ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of May 5, 2018 No. 555

About single state information system in health sector

According to part 2 of article 91.1 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on single state information system in health sector.

2. Determine that the actions provided by the Provision approved by this resolution are performed by federal executive bodies within the established powers and within the budgetary appropriations provided by the Federal Laws on the federal budget for the corresponding financial year and planning period on management and management in the sphere of the established functions.

3. To the Ministry of Health of the Russian Federation to approve the acts provided by the Provision approved by this resolution in 4-month time.

4. Norma Polozheniya, approved by this resolution, in the part concerning submission of information in single state information system in health sector are not applied to the medical organizations of private health care system till January 1, 2019 if such medical organizations did not make the decision on submission of information in the specified system earlier.

Approved by the Order of the Government of the Russian Federation of May 5, 2018 No. 555

Regulations on single state information system in health sector

I. General provisions

1. This Provision determines:

a) tasks of single state information system in health sector (further - single system);

b) structure and procedure for maintaining single system;

c) procedure and terms of submission of information in single system;

d) participants of information exchange;

e) procedure for information access, containing in single system;

e) requirements to program technical means of single system;

g) procedure for exchange of information with use of single system;

h) procedure for the information security containing in single system.

II. Tasks and functions of single system

2. Tasks of single system are:

a) information support of state regulation in health sector;

b) information support of activities of the medical organizations, including support of implementation of medical activities;

c) information exchange of suppliers of information in single system and users of information containing in single system;

d) informing the population concerning maintaining healthy lifestyle, prevention of diseases, receipts of medical care, transfer of data on the issued recipes on medicines from medical information systems of the medical organizations in information systems of the pharmaceutical organizations;

e) ensuring access of citizens to services in health sector electronically, and also interactions of the information systems specified in parts 1 and 5 of article 91 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" (further - the Federal Law), information systems of state non-budgetary funds.

3. Accomplishment of the tasks specified in Item 2 this provision is performed by means of the following functions of single system:

a) support of acceptance of management decisions and resource management of health care system;

b) creation of conditions for implementation of measures for development of health care system, support of implementation of measures for prevention of diseases, to sanitary and epidemiologic wellbeing of the population, delivery of health care and organization of medical activities;

c) support of the organization of providing citizens with medicines according to Items 19 and 20 of part 1 of Article 14 and part 7 of article 44 of the Federal Law;

d) maintaining the federal registers provided by part 2.1 Articles 43, parts 4 and 8 of article 44 of the Federal Law, article 24.1 of the Law of the Russian Federation "About social protection of the citizens who were affected by radiation owing to catastrophic crash on the Chernobyl NPP";

e) centralization of maintaining the subsystems of single system specified in subitems "an" - "and" item 4 of this provision, and also federal information systems in health sector, federal databases and federal registers in health sector which maintaining is performed by the Ministry of Health of the Russian Federation with use of single system based on the Federal Laws and acts of the Government of the Russian Federation;

e) processing and storage specified in article 94 of the Federal Law and depersonalized according to the procedure, established by the Ministry of Health of the Russian Federation in coordination with Federal Service for Supervision in the Sphere of Telecom, Information Technologies and Mass Communications of information about persons to whom medical care, and also about persons concerning whom medical expertizes, medical examinations and medical surveys according to item 4 of part 3 of article 91.1 of the Federal Law are performed is provided;

g) processing and storage of the information about persons specified in article 93 of the Federal Law who participate in implementation of medical activities, including maintaining the federal register of health workers according to the procedure, established by the Ministry of Health of the Russian Federation according to part 3 of article 92 of the Federal Law;

h) maintaining based on data of the summary register of licenses for implementation of medical activities of the register of the medical organizations according to the requirements established by the Ministry of Health of the Russian Federation including their equipment by the medical equipment, except for the medical organizations subordinated to federal executive bodies in which the Federal Laws provide military service or the service equated to it;

i) maintaining normative reference information in health sector according to the procedure and according to the list which are determined by the Ministry of Health of the Russian Federation according to Item 10 of part 3 of article 91.1 of the Federal Law;

j) provision to citizens of services in health sector electronically by means of use of the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the single portal of the state services) according to the list approved by the order of the Government of the Russian Federation of November 15, 2017 No. 2521-r, other information systems intended for collection, storage, processing and provision of information concerning activities of the medical organizations and the services provided by them;

k) ensuring delivery of health care in the medical organizations, including issue of the directions on conducting diagnostic testings and physical examination (consultation);

l) carrying out consultations and consultations using telemedicine technologies, and also carrying out remote medical observation of the state of health of the patient according to article 36.2 of the Federal Law;

m) implementation of monitoring and control of purchases of medicines for ensuring the state and municipal needs, including by interaction with unified information system in the sphere of purchases, according to the requirements established by the Ministry of Health of the Russian Federation in coordination with the Ministry of Finance of the Russian Federation, the Federal Tax Service and the Federal Service on supervision in health sector;

o) the organization of statistical observation in health sector and forming of summary analytical information on questions of implementation of medical activities and delivery of health care;

o) submission of the data containing in single system according to article 91.1 of the Federal Law and this Provision;

p) the organization of information exchange of the participants specified in the Section V of this provision.

III. Structure and procedure for maintaining single system

4. The single system includes the following subsystems:

a) federal register of health workers;

b) federal register of the medical organizations;

c) federal electronic registry;

d) the federal integrated electronic medical record;

e) federal register of electronic medical documents;

e) subsystem of maintaining specialized registers of patients on separate nozologiya and categories of citizens, monitoring of the organization of rendering high-technology medical care and sanatorium treatment;

g) information and analytical subsystem of monitoring and control in the sphere of purchases of medicines for ensuring the state and municipal needs;

h) subsystem of the automated information collection about health care system indicators from various sources and submission of the reporting;

i) the federal register of normative reference information in health sector;

j) subsystem of depersonalization of personal data;

k) geoinformation subsystem;

l) the protected data transmission network;

m) integration subsystems.

5. The structure of information placed in single system is given in appendix No. 1.

The structure of information provided to users of single system is given in appendix No. 2.

6. The federal register of health workers represents subsystem of single system and is intended for accounting of data on staffing of the medical organizations and employment of health workers in the medical organizations.

7. The federal register of health workers provides collection, accumulating, storage, processing and transfer of the information about persons specified in article 93 of the Federal Law who participate in implementation of medical activities.

8. The information about persons who participate in implementation of medical activities 11 - 14 articles 93 of the Federal Law specified in subitems 1,, is subject to placement on the Internet by means of the federal register of health workers.

9. The federal register of the medical organizations represents subsystem of single system and is intended for accounting of data on the medical organizations of the state, municipal and private health care systems, about their structural divisions with indication of profiles of their medical activities, the location, and also data on their equipment and use of medical products.

10. The federal register of the medical organizations provides collection, accumulating, storage, processing and transfer of data on the medical organizations in which medical care, including about buildings, structures, constructions, structural divisions of such medical organizations, about departments, about bed fund, about equipment, about the staff list, and also about the organizations performing educational sales activity of the main and additional professional educational programs of medical education and pharmaceutical education is provided.

Data on the medical organizations specified in Items 9 and 10 of this provision, except for to information on their financial and economic activities are subject to placement on the Internet by means of the federal register of the medical organizations.

11. The federal electronic registry represents the subsystem of single system intended for monitoring and management of flows of patients in real time by means of information exchange with the state information systems in health sector of subjects of the Russian Federation, medical information systems of the medical organizations of the state, municipal and private health care systems.

12. The federal electronic registry provides:

a) making an appointment with the doctor in the medical organization;

b) record on routine medical examinations;

c) maintaining schedules of acceptance of patients in the medical organization;

d) planning and carrying out consultations and consultations using telemedicine technologies;

e) order taking registration (record) for challenge of the doctor on the house in the medical organization;

e) submission of the reporting and other data necessary for resource management of the medical organizations;

g) access for citizens to services in health sector by means of the single portal of the state services.

13. The federal integrated electronic medical record represents the subsystem of single system intended for collection, systematization and processing of the structured depersonalized data specified in article 94 of the Federal Law about persons to whom medical care, and also about persons concerning whom medical expertizes, medical examinations and medical surveys, by means of information exchange with the state information systems in health sector of subjects of the Russian Federation, are performed by medical information systems of the medical organizations of the state, municipal and private health care systems is provided.

14. The federal integrated electronic medical record provides:

a) obtaining, check, processing and storage of the structured depersonalized data specified in article 94 of the Federal Law about persons to whom medical care, and also about persons concerning whom medical expertizes, medical examinations and medical surveys are performed is provided;

b) forming of the databases of the depersonalized information on separate nozologiya and profiles of delivery of health care allowing to systematize information for studying of current and outcome of diseases, clinical and cost efficiency of methods of prevention and also for diagnostics, treatment and rehabilitation in case of separate diseases, conditions according to the International Statistical Classification of the diseases and problems connected with health, and the nomenclature of medical services approved by the Ministry of Health of the Russian Federation according to Item 5 of part 2 of article 14 of the Federal Law.

15. The federal register of electronic medical documents represents the subsystem of single system containing data on medical documentation in the form of electronic documents by which structure it is impossible to determine the state of health of the citizen and data on the medical organization in which such medical documentation is created and is stored.

16. The federal register of electronic medical documents provides:

a) obtaining, check, registration and storage of data on medical documentation in the form of electronic documents which is created and stored by the medical organizations;

b) succession and improvement of quality of delivery of health care due to provision to health workers with the consent of the patient or his legal representative of access to medical documentation in the form of electronic documents regardless of the place and time of its rendering;

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