The article is devoted to the issues of using information system Roszdravnadzor 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 divisions of the central office and territorial bodies Services. 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 standards Federal Law dated December 26, 2008 No. 294-FZ “On the Protection of Rights 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 divisions), 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 activity, 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 full story of an economic entity 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 of 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 full information for the next stage of AIS modernization - the formation of automatic downloading of standard reports. At the same time, the collection and recording of indicators should be formed both at the level of the territorial body and as a set of activities 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– a unique system that 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 in the context of types of activities. 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.
Creation of an automated information system of Roszdravnadzor
The results of the implementation of the Roszdravnadzor AIS concern each of us - these are higher quality medicines in pharmacies, this is less workload in hospitals, this is fast service. These include accurate diagnoses and a reduction in the mortality rate of old people from strokes and heart attacks.
The automated information system of Roszdravnadzor ensures the collection of data on the release of medicines (medicines) into circulation from subjects of medicine circulation; generation of reporting on data on the release of drugs entered into the external information resource AIS Roszdravnadzor “Control of the quality, effectiveness and safety of medicines”, state control during the circulation of drugs in accordance with the requirements of regulations (subsystem “Drug Destruction”), as well as collection and analysis of information within the framework of operational monitoring of medicines.
- AIS includes 42 subsystems
- Internet portal and websites of 78 territorial branches
- 10 external information systems
- Support for the provision of 9 public services electronically
- Interdepartmental interaction with 26 departments
Users of the system are: medical organizations, commercial organizations, citizens, expert organizations, subordinate organizations and territorial bodies of Roszdravnadzor, federal executive authorities and regional executive authorities
2018
GC "Software Product" will continue to develop the AIS of Roszdravnadzor
The system is the main working tool for Roszdravnadzor employees. It implements the key principles of the reform of control and supervisory activities: planning inspections based on a risk-based approach, improving the quality and productivity of inspections, and ensuring monitoring of the situation. The system is used daily by more than 50 thousand department employees in all regions of the Russian Federation.
“All projects related to the development of the healthcare industry are of great interest to us. Since this area is extremely complex and has many different needs that are not always technically interconnected, we see great potential for applying our knowledge and experience in terms of custom software development. The work on creating an automated information system for Roszdravnadzor, which we carried out previously, needs to be developed in connection with regular updates of resource requirements. Tasks not only in creation, but also in practical application help us better understand our customers and improve systems so that they are in demand by end users,” Nikolai Podobaylo, General Director of Software Product, commented on the news.
2017
Roszdravnadzor has become a leader in the implementation of new technologies among supervisory agencies
Roszdravnadzor in the Astrakhan region, the department was recognized as one of the leaders among supervisory agencies in introducing new state control mechanisms in their work. The meeting took place on October 29 with the participation of the curator of state control reform, Russian Minister for Open Government Mikhail Abyzov.
Experience in automating tasks of control and supervisory activities using the example of AIS Roszdravnadzor
The KND system demonstrates inefficiency
Reform of the state control system- one of the key areas of work of the Presidential Council for Strategic Development and Priority Projects
The CND reform program involves
- implementation of a risk-based approach in KND,
- abandoning the repressive approach and moving towards the prevention of violations,
- increasing the transparency of KND and reducing corruption risks
Program targets
- reduction in the level of damage to legally protected values (human life and health) by 50%
- reduction in the level of material damage for controlled types of risks by 30%
- reducing the administrative burden on organizations and entrepreneurs by 50%
- increase in the quality index of administration of control and supervisory functions by 200%
AIS of Roszdravnadzor
Implementation of the key principles of the CND reform
- Provides planning of inspections based on a risk-oriented approach
- Helps reduce damage to the life and health of citizens and prevent crime
- Improves the quality and productivity of inspections
- Stimulates inspector activity
- Provides situation monitoring
- Supports real-time mode and improves efficiency
- Full information about control activities is transferred to the Unified Register of Inspections, which is administered by the Prosecutor General's Office
- Information after entering into the State Automated System “Management” will be available to all departments
In 2018 it is planned:
Adaptation of the solution to the requirements of the created KND Informatization Standard, which contains comprehensive requirements for departmental and interdepartmental federal state information systems of EPGU, FRGU, GASU, ERP
78 technical centers of Roszdravnadzor operate software and hardware systems that implement the functions of a firewall and cryptographic gateway(ViPNet Coordinator HW1000).
Number of working places used:
- stationary and mobile workplaces for Central Asian employees – 230
- stationary and mobile workplaces of employees of 78 technical departments of Roszdravnadzor with a maximum number of employees of at least 1200 units
- ensuring access to external information resources of the AIS of Roszdravnadzor for employees of institutions, companies and medical institutions - at least 50,000
Risk-based approach
Registers of controlled objects include
- organizations implementing medical activities
- enterprises of wholesale and retail trade in medicines; production of medicines
- production, service, circulation of medical devices
Objects of analysis: incoming threats, actual damage from realized threats, carriers of danger
Ratings
Following a meeting dedicated to the results of an audit of Roszdravnadzor in the Astrakhan region, the agency was recognized as one of the leaders among supervisory agencies in introducing new state control mechanisms in its work. The meeting was held on October 29, 2017 with the participation of the curator of state control reform, Russian Minister for Open Government Mikhail Abyzov.
“With all the features of Roszdravnadzor, which should be both moderately progressive and moderately conservative, since it is supervision of a very sensitive area, it must be said that the team of Mikhail Albertovich Murashko (head of Roszdravnadzor) both at the federal level and at the regional level is today, one of the most successful in implementing the tasks provided for by the reform of control and supervisory activities,” noted Mikhail Abyzov, Minister for Open Government Issues, at the meeting.
The high results of the department’s work were influenced by several factors, among which we can highlight competent leadership, the professional work of the Rozdravnadzor employees themselves and the introduction of new technical means. Now this successful experience can be replicated in other departments.
The high performance of Roszdravnadzor was ensured by the automation of the department’s main work processes through the introduction of an automated information system. The development and implementation was carried out by Software Product specialists.The system is the main working tool for Roszdravnadzor employees. It implements the key principles of the reform of control and supervisory activities: planning inspections based on a risk-based approach, improving the quality and productivity of inspections, and ensuring monitoring of the situation. The system also allows you to maintain registers of controlled objects - organizations engaged in medical activities, wholesale and retail trade enterprises in medicines, organizations involved in the circulation of medical devices. In addition to this, on this moment The processes of planning performance indicators, collecting and processing indicators, assigning risk categories have already been automated, “ Personal Area» official.
“The project to create an AIS for Roszdravnadzor has become a challenge for us. Quite quickly we were able to automate the processes of planning performance indicators, collecting and processing indicators, and assigning risk categories. We are proud of the successful implementation of this project and are confident that our practical experience and team allows us to offer the market a confident transition to the average level of the KND automation standard in 6-8 months,” commented the news CEO"Software Product"
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 level of health care facilities can also be used for control by the head health care facility (legal entity) of the network 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 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, and the AIS MMI software product is obtained in regional organization health department.
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
K.G. POSPELOV,Head of the Interregional Information and Analytical Department of Roszdravnadzor
The article discusses the history of the creation and transformation of the Roszdravnadzor information system over a 10-year period, the 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 Roszdravnadzor automated information system (Roszdravnadzor AIS) is comparable to the time when the Federal Service for Surveillance in Healthcare began its activities.
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 October 5, 2007 No. 3003-Pr/07, the Interregional Information and Analytical Directorate 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 search services have been put into operation to provide information about registered drugs, medical devices, and 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 largest projects for informatization of government bodies was launched in Russia. 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 at the disposal of the federal executive authorities of the Russian Federation, in the provision of public services, technological maps of interdepartmental interaction with 11 federal departments - information providers were developed and agreed upon.
In accordance with the agreed technological maps of 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 for ensuring transparency of the Service and accessibility of legal 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 great, fundamentally new job, which was carried out by employees of the central office, the Interregional Information and Analytical Directorate of Roszdravnadzor and territorial departments of Roszdravnadzor in the implementation of public services in electronic form 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 governments on the Internet information and telecommunications network in the form of open data” and the Decree of the Government of the Russian Federation dated July 10, 2013 No. 1187-r “On Lists of information on the activities of state bodies, local governments, posted on the Internet in the form of open data”, mandatory sets of open data are posted on the official website of Roszdravnadzor and the websites of territorial bodies and a connection is provided with AIS databases of Roszdravnadzor for regular automatic update. In the protocol of the Government Commission for Coordinating the Activities of the Open Government, Roszdravnadzor is noted among 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 that meets 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 receipt of 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 the Unified Portal of Public Services, the system of interdepartmental electronic interaction, the system of interdepartmental electronic document management, the state system “Management” and a number of others.
Close integration of the information system with the official website of Roszdravnadzor and transition to a service-oriented architecture corresponding modern trends, allows us to ensure high efficiency in obtaining information from participants in the healthcare industry and, in turn, ensure transparency and prompt information through the official website to a wide audience of interested legal entities and citizens.