News Digest 07.06.2024 — 10.06.2024
Regulators
New national standards for medical and healthcare professionals have been approved
GOST R ISO 18113-1-2024 "In vitro diagnostic medical devices. Information provided by the manufacturer (labeling). Part 1. Terms, definitions and general requirements" was approved by the order of Rosstandart dated May 23, 2024 No. 647-st.
The standard establishes terms and specifies the basic requirements for information provided by the manufacturer of in vitro diagnostic medical devices (IVD). The standard does not cover the requirements for the languages of information provision regulated by national regulations. The standard does not apply to: a) IVD medical devices for evaluating functional characteristics (e.g., only for use in research purposes); b) accompanying documents; c) material safety data sheets/safety data sheets; d) marketing information (in accordance with applicable legal requirements).
GOST R ISO 18113-1-2024 shall be put into effect in the territory of the Russian Federation from January 1, 2025.
GOST R ISO 18113-2-2024 "In vitro diagnostic medical devices. Information provided by the manufacturer (labeling). Part 2. In vitro diagnostic reagents for professional use" was approved by the order of Rosstandart dated May 23, 2024 No. 648-st.
The standard establishes requirements for information provided by the manufacturer of reagents, calibrators and control materials for in vitro diagnostics (IVD) intended for professional use. The standard may also be applicable to accessories for medical devices. The standard is applicable to labels for outer and inner packaging, as well as to instructions for use. The standard does not apply to: a) IVD equipment; b) IVD reagents for self-testing.
GOST R ISO 18113-2-2024 shall be effective in the Russian Federation from January 1, 2025.
GOST R ISO 18113-3-2024 "In vitro diagnostic medical devices. Information provided by the manufacturer (labeling). Part 3. In vitro diagnostic equipment for professional use" was approved by the order of Rosstandart dated May 23, 2024 No. 649-st.
The standard establishes requirements for information provided by the manufacturer of in vitro diagnostic equipment (IVD equipment) intended for professional use. The standard is also applicable to information provided by manufacturers for equipment intended for joint use with IVD equipment for professional use.
GOST R ISO 18113-3-2024 shall be effective in the Russian Federation from January 1, 2025.
Market news
Pharmasyntez Group to Build Medical Device Manufacturing Plant in Kaluga Region
Pharmasyntez Group will invest 5 billion rubles in the construction of the Pharmasyntez-Medtech plant. About 250 new highly qualified jobs will be created. The construction of the Pharmasyntez-Medtech plant will begin in 2025 on the territory of the Babyninsky District municipal district of Kaluga Region within the boundaries of the Kaluga SEZ and will be completed by 2026.
The project envisages the creation of a high-tech production of consumables and equipment for medical organizations using modern quality control methods. The implementation of the project will ensure import substitution and increase the availability of high-quality medical products on the Russian market, the parties to the agreement noted.
Recall that last year at the SPIEF, Pharmasyntez and the Kaluga Region signed an agreement on an investment project worth more than 20 billion rubles. In March of this year, Russian Prime Minister Mikhail Mishustin signed a decree on the expansion of the Kaluga SEZ. Thus, the third site in the Babyninsky District will be completely dedicated to the development of the pharmaceutical cluster.
Another 1.8 billion rubles will be allocated for the purchase of medicines and medical products for beneficiaries
The Russian government will allocate an additional 1.8 billion rubles to provide preferential categories of citizens with free medicines, medical products and therapeutic nutrition. The list of recipients of social services includes disabled people, including WWII participants, disabled children, and Chernobyl victims.
The decision was made in connection with the indexation of the amount for which medicines and medical products will be purchased for beneficiaries, which required additional funding. In total, 58 billion rubles will be allocated from the federal budget for these purposes in 2024 (in 2023, 48.2 billion rubles were allocated for the same purposes).
According to the new order, Moscow, in particular, will receive 222 million rubles for preferential drug provision to citizens, St. Petersburg - 77 million rubles, Rostov Region - 46.8 million rubles, Sevastopol - 6.5 million rubles, Altai Republic - 3 million rubles, Jewish Autonomous Region - 2.7 million rubles, Nenets Autonomous Okrug - 1.06 million rubles.
The need for certain drugs and medical devices for a specific person will be determined by his or her attending physician.
In April 2024, the Government of the Russian Federation established a new standard for monthly expenses on social assistance for beneficiaries. Now the amount is 1,211.3 rubles per month, which is 83.5 rubles more than in the previous year. The resolution states that beneficiaries will receive such assistance "in the form of a social service to provide in accordance with the standards of medical care on the prescriptions of a doctor (paramedic)." The document applies to legal relations that arose from February 1, 2024. Medicines and medical devices are provided to more than 20 categories of preferential groups of citizens. Among them are disabled people, war veterans, unemployed pensioners living alone, people with chronic diseases, children under three years of age (for large families - up to six years). In 2020, this standard was 886.4 rubles (increased by 26 rubles compared to 2019), in 2021 - 929.8 rubles (increased by 43 rubles), and in 2022 it was increased to 1,007.9 rubles (increased by 78.1 rubles). Last year, the amount per person per month increased by 119.9 rubles and amounted to 1,127.8 rubles.
Up to 12 billion rubles will be invested in the construction of a medical center with PET-CT in Syktyvkar
The Governor of the Komi Republic Vladimir Uyba announced at the 2024 SPIEF that the investor will invest about 10-12 billion rubles in the construction of a comprehensive medical center with positron emission tomography in Syktyvkar.
The region received a conclusion on the feasibility of building such a center in Komi from the chief freelance specialist - oncologist of the Russian Ministry of Health Ivan Stilidi. An agreement with the investor has been concluded, and the design of the medical organization is being completed.
Currently, the closest PET centers to Komi are only in Kirov and Kazan. Information about the development of a PPP for the construction of a medical center in Lesozavod (a microdistrict of Syktyvkar) appeared in February 2024. The medical institution plans to provide all types of medical research and services. Participants in a special military operation will also be able to undergo rehabilitation there. It is known that the medical organization will include a 50-bed hemodialysis department and a cyclotron for the production of radiopharmaceuticals.
Other
Study: by 2034, the greatest increase in insurance risks from the use of AI will be in healthcare
One of the largest insurers in the world, Swiss Re, conducted a study on the impact of artificial intelligence (AI) on the work of insurance companies in 2024-2034. According to analysts' forecasts, in the next 10 years, the use of AI in healthcare and pharmaceuticals will carry the greatest insurance risks for insurer clients. This will be influenced by both the rapid development of AI solutions for medical use and the high responsibility for maintaining people's health.
Swiss Re assessed the growth in the level of insurance risks based on the current market situation and data on adverse events from AI in various sectors of the economy.
At the moment, according to the report, the IT industry ranks first in this indicator, while healthcare and the pharmaceutical industry are in third place. The picture will change, according to the insurer, by 2034, when medicine will take first place, followed by transport, energy, and only then IT.
This conclusion is based on the high probability of incidents, given the volume of investments in this area and the broad possibilities of using AI in all chains of medical care, as well as potentially serious damage to patients due to the use of technologies.
In terms of specific examples, analysts believe that the introduction of AI to protect personal data is potentially risky, and the use of self-learning neural networks can lead to biased conclusions and limited data, since AI relies on an already potentially imperfect, human-generated knowledge base. In addition, even the slightest failure in the operation of AI solutions in clinical practice will have significant consequences for patients.
“AI has long required a systematic approach to risk assessment,” comments Alexey Ogarkov, an expert in the commercial efficiency of pharmaceutical companies, former head of sales efficiency and business analytics at AstraZeneca and Bayer, on the results of the report. – The biggest problem associated with AI is its rapid development, which outpaces the adaptation of regulatory processes and legislation. That is why some researchers even asked to suspend developments in this area." According to the expert, the problem will be especially noticeable in the field of generative AI and deep learning: "Problems of generating incorrect information (sometimes called hallucinations) cannot be ruled out. There is also a risk of overtraining neural networks, when the network loses the ability to generalize, that is, adapt to new data." Ogarkov cites Classical Machine Learning and Big Data Analytics as an example of the effective use of AI in medicine and pharma. These technologies helped in creating training programs for doctors through the analysis of conversations with patients.
In 2023, The Lancet Digital Health published the results of a large-scale study on the impact of digitalization on global medicine. An international group of scientists came to the conclusion that thanks to AI and other technologies, it has become much easier for doctors to make adequate clinical decisions, but it turned out that digitalization and the participation of neural networks do not reduce indirect and direct costs of medicine.
Russian developer NtechLab announced the creation of a neural network for the early diagnosis of Alzheimer's and dementia
NtechLab CEO Alexey Palamarchuk spoke about the development of a neural network for the early detection of prerequisites for Alzheimer's disease, dementia and other neurodegenerative diseases. The company plans to identify changes in the brain that lead to such diseases ten years before the onset of clinical manifestations. This will allow early start of preventive treatment.
According to Palamarchuk, the neural network, trained jointly with top-category doctors from large Russian hospitals and medical centers, will be able to process CT and MRI images of the brain. Russian company NtechLab is developing video analytics services based on artificial intelligence. It has previously received a certificate for a neural network that diagnoses ischemic and hemorrhagic stroke.
Source: https://tass.ru/obschestvo/21055811
The IRA Labs team received a registration certificate from Roszdravnadzor for a medical device with artificial intelligence
The guys from IRA Labs brought great news over the weekend: the company received a registration certificate from Roszdravnadzor No. RZN 2024/22895 for “Software for analyzing computed tomography studies using artificial intelligence technology “Intelligent Radiology Assistants” according to TU 58.29.32-001-44270315-2021”.
Source: https://ira-labs.ru/
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