2016 № 3 About the definition of the classes of potential risk of medical software
Describes the Nomenclature classification of medical devices (MD). Lists the problems related to the inclusion of software in the nomenclature of the types of MD. Proposed criteria for Software as a Medical Device (SaMD). The proposed classification of SaMD based on potential risk to the health of the patient. Describes the rules for identifying these risks and determining the risk class for SaMD.
2020 № 4 Predictive analytics technologies in the management of the COVID‑19 pandemic
Recently, a new coronavirus infection, or COVID‑19, caused by the pathogen SARS-CoV‑2, has been continuing to
spread around the world rapidly. According to the World Health Organization (WHO), which declared this outbreak a pandemic, COVID‑19 is a serious public health problem of international concern. Due to the lack of proven effective treatment and vaccination against COVID‑19, precautions are considered by WHO to be strategic goals and a primary response to the pandemic. It is recommended that country guidelines adopt national health care programs aimed at assessing and reducing the risk of infection spread. Predictive analytics have begun to be actively used to compile population and personal forecasts of the progression of morbidity, mortality, assess the severity of the course of the disease, etc. This article provides an overview of available developments and publications on the use of predictive analytics in the management of COVID‑19 pandemic.