1. In order to ensure access of citizens to services in the field of healthcare in electronic form, as well as the interaction of information systems in the field of healthcare, 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. The regulation on the unified system, including the procedure for accessing the information contained in it, the procedure and terms for submitting information to the unified system, the procedure for exchanging information using the unified system, is approved by the Government Russian Federation.

3. A single system includes:

1) information contained in federal information systems in the field of health care, federal databases and federal registers in the field of health care, which are 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 bodies, in which federal laws provide for military service or service equivalent to it;

3) the information specified in Article 93 of this Federal Law on the persons who participate in the implementation of medical activities;

4) specified in Article 94 of this Federal Law and depersonalized in the manner established by the authorized federal executive body in agreement with the federal executive body exercising the functions of control and supervision in the field of mass media, information about persons who are provided with medical care, and also about persons in respect of whom medical examinations, medical examinations and medical examinations are carried out;

5) information about medical records, according to the composition of which it is impossible to determine the state of health of a citizen, and information about the medical organization in which the medical records are created and stored;

6) information of 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 about the organization of providing citizens with medicines for medical use, medical devices (medical products) and specialized medical food products in accordance with Article 6.2 of the Federal Law of July 17, 1999 N 178-FZ "On State social assistance", Clauses 19 and 20 of Part 1 of Article 14, Article 44 and Clause 5 of Part 2 of Article 81 of this Federal Law;

10) classifiers, reference books and other regulatory and reference information in the field of health care, the list, the procedure for maintaining and using which are determined by the authorized federal executive body.

4. The unified system ensures the maintenance of the federal registers provided for by Part 2.1 of Article 43, Parts 4, 8 of Article 44 of this Federal Law, Article 24.1 of the Law of the Russian Federation of May 15, 1991 N 1244-1 "On social protection citizens exposed to radiation as a result of the disaster at the Chernobyl nuclear power plant.

5. The unified system provides the possibility of providing citizens with services in the field of healthcare in electronic form through single portal state and municipal services, the list of which is approved by the Government of the Russian Federation.

6. Providers of information in a single system are:

1) an 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 functioning of an informatized organization (LPU)

UIS in the field of healthcare and social development is an automated system aimed at 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 the adoption of managerial decisions in ensuring the effective operation of the Ministry of Health and Social Development of the Russian Federation, its subordinate agencies, etc.

    improving the efficiency of servicing citizens and organizations.

    ensuring information transparency of the activities of the Ministry of Health and Social Development of the Russian Federation, etc.

    improving the efficiency of interdepartmental relations.

36. The concept of telemedicine. Strategic tasks of using information technologies in medicine.

Telemedicine- a direction 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 systems, services and activities in the field of health, which can be remotely transmitted by means of information and telecommunications technologies, for the development of world health, disease control, and education, management and research in the field of medicine.

Tasks of telemedicine:

    Preventive maintenance of the population.

    Reducing the cost of medical services.

    Maintenance of remote subjects, removal of isolation.

    Increasing the level of service.

With the current level of development of information technology, it becomes possible to exchange electronic versions of medical records, pictures, video images, communicate using the Internet, and arrange video conferences.

37. Modeling as a method of knowledge. Definition of the model, its properties and characteristics. Classification of models.

Modeling is a method of understanding the surrounding world, consisting in the creation and study of models. Different sciences explore objects and processes from different angles of view and build different 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.

Mathematics as a cognitive device is inseparable from the development of knowledge. In essence, mathematics, as a form of reflection of reality, was born in antiquity simultaneously with the emergence of scientific knowledge. However, in a distinct form (although without using the term itself), M. begins to be widely used in the Renaissance

Model- a new object that reflects the essential features of the object, phenomenon or process under study. One and the same object can have many models, and different objects can be described by one model.

Model properties:

Finiteness: the model reflects the original only in a finite number of its relations and, in addition, the modeling resources are finite;

Simplicity: the model displays only the essential aspects of the object;

Approximation: reality is represented roughly or approximately by the model;

Adequacy: how well the model describes the modeled system;

Informativity: the model must contain sufficient information about the system - within the framework of the hypotheses adopted in the construction of the model;

Potentiality: predictability of the model and its properties;

Complexity: ease of use;

Completeness: all necessary properties are taken into account;

Adaptability.

According to the form of presentation of figurative-sign models, the following groups can be distinguished among them:

Geometric models that reflect the appearance of the original (picture, pictogram, drawing, plan, map, three-dimensional image);

Structural models that reflect the structure of objects and the relationship of their parameters (table, graph, diagram, diagram);

Verbal models fixed (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 of various parameters of an object, system or process;

Special models presented in special languages ​​(sheet music, chemical formulas etc.);

Algorithmic models representing the process in the form of a program written in a special language.

"

Dmitry Medvedev signed Decree of the Government of the Russian Federation No. 555 of 05/05/2018 "On a unified state information system in the field of healthcare". The document is available at http://publication.pravo.gov.ru/Document/View/0001201805070034

Earlier, at the end of March, the Ministry of Health published a draft of this document on the portal for the operational interaction of participants in the Uniform State Health Information System at http://portal.egisz.rosminzdrav.ru/materials/547.

Review

The document establishes the legal basis for the functioning Unified State Information System in the field of healthcare (hereinafter referred to as the Unified State Health Information System), including the tasks of the system, the main functions, the procedure for accessing information, the procedure and timing for the submission and exchange of information, operators and participants in the system, etc.

It has been established that the Uniform State Health Information System will provide a solution to a set of tasks in the following areas:

  • improving management efficiency in the field of healthcare based on information technology support for solving forecasting problems
  • improving the quality of medical care on the basis of improving information support for the activities of medical organizations
  • raising public awareness on the issues of maintaining a healthy lifestyle, disease prevention, receiving medical care, quality of service in medical organizations.

The document provides that the Unified State Health Information System includes the following components and subsystems:

  • federal register of medical professionals (FRMR)
  • federal register of medical organizations (FRMO)
  • federal electronic registry (FER)
  • federal integrated electronic medical record (FIEMK)
  • federal register of electronic medical documents (FREMD)
  • specialized patient registries for individual nosologies and categories of citizens
  • 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 regulatory background information(FNSI)
  • subsystem of depersonalization of personal data
  • geoinformation subsystem
  • secure data network
  • integration subsystems.

Annexes 1 and 2 describe in sufficient detail the composition of the registered and provided data that must be processed by the Uniform State Health Information System.

Comments and thoughts on the document

According to it, our main federal law " On the basics of protecting the health of citizens in the Russian Federation» No. 323-FZ included « Article 91 Information Support in healthcare", paragraph 1 of which reads:" Information support in the healthcare sector is carried out through the creation, development and operation of:

  • federal state information systems in the field of healthcare,
  • health information systems MHIF and TFOMS,
  • state information systems in the field of healthcare of the constituent entities of the Russian Federation,
  • medical information systems of medical organizations (MIS MO),
  • information systems of pharmaceutical organizations (IS FO)

All these names are united by one common name "Information systems in the field of healthcare".

At the same time, 242-FZ provides for a separate “ Article 91-1. Unified state information system in the field of healthcare", clause 1 of which states that " the authorized federal executive body [Ministry of Health of the Russian Federation] creates, develops and operates a unified state information system in the field of healthcare"(EGISZ or in terms of 242-FZ -" Unified System "). Paragraph 2 of this article says that the "Regulations on a unified system" is approved by the Government of the Russian Federation. Actually, in pursuance of this paragraph 242-FZ, a draft resolution published by the Ministry of Health was developed.


EGISZ is now only federal services

The first and, perhaps, the most important thing that needs to be paid attention to is the legislative clarification of the definition - what is the Uniform State Health Information System.

Recall that according to section 6 "General architecture of the system" of the order of the Ministry of Health and Social Development of Russia dated April 28, 2011 No. 364 " About the approval of the Concept of creation of Uniform State Health Information System” (as amended by the Order of the Ministry of Health and Social Development of Russia No. 348 dated April 12, 2012, the text of the document: https://portal.egisz.rosminzdrav.ru/materials/99), the system consisted of centralized and applied components of health authorities and organizations, divided into federal and regional levels, including MIS MO.

Now, with the entry into force of 242-FZ and the approved regulation on the Uniform State Health Information System, the architectural outline has changed significantly. Now Uniform State Health Information System is exactly the federal state information system in the field of healthcare, the operator of which is the authorized federal executive body - the Ministry of Health of the Russian Federation. USHIS is a central component of health information systems.

It turns out that now, after the approval of the regulation on the Uniform State Health Information System, the order of the Ministry of Health and Social Development 364 will need to be canceled, because. it already now, in fact, comes into conflict with the current federal law.

This change has a very understandable explanation. If the Unified State Health Information System were further considered as a system that includes regional segments and MIS MO, then the Ministry of Health, from a legislative point of view, would have to provide full support for all its components, including financing of regional and institutional systems, communication channels, security measures and support and development services. There is simply no such money in the Ministry of Health. In reality, the development of reg.segments is carried out with regional funds and, in fact, is not directly regulated by the federal Ministry of Health. Therefore, in order to bring the de facto and de jure situations under a common denominator, the Uniform State Health Information System will now be considered precisely as a federal system. But at the same time, it will provide a common orchestration of all other information systems in healthcare through one common NSI and common protocols and principles of information exchange.

The document provides for fairly strict requirements for the timing of the provision of information. For example, information about the doctor's appointment schedule, calling the doctor to the house, the fact of the patient's appointment by the doctor or information about the medical document signed by the doctor must be posted in the Uniform State Health Information System within 1 working day from the date of receipt of the updated data, information about medical workers - within 3 working days , about medical organizations - within 5 working days. In fact, we need to talk about the fact that RMIS and MIS MO connected to the Uniform State Health Information System are required to transmit information online so as not to fall into violation of the regulated deadlines. As we will show below, starting from January 1, 2019, this requirement will also apply to commercial (private) medical organizations.

Appendix No. 2 describes in great detail and in detail - what kind of information from the federal services of the Unified State Health Information System to whom can be provided, including links to the legal grounds for such provision. Now in one place it is legally fixed - who can get what for processing.

As an independent service, “Administrative and economic activity” (AHD) was excluded from the composition of the federal subsystems. Now the information that previously constituted the content of the AHD, according to clause 2.12 of Appendix 1, is included in the federal register of medical organizations.

Paragraph 3, subparagraph j) of section II provides for the following function of the Unified State Health Information System " Providing citizens with healthcare services in electronic form through the use of EPGU ... other information systems designed to collect, store, process and provide information regarding the activities of medical organizations and the services they provide". In other words, the main way to provide information to citizens is, of course, EPGU, but if there are other systems (including the GIS of the constituent entities of the Russian Federation) that collect data on the work of the Ministry of Defense or the services they provide, then they too. Thus, we received explicit legislative permission for the operation of regional health portals and services for making an appointment with a doctor via the Internet, about the fate of which we were somewhat worried last year.

An important change affected the federal IEMK. Clause 13 of Section III describes the federal IEMC as " ... a subsystem designed to collect, organize and process structured anonymized information ...». Keyword here - depersonalized. As you know, now quite personal data is transmitted and stored in IEMK, including the full name and date of birth of patients, information about the policy, etc. Now the Ministry of Health is bringing this into line with the provisions of FZ-323. In order to avoid the need to redo the already implemented and operating integrations of RMIS and MIS MO with FIEMK, a special “personal data depersonalization subsystem” is introduced into the Uniform State Health Information System, which will just depersonalize personal data received from MIS MO.

Clause 15 of Section III introduces a new federal service into the Uniform State Health Information System - the Register of Electronic Medical Documents (REMD). Information about REMD appeared on January 30, 2018 on the USISZ portal at http://portal.egisz.rosminzdrav.ru/materials/617. This service implies that medical documents signed by UKEP doctors should be accumulated in the region. Currently, PDF / A is chosen as the format for providing documents, information about which (but not the documents themselves!) Should then be transferred from RMIS (namely from RMIS, and not MIS MO - pay attention) to the Uniform State Health Information System. Considering that these documents will be stored with personal information- then, apparently, it is the REMD that will become in the near future a source for obtaining copies of medical documents in personal account patient "My Health" at EPGU.

Clause 18 of Section III contains a list of 7 specialized patient registries for certain nosologies and categories of citizens (7VZN, patients with orphan diseases, etc.). This part has one important nuance which I would like to comment on. The fact is that now in our country there are more than 7 nosological registers and databases indicated in the document. For example, our publication presents a list of 60 such systems. And even though this list contains some services that are placed in separate subsystems of the Unified State Health Information System, and some may no longer be in operation, there are still some registers that are essentially federal specialized or nosological services, but were not provided for in the Unified State Health Information System. For example, the well-known "Cancer Register" (quite alive and according to which some kind of development is also planned). There are other systems: "Federal register of an inpatient with acute cerebrovascular accident", "Federal register of patients with acute coronary syndrome", "State register of patients with diabetes mellitus", etc. So, the nuance here is that, according to the legislative tradition adopted in Russia, the Ministry of Health can maintain in the status of a state information system (and therefore store personal data in them) only those products that are clearly indicated in one of the federal laws. Therefore, it turns out that those nosological registers that have not yet been fixed in the current Federal Laws have not been included in the Uniform State Health Information System. However, such systems may store personal data and be processed at a regional level. Further, they can be consolidated into existing federal systems, but the information in them must be depersonalized.

Clause 36 of Section IV unequivocally defines a quite logical and expected requirement that the assurance of the reliability of the information provided in the Uniform State Health Information System will be confirmed through the use of enhanced qualified electronic signatures (ECES). It seems that such an approach - along with the requirement to use the UKEP in terms of integration with REMD, as well as other similar legislative solutions - for example, the requirement to use the UKEP in terms of maintaining electronic sick leave certificates, nevertheless shifted the transition of healthcare to a truly legally significant electronic document flow. And we will finally begin to get out of the “mixed workflow” scheme that has tortured everyone - when doctors are forced to keep their medical records in the MIS and at the same time duplicate it with printouts and manual signing. The trouble here lies for commercial MOs (which will have to purchase these very UKEPs and then spend annually on their renewal), as well as for those subjects of the Russian Federation that, for some reason, have not yet created their regional certification centers, although this was recommended in the “Concept of Regional Informatization”, approved by the order of the Chairman of the Government of the Russian Federation D.A. Medvedev No. 2769-r dated December 29, 2014, http://government.ru/media/files/Ea8O35fPr3I.pdf.

Paragraph 40 of Section V regulates the composition of participants (information providers) of the Unified State Health Information System, including medical and pharmaceutical organizations of the state, municipal and private healthcare systems (with the exception of the Ministry of Defense, subordinate to federal executive authorities, in which federal laws provide for military service or service equivalent to it). At the same time, a derogation was made for private medical (but not pharmaceutical!) organizations that if they have not yet decided to provide information to the Uniform State Health Information System, then the norms of this document will not apply to them until January 1, 2019. Thus, commercial MOs have only a few months left to provide and test their MIS MO in terms of integration with the Uniform State Health Information System. From January 1, 2019, they should become full-fledged providers of information to the system and provide all the same integration and technological requirements that are now provided in state and municipal healthcare.

On May 07, 2018, the Decree of the Government of the Russian Federation of May 5, 2018 No. 555 "On the unified state information system in the field of healthcare" (hereinafter referred to as the RF Government No. 555, Regulations on the Uniform State Health Information System) was published on the legal information portal (entered into force on May 15, 2018) .

The Regulation on the Unified State Health Information System is aimed at more detailed regulation of the functioning of the unified state information system in the field of healthcare (hereinafter referred to as the Unified State Health Information System), including issues of the structure of the Unified State Health Information System, the procedure for accessing the information contained in it, the procedure and terms for providing information to the Unified State Health Information System, the procedure for exchanging information using the Unified State Health Information System , software requirements technical means Unified State Health Information System and the procedure for protecting information in the Unified State Health Information System. At the same time, the basic rules 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 the Application of information technologies in the field of health protection.

We recall once again that according to Art. 91.1 of the Federal Law of November 21, 2011 No. 323-FZ "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation" (hereinafter - 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 healthcare sector with the Ministry of Health of Russia a unified state information system in the field of healthcare is being created, developed and operated.

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 Unified State Health Information System are tied to an additional regulatory framework that has not yet been adopted. Moreover, the PP RF No. 555 itself leaves much to be desired in terms of certain standards.

PS: Please note that in accordance with paragraph 4 of the RF PP No. 555, the Regulations on the Uniform State Health Health Information System in terms of submitting information to the Uniform State Health 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 decided to submit information to the specified system.

Thus, it turns out that from January 1, 2019, medical organizations of the private health care system are required to join the Unified State Health Health Information System without fail.

Tasks and functions of the Uniform State Health Information System

Before proceeding to a brief analysis of RF PP No. 555, we note that the entire range of tasks (5) and functions (16) of the Unified State Health Information System is reflected in paragraphs 2-3 of the Regulations on the Unified State Health Information System. In our opinion, the most interesting of them are the following:

  • processing and storage, depersonalization of information about persons who are provided with 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 the implementation of medical activities, including the maintenance of the federal register;
  • maintaining a register of medical organizations ( the requirements for maintaining the register must be approved by the Ministry of Health of Russia);
  • maintenance of regulatory and reference information in the field of healthcare ( the list, the procedure for maintaining and using this information must also be approved by the Ministry of Health of Russia);
  • ensuring the provision of medical care in medical organizations, including the issuance of referrals for diagnostic tests and medical examinations (consultations);
  • organization of statistical observation in the field of healthcare and the formation of consolidated analytical information on the implementation of medical activities and the provision of medical care;
  • other functions.

What is included in the structure of the EGISZ

The structure of the Unified State Health Information System, as previously assumed, 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 certain 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 - analytical subsystem of monitoring and control in the field of procurement of medicines to meet state and municipal needs;
  • a subsystem for automated collection of information on health system indicators from various sources and reporting;
  • federal register of normative - reference information in the field of healthcare;
  • subsystem of depersonalization of personal data;
  • geoinformation subsystem;
  • secure network for the transfer of personal data;
  • integration systems.

Please note that specialized patient registries are presented in the form of a federal register of people infected with HIV, a federal register of people with tuberculosis, a federal register of people suffering from orphan diseases, a federal register of people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after organ and (or) tissue transplantation, National Radiation Epidemiological Register.

We emphasize that many subsystems of the Unified 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, because, 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 Regulation on the Uniform State Health Information System).

Currently, there are several subsystems of the Unified 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 in the implementation of medical activities of persons involved in the provision of medical services through the maintenance of the federal register of medical workers. Thus, this wording can be interpreted in such a way that personalized accounting is part of the Uniform State Health Information System);
  • RF GD No. 426 dated 08.04.2017 (regulates the rules for the management of RF of persons infected with HIV and persons with tuberculosis);
  • RF GD dated April 26, 2012 No. 403 (regulates the procedure for managing the RF of persons suffering from orphan diseases);
  • RF GD dated April 26, 2012 No. 404 (regulates the rules for managing the RF of persons with hemophilia, cystic fibrosis ... ..);
  • RF GD dated July 23, 2013 No. 625 (regulates the rules for maintaining the National Radiation 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 medical organizations 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 Uniform State Health Information System (PP RF No. 555). In addition, many of them do not directly establish requirements for the functioning of the Unified State Health Information System subsystems (for example, order No. 1159n).

Participants of information interaction

In accordance with the Regulations on the Uniform State Health Information 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 by clause 40 of the Regulations on the Uniform State Health Information Health Information System, including medical organizations of the state, municipal and private health care systems), as well as users of information (the list is established by clause 42 of the Regulations on the Uniform State Health Information System).

Recall that the conditions for the 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 means of such organizations, are established by the Government of the Russian Federation of April 12, 2018 No. 447.

On the procedure and terms 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 Uniform State Health Information System is carried out using the following information systems: IS in the field of CHI, automated IS of the Federal Tax Service of Russia, FSIS "Federal Register of Disabled Persons", FSIS "Unified Integrated Information System "Sotsstrakh" of the FSS of the Russian Federation", medical IS of medical organizations of state, municipal and private healthcare systems and others. A complete exhaustive list of such information systems is presented in paragraph 51 of the Regulations on the Uniform State Health Information System.

The term for providing information to the Unified State Health Information System, depending on its content, varies from 1 to 5 business days.

However, it is worth noting that RF GD No. 555 does not contain provisions on the consequences of violating the established deadlines, including for failure to provide information, as well as providing information outside the established deadline.

On conflicts in the rules on the composition of information posted in the Uniform State Health Information System

It is impossible to ignore the information that suppliers are required to provide to the Uniform State Health Information System.

Thus, in the federal register of medical workers (based on Order No. 1159n, it is tied to personalized records in relation to persons providing MP) in accordance with Appendix No. organization, structural subdivision of the Ministry of Defense, position, type of position, rate, date of commencement of employment, date of termination of employment, reason for termination). However, this provision is contrary to Art. 93 of the Federal Law No. 323, which does not provide information on the type of position held by a medical worker, rate, start and end dates of employment, termination grounds (the established list is exhaustive). Moreover, Order No. 1159n does not contain such information.

The situation is similar with information about persons who receive medical care in the subsystem "Federal Integrated Electronic Medical Record". So, under Art. 94 of the Federal Law No. 323, the Regulations on the Uniform State Health Information System establish additional information on the prescription and use of medicines, indicating the means of identifying medicines (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 "Federal Electronic Registry" is the protocol of telemedicine consultation. 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. the consultant draws up a medical report (minutes of the consultation of doctors). And it is these documents that are compiled 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 high-tech medical care... such a document as "referral for hospitalization for the provision of high-tech medical care" is presented. Meanwhile, according to the Procedure for organizing the provision of high-tech medical care using a specialized information system, approved by the Order of the Ministry of Health of Russia dated December 29, 2014 No. 930n, such a document is issued 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). The requirements for the electronic form of referral for HCW hospitalization are not established by other acts regulating legal relations for the provision of HCW. 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 HTMC?

It seems doubtful the requirement of RF PP No. 555 to confirm the accuracy of the information provided to the Uniform State Health Information System in electronic form, citizens through the use of enhanced qualified electronic signature or a simple electronic signature through the use of a unified system of identification and authentication(clause "b" clause 35 of the Regulations on the Uniform State Health Information System). The Faculty of Medical Law has repeatedly written in its notes and articles that with the establishment of such requirements, a significant layer of patients who are not registered in the unified system of identification and authentication is cut off from participation in the Unified State Health Information System, despite the fact that the only information provided in the Unified State Health Information System citizens is "an appointment for a patient appointment or a call to a doctor at home" in the "Federal Electronic Registry" subsystem.

"Porridge" on 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."Subsystem for automated collection of information on health system indicators from various sources and reporting».

Thus, this subsystem includes information about the indicators of the health care system, including medical and demographic indicators of the health of the population. The providers of this information are, among other things, medical organizations of all health care systems.

From the concept of the specified subsystem of the Uniform State Health Information System (clause 21 of the Regulations on the Uniform State Health Information System), it follows that it is a subsystem of the Uniform State Health Information System, 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 authority, healthcare authorities of the constituent entities of the Russian Federation, medical organizations of the 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 Government of the Russian Federation of August 18, 2008 No. 620, the Order of Rosstat of October 27, 2010 No. 370), then with regard to sectoral statistical monitoring, here we should talk about a deep legal hole, since the Ministry of Health of Russia has not yet developed a regulatory document on the procedure for conducting sectoral statistical monitoring in the healthcare sector, not to mention the fact that the collection of such data can carried out in electronic format. As for regional monitoring, here, too, the norms of the subjects of the Russian Federation do not clearly spell out the provisions on the provision of reports in electronic form. For example, in accordance with the Regulations on the automated information system of Moscow "EMIAS", approved by the Moscow GD dated January 20, 2015 No. 16-PP, only formation and maintenance of medical reporting of medical organizations the state healthcare system of the city of Moscow, medical organizations that are not part of the state healthcare system of the city of Moscow and performing 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 information from the Unified State Health Information System, according to clause 46 of the Regulations on the Unified State Health Information System, such access is received by registered users. At the same time, the registration of users of the Uniform State Health Information System is established in accordance with the requirements of the Ministry of Health of Russia ( in this moment not accepted yet).

Despite this, one of the conditions for accessing information from the Unified State Health Information System in accordance with the RF PP No. 555 is the passage of identification and authentication using the identification and authentication system.

In addition, the regulator has 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 the RF PP No. 555).

One of the users of the Uniform State Health Information System, as noted in the RF PP No. 555, are citizens. In accordance with Annex No. 2, they have the right to access the following information:

  • Making an appointment with patients or calling a doctor at home (in the subsystem "Federal Electronic Registry");
  • Information about medical records and information about the medical organization in which the medical records are created and stored ("Federal Register of Electronic Medical Documents").

However, as we see from Appendix No. 2 to the RF PP No. 555, remote acquaintance 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 electronic documents, provided h. 5 Article. 22 FZ No. 323.

And finally

In addition to the above, RF PP No. 555 established requirements for software and hardware tools 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 regulation on the main health information system, many questions remain open. So, for example, from the Regulations on the Unified State Health Information System, it is not clear how the Unified State Health Information Health Information System will work with those medical organizations that are located in settlements where the Internet speed is 1 Mb? At the expense of what financial resources will access to the Uniform State Health Information System be provided to medical organizations and patients located and living in small settlements? Etc.