Telemedicine: Legal Regulation in Russia

 

March 14, 2021

Anna Ivanova, Associate at BRACE Law Firm ©

 

Currently, information technologies are actively developing and entering all spheres of life and almost all sectors of the economy. It can be argued that today information technologies closely affect medicine, including the interaction of medical workers, personnel training, and the provision of medical services.

The Concept for the Development of Telemedicine Technologies in the Russian Federation and its implementation plan declare that progress in information and telecommunication technologies has created a basis for a fundamentally new direction in the organization and provision of medical care to the population—telemedicine [1].

According to Article 2 of Federal Law No. 323-FZ dated November 21, 2011 "On the Fundamentals of Health Protection of Citizens in the Russian Federation", telemedicine technologies are information technologies ensuring remote interaction of medical workers with each other, with patients and/or their legal representatives, identification and authentication of said persons, and documentation of their actions during conciliums, consultations, and remote medical monitoring of the patient's health status [2].

In addition to the development of telemedicine technologies within the Russian Federation, their development is also envisaged throughout the EAEU. For example, the concept of a pilot project for a compatible telemedicine system between the Republic of Armenia and the Russian Federation was adopted in 2010 [3].

Furthermore, a significant need for the development of telemedicine is associated with the COVID-19 pandemic period.

For example, as stated by the Deputy Prime Minister of Armenia, Mher Grigoryan, on January 20, 2021, a unified digital control of coronavirus test results will help lift entry and exit restrictions previously introduced by Armenia and Russia.

In the Republic of Belarus, Law No. 94-Z dated December 11, 2020, introduced amendments to the laws "On Healthcare" and "On Psychological Assistance", introducing the terms "electronic medical document" and "electronic medical record of the patient". The Law regulates relations regarding the creation, development, maintenance, and operation of a centralized healthcare information system, the provision of medical care, medical monitoring, and conducting medical examinations using telemedicine technologies [4].

According to the Strategy for the Development of Service Exports of the Russian Federation until 2025, increasing the export of medical services is possible by solving the following tasks: developing the export of telemedicine services and resolving the issue of access for foreign citizens to Russian telemedicine services. This requires the adoption of measures to support doctors using telemedicine technologies. To stimulate the development of telemedicine service exports, the Joint Stock Company "Russian Export Center" was instructed to provide support for specialized missions to other countries, including Eurasian Economic Union countries, European countries, the Socialist Republic of Vietnam, the People's Republic of China, and the Republic of India, to advertise Russian telemedicine technologies with the possibility of concluding agreements between Russian companies and foreign medical service providers [5].

Thus, the development of telemedicine is currently taking place not only within individual states but also at the international level.

In this article, we examine the features of the legal regulation of telemedicine in the Russian Federation in more detail.

Technical Conditions and Other Requirements Necessary for the Application of Telemedicine Technologies

In accordance with Part 1 of Article 36.2 of Federal Law No. 323-FZ dated November 21, 2011 "On the Fundamentals of Health Protection of Citizens in the Russian Federation" (hereinafter, the "Law on Fundamentals of Health Protection"), 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 taking into account medical care standards [6].

Medical care using telemedicine technologies is provided in accordance with the Procedure for the organization and provision of medical care using telemedicine technologies, approved by Order of the Ministry of Health of Russia No. 965n dated November 30, 2017 (hereinafter, the "Procedure").

According to the said Procedure, to carry out remote interaction of medical workers with each other or remote interaction of medical workers with patients, the medical organization whose medical worker provides medical care using telemedicine technologies ensures the necessary premises, communication means, and equipment for conducting consultations. In the case of consultations using telemedicine technologies in mobile conditions, the consulting medical organization provides mobile communication means and equipment for conducting consultations.

However, the Procedure does not establish precise and specific requirements for the necessary premises and equipment. The answer to this question is provided by clarifications contained in the Letter of the Ministry of Health of Russia No. 18-2/0579 dated April 9, 2018, according to which the provision of medical care, including using telemedicine technologies, is carried out in accordance with the provisions of Decree of the Government of the Russian Federation No. 291 dated April 16, 2012 "On Licensing of Medical Activities (except for specified activities carried out by medical organizations and other organizations that are part of the private healthcare system on the territory of the Skolkovo Innovation Center)". Thus, the provision of medical care using telemedicine technologies, including regarding the determination of conditions for its provision, as well as regarding the equipment used (medical devices), is carried out exclusively in accordance with licensing requirements, as well as in compliance with medical care provision procedures [7].

However, we assume that these clarifications by the Ministry of Health of Russia use a very formal approach to determining requirements for equipment and premises when providing medical care via telemedicine technologies. After all, in some cases, a doctor can actually advise a patient without being directly in a room that meets licensing requirements.

Also, questions arise in practice as to whether a doctor providing medical care via telemedicine technologies can provide it independently, or whether they are required to be employed by a medical organization. As a general rule of Clause 2 of the Regulation on Licensing of Medical Activities, approved by Decree of the Government of Russia No. 291 dated April 16, 2012, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) carries out licensing in relation to:

• Medical and other organizations subordinate to federal executive bodies, as well as organizations of federal executive bodies in which military and equivalent service is provided by federal law;
• Medical and other organizations engaged in activities for the provision of high-tech medical care;
• Other organizations and individual entrepreneurs engaged in medical activities, regarding licensing control.

In this regard, it can be noted that legislation does not directly regulate the issue of obtaining a license by self-employed citizens. On the one hand, Federal Law No. 422-FZ dated November 27, 2018 "On Conducting an Experiment to Establish a Special Tax Regime 'Tax on Professional Income'" does not contain prohibitions on the implementation of licensed types of activities by self-employed citizens (Clause 2 of Article 4 of the said regulatory legal act). However, licensing requirements for carrying out medical activities do not imply obtaining a license by the self-employed, although they do not contain a direct prohibition.

Thus, in the indicated case, the doctor must have a license to carry out medical activities, and to obtain it, they need to obtain the status of an individual entrepreneur or be an employee of a medical organization. We believe that with the improvement of tax legislation, amendments to licensing requirements may be possible in the future, subject to the doctor's compliance with certain conditions (for example, compliance with licensing requirements applicable to doctors as individual entrepreneurs) [8].

Another important requirement for providing medical care using telemedicine technologies is that the Unified Identification and Authentication System (ESIA) is used for the identification and authentication of participants in remote interaction.

Medical care using telemedicine technologies is provided by medical workers whose information is entered into the Federal Register of Medical Workers, and provided that the relevant medical organizations are registered in the Federal Register of Medical Organizations of the Unified State Health Information System in the Sphere of Healthcare (hereinafter, "EGISZ") [9].

The entry and updating of information in the federal and regional segments of the Federal Register of Medical Workers are carried out based on documents submitted by persons participating in the provision of medical services [10].

EGISZ includes such a subsystem as the federal electronic registry, which ensures the planning and conduct of consultations and conciliums using telemedicine technologies.

Medical organizations of the state and municipal healthcare systems enter a request for a telemedicine consultation, as well as protocols of a telemedicine consultation and protocols of a consultation (concilium) using telemedicine technologies into EGISZ within one working day from the date of receipt of updated data [11].

Thus, the application of telemedicine technologies requires:

• Registration in EGISZ;
• Entering information about the medical worker directly providing medical services via telemedicine technologies into the federal register of medical workers;
• Compliance with licensing requirements by a doctor registered as an individual entrepreneur, or by the medical organization with which the doctor has concluded an employment contract.

Key Features and Problems of Providing Aid to Patients via Telemedicine Technologies

Direct interaction with patients via telemedicine raises a number of ethical questions, such as the quality of medical care, preservation of medical confidentiality, and several others.

The Procedure establishes the following types of medical care in which telemedicine technologies can be used:

• Primary health care;
• Specialized, including high-tech, medical care;
• Emergency, including specialized emergency, medical care;
• Palliative medical care.

The specified list is exhaustive.

At the same time, it is established that medical care using telemedicine technologies can be provided in any conditions:

• Outside a medical organization;
• On an outpatient basis;
• In a day hospital;
• In a hospital setting (inpatient).

The conditions for providing care are determined by the actual location of the patient. On the one hand, this provision gives medical organizations freedom regarding the possibilities of providing medical care via telemedicine technologies. On the other hand, it raises the question of the necessity for a medical organization to have the necessary premises (which is provided for by mandatory licensing requirements), if, for example, medical care is provided by such an organization only via telemedicine. Nevertheless, the Procedure indirectly contains an answer to this question. Thus, during consultations of patients and/or their legal representatives using telemedicine technologies, the doctor may correct previously prescribed treatment for the patient, including generating prescriptions for medicinal products in the form of an electronic document, provided the doctor established the diagnosis and prescribed treatment for this specific case at an in-person appointment (examination, consultation). The result of the consultation is a medical report (opinion) or, provided a diagnosis was preliminarily established at an in-person appointment (examination, consultation) for the given case. Thus, providing medical care via telemedicine technologies still actually implies the necessity of an in-person appointment with the patient. However, it can be assumed that with the active development of telemedicine in the future, adjustments to licensing requirements may be required specifically for medical organizations engaged in providing medical care via telemedicine technologies.

Some questions are raised by the provision that the conditions for providing medical care are determined by the actual location of the patient. On the one hand, this norm presumably allows the doctor to independently determine and assess the conditions for possible medical care to the patient depending on where and in what conditions the patient is located. On the other hand, some authors express the opinion that this provision is an indirect reference to the application by analogy of Article 30 of the Civil Procedure Code of the Russian Federation on exclusive jurisdiction. For example, it is noted that: "application by analogy comes to mind, in view of the numerus clausus of types of exclusive jurisdiction under the Civil Procedure Code of the Russian Federation, although it is quite possible that amendments will be made to this procedural norm" [12].

Also, the question remains open as to who can initiate the process of providing medical care via telemedicine technologies. In commentaries to the current Procedure, as well as when applying general provisions of legislation on telemedicine, one can agree with the argument that the patient (their legal representatives), the attending physician (other medical workers), and other persons can initiate the use of telemedicine technologies. Additionally, the decision to use telemedicine technologies may be made at a meeting of the medical commission (subcommission) of a medical organization or be the result of a concilium of doctors [13].

In addition to the aforementioned requirements regarding the necessity of a preliminary in-person appointment with the patient, the Procedure regulates additional, no less important requirements for providing medical care via telemedicine technologies.

For example, when providing medical care, the following information must be presented to the patient in an accessible form, including by posting on the Internet:

• About the consulting medical organization (name, location, contact phone number, email address, license for carrying out relevant types of activities, list of profiles for providing medical care using telemedicine technologies);
• About the organization that is the operator of other information systems (name, location, contact phone number, email address);
• The storage location of documentation and accompanying documents obtained as a result of providing medical care (name of the information system and name and contacts of the information system operator);
• About the consultant, doctor participating in the concilium (surname, first name, patronymic (if available), information on education, information on the medical organization or information on the individual entrepreneur carrying out medical activities based on a license, as well as information on the license itself, position held in the medical organization, work experience, information on qualification category, academic degree, information on previous places of work, essential terms of the contract for the provision of relevant services, schedule of consultants' work);
• Information on the procedure and conditions for providing medical care using telemedicine technologies, including the procedure for executing informed voluntary consent of the patient for medical intervention;
• Possibility of obtaining an anonymous paid consultation, procedure for identification and authentication of the patient, procedure for executing the patient's consent to the processing of personal data, paid or gratuitous nature of the consultation, cost of providing the consultation and procedure for its payment (in the case of providing a paid consultation), procedure for obtaining a medical report based on consultation results, technical requirements for electronic documents provided by the patient to the medical worker, mode of provision by the medical organization of medical care using telemedicine technologies;
• About information systems used during consultation and operators of said systems (name of the information system, name and contacts of the information system operator, storage location of documentation and accompanying documents obtained as a result of providing medical care using telemedicine technologies).

These requirements for mandatory information provision raise a number of problematic issues. Let us consider some of them.

In particular, the Procedure does not indicate who exactly will be liable for unreliable information provided to the patient, including when placing relevant information on a specially created Website. We believe that in this case, it is necessary to be guided by the general provisions of consumer protection legislation. Thus, according to Part 2.1 of Article 12 of Law of the Russian Federation No. 2300-1 dated February 7, 1992, "On Protection of Consumer Rights", unless otherwise provided by an agreement between the owner of the aggregator (owner of the program, computer, or website through which the service is provided) and the seller (executor) or follows from the essence of relations between them, liability for the performance of the contract concluded by the consumer with the seller (executor) based on information provided by the aggregator owner about the product (service) or seller (executor), as well as for the observance of consumer rights violated as a result of the transfer to the consumer of a product (service) of improper quality and the exchange of a non-food product of proper quality for a similar product, is borne by the seller (executor). The aggregator owner is not liable for losses caused to the consumer due to the provision of unreliable or incomplete information about the product (service) if the aggregator owner does not change the information about the product (service) provided by the seller (executor) and contained in the proposal to conclude a purchase and sale agreement (service agreement). Thus, liability for presenting relevant information, as a general rule, will be imposed on the medical organization or individual entrepreneur providing services. At the same time, as a general rule, the consumer has the right to present a demand to the aggregator owner for the return of the amount of advance payment made by them for the product (service) [14].

A fairly large number of questions are raised by the specifics of concluding a contract for the provision of medical care via telemedicine technologies. According to the Procedure, such care can be provided both on a paid basis and free of charge. At the same time, information on the essential terms of the contract for the provision of medical services via telemedicine technologies is mandatory for disclosure to the patient. Consequently, the contract is mandatory for conclusion. However, legislation does not define the form in which the contract may be concluded (oral, written, whether a contract can be concluded via public offer), who is the party to the contract with the patient (the medical organization whose medical worker provides medical care using telemedicine technologies, another medical organization where the patient normally receives medical care, etc.). Since the provision of medical care has many features and requires more detailed legislative regulation, one can agree with the opinion on the possible need for legislative regulation of the procedure and conditions of the contract for the provision of medical care (services) using telemedicine technologies [15].

When providing medical care via telemedicine technologies, one must not forget about the need to comply with requirements for the processing of personal data. Such data as surname, first name, patronymic, gender, date and place of birth, place of residence, place of work, education, marital status, as well as photos of the patient subject and other information about them, including their disease and diagnoses, are personal data by virtue of law. By receiving this information about the patient, the doctor and the medical organization, as well as in some cases the aggregator (owner of the computer program or website through which services are provided), automatically act as personal data operators and carry out their processing (that is, any action or set of actions performed using automation tools or without using such tools with personal data, including collection, recording, systematization, accumulation, storage, clarification, extraction, use, transfer, depersonalization, blocking, deletion, destruction of personal data). At the same time, any processing of personal data is carried out with the consent of the personal data subject [16]. We remind you that failure to obtain such consent entails the imposition of an administrative fine:

• On citizens: from 3,000 to 5,000 rubles;
• On officials: from 10,000 to 20,000 rubles;
• On legal entities: from 15,000 to 70,000 rubles (Article 13.11 of the Code of Administrative Offenses of the Russian Federation) [17].

Also, the Procedure does not unequivocally regulate the issue of the possibility of providing services via telemedicine technologies anonymously. The Ministry of Health of Russia provided the following clarifications. In accordance with Article 84 of the Law on Fundamentals of Health Protection, medical organizations participating in the implementation of the program of state guarantees of free provision of medical care to citizens and the territorial program of state guarantees of free provision of medical care to citizens have the right to provide paid medical services to patients, including anonymously, except for cases provided for by the legislation of the Russian Federation. At the same time, for medical organizations not participating in the implementation of the program of state guarantees of free provision of medical care to citizens and the territorial program of state guarantees of free provision of medical care to citizens, no prohibition is established for providing paid medical services anonymously. However, according to Part 6 of Article 36.2 of the Law on Fundamentals of Health Protection, the Unified Identification and Authentication System is used for identification and authentication of participants in remote interaction when providing medical care using telemedicine technologies [18]. Thus, obtaining an anonymous consultation using telemedicine technologies is possible exclusively after determining, jointly with the Ministry of Digital Development (Minkomsvyaz) of Russia, the procedure for using the unified identification and authentication system when receiving it, as well as cases in which such a consultation can be conducted. At the same time, no exceptions regarding the mandatory use of the Unified Identification and Authentication System (ESIA) when providing medical care using telemedicine technologies are provided. Currently, the website of the Ministry of Digital Development of Russia has published a draft of Methodological Recommendations on the use of the Unified Identification and Authentication System. However, the said draft does not contain information on the procedure for anonymous use of this system. Thus, the procedure for providing anonymous assistance via telemedicine technologies is unregulated [19].

Thus, a fairly significant number of issues related to the provision of medical care via telemedicine technologies remain unregulated and require additional clarifications. We believe that the Ministry of Health of Russia will subsequently initiate additions to the procedure, and in the process of forming law enforcement practice, appropriate clarifications will be given.

Application of Telemedicine Technologies in Pandemic Conditions

In connection with the pandemic, the issue of providing medical care to patients in a "remote manner" became particularly acute. The Ministry of Health of Russia ordered medical organizations to organize the provision of medical care using telemedicine technologies to citizens with a confirmed diagnosis of the new coronavirus infection COVID-19, whose condition allows them to be observed at home, as well as with signs or a confirmed diagnosis of community-acquired pneumonia, acute respiratory viral infections (ARVI), and influenza. It was also instructed to ensure, if technically possible and taking into account information security requirements, the application of modern information technologies and information systems to implement measures for the prevention and reduction of risks of the spread of the new coronavirus infection COVID-19, including the application of artificial intelligence technology (including diagnostics of the new coronavirus infection COVID-19 based on image analysis, natural language processing and speech recognition, intellectual decision support) [20].

At the same time, the issue of providing medical workers with appropriate technical means necessary for remote aid arose urgently. Since the problem of a lack of IT resources is characteristic of Russian healthcare [21].

It is important to pay attention to the fact that the Ministry of Health of Russia developed methodological recommendations for medical rehabilitation in case of the new coronavirus infection (COVID-19), which provide for a proposal to replace rehabilitation care for patients in day hospitals and outpatient medical organizations with remote sessions using telemedicine and information technologies (in terms of the third stage of providing rehabilitation care) [22]. We remind you that rehabilitation stages are determined depending on indicators on the rehabilitation routing scale developed by the Ministry of Health of Russia [23].

A significant factor for the development of telemedicine was the development of a procedure for calculating the financing of medical care provided via telemedicine technologies within the framework of mandatory medical insurance [24].

Thus, in pandemic conditions, problems of legal regulation of telemedicine technologies are of very great importance, and in 2020 a fairly significant number of legal acts regulating telemedicine issues were adopted. At the same time, we believe that the situation with COVID-19 more clearly revealed the existing problems of telemedicine, which gives grounds to assume active improvement of legislation in the field of providing medical services via telemedicine technologies in the near future.

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References

[1] Order of the Ministry of Health of Russia No. 344, RAMS No. 76 dated August 27, 2001 "On approval of the Concept for the Development of Telemedicine Technologies in the Russian Federation and its implementation plan".

[2] Federal Law No. 323-FZ dated November 21, 2011, "On the Fundamentals of Health Protection of Citizens in the Russian Federation".

[3] Information and analytical report of the Eurasian Economic Commission "Analysis of world experience in industrial development and approaches to digital transformation of industry of the Eurasian Economic Union member states" (January 2017).

[4] Weekly monitoring of mass media in the field of migration and social protection prepared by the Eurasian Economic Commission (January 16-22). EEC website.

[5] Decree of the Government of the Russian Federation No. 1797-r dated August 14, 2019, "On approval of the Strategy for the Development of Service Exports until 2025" (together with the "Action Plan for the Implementation of the Strategy for the Development of Service Exports until 2025").

[6] Federal Law No. 323-FZ dated November 21, 2011, "On the Fundamentals of Health Protection of Citizens in the Russian Federation".

[7] Letter of the Ministry of Health of Russia No. 18-2/0579 dated April 9, 2018, "On the procedure for organizing and providing medical care using telemedicine technologies".

[8] Federal Law No. 422-FZ dated November 27, 2018, "On Conducting an Experiment to Establish a Special Tax Regime 'Tax on Professional Income'".

[9] Order of the Ministry of Health of Russia No. 965n dated November 30, 2017, "On approval of the procedure for organizing and providing medical care using telemedicine technologies".

[10] Order of the Ministry of Health of Russia No. 1159n dated December 31, 2013, "On approval of the Procedure for maintaining personalized records when carrying out medical activities by persons participating in the provision of medical services".

[11] Decree of the Government of the Russian Federation No. 555 dated May 5, 2018, "On the Unified State Health Information System in the Sphere of Healthcare" (together with the "Regulation on the Unified State Health Information System in the Sphere of Healthcare").

[12] Mazitov M. On the transactional nature of providing medical care using telemedicine technologies // Zakon.ru: website (July 18, 2019).

[13] Starchikov M.Yu. Legal regulation of providing medical care (services) using telemedicine technologies: problematic issues and ways to resolve them // SPS ConsultantPlus. 2019.

[14] Law of the Russian Federation No. 2300-1 dated February 7, 1992, "On Protection of Consumer Rights".

[15] Starchikov M.Yu. Legal regulation of providing medical care (services) using telemedicine technologies: problematic issues and ways to resolve them // SPS ConsultantPlus. 2019.

[16] Federal Law No. 152-FZ dated July 27, 2006 "On Personal Data".

[17] Code of the Russian Federation on Administrative Offenses No. 195-FZ dated December 30, 2001.

[18] Letter of the Ministry of Health of Russia No. 18-2/0579 dated April 9, 2018 "On the procedure for organizing and providing medical care using telemedicine technologies".

[19] Methodological recommendations on the use of the Unified Identification and Authentication System (version 2.79). Website of the Ministry of Digital Development, Communications and Mass Media of the Russian Federation.

[20] Order of the Ministry of Health of Russia No. 198n dated March 19, 2020, "On the temporary procedure for organizing the work of medical organizations in order to implement measures for the prevention and reduction of risks of the spread of the new coronavirus infection COVID-19".

[21] Telemedicine against the pandemic: how to get a remote appointment with a doctor. Review: IT in healthcare 2020. CNews.

[22] Temporary methodological recommendations "Medical rehabilitation for the new coronavirus infection (COVID-19). Version 2 (July 31, 2020)", approved by the Ministry of Health of Russia.

[23] Order of the Ministry of Health of the Russian Federation No. 788n dated July 31, 2020, "On approval of the Procedure for organizing medical rehabilitation of adults".

[24] Letter of the Ministry of Health of Russia No. 11-7/I/2-20691, FFOMS No. 00-10-26-2-04/11-51 dated December 30, 2020 "On methodological recommendations on methods of payment for medical care at the expense of mandatory medical insurance funds".