Experimental legal regimes in the field of digital innovation in Russia

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

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

History

2024: Drones will fly over Moscow. Mishustin approved the launch of a special mode for drones

At the end of May 2024, Prime Minister Mikhail Mishustin signed a decree on the establishment of an experimental legal regime (EPR) developed by the Ministry of Economic Development of Russia together with the Government of Moscow and ANO "Federal Center for Unmanned Aircraft Systems" (Fedtsentr ALS). Thanks to the EPR, it will be possible to start testing drones in the capital's industrial park "Rudnevo." Read more here.

2023

The Ministry of Economic Development has developed a mechanism for protecting against harm caused by AI technologies

The Ministry of Economic Development of the Russian Federation has developed a mechanism for protecting against harm caused by artificial intelligence. Amendments were made to the law "On experimental legal regimes in the field of digital innovation." Read more here.

Mishustin introduced a special legal regime for testing drones in the Moscow and Tver regions

Prime Minister Mikhail Mishustin signed a decree on the introduction of an experimental legal regime (EPR) in the field of digital innovation called "Aerologistics." The corresponding document was published in early November 2023. Read more here.

An experimental legal regime has been introduced in 12 regions of the Russian Federation, allowing the use of agricultural drones

The Government of the Russian Federation signed a decree on the establishment of an experimental legal regime (EPR) in the field of digital innovations in the operation of agricultural unmanned aircraft systems. The document was published on the official Internet portal of legal information on September 19, 2023. Read more here.

Flight tests of civilian drones will begin in Samara and Togliatti

The Ministry of Economic Development of Russia considered and supported the application of the Transport of the Future company to establish an experimental legal regime (EPR) in the field of digital innovations in the operation of unmanned aircraft systems (ALS) in the Samara region. The corresponding document is published on the federal portal of draft regulatory legal acts. The application itself was sent to the Government of the Russian Federation on March 17. Transport of the Future announced this on April 14, 2023.

The EPR for a period of three years will begin to operate in 20 days from the date of signing the resolution - approximately in mid-May.

Seven companies will take part in the implementation of the project: Transport of the Future, RANAVIA, Research Center Aeroscript, Biryuch Scientific and Educational Center and others. The project provides for the use of ALS for air transportation of goods, aviation work, including work to protect crops and protect forests from fires.

The establishment of the EPR makes it possible for the Samara region to become one of the few subjects where drones will be used for agricultural work, "said Vladimir Voloshin, director of the digital economy development department of the Ministry of Economic Development of Russia. - The Transport of the Future project provides for the creation of a separate production complex in the region. Such an approach, when the production and testing of technology are located nearby, will allow you to most effectively receive feedback and make the necessary improvements and improvements. We expect significant results that will help achieve the goals of the national project for the development of unmanned aircraft,

The Samara region has shown high adaptability to existing realities, the ability to find new growth points, confirming the status of the supporting edge of the country. The region is becoming a driver for the development of unmanned aircraft systems in Russia. We intend to create a large, modern, high-tech cluster for the development, design and production of drones, as well as components for them. The introduction of an experimental legal regime opens up opportunities for testing new aircraft as early as 2023, which will allow the fastest possible introduction of new technologies into serial production. I am sure that together with the Transport of the Future company, we will move faster to the intended goals, - said the Governor of the Samara Region Dmitry Azarov.

The Samara region may become one of the first regions in Russia where the work of all ALS will be systematized and automated. This will not only increase the flight safety of all devices, but also provide an important contribution to the entire industry. The key element that will be subject to development under the EPR is the safety of integrating ALS into the general airspace in the real current conditions of flight bans in the regions, the fears of ministries and departments. Our task is to work out a reliable mechanism that is understandable to everyone, which will make it possible to "open the sky" for ALS today due to the correct coordination of the work of participants in the ALS industry based on the current level of technological development and to spread this experience everywhere ensuring the safety of our country's citizens, "said Yuri Kozarenko, General Director of Transport of the Future.

In the Samara region created a special legal regime for launching cargo drones

On March 20, 2023, it became known about the creation in the Samara region of a special legal regime for launching cargo drones. This was announced on March 20, 2023 by the Transport of the Future company (manufacturer of unmanned aircraft systems, ALS), which is the initiator of this project.

We are talking about the creation of an experimental legal regime for flight tests of cargo drones. The creation of such a regime was discussed during a working trip of the plenipotentiary of the president in the Volga Federal District Igor Komarov to the Samara Region. Regional authorities note that drones will be used in all sectors of the economy, including transport, agriculture and others.

Russian-made cargo drone AKM Oslik-30

The Transport of the Future company believes that the Samara Region may become one of the first regions in Russia where the work of all such devices will be systematized and automated. Within the framework of a special legal regime, it will be possible to conduct flight tests for the delivery of medicines, products and other goods over the Volga and along other allocated transport corridors, as well as monitoring and processing of agricultural land by ALS, the company noted.

The Samara ALS cluster is created in accordance with the targets approved by us together with the government of the Samara region, in pursuance of the instructions of the President of the Russian Federation. These are specific obligations to create capacities for the serial production of several thousand ALS per year, including domestic structural elements, components, as well as the development of typical business models for the use of ALS, - said the general director of Transport of the Future Yuri Kozarenko (quoted by TASS).[1]

Ministry of Economic Development launches experiment on the use of agricultural drones in 10 regions

The Ministry of Economic Development is launching an experiment on the use of agricultural drones in 10 regions. This became known in early March 2023. Read more here.

2022

Mishustin approved a project for remote monitoring of patients with chronic diseases using wearable devices

In December 2022, Prime Minister Mikhail Mishustin signed a decree approving a project for remote monitoring of patients with chronic diseases using wearable devices. Read more here.

Mishustin approved testing of unmanned vehicles on the Moscow-Petersburg highway

In October 2022, Prime Minister Mikhail Mishustin signed a decree approving testing of unmanned vehicles on the M11 highway (Moscow-St. Petersburg).

We are talking about a new experimental legal regime (EPR) in the field of digital innovations in the operation of highly automated vehicles (project "Unmanned logistics corridors"). The experiment will take place in Moscow, St. Petersburg and four regions - Moscow, Tver, Novgorod and Leningrad.

Mishustin Mikhail

This EPR involves VATS manufacturers (PJSC, KAMAZ NPO), StarLine the largest carriers (Globaltrak Logistic LLC, PJSC, Magnet Kh5 Logistics), the infrastructure operator is a state-owned company. "Avtodor

According to Victoria Erkenova, Deputy Chairman of the Board for Intelligent Transport Systems and Digitalization of Avtodor, the state-owned company, together with drone manufacturers, is entering an active phase of preparation for their test passes along the M11 highway.

{{quote 'We plan to test the information service for the exchange of data between the digital map and the road infrastructure of the M11, as well as various scenarios for the operation of highly automated vehicles, for example, when data on accidents, weather conditions and traffic situations comes from the infrastructure, she said. }} The deputy Minister of Transport of the Russian federation Dmitry Bakanov stressed that the state fulfilled its task by taking on the legal risks associated with the introduction of the new technology. Now business representatives must ensure the development of unmanned trucks and the development of models of unmanned cargo transportation.

The press service of the Ministry of Transport added that the use of unmanned vehicles on public roads will not only improve traffic safety and will contribute to the creation of new types of commercial activities, but will also reduce the cost of remuneration for drivers by 30% until 2025, for fuel - by 28%.^[2]

Minek will update the conditions for digital sandboxes

In October 2022, the Ministry of Economic Development presented amendments to the federal law on experimental legal regimes (EPR, "digital sandboxes"). The agency proposes changes that are designed to improve the mechanisms for using EPR and take into account a number of presidential instructions to regulate the turnover of intellectual property created with the participation of artificial intelligence.

Thus, the Ministry of Economic Development proposed to expand the circle of persons obliged to insure the potential harm to life and property when implementing innovative projects within the framework of the EPR.

The Ministry of Economic Development will update the conditions for digital sandboxes

The ministry notes that the clarification of the circle of persons responsible for causing harm in the implementation of projects, including using artificial intelligence technologies, is consistent with the principles for the development of this area outlined in the national strategy.

Another innovation aims to strengthen the protection of exclusive rights to the results of intellectual activity created using artificial intelligence technologies.

It is also proposed to clarify the norm of the law, which excludes from the field of special regime activities associated with a high risk of damage to the person and the state.

Thus, risks are created to establish some EPRs, including those related to the sale of prescription drugs, individual batches of agricultural plants, breeding products, which can be considered goods with limited turnover, the ministry explained. The changes proposed by the bill remove such a restriction.

Of course, such changes are sensitive, since the regulation of EPR should be aimed primarily at expanding the development, testing and implementation of digital innovations. Therefore, it is necessary to maintain a sound balance, which will contribute to the safe testing of new technologies for the convenience of life of citizens in our country, "Dmitry Ter-Stepanov, deputy head of the Digital Economy ANO, told Kommersant.[3]

Self-driving drones will begin to be tested in Innopolis. This requires 260 million rubles

On September 15, 2022, it became known that self-driving drones would be tested in Innopolis. The city hall estimates the implementation of the project at 260 million rubles for 3 years.

According to Vedomosti, the Innopolis authorities decided to establish an experimental legal regime (EPR) in the city, allowing test flights of unmanned aerial vehicles. It is planned to apply to a meeting of the expert working group at the ANO "Digital Economy" with a corresponding initiative.

Self-driving drones to be tested in Innopolis

The ANO confirmed to the publication that the proposal to introduce EPR in Innopolis will be considered at a meeting of the expert group in the second half of September 2022. After the ANO will send its conclusion to the Ministry of Economic Development for a final decision.

The digital economy, "as an organization of the entrepreneurial community, supports the expansion of the list of EPRs, we continue to search for new initiatives of Russian business that need to remove regulatory barriers, - added the representative of the ANO.

Testing will be carried out in a small area with a radius of 2 km. According to the interlocutors of the publication, the new zone can be used to test the delivery of goods, conduct entertainment shows, as well as cartography with the participation of drones.

Innopolis University will develop special drones for the test zone in Innopolis. The devices will be tested by the Conversavia BS company, and the expert organization New Information Technologies in Aviation may issue conclusions on technical examination.

In March 2022, Prime Minister Mikhail Mishustin signed a decree introducing an experimental regime for the introduction of unmanned aircraft systems in five regions of the Russian Federation. The project will last three years, it involves:

• Tomsk region;
• Kamchatka Territory;
• Chukotka Autonomous Okrug;
• Khanty-Mansi Autonomous Okrug;
• Yamal-Nenets Autonomous Okrug.^[4]

The government approved the parameters of the experiment on the introduction of unmanned aircraft in five regions

In March 2022, Prime Minister Mikhail Mishustin signed a decree approving the introduction of an experimental legal regime for launching unmanned aerial vehicles. The program will be attended by the Tomsk region, Kamchatka Territory, Chukotka, Khanty-Mansi and Yamalo-Nenets Autonomous Okrugs.

During the experiment, special regulatory conditions will apply in these regions - experimental legal regimes for the operation of unmanned aircraft systems. This will allow such flights to be carried out without excessive regulatory load and accelerate the development of the unmanned aircraft segment as a whole.

Mishustin approved a special legal regime for drones

Drones in the Kamchatka Territory, Chukotka, Khanty-Mansi and Yamalo-Nenets Autonomous Districts will primarily be used to deliver mail and cargo. This is especially true for residents of remote and hard-to-reach areas.

In the Tomsk region, drones will be able to participate not only in the transportation of goods and photography, but also to carry out aerial and chemical work to combat pests in agriculture. This will make such works safer for humans and expand the geography of their application. In the Tomsk experiment, it is planned to test the use of unmanned cargo drones with a maximum take-off mass of more than 30 kg

As noted in the Cabinet of Ministers, for security reasons, drone routes will be held outside large settlements, airfields and venues for mass events, and external pilots will control flights throughout the entire journey. Automatic mode can only be activated if the signal is lost. Also, pilots will form a flight plan, set route points, altitude and flight speed. All this information will be sent to the local aviation authorities.^[5]

Mishustin approved a legal regime for unmanned vehicles

The Government of the Russian Federation approved the program of the experimental and legal regime (EPR) for the operation of unmanned vehicles. This was announced on March 17, 2022 by the press service of the Cabinet.

As Deputy Prime Minister Dmitry Chernyshenko explained, the first experimental legal regime adopted by the government made it possible to speed up this process and remove regulatory barriers to launching the project. Subject to successful testing, self-driving vehicles can become an organic part of urban infrastructure by 2025, he said.

Mishustin approved the program of the experimental legal regime for the operation of unmanned vehicles

According to the EPR program, unmanned vehicles on the streets, in the Moscow city (Innopolis Republic of Tatarstan) and the federal territory "Sirius" will be able to operate with a test driver in the cabin, and without its presence in the cabin - in the territories of Innopolis and the innovation center. "Skolkovo

Unmanned vehicles participating in the experiment were developed by specialists of the company Yandex"." After 20 days from the date of publication of the decree, it will be possible to operate unmanned vehicles in two modes: with a test driver in the cabin (in the passenger seat, to the right of the driver's seat) and without a test driver in the cabin, if necessary, an operator can connect for remote support.

The experiment will make it possible to use unmanned vehicles as a taxi in Moscow. The first zone for launching unmanned taxis was the Yasenevo area - between the Yasenevo, Novoyasenevskaya and Bitsevsky Park metro stations.

Live technology testing will help in 3 years to change the overall regulation - to introduce drones as safely and efficiently as possible. This EPR opens a series of experimental regimes for which the Ministry of Economic Development has prepared appropriate decisions, - said Dmitry Ter-Stepanov, Deputy General Director, Director for Regulatory Regulation of the ANO Digital Economy[6]

2021

Russia adopted a law on 7 projects for the "digital sandbox"

In mid-June 2021, the State Duma in the third (final) reading adopted a law on seven projects for the "digital sandbox" - experimental legal regimes (EPR) designed to develop technological innovations.

The law provides for legal norms, the provisions of which are applied with the features that can be established by the EPR program, in the following areas of development and testing of digital innovations:

• medical activities;
• telecommunications;
• design;
• production and operation of highly automated vehicles, including drones;
• provision of transport and logistics services;
• organization of transport services;
• sale of goods, works and services remotely.

Russia adopted a law on 7 projects for the "digital sandbox"

As for the seven projects approved for digital sandbox operation, they are as follows:

• providing medical care using telemedicine technologies (MTS);
• remote conclusion of agreements on the provision of communication services using biometric technologies (MTS);
• cargo transportation service using unmanned aircraft systems providing delivery of a wide range of goods from 0.1 kg to 500 kg (Advanced Research Fund);
• commercial use of unmanned ground transport (Yandex);
• introduction of medical decision support systems using artificial intelligence technologies (National Medical Knowledge Base Association);
• a service for small and medium-sized businesses to select the optimal areas and places of activity based on big data ("Big Data Association");
• studies of routine clinical practice based on impersonal data from electronic medical records (Data Matrix).

The approval of these projects for the "digital sandbox" will ensure the development of science and the social sphere, will allow the formation of new types of economic activities, develop competition, expand the composition, quality or availability of goods, works and services, increase profits from entrepreneurial activities and reduce the costs of companies, increase the efficiency of state or municipal management during the introduction of digital innovations, as well as improve general regulation based on the results of the implementation of EPR.^[7]

The government has chosen the IT projects of MTS and Yandex for a special legal regime

In mid-March 2021, it became known about the IT projects of MTS and Yandex, which were chosen by the Government of the Russian Federation to provide them with a special legal regime.

According to Interfax, the list of the first seven projects that are planned to provide a special experimental legal regime for digital innovations is listed in the explanatory note to the bill (N1129501-7). The document is published in the electronic database of parliament.

MTS and Yandex will receive a special legal regime for a number of projects in IT

The list includes the MTS project for remote conclusion of agreements on the provision of communication services using biometric technologies. The implementation of the project will ensure the possibility of concluding an agreement on the provision of cellular services without the need to visit the operator's salon. Identity will be determined through biometric identification.

The second project of MTS, which will operate a special legal regime, is associated with telemedicine. The initiative is aimed at developing the availability of qualified medical services, including when medical institutions offering appropriate services are not available.

The list also names the Yandex project on the commercial use of unmanned ground transport - highly automated vehicles (VATS). The current legislation does not allow the operation of cars without a driver, for the implementation of the project it will be necessary to amend the law on technical inspection, insurance, road safety.

In addition, it is planned to use a special legal regime for the project of freight transportation service using unmanned aerial vehicles that ensure the delivery of goods from 0.1 kg to 500 kg (Advanced Research Fund). The government notes that the aviation legislation in force by March 2021 imposes impracticable requirements for some types of unmanned aircraft systems.^[8]

In the Russian Federation, the law on "digital sandboxes" came into force, in which IT-Innovations will develop

On January 28, 2021, a law on "digital sandboxes" came into force in Russia, in which IT-Innovations will be developed. By this time, at the site of the Digital Economy organization, a discussion and study of projects of experimental legal regimes (EPR), prepared by the initiators on the first eight cases for sandboxes, began.

The draft EPR programs will be developed within the framework of expert groups, which will be headed by experts in the relevant fields, with the involvement of other potential EPR participants, the expert community, as well as representatives of the Ministry of Economic Development of the Russian Federation and regulatory bodies in the relevant areas of EPR.

In the Russian Federation, the law on "digital sandboxes" came into force, in which IT-Innovations will develop

All projects that were included in the first satellite bill, by the end of January 2021, were discussed at the working group "Regulatory Regulation" of the organization "Digital Economy" and have a high degree of technical study. In accordance with the instructions of Russian President Vladimir Putin, the satellite bill should be adopted by May 1, 2021

To consult and help the initiators, a page has been created on the website of the Digital Economy organization, which contains basic information on the goals and procedure for establishing EPR, as well as accepting initiative proposals.

The mechanism of "regulatory sandboxes" is a new tool for changing legal regulation, therefore, at this stage, the quality and elaboration of initiative proposals plays an important role, "says Dmitry Ter-Stepanov, Deputy General Director and Director for Regulatory Regulation of the Digital Economy organization.

According to him, the role of the Digital Economy organization in the process of establishing the EPR is not only to act as a state partner in the acceleration of application submission, but also through the mechanisms for discussing proposals with the business community to prevent the launch of non-competitive sandboxes, for example, formed under one player, and testing ineffective, outdated or unrealizable technologies.^[9]

2020

TAdviser Regulatory Sandbox Cyber Security Podcast Release

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Launch of opening accounts via video link within the framework of the "regulatory sandbox"

On November 9, 2020, it became known that Russian banks began to open accounts via video link without visiting the branch. The National Council of the Financial Market sent an application to the Central Bank to test this technology in its "regulatory sandbox."

At the first stage, it is planned to open accounts for clients with disabilities by video link, salary accounts and accounts for receiving social benefits. The balance on accounts will not exceed 100 thousand rubles, the monthly volume of transactions - 60 thousand rubles. Emelin explained that in the future, using the technology, it will be possible to open accounts for paying for housing and communal services, communications for checking customers when concluding service contracts, for checking customers - individuals when deciding on loan applications received from digital channels, for checking users of crowdfunding platforms, marketplaces, etc.

Russian banks began to open accounts via video link

The procedure for communicating between a client and a bank employee through video communication will be similar to ordinary communication at a bank branch. The scenario of remote interaction will be as follows: the client must apply for a video communication session through the bank's website and leave personal data (passport number, SNILS, TIN, phone number and postal address for identification), then establish a video connection (through a mobile application, social networks, instant messengers), and after establishing communication through the camera, show the documents again and let the employee make sure that you are this person. After a successful check, the client agrees to conclude an agreement (enters a code from SMS or draws it up through a mobile application).

18 large financial institutions will take part in the experiment. If the initiative demonstrates its effectiveness, then they will come up with a proposal to adjust the legislation.

The main risk is that the technology of video calls is developing in parallel with other special technologies of artificial intelligence, warns Yaroslav Shitsle, head of the IT&IP Dispute Resolution section of the law firm Rustam Kurmaev and Partners.^[1]

Mishustin approved 10 technologies for legal regimes developing digital innovation

At the end of October 2020, the Government of the Russian Federation approved a list of technologies that will be subject to special regulation in the so-called "regulatory sandboxes" - experimental legal regimes designed to develop IT-Innovations. The list includes 10 technologies:

• neurotechnology and artificial intelligence technologies;
• Big Data Technologies
• quantum technologies;
• production technologies;
• robotics and sensorics technologies;
• distributed registry systems technologies;
• wireless communication technologies;
• virtual and augmented reality technologies;
• internet of things;
• industry digital technologies.

The creation of a legal framework for the accelerated introduction of new digital products and services in Russia is reaching the finish line... This will free developers from unnecessary administrative burden and speed up the launch of new digital services on the market, the press service of the Cabinet of Ministers said on October 29, 2020.

Mikhail Mishustin approved ten technologies for legal regimes developing digital innovation

Prime Minister Mikhail Mishustin also signed a decree that gives ANO Digital Economy the authority to represent business interests in these matters. The organization was created to support socially significant projects in the field of information technology. The founders of Digital Economy include leading Russian innovative companies, including Sber, Yandex, Mail.ru Group, Rambler and Rusnano.

The law on "regulatory sandboxes," signed earlier by Russian President Vladimir Putin, does not determine exactly what indulgences can be in the sandbox for its participants - special regulation is established in the program of each of them. For example, within the framework of some "sandbox" it will not be necessary to obtain certain permits or licenses from government agencies.^[2]

Mishustin endowed the Ministry of Economic Development with the functions of regulating legal regimes for the development of IT-Innovations

The Russian government has endowed the Ministry of Economic Development with the functions of legal regulation of the so-called "regulatory sandboxes" for the development of technological innovations. This became known on October 13, 2020.

The Ministry of Economic Development of the Russian Federation is an authorized federal executive body exercising the functions of regulatory legal regulation and the powers provided for by the federal law "On experimental legal regimes in the field of digital innovation in the Russian Federation," - said in a government decree published on the official portal of legal information.

Mishustin endowed the Ministry of Economic Development with functions to regulate legal regimes

It is noted that the implementation of the provided functions and powers will be carried out by the Ministry of Economic Development within the established number of employees of the central office, as well as funding provided for by the budget.

Sandboxes allow you to abandon a number of regulatory requirements that impede the development of innovation. Due to this, companies engaged in the development of new products and services, as well as representatives of authorities, can test them without risk of violating the current legislation, and subsequently, if the testing was successful, to disseminate the experience of introducing such digital innovations.

The establishment of the experimental regime is preceded by a number of mandatory procedures involving industry authorities in order to comprehensively assess the possible risks of a legal experiment. The final decision on the possibility of conducting a legal experiment is made by the Government of the Russian Federation.

The program of the experimental legal regime is an act of special regulation that establishes special regulation for a particular experimental legal regime. At the same time, such regulation applies only to participants in the "regulatory sandbox" with a strict time and territory limit.^[3]

The Ministry of Economics explained how the law on digital sandboxes will work

On August 11, 2020, the Ministry of Economic Development and Trade clarified how the law on digital sandboxes will work. We are talking about the law "On experimental legal regimes (EPR) in the field of digital innovation in the Russian Federation" adopted in July.

This law, as Deputy Minister of Economic Development Vladislav Fedulov, organized by Kommersant, said at the online conference "Will digital sandboxes become the foundation for the digital transformation of Russia?" It should contain a justification for the feasibility of introducing EPR from the point of view of consumers and an explanation of how the experimental regime will be useful to citizens.

After the development of the EPR program, it enters the Ministry of Economics. Then the department checks for the following factors:

• whether anyone from the management of the company that developed the EPR program was convicted;
• whether this company has tax arrears;
• according to other formal features provided for by law.

After that, the Ministry of Economic Development sends the EPR program to the sectoral ministry, as well as to the "organization of the entrepreneurial community," which is still being considered by the Digital Economy ANO. If they have no objections, the Ministry of Economic Development is preparing a draft government decree on the approval of the EPR, indicating in it the validity period of the experimental legal regime, its participants and the date of introduction. In the future, by the decision of the sectoral ministry, other participating companies may join the EPR.

Minek explained how the law on digital sandboxes will work

I would like to avoid speculation on the adoption of this federal law from the point of view of the fact that the state allegedly tries to disclose personal data of citizens when introducing certain technologies or innovative decisions - for example, medical secrets or secret negotiations. Of course, nothing of the kind is happening within the framework of this law, "the deputy minister emphasized.

According to him, the Government of the Russian Federation tried to make the most balanced decision both in terms of how the technology could develop and be used, and in terms of ensuring that all the legal rights of citizens were preserved.^[4][5]

The emergence of "regulatory sandboxes" for the development of digital innovations in the Russian Federation

At the end of July 2020, the Ministry of Economic Development chose projects for "regulatory sandboxes." The decision was made based on the results of work with Russian high-tech companies, including MTS, Yandex and Medsi, as well as the Advanced Research Fund, the National Medical Knowledge Base and the Big Data Association (ABD).

As Kommersant writes with reference to the representative of the Ministry of Economic Development, the first projects within the framework of experimental regimes will include:

• creation of robotic hotels;
• launching cargo transportation by drones;
• commercial use of self-driving cars, including taxis;
• remote conclusion of contracts for communication services;
• Voice antifrod service to protect subscribers from fraudsters;
• service for small and microbusiness in the selection of optimal areas of activity;
• introduction of artificial intelligence (AI) in medicine and telemedicine technology.

Project "Smart Hotel" from ABD

The Smart Hotel project from ABD involves the automation of booking, check-in, check-in and guest service processes using the technologies of the Internet of Things, virtual reality, artificial intelligence, machine learning and machine vision (remote identification of persons).

However, Russian legislation prohibits the operation of hotels without staff: not only the law "On Personal Data" impedes, but also a number of other regulations regarding cash registers and ensuring the safety of guests, says the owner of Ivashkevich Hospitality Stanislav Ivashkevich. According to him, the business is not interested in such projects. Accor's regional director for Russia, Georgia and the CIS Alexis Delaroff agrees with him, adding that the guests do not have such a request either.

ABD President Anna Serebryanikova, in a conversation with the publication, noted that the association has also developed a concept of an experimental legal regime in the field of data collection, storage and processing, which has already been sent to the Moscow Information Technology Department and will be sent to the Minek.^[6]

 "Regulatory sandboxes" will appear in Russia for the development of digital innovations - the law was adopted

On July 22, 2020, the State Duma adopted in the third reading a law on the introduction of the so-called "regulatory sandboxes" - experimental legal regimes designed to develop IT-Innovations.

The point of such regimes is to remove a number of legal restrictions, allowing those involved in the development and implementation of digital innovations to put them into practice and check how useful they are.

The State Duma adopted a law on "regulatory sandboxes" in the field of digital innovation

According to the authors of the law, as a result of its adoption, the development of science and the social sphere, competition will be ensured, new types of economic activity will be formed, the costs of entrepreneurial activity will decrease and the effectiveness of public administration will increase. The initiative will be implemented at the expense of funds allocated under the Digital Economy program.

Initially, it was assumed that   medical and pharmaceutical activities, transport, including unmanned, as well as e-learning and distance learning technologies, the financial market, distance trade, industry, construction, state and municipal services will fall under the law. But  by the second reading, they decided not to limit the list of applications of "regulatory sandboxes."

The mechanism of "regulatory sandboxes" is used in many foreign countries. The first "sandbox" was created Great Britain  in 2016 . They were later implemented in,,, Malaysia USA,, Australia, Singapore UAE Bahrain, Thailand Indonesia and. Switzerland  To Canada 

According to the Chairman of the State Duma Vyacheslav Volodin, in the IT industry it is critically important not to miss the moment and not to lag behind other countries. A special mode will allow you to apply new digital technologies and in practice check how useful and promising they are. At the same time, such experiments should be carried out in compliance with all safety standards, Volodin emphasized.^[7]

Cabinet approved the introduction of experimental legal regimes for the development of IT-Innovations

In July 2020, the government commission on legislative activities approved amendments to the bill on the introduction of experimental legal regimes for the development of digital innovations.

As the first deputy speaker of the State Duma Alexander Zhukov clarified to journalists, this bill proposes to establish experimental legal regimes to simplify the emergence and introduction of digital innovations, such as artificial intelligence, blockchain, neurotechnology, etc.

The bill "On experimental legal regimes in the field of digital innovation" is designed to make legal regulation in the IT sphere more flexible. As part of the experiment, the government will have the right to change certain rules of law for a limited range of people, for a certain time or in a certain territory.

The Cabinet of Ministers approved the introduction of an experimental legal regime for the development of IT-Innovations

The document, which is known as the draft law on regulatory sandboxes, lays the foundations for experimental legal regimes in the field of innovation, in particular, medicine, pharmaceuticals, transport, e-learning and distance learning, finance, distance trade, construction, state and municipal services and state control, as well as industry. These platforms will help reduce business costs and accelerate innovation.

The term of the experimental legal regime is planned to be limited to three years if possible to extend it under certain conditions. Participants in such a regime cannot be foreign legal entities, as well as Russian legal entities, if in their authorized capital the share of foreign legal entities registered in offshore companies is 50% or more.

Russia Vladimir Putin The President instructed to ensure the adoption of a federal law on experimental legal regimes in the field of digital innovation in the Russian Federation. The deadline for the execution of the order is July 26, 2020.^[8]

Russian laws will be temporarily changed for experiments by Yandex, MTS and the state fund related to military developments

The Ministry of Economic Development has developed a list of provisions of federal laws, from which separate norms will be temporarily withdrawn in order to create experimental legal regimes to help digital projects. The list of provisions is contained in the draft federal law "On Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Adoption of the Federal Law" On Experimental Legal Regimes in the Field of Digital Innovation in the Russian Federation. " On June 17, 2020, the bill was submitted for public discussion, which will last until June 23, 2020.

Content of the draft law

TAdviser got acquainted with the explanatory note of the draft law. It says that specific points that will be removed from the laws for the duration of the experimental regimes should be submitted to a separate program. It will have to be approved by the government of the Russian Federation. And the bill defines a list of provisions of certain federal laws from which exemptions can be made. They relate to the following areas:

• medical activities;
• telecommunications;
• design, production and operation of highly automated vehicles (VATS), including unmanned aerial vehicles, provision of transport and logistics services and organization of transport services;
• application of artificial intelligence systems in the provision of services.

The provisions of federal laws, from which certain norms can be temporarily removed, were highlighted on the basis of proposals received by the Ministry of Economic Development from a number of organizations. They need experimental legal regimes for the following projects:

• Mobile Telesystems (MTS) project, which involves the provision of medical care using telemedicine technologies.

Medical examinations, diagnosis, appointment of treatment and remote monitoring of the patient's health, as well as identification using telemedicine technologies are still impossible, the explanatory note says. In this regard, the document provides for the possibility of a limited withdrawal of certain requirements from the federal law "On the basics of protecting the health of citizens in the Russian Federation."

• MTS project, which involves the protection of mobile subscribers and bank customers from fraudulent calls aimed at stealing citizens' funds using social engineering methods.

The Federal Law "On Communications" classifies any technical data on a telephone connection as a secret of communication, preventing the possibility of using the software and hardware of a telecom operator for automated detection of fraudulent actions, the developers of the bill note.

• MTS project involving remote conclusion of agreements on the provision of communication services using biometric technologies;

According to the authors of the regulatory act, the provisions of the federal law "On Communications" and the federal law "On Personal Data" do not allow the implementation of the project, strictly limiting the procedure for concluding a communication agreement (mainly due to the condition of personal presence) and the use of biometric data by a citizen.

• MTS project, which provides for the creation of a robotic hotel without the physical presence of personnel, called "Smart Hotel." It is planned to automate the processes of booking a hotel room, check-in, check-in and guest service.

To implement the project, it is required to ensure the legal possibility of using the technologies of the "Internet of Things," virtual reality, electronic payments and remote identification, the barrier to the application of which is the provisions of the federal law "On Personal Data," - noted in the explanatory note to the bill.

• A project of the Advanced Research Fund, which involves the creation of a freight transportation service using unmanned aircraft systems that provide delivery of a wide range of goods from 0.1 kg to 500 kg.

The current aviation legislation is aimed at regulating manned aviation and imposes impracticable requirements for unmanned aviation systems, the authors of the bill note. In this regard, the document provides for the possibility of not applying certain provisions of the air code within the framework of the experimental legal regime.

• Yandex's project on the commercial use of unmanned ground transport - highly automated vehicles.

The current legislation on road safety does not allow the operation of cars without a driver, and the requirements of the experiment on experimental operation on public roads of highly automated vehicles significantly limit the development of VATS technologies. For this reason, the bill provides for the possibility of not applying certain provisions:

• Federal Law "On Road Safety";
• Federal Law "On Compulsory Insurance of Civil Liability of Vehicle Owners";
• Federal Law "Charter of Road Transport and Urban Land Electric Transport";
• Federal Law "On Amendments to Certain Legislative Acts of the Russian Federation";
• Federal Law "On technical inspection of vehicles and on amendments to certain legislative acts of the Russian Federation."

TAdviser has reached out to companies operating in the above areas to see what they see as regulatory hurdles in their tracks.

Положения федеральных законов, из которых могут быть изъяты отдельные нормы, были выделены на основе поступивших в Ministry of Economic Development proposals from MTS, Yandex and the Advanced Research Fund. (фото - unmannedcargoaircraftconference.com)

Scenario of exemptions required for medical technology development

Anna Meshcheryakova, General Director and co-owner of the Third Opinion company, explained to the publication what changes need to be made to the 323rd Federal Law "On the Basics of Protecting the Health of Citizens in the Russian Federation" for the successful implementation of experimental legal regimes.

The amendments to the 323rd Federal Law adopted 3 years ago gave the industry an impetus for development, but in fact, telemedicine is still limited to consultations, while technologically it allows, in certain cases and subject to certain conditions, to diagnose, adjust appointments, and remotely monitor the patient's condition. In this regard, I consider Article 36.2 of the 323rd Federal Law, in particular, imposing some restrictions on medical care and providing consultations to the patient using telemedicine technologies, to be primary for withdrawal within the framework of the application of experimental legal regimes, "said Anna Meshcheryakova.

At the same time, she drew attention to the fact that one of the goals of the application of experimental legal regimes, according to the bill under discussion, is "testing digital innovations for their accelerated implementation."

The procedure for clinical testing is legislatively enshrined in Article 36.1 of the 323rd Federal Law. I consider it important to maintain the norm that provides for the approval of clinical approval by the expert council, specifying the procedure for the appointment and work of such an expert council - the center of expertise - within the framework of the application of experimental legal regimes. In practice, the expert council can be a functional customer for testing the technology. Article 36.1 also contains norms that make the federal executive body fully controlled by testing. Therefore, it is advisable to remove them to reduce bureaucratic barriers and increase the speed of launching testing, "Anna Meshcheryakova told TAdviser.

Speaking about the grounds for using innovative services to provide medical care, she noted that they are established by Article 37 of the 323rd Federal Law. In this article, according to her, it is possible to withdraw the norms that make it necessary to have innovative services in the procedure for providing medical care, clinical recommendations and standards of medical care.

It is also possible to change the norm determining in what order and by whom the decision is made to use innovative services, despite their absence in the list, standards of medical care and clinical recommendations as of the date of the experimental introduction of the innovative service.

The 323rd Federal Law prescribes mandatory authorization through the ESIA to receive telemedicine care; within the framework of experimental legal regimes, it makes sense to provide alternative authorization opportunities - both for a doctor and a patient. Authorization methods may differ from region to region. The transition to electronic medical records, the patient and doctor's access to medical history and research will allow them to move to a fundamentally new level of "digitalization of medical care," said Anna Meshcheryakova.

In her opinion, it is still necessary to make it possible to post all information related to the patient's health in his electronic medical record, so that the medical worker has the opportunity to remotely make a decision on a possible diagnosis, prescribe or adjust treatment. At the same time, it is necessary not to comply with the requirements for the security of personal data and non-disclosure of medical secrets.

In the mode of legal experiments, it is necessary to exclude the mandatory requirement that digital medical services intended for the provision of medical care have a registration certificate of a medical device of Roszdravnadzor, established by one of the norms of Article 38 of the 323rd Federal Law. Innovative services must be piloted within the framework of the application of experimental legal regimes in order to work out the most effective scenario for their application in the region, identify the medical and economic effects of implementation, work out the issues of tariff regulation in order to be able to plan and budget the use of digital services at the regional level, - Anna Meshcheryakova told TAdviser.

She also added that on the basis of the norms of the 323rd Federal Law agreed to be withdrawn, it is necessary to work out and discuss specific exemptions of the accompanying norms in the relevant government decrees and orders of the Russian Ministry of Health.

Telecommunications Exemptions Scenario

According to Nikita Danilov, head of legal relations with the executive authorities of Megafon, the current legislation largely limits the further development of big data processing and storage tools. Thus, the customer can receive analytics separately from a mobile operator, separately from a bank, separately from a social network or an Internet company, but at the same time he does not have the opportunity to use Big Data from several sources at once.

Combining such data would allow for more accurate results, according to Danilov. Despite the fact that all such data sets are, by definition, impersonal, their mutual enrichment is in the conditional legal "gray zone."

Therefore, together with the Big Data Association, Megafon proposed to implement specific cases that will have social significance and help in the interests of small and micro-businesses to create services for the selection of optimal areas and places of activity in the city. As part of the experiment, this initiative involves a whole package of amendments and exemptions from laws, for example, amendments to the law "On Communications," "On Banks and Banking," "On Personal Data," Nikita Danilov told TAdviser.

Withdrawal Scenario for Highly Automated Vehicles

According to Anton Seryakov, a leading lawyer at CROC, the development of autopilot funds is simply impossible without the temporary refusal of a large number of existing legal norms. In particular, the requirements for mandatory certification, technical inspection, work and rest mode of drivers.

It is not clear what to do with the insurance of this area, how and on whom to impose responsibility for the damage caused by an autonomous vehicle, "Anton Seryakov told TAdviser.

On the other hand, developers need "autopilots" to drive in real traffic on city streets and quickly learn, since in the "sterile" environment of landfills it is extremely difficult to recreate all possible road situations.

It is important to allow the use of "concept cars" on common roads to test the latest technologies, but so far companies have to use only serial samples that have passed certification for testing, - said Anton Seryakov.

Exemptions for artificial intelligence systems used in service delivery

VR Bank Product and Innovation Director Mikhail Petrov told TAdviser that he does not see any sharp points in regulation that impede the development of artificial intelligence systems in Russia. The main obstacle for them is the very weak integration of data sources and their exchange, he said. Therefore, the successful implementation of artificial intelligence systems requires the qualitative implementation of big data technology in large companies, corporations and in the state as a whole.

Perhaps it is worth slightly simplifying the acquisition of the status of the subject of the experimental legal regime and reducing the level of necessary criteria. Since, as practice shows, the submission with the subsequent consideration of the application can be delayed for several months, which, in turn, can slow down the launch of the pilot and, as a result, obtaining the first results for subsequent commercialization, - said TAdviser Mikhail Petrov.

The State Duma adopted in the first reading a bill on experimental legal regimes in the field of digital innovation

On May 14, 2020, it became known that the State Duma adopted in the first reading a draft federal law "On experimental legal regimes in the field of digital innovation in the Russian Federation." The bill was developed by the Ministry of Economic Development of Russia together with the entrepreneurial and expert community, approved by the Regulatory Regulation working group of the Digital Economy ANO and included in the list of priority milestones of the federal project "Regulatory Regulation of the Digital Environment" of the national program "Digital Economy of the Russian Federation."

As reported, the bill is aimed at creating special regulatory regimes (the so-called "sandboxes"), in which the effect of the legislation of the Russian Federation will be limited for conducting tests on the practical application of digital innovations, checking their usefulness in the context of refusal of restrictions established by current laws without the risk of violating them. For example, sandboxes can become polygons for breaking into real application unmanned vehicles and - financial blockchain projects.

Experimental legal regimes will allow the development of digital technologies, but in the future, if the experiment is positive, they will be included in the general regulatory system. At the same time, representatives of both the State Duma and the Federation Council can take part in the preparation and consideration of regulations . For May 2020, we are discussing a bill that forms a general regulatory framework so that any initiative that implies the creation of socially useful technology passes through a regime that we understand, including one that would take into account the history of mutual responsibility or responsibility of the subject of such a regime to citizens. told at the meeting Vladislav Fedulov, official representative of the Government of the Russian Federation, Deputy Minister of Economic Development of the Russian Federation

Digital innovation for May 2020 has become the key means to allow enterprises, institutions and citizens to continue their activities in the context of the coronavirus pandemic. At the site of our committee, the discussion on the discussion of this bill took place several times. So-called experimental legal regimes, or legal "sandboxes," are desperately needed, and this bill is really "ripe." I am sure that within the framework of the presidential order, which the government is fulfilling and within the framework of which it is preparing further cooperation between the state and business in the field of socially useful development, which will be reflected in this bill. told Dmitry Sazonov, Deputy Chairman of the State Duma for Economic Policy, Industry, Innovative Development and Entrepreneurship, member of the working group "Regulatory Regulation of the Digital Environment"

Denis Kravchenko, Deputy Chairman of the Committee on Economic Policy, Industry, Innovative Development and Entrepreneurship, the relevant committee of the State Duma also approved the bill. The bill contains eight directions in which it will be possible to test digital innovations in sandboxes. These are, medicine,, transport, distance education trade the financial market, architecture and, industry, construction as well as the provision of services state.

Both large companies and small and medium-sized businesses, individual entrepreneurs, authorities, local governments will be able to participate in the experiments. The conditions of the sandboxes are as flexible as possible, but do not exempt from the obligation to monitor the safety of the product. The terms and rules of each experiment will be determined individually.

The creation of special legal regimes - "sandboxes" - is the most effective way to test the "legal framework" in a "manual" guided experiment. It is important to test solutions and understand how they need to be regulated and whether they need to be. The bill on "regulatory sandboxes" will give the Government the right to create sandboxes even when there are legislative restrictions on innovation. explained Dmitry Ter-Stepanov, Deputy General Director, Director for Regulatory Regulation of the Digital Economy organization

An active participant in the process of creating and implementing an experimental legal regime is the business community participating in the dialogue at the Digital Economy ANO site.

Notes