Russian health authorities halt use of AI medical software amid safety concerns
Russian medical institutions have paused the deployment of software that relies on artificial intelligence because it poses a risk to patient safety. The pause was announced by Roszdravnadzor, the federal supervisory body responsible for health and pharmaceutical oversight.
According to Roszdravnadzor, the immediate concern centers on Botkin.AI, a software system developed by Intellogic LLC. Officials say the program can potentially endanger life and health because its performance diverged from the indicators registered with the state. The agency reached this conclusion after conducting a detailed analysis of Botkin.AI and comparing its operational characteristics to those listed in official registrations.
In a written statement, Roszdravnadzor explained that the use of Botkin.AI has been suspended and an unscheduled random audit has been initiated against Intellogic LLC, the company behind Botkin.AI. The ministry also noted that all relevant documents and a formal notification have been sent to the Moscow prosecutor’s office for review.
News outlets have reported on the situation as it unfolded. Previously, Roszdravnadzor had signaled the possibility of pausing use of AI-powered medical systems, highlighting a precedent for closer scrutiny of AI tools in clinical settings. The current action marks a notable step in the ongoing dialogue about safety thresholds and regulatory compliance for medical AI in Russia.
The events underscore a broader shift in the healthcare sector where technology that assists clinical decision-making must align with established safety standards and regulatory mandates. The focus remains on ensuring that AI tools used by doctors maintain reliability, transparency, and a verifiable track record that protects patients while enabling clinicians to deliver high-quality care.
From a policy perspective, the Roszdravnadzor action illustrates how regulators balance innovation with patient protection. Stakeholders in the medical technology space are watching closely to understand how investigations will unfold, what revisions to registration data might be required, and how future AI medical devices will be evaluated before they are approved for use in the Russian healthcare system.
Clinicians and healthcare organizations are urged to monitor official communications from Roszdravnadzor and to follow guidance closely while the investigation progresses. The outcome of this case could have implications for similar AI tools operating in the country, potentially shaping licensing processes, post-market surveillance, and the criteria for ongoing performance verification of machine-learning medical software.
In the meantime, healthcare facilities are advised to rely on established clinical protocols and human oversight to ensure patient safety. The collaboration between regulators, manufacturers, and medical professionals remains essential to fostering innovation that does not compromise patient outcomes.