News Digest 26.01.2024 — 29.01.2024
Regulators
Rules for conducting clinical and clinical laboratory tests (research) of medical devices have been updated
The Council of the Eurasian Economic Commission at a meeting on January 26, taking into account the experience of application and changes in international practice, adopted a new edition of the Rules for conducting clinical and clinical laboratory tests (research) of medical devices.
The updated version of the Rules clarifies the conditions for recognizing the equivalence of medical devices for the purpose of accepting test results, the procedure for obtaining permission to conduct tests, requirements for testing, grounds for excluding medical organizations (clinical centers) from the unified register of authorized organizations that have the right to conduct research on medical devices in for the purposes of their registration, test report forms. The conditions for obtaining clinical data for software that is a medical device are determined, as well as the requirements for the technical file of such products.
Changes come into force after 180 calendar days from the date of their official publication. At the same time, a mechanism has been established to ensure a smooth transition to the application of the new edition of the Rules. In order to maintain the continuity of the process, it is possible to conduct clinical and clinical laboratory tests in accordance with the edition in force at the time of concluding the contract with the medical organization. Test reports issued in accordance with the forms in force at the time of concluding an agreement with a medical organization are accepted for registration of medical devices under Union law.
Market news
In 2024, in the Sverdlovsk region, within the framework of the national project “Healthcare,” 27 medical institutions will be renovated, 10 new facilities will be built in villages, 43 cars and new medical equipment will be purchased for hospitals and clinics.
The Federal Service for Surveillance in Healthcare constantly monitors the implementation of the National Healthcare Project in all regions of the country. According to the Territorial Authority of Roszdravnadzor for the Sverdlovsk Region, as part of the implementation of the regional program “Modernization of Primary Health Care” of the national project “Healthcare” in the region in 2024, the following is planned:
- major renovation of 27 facilities (16 clinics, 5 general medical practice departments, 4 outpatient clinics and 2 local hospitals);
- acquisition of 226 units of medical equipment, 34 of which have already been put into operation (among those planned for acquisition - 9 x-ray machines);
- construction of 10 prefabricated modular structures (9 medical and midwifery stations and 1 general medical practice department). To date, workers have already begun installation of all facilities;
- purchase of 43 Lada cars for 31 medical institutions in the Sverdlovsk region.
Modern medical equipment, the operation of which became possible thanks to the regional program “Modernization of Primary Health Care”, will improve the availability and quality of primary health care in the Sverdlovsk region.
Element has received CE and UKCA certification for its portable defibrillator
US medical technology company Element Science has received European Union CE and UKCA certification for its digital wearable defibrillator.
The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) continuously monitors the heart rhythm and delivers therapeutic shock to the heart when a life-threatening arrhythmia, such as ventricular tachycardia or ventricular fibrillation, is detected.
The device can also store data related to heart rate and events for later analysis by medical professionals using a smartphone application that can transmit data to medical professionals in near real time.
Other
The UK and US are looking for options to stimulate the development of biotechnology and AI
The United Kingdom and the United States are studying the possibilities of ensuring the leadership of these countries in the field of biotechnology and artificial intelligence on the world stage. The UK's National Health Service could start trading health data so that the proceeds could be spent on developing advanced technologies, and the US could do well to address the problem of reducing the number of research doctors.
In the USA, the introduction of voice filling of medical documentation reduced the amount of administrative work of doctors by 50%
According to Fierce Healthcare, as a result of an experiment to implement patient voice recognition for filling out electronic medical records in a test group of practicing doctors, the amount of administrative work for the latter was reduced by 50%, and the level of burnout (a subjective indicator, but still) decreased by 70%. This takes into account the fact that the recognized speech had to be checked by the doctor. The result of the experiment is encouraging: patients note the doctor’s attention, doctors are satisfied with the work.
The experiment conducted by Epic together with Microsoft is interesting:
From the note it follows that during the examination, the service records the patient’s conversation with the doctor with the patient’s consent, and then, using ambient listening technologies, speech recognition and natural language processing, enters the data into the Epic mobile application. Next, the system creates a draft patient examination protocol in electronic form for subsequent verification by a doctor.
News
