2016 № 5 About the definition of the classes of Cybersecurity of Medical devices.
The paper discusses problems of Cybersecurity (CS) digital medical devices (MD). Lists the main threats associated with unauthorized external cybervandalism (CV) MD for patient safety. The classification of MD depending on the level of initial security from CV. The rules identify classes of CS medical devices.
2017 № 3 De-identification of Personal data in Health care
The methods of de-identification: anonymization and pseudonymization of personal data in information systems in health care. Lists the key normative documents and standards defining the requirements for the protection of personal data and their depersonalization. Described embodiments and examples of the use of technology pseudonymization in health care. Formulated proposals for the introduction of methods of pseudonymization in health care
2019 № 3 About the classification of risks of application of the medical software in the Eurasian economic union
The rules of classification of risks of medical software – Software as a Medical Device (SaMD), adopted by the International forum of regulators of medical devices (IMDRF), the Eurasian economic Union (EAEU) and the European Union (EU). Formal models of these rules are described. A comparative analysis of the risk classes of SaMD is done, examples of which are described in the documents IMDRF, defined by these rules.
2017 № 1 On the Criteria for evaluating the level of function execution «maintenance of the electronic medical Records of patient».
Describes the main stages of implementing electronic health records (EHR) of a patient in a medical facility and corresponding models of access and organization of primary medicaling documents of different categories of health workers. Reviewed the indicators and criteria used to assess the level of implementation of EHR.
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.
2015 № 2 About the definition and classification of telemedicine services
The definition of telehealth. Describes a set of criteria for the classification of telemedicine services and proposed their classification. The rules of naming telemedicine services for inclusion in the Nomenclature of medical services.