September 16, 2019 Roszdravnadzor and the Russian Ministry of Health held a seminar in Yekaterinburg as part of the International Medical Device Regulators Forum (IMDRF) on the topic “Artificial Intelligence in Healthcare”

On September 16, 2019, in Yekaterinburg, as part of the International Forum of Medical Device Regulators (IMDRF), a joint seminar of the IMDRF Cybersecurity Working Group and the Global Association of Radiography, Medical IT and Radiation Therapy Systems (DITTA) Manufacturers on the topic “Artificial Intelligence in Healthcare” was held .
The seminar was attended by more than 200 representatives of subjects of circulation of medical devices, including the regulatory authorities of South Korea (MFDS), the Russian Federation (Roszdravnadzor), China (NMPA), the Ministries of Health of Germany and Japan, DITTA, the World Health Organization (WHO) , manufacturers of medical devices (Siemens Healthineers, Philips, GE Healthcare, Shimadzu).
The event discussed key regulatory issues in the field of Artificial Intelligence (hereinafter referred to as AI) in healthcare of different countries related to the development of regulatory requirements for software, its use, as well as the need to adapt the existing regulatory framework for IMDRF.
Also during the reports and discussions, the seminar participants raised the following topics:
– global prospects for the use of AI in the healthcare system;
– Opportunities and challenges in developing regulatory frameworks in the field of AI;
– current issues of cybersecurity;
– problems of clinical evaluation of AI software;
– AI standardization activities, including at the ISO, IEC and WHO levels;
– Responsibility of manufacturers and the development of the industrial sector related to AI.
Information from Roszdravnadzor: The International Forum of Medical Device Regulators (IMDRF) was established in October 2011 with the goal of harmonizing internationally the regulatory requirements for the circulation of medical devices (market access, quality control, safety, effectiveness, etc.). In 2019, the Russian Federation was elected Chairman of the Forum.
The Forum Steering Committee (IMDRF Management Committee) currently includes official representatives of 10 regulatory authorities in Australia, Brazil, the European Union, Canada, China, the Russian Federation, Singapore, the USA, South Korea and Japan.
Forum official observer is the World Health Organization (WHO). Affiliates are APEC (represented by the Life Sciences Innovation Forum), the Asian Harmonization Working Party, and the Pan American Health Organization.
Currently, eight working groups have been formed within the IMDRF in the following areas: international standards for regulatory use, clinical trials, personalized medical devices, good regulatory practices, terms and codes of adverse events that occur when using medical devices, documentation requirements and dossier structure, provided for registration purposes, the cybersecurity of medical devices and the principles of classification of medical devices for in vitro diagnostics.