The role of telemedicine in ensuring the accessibility and development of medical care in Russia, United States of America and India

By nature, modern telemedicine projects are divided into analytical, informational, educational and clinical. By geographic prevalence they are international (17%), nationwide (16), regional (40) and local (27%) [27]. Most are multi-purpose. In almost half of all cases (about 48%) such projects are related to tele-education. One in four provides for the use of new information transfer channels for the needs of the administration and management. In 23% of telemedicine programs used for medical care of residents of remote and rural areas [27].

A positive aspect of such a system is the high qualification specialists providing consulting services. Another of its advantages is the possibility of undergoing a course of classical treatment on the basis of a consulting medical institution

On January 1, 2018, the Federal Law on Telemedicine No. 242- dated July 29, 2017 was implemented. The law is related to “Making amendments to certain legislative acts of the Russian Federation on the application of information technologies in the healthcare sector” [27].

Thanks to the order of the Ministry of Health No. 4n of January 14, 2019, medical institutions were able to write electronic prescriptions. Recently, the Ministry published a draft order authorizing the issuance of prescriptions for narcotic substances in electronic form. Now the project is at the stage of public discussions and independent anti-corruption expertise.

In addition, you cannot dwell on one group of documents. An important role in the system of regulation of telemedicine activity belongs to state standards (GOSTs).

The first of the "telemedicine", probably, can be considered GOST R 52636-2006 - "Electronic medical history.

A number of standards were introduced in 2017. First of all, it is GOST R 577572017 “Remote evaluation of the parameters of functions vital for human life. General requirements - This document is directly related to the remote monitoring of the patient's health status.It is noteworthy that this involves not only doctors, but also consulting specialists.

Standards are designed to unify the general requirements for technologies and processes for obtaining data, transferring and processing data by a doctor (paramedic) parameters of vital functions for human life functions.

What happened over the course of several years: the legislator made an attempt to resolve the legal aspects of the remote provision of medical care and services as part of the remote monitoring and counseling of patients.

Based on the amended norms of the Federal Law No. 323 dated November 21, 2011, “On the Basics for the protection of public health in the Russian Federation ”, the Ministry of Health of Russia issued order No. 965n of November 30, 2017,“ On approving the procedure for organizing and providing medical care using telemedicine technology [27] . " This document governs the provision of the “telemedicine assistance” and provides for remote monitoring and counseling of patients.

In accordance with the law on telemedicine, if necessary, consultations can be carried out remotely. To participate in the consultation through telemedicine, the institution is not required to have a special license. A medical organization may conduct such consultations on the types of care for which it has a valid license. The only requirement for the clinic is the availability of a room equipped for the implementation of such a consultation (consultation).

According to the Order, the participants of the consultation (consultation) in telemedicine are the attending doctor and visiting consultant. In this case, the document strictly complies with the provisions of the Federal Law No. 323. So, the documentation of a consultation conducted using telemedicine does not have fundamental differences from paper recording of procedures conducted in person.

Consultations carried out by means of telemedicine should be drawn up in accordance with the provisions of the Federal Law No. 323, i.e., in electronic form and using enhanced qualified electronic digital signature of all the participants.

However, not all doctors who are usually loaded with work, have any such electronic signature. To get it, a specialist needs to spend a lot of time. In addition, the certificate of such a signature is valid for a limited period of time. There is a big possibility that medical practitioners will massively issue and reissue signatures.

In accordance with the Federal Law No. 323, the preparation of documents and execution of the process are entrusted to the attending physician. As part of telemedicine, he needs to familiarize the participants in the procedure with the medical history and results of the patient's examination, providing consultants with other necessary information.

As a member of the consultation, the attending physician must sign under the documents, which again leads to the issue of the mandatory supply of all specialists with an enhanced qualified electronic digital signature.

Responsibility for medical error lies with the medical organization in which the patient is being treated. This refers to two possible options for providing telemedicine consultations - “doctor-doctor” and also “doctor-patient”.

In the first case, when there is a “remote interaction between medical workers”, in which medical organizations that provide patient care services and counseling medical organizations participate, the medical organization decides on the need for remote counseling and forms a referral. A medical consultation organization prepares a medical report based on the data provided.

The decision about whether to use the recommendations of a consultant in the treatment of a particular patient is made by his/her attending physician. This means that if the recommendations of the consultant led to a violation of the rights of the patient as a consumer, causing harm to his health, then the medical organization in which the patient is being treated will be held civilly liable on the basis of Article 2 of the Federal Law “On the Basics of Protecting Citizens' Health in the Russian Federation” "No. 323” dated November 21, 2011 (hereinafter - the Law 323).

The patient has the right to demand compensation for harm caused to health from the medical organization that provided him with medical care, that is, in which he was treated, but not from the consulting medical organization. In addition, the medical organization in which the patient is being treated, in accordance with Article 403 of the Civil Code of the Russian Federation (Civil Code of the Russian Federation), as a debtor is liable for non-fulfillment or improper performance of the obligation of the consultative medical organization as a third party entrusted with the performance of services medical patient.

The consulting medical organization is responsible for the recommendations provided as a result of the consultation using telemedicine technologies as part of a medical report, before the medical organization that applied such recommendations in the treatment of the patient. If medical care was poor due to the fault of the consulting medical organization, the medical organization that applied the recommendations when treating the patient, after reimbursing the patient for the necessary amount, has the right to contact the medical consulting organization with a claim to return the amounts paid to the patient.

Secondly, the “remote interaction of the medical worker and the patient”, this includes the patient (his legal representative) and the medical consultation organization represented by the medical worker. The consulting medical organization is directly responsible for the patient, whose rights as a consumer may be violated due to poor-quality medical care using telemedicine technologies. At the same time, since in most cases, consulting medical organizations provide patients with medical services remotely using online platforms, the rights of which belong to operators of other information systems, consulting medical organizations should establish redistribution of responsibilities in the case of providing high-quality telemedicine assistance in agreements with operators other information systems for reasons related to the functioning of such an online platform.

The Civil Code of the Russian Federation in article 406.1 allows to include in the contract the obligation of one of the parties to compensate the property losses of the other party that arose in the event of circumstances specified in such an agreement that are not related to violation of obligations under the agreement.

Barriers to the functioning of telemedicine in Russia

Since legislative projects and documents in the field of telemedicine appeared relatively recently in Russia and around the world as a whole, they have a number of shortcomings and problems associated with:

• no telemedicine diagnosis

• legal regulation of telemedicine;

• insufficient protection of personal data;

• licensing of telemedicine activities;

• responsibility of operators operating in this field;

• the need to purchase non-medical equipment;

• issues related to economic incentives for specialists who provide advisory services;

• unification and standardization of information transmitted between different systems and networks.

• lack of personnel

In pursuit of the goal of regulating telemedicine in such a way as to prevent the provision of low-quality medical services, the legislation states it clearly that a diagnosis can only be established if the patient comes to an appointment with a doctor.

The law currently allows the following types of medical services for patients using telemedicine technologies (article 36.2 of the Federal Law of 21.11.2011 N-323as amended on 08/03/2018) "On the Basics of Protecting the Health of Citizens in the Russian Federation").

Primary telemedicine (remote) consultation, which is limited by the possibility of carrying out prophylaxis, collection, analysis of patient complaints and medical history data, evaluating the effectiveness of treatment and diagnostic measures, medical monitoring of the patient's health, is a recommendation on the need for an in-person examination by a doctor.

Remote monitoring of the patient's health status, which can be prescribed by the attending physician (according to Article 2 of the Federal Law of November 21, 2011 No. 323, the attending physician is a doctor who is entrusted with the organization and direct provision of medical care to the patient during monitoring him and his treatment, the attending physician is appointed by the head of the medical organization) or selected by the patient, taking into account the consent of the doctor after a face-to-face appointment to assess the effectiveness of treatment and diagnostic measures, remote counseling on all questions from a patient, it is noted that the concept of “face-to-face admission” appeared in the law only with the introduction of norms on telemedicine, and, apparently, was identified as a need to distinguish between when and for what purposes telemedicine can be applied.

Correction of the treatment previously prescribed by the attending physician, is subjected to the confirmation of a diagnosis and the appointment of treatment in person (examination, consultation).

Thus, in the framework of providing medical care to a patient using telemedicine technologies, a “remote diagnosis” is not allowed, that is, without an in-person visit to a doctor.

To a greater extent, it was precisely these limitations that diluted the excitement of the public. The exclusion of the possibility of making an online diagnosis turns such counseling to a greater extent into impractical services and forces one to look for other forms of service provision.

The next condition is to register the institution in the Federal Register of Medical Organizations of Unified State Information System (UIS) in Healthcare. That is, consultations can be requested and carried out only by those employees who are included in the Federal Register of Medical Workers. Thus, some organizations (mostly non-state owned/private) and medical workers are cut off from telemedicine. This violates the right of patients to choose a medical institution and medical staff, provided for in the aforementioned Law No. 323 and Law No. 326 dated November 29, 2010 “On Compulsory Medical Insurance in the Russian Federation”.

In addition, the telemedicine normative act does not contain a clear regulation on access to information, transfer of information to the Unified State Information System (UIS), conditions for maintaining the confidentiality of the transmitted data and their exchange between users.

The process of studying medical documents “at a distance” is not accurately described. The procedure contains a requirement for the use of a single authentication and identification systemofUIS (part 6 of Article 36.2 of Federal Law No. 323 dated November 21, 2011). That is, for participants in relations related to the provision of telemedicine services, it is necessary to have an account in UIS, and for operators of other information systems to connect to the UIS system .Since it is supposed to provide only municipal and state services, it does not imply an indication of private clinics. Note that access to the system is possible only when using an enhanced and simple qualified electronic digital signature (hereinafter - EDS).

This means that those patients who are not registered in the unified identification system cannot be included in the list of persons who can join remote assistance. Another procedure for the identification of patients in the law on telemedicine is not provided. In this connection, a logical question arises: why do clinics that have requested a consultation cannot identify patients in their system with the subsequent use of data in telemedicine? The fundamental difference between a tele-consilium and similar consilium when a specialist arrives at a medical institution is unclear.

Particular importance is attached to the responsibility of operators who operate in the field of telemedicine, since violation of their duties can cause harm to patients, especially since this may result from insufficient knowledge of specialized equipment by patients and doctors. In such situations, the patient may claim to have been deprived of assistance, indicating that the devices used have ceased to function without warning. Such accusations against operators can be evidence of leaving a person in distress and criminal negligence.

The use of telemedicine systems in the health sector raises the question of material incentives and financing of specialists. Among the currently existing models of remuneration, paid (where the payer is either the state or the patient) and free (based on a collegial or charitable basis) are distinguished. In the Russian healthcare system, the second model is most common. In this case, the costs of medical institutions are minimal, since they include the costs of acquiring and maintaining the availability of computer equipment.Separate remuneration for specialists providing advisory services is not made, which leads to a lack of responsibility and various legal and economic difficulties. A significant drawback of this scheme is the lack of incentives forcing employees to carry out such consultations with full dedication.

Financing the healthcare system closes the existing financial needs of hospitals (payroll, medicines, supplies, fixed assets). This is especially felt by managers on the background of high commitments to pay doctors. Therefore, the vast majority of regions do not even have tariffs for telemedicine services in the direction of “doctor-patient” [27].

Even Moscow is no exception to this list - one of the largest and richest regions of Russia with a progressive approach to the use of modern technologies, including medicine. At the same time, many regions have tariffs for doctor-physician consultations which have only a very insignificant use in telemedicine as a whole - their contribution to the total turnover of telemedicine services makes up almost one percent (1%) of the total demand for telemedicine services, where the main need is a doctor-patient consultation and remote health monitoring [27].

Furthermore, in the hospitals there is a shortage of personnel, primarily doctors (to a greater extent - primary care). At the same time, many medical staff members working in practical care have a pre-retirement, retirement and post-retirement age. This leads to the fact that the doctors are busy, and many of them evaluate telemedicine as an additional burden.

Even if telemedicine services are legalized for clinics in the commercial sector by simplifying the rules for entering the unified register, the question of the profitability of such services still remains unanswered.

Doctors of commercial medicine in telemedicine see an additional source of income for the clinic. They are not as busy as public sector doctors. Although there are risks, not so much in the legal aspects, but in matters of the cost of telemedicine services. Consumers expect that a telemedicine service, such as a doctor's consultation, should cost less than a similar real-time consultation. But, for the clinic, by the time the service is provided, there is no difference between them - these are the resources of the doctor.

A full-time appointment with a doctor, as a rule, costs more than an in-person meeting: a full-time appointment doctor can provide or send a patient for additional services, which together leads to an overall increase in the check. However, if you set a goal to exclude idle resources (when the doctor is not available all the time), or increase your presence in regions where the clinic does not have a full-time representation or needs a competitive advantage, then telemedicine can be a good tool.

The issue of the cost of purchasing third-party equipment (non-medical) when organizing telemedicine centers also presents difficulties. This process requires modern network and computer equipment, the acquisition of video and photo equipment, networking, conclusion of agreements with external telecommunication companies on the provision of network traffic, the allocation of new space and the expansion of staff of non-medical workers.

In order to unify and standardize information, it is necessary to develop a single image transmission format (DICOM) and medical data. Some formats (e.g. EDF and UDF) are already widely used. Nevertheless, the complexity of forming a common set of medical tasks for patients (the so-called electronic medical history), i.e., the results of studies and medical observations that reflect the course of the disease of a particular person, continues to remain unresolved. Many companies are engaged in the creation of such systems, but such developments are only local in nature (within the same network of clinics or a specific medical institution), and not global.

2.3 The problems of Regulation of Telemedicine in India

With the advances in technology, the delivery of healthcare to even remote locations has become feasible through methods like Telemedicine. Yet, the full potential of these advances cannot be reached without legal, clinical and technical standards and guidelines.

Telemedicine technology has been growing rapidly as a new way of medical practice. Unfortunately, the legal and regulatory environment has not progressed as rapidly.

Telemedicine's legal issues mainly fall into two categories:

* The traditional medico-legal issues not unique to the telemedicine; [5]

* Issues unique to telemedicine [5].

Government's commitment in providing equal access to quality care to all and digital health is a critical enabler for the overall transformation of the health system of India. That is why mainstreaming telemedicine in health systems will minimize inequity and barriers to access to quality care. India's digital health policy promotes more and more use of digital tools for improving the efficiency and outcome of the healthcare system and that's why it lays a significant focus on the use of telemedicine services, especially in the Health and Wellness Centers at the grassroots level wherein a midlevel provider/health worker can connect the patients to the doctors through technology platforms in providing timely and best possible care.

However, there have been concerns on the practice of telemedicine. Lack of clear guidelines has created significant ambiguity for registered medical professionals, raising too many questions &doubts on how to practicetelemedicine. The 2018 judgment of the Honorable High Court of Bombay had created uncertainty about the place and legitimacy of telemedicine because there was no existence of an appropriate framework.

But very recently the Medical Council of India and the NITI Aayog (Policy Commission) developed new guidelines released on March 25, 2020 for registered medical practitioners to consult patients via telemedicine [23].

The aim of the guidelines is to empower registered doctors to reach out to patients safely especially in the wake of a pandemic COVID-19, using technologies for the exchange of valid informationfor diagnosis, treatment and prevention of disease and injuries, research and evaluation and for continuing the education of healthcare providers.

The guidelines have empowered and restricted the medical practitioners at the same time. Registered medical practitioners (RMP), for instance, have to take the patient's consent.

The guidelines for providing telemedicine services laid down by the Medical Council of India and NITI AYOG are new, not time-tested and have some specificities.

Not applicable to Indian medicines:-

The Telemedicine Guidelines do not apply to practitioners of Ayurveda, Yoga, Homeopathy, Unani or Siddha [24].

Prescribing Medicines:

Prescribing medications, via telemedicine consultation is at the professional discretion of the Registered Medical Practitioner (RMP). It calls for the same professional accountability as in the traditional in-person consultation. RMP may prescribe medicines via telemedicine ONLY when RMP is satisfied that he/ she has gathered enough information about the patient's medical condition and prescribed medicines are in the best interest of the patient. Prescribing Medicines without an appropriate diagnosis/provisional diagnosis will equivalent to a professional misconduct. There are certain limitations on prescribing medicines on consultation via telemedicine depending upon the type of consultation and mode of consultation. The categories of medicines that can be prescribed are listed below:

List O: It will comprise of those medicines which are safe to be prescribed through any mode of tele-consultation. In essence they would comprise of o Medicines which are used for common conditions and are often available `over the counter' [24].

List A: This list comprises of those medicines which can be prescribed during the first consultation which is a video consultation and are being re-prescribed for re-fill [24].

List B:Is a list of medicines for patients who are undergoing follow-up consultation[24].

Prohibited List: A registered medical practitionercannot prescribe medicines from this list. These medicines have a high potential of abuse and could harm the patient or the society at large if used improperly. Medicines listed in Schedule X of Drug and Cosmetic Act and Rules or any Narcotic and Psychotropic substance listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985 [24].

In India, till now there was no legislation or guidelines on the practice of telemedicine, through video, phone, Internet based platforms (web/chat/apps etc) [24]. The existing provisions under the Indian Medical Council Act, 1956, the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 2002), Drugs &Cosmetics Act, 1940 and Rules 1945, Clinical Establishment (Registration and Regulation) Act, 2010, Information Technology Act, 2000 and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 primarily govern the practice of medicine and information technology. Gaps in legislation and the uncertainty of rules pose a risk for both the doctors and their patients.

Telemedicine will continue to grow and be adopted by more healthcare practitioners and patients in a wide variety of forms, and these practice guidelines will be a key enabler in fostering its growth.

2.4 Comparative analysis of the laws of telemedicine in U.S.A, Russia and India

Laws, directives and legislations regarding telemedicine and their utility have been already well recognized, especially in the wake of a pandemic like COVID-19. That's why the countries around the world are trying to extend the expanse of telemedicine and bringing out new legislations and reforms for its proper functioning. But irrespective of the efforts made by the three countries mentioned above, as we have already seen, the laws in each country differ a lot from the other in many aspects. Some of the major differences noted in this study are mentioned below:

a) Freedom of Choice of healthcare provider -

Laws in United States of America allow the patients to get a direct access to the health professionals and the medical institutions of their own choice, which is also similar in the case of India as well but in Russia only the doctors and medical institutions which are registered in the Federal Registry are allowed to provide telemedicine services. This violates a patient's right to choose according to the Federal Law No-323 (OMC) of Russia.

b) Guidelines for Prescription of medicines -

The laws in Russia and the United States of America do not put any restrictions over drug prescriptions [29]. Even prescription of narcotic drugs is allowed. Whereas the latest guidelines for practicing telemedicine released by the Health Ministry of India put some specific restrictions on prescription of drugs. The categories of medicines that can be prescribed are listed below:

List O: It comprises of those medicines which are safe to be prescribed through any mode of telemedicine.

List A:This list comprises of those medicines which can be prescribed during the first consultation which is a video consultation and are being re-prescribed for re-fill.

List B: Is a list of medicines for patients who are undergoing follow-up consultation.

Prohibited List: Thelist of drugs whichcannot be prescribed by a registered medical practitionerwho provides consultation via telemedicine. These medicines have a high potential of abuse and can harm the patient if used improperly or the society at large.

In Russia and the United States of America there is no restriction or classification of drugs that cannot be prescribed by a doctor during a tele-consultation in the format of an electronic document.

c) Telemedicine services in real time -

While United States of America and India are focusing on providing telemedicine consultations in real time, remote monitoring of the patient's state of health in Russia is prescribed by the attending physician predominantly after an in-person appointment for examination or consultation[29]. Remote monitoring is carried out on the basis of patient data recorded using medical devices designed to monitor the state of the human body, and (or) on the basis of data entered into a single state information system of healthcare.

d) Technology/ Mode of Communication -

Nowadays multiple technologies are being used to deliver telemedicine consultations. There are 3 primary modes: Video, Audio, or Text (chat, messaging, email, fax etc.) Each mode of technology has its own respective strengths, weaknesses and contexts, in which, it may be helpful or inadequate to deliver a proper diagnosis. In the United States of America the mode of communication/technology used for providing telemedicine services is primarily- live video, because the other types of telemedicine services don't fall into the category for reimbursement [22]. Whereas in Russia and India usually chats, images, audio, messaging, email, fax etc. are also used. This possesses it own benefits and shortcomings as well.

Benefit- The doctor/healthcare provider doesn't has to check the authenticity/or ask for an id proof of the patient every single time.

Shortcoming- Restricting telemedicine services to only one mode of communication prohibits its(telemedicine's) real goal to be realized, which is to provide healthcare services to the patients in the remotest areas of the world.

e) Permission of remote diagnosis

No doubt telemedicine helps the healthcare professionals to practice modern medicine in a lot of ways but coming to a conclusion about a patient's state of health or putting a diagnosis is still a matter of discussion among the healthcare providers around the globe. The complexity of the matter is subjective to each country and every country has its own laws and norms regarding it. The findings show that United States of America and India have opted to take away the restrictions and make it easy for the doctors to put a diagnosis while attending a patient via telemedicine [30]. But on the other hand, in Russia, the main problem of the new law is that it establishes a ban on making a diagnosis remotely [28]. At the same time, the main requirement of patients for telemedicine is the ability to remotely receive a diagnosis and a course of treatment.

f) Misdiagnosis and punishment-

Misdiagnosis happens often in in-person health care, but the risks increase with tele-consultation. Add to this the fact that there is no clear standard of care established by state legislatures, and quality may be uneven between one provider and the next.

Misdiagnosis has the potential to drive up overall costs to the general health care system as well, because misdiagnosis leads to wrong prescriptions and treatments. This is a very prominent obstacle in the path of telemedicine which needs to be properly addressed in all the three countries mentioned above. None of the countries above have any specific law regarding punishment for misdiagnosis via telemedicine.

By analyzing the above accumulated experience and knowledge it is concluded that at the moment the field of telemedicine is abundant with many barriers that are country-specific, concerning legislations and laws related to medical malpractice, technological development and some very common concerns, that need to be addressed properly. The speed of formulation of laws around the globe is not the same as each country is coping up with the issues mentioned above at their own pace, depending upon their financial ability and the availability of technology. We hope the year 2020 will be the definitive year when significance of telemedicine is established world-wide and all the countries shift to this new mode of healthcare medium with all the necessary changes that are to be done especially in the area of legislation for the proper regulation of telemedicine services.

telemedicine healthcare law legal

Chapter 3. Impact of Telemedicine on the medical care system in Russia, United States ofAmerica and India

The previous two chapters give us a very good overview of the developments in the field of telemedicine and the legislations in the respective countries to regulate it. This chapter focuses on the impact that telemedicine has had on the clinical outcomes, accessibility of care and cost effectiveness in the recent years.

3.1 Clinical Outcomes

Improvements in technology have highly increased the use of telemedicine. Now instead of a visit to the doctor's clinic, follow-ups, consultations, and even diagnosis can be done through a telephone or video chat. The use of telemedicine may be increasing and with passing time the implementation and acceptance of telemedicine in all the fields of medicine is becoming more and more prominent. Let's take a look at the latest trends.

3.1.1 Asthma Control and Patient's quality of Life Assessment in U.S.A.

In a recent study[31] by the American Academy of Allergy some researchers determined the health outcomes of telemedicine implementation in patients with asthma through a meta-analysis of 22 studies on asthma control and quality of life. In atotal of 22 studies 10,281 participants were observed. Each of 22 studies observed the effects of single-telemedicine and combined-telemedicine (combinations of telemedicine approaches), and the meta-analyses showed that combination of telemedicine approaches significantly improved asthma control compared with usual care.

This analysis on the impact of telemedicine on patients with asthma showed that combined telemedicine was the most effective telemedicine method in improving patient care.

Fourteen of the 22 studies [32] also examined the effect of telemedicine on quality of life with the help of a Mini Asthma Quality of Life Questionnaire. Furthermore, combined tele-case management, combined tele-consultation, and combined tele-case management and tele-consultation, all showed some significant evidence of improving quality of life.Other outcomes were also reviewed in many of these studies that were used for the meta-analysis. In one of the studies, tele-case management and tele-consultation showed reduction of total corticosteroid use without lowering asthma control or quality of life.

The use of different approaches seems to increase the combined effect of each other and create better results for the patient, as it is evident from the improved asthma control and quality of life. Although the results cannot be generalized to other chronic diseases, nevertheless these findings help at least provide the initial evidence that telemedicine is indeed very effective.

3.1.2 Improved treatment compliance of pediatric HIV patients in India

India recently introduced telemedicine initiatives to enhance access to specialized care at a low cost for the pediatric HIV patients, who face a number of challenges due tothe burden of growing diseaseand lack ofpreparedness of the health system to tackle it.

A study [33] was conducted in Maharashtra, a province, located in the western region of the country, to check the policy regarding the effectiveness of this program.

In October 2013, Pediatric HIV Telemedicine Initiative, e-decentralized model of expert Pediatric HIV care and referral services was established in Maharashtra, as a multi partner collaboration of the National AIDS Control Organization's Pediatric HIV Center of Excellence at Sion Hospital, Mumbai, Maharashtra State AIDS Control Society (MSACS), National Health Mission in Maharashtra, Municipal Corporation of Greater Mumbai (MCGM) and UNICEF.

The telemedicine initiative was to provide an expert pediatric service with the use of video communications, designed to reach inaccessible children, with quality care. Services included expert advice and guidance on initiating antiretroviral therapy (ART) for children, nutritional counseling and treatment adherence, first-line failure analysis, HIV infant mortality surveys, and capacity building for medical staff.

The telemedicine linkage initially led to an increase in the case load which consequently decreased the cost of provisioning services. Although uniformity in the case load among the linked centers was not identified overall, there were some positive results of the telemedicine linkage. Very importantly, this initiative also led to the improvement in treatment compliance in the linked centers as compared to non-linked centers. These advantages demonstrated that such initiatives should be encouraged and scaled-up in similar settings for the times to come.

3.1.3 Effective tele-ophthalmology examinations in India

One of the important ongoing projects [34] in telemedicine started by Madras Diabetic Research Foundation (MDRF), Chennai, in collaboration with the World Diabetes Foundation (WDF), is the MDRF/WDF Rural India Diabetes Prevention Project. This program which serves a cluster of 42 villages (in and round Chunampet village) in Kancheepuram District, Tamilnadu, India, was initiated for a rural community outreach. Screening is carried out in Chunampetdistrict for diabetes and its complications especially diabetic eye diseases by using a mobile telemedicine van with satellite connectivity.

Several benefits of tele-ophthalmology applications have been achieved which include detecting, screening, and diagnosing diabetic retinopathy; anterior segment imaging; glaucoma screening; low vision consultation and tele-mentoring. Tele-ophthalmology can be performed in real-time, by store-and-forward mode, or by hybrid techniques. In a screening (under the previously mentioned project) diabetic retinopathy was detected in 19% of rural people with diabetes, 73.6% of whom had never undergone an examination of eyes, in rural South Indian population by telemedicine facilities,. Out of all the patients, surgery was advised to 61.3% patients, medical treatment to 12.8%, and the rest needed further investigations at a tertiary center for better examination and treatment [34]. The analysis of cost-effectiveness of the screening test for diabetic retinopathy was performed using two models, the model of tele-ophthalmology and the base hospital screening model. The tele-ophthalmology screening test was found to have a considerably lowered the cost per case in comparison to the base hospital.

3.2 Accessibility

3.2.1 Outcomes of Handheld tele-ECG for health care delivery in rural India

In the rural underserved population where the doctor-patient ratio is low, the access to health care services is also limited. A study [35] was conducted in Punjab, India in 2011 to test a technology of handheld tele-electrocardiogram (ECG) developed by Bhabha Atomic Research Center (BARC).The objective of the study was to confirm productivity/usefulness of handheld tele-ECG as a screening tool for evaluation of cardiac diseases in the rural population. ECG was obtained in 450 individuals, natively living in the periphery of Chandigarh, India, from April 2011 to March 2013, using the handheld tele-ECG machine.

For expert opinion the data was then transmitted to physicians in Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh. In 70% individuals the ECG was interpreted as normal and 95% of the patients were reported to be satisfied. Thus, it can be concluded very safely, that handheld tele-ECG is a portable, very cost-effective, and tremendously convenient tool for diagnosis and monitoring of heart diseases and also improves quality of care and its accessibility, especially in rural areas [35].

3.2.2 Expanding telemedicine services throughout Russia-

Russia is not an exception in the process of proliferation of telemedicine. The implementation of the pilot projectof “Improving the processes of organization of medical care based on the introduction of information technologies” [36] for 2016-2025 is an example of increasing telemedicine use in Russia. The project was approved by the Presidium of the Presidential Council for Strategic Development and Priority Projects on October 25, 2016 and the proclaimed target indicator of this project is improvement of medical assistance to citizens via:

· implementation of information technologies,

· monitoring the possibility of recording a doctor's appointment,

· transition to management of medical records in digital form of at least 80% by 2020,

· performance of at least 10 digital services via a patient's personal online

“My Health” account on the Unified Public Services Portal (UPSP), which will be used by at least 30 million citizens in 2020, will help the populations of rural areas to get high quality medical care remotely. By the end of 2025, the number of administrative regions in Russia, where the processes of rendering medical assistance using telemedicine technologies are organized, should increase from 7 (in 2017) to 85 (in 2025).

At present in Russia most telemedicine services are provided in the Siberian and Ural Federal Districts, with about half of them in the Krasnoyarsk Territory, Kemerovo and Tomsk regions. The least of them are provided in the Samara region, and more than 10 thousand times in comparison with Tomsk (per capita).

By mid-2018, in four regions (Vladimir Region, Altai and Ingushetia republics, Chukotka Autonomous Okrug) there was not a single medical organization “having access to systems or complexes providing telemedicine services” [41].

According to the organization of Federal Voluntary Medical Insurance, such services were provided in 20 regions with the right systems. “The level of technical equipment of the structural units of medical organizations necessary for counseling using the capabilities of telemedicine technologies is insufficient,” the Account Chamber concluded. Of the 10 types of medical services provided by the relevant nomenclature, in 2017, six were provided, and in 2018 seven, and mainly two were in demand: decoding, description and interpretation of data from electrocardiographic studies (81.4%), as well as a description and interpretation of X-ray data (15.4%) [41].

Telemedicine programs which have been successfully implemented in Arkhangelsk, Voronezh, Chelyabinsk regions, St. Petersburg, Mordovia etc. have raised the number offunctioning telemedicine centers in Russia today by more than 50 [25]. There is an experience of using telemedicine methods in the operating room. Doctors from Primorskiy region conducted the first telemedicine consultation in 2018. In the regional clinical center of medical assistance specialized types two tele-bridges connected Vladivostok with Novosibirsk and Moscow were held.

3.3 Cost Effectiveness

3.3.1 U.S.A.

Remote monitoring services and analysis, electronic data storage have significantly reduced healthcare service costs, saving a considerate amount of money for healthcare services providers, patients, and insurance companies. Reduction of unnecessary non-urgent emergency room (ER) visits and elimination of transportation expenses for regular checkups have been achieved via telemedicine.

Beyond these general cost-savings, telemedicine also helps boost revenue by turning on-call hours into billable time, attracting new patients, reducing cancelled appointments, and even reducing the load for physicians who decide to switch to a flexible work-from-home mode for part of the week.

According to a report [37] of the American Hospital Association, in 2015 the hospitals saved 11% in costs and more than triple was the return on investment (ROI) for investors because of a telemedicine program.

3.3.2 India

A recent study [38] was conducted to assess the cost-effectiveness of telemedicine for elective post-neurosurgical care patients from a predominantly nonurban cohort in West Bengal, India. Data of cost and effectiveness of 1200 patientswas collected for a period of 52-months.

Effectiveness of care through telemedicine was calculated using efficiency in terms of the percentage of successful telemedicine consultations, as well as utility values of patient's perception of overall experience of the type of health care access that they received. The overall utility in this case was found to be higher (89%) than that of the utility of routine care (80%) and the price of the service was also cost-effective (Indian rupee [INR] 2630 per patient) as compared to the routine care (INR 6848 per patient). The results evidently show that telemedicine strategy "dominates" the routine care by being more effective and less expensive as well [38].

Sensitivity analysis in this study revealed that changes in the number of telemedicine patients, utility and success rate of telemedicine, and travel distance to the telemedicine center, dictated the cost-effectiveness of telemedicine. Evidently it is concluded that in-person care strategy is less effective as compared to the telemedicine care as telemedicine provides more effective and less expensive follow-up care for a remote post-neurosurgical care population in India.

3.3.3 Russia

In Russia, the issue of effectiveness and economic feasibility of telemedicine consultations is also highly relevant and largely determines the further development of telemedicine technologies in healthcare.

The cost of telemedicine services consists of three components: capital costs, costs during operation and remuneration of staff.

The most common way to calculate the effectiveness of telemedicine activities is a comparative assessment based on an analysis of the ratio of the cost and volume of telemedicine services provided and the magnitude of the economic effect of their implementation. This method [39] of economic analysis - cost-effectiveness - allows you to compare projects (programs, services, procedures) aimed at achieving one goal, but are achieving it with different rates of success. To conduct this analysis, several alternatives are compared: - providing medical care to patients using telemedicine technologies; - the provision of medical care without the use of telemedicine; - the provision of medical care without the use of telemedicine, but with the obligatory referral of patients to federal clinics.

Analyzing the data on the main telemedicine projects implemented in the Russian Federation over the past 5 years, we can see their positive financial results for each year, even with a small number (27-35 consultations per year), as in the project “Telemedicine in the north-west of Russia”, in remote areas of the Arkhangelsk region [39].

The issue of the cost-effectiveness of telemedicine is being actively studied, but at the moment there are no developed evaluation criteria to compare various applications and projects. Classic analysis models based on the principle of “price-profit” are of little use, since the definition is not clear, what is considered profit in this case.The “price-effectiveness” analysis is more acceptable when the price is a monetary value, and the effectiveness is not monetary.

However, the question arises - how to quantify effectiveness. Criteria can be applied, for example, to increase life expectancy, but it is difficult to determine the partial contribution of telemedicine to this indicator. The most frequently used indicator is minimization of cost, which allows us to evaluate the cost savings per consultation.

Consider the methodology [39] for assessing and comparing the cost-effectiveness of telemedicine and the standard form of medical care according to Jejelaeva E.I. The formula for determining the annual costs of telemedicine: T = Nt · Vt + Ct , where T is the annual cost of telemedicine; Nt is the number of patients who underwent telemedicine procedures throughout the year; Vt - variable costs per patient; Ct is the total fixed cost of telemedicine per year.

Formula for determining the annual costs of standard medical care:

A = Na · Va + Ca ,

Where A is the annual cost of standard medical care; Na is the number of patients who received standard medical care; Va - variable costs per patient; Ca is the total fixed cost of standard health care per year. Using the proposed methodology, a comparative financial study of telemedicine and an arbitrary standard medical care system is possible.

Table.2 Expenditure type of telemedicine and items

Cost Type	Items
Project Creation	Preparation of funding requests, project competition, recruitment, feasibility analysis, preparation for tenders for equipment, selection and installation of equipment, audit of organizational preparations, consultations with personnel, staff training, determination of assessment methods
Equipment	Computers and peripherals, video conferencing kits
Communication	Communication costs should gradually decline in a successful telemedicine program
Staff	A successful telemedicine program should be economical and reduce staff time; there should be an hourly wage for staff and consultants
General	General depreciation (10-15% per year), transportation costs, downtime

In 2017 and the first half of 2018, telemedicine in the regions were not financed from the federal budget, but at the expense of voluntary medical insurance (VMI)within the framework of territorial programs, and in 2017 in 17 regions (20% of their total number) with 21.2 million rubles, and in 2018 - in 19 regions with 18.8 million rubles [41].

The average cost of medical services using telemedicine technologies varied from region to region almost 25 times - from 97.2 rubles in the Ulyanovsk region up to 2.4 thousand rubles in Samara, as the tariffs are calculated differently [41].

Also, by shifting consultations to the residence or home of the patient, telemedicine reduces the number of time-consuming in-person visits. So as to speak, if the patient needs to visit the doctor on an average, 5-6 times a year, he can come only twice and the rest of the time he can receive consultations at home. This also increases the amount of assistance provided to patients without compromising with the quality of care.

The model was proposed and tested in one of the Russian Federal Medical Centers. The results showed that the processing time of requests got reduced from 20 minutes per request to 15 minutes onanaverage via online. This makes an increment of about 15% in time savings. Within a very short span of year and a half (2016-2017 years), the number of telemedicine consultations conducted increased from 1.5 to 5.5 thousand [25].

3.4 Other Benefits

3.4.1 Benefits for patients

Patients want convenience and waiting in a queue for up to 90 minutes to see someone is definitely inconvenient. They are always in search for care options thatvalue their time and resources. Telemedicine gives the opportunity to the medical professionals to offer care passionately while improving their patient's satisfaction also.

Access to a number of Physicians and Specialists

With telemedicine, patients in rural or remote areas have the benefit of a quicker and more convenient access to the specialists. The number of specialists available for every 100,000 rural patients in the United States of America is only 43 [37]. The patients have to endure the travelling of long distances and to commute to the specialists and have trouble to get an access to lifesaving consultations for specific chronic diseases care plans.

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