Legal regulation of artificial intelligence software in healthcare in the Russian Federation

Author:

Gusev A.V.,Morozov S.P.,Kutichev V.A.,Novitsky R.E.

Publisher

Media Sphere Publishing Group

Subject

General Medicine

Reference13 articles.

1. High-performance medicine: the convergence of human and artificial intelligence

2. Topol EJ. Deep Medicine. How Artificial Intelligence Can Make Healthcare Human Again. New York: Basic Books; 2019

3. The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

4. IMDRF/SaMD WG/N10:2013. Software as a Medical Device (SaMD): Key Definitions. Accessed December 12, 2020. https://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf

5. IMDRF/SaMD WG/N12:2014. Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. Accessed December 12, 2020. https://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf

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