"Software product" will continue development of the AIS of Roszdravnadzor

Creation of automated information system of Roszdravnadzor

Results of implementation of the AIS of Roszdravnadzor concern each of us are better medicines in drugstores, it is smaller load of hospitals, this fast service. It both exact diagnoses and decline in mortality of old men from strokes and heart attacks.

Automated information system of Roszdravnadzor, provides collection of data on issue of the medicines (M) from subjects of the address of a LAN; reporting by data about release of a LAN, entered to an external information resource of the AIS of Roszdravnadzor "Quality control, efficiency and security of medicines", state control at the address of a LAN according to requirements of regulatory legal acts (a subsystem Destruction of LAN), and also collecting and the analysis of data within operational monitoring of medicines.

• The AIS includes 42 subsystems
• Internet portal and websites of 78 territorial departments
• 10 external information systems
• Support of providing 9 public services in electronic form
• Interdepartmental interaction with 26 departments

Users of a system are: medical organizations, commercial organizations of spheres, citizens, expert organizations subordinated to the organization and territorial authorities of Roszdravnadzor, federal executive authority and ROIV

2019

"Software product" helped Roszdravnadzor to become the leader of the rating of openness of the websites of authorities

At the beginning of April, 2020 the Ministry of Economic Development provided the next annual rating of openness of the websites of authorities. During the research, from September to December, 2019 experts carried out the analysis of openness of 72 federal executive authorities (FEA). First place in rating at the end of 2019 was won by the Internet the resource of Roszdravnadzor developed ^[1].

"Software product" performs works on development and maintenance of Automated information system and the Internet portal of Federal Service for Surveillance in Healthcare since 2016. During this time the company implemented new functionality of the website, upgraded the majority of subsystems and sections, ensured reliability and smooth operation of the Internet portal. Also mobile version of the website was developed. Thanks to work of specialists of Software product, the Internet portal of Roszdravnadzor became one of leaders of final rating of the websites of authorities regarding openness and technical convenience to users. The final rating developed by addition of several ratings: expert, technical, national and rating of open data.

The Internet portal was highly appreciated in expert rating thanks to compliance to requirements of information openness. The resource provides the exhaustive information on all control functions of federal service, among them there are regulatory legal acts, information letters, orders, links to reporting subsystems, etc.

The website of Roszdravnadzor was also mentioned in the national rating reflecting satisfaction of users with work of the website. For convenience in the upper menu of the website access to the section Services which contains references to all state services of federal service thanks to what there is an opportunity to submit the application for receiving service directly via the website of Roszdravnadzor, without transition to the Gosuslugi portal is located. In the section references to personal accounts for tracking of information on the course of consideration of the documents filed to department are also given. In addition, the website contains references to all external information resources of Roszdravnadzor — subsystems in which external users work (drugstores, health facilities, the pharmaceutical companies, medical schools). The resource also contains references to forms of search in those registers which maintaining is in powers of Roszdravnadzor. First of all, it is registers of licenses for medical, pharmaceutical activity, production and maintenance of medical equipment and also registers of the issued permissions to clinical trials, the certified experts, the medicines withdrawn from circulation, etc. On the website the different forms of submission of addresses separated on subjects and orientations both with authorization of a Unified identification and authentication system are provided, and without.

In the cellar of the website there is a link to open data of Roszdravnadzor thanks to what the Internet resource was highly appreciated in the rating of open data. This section is intended for machine-readable search in all open supplied and to the information of Roszdravnadzor for a certain period.

2018

Programmny Produkt Group will continue development of the AIS of Roszdravnadzor

The Software product group which earlier implemented the project on development of Automated information system of Federal Service for Surveillance in Healthcare will continue in 2018 upgrade of a system regarding compliance to requirements of the Standard of informatization of the control and supervising activity (CSA) containing complex requirements to departmental and interdepartmental federal state information systems, such as EPGU (Uniform portal of the public and municipal services), FRPS (Federal Register of Public Services), GASU (The state automated information system) and URC (Unified Register of Checks).

During the project works on development of a dynamic component of risk-oriented model, improvement of the mechanism of planning of checks taking into account risk-oriented approach, to formation of test sheets of objects of supervision, the automated measure calculation of efficiency evaluation and effectiveness of KND will be carried out.

Also within the signed contract integration of the AIS of Roszdravnadzor with the systems of the Eurasian Economic Union, regarding providing public services and automatic exchange of information with member countries of the Eurasian Economic Union on post-registration clinical monitoring of medical products, on security of medicines according to requirements of rules of proper practice of pharmacovigilance, on monitoring of clinical trials of medicines, according to requirements of rules of proper practice of clinical trials of the Eurasian Economic Union and other information will be executed.

Besides, in the project progress development of the Internet portal of Roszdravnadzor and the websites of the territorial authorities supporting interaction with a Unified identification and authentication system will be provided.

A system is the main working tool of staff of Roszdravnadzor. In it the key principles reforms of control and supervising activity are implemented: planning of checks on the basis of risk-oriented approach, quality improvement and productivity of checks, ensuring monitoring of a situation. More than 50 thousand employees of department in all regions of the Russian Federation daily use a system.

"All projects connected with development of the industry of health care are of great interest to us. As this area extremely difficult and having a set of the different need not always connected among themselves technically we see high potential for use of our knowledge and experience in a part of custom software development. Works on creation of the AIS of Roszdravnadzor which we performed earlier are required to be developed in connection with regular updating of requirements to a resource. Tasks not only of creation, but also practical application help us to understand better the customers and to improve systems for their demand end users" - the CEO of Software product Nikolay Podobaylo commented on news.

2017

Roszdravnadzor became the leader in implementation of new technologies among supervising departments

According to the results of the meeting devoted to results of check of Roszdravnadzor in the Astrakhan region, department was recognized by one of leaders among supervising departments in implementation in the operation of new mechanisms of state control. The meeting took place on October 29 with participation of the curator of reform of state control, the minister of the Russian Federation of the Open government Mikhail Abyzov.

"At all features of Roszdravnadzor which should be both is moderately progressive, and is moderately conservative as it is supervision of very sensitive sphere, it is necessary to tell that Mikhail Albertovich Murashko's team (the head of Roszdravnadzor) and at the federal level, and at the level of regions is today one of the tasks, most successful in implementation, which are provided by reform of control and supervising activity" — the Minister of the Open Government Mikhail Abyzov noted at a meeting.

Main article

Experience of automation of problems of control and supervising activity on the example of the AIS of Roszdravnadzor

The KND system shows inefficiency

• In the country undergoes 2 million testing annually, about 40 federal agencies participate in them
• In the Russian Federation there are more than two hundred types of control
• By estimates of the HSE, costs of the state for control actions make 1.5% of GDP, load of business from observance of excess requirements makes up to 6% of GDP
• Despite large-scale work on reforming of the control and supervising activity (CSA), it is essential to move ahead not ^[2]

Reform of a system of state control - one of the key areas of work of Council at the President for strategic development and priority projects

The program of reform of KND assumes

• implementation of risk-oriented approach in KND,
• failure from repressive approach and transition to prevention of violations,
• increase in transparency of KND and decrease in corruption risks

Target indicators of the program

• decrease in level of damage to the values (life and human health) protected by the law by 50%
• decrease in level of material damage by controlled types of risks for 30%
• decrease in administrative load of the organizations and entrepreneurs by 50%
• growth of the index of quality of administration of control and supervising functions for 200%

AIS of Roszdravnadzor

Implementation of the key principles of reform of KND

• Provides planning of checks on a basis of risk-oriented approach
• Promotes decrease in damage of life and health of citizens, prevention of offenses
• Increases quality and productivity of checks
• Stimulates activity of inspectors
• Provides monitoring of a situation
• Supports a real-time mode and increases efficiency

AIS of Roszdravnadzor of the Subsystem and data streams

• The complete information about control actions is transferred in URC (unified register of checks) which is under authority of the Prosecutor General's Office
• Information after entering into Management state automated system will be available to all departments

In 2018 it is planned:

Adaptation of the solution to requirements of KND created the Standard of informatization containing complex requirements to departmental and interdepartmental federal state information systems EPGU, FRGU, GASU, ERP

Scheme of connection and jobs of Territorial authorities of Roszdravnadzor and Central office of Roszdravnadzor

In 78 TO of Roszdravnadzor the hardware and software systems implementing functions of the firewall and the cryptographic gateway (ViPNet Coordinator HW1000) are operated.

Quantity of the used jobs:

• stationary and mobile jobs of staff of TsA – 230
• stationary and mobile jobs of staff of 78 TO of Roszdravnadzor with an extreme number of staff not less than 1200 units
• providing access on external information resources of the AIS of Roszdravnadzor of staff of organizations, companies and medical institutions – not less than 50000

Risk-oriented approach

Registers of under control objects include

• the organizations performing medical activity
• enterprises wholesale and retail by medicines; production of medicines
• production, service, turnover of medical products

Subjects of the analysis the arriving threats, the actual damage from the implemented threats, danger carriers

AIS basic procedures of Roszdravnadzor

Functionality automated workplace AIS Roszdravnadzora Lichny account

Example of screen forms Summary register of ROM

Planning of KND

The number of checks decreases

• 2017 - 5500 checks
• 2018 - 4900 checks (plan)

The number of violations does not decrease:

• So, for the second quarter 2017 of penalties it is written out for 32 million rubles.
• 26 million fall on the penalties connected with storage of a LAN
• In comparison with the same period of last year the number of the revealed violations did not decrease, and only increased

Planning of KND

Estimates

According to the results of the meeting devoted to results of check of Roszdravnadzor in the Astrakhan region, department was recognized by one of leaders among supervising departments in implementation in the operation of new mechanisms of state control. The meeting took place on October 29, 2017 with participation of the curator of reform of state control, the minister of the Russian Federation of the Open government Mikhail Abyzov.

"At all features of Roszdravnadzor which should be both is moderately progressive, and is moderately conservative as it is supervision of very sensitive sphere, it is necessary to tell that Mikhail Albertovich Murashko's team (the head of Roszdravnadzor) and at the federal level, and at the level of regions is today one of the tasks, most successful in implementation, which are provided by reform of control and supervising activity", - the Minister of the Open Government Mikhail Abyzov noted at a meeting.

Several factors among which it is possible to select the competent management, professional work of staff of the Rozdravnadzor and implementation of new technical means had an impact on good result of work of department. Now this successful experience can be replicated also in other departments. Automation of the main workflows of department due to implementation of automated information system helped to provide high rates of work of Roszdravnadzor. Specialists of Software product were engaged in development and deployment.

A system is the main working tool of staff of Roszdravnadzor. In it the key principles reforms of control and supervising activity are implemented: planning of checks on the basis of risk-oriented approach, quality improvement and productivity of checks, ensuring monitoring of a situation. A system also allows to maintain registers of under control objects – the organizations performing medical activity, the enterprises wholesale and retail by medicines, the organizations participating in turnover of medical products. In addition, planning processes of KND, collecting and processing of indicators, assignments of category of risks are at the moment already automated, "personal account" of the official functions.

"The project on creation of the AIS of Roszdravnadzor became for us a call. Quickly enough we managed to automate planning processes of KND, collecting and processing of indicators, assignments of categories of risks. We are proud of successful implementation of this project and are sure that our practical experience and a command allows to offer the market sure transition to the average level of the standard of automation of KND in 6-8 months," - the CEO of Software product Nikolay Podobaylo commented on news.

Notes