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The law makes provision for implementing experimental legal regimes in the area of medical practice, communications services and autonomous transport technologies

Pepeliaev Group advises of the coming into force of Federal Law No. 331-FZ dated 2 July 2021 “On amendments to individual items of legislation of the Russian Federation in connection with the adoption of the Federal Law ‘On experimental legal regimes in the area of digital innovations in the Russian Federation’” (the “Law”). Pursuant to the Law, participants of experimental legal regimes in the area of medical practice, communications and autonomous transport technologies may be granted exemptions from individual legislative requirements.

The possibility of experimental legal regimes being established in Russia is provided for in the Federal Law “On experimental legal regimes in the area of digital innovations in the Russian Federation”[1] (the “Law on Experimental Regimes”). An experimental regime presupposes that participants are subject to a special regulation that excludes or changes the effect of certain statutory requirements. This is necessary to eliminate regulatory barriers that constrain the development and implementation of digital innovations in Russia.

Under article 5(3) of the Law on Experimental Regimes, the provisions of an experimental legal regime programme that establish the conditions for such a regime may exclude or change the effect of a federal law if the relevant federal law directly provides for doing so. To comply with this requirement and ensure that experimental legal regimes are implemented, the Law specified above was adopted.

The Law came into force on 2 July 2021 and it amends legislation in a number of areas.

Medical practice

At present, the remote observation of a patient’s condition is possible only after a doctor has examined the patient in person. It is permitted to give voluntary consent to a medical intervention or reject a medical intervention using an enhanced qualified electronic signature or a simple electronic signature through the public services portal. Moreover, current regulation in the area of state registration and the expert examination of the quality and safety of medical products does not take proper account of the specifics of AI technologies that are used in innovative medical products. According to the authors of the adopted Law[2] this constrains the development of telemedicine and the use of AI technologies in medical practice. To eliminate such legislative barriers and facilitate the implementation of experimental legal regimes the relevant amendments have been made to Federal Law No. 323-FZ “On the fundamental principles of healthcare in the Russian Federation” dated 21 November 2011.

Communications services

At present, it is permitted to enter into contracts for communications services only if the individual personally attends the operator’s office or enters into such contract via the Internet using a qualified electronic signature or a simple electronic signature received under a specific procedure. Within the scope of the experimental legal regime its participants will be able to enter into contracts for communications services via the Internet with clients being identified by voice, face image or other biometric data (biometric identification). The relevant amendments have been made to Federal Laws Nos. 126-FZ “On communications” and 152-FZ “On personal data” dated 7 July 2003 and 27 July 2006, respectively.

Autonomous transport technologies

The current traffic safety rules prohibit the use of autonomous transport. Requirements of aviation legislation are aimed at regulating manned aviation. For some types of autonomous aviation systems, the statutory requirements are hard to comply with. This may constrain the development of autonomous transport technologies in Russia. To eliminate such constraints the Law amends Federal Laws Nos. 196-FZ “On traffic safety” and 259-FZ “The Charter of motor transport and city ground electric transport” dated 10 December 1995 and 8 November 2007, respectively, as well as the Russian Aviation Code and other items of legislation.

Therefore, the adoption of the Law allows the participants of experimental legal regimes to develop and implement digital innovations while remaining in compliance with current legislation.

What to think about and what to do

Companies conducting business in the area of digital innovations are recommended to audit their current and intended business processes and pay attention to the possibility of implementing innovation projects by participating in experimental legal regimes.

Help from your adviser

Pepeliaev Group’s specialists are ready to provide comprehensive legal support to companies engaged in the sphere of digital innovations. The range of our services includes:

  • Advising on legal risks;
  • Auditing business processes as to their compliance with the regulatory requirements;
  • Representing clients in their dealings with public authorities, including when clients participate in experimental legal regimes, as well as providing other services.


[1] Federal Law No. 258-FZ “On experimental legal regimes in the area of digital innovations in the Russian Federation” dated 31 July 2020.
[2] See the index record for draft law No. 1129501-7.

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