News Digest 07.02.2024 — 09.02.2024
Regulators
On 02/08/2024, at the plenary session of the ITM II conference, Deputy Director of the Department of Digital Development and Information Technologies of the Russian Ministry of Health, Oliya Artemova, spoke about the initiatives of the Russian Ministry of Health to introduce artificial intelligence (AI) into regional healthcare.
From the current and the new
In 2024, Russian regions must introduce 3 AI-based medical products into their healthcare systems. Currently, there are already 26 domestic medical devices registered by Roszdravnadzor. The solutions being implemented must also be included in the register of domestic software.
Agreements with entities for the purchase of medical products also included solutions for voice filling of medical records.
Russian regions need to create business scenarios for the use of AI-based medical products and plans for their implementation.
In 2024, it is necessary to increase the number of scientific publications on the practice of using AI in medical organizations. There are no strict requirements for publications.
Source: https://itm-ai.ru/
Market news
Almost 500 million rubles were spent on the purchase of medical products with AI in Russia over the year.
In 2023, regions purchased 106 medical products with artificial intelligence (AI). At the same time, 14 subjects purchased two or more such MIs. Since a significant part of the purchases occurred in the second half of the year, 58 entities managed to start operating the MI. Such data was presented at the All-Russian Scientific and Practical Conference ITM-AI by Oliya Artemova, Deputy Director of the Department of Digital Development and Information Technologies of the Russian Ministry of Health, reports the MV correspondent.
By the end of 2024, three AI-based solutions should be implemented in practical healthcare in the regions. In order to avoid the mistakes of last year, it is necessary to pay special attention to ensuring that all purchased solutions are registered by Roszdravnadzor and have the status of a medical device, Artemova emphasized. All subjects must formulate plans for the acquisition of medical devices with AI for 2024, for the development of a regulatory framework governing their work in the region, for the publication of scientific articles, follows from the recommendations that the Ministry of Health sent to the subjects in January. There are no special requirements for these articles, but scientific activity must be carried out.
Other
AI will process side effect reports for the FDA
The US Food and Drug Administration (FDA) is using artificial intelligence (AI) to analyze cases of adverse drug events. RAPS writes about this.
The American regulator annually receives more than 2 million reports of side effects of drugs, the number of which is gradually growing every year. Based on them, the FDA should identify signals about drug safety, that is, a possible cause-and-effect relationship between an adverse reaction and taking the drug.
Apple Vision Pro virtual reality glasses began to be used in an American hospital
Sharp Healthcare, a non-profit regional group, purchased 30 Apple Vision Pro virtual reality glasses and donated them to doctors in various specialties at the Advanced Center for Spatial Computing in San Diego. This decision was made to study the possibilities of using the technology for medical purposes. Sharp Healthcare also plans to use the glasses to train doctors.
Using glasses, the doctor can instantly see blood pressure graphs, X-ray and tomography results. Anesthesiologists will also be able to monitor vital signs, ECG, spirometry in real time.
In addition, the developer of augmented reality and navigation for surgeons, Medivis, has created the SurgicalAR application for Vision Pro, which allows you to convert 2D images (CT/MRI) into 3D format and view them from different angles.
New registered medical devices
We publish a list of new medical devices registered from 09/02/2024 to 02/09/2024
Link to the list: [see. table in attachment]
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