The Artificial Intelligence in Healthcare. Opportunities and Challenges workshop was held on September 16, 2019, in Yekaterinburg. It was organized by the International Forum of Medical Devices regulators (IMDRF) in cooperation with Roszdravnadzor and the Ministry of Health (Russia).
Experts of our team took part and made presentations.
The seminar was attended by industry experts and representatives of regulatory authorities from South Korea (MFDS), the Russian Federation (Roszdravnadzor), China (NMPA), the Ministries of health of Germany and Japan, as well as experts from DITTA, the World Health Organization (WHO) and international companies-developers of medical devices (Siemens Healthineers, Philips, GE Healthcare, Shimadzu).
The discussion was about the prospects of artificial intelligence in medicine and health care and the effectiveness and risks of these technologies.
Alexander Gusev made the report on Prospects for using artificial intelligence technologies in the Russian Healthcare System.
In his report, Alexander noted: "Despite all the difficulties, artificial intelligence for medicine has been actively developing in Russia recently. We have a lot of developments in this field on the market. Existing solutions are presented in all key areas, including prevention, image analysis, treatment selection, drug prescribing analysis, etc."
What is more, he added that there are several obstacles to the introduction of AI: The main obstacle according to the survey is " Unwillingness of medical staff to trust artificial intelligence": The second problem is the lack of ready-made and proven solutions, including due to the high complexity and high costs of their development. Finally, the third barrier, significantly constraining the penetration of AI, are legislative shortcomings and requirements for the registration of AI as a medical product, including long-term clinical trial procedures."
Denis Gavrilov, Chief Medical Officer of our company, and Olga Belorus, the Head Medical Information and Analytical Center of YaNAO, made the reports at the seminar as well.
Olga Belorus referred to the experience about the experience of implementing artificial intelligence technologies in healthcare of the Yamal-Nenets Autonomous Okrug. She represented the results of the pilot project and the advantages of using this technology in practical medicine.
Denis Gavrilov's report was devoted to the topic of preparation and conduct of clinical trials for intelligent systems including clinical decision support system.
As a result, the discussion was very informative, interesting and extensive.
About the forum
The International Medical Device Regulators Forum (IMDRF) was created in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.
It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.
The IMDRF Management Committee, composed of regulatory officials, provides guidance on strategies, policies, directions, membership and activities of the Forum. Furthermore, the Management Committee oversees Working Groups, which draw upon expertise from various stakeholder groups such as industry, academia, healthcare professionals, consumer and patient groups.
The roles of IMDRF Chair and Secretariat rotate annually. The Russian Federation was elected Forum Chairman in 2019.
The current members are:
• Australia
• Brazil
• Canada
• China
• Europe
• Japan
• Russia
• Singapore
• South Korea
• the United States of America
The World Health Organization (WHO) is an Official Observer.
Currently. there are several working groups in the following areas:
International standards for regulatory use; Clinical trials; Personalized medical devices; Good regulatory practices; Terms and codes of adverse events arising from the use of medical devices; Documentation requirements and the structure of the dossier provided for registration purposes; Cybersecurity of medical devices and Principles of classification of medical devices for the diagnosis of Invitro.
You can download materials from the event on the official website of DITTA: https://www.globalditta.org/media-centre/events/article/dittas-involvement-in-the-15th-imdrf-meeting-1.html