The "software product" will continue to develop the automated information system of Roszdravnadzor. Using the automated information system of Roszdravnadzor to optimize control and supervisory activities (using the example of the work of the Office of Roszdravnadzor in the Krasnodar Territory) О

Altai Republic. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Chuvash Republic - Chuvashia. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Kostroma region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Murmansk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Lipetsk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Moscow. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Kursk region. 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Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; The Republic of Ingushetia. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Chelyabinsk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Transbaikal region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Kirov region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Republic of Kalmykia. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Rostov region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Ryazan Oblast. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Smolensk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Kabardino-Balkarian Republic. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Kamchatka Krai. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Orenburg region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Penza region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; The Republic of Buryatia. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Sverdlovsk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Irkutsk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Primorsky Krai. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Komi Republic. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Tula region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Tyumen region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Arhangelsk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Vologda Region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Jewish Autonomous Region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Saint Petersburg. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Republic of Bashkortostan. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Sakhalin region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Republic of Tatarstan (Tatarstan). Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Udmurt republic. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Chechen Republic. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Moscow region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; The Republic of Sakha (Yakutia). Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Novosibirsk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Pskov region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Khanty-Mansiysk Autonomous Okrug - Ugra. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Omsk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Oryol Region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; The Republic of Dagestan. 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Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Mari El Republic. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Voronezh region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Kaluga region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Leningrad region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Tambov Region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Tomsk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Republic of North Ossetia - Alania. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Amur region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Republic of Karelia. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; The Republic of Mordovia. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Belgorod region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Kurgan region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Volgograd region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Ivanovo region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Karachay-Cherkess Republic. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Kemerovo region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Nizhny Novgorod Region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Saratov region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Yamalo-Nenets Autonomous Okrug. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Altai region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Bryansk region. Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation; Republic of Adygea (Adygea). Powers: Control and supervision in the field of healthcare on the territory of the relevant constituent entity of the Russian Federation;

K.G. POSPELOV,Head of the Interregional Information and Analytical Department of Roszdravnadzor

The article discusses the history of creation and transformation information system Roszdravnadzor over a 10-year period, main achievements and key areas of development.

Since the formation of the Federal Service for Surveillance in Healthcare, the need arose to create a system that would provide information support for the execution of its state powers. By 2004, federal executive authorities had come a long way in creating their own information systems. Roszdravnadzor found itself in the role of “catching up”, since there were no analogues of the information system for solving Roszdravnadzor’s problems. Thus, the history of the creation and development of the automated information system of Roszdravnadzor (AIS of Roszdravnadzor) is comparable to the time when the activities began Federal service on supervision in the field of health care.

At the first stage, a decision was made to implement the tasks of managing financial and administrative activities, as well as automating the process of collecting information on quality control of medicines. This decision was confirmed by Roszdravnadzor order No. 529-Pr/05 dated March 17, 2005 “On the creation and implementation of the Roszdravnadzor AIS system.” In 2006, the first version of the Roszdravnadzor AIS was put into commercial operation.

In the same year, the foundation was laid for providing information support processes for the execution of government functions of the Service within the framework of the Roszdravnadzor AIS. By Order of Roszdravnadzor dated December 28, 2007 No. 5525-Pr/07 “On the organization of work on the implementation of the automated information system of Roszdravnadzor”, AIS Roszdravnadzor software products were accepted for commercial operation and approved as means for performing control and supervision functions within the scope of powers of Roszdravnadzor and its territorial bodies . Since 2008, the AIS of Roszdravnadzor has been used in the central office and in territorial bodies.

At the first stage of development, the information system was formed as a set of independent software products in individual areas of activity of the specialized departments of Roszdravnadzor and contained disparate amounts of information. For more effective use of this information in practical and analytical work, the need arose to create a unified information space and a unified information repository of interrelated data obtained from various sources. This required the creation of a structure coordinating all issues related to the implementation information technologies Roszdravnadzor. At the end of 2007, by order of the head of Roszdravnadzor dated 05.10.2007 No. 3003-Pr/07, the Interregional Information and Analytical Department of Roszdravnadzor was formed, one of the main functions of which was the organization of the development, implementation and operation of the state information system to support the activities of Roszdravnadzor, taking into account ensuring the functioning unified information space.

Key milestones in the development of AIS Roszdravnadzor

Year 2008

Since 2008, Roszdravnadzor has taken a course towards building a unified vertically integrated information system that provides information support for the execution of government, financial and administrative tasks of the Service.

The first serious integration task was the creation of the “Licensing” subsystem of the AIS of Roszdravnadzor, combined with document flow. From January 1, 2008, part of the powers for certain types of licensing was transferred to the level of authorities of the constituent entities of the Russian Federation. The task of Roszdravnadzor was to ensure continuity of the licensing process and maintain the integrity of the Unified Register of Licenses when transferring part of the powers to the constituent entities of the Russian Federation. As a result, an information system was built to ensure that the necessary information is entered into both the central office of Roszdravnadzor and its territorial bodies, as well as the licensing authorities of the constituent entities of the Russian Federation, with the further publication of information included in the register of licenses on the official website of Roszdravnadzor in real time.

Year 2009

Roszdravnadzor has taken the first steps to create electronic services on its official website.

Within the framework of current regulatory and legal acts, electronic services have been implemented - “applicant offices” to inform applicants about the progress of consideration of documents submitted for drug registration and licensing of pharmaceutical activities. The mechanism for posting and searching for information on the Unified Register of Roszdravnadzor licenses, published on the official website, has been improved. Similar ones were put into operation search services on the provision of information on registered drugs, medical devices, medical technologies.

Work continued to improve the information system for drug quality control. For this purpose, the following subsystems of the AIS of Roszdravnadzor have been implemented: “Pharmaconadzor”, “Monitoring of clinical trials of drugs”, “Preliminary state control”, “Selective state control” and electronic services for entering information through the website. This approach made it possible to link Roszdravnadzor, its territorial bodies, drug quality control laboratories and pharmaceutical market participants into a single information space: drug manufacturers, wholesale organizations, pharmacy chains and medical institutions. By the end of 2009, access to the “Selective Quality Control of Medicines” subsystem of the AIS of Roszdravnadzor was provided to more than 800 pharmaceutical organizations, and to the “Pharmaconadzor” subsystem - to more than 1,200 pharmaceutical organizations, drug manufacturers and medical institutions.

All this required a radical modernization of the official website of Roszdravnadzor, which included, among other things, a module “Appeals from Citizens”, allowing citizens of the Russian Federation to submit appeals through the official website. The launch of the modernized version of the official website of Roszdravnadzor took place in October 2009, including the commissioning of 82 websites of territorial bodies.

In accordance with the Decree of the Government of the Russian Federation dated June 15, 2009 No. 478 “On a unified system of information and reference support for citizens and organizations on issues of interaction with executive authorities and local governments using the information and telecommunications network Internet” Federal Service for Surveillance in Healthcare began implementing measures to transfer government services and functions into electronic form. By the end of the year, the Consolidated Register of State and Municipal Services (functions) contained information on public services provided by Roszdravnadzor and how to obtain them.

By the beginning of 2010, the information and analytical system included 78 software products, logically combined into 38 subsystems and 8 sections, covering all aspects of Roszdravnadzor’s activities.

Year 2010

In 2010, one of the most major projects on informatization of public authorities. The project was launched from the moment the Federal Law of July 27, 2010 No. 210-FZ “On the organization of the provision of state and municipal services” came into force.

Issues regarding the organization of interdepartmental electronic interaction had to be resolved step by step - first between all federal executive authorities and bodies of state extra-budgetary funds, and then with the executive authorities of the constituent entities of the Russian Federation and local governments.

The first step towards the implementation of electronic interaction was the formation by Roszdravnadzor of technological maps of interdepartmental interaction. In order to obtain information available federal bodies executive power of the Russian Federation, in the provision of public services, technological maps of interdepartmental interaction with 11 federal departments - information suppliers - were developed and agreed upon.

In accordance with the agreed technological maps For interdepartmental interaction, Roszdravnadzor developed 14 electronic requests to departments that provide information. In addition to the development of requests, the subsystems of the Roszdravnadzor AIS were modernized, since at the initial design stage it was decided that each request should be generated when processing a specific application for a public service provided in the Roszdravnadzor AIS.

In addition, the federal executive authorities identified the need to obtain information (information) from Roszdravnadzor from such Roszdravnadzor information resources as the Unified State Register of Roszdravnadzor licenses and the database of registered medical devices, which required the implementation of their own electronic services and their registration in the interdepartmental electronic interaction system (SMEV).

Year 2011

At the beginning of 2011, the updated website of Roszdravnadzor and the websites of territorial bodies of Roszdravnadzor for the constituent entities of the Russian Federation were put into operation. The updated websites have become an effective mechanism to ensure transparency of the Service and accessibility of legal entities and individuals to its information resources.

Fundamental changes were made to the Roszdravnadzor information system regarding issues related to medical devices. Work on creating a database of registered medical devices has been fully completed and its updated version has been posted on the official website of Roszdravnadzor.

Modernization of the AIS subsystems of Roszdravnadzor, which provide monitoring of the range and prices of vital and essential medicines and monitoring of drug supply, made it possible to create a full range of necessary monitoring indicators, increase the efficiency and quality of monitored information and ensure the collection of information from pharmacies using the developed electronic service.

A separate task set already in 2011 was to provide information support for monitoring the implementation of healthcare modernization programs in the constituent entities of the Russian Federation. For this purpose, it was developed in a short time software to collect information from territorial bodies of Roszdravnadzor for the constituent entities of the Russian Federation, its consolidation and preparation of consolidated reports to the Ministry of Health of Russia.

During the year, work continued on the implementation and testing of electronic services for placement in SMEV. Since October 1, 2011, Roszdravnadzor has been connected to the Interdepartmental Electronic Interaction system; employees of the central office of Roszdravnadzor and territorial bodies of Roszdravnadzor in the constituent entities of the Russian Federation are provided with the ability to send electronic requests to other federal departments. In turn, access to the information resources of Roszdravnadzor was provided from interested departments, such as the Ministry of Internal Affairs of Russia, the Ministry of Health of Russia, the Federal Drug Control Service, Rospotrebnadzor, the Federal Customs Service of Russia and a number of others.

Thus, in 2011, the Roszdravnadzor information system entered the unified information space of federal executive authorities.

Year 2012

In May, within the framework of the III International Forum “Electronic Government in Russia 2012”, the results of the IV competition “Best 10 IT projects for the public sector” were summed up, designed to celebrate the achievements of departments and IT companies in the field of implementation of electronic government services. The Federal Service for Surveillance in Healthcare became a laureate in the category “Best informing business about the procedure for obtaining public services with elements of interdepartmental interaction.” Such a significant assessment of the Service’s activities in the field of informatization was an important milestone on the path of a large, fundamentally new work that was done by employees of the central office, the Interregional Information and Analytical Directorate of Roszdravnadzor and the territorial departments of Roszdravnadzor in the implementation of public services in in electronic format and interdepartmental electronic interaction.

An important task to increase the speed of document exchange in federal executive bodies was the preparation of departmental information systems for inclusion in the Interdepartmental Electronic Document Management System in 2012. Roszdravnadzor has completed work on modernizing its system and has implemented the ability to exchange scanned images of documents within the electronic office using the interdepartmental electronic document management system (EDF).

The AIS subsystems of Roszdravnadzor, which support the processes of carrying out control and supervisory activities, have been modernized, which has made it possible since 2012 to conduct unified planning and accounting of control activities, prepare the necessary statistical and analytical reporting in real time and carry out constant monitoring of the implementation of the plan of control and supervisory activities of Roszdravnadzor on the territory of the Russian Federation.

Year 2013

The “Medical Products” subsystem of the AIS of Roszdravnadzor has been radically redesigned. In accordance with the Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416 “On approval of the Rules for state registration of medical devices”, procedures for registering medical devices, maintaining the state register of registered medical devices, providing applicants on the official website of Roszdravnadzor with information in electronic form about the progress of consideration of submitted documents are provided , the system for storing and presenting graphic images of documents and files associated with the database of registered medical devices has been improved.

In accordance with the Decree of the Government of the Russian Federation dated July 10, 2013 No. 583 “On ensuring access to publicly available information on the activities of state bodies and local self-government bodies on the information and telecommunications network “Internet” in the form of open data” and the order of the Government of the Russian Federation dated July 10, 2013 No. 1187-r “On Lists of information on the activities of state bodies and local self-government bodies posted on the network "Internet" in the form of open data" on the official website of Roszdravnadzor and the websites of territorial bodies, mandatory sets of open data are posted and communication with Roszdravnadzor AIS databases is provided for regular automatic update. In the protocol of the Government Commission for Coordination of Activities Open Government Roszdravnadzor was noted as one of the 10 departments that most effectively carried out this work.

For the purpose of promptly collecting and compiling information from the territorial bodies of Roszdravnadzor, an innovative subsystem “Operational collection of information” has been developed and put into operation within the framework of the AIS of Roszdravnadzor, which allows you to submit a consolidated report of the Service almost within one day after posting the corresponding reporting form for filling out in the specified subsystem.

In 2013, work began on creating a secure departmental information network, satisfying all requirements information security. By the end of 2013, the network segment protected by certified software and hardware covered the central office of Roszdravnadzor and 51 territorial bodies.

Year 2014

The work carried out this year is a logical continuation of the development of the Roszdravnadzor information system.

In accordance with the newly adopted regulatory and legal acts, the “Checks” subsystem of the AIS of Roszdravnadzor was modernized, which implemented the ability to reflect control activities and monitor the implementation of healthcare modernization programs, measures to comply with the procedures for providing medical care and standards of medical care, and also implemented mechanisms for recording implementation orders and collection of fines in accordance with changes made to the Administrative Code of the Russian Federation in relation to the control powers of Roszdravnadzor.

Changes have been made to the “Licensing” subsystem of the AIS of Roszdravnadzor. For the licensing authorities of the constituent entities of the Russian Federation, the possibility of maintaining a regional segment of licenses has been implemented, and work has been completed on integration with the PTP "AIS LOD" (a standard software and hardware solution for automating the provision of public services for licensing certain types of activities), created with the participation of the Ministry of Economic Development of Russia to ensure integration with licensing information systems of constituent entities of the Russian Federation.

Work has been completed on the development of the “Medicine Quality Monitoring” subsystem of the Roszdravnadzor AIS, one of the main tasks of which was the creation of an information retrieval system for rejected, counterfeit and falsified drugs on the Roszdravnadzor Internet portal. On July 22, 2014, the Federal Service for Surveillance in Healthcare held a presentation of new electronic services that allow online obtaining information on substandard and falsified medicines through search engine, and not in the form of separate letters on the site.

On April 10, 2014, the Public Services Portal of Roszdravnadzor began operating, providing applications for the provision of 11 public services electronically using Unified system identification and authentication (USIA) of the Unified Portal of Public Services. To date, more than 50 electronic applications for receiving public services of Roszdravnadzor have been submitted through the portal.

Work has been completed to create a secure departmental information network using certified means that meets all information security requirements.

Thus, during its development, the Roszdravnadzor information system has been transformed from separate, disparate software products and databases into a single secure state information system that provides a comprehensive solution to the tasks assigned to Roszdravnadzor, an interactive environment for interaction with participants in the healthcare industry and citizens, integrated with state information systems , such as Single portal public services, interdepartmental electronic interaction system, interdepartmental electronic document management system, government system"Management" and a number of others.

Close integration of the information system with the official website of Roszdravnadzor and the transition to a service-oriented architecture that meets modern trends allows for high efficiency in obtaining information from participants in the healthcare industry and, in turn, ensures transparency and prompt information through the official website to a wide audience of interested legal entities and citizens.

The article is devoted to the use of the Roszdravnadzor information system in the implementation of control and supervisory activities by the territorial body of the Federal Service for Surveillance in Healthcare and Social Development. The functions of the system are revealed and ways to optimize it are proposed.
(using the example of the work of the Roszdravnadzor Office in the Krasnodar Territory)

In accordance with current legislation, the Federal Service for Surveillance in Healthcare and Social Development carries out more than 60 government functions and powers.

Ensuring control and supervisory activities is currently impossible without the use of modern information systems that support the completeness of information presentation, operational information interaction of all structural units of the central office and territorial bodies of the Service. AIS of Roszdravnadzor is a unified automated information system that provides information support for the control and supervisory activities of the Service, uniting the territorial bodies of Roszdravnadzor with the central office into a single information space.

Let's consider the operation of the system in terms of collecting and processing statistical information in terms of preparing individual reports from the Roszdravnadzor Office for the Krasnodar Territory (hereinafter referred to as the Office) on benchmark indicators.
One of the key information subsystems is the “Inspections” subsystem, which accumulates information, starting from the formation of a unified inspection plan for the year to entering the results of scheduled and unscheduled inspections in real time.

When carrying out control and supervisory activities, the Department is guided by the norms of the Federal Law of December 26, 2008 No. 294-FZ “On the protection of the rights of legal entities and individual entrepreneurs in the exercise of state control (supervision) and municipal control.” In accordance with paragraph 4 of Art. 9 of the Law, when drawing up an annual inspection plan, the following information must be indicated: names of legal entities (their branches, representative offices, separate structural units), locations of legal entities and places where they actually carry out their activities. Following paragraphs. 8th and 9th Art. 9 of Federal Law No. 294-FZ, it is necessary to take into account that the basis for including a scheduled inspection in the annual plan for conducting scheduled inspections is a certain time interval from the date of state registration of a legal entity (individual entrepreneur) and the end of its last scheduled inspection. All this information is available in the AIS: Department specialists analyze the information contained in the directory of organizations and the register of licenses to formulate an inspection plan and subsequently approve it in the prescribed manner at the prosecutor's office. Having received an agreed and approved plan for control and supervisory activities, we enter it into the “Planning” section of the “Inspections” subsystem. In the future, immediately after the completion of each control event, the verification data is entered in the same section on the “Results” tab.

Each unscheduled inspection, whether on-site or documentary, also begins with an analysis of the information about the organization available in the AIS (its organizational and legal form, OGRN, TIN, legal address, place of business, etc.). Then, when visiting the organization, the Department’s specialists check the accuracy of the information received.

Since Art. 11 of Federal Law No. 294-FZ defines that “the subject of a documentary check is the information contained in the documents of a legal entity, individual entrepreneur, establishing their organizational and legal form, rights and obligations, documents used in the implementation of their activities and related to the fulfillment of mandatory obligations by them.” requirements and requirements established by municipal legal acts, execution of instructions and resolutions of state control (supervision) bodies, municipal control bodies,” then in the process of conducting a documentary check, officials of the Department first of all consider the information available in the AIS, and this is the complete history of the business subject for the licensed type of activity: information about all the organization’s licenses, changes in their status, re-registrations, reports of previous inspections, inspection results, instructions and the timeliness and completeness of their execution, materials on consideration of cases of administrative offenses.

In essence, AIS is the basic platform for ensuring the control and supervisory activities of Roszdravnadzor. The AIS system contains information on control and supervisory activities for all licensed types of activities, and now also on pre-licensing inspections, both documentary and on-site, which are registered as unscheduled. Information is entered on control and supervisory activities in the implementation of state control of the quality of medicines, monitoring the implementation of healthcare modernization programs and the progress of the priority national project “Health”, monitoring compliance with quality standards of medical care and the implementation of medical examinations, monitoring the implementation of expenses subventions from the federal budget, control and supervision over compliance with state standards of social services and control over the procedure for organizing and implementing the rehabilitation of disabled people and many other activities carried out by Roszdravnadzor in the implementation of government functions.

Thus, the Roszdravnadzor AIS system accumulates a significant amount of information on all areas of the Service’s activities in real time.

This allows the Department, firstly, to monitor the implementation of the plan of control and supervisory activities; secondly, it significantly facilitates the flow of documents between territorial authorities and the central office: the results of inspections in attached files are available for reading immediately after the end of the control and supervisory activity; thirdly, it allows you to collect some statistical and analytical reporting on individual user requests. However, the AIS system does not have the most important thing for ordinary performers - the generation of regular statistical monthly reports in automatic mode.

Quarterly by territorial bodies of Roszdravnadzor on behalf of the head of Roszdravnadzor dated October 1, 2010 No. 57 in accordance with Rosstat order No. 331 dated September 27, 2010 “On approval of statistical tools for the organization of the Ministry of Economic Development of Russia of federal statistical monitoring of the implementation of state control (supervision) and municipal control” in the AIS information is entered into Form No. 1 “Information on the implementation of state control (supervision) and municipal control.” And every month, by order of Roszdravnadzor dated 06/05/2009 No. 4565, and from February 1, 2012 by order of Roszdravnadzor No. 8429 “On the collection and recording of indicators of state control and supervisory functions of the Federal Service for Surveillance in Healthcare and Social Development,” enough is filled out in the AIS capacious module.

At the same time, a significant part of the information for generating these statistical reports can be obtained by correctly and completely filling out the existing modules in the “Checks” subsystem, and with the appropriate expansion and addition of the module editing windows, it is practically possible to obtain complete information for the next stage of AIS modernization - the formation of an automatic downloading standard reports. At the same time, the collection and recording of indicators should be formed both at the level territorial body, and as a summary of areas of activity in the central office.

To work analytically with the existing database of information based on the results of checks, it is necessary to modify the editing windows, expanding them to exactly the information required in the reports, and modifying the filter system, which will allow, by combining different values, to obtain all the necessary information for generating reports.

So, for example, when filling out the “Object of Inspection” window, the program offers to select sub-objects - according to the addresses of the activity, which means that it is actually possible to count the number of separate objects inspected in the reporting period (this is required in the report) - you just need to programmatically register the choice of this value. In the “Grounds” window for unscheduled inspections, it is necessary to provide a reference book, including positions in accordance with the grounds for inspections according to the Federal Law of December 26, 2008 No. 294 “On the protection of the rights of legal entities and individual entrepreneurs in the exercise of state control (supervision) and municipal control”, such such as the receipt of information about the threat of harm to life, health, harm to life, health, violation of the rights of citizens, the need to control (or due to the expiration of the deadline) the execution of orders to eliminate identified violations, instructions from the Ministry of Health and Social Development of Russia, Roszdravnadzor, and the prosecutor's office. Also, as a basis for unscheduled inspections, provide for the receipt of information about possible violations of the law committed by public authorities of the constituent entities of the Russian Federation in the exercise of delegated powers, inconsistencies and discrepancies in the information presented in the reports of public authorities of the constituent entities of the Russian Federation, and the receipt of applications from applicants and licensees.

In order to implement a results-based budgeting (RBB) system, a specialist from our Department quarterly generates information in the AIS on the estimated and standard costs for the provision of relevant public services. At the same time, the benchmark for most government functions carried out by the Federal Service for Surveillance in Healthcare and Social Development is the number of inspections performed. This control indicator can be obtained in the AIS based on the entered actually executed scheduled and unscheduled inspections for the period under study, provided that identity is established between the entered value in the “Subject of Inspection” window (one topic is entered during a thematic inspection and a set of topics when conducting a comprehensive inspection) and the executed when implementing control and supervisory measures on this topic by a state function. In this case, with appropriate program settings, selecting the performed government function for the reporting period will allow you to count the number of inspections that affected the performance of a certain government function, i.e. obtain the correct benchmark for calculating cost standards in the budget budget system.

AIS– unique system, which combines large blocks of databases into a single information space, which is an effective mechanism that allows you to obtain operational, statistical and analytical information by type of activity. Its further development should serve not only the purpose of obtaining summary and analytical information for making management decisions, but also meet the needs of the user to optimize work and facilitate the routine work of ordinary performers.

Automated information system of Roszdrav

The Federal Agency for Health and Social Development sends for information and use in work recommendations on the procedure for information interaction between federal executive authorities, authorized bodies of constituent entities of the Russian Federation in the field of health care and organizations in the implementation of a national priority project in the field of health care, federal target programs and centralized procurement of medicines , medical equipment and medical products.

1. General Provisions

1.1. Purpose and scope

These recommendations have been developed in order to increase operational efficiency and improve the system for collecting, storing and processing information when implementing measures for the supply of goods, performance of work and provision of services at the expense of the federal budget.

The recommendations determine the procedure for information interaction between the Federal Agency for Health and Social Development, constituent entities of the Russian Federation, recipients and suppliers of goods, works and services in the implementation of the following activities.

Priority national project in the field of healthcare:

provision of outpatient clinics and sanitary clinics with diagnostic equipment for the organization of primary health care, as well as antenatal clinics;

equipping state and municipal institutions and units providing emergency medical care and specialized (sanitary-aviation) emergency medical care with ambulance vehicles, including ambulances and ambulances based on tracked tractors;

provision of state and municipal health care institutions with diagnostic tools and antiretroviral drugs for the purpose of prevention and treatment of persons infected with human immunodeficiency viruses and hepatitis B and C;

providing state and municipal health care institutions with equipment and consumables for neonatal screening;

provision of state and municipal health care institutions with medical immunobiological preparations for immunization of the population within the framework of the National Calendar of Preventive Vaccinations, including for additional immunization.

Federal target programs:

"Prevention and control of socially significant diseases for 2007-2011":

Centralized procurement for subordinate institutions:

purchase of medicines;

purchase of medical equipment;

purchase of medical products.

1.2. Basic regulatory documents

If you are a user of the Internet version of the GARANT system, you can open this document right now or request it via the Hotline in the system.

STATE INSTITUTION FOR SCIENCE

ALL-RUSSIAN RESEARCH AND TESTING INSTITUTE OF MEDICAL ENGINEERING

Automated information system for monitoring medical devices

Brief instructions for filling out data in the environment

Version 1.81

1. General Provisions. 3

2. Structure of AIS MMI.. 5

3.1. Basic capabilities of the health care facility level.. 6

3.2. General information. 6

3.3. Equipment. 9

3.3.1. Card of the main hospital.. 9

3.3.2. Subordinate health care facility.. 14

3.3.2.1. Divisions of health care facilities.. 15

3.3.3. Card MI.. 17

3.3.3.1. Operating data. 17

3.3.3.2. Additional information. 22

3.3.3.3. Service log. 27

3.3.3.4. Metrology. thirty

3.3.3.5. Consumables.. 32

3.3.3.6. Medical services. 34

3.3.3.7. Staff. 35

3.3.4. Staffing schedule. 36

3.3.5. Quick view. 40

3.3.6. Equipment sheet. 41

2. General provisions.

As a means of monitoring the supply and use of diagnostic equipment and sanitary vehicles for the priority national project in the field of healthcare (hereinafter referred to as the “Health” project), software and part information support Automated information system for monitoring medical devices (AIS MMI), developed by the Federal State Institution VNIIMT.

AIS MMI is a three-level system:

1. The main base level of the monitoring system, at which databases on the availability and condition of medical devices are maintained, are healthcare facilities.

2. Information from healthcare facilities is integrated at the level of the constituent entity of the Russian Federation (regional level) to solve their own problems and transfer information about each healthcare facility to the federal level.

3. The federal level is fundamental in determining the methodology for automated control, as well as the development and dissemination of the information and reference base on which the ability to integrate and analyze the collected data is based.

Functionally, the healthcare facility level can also be used to control the head healthcare facility ( legal entity) networks of subordinate health care facilities (separate structural units), and the regional level of AIS can be used by local governments both to solve their own problems and as an intermediate link for summarizing and transmitting information to a higher level.

The AIS MMI data structure allows you to actually maintain an electronic form for each product in a healthcare facility, which takes into account the ongoing service work, metrological support, operating time, downtime, current technical condition, operating and maintenance costs, which allows you to carry out functions to control the use of products.

It should be noted that maintaining the AIS database does not cancel maintaining the form, but only complements it, providing the possibility of computer processing of the operational data contained in it. The form serves as documentary evidence of the completeness and accuracy of the data entered into the AIS.

The AIS MMI reference book system is of great importance for the integration and analysis of information. The reference database is formed at the federal level and supplied to the regions and health care facilities as part of the information support of the AIS MMI. When compiling reference books, all-Russian classifiers, State registers of medical devices and measuring instruments, technical specifications, and information materials from developers and suppliers of medical devices are used as initial data.

A large number of medical products of various names on the market creates difficulties in finding them and choosing analogues. In the AIS MMI, products are grouped into types according to their functional purpose and technical specifications, according to the values ​​of which products of the same type can be compared with each other.

Indicating the type for each product allows you to control their availability in health care facilities, regardless of differences in the names of specific products.

Sources of information provided to Roszdravnadzor (FGU VNIIIMT) for monitoring the “Health” project:

1. Procurement control (according to Roszdrav):

Applications from regions for equipment and vehicles;

Procurement plan - based on announced tenders;

Fulfillment of procurement plans - according to concluded contracts.

2. Supply control:

Supply plan for healthcare institutions (Roszdrav);

Acceptance and transfer certificates (according to health care facilities);

Commissioning certificates (according to health care facilities).

3. Control of use (according to health care facilities):

AIS MMI data on the registration, commissioning, condition and use of diagnostic equipment and sanitary vehicles in health care facilities;

AIS MMI data on the conclusion of contracts for service and metrological support of received products.

3. Structure of AIS MMI

From the federal level, the AIS receives the information necessary for the functioning of the system at the lower levels: a directory of medical devices, directories of enterprises - manufacturers and suppliers of medical devices, all-Russian classifiers and other regulatory and reference information.

At the healthcare facility level, databases are maintained on the structure of healthcare facilities (list of departments), the availability, condition and use of medical devices in the departments of healthcare facilities, as well as on their service and repair.

Data from lower levels is loaded into a higher-level database, creating a consolidated database for the region or federation, respectively.

At the regional level, by order of the regional health authority, a responsible executive is appointed and the procedure for implementing AIS MMI in health care facilities is determined.

In health care facilities, the chief physician is responsible for maintaining and presenting data to a higher level. By order of the health care facility, a responsible executive is appointed, computer equipment is allocated, it turns out software AIS MMI in the regional health management organization.

Data entry into the AIS MMI is carried out on the basis of operational documents. The main document containing information about the operation of the product is the form.

Most healthcare facilities (especially primary care) do not have the ability to keep computer records of used products. In such cases, information is entered into the AIS MMI by a higher-level organization based on the records of forms maintained at the place of operation of each product.

In the absence of personnel and equipment to maintain health care facility databases, this work can be performed by an authorized organization on a contractual basis with health care facilities or a regional health department organization. For this purpose, it is most advisable to use the capabilities of the organization that provides service maintenance for the bulk of the products received under the “Health” project.

4.1. Main capabilities of the healthcare facility level

Work at the healthcare facility level is simplified as much as possible for the user, so all information is located practically in one window and can be presented either as a tree structure ("Healthcare facility equipment") or in the form of a table ("Quick View"). The staffing table is presented as a separate menu item and is used when generating the needs of health care facilities for comparison with the equipment sheet, which can also be viewed using the corresponding menu item. Equipment sheets are generated at the regional level and called up to health care facilities for viewing in accordance with the type of specific health care facility. The item “Data for transfer to the region” serves to prepare information from health care facilities for transfer to the health management organization that carries out monitoring functions in the region.

4.2. General information

Due to the fact that in new version Since the AIS MMI program has changed only some fields for filling out accounts, the structure and descriptions of such menu items as “Directories”, “Reports”, “Service”, “Clipboard”, “Windows”, “Help” are not discussed in this manual. If you need information about these menu items, you can refer to the “User Manual version 1.71”

Before moving on to describing the procedures for maintaining accounts, it is worth paying attention to some functions of the environment that are the same in all windows.

The position of the cursor ruler in any window determines the functions of the “Add”, “Change” and “Delete” buttons;

The presence of such an icon means that when filling out a field, you can use a directory or calendar, which can be accessed by clicking on the indicated button;

Deleting an object is possible if it is selected in the list and when you click on the specified button;

Responsible for adding an object to a list or linking two records;

When filling out the following fields, you must use your registration documents:

Organization code according to OKPO;

Code of ownership according to OKFS;

Code of organizational and legal form according to OKOPF;

Name of institution, legal address;

The fields are filled in only for SIMN:

Type of measurement;

Measurement range;

Class of measuring instrument;

Last verification date