Stability of telemedicine legislation: current issues

Usenkov Ivan Alekseevich Volgograd State University 100 Universitetskiy ave., Volgograd, Volgograd region, 400002, Russia i.usenkov@volsu.ru Other publications by this author

The stability of legislation is a complex and multidimensional problem that needs to be investigated comprehensively for the entire legislative system. However, the specifics of the implementation of the stability of individual industries, sub-sectors or institutions can serve as empirical or illustrative material, the conclusions of which will allow a deeper understanding of the problem or they can be extended to legislation as a whole. A special case of the formation and development of legislation on telemedicine in Russia quite significantly demonstrates some problems common to the entire domestic legal system as a whole.

Legal research, one way or another affecting telemedicine, is mainly devoted to the definition of the term "telemedicine" (for example, Blinov S.V., Revina S.N.), the peculiarities of legal regulation of telemedicine technologies (for example, Kamenskaya N.A., Pavlova Yu.V., Pospelova S.I., Sergeev Yu.D., Starchikov M.Yu.) and its development (Vavilova E.M., Demchenko M.V.). The necessary context is set by the works and the assessments contained in them of the implementation of telemedicine technologies in practice by Bazina O.O., Vladzimirsky A.V., Simenyura S.S. Foreign experience in the application of telemedicine is described in the works of Akulin I.M., Gallese-Nobile K., Tretyakova E.P., Chesnokova E.A. Thus, the current legal regulation of telemedicine in Russian science has received a comprehensive assessment, problems have been formed on a number of issues (definition of the concept of "telemedicine", gaps in legal regulation), however, the question to what extent these problems are due to the peculiarities of the development of legislation in this area, excessive legal regulation and, consequently, how effective there may be a solution through deregulation.

In this regard, the research methodology is based on historical and teleological methods that allow us to consider the problems of legal regulation of telemedicine, based on the peculiarities of the formation of legislation in this area. Also, in preparing the work, an analysis of statistical data, regulations and materials of judicial practice was carried out; using the comparative legal method, general and various trends with the development of some other legislative institutions were identified.

Telemedicine legislation in Russia is developing at a fairly slow pace. The "Concept for the development of telemedicine technologies in the Russian Federation" was approved back in 2001, while telemedicine technologies received legislative consolidation only in 2017 ^{[1, p. 32]}. It was then that Federal Law No. 323-FZ of 11/21/2011 "On the Basics of Public Health Protection" (Article 36.2) formulated the definition of telemedicine technologies (Federal Law No. 323-FZ of November 21, 2011 "On the Basics of Public Health Protection in the Russian Federation" // Collection of Legislation of the Russian Federation, 11/28/2011, No. 48, v. 6724). Telemedicine technologies are technologies that make it possible to provide qualified medical care remotely using various means of electronic interaction with both other doctors and patients.

In the same year, Order No. 965n of the Ministry of Health of the Russian Federation dated 11/30/2017 approved the "Procedure for the organization and provision of medical care using telemedicine technologies", according to which medical care using telemedicine technologies is provided only by those employees whose information is contained in the Federal Register of Medical Workers, and only if the medical organization in which they work, registered in the relevant register (Order of the Ministry of Health of the Russian Federation dated 11/30/2017 No. 965n "On approval of the procedure for organizing and providing medical care using telemedicine technologies" // [Electronic resource]. URL: https://online.consultant.ru/riv/cgi/online.cgi?req=doc&base=LAW&n=287515&cacheid=EC29FB7F1C7E2DF47C4F106135E17B87&mode=splus&rnd=05sjAg#hnBT6zTe2vxDY78x (Date of application: 02/01/2024)).

The order of the Ministry of Health also stipulates that using telemedicine technologies, patients can receive primary, specialized, ambulance, as well as palliative care. However, it is worth noting that palliative care using telemedicine technologies will not be advisable at present, since such patients often need not so much an anamnesis of their situation and treatment as proper care and psychological assistance, which must be provided for a long time.

A study conducted by GBUZ "Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Department of Health" showed that using telemedicine technologies, the analysis of patient complaints was carried out in 100% of cases, and practical recommendations were given in 25% of cases ^{[4, p. 59]}.

At the same time, the legislator has established certain restrictions on the provision of remote telemedicine services to the Patient, it is impossible to diagnose and prescribe medication without face-to-face admission. Remote admission can only be carried out for the purpose of anamnesis, prevention, evaluation of the effectiveness of already prescribed medications, as well as making a decision on face-to-face admission or hospitalization. However, in 62.5% of cases, doctors of telemedicine services ignored these restrictions and still prescribed medications ^{[4, p. 59]}.

Most often, medical care using modern remote technologies is provided to pregnant women who are registered in a women's clinic. For the most part, they are in touch with their doctor through messengers, and in case of certain situations, the doctor can make timely recommendations (even at night), or prescribe medications, since the doctor is conducting the patient's pregnancy and has an idea about her medical history and possible risks. Also, the patient is often in touch with the doctor via messengers after surgery in order to exclude possible complications and monitor the rehabilitation process. However, these examples cannot be fully attributed to the provision of medical care using telemedicine technologies, since patients and doctors use ordinary messengers and provide their personal contact information.

To date, there are several popular services in Russia that specialize in providing medical care using telemedicine technologies. One of them is the NaPopravku service - it is a whole system that includes doctors of more than 15 specialties, among them therapists, neurologists, cardiologists and pediatricians. The service provides patients with the opportunity not only to consult with a doctor, but also to get a transcript of almost any tests (including CT and MRI reports) without going to the clinic in person. Consultations are held around the clock, you can ask both about your health and about the health of your loved ones. The service's website is clear and modern, the chat itself works smoothly, which meets the modern request of a patient who cannot visit the clinic in person or does not see an urgent need for this.

In 2021, the first significant changes will be made to Article 36.2 of Federal Law No. 323-FZ of 11/21/2011. They provide for the possibility to cancel part of the legislative requirements for the provision of telemedicine services for participants in the experimental legal regime. In 2023, the Decree of the Government of the Russian Federation dated 07/18/2023 No. 1164 introduces such an experimental legal regime.

At the same time, it is necessary to agree with lawyers practicing medical law that in the absence of a direct legislative ban, telemedicine services were provided to patients until 2017 ^{[3, p. 170]}. This was due to the fact that the legislation in its original version did not prohibit providing medical care remotely if such services met the criteria for providing medical care. Consequently, there was a different purpose for introducing regulation, other than the legalization of telemedicine.

Often, legal regulation is necessary when it is necessary to streamline certain social relations or to push their development. For example, civil law has never prohibited the conclusion of option agreements, but until the moment of regulation of this instrument in the Civil Code of the Russian Federation, few people used it, fearing law enforcement risks. As a result of the amendments made to the Civil Code of the Russian Federation, the previously unnamed, but used in practice, option design received its regulatory basis, which positively affected the prevalence of the use of the option in civil circulation ^{[5, p. 118]}.

Indeed, since the 2017-2020s, there has been a sharp increase in both the volume of telemedicine services provided and the turnover of this market, which researchers associate first with legislative innovations, and subsequently with the pandemic. Russia has entered the top five in terms of the introduction of telemedicine technologies at the end of 2019 (Analysis of the telemedicine market in Russia in 2017-2021, forecast for 2022-2026 Market prospects in the context of sanctions // [Electronic resource]. URL: https://businesstat.ru/images/demo/telemedicine_russia_demo_businesstat.pdf?ysclid=lpjuoey0tv138502278 (accessed 01.02.2024); Telemedicine market in Russia: prospects for the development of digital medicine // [Electronic resource]. URL: https://delprof.ru/press-center/open-analytics/rynok-telemeditsiny-v-rossii-perspektivy-razvitiya-tsifrovoy-meditsiny/?ysclid=lpjuisuia0313693724 (Accessed 01.02.2024)). According to the Doctor Nearby service, before the pandemic was announced, doctors were contacted remotely about 500 times a day, and with its onset – more than 2 thousand times daily ^{[1, p. 37]}.

However, already in 2021, this growth is slowing down: restrictions in connection with the pandemic are weakening, and the potential for legislative consolidation as a driver of development has apparently already been exhausted. At the same time, it was exhausted earlier than expected, which the legislator recognizes, creating opportunities for deregulation in the same year (albeit so far within the framework of legal experiments).

Decree of the Government of the Russian Federation No. 1164 of 07/18/2023 introduced an experimental legal regime, which resolves many of the problems of telemedicine regulation highlighted in scientific and practical literature ^{[2, p. 35]} mainly through deregulation. In particular, the resolution excluded the effect of 10 paragraphs and parts of various legislative and by-laws. For example, the provisions on the possibility of providing medical care using telemedicine technologies only by the same doctor who conducted an in-person examination, on the written form of a contract for the provision of services, on giving informed voluntary consent only with the help of the ESIA are not applied within the framework of the experimental legal regime.

Summarizing the above, the development of legislation on telemedicine in Russia has passed the following stages: the existence of only a concept (16 years – from the moment of its adoption in 2001 to the moment of regulatory implementation in 2017), the existence of detailed regulation (4 years – from 2017-2021), the establishment of the possibility of deregulation within the framework of a legal experiment (2021), the beginning of a legal experiment (from 2023 to the present). Such a chronology raises questions not only about the quality of the concept of legislative development and compliance with it, but also about the scope of the initially necessary regulation and the timeliness of the legal experiment. At the same time, the simultaneous introduction of general legislative regulation and detailed by-law regulation of institutions previously used in practice is a very common practice for domestic law-making bodies. For example, the provisions on taxpayer integrity, previously formulated by judicial practice, were introduced in Article 54.1 of the Tax Code of the Russian Federation (very careful and restrictive regulation) and at the same time detailed at the level of acts with regulatory properties.

Of course, the attention of the state should be paid to medical services, since there is a public interest in them. However, since the introduction of Article 36.2 of Federal Law No. 323-FZ dated 11/21/2011 "On the Basics of Public Health Protection in the Russian Federation", all judicial practice on it is administrative, not civil law. In this regard, since citizens do not have any widespread and significant claims to the provision of telemedicine services, their initially detailed regulation seems unnecessary, and the extension of deregulation introduced as part of a legal experiment to current legislation is the optimal solution.