The agency presented for public discussion a draft proposal to extend and strengthen oversight of medical devices operating using artificial intelligence technologies.
According to the document, the mechanism providing for the automatic transfer of data on the operation of such devices is planned to be extended until December 31, 2027.
Key changes and continuing requirements:
• A new field—”AI medical device solution type”—is being added to the list of information required to be submitted. This will allow for a more detailed categorization of system functionality, including diagnostics, disease prognosis, and therapy planning support.
• For manufacturers and their authorized representatives, the current rule remains: if a product has an automatic data transfer function, information must be sent to the Roszdravnadzor information system via an electronic account.
The information transmitted remains detailed: the agency receives information about the product name and version, the number of clinical cases processed, the results of the algorithms, any errors recorded, and the identification number of the medical organization using the solution.
This initiative continues the development of a regulatory framework for the use of artificial intelligence technologies in healthcare. Previously, the “Code of Ethics for the Use of AI in Healthcare” was approved (December 2024), which enshrines the principles of maintaining control by medical personnel and protecting the privacy of patient data.
Thus, the regulator is not only extending the validity of existing regulations but also improving the data collection system, making monitoring the use of artificial intelligence in medical practice more structured.
