International legal regulation of medical care using telemedicine technologies

Grigorev Ivan Vladimirovich PhD in Law Associate Professor; Department of Labor Law; Ural State Law University named after V.F. Yakovlev 620137, Russia, Sverdlovsk region, Yekaterinburg, Komsomolskaya str., 21 adarichi@mail.ru Other publications by this author

In the context of the "fourth industrial revolution", digital infrastructure is necessary for the sustainable functioning of both public and private healthcare systems ^[1], and its use in the exercise of citizens' rights to health protection and medical care is especially important for socially vulnerable groups of the population and people living in remote areas ^[2]. In the messages of the President of the Russian Federation to the Federal Assembly in recent years, attention has been focused on the need to "use the accumulated technological experience to make a breakthrough in improving people's quality of life, modernizing the economy and public administration"; "forming our own digital platforms compatible with the global information space, adopting a general scheme for the development of the digital economy infrastructure, including telecommunications networks, data storage and processing capacities"; "connecting all hospitals and polyclinics to high-speed Internet, which will allow doctors even in a remote city or village to use telemedicine capabilities, quickly receive consultations from colleagues from regional and federal clinics"; and "the Covid-19 epidemic has accelerated the introduction of telemedicine in Russia everywhere and many times" and required "...the adoption of appropriate legislative measures aimed at securing guarantees for the protection of citizens' rights and ensuring public health" ^[3]. Parallel improvement of the legislative framework, together with the adaptation of new technologies, is a key moment in the process of infrastructure development to ensure successful digital transformation in the field under consideration ^[4].

Recently, many scientific events have been held where discussions are held about the advantages and disadvantages of new technologies from the point of view of public health. The problems of telemedicine still generate a lot of heated discussions, despite the fact that the ideas of its global implementation have been implemented for decades ^[5], while the majority of citizens (almost 80% of respondents) are familiar with telemedicine and are ready to evaluate its quality ^[6]. For a long time, the relationship between doctor and patient was based solely on the "friendly attitude of the doctor to the patient and the patient's trust in the attending physician" ^[7], developed during face–to-face meetings and the introduction of new practice - telemedicine technologies often leads to a break in communication between the doctor and the patient, which is often the cause of dissatisfaction and complaints from patients ^[8].

Of course, the provision of medical care using telemedicine technologies requires detailed legal regulation ^[9] by national law, despite the fact that, in accordance with part 4 of Article 15 of the Constitution of the Russian Federation, it should not contradict generally recognized principles and norms of international law. The above makes it possible to draw an unambiguous conclusion about the relevance and necessity of a comprehensive study of the regulation of relations in the provision of medical care using telemedicine technologies.

Being an integral part of the Russian legal system, generally recognized international principles and norms play an essential role in regulating the social security of citizens (despite the fact that they regulate the behavior of participants to a limited extent ^[10]), since they not only oblige states to create a national social security system; they consolidate the right to security, the conditions for its provision, but also and they set guidelines-guarantees of the amount of security (acting as "international standards of social security" or "minimum guarantees of citizens' rights to social security" ^[11]). Medical care, as an element of social security, is characterized by all the above-mentioned features of international legal regulation.

International acts on the provision of medical care using telemedicine technologies can be classified for various reasons. The first is the legal force of international norms, determined in accordance with Resolution No. 5 of the Plenum of the Supreme Court of the Russian Federation dated October 10, 2003 "On the Application by Courts of General Jurisdiction of Generally Recognized Principles and Norms of international Law and International Treaties of the Russian Federation." Paragraph 8 of the Resolution stipulates that the rules of an existing international act of the Russian Federation, the consent to be bound of which was adopted in the form of a federal law, have priority in application to the laws of the Russian Federation; the rules of an existing international treaty, the consent to be bound of which was not adopted in the form of a federal law, have priority in application to subordinate regulations, issued by the public authority that concluded this agreement. Thus, international acts can be classified into: a) having priority over federal laws and b) having priority over subordinate regulatory legal acts adopted by the President of the Russian Federation or the Government of the Russian Federation.

The second basis for classification is the subject-territorial scope of international sources, according to which international normative legal acts on health protection and medical care using telemedicine technologies can be divided into four groups: the first includes international legal acts of a universal nature, such as the Universal Declaration of Human Rights (adopted by the UN General Assembly on 10.12.1948), the International Covenant on economic, social and cultural rights (Adopted at the plenary session of the UN General Assembly on 12/16/1966) and others; the second group consists of acts of regional significance, for example, adopted within the framework of the Commonwealth of Independent States (the opinion on the expediency of ensuring the development of the agenda in the field of health protection within the framework of the BRICS ^[12], the Eurasian Economic Union [13 or the Shanghai Cooperation Organization [14]); the third group consists of bilateral international treaties and agreements; the fourth – acts of specialized agencies – the International Labor Organization and the World Health Organization ^[15].

The study of the Universal Declaration of Human Rights and the International Covenant on Economic, Social and Cultural Rights leads to the conclusion that these acts only consolidate the right to health protection and medical care, therefore their norms should be considered starting points for the development of international law^[16], whereas agreements have been concluded within the framework of the Commonwealth of Independent States, in detail regulating the provision of medical care using telemedicine technologies ^[17].

So by the Agreement of November 10, 2010. "On cooperation of the CIS member States in the creation of compatible national telemedicine systems and their further development and use" establishes the need for the Parties to create joint national telemedicine systems or to ensure compatibility of existing national telemedicine systems in order to ensure conditions in the member States of the Agreement for the provision of qualified telemedicine services with the protection of the rights and legitimate interests of individuals and legal entities guaranteed by the States individuals in the process of receiving and providing medical care. According to the Agreement, the main tasks solved by compatible national telemedicine systems include: public service and provision of high-quality medical care to the population regardless of place of residence; ensuring accessibility and a high standard of quality of medical care; development of scientific and industrial fields related to telemedicine; development of regulatory support for cross-border telemedicine services; accelerated exchange and implementation introduction of modern medical techniques into healthcare; implementation of various special programs for the provision of telemedicine services; provision of an effective system of training and retraining of medical personnel; creation of effective mechanisms for building and operating compatible national telemedicine systems; training, advanced training and certification of telemedicine specialists.

In addition, the Agreement provides for the obligation to adopt specific national regulations necessary for the creation and effective operation of compatible national telemedicine systems, which should clearly define: issues of operation of compatible telemedicine systems; measures to protect human and civil rights and freedoms in the operation of compatible telemedicine systems; the possibility of using compatible telemedicine systems to provide highly qualified medical care. assistance to the population; the procedure for collecting and accessing information contained in compatible telemedicine systems; the powers, responsibilities and interaction of national executive authorities involved in the development and operation of compatible telemedicine systems; the procedure for documenting, processing, storing, presenting, using and protecting information in compatible telemedicine systems; the procedure for developing and introducing standards in the field of creation and use of compatible telemedicine systems, harmonized with international standards, necessary to ensure the functioning of compatible telemedicine systems.

In this group of regulations, special attention should be paid to the Model Law "On Telemedicine Services", adopted on October 28, 2010 by Resolution 35-7 at the plenary session of the Interparliamentary Assembly of the CIS member States in St. Petersburg (model regulation for the countries of the Commonwealth of Independent States is one of the forms of harmonization and unification of legislation ^[18]). Article 2 of the Model Law defines the concept of "telemedicine" as a set of organizational, technological and financial measures that ensure the operation of a remote consulting and diagnostic medical service system, in which a patient or a doctor who directly conducts an examination or treatment of a patient receives remote medical advice using modern information and communication technologies, and "telemedicine services" mean delayed consultations, real-time consultations, remote monitoring of the physiological parameters of the patient's body, remote diagnostic and therapeutic manipulations, medical videoconferences, teleconferences, teleseminars, telelections and other medical services provided using modern information and communication technologies. In our opinion, medical videoconferences, teleseminars, telelections, and advanced training of medical professionals should not be covered by the concept of telemedicine services, since they pursue other goals than receiving "remote consultation by a patient or doctor."

The analyzed act includes among the participants in the process of providing telemedicine services: suppliers; consumers; providers and telecommunication operators. At the same time, it is noteworthy that consumers of services can be not only individuals, but also legal entities, which is atypical for Russian legislation, where medical care is provided only to individuals. The legal status of the above-mentioned participants is determined in detail by Chapter 4 of the Model Law. Attention is drawn to the provisions related to informed consent for telemedicine services, which "must be documented at the place of application for telemedicine services and communicated to all participants in the telemedicine service provision process." We support the authors who consider questionable the provisions on the need to duplicate information about services in digital form on paper, as this complicates the process of providing medical care and reduces the convenience of telemedicine, requiring significantly more time ^[19].

Unfortunately, despite the existence of the Model Law for more than fourteen years, the CIS countries have not yet adopted legislation based on it. We believe that the provisions of the Model Law under consideration should serve as a guideline for national legislators, despite the fact that its provisions are advisory in nature.

Bilateral interstate cooperation in the field of health protection and medical care has not been widespread. Currently, there is one bilateral agreement in this area – the Agreement on the provision of medical care between the Government of the Russian Federation and the Government of the Republic of Belarus dated January 24, 2006 "On the procedure for providing medical care to citizens of the Russian Federation in healthcare institutions of the Republic of Belarus and citizens of the Republic of Belarus in healthcare institutions of the Russian Federation." This Agreement guarantees citizens of the Republic of Belarus legally residing in Russia and working in institutions (organizations) of the Russian Federation equal rights with citizens of the Russian Federation to receive medical care, but exclusively in state and municipal healthcare institutions of the Russian Federation. The issues of medical care using telemedicine technologies are not regulated by the Agreement under consideration due to the fact that there was no corresponding need at the time of its conclusion, however, we do not exclude the possibility of new bilateral agreements in which the issues under consideration will be consolidated.

The International Labour Organization (ILO) pays considerable attention to the issues of workers' health protection. The importance of the ILO acts lies in the existence of an effective monitoring mechanism based on government reports and the analysis of submissions and complaints ^[20]. At the same time, the provisions concerning telemedicine are fragmentally fixed only in the Convention of the International Labour Organization No. 164 "On Health and Medical Care for Seafarers" (concluded in Geneva on 08.10.1987, as amended. dated 02/23/2006). Article 7 defines the obligation of the competent authorities of States to ensure that ships at sea receive medical advice by radio or satellite, including specialist advice, at any hour of the day or night. Consultations should be free of charge for all courts, regardless of the territory of their registration ^[21]. Despite the risks of medical errors during telephone consultations ^[22], they remain the only ones available to the category of patients under consideration. To ensure optimal use of the possibilities of receiving medical care using telemedicine technologies, ships should be equipped with radio installations, have a complete list of radio stations through which medical advice can be obtained, and also have a complete list of shore-based ground stations through which medical advice can be obtained. These lists should be periodically updated and kept by those responsible for communications on on board the ship. For vessels of the Russian Federation, medical consultations by radio are carried out through the marine rescue coordination subcenter, and if possible, by telephone directly with the consulting specialist, which is preferable ^[23].

Perhaps the main place in the international regulation of relations in the provision of medical care using telemedicine technologies is occupied by the documents of the World Health Organization, a specialized agency of the United Nations, which is the governing and coordinating body in international health work. The main goal of the World Health Organization is to achieve the highest possible level of health for all peoples (Article 1 of the Charter of the World Health Organization, Official website of the World Health Organization). To achieve its goals, it uses the introduction of "soft law" provisions – informal sources that are not given regulatory significance, but which are tacitly recommended for practical application ^[24]. The "research results", "reports", various "strategies" and the recommendations contained in them actually become binding on the Member States of the Organization.

In relation to medical care using telemedicine technologies back in 2009. The World Health Organization conducted a study in the field of e-health in order to obtain general information on the state of development of this area. The study covered 114 countries (59% of Member States) that started using the available telemedicine elements at that time. The result of the study was the report "Global Observatory on Electronic Health Care" (Telemedicine. Opportunities and Development in Member States. Report on the results of the second global eHealth survey Global Observatory on eHealth Series 2012; 2: 93.), according to which obstacles to the introduction of telemedicine in developing countries are resource problems ^[25], such as high cost, underdeveloped infrastructure and lack of technical knowledge, and in developed countries – legal problems related to the problem of protecting the privacy and personal data of patients ^[26], as well as competing priorities of the healthcare system and the alleged lack of demand. In our opinion, the problems of legal regulation of relations in the provision of medical care using telemedicine technologies should be placed in one of the first places, along with financial and personnel barriers ^[27], since modern legal regimes are not adapted to the technologies being introduced. Because of this, experimental legal regimes are often introduced ^[28], which are met with widespread misunderstanding and rejection.

In 2018, the Health Assembly, in its resolution, called for the development of a Global Digital Health Strategy to support national efforts to achieve universal health coverage (Draft global digital health strategy 2020-2025). The World Health Organization has also developed an online platform for the global registry of technologies, called the Digital Health Atlas, designed to improve coordination of digital health activities on a global scale and provide specialists with access to modern advanced software products in this field, which can also contribute to the "introduction of computer algorithms to clinical data." for medical purposes" ^[29].

In 2019 The World Health Organization has developed the WHO Guideline (recommendations on digital interventions for health system strengthening), which contains 10 recommendations on the use of digital technologies to improve human health. The recommendations are based on a systematic study of evidence related to digital technologies, consultations with experienced specialists from around the world in order to develop the main directions for using these tools to maximize the benefits for health systems and human health. One of the measures of digital healthcare, which has already proven itself in a number of regions, is sending pregnant women reminders about the need for another visit to the doctor during prenatal care ^[30] and the appearance of children for vaccination. Other digital health measures studied include decision support tools to help healthcare workers provide medical services; as well as tools to enable patients and healthcare workers in different locations to connect and participate in consultations on medical issues. In addition, the recommendations highlight the possibilities for improving inventory management: digital technologies enable healthcare professionals to more effectively share information about the state of necessary funds or their shortage.

Summarizing the above, it can be stated that existing international regulations establish norms that allow citizens to exercise the right to various types of medical care, including using telemedicine technologies, and some of them define in some detail the procedure for its provision. At the same time, the existence of a considerable number of international "de facto regulatory documents" that are not mandatory, but are actively implemented by States, deserves a negative assessment.