16 ноября 2020

Regulation of artificial intelligence in healthcare in Russia

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Alexander Gusev,
Chief Business Development Officer, PhD

The use of artificial intelligence technologies in Russian healthcare opens up impressive prospects. At the same time, the healthcare industry is reasonably conservative. Many issues concerning the use of certain technologies and products, from drugs to innovative solutions, are subject to state control and regulation.

In this publication, we have listed some important regulatory acts that in one way or another govern the use of AI in healthcare in Russia.

Federal Acts and Presidential Decrees

Regulation Description, comments
Decree of the President of Russia No. 490 of October 10, 2019 “On the development of artificial intelligence in the Russian Federation”
Download (in Russian) >>>
The decree establishes the national strategy for the development of AI, including that in the field of health. AI is expected to improve the quality of services, including preventive examinations and diagnostics based on image analysis. Technologies will make it possible to predict the occurrence and development of diseases, choose drug dosages and reduce the threat of pandemics. What is more, artificial intelligence should automate surgery and make it more accurate. More details (in Russian):
https://webiomed.ai/blog/realizatsiia-natsionalnoi-strategii-iskusstvennogo-intellekta-v-sfere-zdravookhraneniia/

Priority projects and National projects

Regulation Description, comments
"Healthcare" National Project Download (in Russian) >>> The key goals of the national project are to reduce mortality, eliminate staff shortages in medical organizations providing primary health care, develop prevention, etc. It includes the "Creation of a single digital circuit in the health sector based on the Unified State Health Information System" program.The project data sheet was approved on the meeting of the Presidium of the Council under the President of the Russian Federation for Strategic Development and National Projects on December 24, 2018.
Decree of the Government of the Russian Federation No. 447 of April 12, 2018 "On the procedure of interaction between state and non-state information systems in healthcare"
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The document establishes technical requirements for information systems of non-governmental organizations that provide services to citizens and medical organizations. Many AI systems provided by the SaaS model for use in the Unified State Health Information System or medical information system of a medical organization must be registered as "Other systems" under this decree. More details (in Russian): http://www.kmis.ru/blog/o-pravilakh-vzaimodeistviia-gosudarstvennykh-i-inykh-informatsionnykh-sistem-v-sfere-zdravookhraneniia
Order of the Government of the Russian Federation No. 2129-R of August 19, 2020 on the approval of the "Concept for the regulation of artificial intelligence and robotics until 2024" Download (in Russian) >>> The document establishes the main approaches to changes in the Russian regulation, which will allow the creation and application of AI and robotics technologies in various fields, including healthcare.

Orders of the Ministry of Health of Russian Federation on AI in Healthcare

Regulation Description, comments
Order of the Ministry of Health of Russia of June 14, 2018 No. 341n "On approval of the Procedure for depersonalization of information about persons who receive medical assistance, as well as persons who undergo medical examinations"
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Establishes the procedure for depersonalization of information processed by the service of the federal integrated HER of USHIS. Anonymization is carried out in order to protect information from unauthorized use while preserving the possibility of its further processing. It can be used by developers of AI systems to implement data depersonalization in their products. More details:
https://pharmvestnik.ru/publs/lenta/v-rossii/minzdrav-utverdil-porjadok-9-8-18.html
Order of the Ministry of Health of Russia of February 21, 2019 No. 79n "On approval of the application form for connecting an information system designed to collect, store, process and provide information regarding the activities of medical organizations and the services they provide to the Unified State Health Information System"
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The document was developed in accordance with clause 9 of the Rules for the interaction of other information systems designed to collect, store, process and provide information regarding the activities of medical organizations and their services, with information systems in the healthcare sector and medical organizations approved by the decree of the Government of the Russian Federation of 12 April 2018 No. 447. Commentary on the document:
http://d-russia.ru/minzdrav-razrabotal-formu-zayavki-na-podklyuchenie-inyh-it-sistem-v-sfere-zdravoohraneniya-k-edinoj-sisteme.html
Order of the Ministry of Health of Russia of July 7, 2020 No. 686n "On Amendments to Appendices No. 1 and No. 2 to the Order of the Ministry of Health of the Russian Federation No. 4n dated June 6, 2012" On Approval of the Administrative Classification of Medical Devices "
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Establishes the classification of software medical devices depending on the degree of risk. For AI systems, it is the maximum risk class 3. More details: https://evercare.ru/news/minzdrav-utverdil-klassifikaciyu-po-dlya-zdravookhraneniya-po-stepenyam-riska-dlya
Order of the Ministry of Health of Russia of August 27, 2020 No. 906n "On approval of the list, procedure for maintaining and using classifiers, reference books and other regulatory and reference information in healthcare"
Download (in Russian) >>>
The document approved the guide of the reference data in healthcare, as well as the procedure for maintaining and using references. It is recommended to take this order into account by the developers of AI systems for subsequent integration with the USHIS, Medical Information System of the Medical Organization and other information systems.
Order of the Ministry of Health of Russia of July 9, 2020 No. 560n "On approval of the Rules for conducting X-ray examinations"
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Establishes the possibility CDSS use when organizing the work of the X-ray service.

Additional information: if you are interested in the Russian legal regulation of the use of IT in health care in general, then a detailed list of current regulatory acts on this topic is available here (in Russian): https://www.kmis.ru/blog/normativno-pravovye-akty-po-informatizatsii-zdravookhraneniia

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