Developers of medical technologies based on artificial intelligence will be required to automatically transmit data on the frequency of use of their solutions, failures, and deviations in operation to Roszdravnadzor. According to the agency, this refers to systems for supporting medical decision-making — from analyzing medical images to processing electronic patient records.
Currently, 48 such medical devices are registered in Russia, 43 of which are of domestic design. Market leaders include Botkin.AI, Webiomed, and "Third Opinion." Currently, reports on problems are sent to Roszdravnadzor manually and once a year, but the new initiative involves the continuous collection of technical telemetry from devices.
According to experts, the idea is similar to the current pharmacovigilance, but with an adjustment for the specifics of the technologies: the system will have to independently record errors and transmit information to the regulator. This does not involve personal patient data, but information about failures and software configurations is considered sensitive: it can reveal weaknesses in the product and be of interest to competitors or attackers.
To reduce risks, it is proposed to transmit data through secure government channels (SMEV) using cryptographic encryption and strict access auditing.
The initiative is currently under interdepartmental discussion. If the project is approved, Roszdravnadzor will have to create a new platform for automated supervision of medical AI solutions.
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