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Law and Politics
Reference:

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
 

 

DOI:

10.7256/2454-0706.2024.3.70044

EDN:

XFDLWY

Received:

04-03-2024


Published:

04-04-2024


Abstract: The main features and problems of the development of legislative regulation of telemedicine in the Russian Federation are considered. The stages of such development are identified and analyzed: the existence of a concept, the existence of detailed regulation, the establishment of the possibility of deregulation within the framework of a legal experiment, the beginning of a legal experiment. The correlations between changes in the telemedicine services market and changes in legislation and regulated public relations are considered. The probable reasons that prompted the legislative bodies to establish detailed regulation of relations in the field of telemedicine have been identified, given that the provision of telemedicine services has never been prohibited (encouraging participants in civil turnover to use this legal institution, public interest in regulated public relations). The aim of the work was to formulate the problems of non-systemic changes in legislation on telemedicine, their determinants and further optimal development vectors.  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. The paper analyzes statistical data, regulations and materials of judicial practice; using the comparative legal method, general and various trends with the development of other legislative institutions are identified. It is concluded that regular changes in legislation on telemedicine, undermining its stability and predictability of legal regulation, have their reasons for the lack of conditionality of reforms with the current concept of development of legislation on telemedicine, as well as the redundancy of the adopted regulatory regulation. Taking into account the absence of civil law litigation on the provision of telemedicine services, it is proposed to expand deregulation in this area beyond the legal experiment: extending its provisions to the current legislation as a whole. This need is indirectly confirmed by statistical data on a significant increase in the provision of telemedicine services after their legislative consolidation, with its subsequent decrease and the introduction of a legal experiment on deregulation after that. The study is financially supported by the Russian Science Foundation, project No. 23-78-10175, https://rscf.ru/project/23-78-10175/.


Keywords:

legislation, medicine, telemedicine, concept, legal regulation, development of legislation, deregulation, stability, dynamism, remote medical care

This article is automatically translated.

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.

References
1. Bazina O. O., Simenyura S. S. (2020). Telemedicine: advantages, disadvantages, realities (legal analysis and practical application). Medical Law, 3, 32-38.
2. Vavilova E. M., & Demchenko M. V. (2018). Development of legal regulation of telemedicine in the Russian Federation. Medical Law, 1, 48-51.
3. Varyushin, M. S. (2018). Legal regulation of telemedicine in Russia and the EU: two steps ahead, one back. Law, 1, 165-174.
4. Morozov, S.P., Vladzimirsky, A.V., & Simenyura, S.S. (2020). Quality of primary telemedicine consultations «patient-doctor» (based on the results of testing telemedicine services). Doctor and information technologies, 1, 52-62.
5. Chernobel, Ya. A. (2016). Option structures in the Civil Code of the Russian Federation. Bulletin of the Arbitration Court of the Moscow District, 1, 110-121.

First Peer Review

Peer reviewers' evaluations remain confidential and are not disclosed to the public. Only external reviews, authorized for publication by the article's author(s), are made public. Typically, these final reviews are conducted after the manuscript's revision. Adhering to our double-blind review policy, the reviewer's identity is kept confidential.
The list of publisher reviewers can be found here.

The subject of the research in the article submitted for review is, as its name implies, the actual problems of stability of legislation on telemedicine. The stated boundaries of the study are observed by the author. The methodology of the research is not disclosed in the text of the article. The relevance of the research topic chosen by the author is beyond doubt and is justified by him as follows: "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. 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]." Additionally, the scientist needs to list the names of the leading experts who have been engaged in the study of the problems raised in the article, as well as reveal the degree of their study. The scientific novelty of the work is manifested in a number of conclusions of the scientist: "... 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 that must be provided for a long time"; "Today in Russia There are several popular services 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 development of legislation on telemedicine in Russia has passed the following stages: the presence of only the concept (16 years – from the moment of its adoption in 2001 to from 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 amount of initially necessary regulation and the timeliness of the legal experiment," etc. Thus, the article makes a certain contribution to the development of domestic legal science and, of course, deserves the attention of potential readers. The scientific style of the research is fully sustained by the author. The structure of the work is quite logical. In the introductory part of the article, the scientist substantiates the relevance of his chosen research topic. In the main part of the work, the author, based on normative and theoretical materials, examines the main problems of stability of Russian legislation on telemedicine. The final part of the article contains conclusions based on the results of the study. The content of the article fully corresponds to its title and does not cause any special complaints. There is a typo in the work. The author writes: "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 within the framework of legal expertise to current legislation is the optimal solution" - "experiment". Thus, the article needs additional proofreading. The bibliography of the study is presented by 5 sources (scientific articles), not counting the normative material. From a formal and factual point of view, this is quite enough. The nature and number of sources used in writing the article allowed the author to reveal the research topic with the necessary depth and completeness. There is an appeal to the opponents, but it is general in nature due to the focus of the research (the work mainly examines the evolution of the regulatory framework of telemedicine). The scientific discussion is conducted by the author correctly; the provisions of the work are justified to the necessary extent. Conclusions based on the results of the study are available ("Summarizing the above, the development of legislation on telemedicine in Russia has passed the following stages: the presence of only the 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 deregulation within the framework of the legal experiment (2021), the beginning of the 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 within the framework of legal expertise to current legislation is the optimal solution"), have the properties of reliability, validity and, of course, deserve the attention of the scientific community. The interest of the readership in the article submitted for review can be shown primarily by specialists in the field of civil law, medical law, provided that it is finalized: disclosure of the research methodology, additional justification of the relevance of its topic (within the framework of the comment made), elimination of violations in the design of the work.

Second Peer Review

Peer reviewers' evaluations remain confidential and are not disclosed to the public. Only external reviews, authorized for publication by the article's author(s), are made public. Typically, these final reviews are conducted after the manuscript's revision. Adhering to our double-blind review policy, the reviewer's identity is kept confidential.
The list of publisher reviewers can be found here.

A REVIEW of an article on the topic "Stability of telemedicine legislation: current problems". The subject of the study. The article proposed for review is devoted to topical issues of ensuring the stability of legislation in the field of telemedicine. The author examines the essence of the category "telemedicine", the norms of legislation in this area, as well as trends in its development and improvement. The opinions of scientists, empirical data, and legal norms were used as a specific subject of research. Research methodology. The purpose of the study is not stated directly in the article. At the same time, it can be clearly understood from the title and content of the work. The purpose can be designated as the consideration and resolution of certain problematic aspects of the issue of the essence of the category "telemedicine", as well as ensuring the stability of legislation in the field of telemedicine. Based on the set goals and objectives, the author has chosen the methodological basis of the study. The author writes that "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, during the preparation of 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." In particular, the author uses a set of general scientific methods of cognition: analysis, synthesis, analogy, deduction, induction, and others. In particular, the methods of analysis and synthesis made it possible to summarize and share the conclusions of various scientific approaches to the proposed topic, as well as to draw specific conclusions from empirical data. The most important role was played by special legal methods. In particular, the author actively applied the formal legal method, which made it possible to analyze and interpret the norms of current legislation. For example, the following conclusion of the author: "The legislation on telemedicine in Russia is developing at a fairly low 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." The possibilities of the empirical research method should be positively assessed. In particular, the following conclusion is drawn: "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 by the end of 2019." Thus, the methodology chosen by the author is fully adequate to the purpose of the study, allows us to study all aspects of the topic in its entirety. Relevance. The relevance of the stated issues is beyond doubt. There are both theoretical and practical aspects of the significance of the proposed topic. From the point of view of theory, the topic of ensuring the stability of legislation in the field of telemedicine. In fact, with all the relevance of using telemedicine in practice, especially in the Russian conditions of a large number of regions and territories, it forces the legislator to create the necessary legal regulation. It is difficult to argue with the author that "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 telemedicine legislation in Russia quite significantly demonstrates some problems common to the entire domestic legislative system as a whole." Thus, scientific research in the proposed field should only be welcomed. Scientific novelty. The scientific novelty of the proposed article is beyond doubt. First, it is expressed in the author's specific conclusions. Among them, for example, is the following conclusion: "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 in as part of the legal experiment (2021), the beginning of the 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 the integrity of the taxpayer, 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." These and other theoretical conclusions can be used in further scientific research. Secondly, the author suggests ideas for commenting on the provisions of current legislation, which may be useful for practicing lawyers. Thus, the materials of the article may be of particular interest to the scientific community in terms of contributing to the development of science. Style, structure, content. The subject of the article corresponds to the specialization of the journal "Law and Politics", as it is devoted to legal problems related to the development of legislation in the field of telemedicine. The content of the article fully corresponds to the title, since the author considered the stated problems and achieved the overall purpose of the study. The quality of the presentation of the study and its results should be recognized as fully positive. The subject, objectives, methodology and main results of the study follow directly from the text of the article. The design of the work generally meets the requirements for this kind of work. No significant violations of these requirements were found. Bibliography. The quality of the literature used should be highly appreciated. The author actively uses the literature presented by authors from Russia (Bazina O.O., Vavilova E.M., Demchenko M.V. Simenyura S.S. and others). Many of the cited scientists are recognized scientists in the field of studying legal problems in the field of telemedicine. Thus, the works of the above authors correspond to the research topic, have a sign of sufficiency, and contribute to the disclosure of various aspects of the topic. Appeal to opponents. The author conducted a serious analysis of the current state of the problem under study. All quotes from scientists are accompanied by author's comments. That is, the author shows different points of view on the problem and tries to argue for a more correct one in his opinion. Conclusions, the interest of the readership. The conclusions are fully logical, as they are obtained using a generally accepted methodology. The article may be of interest to the readership in terms of the systematic positions of the author in relation to issues of ensuring the stability of legislation in the field of telemedicine.
Based on the above, summing up all the positive and negative sides of the article, "I recommend publishing"