For a period of time health informatics was lacking the general approaches to regulation of requirements to medical in-formation systems and their full heterogeneity. While information data exchange of medical statistics between medical health institutes and Ministries of Health in regions of Russia the special own rules of each region operate.
The issue of elimination of these disagreements is timely, important and actual. The decision of this issue according to the Russian legislation lies in sphere of action of the Federal law «On technical regulation». The law defines that application of procedure of an estimation of conformity of medical information systems via certification on conformity to national standards will allow to enter unified requirements to medical information systems .
The above mentioned national standard allows to establish unifiedrequirements to all medical information systems used in medical aid institutions of the Russian Federation for information data exchange of medical statistics.
While developing the national standard the method and rules of input of the primary patients data and an its information exchange has been defined, the structure of the data supplied by medical aid institution to Ministry of Health has been defined, the unified formalism of data presentation has been developed, unified qualifiers has been generated and the content of information parcels has been defined.
For designing and visual presentation of structure of information objects in the standard diagrams of classes UML are used. As a result of designing stage the platform-independent specification of structure of classes of objects which can be if necessary transformed to descriptions of information objects in language abstract syntactic notations, in schemes in language XML and in other specifications of structure of the data was created.
The structure of the data is devided into auxiliary classes and the primary data of medical statistics. Auxiliary classes are included by 19 classes which are used in tables of basic classes.
Specification of primary medical statistics includes six essences, characterizing process of an information exchange: the patient, the data of the out-patient treatment, given hospitalization, the document of time invalidity, operation, medical service. Fully detailed structure essences allows to introduce unification in all the medical information systems using this standard.
The standard has come into force May, 1st, 2009. Its application will bring the important contribution to establishing of a unified information field of public health of the Russian Federation.