04 марта 2020

On the subtleties of legal regulation of AI in healthcare

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On February 25, the Center for Diagnostics and Telemedicine hosted the second online lecture in the IT and Telemedicine series: "Standards-compliant application of Artificial Intelligence in Medicine and Healthcare". The webinar was hosted by our colleague, an expert in the field of digital health, Ph.D. in technical sciences Alexander Gusev.

The lecture gave an overview of the regulatory requirements for the use of software in medicine and healthcare. The issue of regulatory requirements for registering software as a medical device was considered meticulously, including the existing administrative and criminal liability for the use and release of such software. What is more, the procedures for quality examination, technical and clinical trials and subsequent registration of software as a medical device as well as the features of artificial intelligence systems in terms of registering software as an MD were discussed.

SaMD

Various issues were discussed, including:

  • which software is a medical device and which is not
  • registration (approval) of software as a medical device
  • administrative and criminal liability
  • technical and clinical trials
  • specificities of artificial intelligence in terms of registering software as a medical device

The webinar was attended by 307 people.

Webinar (in Russian):

 

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