Roszdravnadzor plans to receive data on the operation of medical AI systems automatically

The department believes that the development of these requirements will improve the efficiency of monitoring the use of these products. According to Vedomosti, the document is currently under interdepartmental discussion. Experts interviewed by the publication note that Roszdravnadzor currently does not have the necessary system or platform, so it still needs to be created.

According to the regulator, 48 medical devices with AI have been registered in Russia, 43 of which were developed in Russia.

Director of the Association of Developers and Users of Artificial Intelligence in Medicine "National Database of Medical Knowledge" Boris Zingerman noted that adverse reactions to medications have been recorded for decades, and Roszdravnadzor intends to organize a similar system. In his opinion, in the case of AI solutions, the system itself should collect information from devices about failures or incorrect operation.

Garnik Arutyunyan, Head of the Marketing Department of the Central Clinical Hospital of JSC RZhD-Medicine, believes that the data planned for collection may be sensitive, since it can be used to assess the quality of a specific product, the frequency of errors, and potential vulnerabilities.

"If such data is linked to specific clinics or systems, it can indirectly reflect the level of morbidity and the workload of medical institutions. This information alone does not allow hacking the system, but it can highlight weak points - recurring failures, configuration features or software versions. On this basis, attackers can prepare targeted attacks," Arutyunyan believes.

In December 2024, the Russian Ministry of Health, with the participation of chief external specialists, presented the Code of Ethics for the Use of AI in Healthcare. The department stated that the document is necessary to regulate relations related to the ethical aspects of the development, implementation and use of AI technologies.

The developers noted that following its provisions will help increase Russians' trust in the technology, and will also allow developers to create safe and competitive solutions necessary for the industry. The document was approved in March 2025. Vademecum invited experts - developers of thematic AI solutions, representatives of the medical community and medical universities - to assess the practical significance of the new regulation for the development of the healthcare industry. Read more in our material .

In mid-August 2025, the Ministry of Digital Development of the Russian Federation, together with the Alliance in the AI ​​sphere, which includes large domestic companies, developed a draft concept for the development of regulation of relations in the sphere of AI technologies until 2030. It sets out the key factors influencing the development and implementation of artificial intelligence in various industries, as well as the principles on which future regulation of the AI ​​sphere should be based. However, specific regulatory initiatives have not yet been formalized.