Requirements to the state ICs in the field of health care of the subjects of the Russian Federation, to medical ICs, the IC of pharmorganization

2019: The Ministry of Health published requirements to GIS in the field of health care

On June 25, 2019 it became known that the Ministry of Health of the Russian Federation published the order, No. 911n 'About the approval of requirements to the state information systems in the field of health care of the subjects of the Russian Federation, to medical information systems of the medical organizations and information systems of the pharmaceutical organizations'^[1].

The order contains functional requirements of the listed types of information systems. For example, it is specified that contained in them data are subject to protection according to the current legislation by means of a number of organizational and technical measures.

In particular, their program technical means should be located in the territory of the Russian Federation and have the Russian origin: the order refers to the order of the Government of the Russian Federation of November 16, 2015 No. 1236 which prohibits purchases of the providing coming from the foreign states for for ensuring the state and municipal needs.

Besides, these means should be certified by FSB or FSTEC regarding existence in them of hardware-software information security systems - anti-virus and cryptographic; and also means of protecting from unauthorized access and illegal manipulations, including, changes and removals of data.

Also smooth round-the-clock functioning of these ICs, except for time necessary for works on service is meant. Its total duration, according to the document, should not exceed 4 hours a month. However, the possibility of "the breaks connected with force majeure circumstances" makes a reservation.

Backup of medical documentation in electronic form and possibility of its recovery from backup copies are without fail provided.

The order describes several types of information systems at once, but all of them should have a possibility of placement of information in a single state information system in the field of health care and interact with each other.

Medical information systems can be carried to critical infrastructure safely. Thereby, the decision of the Ministry of Health to use only domestic means for ensuring functioning of these systems completely corresponds to the general paradigm of the state concerning technical solutions on objects of KII: only the Russian developments which are based only in the territory of the Russian Federation. As for ensuring information exchange between the different systems, in essence it means the requirement to unify a format of data. The system integrators which are engaged in developments and upgrade of information systems for state agencies too often should face "vinaigrette" of the formats used in information systems of adjacent departments because of what data exchange between them appears or is complicated, or at all it is inefficient. Apparently, authors of the order of the Ministry of Health considered a similar opportunity and tried to prevent it, specifies Dmitry Gvozdev, the CEO of Information Technologies of the Future company

As for requirements to separate categories of information systems, actually the order describes key functionality which should be present at each of them. So, for example, InformSystems of the medical organizations should provide information support of acceptance of management decisions in the organization, and perform functions of electronic registry, support maintaining the electronic medical record of the patient, promote rendering "medical care using telemedicine technologies" and holding preventive actions.

In turn, by means of information systems for the pharmaceutical companies accounting of recipes and a holiday of medicines and medical products and also "formation of the accounting, reporting and other documents characterizing activity of the pharmaceutical organization" on wholesale and retail trade by medicines, to their storage, transportation and production should be provided.

The order becomes effective since January 1, 2020.

2016: Recommendations of the Ministry of Health about creation of regional medical information systems, RMIS

At the end of June, 2016 the Minister of Health of the Russian Federation Veronika Skvortsova signed the document describing methodical recommendations for the regional medical information systems (RMIS). In the document published on the portal of operational interaction of participants of Uniform State Health Information System basic recommendations to the RMIS functions, its structure, design approaches and also particular purposes and problems of a system as one of levels of a regional Uniform State Health Information System segment are stated.

According to the recommendation of the Ministry of Health, when developing RMIS such basic principles as compatibility of medical IT systems, use of solutions SaaS, information security and data protection in accordance with the legislation of the Russian Federation, integration with components of the electronic government and the universal electronic card should be considered.

The Ministry of Health published recommendations for regional MIS

Also the greatest possible preserving of the existing systems of the medical organizations should be provided, and development of RMIS should be performed on a competitive basis.

The Ministry of Health recommends to build RMIS on the software platform providing integration and joint data processing received from different sources. The "end-to-end" data collection system should be based on a basis of information compatibility when using uniform reference books and standards of exchange.

As a part of RMIS use of the subsystems providing maintaining the normative reference information of the region, accounting of demographic indicators and resources of health care, record to the doctor on the Internet, maintaining standards of treatment, the organization of ambulance and services of telemedicine, accounting of routine inspections of the population, etc. is recommended.

In process of development of RMIS, according to recommendations Minzdava, should pass three stages differing in functionality: minimum, basic and expanded. Such necessary components as electronic registry, maintaining passports of the medical organizations, the register of medics and the equipment concern the first.

The advanced functionality provides automation of the clinical and specialized medical directions (service of blood transfusion, emergency medical service, sanitary and epidemiologic work, etc.).

The main technical recommendations to RMIS the following: the software and the equipment used in system operation should provide continued operation of RMIS with a performance sufficient for fast processing of user queries and also provide high reliability of system operation by an exception of data loss and long idle time because of a hardware failure, maintenance of reservation and data recovery on any timepoint within one day and in any technology point.

Besides, IT infrastructure of RMIS should work constantly, support "hot" reservation of necessary components the systems and inclusion of additional hardware opportunities without stopping and a break in system operation, to balance loadings between servers and to redistribute them in case of failure of components, to provide compatibility of operating environments, technical infrastructure and applied applications and also to contain a backup system using three-level storage system.

At the same time the specific requirements limiting use of the computer park by any specific producer should not be imposed to the RMIS hardware.

The recommendations of the Ministry of Health to the communication equipment are that these devices should provide necessary data transfer rate and use the TCP/IP protocol as the basic protocol of network and network interconnection.

From the software of RMIS the functional sufficiency (completeness), reliability (including restorability and existence of means of identification of errors), adaptability, changeability, scalability and convenience of operation is required.

The system software (operating systems, DBMS, application servers , etc.) should be from different producers, is suitable for work in workplaces of users of RMIS, is compatible to other participants of information exchange and is protected from cracking. In case of inclusion in the structure of RMIS of the functions implementing export of documents to formats of office suites support of formats of freely extended software should be provided, the document says.

In more detail about the methodical recommendations of the Ministry of Health to the RMIS functions it is possible to learn^[2] from this document].

You See Also

• Experience of informatization of health care of the Kirov region

Шаблон:Subject Medicine

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