Telemedicine regulation in Russia

The main articles are:

• Telemedicine
• Telemedicine (Russian market)
• Telemedicine (Global Market)

2023

Experimental legal regime in the field of telemedicine: The most significant innovations

As you know, medical care using telemedicine technologies has become available to patients since 2018, when this method of providing it was enshrined in the federal law "On the Basics of Protecting the Health of Citizens in the Russian Federation," and the corresponding procedure and a number of other by-laws were published. Despite the fact that the medical industry was waiting and preparing for these changes, they turned out to be difficult to implement in practice due to the need to comply with the strict requirements contained in them both on the part of medical institutions and on the part of patients. This largely restrained the development of the telemedicine market.

From August 1, 2023, the Program of an experimental legal regime in the field of digital innovations in the field of medical activities, including the use of telemedicine technologies and technologies for collecting and processing information about the state of health and diagnoses of citizens (program), was put into effect. The new regime has been introduced for three years, and applies to a limited number of participants. The article discusses the most important innovations of the program and their significance for the future of the medical industry. Learn more here.

Mishustin allowed private clinics to advise patients online

In July 2023, Prime Minister Mikhail Mishustin signed a decree on the introduction of an experimental legal regime (EPR) to expand the possibilities of remote interaction between a doctor and a patient using telemedicine technologies. As part of the experiment, doctors in private clinics will be able to provide consultations to patients from different cities and regions in order to increase the availability of medical care.

In the clinics participating in the experiment, patients will be given the right to choose the attending physician when receiving medical care in a planned form for re-admission. For example, if the initial face-to-face appointment was carried out by one doctor, then for further observation and consultation of the doctor on this disease, the patient, if desired, can independently choose the provision of services in another branch of the same medical institution in any city, region of Russia thanks to telemedicine technologies. In addition, it will be possible to adjust the treatment or prescribe it in cases where it was not prescribed at full-time admission, including writing prescriptions for drugs, online.

Mikhail Mishustin

The participants of the EPR will be 15 medical organizations that have the appropriate license, as well as the necessary ones, IT infrastructure including, Savings health"" Russian Railway Medicine JSC "Group of Companies," "LLC," ", "MedsiDoctor nearby LLC" RenKlinik, "JSC". "European Medical Center

Starting from August 1, legal grounds for testing several telemedicine technologies will appear throughout Russia. There are 15 companies in the experiment, but their number can be increased. Such a vast number of participants once again emphasizes the interest of business as soon as possible to confirm the effectiveness of telemedicine technologies and provide services demanded by the population, - said the Minister of Economic Development Maxim Reshetnikov.[1]

2022: Russian government bans use of telemedicine to check health of bus drivers

The government commission on legislative activities approved amendments to the bill on telemedicine as part of the health check of drivers working for hire. This was reported on December 6, 2022 by the Kommersant newspaper with reference to the Association of Lawyers of Russia (AYUR).

According to the chairman of the board of AYUR Vladimir Gruzdev, remote medical examinations will be prohibited for drivers of intercity buses carrying passengers over distances of more than 300 km or carrying children. For other carriers, remote control of personnel will be allowed. At the same time, drivers will be additionally tested for drugs twice a year.

The Russian government has banned the use of telemedicine to check the health of bus drivers

{{quote "The use of telemedicine technologies in conducting medical examinations of drivers will increase the availability of such examinations, reduce the financial and time costs of enterprises. Another advantage: they can be carried out at any time of the day and night seven days a week, "he said. }} According to the rules in force by the beginning of December 2022, employers must check the health of taxi, truck or bus drivers as part of pre-trip and post-trip medical examinations - this is the responsibility of full-time or involved doctors. The procedure has become a formality in recent years. In 2017, President Vladimir Putin instructed to prepare a bill on the remote passage of such examinations.

Шаблон:Quote "The use of telemedicine technologies in conducting medical examinations of drivers will increase the availability of such examinations, reduce the financial and time costs of enterprises," says Vladimir Gruzdev, Chairman of the Board of AYUR. Vladimir Matyagin, President of the Gruzavtotrans Association, says that only large transport companies with a fleet of 50 trucks can take a doctor to the staff, and individual entrepreneurs and small companies cannot afford this for financial reasons, therefore they draw up fictitious pre-trip permits.^[2]

2020

Ministry of Health recommends treating coronavirus at home with telemedicine

In November 2020, the Ministry of Health of the Russian Federation issued an order to organize the treatment of people infected with coronavirus COVID-19 at home using telemedicine technologies. Read more here.

Plan for the adoption of amendments to allow diagnoses and treatment remotely

On February 19, 2020, it became known about the amendments to the law "On the Basics of Health Protection," according to which doctors in Russia will be allowed to make preliminary diagnoses and prescribe treatment remotely. The corresponding document was developed by the Council for the Development of the Digital Economy under the Federation Council. The Ministry of Health, the Ministry of Telecom and Mass Communications and other relevant departments generally approved the amendments.

According to Andrei Turchak, Secretary of the General Council of United Russia, the innovation will allow a medical examination using telemedicine, which will significantly reduce the burden on medical institutions, especially during the peak of seasonal diseases. In addition, the amendments greatly simplify the provision of emergency care in the event of mass disasters and natural disasters, since there will be no need to establish the identity of the patient, he said.

It became known about the amendments to the law "On the Basics of Health Protection," according to which doctors in Russia are allowed to make preliminary diagnoses and prescribe treatment remotely

Alla Kanunnikova, director of commercial activities and marketing at Medsi Group of Companies, believes that thanks to the innovations, the availability and quality of medical services will increase. According to her, she is often placed at a second appointment, and it is possible to prescribe tests to the patient remotely - this will save both his time and the time of the doctor. If the information received from the consultation is not enough, the doctor can invite the patient to a face-to-face appointment, Kanunnikova explains.

The Vice-Speaker of the Federation Council also proposed to the Government of the Russian Federation to create a program to train medical workers in the practical use of telemedicine technologies.

Telemedicine staffing is fundamental at this stage. Now there is no specialized teaching in this area. Therefore, we propose to the government to develop a separate program for training medical workers in practical telemedicine technologies, "Turchak said at a meeting of the Council for the Development of the Digital Economy at the Federation Council in Samara.[3]

2019

• Regulation on the formation of a network of national medical research centers and on the organization of activities of national medical research centers (Order of the Ministry of Health of the Russian Federation No. 125 of 13.03.2019)

• Draft Order of the Ministry of Health of the Russian Federation "On Approval of Requirements for State Information Systems in the Field of Health of the Constituent Entities of the Russian Federation, Medical Information Systems of Medical Organizations and Information Systems of Pharmaceutical Organizations"
• Project Passport of the federal project "Creation of a single digital circuit in healthcare on the basis of a single state health information system (Uniform State Health Information System)"
• Projects of passports of the regional level of the regional project "Creation of a single digital circuit in healthcare..."

Accounts Chamber: Telemedicine needs to update the regulatory framework

The current regulatory framework is insufficient for the introduction of telemedicine technologies in Russian medical organizations. Such conclusions were reached by the Accounts Chamber of the Russian Federation, having studied the practice of using telemedicine technologies in 2017-2018. According to the observations of auditors, the Ministry of Health does not conduct statistical monitoring of the introduction and use of telemedicine technologies. Accordingly, this does not allow making timely management decisions on the development of^[4] practice^[5].

According to the Accounts Chamber, the development of telemedicine in Russia is hindered by the lack of a systematic mechanism for calculating tariffs for services using these technologies. Telemedicine services in the public sector are paid for at the expense of Campus Management compulsory medical insurance on the basis of point tariff agreements formed at the regional level by TFCMI, regional authorities and insurance organizations. Also, the structural units providing medical care using telemedicine technologies have not been identified, the standards for equipping medical institutions with the necessary equipment and software providing interaction with the Uniform State Health Information System have not been established, the procedure and period for providing medical documents in electronic form during telemedicine consultations. At the same time, the Ministry of Health does not conduct statistical monitoring of the introduction and use of telemedicine technologies, which means that it does not have the opportunity to promptly respond on emerging problems.

The Accounts Chamber found out that over the past two years, the regions have not received funds from the federal budget for services using telemedicine technologies. "This assistance was paid within the framework of territorial programs of compulsory health insurance," said the auditor of the joint venture Mikhail Men. - The corresponding expenses in 2017 in 17 constituent entities of the Russian Federation amounted to 21.2 million rubles, and in 2018 in 20 regions - 18.8 million rubles. "

2018

• Decree of the Government of the Russian Federation dated 12.04.2018 No. 447 "On Approval of the Rules for Interaction of Other Information Systems... with information systems in the sphere health care medical and organizations "
• Letter of the Ministry of Health of Russia dated 09.04.2018 No. 18 2/0579 "On the procedure for organizing and providing medical care using telemedicine technologies"
• Decree of the Government of the Russian Federation No. 555 of 05.05.2018 "On a unified state information system in the field of health care"
• Order of the Ministry of Health of Russia dated 14.06.2018 N 341n "On approval of the Procedure for depersonalization of 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"
• Federal Law of 29.06.2018 No. 173 FZ "On Amendments to Certain Legislative Acts of the Russian Federation" (PPP in IT)

2017

The Ministry of Health has developed a procedure for providing telemedicine care

The Ministry of Health described the procedure for providing remote medical care. The document does not establish responsibility for operators, due to the poor work of which the patient may be harmed^[6] for^[7]

Objectives and Timelines

The Ministry of Health has prepared a draft order establishing the procedure for organizing and providing medical care with the "use of telemedicine technologies." RBC got acquainted with the document, its authenticity was confirmed by two sources on the market who received the document from the Ministry of Health. It defines the rules for providing telemedicine (remote) care to patients and remote interaction of health workers with each other. The Ministry of Health must approve its final version by order, which will enter into force on January 1, 2018.

The project spelled out the rules for the use of telemedicine technologies both between the doctor and the patient, and between the doctors themselves. In the first case, telemedicine is planned to be used to prevent, collect and analyze patient complaints, history data, monitor his health, adjust treatment previously prescribed at face-to-face, as well as decide on the need for personal admission, the document says. The document does not allow the diagnosis remotely.

If one doctor remotely consults another, the procedure allows doctors to establish and correct the diagnosis. They can assess the patient's condition, clarify the tactics of examination, treatment, etc.

Telemedicine care will be both free, within the framework of compulsory health insurance and other state guarantees, and paid. The specifics of payment for such assistance are not spelled out in the document.

All medical institutions and doctors planning to provide remote consultations must register in the unified state information system in the field of health care (Uniform State Health Information System). The Ministry of Health will prescribe the requirements for communication channels, information protection tools, as well as technical and software tools used in telemedicine consultations separately, the document says. ​​

The document also approves what information the medical institution and doctors will have to provide to patients planning to contact them for telemedicine advice. The patient will be able to find out the doctor's experience, his scientific degrees and previous places of work.

Contradictions and inaccuracies

The draft order describes ways to communicate between a doctor and a patient, but there is a contradiction in this part of the document. According to one item, patients and doctors will be able to communicate through audio or video communication, as well as through electronic messages. Another item states that real-time consultations (discussion of the patient's current condition) are possible only when using telemedicine equipment and video conferencing. The Ministry of Health did not tell RBC which point reflects the position of the department and which should be considered a priority.

Adoption of the 242-FZ law for the development of telemedicine

The adoption of the Federal Law of 29.07.2017 No. 242-FZ "On Amendments to Certain Legislative Acts of the Russian Federation on the Use of Information Technologies in the Field of Health Protection," which entered into force on January 1, 2018, provided an opportunity to develop areas of medical care related to the use of telemedicine technologies.

Fuzzy definitions of "e-health" and "telemedicine"

The Russian approach to defining the concepts of "e-health" and "telemedicine" is not clearly ordered. In earlier legal sources (Order of the Ministry of Health of the Russian Federation No. 344, RAMS No. 76 of 27.08.2001 "On Approval of the Concept for the Development of Telemedicine Technologies in the Russian Federation and its Implementation Plan") the terms "telemedicine technologies" and "Internet medicine" are used, while telemedicine technologies are understood as "medical and diagnostic consultations, management, educational, scientific and educational measures in the field of health care implemented using telecommunication technologies," and "Internet medicine" is considered as an integral part of telemedicine technologies and includes information support for clinical medicine in matters of counseling patients; Health Reference Service; providing access to library databases, etc.

In 2017, a new concept of "telemedicine technologies" was introduced into the Russian Law on the Basics of Health Protection, which began to mean "IT that ensure remote interaction of medical workers with each other, with patients and (or) their legal representatives, identification and authentication of these persons, documenting the actions they take during consultations, consultations, remote medical monitoring of the patient's health." Thus, the legal definition of telemedicine is not enshrined in Russian legislation; the use of telemedicine technologies is defined as the subject of legal regulation. At the same time, only measures related to the provision of medical services are included in the circle of use of telemedicine technologies. Healthcare management issues and other aspects related to the use of IT in healthcare are not covered by the use of telemedicine technologies under Russian law.

The new law establishes the ability to issue medical reports, certificates, prescriptions for medicines and medical devices in electronic form, give informed consent to medical intervention or refusal of it in electronic form, and also enshrines the legal framework for the creation and functioning of information systems in the field of health care.

Limitation of the use of telemedicine technologies in Russia

The legislation of the Russian Federation establishes restrictions on the provision of remote telemedicine services to a patient. Thus, the patient cannot be diagnosed, treatment is prescribed and remote monitoring of the state of health without face-to-face admission is established. Telemedicine technologies can only be used in:

• prevention goals,
• collection, analysis of patient complaints and history data,
• assessment of the effectiveness of medical and diagnostic measures,
• medical monitoring of the patient's health;
• making a decision on the need for face-to-face reception (inspection, consultation);
• in order to adjust the previously prescribed treatment (parts 2-4 of the Health Protection Fundamentals Act).

Telemedicine Internet services existing in Russia, such as Yandex.Health, Doctor Nearby. Telemedicine "in their user agreements stipulate that the client is provided only with consulting services, and to make a diagnosis and prescribe treatment, you should contact a full-time appointment with a specialist. Based on the results of the provision of the consulting service, a medical conclusion is drawn up - a document in electronic form, compiled by a doctor, containing the results of medical advice without making, adjusting the diagnosis and prescribing treatment.

• Order of the Ministry of Health of Russia dated 30.11.2017 No. 965n "On approval of the procedure for organizing and providing medical care using telemedicine technologies"
• FZ dated 29.07.2017 No. 242 FZ "On Amendments to Certain Legislative Acts of the Russian Federation on the Use of Information Technologies in the Field of Health Protection" (entered into force in 01.01.2018 with regard to the main provisions)

The State Duma forbade doctors to diagnose via video link

On July 20, it became known that the State Duma approved in the second reading a bill on the use of IT in the medical care of citizens. According to the document, the doctor can advise patients remotely, via video link, but he has no right to diagnose during such a consultation, as well as prescribe treatment - at least if he sees the patient for the first time.^[8]

The initial version of the bill prepared by the Ministry of Health of the Russian Federation also did not allow the diagnosis to be made remotely. However, before submitting the document to the government, a clause was added to it that allowed it. After considering this version of the bill in the first reading in June 2017, State Duma deputies proposed a number of amendments. In particular, one of the amendments again imposed a ban on the possibility of remote diagnosis. The telemedicine law is expected to take effect from early 2018.

Photo: www.medmix.at

What is allowed by law

In accordance with the current version of the bill, doctors can conduct telemedicine consultations and consultations with each other, with patients and with official patient representatives. At the same time, the identity of the session participants must be confirmed using a digital signature or authorization on the public services portal, and all actions during consultations must be documented.

By video link, a doctor can write out a certificate or prescription, including for drugs of narcotic or psychotropic nature, and issue them in the form of an electronic document. Digital prescriptions will be sent directly to pharmacy organizations. However, the patient will have the right to choose the method of obtaining a prescription - in paper or electronic form. The regulation on electronic prescriptions will come into force from the beginning of 2019.

The patient at the very first visit to the doctor via video link is obliged to make an appointment. During a face-to-face appointment, the doctor will conduct an examination, diagnose and prescribe treatment. After that, he will be able to monitor the patient's condition and adjust the treatment method via video link.

The bill of the Ministry of Health on telemedicine was sent to the State Duma

In April 2017, a bill from the Ministry of Health of the Russian Federation on the use of ICT in health care was supported by the government commission on lawmaking. After approval by the government, the document will be sent to the State Duma of the Russian Federation.

The commission of the Government of the Russian Federation approved the bill of the Ministry of Health of telemedicine. It is expected that the State Duma will approve it back in the first half of 2017.

As noted on the official website of the government of the Russian Federation, the document "is designed to create the legal basis for the use of ICT in the field of protecting the health of citizens."

"In particular, it provides for the possibility of providing medical care using telemedicine technologies by holding consultations and consultations that ensure remote interaction of doctors with each other, the doctor and the patient or his legal representative, as well as remote monitoring of the patient's health," - indicated in the explanation to the bill.

The new document also makes changes to such laws as "On the basics of protecting the health of citizens in the Russian Federation," "On narcotic drugs and psychotropic substances" and "On the circulation of medicines."

According to him, it is planned to create a Unified State Information System in the field of health care, which will accumulate all the data of medical organizations and state authorities in the field of health care, ensuring the formation of medical records of patients in electronic form and maintaining the existing federal registers of persons with certain diseases. Thanks to the innovation, the process of determining the need for drug supply will be more effectively debugged. The bill also provides for the transfer to digital format of the issuance of prescriptions for drugs and certificates.

The document was created by the Ministry of Health of the Russian Federation as part of the project "Improving the processes of organizing medical care based on implementation" information technologyE-Health(""). On October 25, 2016, following a meeting of the Presidium of the Presidential Council Russia for Strategic Development and Priority Projects, his passport was approved.

The head of the Yandex.Health service, Grigory Bakunov, speaks positively about the new bill:

"We positively assess the news about the approval of the bill of the Ministry of Health, since this allows us to hope that telemedicine in Russia will be allowed by law in the near future. According to the information we have, the bill in its current form allows not only remote communication of doctors with each other, but also remote consultations of patients with doctors, and it takes into account the wishes of the industry, which were reflected in the previously proposed bill. "

Speaking about the bill of the Ministry of Health, Deputy Director of the IIDF for Legal Affairs Iskender Nurbekov draws attention to shortcomings. So, in his opinion, the document does not contain clarity in such a matter as what service the patient can receive, remotely consulting with a doctor, there is no exact wording of what exactly the doctor will be allowed to do remotely. The expert says: "The revision of the bill of the Ministry of Health assumes the use of technologies for the interaction of doctors, patient consultation and monitoring, but the concept of medical advice has not been recorded. It is not clear whether the doctor will be able to prescribe or change treatment remotely. In addition, the bill of the Ministry of Health does not prescribe the interaction of a doctor and an average health worker for remote treatment. Today, medical personnel of feldsher-obstetric stations cannot always prescribe qualified treatment for patients. If this issue is not resolved today, in the near future the points will not be able to properly serve patients, mortality in hard-to-reach points may increase. The mechanism of "simplified" identification by doctors is not prescribed, for example, through the portal of public services and SMS alerts. " Nurbekov notes that the purpose of telemedicine is to ensure operational interaction between the doctor and the patient.

In 2016, a bill on the use of ICT in health care was developed and submitted to the State Duma by the Development Institute Internet (IRI) with the participation of the Internet Initiatives Development Fund (IIDF) and the Internet company Yandex"," but a year later it was never considered. According to Nurbekov, such a document is very important both for medicine and for the Internet industry, because the availability of medical services is insufficient.

It is vital that the patient-doctor relationship is established so that those in need of care are able to obtain a qualified health service. We believe that the two bills have the same theme and should be considered simultaneously according to the regulations of the State Duma, then the opinion of industry representatives and the opinion of the market regulator will be taken into account. The decision on this is made by the State Duma, "he stressed

2016

Ministry of Health publishes a bill

In April 2016, it became known about the development by the Ministry of Health of the Russian Federation of a bill on the legalization of telemedicine. The innovations may come into force in 2017.

The fact that the Ministry of Health is going to introduce remote medical care services via the Internet into the legal field was reported by Vedomosti with reference to the draft law published on the website of legal information regulation.gov.ru.

The Ministry of Health decided to legalize telemedicine in Russia

The bill notes that telemedicine services can only include remote prevention, diagnosis or monitoring of a patient's health, but not treatment.

The initiative of the Ministry of Health also provides for the exchange of medical documents in electronic form, but only between doctors with the mandatory identification of them and patients, as well as subject to non-disclosure of personal data.

The Ministry of Health was developing a bill on the legalization of telemedicine in Russia with the participation of the presidential adviser on the Internet German Klimenko and a special working group, which includes representatives of the Internet Initiatives Development Fund (IIDF). According to Klimenko, this working group is going to submit its own version of the bill, which, in particular, implies an accelerated start of telemedicine regulation in the Russian Federation.

According to Vladimir Gurdus, a member of the board of directors of the Doctor Nearby clinic network, the Russian telemedicine market is very weak and has a small volume, and the bill will help it grow several times by 2021-2023.

Managing Director Alexander Ledovsky of the Ramsey Diagnostics network of clinics considers the bill insufficiently detailed, but capable of removing telemedicine from a semi-legal position.

At the same time, remote consultation will not be able to completely replace face-to-face examination and functional diagnostics, telemedicine is an option for medical care in the extreme case if the patient cannot personally come to the doctor, said Igor Krylov, first vice president of the Medsi network of clinics.^[9]

Yandex and the Ministry of Health are preparing a bill on telemedicine

On March 4, 2016, it became known that the Internet company Yandex and the Ministry of Health of the Russian Federation will develop a bill on telemedicine. Thanks to him, Russian patients will be able to receive remote consultations and treatment.

According to Kommersant, citing the general director of Yandex in Russia, Alexander Shulgin, in March 2016, the company, together with the Ministry of Health, will form a working group to prepare a bill on telemedicine, which will create the legal basis for the use of IT in healthcare. The Ministry of Health posted a notification of the start of the development of the relevant bill on the federal portal of draft regulatory legal acts.

Yandex and the Ministry of Health begin to develop telemedicine in Russia

We consider it important to develop and approve a single storage standard and protocol for the exchange of health data. This is an important condition for the development of telemedicine in Russia, - said Alexander Shulgin.

According to him, the main directions in this area are the patient's access to electronic data of the medical record, the settlement of issues of patient and doctor identification in the provision of telemedicine services, as well as the ability to electronically provide consent to access and processing health data.

As part of the development of information technologies in Russian medicine, the Ministry of Health is also going to introduce the issuance of sick leave and prescriptions in electronic form from July 1, 2016. An exception will be made for narcotic and psychotropic substances, the newspaper reports, referring to the bill published by the Ministry of Health.

Stanislav Sazhin, co-founder of Doctor at Work, says that writing electronic prescriptions in Moscow began back in 2014. However, such a service is limited and applies only to drugs for preferential categories of the population - according to such a prescription, drugs are free, so patients themselves require it to be issued, Sazhin noted.^[10]

Notes