The Unified State Information System in Healthcare (USISZ) is understood as a set of information, technological and technical means that provide information support for methodological and organizational support for the activities of participants in the healthcare system.
Data processing center
This will allow real-time monitoring of the loading of medical resources and prompt management of patient flows.
- provide information support for all processes to protect public health,
- move from a system of “medical care as needed” to “current medical care based on current and complete information about the patient's health status"
- significantly reduce the labor costs of doctors for filling out statistical and regulatory reporting,
- timely solve many organizational and personnel problems of healthcare
- provide a comprehensive solution to problems of quality of medical care and healthcare management.
May 07, 2018 on the portal legal information Decree of the Government of the Russian Federation dated 05.05.2018 No. 555 “On the unified state information system in the field of healthcare” (hereinafter referred to as RF PP No. 555, Regulations on the Unified State Health Information System) was published (came into force on 05.15.2018).
The Regulations on the Uniform State Health Information System are aimed at more detailed regulation of the functioning of the unified state information system in the field of healthcare (hereinafter referred to as the Uniform State Health Information System), including issues of the structure of the Uniform State Health Information System, the procedure for accessing the information contained in it, the procedure and timing for providing information to the Uniform State Health Information System, the procedure for exchanging information using the Uniform State Health Information System , software requirements technical means Uniform State Health Information System and the procedure for protecting information in the Uniform State Health Information System. At the same time, the basic norms on the Uniform State Health Information System were enshrined in the Federal Law of July 29, 2017 No. 242-FZ “On amendments to certain legislative acts of the Russian Federation on issues of application information technologies in the field of health care."
Let us remind you once again that according to Art. 91.1 Federal Law No. 323 of November 21, 2011 - Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” (hereinafter referred to as Federal Law No. 323) in order to ensure citizens’ access to healthcare services in electronic form, as well as the interaction of information systems in the field of healthcare, the Russian Ministry of Health creates, develops and operates a unified state Information system in the healthcare sector.
And although this act has been expected for a long time, there is no reason to be particularly happy yet, since many norms on the Uniform State Health Information System are tied to an additional regulatory framework that has not yet been adopted. Moreover, RF PP No. 555 itself leaves much to be desired in terms of certain standards.
PS: Please note that in accordance with clause 4 of the RF PP No. 555, the Regulations on the Uniform State Health Information System in terms of the provision of information in the Uniform State Health Information System do not apply to medical organizations of the private healthcare system until 01/01/2019, if such medical organizations have not previously made decisions on submitting information to the specified system.
Thus, it turns out that from January 1, 2019, medical organizations of the private healthcare system are required to join the Unified State Health Information System.
Tasks and functions of the Uniform State Health Information System
Before moving on to a brief analysis of RF PP No. 555, we note that the entire range of tasks (5) and functions (16) of the Uniform State Health Information System are reflected in paragraphs 2-3 of the Regulations on the Uniform State Health Information System. In our opinion, the most interesting of them are the following:
- processing and storage, depersonalization of information about persons who receive medical care, as well as about persons in respect of whom medical examinations, medical examinations and medical examinations are carried out ( the adoption of the depersonalization procedure is entrusted to the Russian Ministry of Health together with Roskomnadzor);
- processing and storage of information about persons who participate in medical activities, including maintaining the federal register;
- maintaining a register of medical organizations ( the requirements for maintaining the register must be approved by the Russian Ministry of Health);
- maintaining regulatory and reference information in the field of healthcare ( the list, procedure for maintaining and using this information must also be approved by the Russian Ministry of Health);
- ensuring the provision of medical care in medical organizations, including issuing referrals for diagnostic tests and medical examinations (consultations);
- organization statistical observation in the field of healthcare and the formation of summary analytical information on the implementation of medical activities and the provision of medical care;
- other functions.
What is included in the structure of the Uniform State Health Information System
The structure of the Uniform State Health Information System, as previously expected, included the following subsystems:
- Federal Register of Medical Workers;
- Federal Register of Medical Organizations;
- federal electronic registry;
- federal integrated electronic medical record;
- Federal Register of Electronic Medical Documents;
- a subsystem for maintaining specialized registers of patients for individual nosologies and categories of citizens (hereinafter referred to as specialized registers of patients), monitoring the organization of the provision of high-tech medical care and sanatorium and resort treatment;
- information and analytical subsystem for monitoring and control in the field of procurement of medicines to meet state and municipal needs;
- subsystem for automated collection of information on health system indicators from various sources and reporting;
- federal register of normative and reference information in the field of healthcare;
- personal data depersonalization subsystem;
- geographic information subsystem;
- secure personal data transmission network;
- integration systems.
Please note that specialized patient registers are presented in the form of a federal register of persons infected with HIV, a federal register of persons suffering from tuberculosis, a federal register of persons suffering from orphan diseases, a federal register of persons suffering from hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after organ and (or) tissue transplantation, the National Radiation-Epidemiological Register.
We especially emphasize that many subsystems of the Uniform State Health Information System have been functioning for a long time, but this happened outside the legal framework. And even the adopted RF PP No. 555 did not solve the legislative problem, since, firstly, this act does not contain any requirements for the functioning of the Uniform State Health Information System subsystems, and secondly, the establishment of such requirements is entrusted to the Ministry of Health of Russia (clause 31 of the Regulations on the Uniform State Health Information System).
Currently, there are several subsystems of the Uniform State Health Information System, which are regulated by the following acts:
- Order of the Ministry of Health of Russia dated December 31, 2013 No. 1159n (by virtue of clause 1 of the Procedure, determines the rules for maintaining personalized records when carrying out medical activities of persons involved in the provision of medical services through maintaining the federal register of medical workers. Thus, the specified wording can be interpreted so that personalized accounting is part of the Uniform State Health Information System);
- RF PP dated 04/08/2017 No. 426 (regulates the rules for conducting FR of persons infected with HIV and persons with tuberculosis);
- RF PP dated April 26, 2012 No. 403 (regulates the procedure for maintaining FR of persons suffering from orphan diseases);
- RF PP dated April 26, 2012 No. 404 (regulates the rules for managing FR of persons with hemophilia, cystic fibrosis.....);
- RF PP dated July 23, 2013 No. 625 (regulates the rules for maintaining the National Radiation and Epidemiological Register);
- Order of the Ministry of Health and Social Development of Russia dated February 28, 2011 No. 158n (regulates the rules for maintaining the register of medical organizations operating in the field of compulsory medical insurance). ( Attention! The regulator has not established requirements for the rules for maintaining a register of all municipalities of the state, municipal and private healthcare system).
However, we note that the above acts also require changes, since they were adopted long before the release of the basic act on the Unified State Health Information System (RF PP No. 555). In addition, many of them do not directly establish requirements for the functioning of Uniform State Health Information System subsystems (for example, order No. 1159n).
Participants in information interaction
In accordance with the Regulations on the Uniform State Health Information System, the participants of the Uniform State Health Information System are divided into 3 categories: the operator of the Uniform State Health Information System (which is the Ministry of Health of Russia), information providers (their list is established in clause 40 of the Regulations on the Uniform State Health Information System, including medical organizations of the state, municipal and private healthcare systems), as well as users of information (the list is established by clause 42 of the Regulations on the Uniform State Health Information System).
Let us recall that the conditions for interaction of other information systems, including the IS of medical organizations, with the Uniform State Health Information System, as well as the requirements for software, hardware and linguistic tools of such organizations are established by the Russian Federation GD dated April 12, 2018 No. 447.
On the procedure and timing for posting information in the Uniform State Health Information System
The main “trend” of the Regulations on the Uniform State Health Information System should be considered the composition of information and the timing of its placement in this system (its subsystems) (Appendix No. 1 to the Regulations on the Uniform State Health Information System). The information itself in Appendix No. 1 is divided depending on the structural unit (subsystem) of the Uniform State Health Information System.
At the same time, the submission of information to the Unified State Health Information System is carried out using the following information systems: IS in the field of compulsory medical insurance, automated IS of the Federal Tax Service of Russia, FSIS " Federal Register disabled people", FSIS "Unified Integrated Information System "Social Insurance" FSS of the Russian Federation", medical information systems of medical organizations of state, municipal and private healthcare systems and others. A complete exhaustive list of such information systems is presented in clause 51 of the Regulations on the Uniform State Health Information System.
The period for providing information to the Uniform State Health Information System, depending on its content, varies from 1 to 5 working days.
However, it is worth noting that RF PP No. 555 does not contain provisions on the consequences of violating established deadlines, including for failure to provide information, as well as providing information outside the established period.
On conflicts in the rules on the composition of information posted in the Uniform State Health Information System
We cannot ignore the information that suppliers are required to provide to the Uniform State Health Information System.
Thus, in the federal register of medical workers (on the basis of Order No. 1159n it is linked to personalized records in relation to persons providing medical care) in accordance with Appendix No. 1 to the Regulations on the Unified State Health Information System (clause 3), information about a medical worker includes information about his employment (medical organization, structural unit of the Moscow Region, position, type of position, rate, start date of employment, end date of employment, reason for termination). Meanwhile, this provision contradicts Art. 93 Federal Law No. 323, which does not provide information about the type of position held by a medical worker, the rate, the start and end date of employment, the basis for termination (the established list is exhaustive). Moreover, Order No. 1159n does not contain such information.
The situation is similar with information about persons receiving medical care in the “Federal Integrated Electronic Medical Record” subsystem. So, in accordance with Art. 94 Federal Law No. 323 The Regulations on the Uniform State Health Information System establish additional information on the prescription and use of medicinal products, indicating the means of identification of medicinal products (except for retail sales) ... (clause 22 of Appendix No. 1 to the Regulations on the Uniform State Health Information System).
Also, one of the types of information provided to the Uniform State Health Information System subsystem “Federal Electronic Registry” is the telemedicine consultation protocol. However, in our opinion, here the legislator made a slight inaccuracy in terminology, since according to the Procedure for organizing and providing medical care using telemedicine technologies, approved by Order of the Ministry of Health of Russia dated November 30, 2017 No. 965n (clause 24) based on the results of a consultation (consilium of doctors) The consultant draws up a medical report (protocol of a consultation of doctors). And it is these documents that are drawn up in electronic form when providing medical care using telemedicine technologies, but not the protocol of telemedicine technologies.
In addition, as information in subsystem... monitoring the organization of providing high-tech medical care... a document is presented as “a referral for hospitalization to provide high-tech medical care.” Meanwhile, according to the Procedure for organizing the provision of high-tech medical care using a specialized information system, approved by Order of the Ministry of Health of Russia dated December 29, 2014 No. 930n, such a document is drawn up manually or in printed form without the use of a specialized information system, that is, it is not an electronic document that can be placed in a specialized information system. While a voucher for the provision of high medical care is issued using this system ( however, it is a separate document and also appears in Appendix No. 1 to the Regulations on the Uniform State Health Information System). Requirements for the electronic form of referral for hospitalization of primary care are not established by other acts regulating legal relations for the provision of primary care. Thus, the question arises: how will the direction be entered into the Uniform State Health Information System if the electronic form of the document is not provided for by the legislation of the Russian Federation? Maybe the legislator had in mind the information reflected in the referral for hospitalization for the provision of emergency medical care?
It seems doubtful the requirement of RF PP No. 555 to confirm the accuracy of the information provided in the Uniform State Health Information System in in electronic format, citizens through the use of enhanced qualified electronic signature or a simple electronic signature through the use of a unified identification and authentication system(clause “b” clause 35 of the Regulations on the Uniform State Health Information System). The Faculty of Medical Law has already written more than once in its notes and articles that with the establishment of such requirements, a significant layer of patients who are not registered in the unified identification and authentication system are cut off from participation in the Uniform State Health Information System, despite the fact that the only information that is provided in the Uniform State Health Information System citizens are “making an appointment for patients or calling a doctor at home” in the “Federal Electronic Registry” subsystem.
“Porridge” about statistical reporting in the Uniform State Health Information System subsystem
The question of the operation of the Uniform State Health Information System subsystem remains unclear.“A subsystem for automated collection of information on health care system indicators from various sources and reporting».
Thus, this subsystem includes information about the indicators of the healthcare system, including medical and demographic indicators of the health of the population. Suppliers of this information include medical organizations of all healthcare systems.
From the concept of the specified Uniform State Health Information System subsystem (clause 21 of the Uniform State Health Information System Regulations) it follows that it is a Uniform State Health Information System subsystem designed to optimize and simplify procedures collection of statistical and other reporting information on indicators in the field of healthcare from organizations subordinate to the Ministry of Health of Russia, federal executive authorities in accordance with their powers, healthcare authorities of the constituent entities of the Russian Federation, medical organizations of state, municipal and private healthcare systems, as well as to reduce the time spent on preparing consolidated reporting on data, collected and processed in the Uniform State Health Information System subsystems.
It is known that in the Russian Federation there are 3 types of statistical observations: federal, sectoral and regional.
However, if everything is clear with the collection of primary data (federal surveillance) in the form of an electronic document ( similar provisions are provided for by the RF PP dated August 18, 2008 No. 620, Rosstat Order No. 370 dated October 27, 2010), then as for sectoral statistical observation, here we should talk about a deep legal hole, since the Russian Ministry of Health has not yet developed a regulatory document on the procedure for conducting sectoral statistical observation in the field of healthcare, not to mention the fact that the collection of such data can be carried out in electronic format. As for regional monitoring, here, too, the regulations of the constituent entities of the Russian Federation do not clearly stipulate provisions on the provision of reporting in electronic form. For example, in accordance with the Regulations on the automated information system of Moscow “EMIAS”, approved by the Moscow City Government dated January 20, 2015 No. 16-PP, the functions of EMIAS include only formation and maintenance of medical reports of medical organizations state healthcare system of the city of Moscow, medical organizations not included in the state healthcare system of the city of Moscow and carrying out medical activities on the territory of the city of Moscow (clause 1.6.7 of the Regulations).
On access to information contained in the Uniform State Health Information System
As for access to Uniform State Health Information System information, according to clause 46 of the Regulations on Uniform State Health Information System, registered users receive such access. At the same time, registration of Uniform State Health Information System users is established in accordance with the requirements of the Russian Ministry of Health ( V currently not yet accepted).
Despite this, one of the conditions for access to Uniform State Health Information System information in accordance with RF PP No. 555 is identification and authentication using an identification and authentication system.
In addition, the regulator determined the composition of the information that is provided to users of the Uniform State Health Information System and the persons to whom it is provided depending on the subsystem of the Uniform State Health Information System (Appendix No. 2 to RF PP No. 555).
One of the users of the Uniform State Health Information System, as noted in RF PP No. 555, is citizens. In accordance with Appendix No. 2, they have the right to access the following information:
- Making an appointment for patients or calling a doctor at home (in the “Federal Electronic Registry” subsystem);
- Information about medical documentation and information about the medical organization in which the medical documentation is created and stored (“Federal Register of Electronic Medical Documents”).
However, as we see from Appendix No. 2 to RF PP No. 555, remote familiarization of the patient with medical documentation in electronic form is not provided. Thus, it is not clear how the patient’s right to familiarize himself with medical documentation in the form of electronic documents, provided for in Part 5 of Art. 22 Federal Law No. 323.
And finally
In addition to the above, RF PP No. 555 established requirements for the software and hardware of the Uniform State Health Information System, the procedure for exchanging information using the Uniform State Health Information System, as well as some provisions on the protection of information contained in the Uniform State Health Information System. Despite the adoption of such an advanced regulatory act on the main information system in healthcare, many questions continue to remain open. For example, from the Regulations on the Uniform State Health Information System it is not clear how the Uniform State Health Information System will work with those medical organizations that are located in populated areas where is the internet speed 1mb? What financial resources will be used to ensure access to the Unified State Health Information System for medical organizations and patients located and living in small populated areas? Etc.
1. In order to ensure citizens’ access to healthcare services in electronic form, as well as the interaction of information systems in the healthcare sector, the authorized federal executive body creates, develops and operates a unified state information system in the healthcare sector (hereinafter referred to as the unified system).
2. Position about the unified system, including the procedure for accessing information contained in it, the procedure and deadlines for submitting information to unified system, the procedure for exchanging information using a unified system is approved by the Government Russian Federation.
3. The unified system includes:
1) information contained in federal information systems in the field of healthcare, federal databases and federal registers in the field of healthcare, maintained by the authorized federal executive body using a unified system;
2) information about medical organizations, with the exception of medical organizations subordinate to federal executive authorities, in which federal laws provide for military service or equivalent service;
3) specified in Article 93 of this Federal Law, information about persons who participate in medical activities;
4) specified in Article 94 of this Federal Law and impersonal in ok established by the authorized federal executive body in agreement with the federal executive body exercising functions of control and supervision in the field of the media, information about persons who are provided with medical care, as well as about persons in respect of whom medical examinations and medical examinations are carried out and medical examinations;
5) information about medical documentation, the composition of which makes it impossible to determine the state of health of a citizen, and information about the medical organization in which the medical documentation is created and stored;
6) information from statistical observation in the field of healthcare, as well as summary analytical information on the implementation of medical activities and the provision of medical care;
7) information on the organization of the provision of high-tech medical care;
8) information necessary for monitoring and control in the field of procurement of medicines to meet state and municipal needs;
9) information on the organization of providing citizens with medicines for medical use, medical products (medical products) and specialized medical nutrition products in accordance with Article 6.2 Federal Law of July 17, 1999 N 178-FZ “On State social assistance", points 19 And 20 part 1 article 14 , Article 44 And clause 5 of part 2 of article 81 this Federal Law;
10) classifiers, reference books and other regulatory and reference information in the field of healthcare, the list, procedure for maintaining and using which are determined by the authorized federal executive body.
4. The unified system ensures the maintenance of federal registers provided for part 2.1 of article 43 , parts 4 , 8 Article 44 of this Federal Law, Article 24.1 Law of the Russian Federation of May 15, 1991 N 1244-1 "On the social protection of citizens exposed to radiation as a result of the disaster at the Chernobyl nuclear power plant."
5. The unified system ensures the possibility of providing citizens with healthcare services in electronic form through a single portal of government and municipal services, scroll which are approved by the Government of the Russian Federation.
6. Suppliers of information to the unified system are:
1) authorized federal executive body;
2) federal executive authorities in the field of health protection and other federal executive authorities in accordance with the powers established by the legislation of the Russian Federation;
Medical information system– a set of methodological, software, technical, information, legal and organizational tools that support the processes of functioning of an informatized organization (HCI)
EIS in the field of healthcare and social development is an automated system aimed at providing information support for the implementation of the functions of the Ministry of Health and Social Development of the Russian Federation, federal services, agencies, etc.
The UIS provides the functions of collecting, storing, processing, transmitting and using information in the areas of healthcare, social development, labor and employment in the Russian Federation and is designed to solve the following problems:
information support for making management decisions in ensuring the effective activities of the Ministry of Health and Social Development of the Russian Federation, its subordinate agencies, etc.
increasing the efficiency of services to citizens and organizations.
ensuring information openness of the activities of the Ministry of Health and Social Development of the Russian Federation, etc.
increasing the efficiency of interdepartmental relationships.
36. The concept of telemedicine. Strategic objectives of using information technologies in medicine.
Telemedicine- a branch of medicine based on the use of computer and telecommunication technologies for the exchange of medical information between specialists in order to improve the quality of diagnosis and treatment of specific patients.
"Telemedicine is a comprehensive concept for health systems, services and activities that can be communicated remotely through information and telecommunications technologies for the purpose of promoting global health, disease control, and medical education, management and research."
Telemedicine objectives:
Preventive services for the population.
Reducing the cost of medical services.
Serving remote entities, eliminating isolation.
Increasing the level of service.
With the current level of development of information technology, it becomes possible to exchange electronic versions of medical documentation, photographs, videos, communicate via the Internet, and arrange video conferences.
37. Modeling as a method of cognition. Definition of the model, its properties and characteristics. Classification of models.
Modeling is a method of understanding the world around us, consisting in the creation and study of models. Different sciences study objects and processes from different angles and build Various types models. In physics, the processes of interaction and change of objects are studied, in chemistry - their chemical composition, in biology - the structure and behavior of living organisms, etc.
M. as a cognitive technique is inseparable from the development of knowledge. Essentially, mathematics as a form of reflection of reality originated in ancient times simultaneously with the emergence of scientific knowledge. However, in a distinct form (albeit without using the term itself) M. begins to be widely used during the Renaissance.
Model- some new object, which reflects the essential features of the object, phenomenon or process being studied. The same object can have many models, and different objects can be described by one model.
Model properties:
Finitude: the model reflects the original only in a finite number of its relations and, in addition, modeling resources are finite;
Simplification: the model displays only the essential aspects of the object;
Approximate: reality is represented roughly or approximately by the model;
Adequacy: how successfully the model describes the system being modeled;
Informativeness: the model must contain sufficient information about the system - within the framework of the hypotheses adopted when constructing the model;
Potentiality: predictability of the model and its properties;
Difficulty: ease of use;
Completeness: all necessary properties are taken into account;
Adaptability.
According to the form of representation of figurative-sign models, the following groups can be distinguished among them:
Geometric models that display the appearance of the original (drawing, pictogram, drawing, plan, map, three-dimensional image);
Structural models reflecting the structure of objects and the relationships of their parameters (table, graph, diagram, diagram);
Verbal models recorded (described) by means of natural language;
Algorithmic models describing the sequence of actions.
Iconic models can be divided into the following groups:
Mathematical models, represented by mathematical formulas that display the relationship between various parameters of an object, system or process;
Special models presented in special languages (notes, chemical formulas, etc.);
Algorithmic models that represent a process in the form of a program written in a special language.
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