News Digest 18.12.2023 — 20.12.2023
Regulators
Inspections 2024: who to expect, what to prepare for?
The Russian government has extended the “testing” moratorium until 2024. Scheduled inspections of medical organizations are prohibited (for high-risk facilities they are replaced by a one-day preventive visit), unscheduled inspections are allowed only for a narrow range of reasons. The moratorium does not apply to some types of inspections - for example, in the field of compulsory medical insurance or prosecutorial ones.
The following will help you prepare for the tests:
- a list of typical violations identified during inspections of medical institutions issued by the Ministry of Health;
- fresh guidance from Roszdravnadzor on compliance with licensing requirements;
- a new video lesson from GARANT experts on preparing for the arrival of auditors to check settlements under compulsory medical insurance.
The government has updated the list of alcohol-containing medical products
The government has made changes to the list of alcohol-containing medical products, the production, production and (or) circulation of which are not subject to the Federal Law on State Regulation, approved by Order of the Government of the Russian Federation No. 2355-r dated September 15, 2020. The corresponding order No. 3663-r dated December 15, 2023 was published on the legal information portal.
According to the document, 367 new items have been added to the list. In particular, the approved list includes reagent kits, adhesive dental materials and control materials for in vitro diagnostics for in-laboratory quality control of laboratory testing procedures. At the same time, 9 items were excluded, among them reagent kits for the detection and quantification of SARS-CoV-2 RNA.
Market news
A rehabilitation center will be opened in Krasnoyarsk for 500 million rubles
The Committee on Health Protection and Social Policy of the Legislative Assembly of the Krasnoyarsk Territory announced the emergence of a rehabilitation center for participants in a special military operation (SVO) and members of their families on the basis of the Berezka sanatorium-preventorium. It is planned to allocate 500 million rubles for the development of the facility in 2024; it should soon become the property of the region.
Other
EMA has published a work plan for the use of AI in pharmacovigilance
The European Medicines Agency (EMA) has approved a work plan until 2028 on the use of artificial intelligence (AI) in the field of drug regulation. This is stated in a statement by the European Union regulator.
The document provides for the creation of a roadmap that will allow the adaptation of AI capabilities to automate processes and evaluate data in pharmacovigilance. The main tools of the regulator will be large language models, in particular chatbots. According to the EMA, this will help make more informed decisions.
Artificial intelligence model could help predict lung cancer risk in non-smokers, study says: 'significant progress'
Among the latest innovations in artificial intelligence in healthcare, routine chest X-rays can help identify non-smokers who are at high risk of developing lung cancer.
The study results will be presented this week at the annual meeting of the Radiological Society of North America (RSNA) in Chicago.
Researchers from the Cardiovascular Imaging Research Center (CIRC) at Massachusetts General Hospital (MGH) and Harvard Medical School in Boston developed a deep learning artificial intelligence model using 147,497 chest X-rays from asymptomatic and never smokers.
News
