On the legal possibility of making a diagnosis during remote counseling

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 introduction of telemedicine technologies is natural due to the digitalization of society. These technologies make it possible to reduce the importance of the geographical factor in the provision of medical services, minimize the costs not only of the patient, but also of the state in the field of healthcare, respond in a timely manner to changes in the patient's health status, as well as receive more complete medical information about him. Due to the special value of health protection as an inalienable human good, it is important to establish an adequate and harmonious legal regulation that could take into account the interests of all parties to the provision of medical care.

The methodology of this research consists in the use of general scientific methods of cognition of the surrounding reality (synthesis, analysis, abstraction, deduction, induction, and others), as well as special legal methods, which is due to the subject of the scientific article.

Among the scientists considering the problems of legal regulation of telemedicine, remote consultation and diagnosis based on its results, it is necessary to single out A.V. Vladzimirsky, I.A. Shaderkin, S.P. Morozov, S.S. Simenyur, B.V. Zingerman, N.E. Shklovsky-Cordi, A.I. Vorobyov, A.V. Buyanova, D.V. Voshev., N.A. Voshev, I.M. Son, O.M. Drapkin, etc. However, the legal issues of drawing up a medical report for remote consultation have not been sufficiently developed in the scientific community.

In 2017, the possibility of conducting remote consultations between a doctor and a patient (his legal representative) was legislatively established by introducing Article 36.2 "Features of medical care provided using telemedicine technologies" into Federal Law No. 323–FZ dated 11/21/2011 "On the Basics of Public Health Protection in the Russian Federation".

This article prescribes that when conducting a remote consultation using digital technologies, the procedure established by the authorized federal government body should be guided. Also, when carrying out such a consultation, the requirements set out in the standards of medical care must be met. Standards of medical care are approved by orders of the Ministry of Health of the Russian Federation for various categories of diseases. For example, Order of the Ministry of Health of the Russian Federation No. 572n dated 10/25/2023 "On approval of standards of medical care for adults with Parkinson's disease, secondary Parkinsonism, Parkinsonism in multisystem degenerations", Order of the Ministry of Health of the Russian Federation No. 1514n dated 12/24/2012 "On approval of the standard of primary health care for organic, including symptomatic, mental disorders, psychoses in connections with epilepsy in outpatient conditions of a neuropsychiatric dispensary (dispensary department, office)".

The procedure for organizing and providing telemedicine care was approved by Order No. 965n of the Ministry of Health of the Russian Federation dated 11/30/2017 (hereinafter also referred to as the Procedure for Organizing and Providing Telemedicine care).

Neither Article 36.2 of Federal Law No. 323–FZ dated 11/21/2011 "On the Basics of Protecting the Health of Citizens in the Russian Federation" nor the Procedure for Organizing and Providing telemedicine medical care contain such a purpose of remote consultation as issuing a medical opinion. However, such a goal is set as prevention, collection, analysis of patient complaints and anamnesis data, evaluation of the effectiveness of therapeutic and diagnostic measures.

Meanwhile, the Procedure for organizing and providing telemedicine care highlights as the purpose of remote interaction of medical workers the preparation of a medical report of an employee of another medical organization. This conclusion is of an evaluative and advisory nature. According to subparagraph "a" of paragraph 2 of the Procedure for the organization and provision of telemedicine care, the limits of such a conclusion include:

– assessment of the patient's health status;

– clarification of the diagnosis;

– finding out the prognosis and tactics of medical examination and treatment;

–assessment of the feasibility of transferring to a specialized department of a medical organization or medical evacuation.

Thus, this medical opinion is based on a review of the primary medical information received by the attending physician, or on the already formed judgments of the attending physician about the necessary medical measures.

Paragraph 17 of the Procedure for the Organization and provision of telemedicine care provides for two types of teleconsultations – in real time and deferred consultations. In science, such types of consultations are also commonly referred to as asynchronous and synchronous ^[2,3].

During the postponed consultation, there is no face-to-face and remote interaction between the consultant, the attending physician and (or) the medical professional who performed the diagnostic study, and (or) the patient (his legal representative). In this paragraph, there are no conditions for conducting a deferred remote consultation, including about the subject who has the right to request it, the content of the medical report. Only the actions of the consultant during the deferred consultation are indicated – the examination of the patient's medical documents, other medical information about his state of health, the preparation of a medical report. A logical question arises: "Is it possible to make a diagnosis during a delayed consultation?". For example, a medical professional conducts a diagnostic examination – MRI, ultrasound, etc. Considering the results of these diagnostic studies, does the consultant have the right to establish a diagnosis? It is also not indicated whether the patient needs to contact a medical organization in person. In such a situation, the doctor who issues a medical report may not have face–to-face contact with the patient. I.I. Chekhonadsky, V.S. Skripov, N.V. Semenova, A.A. Shvedova, L.V. Malyshko during the study of remote consultations conducted in the format "doctor-doctor" between the State Medical Institution "Orenburg Regional Clinical Psychiatric Hospital No. 1" and the Federal State Budgetary Institution "V.M. Bekhterev National Medical Research Center of Psychiatry and Neurology" in 2019-2020, found that 82.4 percent of consultations were conducted asynchronously. The main goals of such consultations were: "clarifying the diagnosis (25.6%), clarifying the patient's treatment tactics (17.6%), clarifying the diagnosis and treatment tactics (56.8%)" ^{[5, pp. 75-76]}.

From the content of paragraph 17 of the Procedure for the organization and provision of telemedicine care, it is impossible to determine whether it applies to remote consultations in the format "doctor – patient (his legal representative)". This item is located in section IV "Consultations (consultations of doctors) in the provision of medical care in real time, deferred consultations". It is located between the sections that establish the rules of remote interaction in the doctor–doctor format.  The provisions governing the procedure for teleconsultation of a doctor with a patient (his legal representative) are fixed only in section IX. We believe that this section is used to regulate the participation of a consultant physician during remote consultations in the "doctor–doctor" format.

This is evidenced by the following:

– Section IV provides for the participation of a consultant physician, an attending physician (medical professional) and a patient in the consultation.

– Section IX indicates the patient (his legal representative) and the medical professional as participants in the teleconsultation "doctor–patient (his legal representative)". Simultaneous participation of the attending physician and the consultant physician is not provided.

When determining the possibility of a diagnosis by a consultant physician during a deferred consultation, it seems necessary to follow paragraph 2 of the Procedure for organizing and providing telemedicine care. It indicates only the clarification of the diagnosis. However, in practice, there may be situations when the consultant physician completely disagrees with the established diagnosis. For example, in the study of remote consultations conducted between the Orenburg Regional Clinical Psychiatric Hospital No. 1 and the V.M. Bekhterev National Medical Research Center for Psychiatry and Neurology in 2019-2020, according to the results of 47.1% of remote consultations, the diagnosis established by the attending physician was revised ^{[5, p. 76]}.

In the case when a remote consultation is conducted by the attending physician to the patient (his legal representative), then clarification of the diagnosis, its determination is possible only if the patient has already visited the medical organization where this doctor works in person with the same treatment.

We believe that it is inappropriate to establish a differentiated approach to the possibility of clarifying the diagnosis during remote counseling without previous face–to–face interaction between the doctor and the patient, depending on the form of interaction ("doctor-doctor", "doctor-patient").

With regard to the medical report, the following can be noted. There is no legal definition of a medical report in the legislation of the Russian Federation. However, the term "medical report" is often used in the labor legislation of the Russian Federation. In particular, a medical report necessitates the transfer of an employee to another job (Article 73 of the Labor Code of the Russian Federation). Until 2020, there were also no regulatory legal requirements for the content of a medical report. By Order of the Ministry of Health of the Russian Federation No. 972n dated 09/14/2020, the Procedure for issuing certificates and medical reports by medical organizations was approved. It indicates that the issuance of a medical report is possible on the basis of a person's request for it. Meanwhile, in the order of organization and provision of telemedicine care, a rule is established on the preparation of a medical opinion based on the results of remote interaction in the formats "doctor–doctor" and "doctor–patient". Paragraph 49 of this procedure establishes the possible content of a medical report formed during a remote consultation of a patient (his legal representative) without prior face-to-face appointment. Such a medical report may include a recommendation to conduct preliminary examinations when deciding on the organization of an in-person appointment. At the same time, during the remote consultation of the patient, the attending physician (consultant) cannot be diagnosed, only the correction of previously prescribed treatment is possible. Meanwhile, it is not indicated whether another diagnosis can be made or it can be clarified. Therefore, the medical report issued to the patient after such a consultation cannot contain a conclusion about the patient's diagnosis. However, paragraph 14 of the Procedure for issuing certificates and medical reports by medical organizations indicates that the medical report includes reasonable conclusions about the presence (absence) of a disease (condition) in the patient. It seems that this provision conflicts with the provisions of the Procedure for the organization and provision of telemedicine care.

Also, the lack of medical information is indicated as an imperfection of remote consultation for making an accurate diagnosis. However, this disadvantage is inherent in traditional consultations. It is noted that it is necessary to use interactive questionnaires in remote counseling. This method will allow the doctor to additionally collect information about the patient that is significant for determining treatment ^{[6, pp. 49-50]}.

I.A. Shaderkin, analyzing the reasons for the regulation of the prohibition on the diagnosis of a patient by the attending physician without his prior face-to-face appointment during a remote consultation, points out their unjustifiability. As the reasons for the appearance of such a ban, he highlights the significant interest of business structures in its removal, the conservatism of doctors, their inexperience in making a diagnosis without direct face–to-face interaction with the patient. The scientist reasonably objects to such a ban, focusing on the fact that not at every face-to-face appointment, the attending physician conducts a physical examination of the patient to establish the diagnosis ^[6]. Another reason that doctors prefer to determine the diagnosis during an in-person appointment is to record the progress of a remote consultation. With the use of digital technologies, it is possible to record the consultation, identify the mistakes of the doctor that led to an incorrect diagnosis ^{[6, p.49]}.

Foreign scientists are also convinced of the effectiveness of using digital technologies to diagnose diseases. For example, M.A. Qadir and A. Hasnain were able to identify skin diseases present in patients from photographic images ^[7].

Back in 2004, A.V. Vladzimirsky, during teleconsultations, revealed that the accuracy of diagnosing injuries and diseases, according to resources transmitted using digital technologies, is 88 percent ^{[1, p. 58]}. Due to the improvement in the quality of electronic technologies, it can be assumed that the effectiveness of diagnosis cannot be reduced compared to 2004, but, on the contrary, should increase. This indicates the minimization of possible medical errors when making diagnoses. At the same time, they can also be fixed during traditional patient counseling. However, in 2020, A.V. Vladzimirsky, together with S.P. Morozov and S.S. Simenyura, conducting a test of online medical services using simulated patients, spoke negatively about the quality of remote consultations organized by doctors. Based on the data obtained, the authors found that only in 25 percent of cases a targeted diagnosis was made, "and targeted appointments were made in 50 percent of cases." As a significant drawback of the remote consultation methodology in the analyzed cases, scientists point to the lack of patient support for seeking emergency medical care, monitoring the implementation of this recommendation. However, the results of this study indicate the need to develop a methodology for conducting remote consultation, including highlighting its stages, as well as ways to monitor the medical care provided ^{[4, pp. 60-61]}.

Based on the above, there are conflicts in the legal regulation of the general provisions of the content of the medical report and the content of the medical report during remote consultation. At the same time, there is no indication in the general rules of the possibility of special rules. In addition, a number of authors consider it possible to make a diagnosis and, accordingly, indicate it in a medical report as part of a doctor–patient teleconsultation. However, a legislative ban has been established on making a diagnosis without an in-person preliminary appointment of the patient by the attending physician. Also, a consultant physician, when giving a medical opinion during a deferred consultation, can review the diagnosis only on the basis of medical information, without conducting a physical and visual examination of the patient. I think it is necessary to mitigate this prohibition. It has been found that in certain areas of medicine – dermatology, psychiatry, neurology, etc., it is possible to establish an accurate diagnosis using digital technologies. We believe that it is necessary to create a standard for the provision of telemedicine care, which will be able to take into account the specifics of diagnosis, depending on the nature of treatment, disease, patient's condition and other circumstances that may affect the reliability of the diagnosis.