NPCC DiT DZM: Preliminary Clinical and Technical Trials of Medical Software

Main article: IT outsourcing

2023: Presentation of the service of preliminary clinical and technical tests of medical software

Experts DMS Diagnostic and Telemedicine Center conduct preliminary clinical and technical tests. medical software This service will be useful for developers. It is needed to pre-evaluate and gain additional knowledge about the capabilities and limitations of medical software. This will support a high level of diagnostics and medical service in. health care This was announced on December 4, 2023 by the chief, radiologist Moscow director of the Center for Diagnostics and Telemedicine. Yuri Vasiliev

source = NPCC DiT DBM

Before a medical device becomes part of routine practice, it is required to undergo both technical and clinical trials to obtain state registration. Such measures certify their suitability for use in medical practice. Clinical trials conducted after a thorough analysis of the results of technical tests play a crucial role in this process. Failed clinical outcomes, in most cases, cause the registration process to begin anew, bringing significant additional time and cost to manufacturers. Thus, assessing the readiness of medical software to conduct technical and clinical trials will contribute to a high level of diagnosis and medical service in healthcare. All this allows you to admit only the best solutions to patients, - said Yuri Vasiliev.

The Center for Diagnostics and Telemedicine of the Department of Health has a large expertise in the field of medicine and information technology - specialists test the introduction of artificial intelligence in radiation diagnostics, develop draft rules and standards for its use in specific clinical scenarios. The organization's experts have created a maturity matrix that allows you to choose the best solutions on the market. It is published on the organization's website and is available to everyone.

Preliminary clinical and technical tests of medical software will help development companies minimize the risks of re-evaluating the safety and effectiveness of the product for state registration. They can go to this short track, where we will quickly analyze those indicators that will be evaluated in technical and clinical trials. On such shortened testing, it will already be clear what companies have a chance of success in the future, - said Anton Vladzimirsky, deputy director for research at the Center for Diagnostics and Telemedicine of the DZM.

The result of preliminary clinical and technical tests is a test report.

Within the framework of the national system, the Center for Diagnostics and Medicine received permission to conduct clinical trials in 2020. In addition, the organization conducts research on artificial intelligence systems in the field of medicine in order to register them within the framework of the Eurasian Economic Union (EAEU). Thus, developers can obtain permission to use their developments simultaneously in Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. This contributes to the accelerated adoption of safe technologies in the medical field, which allows patients to receive more prompt and high-quality diagnostics.