Experimental legal regimes in the field of digital innovation in Russian medicine

Main article: Experimental legal regimes in the field of digital innovation in Russia

2023

Experimental legal regime in the field of telemedicine: The most significant innovations

As you know, medical care using telemedicine technologies has become available to patients since 2018, when this method of providing it was enshrined in the federal law "On the Basics of Protecting the Health of Citizens in the Russian Federation," and the corresponding procedure and a number of other by-laws were published.

Despite the fact that the medical industry was waiting and preparing for these changes, they turned out to be difficult to implement in practice due to the need to comply with the strict requirements contained in them both on the part of medical institutions and on the part of patients. This largely restrained the development of the telemedicine market, a large number of private clinics chose the "gray" path of its promotion, allowing non-compliance with the established procedure for the provision of services.

The analysis of the current situation prompted the state to try to optimize the initial requirements for telemedicine, their adaptation to the formed reality. For these purposes, the mechanism provided for by the Federal Law "On Experimental Legal Regimes in the Field of Digital Innovation in the Russian Federation" was used and from August 1, 2023, the Program of an Experimental Legal Regime in the Field of Digital Innovation in the Field of Medical Activity was put into effect. including using telemedicine technologies and technologies for collecting and processing information about the state of health and diagnoses of citizens (program). The new regime has been introduced for three years, and applies to a limited number of participants.

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Freepik

This article discusses the most important innovations of the program and their significance for the future of the medical industry.

Provisions mitigating the procedure for medical services with the use of telemedicine

Among those provisions of the program that soften the current procedure for the provision of medical services using telemedicine technologies, the following can be distinguished:

1. As part of the telemediconsultation, doctors were able to prescribe treatment to the patient if it was not prescribed at the previous face-to-face appointment.

As a general rule, treatment should be prescribed strictly at a face-to-face appointment, and during a remote consultation, the doctor has the right only to adjust it. Patients receiving telemedicine care within the framework of the experimental regime are given the opportunity to remotely discuss its results with the doctor after completing the examination scheduled for the primary face-to-face appointment, receive appointments and do not visit the clinic in person.

2. The patient received the right to choose for telemediconsultation another doctor of the same medical organization, whose work experience in his specialty is at least 7 years, and continue to monitor him. This obviously expands the range of possibilities of the patient, who, as a general rule, should be observed remotely only with the same specialist whom he visited at a face-to-face appointment.

But this provision has even more significant consequences. In fact, it opens up access for patients to remote medical care for specialists from other regions of the country. In particular, within the framework of the experimental regime, a patient can attend a face-to-face reception in his city in a clinic belonging to a medical organization participating in the experiment, and then remotely receive advice from a specialist working in another unit of this organization located in another region.

3. identification The patient is allowed by number, identification using phone the banking system and identification using/subject passwordsSMS to their preliminary use or personal appearance of the patient in the clinic.

Of course, this provision removes one of the key blocks for the promotion of telemedicine services to consumers. Since it is the strict requirement for identification exclusively with the use of the State Unified Identification and Authentication System (ESIA) that prevents the appeal for telemedicine assistance from patients who are not registered in this system, among whom, for example, there are many elderly patients who especially need this type of consultation, but do not have the skills to freely handle digital devices.

4. The patient was granted the right to sign a contract for the provision of medical services, informed voluntary consent to medical intervention, consent to the processing of personal data, including health data also not only with the help of ESIA, but also in other ways listed in the paragraph above.

This position can be assessed as revolutionary. Indeed, it is precisely such methods of identifying patients that many clinics that are not participants in the experimental regime use in practice, in an attempt to adapt telemedicine to real conditions, but now their actions do not correspond to the established procedure for the provision of services.

The above conditions entail simplification and facilitation of interaction between participants in telemedicine consultations. But, as you know, the provision of additional freedoms also entails an increase in responsibility, since the risks of providing poor-quality medical care increase in proportion to the indulgences provided.

Program restrictions

In this regard, the following restrictive provisions of the program can be distinguished:

1. Within the framework of the experimental regime, telemedicine assistance cannot be provided to minor patients, patients with infectious diseases, as well as for the purpose of conducting medical examinations, examinations and examinations.

2. The clinic's medical information system must meet a number of technical requirements for internet connection speed, camera resolution for image transmission. As practices note, in fact, we are talking about the quality of an image equivalent to a picture of a television screen.

3. Telemedicine consultation is allowed only if the patient provides a medical document confirming a face-to-face appointment at least 30 days before the day of applying for such consultation.

4. The duration of the first telemedicine consultation should be at least 20 minutes.

5. Information on the assistance provided is taken into account in the medical information system of a medical organization, the state information system of a constituent entity of the Russian Federation and the Unified State Information System in the field of health care and can be provided to the attending physician.

6. Also, the medical organization is obliged to carry out internal quality control and safety of medical activities, including maintaining a register of negative events and complaints of patients during the provision of telemediconsultations, drawing up quarterly conclusions on the data of this register.

As of mid-November 2023, 30 medical organizations are participants in the experimental legal regime. This list is not closed, and other market players have the opportunity to join the experiment, subject to the requirements established by the program.

Despite the limited number of participants in the experiment, one should be prepared for the fact that the results obtained during its conduct will affect everyone. In particular, as the goals of introducing an experimental legal regime, the program enshrines improving the quality or availability of services and improving their regulation. That is, everything that is now experimental in nature, after a few years to a greater or lesser extent will be introduced into the generally applicable practice, and therefore requires close attention of market participants today.

In this regard, it is worth paying attention to the most significant requirements that are imposed on participants in the experimental regime in order to prepare in advance for the time when the results of this experiment will be legally extended to the entire industry.

Recommendations to commercial medical organizations

In particular, it is possible to recommend commercial medical organizations providing medical care using telemedicine technologies at this stage:

• Implement the connection of the medical information system used in the organization to the Unified State Information System in the healthcare sector, or
• Conclude an agreement with the operator or owner of another information system included in the list of systems connected to the Unified State Information System in the field; health care
• Analyze and update the internal regulation on the procedure for organizing and conducting internal quality control and safety of medical activities, as well as the rules for conducting consultations with the use of telemedicine technologies approved by the medical organization.

In conclusion, I would like to note that despite the imperfection of legal regulation, the provision of telemedicine services inevitably progresses, primarily under the influence of customer demand. Russian users, amicably spoiled by the convenience of digital services in various fields, certainly expect and readily accept all manifestations of digitalization of medicine. And in the struggle for customer loyalty, those who are ahead of time and take a step towards digitalization in compliance with legislative requirements will definitely win now.

Author: Elena Shershneva

A number of private clinics will be able to advise Russians online

In Russia, from August 2023, an experimental legal regime begins to operate, which will allow a number of private clinics to advise Russians online. All of them have the appropriate license, as well as the necessary IT infrastructure. This approach will allow planning a more flexible method of treatment, connecting several doctors to the process at once. This was announced on August 10, 2023 by the press service of the State Duma deputy RFAnton Nemkin.

So, starting from August 1, 2023, private medical organizations will have the right to online patient consultations - the corresponding decree was signed by Prime Minister RFMikhail Mishustin.

Among them are such clinics as Savings health"," Russian Railways Medicine"," JSC "Group of Companies," "Medsi LLC." "Doctor nearby

Telemedicine makes it possible to plan a more flexible method of treatment, to connect several doctors to the process. This is very convenient from the point of view of objectivity, when several specialists can fully draw up a picture of the disease, determine the method of its treatment or prevention. In addition, it will be possible to adjust the treatment or prescribe it in cases where it was not prescribed at a face-to-face appointment, including online prescribing for drugs. And there is no need to sit in line again, but you can literally get an appointment with the right doctor in your dressing gown, - said the deputy.

Whether it's education, where we promote VR technologies, industry, where digital twins and AI technologies are gaining all the popularity, or healthcare, where telemedicine goes in broad steps. Still, we live in the age of high technologies and not investing in them today - this means losing the technological race tomorrow, - concluded the parliamentarian.

2022

An experiment on remote health monitoring through wearable devices is being launched in Russia

At the end of August 2022, it became known about the introduction in Russia of an experimental legal regime (EPR) for remote health monitoring using special wearable devices. Data from such equipment will be collected on the Personal Medical Assistants platform. Read more here.

Russia has developed a program for collecting medical information through fitness trackers

The Skolkovo Foundation and the Rostec state corporation have developed a program for an experimental legal regime (EPR) in the field of medicine, involving the use of wearable electronic devices for remote monitoring of patient health. The program was sent for consideration by Deputy Minister of Economic Development Maxim Kolesnikov. This became known on August 13, 2022. Read more here.