers of the Unified State Health Information System.

The adopted changes in the use of telemedicine technologies open up a number of other opportunities for patients and doctors:

  • Doctors can obtain, and patients/their legal representatives can give, informed voluntary consent/refusal to conduct surgical intervention (Article 20, Part 7).
  • Patients or their legal representatives can send requests to medical institutions to receive electronic form medical documents or their copies (certificates, examination results, extracts from the medical history, etc.) (Article 22 Part 5).
  • Doctors are given the opportunity to issue and patients are able to receive prescriptions for medicines in electronic form (Article 78).

Important! New order issuing electronic prescriptions also applies to drugs with narcotic and potent psychotropic effects, but it will only work from January 1, 2019.

  • Doctors can remotely organize consultations with colleagues, using research results and other documents received by email (Article 2, paragraph 22).

Despite the fact that the law on telemedicine came into force on January 1, 2018, it is too early to talk about the full functioning of all innovations. Such a major reform of the healthcare industry requires time, first of all, to establish connections between hospitals, individual specialists and patients. In this regard, during 2018, the Ministry of Health still has to do a considerable amount of work to regulate the operation of telemedicine systems and make their services accessible and around the clock for every resident of Russia.

Video about the telemedicine project for Russians:

From 2018, doctors will be allowed to consult patients via Skype or Viber, – this and much more is provided for by the entered telemedicine. We propose to understand what is included in this concept, what are the advantages and disadvantages of the innovation.

New rules of dialogue

From the beginning of 2018, key adjustments made to the law “On the fundamentals of protecting the health of citizens in Russia” will come into force. The main breakthrough of the law on telemedicine 2017 ( Federal Law-242 dated July 29, 2017) became an opportunity remote consulting, in which the patient will be able to receive explanations from a specialist not only by phone, but by Skype, Viber, WhatsApp and other available messengers.

It is important to understand that it will be possible to communicate at a distance only if the main condition is met - the diagnosis and treatment were carried out in person.

Remotely you can:

    view and discuss the survey results;

    get a prescription for monthly medications for a chronic illness;

    make complaints about your health;

    adjust the treatment regimen.

The foundation for innovation was the Unified Health Information System, which the Ministry of Health has been developing for 5 years. In the future, the online system will connect all medical institutions throughout the country - hospitals, clinics, paramedic stations, and administrative buildings. True, to launch it, you need to bring the Internet to the most remote corners of the country. But in the end general system will cover all areas of medical care: from making appointments and online consultations to receiving prescriptions and access to the patient’s electronic card (medical history).

Note! 4.5 thousand have already been connected to the telecommunication medicine project medical institutions throughout the country, including the largest federal clinics. Only two regions remain out of access - Altai and Chukotka.

Patient comfort

Today, only those patients who are independently insured can receive a consultation via Skype, and provided that insurance company aims to organize such a format of communication.

According to the authors, the law on telemedicine will make medical care more accessible and more comfortable, primarily for people with chronic pathologies, the disabled and those who find it difficult to leave home. They are the ones who have to make an appointment every month (it’s good if this can be done by phone), get to the clinic and often wait in a general queue to receive the same prescription for subsidized medications. Each prescription received online will contain an enhanced digital signature of the doctor, because it is now allowed to prescribe strong narcotic and psychotropic medications remotely.

Important! There are no plans to give up paper prescriptions yet: if it is more convenient for someone to receive a piece of paper the old fashioned way, please do so. People will not be forced to become active Internet users.

The new format is also convenient for patients undergoing surgery away from home. Upon their return, they were deprived of the opportunity to contact the surgeon and the attending physician, because even telephone conversation The specialist does not always have time - either a round or a planned operation. The Ministry of Health plans to develop special mobile applications and introduce separate forms on hospital websites through which people can receive a video consultation with their doctor.

Transcripts of tests and diagnostics, including magnetic resonance imaging and electrocardiography, are now allowed to be sent to the patient’s email, which means there is no need to travel to the regional center from a remote village again to find out the results.

Note! It will also be possible to give consent for a child’s surgery electronically.

Upon request, clinics will begin to send various documents to patients’ emails: extracts from the medical history, certificates, etc.

The progressive Telemedicine Act of 2017, if news reports are anything to go by, does not make online practice limitless and unregulated. The law clearly states that a person can only receive recommendations from a specific doctor - the local doctor, or the one who made the diagnosis, the operator or the treating specialist - those who previously met with the patient in person and prescribed treatment. This means that the ban on dubious online hospitals with strange doctors who, in fact, are not responsible for recommendations, remains in force.

Conversation with colleagues online and more

Telemedicine, the bill of which was actively discussed in recent months and was finally adopted in 2017, will make it more convenient for doctors to communicate with each other. If necessary, they will be able to organize a teleconference or contact via Skype with colleagues to discuss a complex case or ask for recommendations from more qualified specialists to clarify the diagnosis. Previously, doctors from the outback were largely deprived of such an opportunity - it is difficult to maintain contacts with colleagues from the capital over a long distance.

Note! It is planned to equip all clinics with equipment for conducting online consultations by the end of 2018.

Doctors are also allowed to:

    provide advice on prevention issues;

    receive and analyze the patient’s complaints about health status;

    evaluate the effectiveness of the treatment and make adjustments if necessary (change the dosage or regimen of medications);

    make appointments for examination and consultation.

About problems and shortcomings

Like any innovation, telemedicine in Russia raises many questions, and the main one is how to protect personal data: addresses, diagnoses, passport data. Supporters of the reform insist: paper document flow does not prevent leaks; on the contrary, it is easier to obtain data about any patient on paper if desired.

Opponents claim that high-quality treatment is impossible without a personal meeting, because through the monitor it is easy to “miss important details.” Their opponents remind: is it possible that during a face-to-face conversation the doctor gets all the information? necessary information? Aren't there misdiagnosis and carelessness on the part of medical staff now?

It is still unclear how communication between a doctor and a patient will be structured in reality, since it is impossible for a doctor to consult everyone 24 hours a day. Will this be an online appointment? Or will the doctor be able to independently prescribe access to the network for the patient?

Today it is already clear that a law on telemedicine has been adopted in Russia. It will only start working in 2018, but district clinics have already started an “educational moment” - making appointments through the registry is cancelled. Thus, in the Moscow region, it will no longer be possible to habitually stand in line at the window from September 1. As an alternative to the usual method, they suggest registering through government services, on hospital websites or through electronic registrars - special machines installed in all medical institutions.

Note! The Ministry of Health expects that the large-scale “Lean Clinic” project, implemented as part of the global reform, will reduce the time of making an appointment by 5 times, and the wait at a specialist’s office by 12.

The implementation of a large-scale healthcare reform will last until 2023. What of the plans will work out and what will not, we will see with our own eyes.

On January 1, 2018, the Federal Law on Telemedicine dated July 29, 2017 No. 242-FZ “On Amendments to Certain Legislative Acts of the Russian Federation on the Application of information technology in the field of healthcare." Simply put, what has been talked about for several years happened: the legislator tried to regulate the legal aspects of remote medical care within the framework of remote monitoring of the patient and his remote consultation. Let’s find out what has changed now.

Based on changed standards Federal Law dated November 21, 2011 No. 323 Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” The Ministry of Health issued Order No. 965n dated November 30, 2017 “On approval of the procedure for organizing and providing medical care using telemedicine technologies”, regulating the procedure for providing “ telemedicine assistance."

This Procedure involves conducting remote consultations and remote monitoring of the patient.

What fundamentally new things did the law on telemedicine introduce into the process of providing assistance?

According to the law on telemedicine, it is now possible to conduct a remote consultation (consilium) if such a need arises. Hasn't this happened before? Of course it was. However, if previously a doctor called (or otherwise contacted) his colleague, received a consultation, and then wrote in the medical history “the case was consulted by telephone with...”, now this is no longer necessary. And the consultant, if something happens, will not be able to refuse his words. Of course, it is convenient to ask a question to a specialist from another region, head institution or research center and receive an official answer.

In order to take part in a consultation via telemedicine, an institution, in accordance with the law on telemedicine, does not require a special license. A medical organization may conduct such consultations on types of care for which the organization has a valid license. The clinic must have appropriately equipped premises for such consultations.

However, not everything is so simple . The main condition is registration of the organization in the Federal Register of Medical Organizations Unified state information system in the field of healthcare - Uniform State Health Information System. It should also be noted that consultations can be provided (and requested, accordingly) only by workers included in the Federal Register of Medical Workers.

We can only hope that the Ministry of Health will consider this appeal and clarify the controversial aspects of the Procedure.

Telemedicine Law, allowing doctors to conduct consultations with patients via the Internet, will significantly reduce the burden on the budget of public hospitals and clinics, so its importance in the current crisis can hardly be overestimated. Thanks to video communication technologies, a doctor will be able to make an official diagnosis of a patient without leaving the medical facility, even if he is on the other side of Russia. The law is currently only in the drafting stage, but it has already attracted a lot of attention. And although similar projects had been considered before, there was no need for them at that time.

What foreshadowed innovations in legislation

In light of recent layoffs in health care workers, the Ministry of Health has begun to develop effective methods of managing human and technical resources, thanks to which, with a smaller budget, it will be possible to carry out the same amount of work and maintain the necessary efficiency of health care. By adopting the law on telemedicine in 2017, the Ministry of Health will relieve both doctors and patients, allowing everyone to save time and effort.

In addition, remote consultations will significantly reduce gasoline costs for minor and false calls; after all, an ambulance is a rather heavy vehicle, especially when it is equipped with medical equipment (life support systems can weigh more than a hundredweight).

But of course, telemedicine technologies will not replace an in-person examination, because a doctor cannot get a complete picture of the disease through a monitor. He is forced to refer only to the patient's words, which is very ineffective, since people are often confused in their own feelings. Therefore, the bill does not prohibit home visits, but only allows for remote consultations when possible. If the doctor decides to visit your home, it will be carried out immediately.

Legal side of the issue

From a legal point of view, the bill does not violate the constitutional rights of citizens and, on the contrary, even gives more freedoms. For example, it facilitates the “debriefing” procedure if the doctor makes a mistake - since the patient’s admission process is recorded on video and sent to a special data archive called the history of remote consultations. Using this recording, you can always determine who is guilty of an erroneous diagnosis - the doctor or the patient himself, who incorrectly interpreted his feelings.

The bill defines the concept of telemedicine as a set of measures and services aimed at remote interaction between employees of medical institutions and citizens. Confidentiality of appointments is ensured in accordance with the law on medical practice, and only representatives of authorized bodies, which have not yet been legally defined, will have access to this information.

What opportunities does telemedicine offer?

Mostly new law aimed at:

  • Possibility of receiving a remote initial consultation with a doctor and making a diagnosis, if possible;
  • Conducting online consultations, including with foreign experts;
  • Exchange of data between doctors of various specialties and other health workers.

Already today, innovation makes it possible to save a significant part of the budget, but the further development of telemedicine will expand the range of medical services provided, starting from volumetric examination and reproduction of odors, which will become possible in the near future, and ending with online surgical operations using manipulators in two - three decades.

Article 1

Introduce into Article 26 of the Federal Law of January 8, 1998 N 3-FZ “On Narcotic Drugs and Psychotropic Substances” (Collected Legislation of the Russian Federation, 1998, N 2, Art. 219; 2003, N 27, Art. 2700; 2011, N 49, art. 7019; 2013, no. 6165; 2016, no. 4238)

1) paragraph 1 should be stated as follows:

"1. Prescriptions containing the prescription of narcotic drugs or psychotropic substances are drawn up on special forms on paper and (or) formed with the consent of the patient or his legal representative in the form of electronic documents signed using enhanced qualified electronic signature the attending physician or paramedic, the midwife who is entrusted with the functions of the attending physician, and the relevant medical organization.";

2) paragraph 2 after the words “format rules” should be supplemented with the words “including in the form of electronic documents.”

Article 2

Amend Federal Law No. 61-FZ of April 12, 2010 “On Appeal medicines"(Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815; 2011, N 50, Art. 7351; 2012, N 26, Art. 3446; 2013, N 48, Art. 6165; 2014, N 52, Art. 7540; 2015, No. 29, Art. 4367) the following changes:

1) paragraph 53 of Article 4 shall be stated as follows:

"53) prescription for a medicinal product - a medical document of the established form containing the prescription of a medicinal product for medical use, issued by a medical professional for the purpose of dispensing the medicinal product or its manufacture and dispensing on paper or with the consent of the patient or his legal representative in the form of an electronic document, signed using an enhanced qualified electronic signature medical worker, or a document in the established form containing the prescription of a medicinal product for veterinary use, issued by a veterinarian for the purpose of dispensing the medicinal product or its manufacture and distribution on paper;";

2) Article 6 shall be supplemented with paragraph 4 as follows:

"4) making a decision on the use on the territory of a constituent entity of the Russian Federation, along with prescriptions for medicinal products issued on paper, prescriptions for medicinal products generated in the form of electronic documents."

Article 3

Introduce into the Federal Law of November 21, 2011 N 323-F3 “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, Art. 3446; 2013, N 27, art. 3483; art. 6165, no. 4257; Art. 85; Art. 27; Art. 4397; Art. 9, 28; N 27, Art. 4219; 2017, N 18, Art. 2663) the following changes:

1) Article 2 shall be supplemented with paragraph 22 as follows:

"22) telemedicine technologies - information technologies that ensure remote interaction of medical workers among themselves, with patients and (or) their legal representatives, identification and authentication of these persons, documentation of actions they perform during consultations, consultations, remote medical monitoring of the patient’s health status ";

2) Article 10 shall be supplemented with paragraph 10 as follows:

"10) the use of telemedicine technologies.";

3) in part 2 of article 14:

a) in paragraph 11, replace the words “electronic form” with the words “form of electronic documents, procedures for maintaining them”;

b) in paragraph 16, delete the words “and writing out”;

4) Part 7 of Article 20 should be stated as follows:

"7. Informed voluntary consent to medical intervention or refusal of medical intervention is contained in the citizen’s medical documentation and is drawn up in the form of a paper document signed by the citizen, one of the parents or another legal representative, a medical professional, or is formed in the form of an electronic document signed a citizen, one of the parents or another legal representative using an enhanced qualified electronic signature or a simple electronic signature through the use of a unified identification and authentication system, as well as a medical professional using an enhanced qualified electronic signature. Informed voluntary consent to medical intervention or refusal of medical intervention by one. from the parents or other legal representative of the person specified in part 2 of this article, can be formed in the form of an electronic document if there is information about his legal representative in the patient’s medical documentation.”;

5) Part 5 of Article 22 should be stated as follows:

"5. The patient or his legal representative has the right, upon request, including in electronic form, to receive medical documents (copies thereof) reflecting the patient’s health status and extracts from them, including in the form of electronic documents. The procedure and timing for the provision of medical documents (their copies) and extracts from them are established by the authorized federal executive body.";

6) Part 8 of Article 34 should be stated as follows:

"8. The organization of the provision of high-tech medical care is carried out using a unified state information system in the field of healthcare in the manner established by the authorized federal executive body.";

7) add Article 36 2 with the following content:

"Article 36 2. Features of medical care provided using telemedicine technologies

1. Medical care using telemedicine technologies is organized and provided in the manner established by the authorized federal executive body, as well as in accordance with the procedures for providing medical care and on the basis of standards of medical care.

2. Consultations of a patient or his legal representative by a medical professional using telemedicine technologies are carried out for the purposes of:

1) prevention, collection, analysis of patient complaints and anamnesis data, assessment of the effectiveness of therapeutic and diagnostic measures, medical monitoring of the patient’s health status;

2) making a decision on the need for an in-person appointment (examination, consultation).

3. When conducting consultations using telemedicine technologies, the attending physician may correct previously prescribed treatment, provided that he establishes a diagnosis and prescribes treatment during a face-to-face appointment (examination, consultation).

4. Remote monitoring of the patient’s health status is prescribed by the attending physician after an in-person appointment (examination, consultation). Remote monitoring is carried out on the basis of patient data registered with the use of medical devices intended for monitoring the condition of the human body, and (or) on the basis of data entered into the unified state information system in the field of health care, or a state information system in the field of health care of a constituent entity of the Russian Federation, or a medical information system, or information systems specified in Part 5 of Article 91 of this Federal Law.

5. The use of telemedicine technologies in the provision of medical care is carried out in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data and in compliance with medical confidentiality.

6. In order to identify and authenticate participants in remote interaction when providing medical care using telemedicine technologies, a unified identification and authentication system is used.

7. Documentation of information on the provision of medical care to a patient using telemedicine technologies, including entering information into his medical documentation, is carried out using an enhanced qualified electronic signature of a medical worker.";

8) paragraph one of part 4 of Article 37 after the words “The standard of medical care is being developed” should be supplemented with the words “in the manner established by the authorized federal executive body”;

9) paragraph 4 of part 2 of article 73 shall be stated as follows:

"4) prescribe medications in the manner established by the authorized federal executive body;";

10) in paragraph 6 of part 1 of Article 74, the word “prescribe” shall be replaced with the words “issue prescriptions for”;

11) in article 78:

a) paragraph 3 should be stated as follows:

"3) issue medical reports, certificates, prescriptions for drugs and medical devices on paper and (or) with the consent of the patient or his legal representative in the form of electronic documents using an enhanced qualified electronic signature of a medical worker in the manner established by the authorized federal executive body authorities;";

b) paragraph 5 should be stated as follows:

"5) create medical information systems containing data about patients, about the medical care provided to them, about medical activities medical organizations in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data and compliance with medical confidentiality.";

12) Article 91 should be stated as follows:

"Article 91. Information support in the field of healthcare

1. Information support in the field of health care is carried out through the creation, development and operation of federal state information systems in the field of health care, information systems in the field of health care of the Federal Compulsory Medical Insurance Fund and territorial funds of compulsory health insurance, state information systems in the field of health care of the constituent entities of the Russian Federation, medical information systems of medical organizations, information systems of pharmaceutical organizations (hereinafter referred to as information systems in the field of healthcare).

2. Information systems in the field of health care collect, store, process and provide information about bodies, organizations of state, municipal and private health care systems and about the implementation of medical and other activities in the field of health care. The processing of personal data in information systems in the field of healthcare is carried out in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data and in compliance with medical confidentiality.

3. Operators of information systems in the field of healthcare are the authorized federal executive body, other federal authorities executive authorities in the field of health protection and their territorial bodies, executive authorities of the constituent entity of the Russian Federation authorized by the highest executive body state power of a constituent entity of the Russian Federation for the creation, development and operation of a state information system in the field of healthcare of a constituent entity of the Russian Federation (hereinafter referred to as the authorized executive authorities of a constituent entity of the Russian Federation), organizations appointed by these bodies, governing bodies of the Federal Compulsory Medical Insurance Fund and territorial compulsory medical insurance funds in part concerning personalized accounting in the compulsory health insurance system, medical organizations and pharmaceutical organizations.

4. Requirements for state information systems in the field of healthcare of the constituent entities of the Russian Federation, medical information systems of medical organizations and information systems of pharmaceutical organizations are established by the authorized federal executive body.

5. Other information systems designed for collecting, storing, processing and providing information relating to the activities of medical organizations and the services they provide (hereinafter referred to as other information systems) can interact with information systems in the field of healthcare and medical organizations in the manner, on the terms and conditions in accordance with the requirements established by the Government of the Russian Federation.

6. Other information systems are connected to a single state system in the field of healthcare by the authorized federal executive body and to a unified system of identification and authentication by the federal executive body of state power, which carries out the functions of developing and implementing public policy and legal regulation in the field of information technology.";

13) add Article 91 1 with the following content:

"Article 91 1. Unified state information system in the field of healthcare

1. In order to ensure citizens’ access to healthcare services in electronic form, as well as the interaction of information systems in the healthcare sector, the authorized federal executive body creates, develops and operates a unified state information system in the healthcare sector (hereinafter referred to as the unified system).

2. The regulations on the unified system, including the procedure for accessing information contained in it, the procedure and timing for submitting information to the unified system, the procedure for exchanging information using the unified system, are approved by the Government of the Russian Federation.

3. The unified system includes:

1) information contained in federal information systems in the field of healthcare, federal databases and federal registers in the field of healthcare, maintained by the authorized federal executive body using a unified system;

2) information about medical organizations, with the exception of medical organizations subordinate to federal executive authorities, in which federal laws provide for military service or equivalent service;

3) information on persons who participate in medical activities specified in Article 93 of this Federal Law;

4) specified in Article 94 of this Federal Law and anonymized in the manner established by the authorized federal executive body in agreement with the federal executive body exercising the functions of control and supervision in the field of funds mass media, information about persons who receive medical care, as well as about persons in respect of whom medical examinations, medical examinations and medical examinations are carried out;

5) information about medical documentation, the composition of which makes it impossible to determine the state of health of a citizen, and information about the medical organization in which the medical documentation is created and stored;

6) information from statistical observation in the field of healthcare, as well as summary analytical information on the implementation of medical activities and the provision of medical care;

7) information on the organization of the provision of high-tech medical care;

8) information necessary for monitoring and control in the field of procurement of medicines to meet state and municipal needs;

9) information on the organization of providing citizens with medicines for medical use, medical products (medical products) and specialized medical nutrition products in accordance with Article 6 2 of the Federal Law of July 17, 1999 N 178-FZ "On State social assistance", clauses 19 and 20 of part 1 of article 14, article 44 and clause 5 of part 2 of article 81 of this Federal Law;

10) classifiers, reference books and other regulatory and reference information in the field of healthcare, the list, procedure for maintaining and using which are determined by the authorized federal executive body.

4. The unified system ensures the maintenance of federal registers provided for in Part 2 1 of Article 43, Parts 4, 8 of Article 44 of this Federal Law, Article 24 1 of the Law of the Russian Federation of May 15, 1991 N 1244-I “On the social protection of citizens exposed to radiation due to the disaster at the Chernobyl nuclear power plant."

5. The unified system ensures the possibility of providing citizens with healthcare services in electronic form through a single portal of state and municipal services, the list of which is approved by the Government of the Russian Federation.

6. Suppliers of information to the unified system are:

1) authorized federal executive body;

2) federal executive authorities in the field of health protection and other federal executive authorities in accordance with the powers established by the legislation of the Russian Federation;

3) Federal Compulsory Medical Insurance Fund and territorial compulsory medical insurance funds, Pension fund Russian Federation, Social Insurance Fund of the Russian Federation;

4) authorized executive authorities of the constituent entity of the Russian Federation;

5) organs local government exercising powers in the field of health protection;

6) medical organizations and pharmaceutical organizations;

7) organizations that are operators of other information systems specified in Part 5 of Article 91 of this Federal Law.

7. Users of information contained in the unified system are the bodies and organizations specified in Part 6 of this article, as well as citizens.

8. Access to information contained in the unified system is provided to suppliers of information to the unified system, as well as to bodies and organizations that are users of the unified system, in accordance with their competence established by federal laws and regulations adopted in accordance with them legal acts President of the Russian Federation and the Government of the Russian Federation.";

14) in Article 92:

a) part 1 should be stated as follows:

"1. When carrying out medical activities, records are kept of the personal data of persons participating in the implementation of medical activities, persons who are provided with medical care, as well as persons in respect of whom medical examinations, medical examinations and medical examinations are carried out (hereinafter referred to as personalized records)." ;

b) in Part 2, the words “information system operators specified in Part 2 of Article 91” shall be replaced with the words “information system operators in the field of healthcare specified in Part 3 of Article 91”;

c) part 4 should be stated as follows:

"4. When maintaining personalized records, the confidentiality of personal data of persons who participate in the implementation of medical activities, persons who are provided with medical care, as well as persons in respect of whom medical examinations, medical examinations and medical examinations are carried out, and the security of these personal data in compliance with the requirements established by the legislation of the Russian Federation in the field of personal data.";

15) in article 93:

a) in the title, replace the words “in the provision of medical services” with the words “in the implementation of medical activities”;

b) in paragraph one, replace the words “in the provision of medical services” with the words “in the implementation of medical activities”;

c) paragraph 11 should be stated as follows:

"11) information about education, including information about organizations carrying out educational activities on the implementation of professional educational programs of medical education, on documents on education and (or) qualifications, on an agreement on targeted training, as well as information on a specialist’s certificate or accreditation of a specialist;";

d) in paragraph 12, replace the words “providing medical services” with the words “carrying out medical activities”;

e) in paragraph 13, replace the words “providing medical services” with the words “carrying out medical activities”;

f) add paragraph 14 with the following content:

"14) information about membership in medical professional non-profit organizations specified in Article 76 of this Federal Law (if any).";

16) in article 94:

a) the name should be stated as follows:

"Article 94. Information about persons who are provided with medical care, as well as about persons in respect of whom medical examinations, medical examinations and medical examinations are carried out";

b) in paragraph one, replace the words “medical services are provided” with the words “medical care is provided, as well as about persons in respect of whom medical examinations, medical examinations and medical examinations are carried out”;

c) in paragraph 14, replace the words “providing medical services” with the words “carrying out medical activities”;

d) paragraph 18 should be stated as follows:

"18) the volume of medical care provided, including information about the medical services provided;";

e) paragraph 21 should be stated as follows:

"21) information on medical examinations, medical examinations and medical examinations carried out and their results;";

f) in paragraph 23, the words “medical service” should be replaced with the words “medical care, medical examinations, medical examinations and medical examinations”.

Article 4

2. The provisions of Article 26 of the Federal Law of January 8, 1998 N 3-FZ "On Narcotic Drugs and Psychotropic Substances" (as amended by this Federal Law), Articles 4 and 6 of the Federal Law of April 12, 2010 N 61-FZ "On Treatment medicines" (as amended by this Federal Law), paragraph 3 of Article 78 of the Federal Law of November 21, 2011 N 323-FZ "On the fundamentals of protecting the health of citizens in the Russian Federation" (as amended by this Federal Law) in terms of the formation and issuance prescriptions for medications containing the prescription of narcotic drugs or psychotropic substances, in the form of electronic documents, are applied from January 1, 2019.

3. The provisions of parts 3 and 6 of Article 91 1 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (as amended by this Federal Law) do not apply until January 1, 2019 insofar as it relates to the provision information to the unified state information system in the field of healthcare, in relation to medical organizations of the private healthcare system, if such medical organizations have not previously decided to provide information to the specified system.

President of the Russian Federation

V. Putin

Moscow, Kremlin



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