Roszdravnadzor proposed recording errors in medical devices with AI

According to the project, regions that use medical devices with AI technologies have the right to send monthly data on the operation of such technologies to the AIS Roszdravnadzor. Information on access to the platform will be posted on the official website of the agency.

After gaining access to the personal account of the system, subjects must connect medical devices to the software interface, which ensures automatic transfer of information. The information will include the name of the medical device, the number and date of the RU, the area of ​​application, data on the period for which the information is provided, the number of studies processed, the results of the medical device, as well as data on the number of errors (network and those that occurred during the processing of studies). In addition, the AIS will reflect the TIN of the medical institution or its unique identifier OID.

In March 2025, the Russian Ministry of Health approved the Code of Ethics for the Use of AI in Healthcare. The document's stated main objective is to define the rights and obligations of AI subjects, as well as mechanisms for regulating the application of the code.

Vademecum talked to developers of thematic AI solutions, representatives of the medical community and medical universities, asking experts to assess the practical significance of the new regulation for the development of the healthcare industry. Thus, the CEO of Smart Engines, Doctor of Technical Sciences Vladimir Arlazarov believes that "the main problem of using AI technologies in healthcare is the difficulty of determining responsibility in case of an error." The experts' opinions are in our material .