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Development of Artificial Intelligence in Healthcare in Russia

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Handbook of Artificial Intelligence in Healthcare

Part of the book series: Intelligent Systems Reference Library ((ISRL,volume 212))

Abstract

Research and development in the field of artificial intelligence in Russia has been conducted for several decades. Amid a global increase in attention to this area, the Russian Federation has also developed and systematically implemented its own national strategy, which includes healthcare as a priority sector for the introduction of AI products. Government agencies in collaboration with the expert community and market are developing several key areas at once, including legal and technical regulation. Based on the IMDRF recommendations, software products created using AI technologies for application in the diagnostic and treatment process are considered in Russia as the Software as Medical Devices (SaMD). Over the last year, the Government of the Russian Federation, the Ministry of Health and Roszdravnadzor made many targeted changes to the current legislation to enable a state registration of software products based on AI technologies and their introduction to the market. More than 20 regions of the Russian Federation have launched various projects to implement AI technologies in the real clinical practice. Work is underway to create the first series of national technical standards to accelerate products’ development and create more trust from healthcare practitioners.

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References

  1. A. Kuleshov, A. Ignatiev, A. Abramova, et al, Addressing AI ethics through codification, in International Conference Engineering Technologies and Computer Science (EnT) (2020), pp. 24–30

    Google Scholar 

  2. S. Gerke, T. Minssen, G. Cohen, Ethical and legal challenges of artificial intelligence-driven healthcare, in Artificial Intelligence in Healthcare (2020), pp. 295–336

    Google Scholar 

  3. E. Topol, Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again (Basic Books, New York, 2019)

    Google Scholar 

  4. Decree of the Government of the Russian Federation No. 2129-r, http://publication.pravo.gov.ru/Document/View/0001202008260005. Accessed 19 Aug 2020

  5. A.V. Gusev, S.P. Morozov, V.A. Kutichev et al., Legal regulation of artificial intelligence software in healthcare in the Russian Federation. Med. Technol. Assess. Choice 1(43), 36–45 (2021)

    Article  Google Scholar 

  6. Decree of the President of the Russian Federation No. 490 On the Development of Artificial Intelligence in the Russian Federation and adoption of National Strategy for the Development of Artificial Intelligence over the Period up to the Year 2030, http://www.kremlin.ru/acts/bank/44731. Accessed 10 Oct 2019

  7. Decree of the President of the Russian Federation No. 204 On the National Goals and Strategic Tasks of the Development of the Russian Federation for the Period up to 2024, https://minenergo.gov.ru/view-pdf/11246/84473. Accessed 7 May 2018

  8. IMDRF/SaMD WG/N10:2013 Software as a Medical Device (SaMD): Key Definitions, http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf. Accessed 9 Dec 2013

  9. IMDRF/SaMD WG/N12:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. International Medical Device Regulators Forum, http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf. Accessed 18 Sep 2014

  10. IMDRF/SaMD WG/N23:2015 Software as a Medical Device (SaMD): Application of Quality Management System. International Medical Device Regulators Forum, http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-151002-samd-qms.pdf. Accessed 2 Oct 2015

  11. IMDRF/SaMD WG(PD1)/N41R3:2016 Software as a Medical Device (SaMD): Clinical Evaluation. International Medical Device Regulators Forum, http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170921-samd-n41-clinical-evaluation_1.pdf. Accessed 21 Sep 2017

  12. Federal Law № 323 On the fundamentals of public health protection in the Russian Federation, http://base.garant.ru/57499516. Accessed 21 Nov 2011

  13. The Code of Administrative Offences of the Russian Federation, 195-FZ Article 6.28 Violation of the existing medical device rules, http://finansovyesovety.ru/statya6.28-koap-rf/. Accessed 30 Dec 2001

  14. Criminal Code, 63-FZ Article 238.1. The production, import or sale of falsified, inferior, or unregistered medicines or medical devices, as well as the circulation of unregistered falsified active additives containing pharmaceutical substances, http://finansovyesovety.ru/statya238.1-uk-rf/. Accessed 13 Jun 1996

  15. Informational letter № 02I-297/20 from Roszdravnadzor, https://roszdravnadzor.ru/medproducts/registration/documents/65752. Accessed 13 Feb 2020

  16. Order of the Russian Ministry of Health № 4n On approval of the nomenclature classification for medical devices, http://www.roszdravnadzor.ru/documents/121. Accessed 6 Jun 2012

  17. Order of the Ministry of Health No. 11n About approval of requirements to the content of technical and operational documentation of medical devices manufacturer, http://base.garant.ru/71626748/. Accessed 19Jan 2017

  18. Order of the Ministry of Health № 2n On approval of the procedure for the assessment of the compliance of medical devices in the form of technical trials, toxicological studies and clinical trials for medical device state registration purposes, http://base.garant.ru/70631448/. Accessed 9 Jan 2014

  19. Government Decree № 1906 On amendments to the rules for state registration of medical devices, https://www.garant.ru/products/ipo/prime/doc/74862496/. Accessed 24 Nov 2020

  20. Order of the Ministry of Health № 300n Approval of the requirements for medical institutions conducting clinical trials of medical devices and procedures of establishing compliance of medical institutions with these requirements, http://www.roszdravnadzor.ru/documents/106. Accessed 16 May 2013

  21. Order of the Ministry of health № 1386n On approval of the methodology for determining the amount of payment for examination and testing of medical devices for state registration of medical devices and the maximum amount of fees for examination and testing of medical devices for state registration of medical devices, http://docs.cntd.ru/document/902314476. Accessed 22 Nov 2011

  22. Government Decree № 1416 On approval of the state registration of medical products”, http://www.roszdravnadzor.ru/documents/121. Accessed 27 Dec 2012

  23. Order of Roszdravnadzor № 9260 On approval of the administrative regulations of the Federal Service for Supervision in Healthcare for the implementation of state control over the circulation of medical devices, http://publication.pravo.gov.ru/Document/View/0001202002200032 Accessed 9 Dec 2019

  24. Government Decree № 633 On amending the rules for state registration of medical devices, http://government.ru/docs/32763/. Accessed 31 May 2018

  25. Order of the Ministry of Health № 1353n On approval of the procedure for medical product quality, efficacy and safety review with changes and amendments approved by the Order of the Ministry of Health № 303n, http://www.roszdravnadzor.ru/documents/115. Accessed 3 Jun 2015

  26. Decision of the Council of the Eurasian Economic Commission № 46 On the rules for registration and expert assessment of safety, quality and efficacy of medical devices, https://docs.eaeunion.org/docs/ru-ru/01510767/cncd_12072016_46. Accessed 12Feb 2016

  27. Guidelines on the procedure for conducting the examination of the quality, efficacy and safety of medical devices for the state registration, http://www.roszdravnadzor.ru/documents/34129

  28. Guidelines on the procedure for conducting the examination of the quality, efficacy and safety of medical devices (in terms of software) for the state registration within the framework of the national system, https://roszdravnadzor.gov.ru/medproducts/documents/71502. Accessed 12 Feb 2021

  29. Government Decree № 615 On approval of the Rules for maintaining the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, http://docs.cntd.ru/document/902353655. Accessed 19 Jun 2012

  30. Order of Roszdravnadzor№ 40-Pr/13 On approval of the form of registration certificate for a medical device, http://base.garant.ru/70329006/. Accessed 16 Jan 2013

  31. Decision of the Council of the Eurasian Economic Commission № 174 On approval of the rules for monitoring of safety, quality and efficacy of medical devices, https://docs.eaeunion.org/docs/ru-ru/01510767/cncd_12072016_46. Accessed 22 Dec 2015

  32. Order of the Russian Ministry of Health № 980n On approval of the Procedure monitoring of safety, quality and efficacy of medical devices, http://www.roszdravnadzor.ru/documents/121. Accessed 15 Sep 2020

  33. Order of the Ministry of Health № 1113n On approval of the Procedure for reporting by the subjects of circulation of medical devices every detection of side effects not specified in the package leaflet or the user manual of a medical device; about adverse reactions during its use; about the peculiarities of the interaction of medical devices between themselves; about the facts and circumstances that pose a threat to the life and health of citizens and medical workers during the use and operation of a medical device, http://publication.pravo.gov.ru/Document/View/0001202012070057. Accessed 19 Oct 2020

  34. Order of the Russian Ministry of Health № 980n On approval of the Procedure monitoring of safety, quality and efficacy of medical devices”, http://publication.pravo.gov.ru/Document/View/0001202011020039. Accessed 15 Sep 2020

  35. Order № 1732 On amendments to the program of national standardization for 2020, approved by Order № 2612 of the Federal Agency for Technical Regulation and Metrology, http://docs.cntd.ru/document/566051442. Accessed 19 Oct 2020

  36. On amending the Order of the Federal Agency for Technical Regulation and Metrology № 1732 On establishment of the technical committee for standardization ‘Artificial Intelligence’, http://docs.cntd.ru/document/564243465. Accessed 25 Jul 2019

  37. I. Korsakov, A. Gusev, T. Kuznetsova, et al., Deep and machine learning models to improve risk prediction of cardiovascular disease using data extraction from electronic health records. Euro. Heart J. 40(1), (2019)

    Google Scholar 

  38. I. Korsakov, D. Gavrilov, L. Serova, et al., Adapting neural network models to predict 10-year CVD development based on regional data calibration. Euro. Heart J. 41(2), (2020)

    Google Scholar 

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Author information

Authors and Affiliations

  1. Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies, Moscow Health Care Department, Moscow, Russia

    A. Gusev, S. Morozov, A. Vladzymyrskyy, V. Zinchenko, D. Sharova, E. Akhmad, D. Shutov & R. Reshetnikov

  2. K-Skai, LLC, Petrozavodsk, Republic of Karelia, Russia

    A. Gusev

  3. I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia

    G. Lebedev & A. Vladzymyrskyy

  4. Federal Research Institute for Health Organization and Informatics, Moscow, Russia

    G. Lebedev

  5. Institute of Molecular Medicine, I.M. Sechenov First Moscow State Medical University, Moscow, Russia

    R. Reshetnikov

  6. National Research Center «Kurchatov Institute», Moscow, Russia

    K. Sergunova

  7. Non-Commercial Organization Foundation for Development of the Center Elaboration and Commercialization of New Technologies, the Skolkovo, Foundation, Moscow, Russia

    S. Izraylit & E. Meshkova

  8. National Telemedicine Agency, Research-and-Production Corporation, Moscow, Russia

    M. Natenzon

  9. Center for Big Data Storage and Analysis Technology, Center for Competence in Digital Economics, Moscow State University M.V. Lomonosov, Moscow, Russia

    M. Natenzon

  10. MGIMO University (Moscow State Institute of International Relations), Moscow, Russia

    A. Ignatev

Authors
  1. A. Gusev
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  2. S. Morozov
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  3. G. Lebedev
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  4. A. Vladzymyrskyy
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  5. V. Zinchenko
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  6. D. Sharova
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  7. E. Akhmad
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  8. D. Shutov
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  9. R. Reshetnikov
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  10. K. Sergunova
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  11. S. Izraylit
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  12. E. Meshkova
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  13. M. Natenzon
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  14. A. Ignatev
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Corresponding author

Correspondence to G. Lebedev .

Editor information

Editors and Affiliations

  1. Institute for Intelligent Systems Research and Innovation, Deakin University, Waurn Ponds, VIC, Australia

    Chee-Peng Lim

  2. College of Information Science and Engineering, Ritsumeikan University, Shiga, Japan

    Yen-Wei Chen

  3. Royal Adelaide Hospital, Adelaide, SA, Australia

    Ashlesha Vaidya

  4. Avanti Institute of Cardiology, Nagpur, India

    Charu Mahorkar

  5. KES International, Shoreham-by-Sea, UK

    Lakhmi C. Jain

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Gusev, A. et al. (2022). Development of Artificial Intelligence in Healthcare in Russia. In: Lim, CP., Chen, YW., Vaidya, A., Mahorkar, C., Jain, L.C. (eds) Handbook of Artificial Intelligence in Healthcare. Intelligent Systems Reference Library, vol 212. Springer, Cham. https://doi.org/10.1007/978-3-030-83620-7_11

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