Telemedicine and experimental legal regimes in the field of healthcare: problems and prospects for implementation

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Abstract

In connection with the adoption of Federal Law No. 258-FZ of July 31, 2020 “On experimental legal regimes in the field of digital innovation in the Russian Federation,” a number of initiatives have been developed to establish experimental legal regimes in the field of telemedicine. The idea of using digital technologies in medicine is certainly relevant. On the one hand, the prospect of remotely receiving medical services is practically in demand; on the other, the level of technology development currently allows for a significant expansion of their implementation. The need to turn to the institution of an experimental legal regime is due to the fact that the current legislation contains norms that seriously complicate the process of widespread dissemination of telemedicine services.The purpose of the study is to reveal the theoretical characteristics of the concept of telemedicine and its current state, to identify legal obstacles to its development, to conduct a comparative analysis of existing draft programs of experimental regimes, to assess the problems and prospects for the development of telemedicine technologies in modern Russian practice. The study is based on domestic and foreign scientific sources of both legal and medical nature, as well as current and projected legal acts in the field of medical services, digital technologies, and personal data protection. Formal-legal, comparative-legal, statistical, and prognostic methods are used. Several problems that require a conceptual solution, including the issue of the safety of personal data and the issue of responsibility for a medical error resulting from the use of artificial intelligence technology or a technical device have been identified. Both are unlikely to be completely resolved at the current level of legal regulation and technological development. This, however, only confirms the need to introduce appropriate experimental regimes in order to use the accumulated empirical material to find solutions to existing and abstractly predictable problems.

About the authors

Marina L. Davydova

Volgograd State University

Author for correspondence.
Email: davidovaml@volsu.ru
ORCID iD: 0000-0001-8392-9592

Doctor of Legal Sciences, Full Professor, Head of the Department of Constitutional and Municipal Law

100 University prosp., Volgograd, 400062, Russian Federation

References

  1. Akulin, I.M. (2020) Application of distributed ledger technology and smart contracts in medicine. Manager zdravoohranenia. (1), 47-55. (in Russian).
  2. Akulin, I.M., Chesnokova, E.A., Presnyakov, R.A., Pryadko, A.E. & Guryanova, N.E. (2022a) The main provisions of the convention on improving supranational legal regulation in the EAEU in the field of healthcare in the context of the development of innovative digital technologies. Medical doctor and information technology. (2), 74-82. https://doi.org/10.25881/18110193_2022_2_74 (in Russian).
  3. Akulin, I.M., Chesnokova, E.A., Presnyakov, R.A., Pryadko, A.E. & Guryanova, N.E. (2022b) Electronic medical record: experience of legal regulation of the EAEU countries. Medical doctor and information technology. (1), 72-83. https://doi.org/1025881/18110193_2022_1_72 (in Russian).
  4. Almazov, A.A., Rumyantsev, P.O., Kupreev, P.P., Murashko, M.M., Rodin, S.A. & Melerzanov, A.V. (2020) Multimodal data analysis, “Human” and “Machine” approaches difference, social problematics of biomedical data collection and turnover. Medical doctor and information technology. (2), 28-35. https://doi.org/10.37690/1811-0193-2020-2-28-35 (in Russian).
  5. Castillo, R.S. & Kelemen, A. (2013) Considerations for successful clinical decision support system. CIN: Computers, Informatics, Nursing. 31(7), 319-326. https://doi.org/10.1097/NXN.0b013e3182997a9c
  6. Craig, J. & Patterson, V. (2005) Introduction to the practice of telemedicine. Journal of Telemedicine and Telecare. 11(1), 3-9.
  7. Currell, R., Urquhart, C., Wainwright, P. & Lewis, R. (2000) Telemedicine versus face to face patient care: effects on professional practice and health care outcomes. Cochrane Database of Systematic Reviews. (2), CD002098. https://doi.org/10.1002/14651858.CD002098
  8. Davydova, M.L., Filimonova, N.Yu. & Seregina, O.L. (2020) Linguistic features of contracts for the provision of medical services for compensation: availability and sufficiency. Academic law journal. 3(81), 60-66. (in Russian).
  9. Davydova, M.L., Filimonova, N.Y., Seregina, O.L., Prodanova, N.A., & Zekiy, A.O. (2020) Medical services contracts: Features and ways of improvement. Systematic Reviews in Pharmacy. 11(6), 40-44. https://doi.org/10.31838/srp.2020.6.09
  10. Fedorov, V.F. & Stolyar, V.L. (2020) Personal telemedicine. Prospects for implementation. Medical doctor and information technology. (2), 36-43. https://doi.org/10.37690/1811-0193-2020-2-36-44 (in Russian).
  11. Gorenkov, R.V., Ivanitsky, L.V., Pozharov, I.V., Kurbatova, E.I., Obedkov, I.V., Chernyavskaya, T.K. & Kakorina, E.P. (2022) Experience of remote monitoring in patients with chronic non-communicable diseases. Medical doctor and information technology. (1), 30-39. https://doi.org/1025881/18110193_2022_1_30 (in Russian).
  12. Gribova, V.V., Petryaeva, M.V., Okun, D.B. & Shalfeeva, E.A. (2018) Ontology of medical diagnostics for intelligent decision support systems. Ontology of design. 8(1(27)), 58-73. https://doi.org/10.18287/2223-9537-2018-8-1-58-73 (in Russian).
  13. Kadyrov, F.N., Kurakova, N.G. & Chililov, A.M. (2020) Legal problems of the use of telemedicine technologies in the context of combating the spread of the coronavirus СOVID-19. Medical doctor and information technology. (2), 46-51. https://doi.org/10.37690/1811-0193-2020-2-45-51 (in Russian).
  14. Karpov, O.E. & Khramov, A.E. (2021) Predictive medicine. Medical doctor and information technology. (3), 20-37. (in Russian).
  15. Kobyakova, O.S., Starodubov, V.I., Kadyrov, F.N., Kurakova, N.G. & Chililov, A.M. (2020) Telemedicine technologies: prospects and limitations. Medical doctor and information technology. (5), 76-85. https://doi.org/10.37690/1811-0193-2020-5-76-85 (in Russian).
  16. Kruse, C.S., Stein, A., Thomas, H. & Kaur, H. (2018) The use of electronic health records to support population health: a systematic review of the literature. Journal of medical systems. 42(11), 1-16. https://doi.org/10.1007/s10916-018-1075-6
  17. Levanov V.M., Orlov O.I. & Merekin D.V. (2013) Historical periods of development of telemedicine in Russia. Medical doctor and information technology. (4), 67-73. (in Russian).
  18. Makareyko, N.V. (2022) Legal risks of digitalization of medical care. Legal Science and Practice: Bulletin of the Nizhny Novgorod Academy of the Ministry of Internal Affairs of Russia. 1 (57), 67-74. (in Russian). https://doi.org/10.36511/2078-5356-2022-1-67-74
  19. Makarov, V.O. & Davydova, M.L. (2021) On the Concept of Regulatory Sandboxes. In: Popkova E.G., Sergi B.S. (eds.). “Smart Technologies” for Society, State and Economy. ISC 2020. Lecture Notes in Networks and Systems. Vol. 155. Springer, Cham. pp. 1014-1020. https://doi.org/10.1007/978-3-030-59126-7_112
  20. Makarov, V. (2022) Experimental legal regimes (regulatory sandboxes): Russian and foreign practices. Revista De Investigaciones Universidad Del Quindío. 34(S2), 71-79. https://doi.org/10.33975/riuq.vol34nS2.901
  21. Maksimov, I.B., Diashev, A.N. & Sinopalnikov, V.I., et. al. (2018) History, analysis of the state and prospects for the development of telemedicine. Journal of Telemedicine and eHealth. (3), 103-110. (in Russian).
  22. Morozov, S.P., Zinchenko, V.V., Khoruzhaya, A.N., Sharova, D.E., Akhmad, E.S., Andreichenko, A.E., Vladzimirsky, A.V. (2021) Standardization of artificial intelligence in healthcare: Russia becomes the leader. Medical doctor and information technology. (2), 12-19. https://doi.org/1025881/18110193_2021_2_12 (in Russian).
  23. Putilo, N.V. & Volkova, N.S. (2018) Telemedicine: the needs of society and the possibilities of legislation. Journal of Russian Law. (6), 124-130. https://doi.org/10.12737/art_2018_6_12 (in Russian).
  24. Vladzimirsky, A.V., Morozov, S.P. & Simenyura, S.S. (2020) Telemedicine and COVID-19: assessment of the quality of telemedicine consultations initiated by patients with SARS symptoms. Medical doctor and information technology. (2), 52-63. https://doi.org/10.37690/1811-0193-2020-2-52-63 (in Russian).
  25. Vladzimirsky, A.V., Lebedev, G.S., Shaderkin, I.A. & Mironov, Yu.G. (2022) Methodology for assessing the risks of diagnosing and prescribing treatment during direct-to-patient and their official representatives telemedicine consultations. Medical doctor and information technology. (2), 34-51. https://doi.org/10.25881/18110193_2022_2_34 (in Russian).
  26. Vygovsky, E.A., Elistratova, O.S. & Fokht, O.A. (2021) Trends of 2021 of the healthcare information technologies market of the Russian Federation. Medical doctor and information technology. (5), 14-31. https://doi.org/1025881/18110193_2021_S5_14 (in Russian).
  27. Wechsler, M., Perlman, L. & Gurung, N. (2018) The state of regulatory sandboxes in developing countries (November 16). Available at: SSRN: https://ssrn.com/abstract=3285938 [Accessed 17th November 2022].
  28. Zapisnaya, T.V. (2021) On the concept of development of legal regulation of relations in the field of digitalization of domestic healthcare. Lawyer. (5), 78-86. (in Russian).
  29. Zetzsche, D., Buckley, R. & Arner, D., et al. (2017) Regulating a Revolution: From Regulatory Sandboxes to Smart Regulation. EBI Working Paper Series. (11). UNSW Sydney NSW 2052 Australia. Available at: https://bit.ly/2NiZlav [Accessed 17th November 2022].

Copyright (c) 2023 Davydova M.L.

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