Legal Regulation of Digital Transformation of Technologies in

Healthcare in Russia and Abroad Under the Influence of the

COVID-19 Pandemic

Iolanta V. Baltutite

and Olesya P. Kazachenok

Volgograd State University, Volgograd, Russia

Keywords: Digital Transformation, Digital Technologies, COVID 19 Pandemic, Telemedicine, Medical Services, Patient

Rights, Medical Secrecy.

Abstract: Currently, in the context of the COVID-19 pandemic and periodically introduced lockdowns for the Russian

healthcare system, an important goal is to create conditions for the provision of medical care to all citizens,

despite the territorial location and the possibility of physical visits to a hospital or polyclinic. In modern

conditions of digitalization of life, an effective way to solve this problem is the development of information

tools in the field of healthcare through the creation of a unified medical information space. The progressive

development of technologies (medical and infocommunication) launches the process of digital transformation

and the development of telemedicine. With all the above, it is fair to note that there is currently no formulated

idea of what telemedicine includes, and there are also no fully formed norms for telemedicine services. A

number of problems specific to telemedicine, but requiring solutions, for example, the question of who and

what responsibility should be borne for the consultation provided, the problem of proper protection of personal

data and compliance with medical secrecy, need to be resolved in the near future, which will make it more

accessible and widespread to provide remote medical care using digital technologies.

1 INTRODUCTION

To date, in the context of the COVID-19 pandemic,

an increasing number of countries have accelerated

the development of projects for the modernization

and implementation of telemedicine technologies in

classical medicine. The World Health Organization

plans to create a global telecommunications network

in the field of medicine. That is, to create a single

network through which it will be possible to carry out

centralized transmission of medical data, to organize

an electronic document management system for

medical documents and a system for storing and

searching medical information, as well as to use it for

remote discussions, meetings, consultations

(Inshakova et al., 2021).

Experts of the American Association of

Telemedicine believe that the direction of

telemedicine suggests that medical data can be

transmitted over different distances between a doctor

https://orcid.org/0000-0001-5443-2157

https://orcid.org/0000-0001-9675-367X

and a patient, doctors, various medical organizations.

The use of telemedicine technologies implies the

active use of infocommunication technologies and

services to ensure communication between medical

professionals and medical organizations, with

patients located at a distance, for the purposes of

therapeutic procedures, consultations, diagnostics

and training."

According to the organization Health On the Net

("Health on the Net"), in most of Western Europe,

telemedicine is an additional technology for

providing medical care. According to M.S. Varyushin

(Varyushin, 2018), the legal framework of

telemedicine can be divided into 2 categories:

1. Legislation that regulates relations between

medical organizations and patients. Refers to the

regulatory framework on healthcare. It defines the

standards of medical care with the use of telemedicine

services, regulates the licensing procedure, regulates

document flow and logging, focuses on protecting the

178

Baltutite, I. and Kazachenok, O.

Legal Regulation of Digital Transformation of Technologies in Healthcare in Russia and Abroad Under the Inﬂuence of the COVID-19 Pandemic.

DOI: 10.5220/0011112600003439

In Proceedings of the 2nd International Scientiﬁc and Practical Conference "COVID-19: Implementation of the Sustainable Development Goals" (RTCOV 2021), pages 178-183

ISBN: 978-989-758-617-0

rights of the patient, and also defines the area of

responsibility of the medical organization and its

employees;

2. The second category includes legal relations

arising between a medical organization, technical

staff and a patient, which are based on telemedicine

technologies. For example, the transfer of patient data

occurs through third parties (provider, technical

staff), which may entail a violation of medical

confidentiality, or disclosure of personal data.

2 MATERIALS AND METHODS

In the course of the research, general scientific

methods used, including formal-logical, dialectical,

system-structural, and critical cognition. Methods of

synthesis, classification, and generalization used to

interpret the results of the study. Private scientific

methods also used in the work: formal-legal, the

principle of assessing legal processes, the method of

comparative analysis, etc.

3 RESULTS AND DISCUSSION

Unlike the Russian Federation, the experience and

practice of foreign countries have allowed the

European Union to create a single legal framework

regulating the provision of telemedicine services. In

addition, EU countries (for example, Belgium,

Germany, the Netherlands, etc.) have their own

internal legislation that complements generally

accepted standards. These are standards regulating

the provision of medical care with the use of

telemedicine technologies, on the transfer of personal

data of participants in telemedicine sessions, on the

provision of information services by medical

personnel. These include:

 Directive 95/46/EC of the European Parliament

and of the Council of the European Union of

October 24, 1995 "On the protection of the

rights of individuals with regard to the

processing of personal data and on the free

movement of such data (repealed from May 25,

2018);

 Directive 98/34/EC of the European Parliament

and of the Council of the European Union of

June 22, 1998 "On the procedure for the

dissemination of information on technical

standards and regulations";

 Directive 2000/31/EC of the European

Parliament and of the Council of the European

Union of June 08, 2000 "On certain legal

aspects of the provision of information services

to the public, in particular e-commerce, in the

domestic market" (Kuznetsov and Syryamkin,

2019).

In addition, Directive 2011/24/EC of the

European Parliament and of the Council of March 9,

2011 "On the rights of patients in cross-border

medical care" was considered.

Of all the countries in which telemedicine

technologies are used, the country with the most

active development of legislation in this area can be

called the United States of America, in which

legislation is common at the state level and its own

for each state. The main reason for such dynamically

developing legislation in the field of telemedicine is

the need to coordinate laws within the state. Due to

the fact that telemedicine involves the use of

infocommunication technologies in healthcare,

difficulties arise caused by restrictions on medical

activities on the part of national jurisdictions

(Bogdanovskaya, 2007).

Modern legislation provides support for programs

that are aimed at the process of forming medical

services, taking into account the use of telemedicine

technologies. For example, in 1997, a bill was formed

in Alaska that regulates the official project for the

development of telemedicine, including defining a

plan for its financing. In the state of Oklahoma, the

telemedicine Law states the following: "in programs

aimed at healthcare, nothing can be a factor that

restricts the right to provide medical services using

audio, video or infocommunication technologies."

This makes it possible to more actively use

telecommunication technologies for consultations,

diagnostic measures, as well as to transmit medical

information in this way, which can be considered a

stimulating factor in the development of

telemedicine.

Medical services in American law could initially

be provided only if the patient made a face-to-face

visit to a doctor, but over time this requirement was

changed. For example, the law in Colorado allows the

use of telemedicine technologies to diagnose,

identify, prevent diseases, pains, ailments, as well as

painful conditions, both mental and physical,

allowing the use of images, including photographs.

According to the law of the State of Indiana, since

1996 medical practice includes the provision of

medical care and diagnostic measures using

infocommunication technologies, based on oral or

written consent to the provision of medical care

(Abashidze et al., 2021).

Legal Regulation of Digital Transformation of Technologies in Healthcare in Russia and Abroad Under the Inﬂuence of the COVID-19

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The law restricts the technologies that can be used

in telemedicine. For example, legislators in some

states specify that telemedicine services cannot be

provided by telephone and fax. In 1999, a law was

passed in Minnesota, which refers interactive video to

the technical means of communication used for

remote consultations.

One of the projects aimed at creating and

developing a global medical infocommunication

system is "Satellite". This project will allow the

participating countries to create a unified system that

promotes the exchange and accumulation of medical

knowledge, and allows simplifying the process of

training and advanced training of medical workers.

Another project, "Planet Here" was developed by

the World Health Organization. The main goal of this

project is to create a global medical

telecommunications system, but aimed at scientific

activity and acting as a management tool. WHO

proposes to use this system as the main one through

which other systems and networks will be managed,

through which international scientific

telecommunications will be conducted, and which

will also be used for international examinations.

4 DISCUSSION OF THE RESULTS

The worldwide interest in the introduction of

telemedicine technologies in the context of the

COVID-19 pandemic contributes to the fact that a

large number of international-scale projects have

been funded and developed in Europe for several

years.

These projects cover a wide range of areas and

methods where telemedicine can be applied: from the

development of systems that simplify and speed up

the provision of medical care, especially ambulance

(an example of such a project is HECTOR), to the

ability to carry out treatment when a patient is at home

(for example, the HOMER-D project). The main goal

of telemedicine projects is the integration of

information technologies into the medical

infrastructure, for the development of methods of

processing and standardization of medical

information, whether it is its registration,

transmission or reception. There are processes of

development and testing of algorithms for effective

compression of information, standard forms that

simplify the exchange of various types of data, both

in the form of source data, that is, images, electrical

or electromagnetic signals, etc., and in the form of a

generated patient's medical record. Automated

workplaces are also being developed, taking into

account the specifics of various medical and

diagnostic specialties.

The regulatory framework of informatization in

the field of healthcare in Russia includes: state

legislative acts that affect the use of telemedicine

technologies; standards and protocols for medical

care; standards for building telecommunication

networks, including international ones; documents

developed by the World Health Organization

(Inshakova et al., 2021).

Since 2001, legal regulation of issues related to

the provision of medical services using telemedicine

technologies has been carried out in the legislation of

the Russian Federation. The Order of the Ministry of

Health of the Russian Federation No. 344 and RAMS

No. 76 dated August 27, 2001 "On approval of the

concept of development of telemedicine technologies

in the Russian Federation and its implementation

plan" was issued. The purpose of this document is to

optimize activities related to the use of telemedicine

technologies. The need for advanced telemedicine

technologies is caused by the problem of shortage of

qualified medical personnel in remote regions and the

territorial peculiarity of the Russian Federation.

Today in Russia, the use of telemedicine

technologies is regulated by the Federal Law "On the

Basics of protecting the Health of Citizens of the

Russian Federation", as well as by-laws, for example,

the Order of the Ministry of Health of the Russian

Federation No. 965n "On approval of the procedure

for organizing and providing medical care using

telemedicine technologies", Decree of the

Government of the Russian Federation No. 1006 "On

approval of the Rules for the provision of paid

medical services by medical organizations", etc.

Paragraph 22 of Article 2 of Law No. 323-FZ

defines telemedicine technologies as "information

technologies that provide remote interaction of

medical workers with each other, with patients and

(or) their legal representatives, identification and

authentication of these persons, documentation of

their actions during consultations, consultations,

remote medical monitoring of the patient's health."

Regulation of telemedicine in the legal field

begins only in 2017, when Federal Law No. 242-FZ

of April 29, 2017 "On Amendments to Certain

Legislative Acts of the Russian Federation on the use

of information technologies in the field of health

protection" was adopted.

A legislative act and by-laws regulating the use of

IT technologies in the field of medicine are needed

(Matytsin et al., 2021). We also need resources, both

organizational and technical, for the full

implementation of modern technologies throughout

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the country. This need is due to the territorial features

of our state. The development of information

technologies enables a wider range of people to take

advantage of the constitutional right to health

protection and affordable medical care, including in

conditions of limited access to public places and

movement with the introduction of restrictive

measures to limit the spread of COVID-19.

Based on Parts 2 and 4 of Article 36.2 of Law No.

242-FZ, medical services using telemedicine

technologies can be provided in the format of

consultations and remote monitoring of the patient

online, that is, in real time, while the interaction of

participants in this format, recorded in the protocol of

medical opinion or consultation of doctors, or in other

available documents, must be stored in the form of

audio recordings, video recordings and text messages.

Another important format in the context of the

COVID-19 pandemic is the use of telemedicine

technologies - an online consultation, for example, of

the attending physician with a doctor or a consultation

of doctors to clarify the diagnosis or exchange

experience. If a medical opinion is issued by a

medical council, it will be stored only in the form of

text messages. This will allow you to receive timely

medical care and advice in lockdown conditions, as

well as persons over 65 years of age who are advised

to refrain from visiting public places.

Both formats assume that the consultation can be

of the type "medical worker or a consultation of

doctors - attending physician" or "doctor - patient"

(Sokolenko and Bagnyuk, 2017).

Telemedicine consultations are conducted so that

the attending physician can analyze the previously

prescribed treatment, its effectiveness, including for

collecting anamnesis and new patient complaints, for

monitoring the patient's condition as a whole. And

already based on the collected data, the doctor decides

whether the patient needs to apply to a medical

organization for a full-time appointment.

The use of telemedicine technologies in the age of

digital development is a new stage in the

improvement of the field of healthcare, especially in

demand in the context of the COVID-19 pandemic.

This becomes possible thanks to the consulting

centers implemented on the basis of medical

institutions located in the central cities of Russia, but

providing medical services online for all residents of

the country.

In Russia, the use of telecommunication

technologies in the field of healthcare is less

developed than in foreign countries.

In progressive countries, digitalization in the field

of healthcare is also aimed at achieving basic

standards for providing medical care and its

accessibility to the population who live in rural areas

or in places with an insufficient number of doctors.

The global digitalization of healthcare in Australia

led to the formation of a governing body in 2016 - the

Australian Digital Health Agency. The example of

Australia shows that the purpose of telemedicine

services is being transformed. Previously, the use of

telemedicine technologies was supposed to provide

affordable medical care in hard-to-reach areas, but

today the tasks are changing somewhat. Now such

goals as: to reduce or eliminate negative adverse

reactions caused by prescribed treatment or

medications are put at the forefront in telemedicine;

to reduce the number of hospitalizations by

preventing possible changes in the patient's health

status; the possibility of achieving more effective

coordination in providing medical care to people in

an emergency situation; the possibility of correcting

treatment for remote patients.

According to foreign scientists, innovative

components in telemedicine should be: new

technologies (including virtual reality, robots with

remote control, 3D printing, etc.), personalized mini-

devices, sensors for remote monitoring.

5 CONCLUSIONS

The use of telemedicine technologies gives the patient

the opportunity to get a doctor's opinion from any city

or even country, as well as for people who are

quarantined by COVID-19. Thanks to them, the

geographical location of the patient is not a decisive

factor in the availability and quality of medical care.

Russian legislation in the field of application of

telemedicine technologies has a number of problems,

including:

 there is no legalized definition of

"telemedicine" as an independent direction in

medicine;

 problems in the field of licensing activities with

the use of telemedicine and information

technologies;

 problems of introduction of telemedicine

services in medical insurance;

 determination of participants in legal relations

in the field of telemedicine, establishment of

their rights and obligations, conditions of

liability.

When conducting a consultation using

telemedicine technologies, its participants are: a

doctor (consultant), a patient (consulted), support

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staff. But the process of informatization expands this

list with new subjects of legal relations: providers,

manufacturers of computer devices, site

administrators, pharmaceutical companies, payment

systems, cloud service operators, etc. It follows from

this that the protection of private information should

also extend to new entities.

According to paragraph 9 of Order No. 965n of

the Ministry of Health of the Russian Federation, the

legal responsibility falls entirely on the consultant

doctor for the recommendations given by him in the

framework of the medical report. At the same time,

there is no responsibility of the attending physician

who diagnoses the patient;

In accordance with paragraph 7 of Article 20 of

the Federal Law "On the Basics of protecting the

health of citizens in the Russian Federation", the

patient has the right to receive medical care using

telemedicine technologies only after submitting a

signed application with an electronic digital signature

(EDS). And obtaining an enhanced qualified EDS is

a difficult process;

 the doctor is not able to make a diagnosis remotely

when using telemedicine services;

 in accordance with paragraph 47 of the Order of

the Ministry of Health of the Russian Federation

No. 965n "On approval of the procedure for the

organization and provision of medical care using

telemedicine technologies”, during consultations

with the attending physician, prescriptions for

medicines can be formed in the form of an

electronic document, subject to the appointment

of treatment to the patient in person. In this case,

the electronic prescription must be certified by an

enhanced qualified EDS of a medical

professional. But the receipt of EDS by medical

professionals is not regulated in any way. In

addition, there is no set list of requirements

according to which pharmacies could accept

electronic prescriptions, each entity should

organize this independently in 2021;

 there are a number of conditions for providing

medical care using telemedicine technologies: a

medical worker must be registered in the Federal

organization must be entered in the Federal

State Information System in the Field of

Healthcare. These conditions also apply to non-

governmental organizations and private

practitioners. They, in turn, also place information

in the registers mentioned above. This raises the

question of protecting the data being entered.

There remains the problem of forming an

electronic patient's medical history, which includes

the results of tests, medical examinations reflecting

the course of the patient's illness.

 the complexity of providing medical care using

telemedicine technologies at the global level;

If the patient - the consumer of medical services

is located in one country, and the doctor (the

performer of medical services) is in another, then the

question arises which state legislation will be applied.

There is no answer to this problem these days.

 another urgent problem is the guarantee of

medical secrecy.

In the classic doctor-patient relationship,

confidentiality has always been a problem, so the

possibility of ensuring secrecy in telemedicine is

questioned. This is also due to the fact that technical

workers who support the system participate in the

process between the consultant and the person being

consulted.

In the Russian Federation, a number of regulatory

legal acts should be adopted to ensure compliance

with medical secrecy. But the problem is that in our

country, on the contrary, there are legal acts that

oblige providers to save user visit histories, call

records, etc. on their servers. This is done to combat

terrorism, but, in turn, may lead to information

leakage.

The above problems show the urgency of prompt

amendments and additions to the existing Russian

legislation in the field of application of telemedicine

technologies in the context of the COVID-19

pandemic. When forming proposals, it is necessary to

rely, among other things, on the experience of foreign

countries, their practice of implementing legal norms

in the field of telemedicine.

ACKNOWLEDGEMENTS

The work was supported by Russian Science

Foundation (project № 20-18- 00314)

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