On the effectiveness of regulatory restrictions in conducting telemedicine consultations

Makarov Vladislav Olegovich ORCID: 0000-0002-3818-6328 PhD in Law Senior Researcher at the Research Laboratory «Legal Regulation in the context of digitalization», Volgograd State University 400002, Russia, Volgograd region, Volgograd, Universitetskiy Prospekt, 100 makarov.legal@gmail.com

Kovalenko Mariya Andreevna ORCID: 0000-0002-8412-7900 Junior Researcher at the Research Laboratory «Legal Regulation in the context of digitalization», Federal State Autonomous Educational Institution of Higher Education Volgograd State University 400002, Russia, Volgograd region, Volgograd, Universitetskiy Prospekt, 100 veruver@mail.ru Other publications by this author

The practice of using telemedicine technologies has revealed a number of problems and limitations of the legal regulation introduced in 2017, which include, for example, the inability to establish a diagnosis, remote monitoring and correction of treatment only by the attending physician ^[5]. Despite the fact that the legislative possibility of using telemedicine technologies has existed for a long time, telemedicine has not received significant distribution, which, in our opinion, is due to regulatory restrictions.

At the same time, in 2020, in connection with the adoption of Federal Law No. 258-FZ dated 07/31/2020 "On experimental legal regimes in the field of digital innovations in the Russian Federation", the concept of "experimental legal regime in the field of digital innovations", new for domestic science and legal practice, appeared in Russia. A similar name was introduced to denote the legal institute of regulatory sandboxes – special legally stipulated experimental legal regimes limited in time and subject matter aimed at testing digital innovations by applying exceptions to participants from the current legal regulation and implemented under the control of a legislatively defined regulator ^[12]. The emergence of this mechanism is due to the fact that modern digital innovations often do not fit into the established legal regulation. Attempts to test a particular technology in practice face limitations in current legislation. In order to overcome such limitations, an experimental legal regime is being established.

In the framework of this article, general scientific research methods (analysis, synthesis, abstraction, deduction, induction, and others) were used to achieve these goals. Due to the specifics of the topic under consideration, special legal methods of cognition of legal reality (formal legal, historical legal) were also applied. 

One of the envisaged directions for the development of digital innovations is the use of telemedicine technologies and technologies for collecting and processing information about the state of health and diagnoses of citizens, which created a legal opportunity to establish experimental legal regimes in the field of telemedicine.

In 2021, the current legislation is being harmonized, that is, the stage of regulatory preparation for the establishment and conduct of legal experiments in the medical field begins by adopting Federal Law No. 331-FZ dated 07/02/2021 "On Amendments to Certain Legislative Acts of the Russian Federation in connection with the adoption of the Federal Law "On Experimental Legal Regimes in the Field of Digital Innovations in the Russian Federation Of the Russian Federation"", which establishes a list of those articles of existing federal laws that may potentially be subject to "freezing" on the basis of a Government decision to establish a specific experimental legal regime. Article 9 of this law lists the relevant provisions of medical legislation (the law on the basics of public health protection), thereby removing potential obstacles to conducting experiments in the field of telemedicine ^{[6, p. 572]}.

During this period, a number of legal studies are being published analyzing the submitted but not accepted projects in the field of telemedicine, as well as predicting the prospects for the development of telemedicine within the framework of experimental legal regimes ^{[5; 6]}.

The direct implementation of experimental legal regulation of digital innovations in the field of telemedicine begins in 2023.

On 07/18/2023, within the framework of the aforementioned Federal Law "On Experimental Legal Regimes in the field of digital innovations in the Russian Federation", the Government of the Russian Federation adopted Resolution No. 1164 "On the establishment of an experimental legal regime in the field of digital innovations and approval of the Program of an experimental legal regime in the field of digital innovations in the field of medical activity, including the use of telemedicine technologies and technologies for collecting and processing information about the health status and diagnoses of citizens."

This resolution expanded the list of purposes for consulting a patient with a doctor using telemedicine technologies. The above two goals were also added: the appointment of laboratory, instrumental and other additional studies; the appointment and implementation of remote monitoring of the patient's health; the appointment (correction) of treatment, provided that the attending physician establishes the diagnosis and prescribes treatment (if any) for the same disease at an in-person appointment (examination, consultation).

However, experimental legal regulation retains the main regulatory limitation of traditional legal regulation, since all of the above actions are possible after the initial face-to-face admission of the patient, made within 30 days before the telemedicine consultation. The liberalization of experimental legal regulation relative to the traditional one in this part consists only in the fact that remote monitoring of the patient's health can be prescribed by a doctor who has not conducted an in-person appointment (examination, consultation) of the same medical organization, whose work experience in the specialty is at least 7 years.

In its absence, only the appointment of the necessary laboratory, instrumental or other additional studies is possible, including remote monitoring of the patient's health, as well as a recommendation to the patient to seek medical help in person in order to establish a diagnosis.

Thus, the patient is not constrained by the restriction in choosing a doctor due to his territorial remoteness from the necessary specialized specialist. When applying for a telemedicine consultation, the patient can be initially examined by a doctor who is located on the territory of the municipality or federal subject in which the patient lives, and then purposefully monitored by a specialized specialist who is a doctor of the same medical organization. In the future, such a design may have organizational consequences, in which there is a primary link of medical workers conducting an initial medical examination, as well as the level of specialized doctors providing follow-up medical care remotely. Thus, the geography is expanding and the availability of medical care for patients is ensured.

Currently, 28 medical institutions are participating in the experiment, but the legislation establishes the possibility of new entities joining the experimental legal regime. Let's assume that the most effective application of telemedicine technologies will be carried out by medical organizations with an extensive structure, assuming the presence of branches. In such a situation, access to healthcare can be ensured for patients living outside large agglomerations.

At the same time, the obligation of face-to-face admission becomes the key limitation that participants in legal relations try to ignore or circumvent. Thus, statistics are provided in the medical scientific literature, according to which doctors often ignore the regulatory prohibition on prescribing medicines during telemedicine consultations ^[8].

In addition, the establishment of a ban on diagnosis, its clarification during remote consultation within the framework of experimental and general regulation in the "doctor-patient" format without a preliminary face-to-face visit to the attending physician on the same request led to the emergence of a shadow sector for online counseling ^{[10, p. 93]}. On the Internet, you can find a significant number of services offering online consultations without face-to-face reception. Let's look at some of them. The HealthMail service provides online text consultations for doctors. On the service's website, you can find anonymous questions from patients (legal representatives) and answers from doctors. After analyzing the answers of doctors, it can be noted that a number of specialists give medical recommendations, some indicate the need for an in-person examination. Each response contains a note that the text consultation is provided solely for reference purposes. However, within the framework of the service, doctors can recommend medications, evaluate their effectiveness and compatibility with others.

Hemotest Laboratory LLC also provides online consulting services. It is indicated that within the framework of the consultation, the patient (legal representative) can provide information about the state of health, complaints. The scope of such consultation includes receiving:

1) recommendations on the need for tests,

2) explanations about the results of medical tests already received,

3) the second opinion of the doctor on the medical opinions issued by other medical organizations,

4) answers about health,

5) an electronic conclusion with conclusions and recommendations.

The service notes that diagnosis, prescribing medications, and prescribing prescriptions are not possible when organizing an online consultation. The website of Laboratory Hemotest LLC contains an offer to conclude a contract for the provision of paid medical services and paid information and advisory services remotely.  The subject of the contract is a service, which means: "medical care in the form of medical advice (written or oral) in remote form within the framework of primary health care on issues within the competence of the Doctor, provided by the Contractor to the Consumer on a reimbursable basis, other information and consulting services provided to the Consumer remotely". Therefore, within the framework of this service, medical remote consultation is one of the information and advisory services. Meanwhile, the right of the customer (consumer) is indicated to receive qualified and high-quality medical care. At the same time, in the specified offer there is a separate clause on the non-application of conditions on the rights and obligations of the Contractor in the provision of non-medical services.

The Medical Response service, as well as HealthMail, provides the opportunity to receive an online text consultation with a doctor. Depersonalized questions and answers from doctors are posted on the service's website.  Mostly doctors give recommendations about laboratory diagnostic tests, but diagnosis is also possible.

Yandex.Health provides the opportunity to receive round-the-clock medical consultations via text messages, audio and video communication. It is noted that within the framework of such a service, a doctor cannot diagnose, write a prescription and adjust treatment due to legislative regulation. But the creators of the service point out that during face-to-face admission, it is also not always possible to immediately establish an accurate diagnosis, therefore, during it, doctors can only give "assumptions".

The aggregator of "Prodoctors" provides a list of doctors, indicating reviews about them, work experience and category, place of work, who can conduct an online consultation. With the help of the Prodoctors website, it is possible to make an appointment for such an online consultation with a selected doctor. Some doctors can only make an appointment for an online consultation after repeated admission.

It seems that information and advisory services in the field of medicine (non-medical) and medical services should be considered.

The legislation of the Russian Federation establishes a legal definition of the concept of "medical service" (paragraph 4 of Part 1 of Article 9 of Federal Law No. 323-FZ dated 11/21/2011 "On the Basics of protecting the health of Citizens in the Russian Federation"). Based on legal provisions, a medical service is a medical intervention or a set of such interventions, the purpose of which is prevention, diagnosis, treatment of diseases, medical rehabilitation. The legislator also defines the term "medical intervention". Medical intervention is the types of medical examinations and (or) manipulations, artificial termination of pregnancy, which can be performed by a medical professional and other employee who has the right to carry out medical activities. Such examinations and/or manipulations affect the physical or mental state of the patient and are aimed at prevention, research, diagnosis, treatment and rehabilitation. In addition, the content of the concept of "diagnostics" is fixed. During the reception (consultation), the doctor performs a diagnosis – "recognition of conditions or establishment of the fact of the presence or absence of the disease." Thus, the medical service is focused on improving health indicators. However, there is a debate in science about what to recognize as the object of medical services – the human body ^{[11, p. 84; 3, p. 22]} or his health ^{[4; 2, p. 14]}.

Meanwhile, the term "information service" in relation to the medical field is not disclosed in Russian legislation. The appearance of such services is due to the dispositivity of the norms of civil law in terms of freedom of contract for the provision of services. In 2019, the concept of a contract for the provision of information services was introduced into the Civil Code of the Russian Federation. However, the additions were related to the establishment of obligations to prevent the dissemination of information received during the execution of the contract to third parties. Based on the current regulation of the service agreement, the parties determine the terms of the agreement by their own will. To establish the content of an information service in the field of medicine, it is necessary to refer to specific examples of contracts. The standard form of the contract for the provision of information services is posted on the website of the DocMa service. By virtue of clause 1.1. of this Agreement, the information service consists in obtaining information from the field of medicine and healthcare from a specialist in a certain field of knowledge. The volume of such information includes information about diseases, their typical symptoms, methods of treatment and diagnosis. It is specifically stipulated that the information received is not a medical opinion, treatment plan, or recommendation. Another area of shadow digitalization of medicine is the provision of services by doctors themselves. Doctors create information resources with which the patient can make an appointment with them for an online consultation, online maintenance, etc. However, due to current legislation, a doctor cannot independently provide medical care, since the license is granted specifically to medical organizations, and the doctor is only accredited. In this regard, doctors who have chosen this way of doing business establish in agreements that they provide information services.

Thus, the patient receives information about possible diseases and treatment methods based on the symptoms and complaints reported to the doctor. Therefore, the patient evaluates this information as a medical recommendation in relation to his clinical case. Patients perceive the information provided in this form as a full-fledged reliable medical consultation. If the doctor specifies the recommended treatment, then patients purchase these medications and do not contact the doctor in person to clarify the treatment. At the same time, the online consultation attribution repeats the traditional method. During the consultation, the patient's medical history and complaints are collected and analyzed, diagnostic tests are prescribed, and documents are issued based on the results of the consultation.

To resolve the issue of the relationship between medical services and information services in the field of medicine, it is necessary to analyze the goals and motives of the patient, forming his will to accept the terms of online counseling. There is no doubt that the patient (consumer) seeks online consultation to resolve problems related to his health. Analyzing the content of contracts for the provision of information services in the field of medicine and information posted on the websites of online consulting services, it can be stated that the information is provided for its use for informational and educational purposes. However, the predominant motive for seeking online consultation is concern about the state of health, the presence of any symptoms, complaints, therefore, the purpose of the patient (consumer) is to use this information to improve health. Despite the reservations in the contract that the information provided is not a medical opinion and treatment strategy, the patient (consumer), based on his motives and goals, will use such information for treatment. Thus, despite the terms of the contract, the patient perceives the service provided to him as medical. In science, another feature for classifying such information services as medical is the collection and study of complaints from a patient (his legal representative) by a specialist in the field of medicine ^{[10, p.96]}.

Having studied the essence of the information service in the field of medicine, it can be stated that it is medical. Its investment in the form of information was made to circumvent the ban on diagnosis without face-to-face admission. The transfer of such a service to the shadow sector may violate the constitutional right of a person to protect his health, including when being held accountable for poor-quality provision of services. For example, a number of scientists note that during a remote consultation, the responsibility of a doctor cannot be assigned due to the fact that the subject of the agreement is an information, not a medical service ^[1]. When conducting online consultations, doctors actually determine the patient's disease and prescribe medications to him, but they do this as recommendations. However, such treatment, if there is a medical error, can lead to harm. The patient, as a weak side, does not have the necessary knowledge to determine the quality and effectiveness of recommendations, therefore, he turns to a medical professional.

In science, as another gap in general regulation, it is noted that there is no time interval after an in-person appointment of the patient, during which he can seek remote consultation ^{[7, p. 185]}. On the contrary, when establishing an experimental legal regime, such a period was established. A condition for the correction of treatment or its appointment is the provision by the patient before the remote consultation of a confirming medical document reflecting information about the physical examination of the patient, carried out no later than 30 calendar days before the day of the initial treatment. It is worth noting that the patient may have a chronic disease, in connection with which he is observed by a doctor for a long time. In such a situation, the time interval from an in-person examination to a remote consultation seems unnecessary. In addition, not all types of diseases require a physical examination.  Changes have been made to the legislation in the field of health protection, according to which clinical recommendations must be followed when providing medical care. Therefore, when conducting an in-person appointment, the doctor should be guided by clinical recommendations to establish a diagnosis and collect anamnesis, complaints. After reviewing them, you may find that a physical examination may not be performed in some cases. For example, the clinical recommendation "Aniridia innate" indicates that a physical examination will not lead to the collection of necessary medical information. In the clinical recommendation "Primary angle-closure glaucoma" there is also no indication of a physical examination for diagnosis. Consequently, the establishment of a mandatory requirement for the availability of physical examination results to adjust treatment and prescribe treatment restricts the rights of patients whose diseases do not provide for its implementation.

As a result of the conducted research, it can be concluded that, fixed in both traditional and experimental legal regulation of the use of telemedicine services, the obligation of primary face-to-face admission becomes a legal norm that participants in legal relations often violate or try to circumvent using the dispositivity of civil law norms. This consequence is the basis for a subsequent discussion about the effectiveness of the current legal regulation, attempts to test its various options through legal experiments, as well as to develop the most appropriate legal structures in the context of smart legal regulation.