News Digest 20.03.2024 — 22.03.2024
Regulators
The government has approved the rules for obtaining a license for disinfection services
The government approved a regulation on licensing activities for the provision of disinfection, disinsection and deratization services for the sanitary and epidemiological well-being of the population. The corresponding norms are enshrined in Decree of the Government of the Russian Federation No. 337 of March 20, 2024.
According to the document, licensing of activities and supervision of them is carried out by the Federal Service for Supervision of Consumer Rights Protection and Human Welfare, as well as its territorial bodies.
The following requirements are imposed on the license applicant:
- Availability of own or rented premises for storing disinfectants or agreements for their safe storage with other organizations.
- Availability of equipment, technical means and personal protective equipment to provide the declared services.
- The presence of at least one employee: before September 1, 2025, with higher education and advanced training or retraining in disinfection, and after September 1, 2025, additionally with higher medical or biological education.
- Availability of a production control program.
The list of necessary equipment and technical means, as well as the list of personal protective equipment for the disinfector necessary for the provision of services, are approved by Appendix No. 1 to the document.
To obtain a license, the applicant must submit an application through the government services portal, attaching the relevant documents. The decision to issue a license is made within ten working days from the date of receipt of the application and documents. In case of application of five or more addresses where the activity will be carried out, the period may be extended by no more than ten working days.
License confirmation is carried out every three years. The document also approves licensing control of compliance with these requirements.
The resolution comes into force on September 1, 2024 and is valid until September 1, 2030.
Earlier, the president signed a law delaying the start date for licensing disinfection services by six months: companies can submit applications from September 1, 2024, and inspections within the framework of state control can be carried out from March 1, 2025.
The provisions of Law N 44-FZ on procurement from a single supplier of medical products, consumables and technical means of rehabilitation ceased to apply on March 8, 2024
According to Part 3 of Art. 22 of the Federal Law of 08.08.2022 No. 46-FZ, on March 8, 2024, the grounds for purchasing from a single supplier, provided for in clause 5.1, clause 5.2, clause 28.1, part 1, art. 93 of Law No. 44-FZ. March 8, 2022 Part 1 Art. 93 of Law No. 44-FZ was supplemented with the specified points, according to which purchases from a single supplier can be carried out, including in the following cases:
- Electronic purchases of medical products and consumables produced by the only manufacturer on the territory of the Russian Federation or the territories of foreign states that have not introduced restrictive measures against the Russian Federation.
- Purchases of SFR in electronic form of technical means of rehabilitation and services produced (rendered) on the territory of the Russian Federation or produced on the territories of foreign states that have not introduced restrictive measures against the Russian Federation).
- Concluding a contract for the supply of medicines or medical devices that have no Russian analogues and the production of which is carried out by a single manufacturer originating from a foreign state that has not introduced restrictive measures against the Russian Federation, with a supplier of such medicines or medical devices included in a special register.
Source: https://t.me/MedTechIndustry/1254
Market news
The ex-head physician of the Republican Clinical Hospital in Mordovia was sentenced to 4.5 years in prison in the case of theft of 9.5 million rubles
The court sentenced the former head physician of the Republican Clinical Hospital named after. S.V. Katkov in Saransk to Vyacheslav Shchapov on two counts of a criminal case involving the theft of 9.5 million rubles during the supply of ventilators and the use of illegal wiretapping. Shchapov was sentenced to 4.5 years in prison in a general regime colony, a fine of 300 thousand rubles and payment of compensation for damage caused to the regional budget in the amount of 9.2 million rubles.
Other
Elon Musk announced the development of an implant that can restore vision
On his social networks, he announced that Neuralink's next product will be a device called Blindsight to restore vision to the blind. At the moment, he says, the device is already working on monkeys.
“Even if someone has never seen, been born blind, we believe we can restore sight,” Musk said.
The new device was announced after yesterday's news that the first patient with another development of the company - a brain implant - played chess.
At PMSMU named after. Sechenov developed a silent anti-decubitus mattress for bedridden patients
Scientists from the laboratory of controlled bionic systems at Sechenov University have created a prototype of an anti-bedsore mattress for massaging bedridden patients under the Priority 2030 project, the university said. Its key features are noiselessness and compactness.
Currently, there are already mattresses with air chambers that allow you to massage bedridden patients by regulating the pressure inside the compressor. But the noise they make interferes with the rest of patients, experts noted.
The new development is based on a ring actuator mechanism, which is a cell filled with mineral oil with two electrodes that drive the actuator under the influence of electric current. Scientists note that the current power required to activate the actuators does not exceed 5 Watts, and the mattress itself is covered with insulating material, which eliminates the risk of electrical injury. The mattress allows a targeted effect on the patient’s body, restoring natural blood flow by adjusting the pressure applied.
Experts say that the development will be ready for testing by the end of 2024.
Source: https://www.gazeta.ru/science/news/2024/03/21/22600141.shtml
The startup NuraLogix showed the public a smart mirror that measures health indicators from a photo of a person’s face
The device scans the face, analyzing blood flow, and displays data on pressure, pulse, respiration, weight, and other parameters (the developer writes that the device analyzes about 100 parameters)
The device can also provide risk assessments for diabetes, heart disease, stroke, hypertension, fatty liver disease and more. Finally, it offers a mental health risk assessment and identifies signs of anxiety and depression, for example.
The facial scan lasts only 30 seconds, then the user receives information about potential diseases.
Source: https://www.nuralogix.ai/magic-mirror/
The EU Parliament has banned the use of artificial intelligence technologies to recognize people's emotions
European authorities have opposed the use of artificial intelligence (AI) technologies, which potentially violate the freedom of EU citizens. We are talking about technologies for recognizing emotions, as well as extracting records from the Internet to create a database for facial recognition. The resolution on this, which was discussed by the European Parliament back in 2023, came into force the other day.
According to the document, clear obligations are also provided for high-risk artificial intelligence systems (due to their significant potential harm to health, safety, fundamental rights, the environment, democracy and the rule of law). Examples of high-risk AI use cases include critical infrastructure, education and training, employment, and essential private and public services (e.g., healthcare, banking).
Legislation requires such systems to assess and mitigate risks, maintain usage logs, be transparent and accurate, and provide human oversight. Citizens will have the right to file complaints against AI systems and receive clarification regarding decisions based on high-risk AI systems that affect their rights.
That is, in theory, Europeans will be able to sue the developer of a chatbot for diagnosing symptoms, for example. O brave new world! It is also interesting what awaits biometric systems in Europe in connection with the new law.
Deka's Innovative Automated Insulin Delivery System Receives FDA Clearance
The US Food and Drug Administration (FDA) has approved the commercialization of Deka Research & Development's Twiist automated insulin delivery system. The device is approved for use in people aged six years and older with type 1 diabetes. There are about 2 million such people in the United States, MedTechDive reports.
The point of the system is that insulin is delivered automatically based on the operational data of the continuous glucose monitoring device thanks to a special control algorithm, which gives patients the opportunity to more effectively control their blood sugar levels. The device will be distributed through pharmacies so that more people with type 1 diabetes will have a “convenient and affordable way to get started,” said CEO and co-founder Alan Lotvin.
New registered medical devices
We publish a list of new medical devices registered from 03/15/2024 to 03/22/2024
Link to the list: [see. table in attachment]
Link to the project passport: [see. project passport in attachment]
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