Artificial intelligence (AI) technologies are considered to be one of the most promising areas of development in various fields of human activity. AI-based systems are used not only in scientific research, but are also actively used in practice. However, the practical implementation of AI technologies has revealed a number of problems associated with the imperfection of the current legislative framework. For this purpose, in July 2019, by order of The Federal Agency for Technical Regulation and Metrology ( Rosstandart ) No. 1732, a technical committee for standardization “Artificial Intelligence” (TC 164) was created, which deals with issues of AI and improving the efficiency of standardization in this area. Within the framework of TC 164, the subcommittee PK01 “Artificial Intelligence in Healthcare” functions separately, developing national and international standards that apply to the requirements for the development, testing, as well as the use and operation of medical software based on AI.
References
1. Morozov SP, Vladzimirskiy AV, Gombolevskiy VA, Klyashtorny VG, Fedulova IA, Vlasenkov LA. Artificial intelligence in lung cancer screening: assessment of the diagnostic accuracy of the algorithm analyzing low-dose computed tomography. Tuberculosis and Lung Diseases. 2020; 98(8): 24-31. (In Russ).
2. Retson , T.A., Eghtedari , M. Computer-Aided Detection/Diagnosis in Breast Imaging: A Focus on the Evolving FDA Regulations for Using Software as a Medical Device. Curr Radiol Rep. 2020; 8: 7.
3. Morozov SP, Chernina VY, Andreychenko AE, et al. How does artificial intelligence affect the assessment of lung damage in COVID-19 on a chest CT scan? Digital Diagnostics. 2021; 2(1): 27-38. ( In Russ ).
4. Gusev AV, Dobridnyuk SL. Artificial intelligence in medicine and healthcare. The information society journal. 2017; 4-5: 78-93. (In Russ).
5. Meldo AA, Utkin LV, Trofimova TN. Artificial intelligence in medicine: current state and main directions of development of intellectual diagnostics. Diagnostic radiology and radiotherapy. 2020; 11(1): 9-17. ( In Russ ).
6. IMDRF/ SaMD WG/N41. Software as a Medical Device ( SaMD ): Clinical Evaluation. 2017. 45 р.
7. IMDRF/ SaMD WG/N23. Software as a Medical Device ( SaMD ): Application of Quality Management System. 2015. 34 р.
8. IMDRF/ SaMD WG/N10. Software as a Medical Device ( SaMD ): Key Definitions. 2013. 9 р.
9. Morozov SP, Vladzymyrskyy AV, Klyashtorny VG, et al. Clinical trials of software based on intelligent technologies (radiology). Ser. Best Practices in Radiology and Instrumental Diagnostics. Moscow, 2 019. Issue 23. 51 p. (In Russ).
10. Morozov S.P., Vladzymyrskyy A.V., Ledikhova N.V., et al. Moscow experiment on computer vision in radiology: involvement and participation of radiologists. Vrach i informacionnye tehnologii. 2020. Vol. 20, N. 8. P. 14-23. (In Russ).
11. Dong J, Geng Y, Lu D, et al. Clinical Trials for Artificial Intelligence in Cancer Diagnosis: A Cross-Sectional Study of Registered Trials in ClinicalTrials.gov. Front. Oncol. 2020. Vol. 10. № 1629.
2. Retson , T.A., Eghtedari , M. Computer-Aided Detection/Diagnosis in Breast Imaging: A Focus on the Evolving FDA Regulations for Using Software as a Medical Device. Curr Radiol Rep. 2020; 8: 7.
3. Morozov SP, Chernina VY, Andreychenko AE, et al. How does artificial intelligence affect the assessment of lung damage in COVID-19 on a chest CT scan? Digital Diagnostics. 2021; 2(1): 27-38. ( In Russ ).
4. Gusev AV, Dobridnyuk SL. Artificial intelligence in medicine and healthcare. The information society journal. 2017; 4-5: 78-93. (In Russ).
5. Meldo AA, Utkin LV, Trofimova TN. Artificial intelligence in medicine: current state and main directions of development of intellectual diagnostics. Diagnostic radiology and radiotherapy. 2020; 11(1): 9-17. ( In Russ ).
6. IMDRF/ SaMD WG/N41. Software as a Medical Device ( SaMD ): Clinical Evaluation. 2017. 45 р.
7. IMDRF/ SaMD WG/N23. Software as a Medical Device ( SaMD ): Application of Quality Management System. 2015. 34 р.
8. IMDRF/ SaMD WG/N10. Software as a Medical Device ( SaMD ): Key Definitions. 2013. 9 р.
9. Morozov SP, Vladzymyrskyy AV, Klyashtorny VG, et al. Clinical trials of software based on intelligent technologies (radiology). Ser. Best Practices in Radiology and Instrumental Diagnostics. Moscow, 2 019. Issue 23. 51 p. (In Russ).
10. Morozov S.P., Vladzymyrskyy A.V., Ledikhova N.V., et al. Moscow experiment on computer vision in radiology: involvement and participation of radiologists. Vrach i informacionnye tehnologii. 2020. Vol. 20, N. 8. P. 14-23. (In Russ).
11. Dong J, Geng Y, Lu D, et al. Clinical Trials for Artificial Intelligence in Cancer Diagnosis: A Cross-Sectional Study of Registered Trials in ClinicalTrials.gov. Front. Oncol. 2020. Vol. 10. № 1629.
For citation
Morozov S.P., Zinchenko V.V., Khoruzhaya A.N., Sharova D.E., Akhmad E.S., Andreychenko A.E., Vladzymyrskyy A.V. Standardization of artificial intelligence in healthcare: Russia becomes the leader. Medical doctor and information technology. 2021; 2: 12-19. (In Russ.). doi : 1025881/18110193_2021_2_12.
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