"Experts from the Center for Diagnostics and Telemedicine under the Moscow Health Department are actively engaged in the preliminary clinical and technical evaluation of medical software. This service proves invaluable for developers, offering essential insights into the capabilities and limitations of medical software, ultimately contributing to the maintenance of a high standard in diagnostics and medical services within the healthcare sector. Yuri Vasiliev, Senior Consultant for Radiology and CEO of the Center for Diagnostics and Telemedicine, emphasized the significance of these assessments in ensuring the readiness of medical devices for routine practice.
Vasiliev explained, "Before integration into routine practice, medical devices undergo rigorous technical and clinical testing to secure state registration, certifying their suitability for medical use. Clinical trials, conducted after careful analysis of technical test results, play a pivotal role in this process. Unfavourable clinical outcomes often necessitate restarting the registration process, incurring substantial time and costs for manufacturers. Thus, evaluating the readiness of medical software for both technical and clinical testing significantly contributes to maintaining high standards in healthcare, offering optimal solutions to patients."
The Center for Diagnostics and Telemedicine, equipped with extensive expertise in both medicine and information technology, focuses on testing the implementation of artificial intelligence in radiology. Specialists are actively involved in developing draft rules and standards for AI utilization in specific clinical scenarios. The organization's experts have devised a maturity matrix, accessible on their website, aiding in the selection of top-tier solutions available in the market.
Anton Vladzimirsky, Deputy Director for Science at the Center for Diagnostics and Telemedicine, highlighted the benefits for development companies, stating, "Preliminary clinical and technical testing of medical software enables companies to minimize the risks associated with re-evaluating the safety and effectiveness of products for state registration. This streamlined process allows for a quick analysis of indicators assessed in technical and clinical trials, providing clarity on a company's likelihood of success in the future."
The culmination of these evaluations is a comprehensive test report. Within the national system, the Center for Diagnostics and Telemedicine, under the Moscow Department of Health, obtained approval for conducting clinical trials in 2020. Additionally, the organization conducts research on artificial intelligence systems in medicine, aiming for registration within the Eurasian Economic Union (EAEU). This strategic approach allows developers to secure permission for simultaneous use of their innovations in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan, facilitating the swift integration of safe technologies into the medical field, leading to faster and higher-quality diagnostics for patients.
Established in 1996, the Center for Diagnostics and Telemedicine at the Moscow Health Department stands as a leading scientific and practical organization within the Social Development Complex of the Moscow City Hall. Specializing in artificial intelligence technologies in medicine, radiation diagnostics, organization of medical departments, scientific research, and medical worker education, the Center remains at the forefront of advancements in healthcare.
For inquiries regarding preliminary clinical and technical tests, please direct them to the email address: [email protected].