ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of July 20, 2015 No. 600

About approval of standards of informatization in the field of health care

According to the subitem 6) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:

1. Approve:

1) the Standard of regulation of maintaining recipes in electronic format according to appendix 1 to this order;

2) the Standard of management of electronic processes of diagnostic testings and medical procedures according to appendix 2 to this order;

3) the Standard of regulation of electronic prevention of diseases according to appendix 3 to this order.

2. To provide to development department of informatization of the Ministry of health and social development of the Republic of Kazakhstan in the procedure established by the legislation:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) official publication of this order in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let within ten calendar days after its state registration in the Ministry of Justice of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan.

3. To impose control of execution of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

4. This order becomes effective after day of its first official publication.

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of July 20, 2015 No. 600

The standard of regulation of maintaining recipes in electronic format

1. General provisions

1. The standard of regulation of maintaining recipes in electronic format (further – the Standard) is developed according to the subitem 6 of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determines requirements and conditions for realization and regulation of procedure for maintaining recipes in electronic format taking into account requirements of the international standard DIN EN 13940 "System of the concepts providing continuity of delivery of health care".

2. Tasks of this Standard are:

1) determination of operating procedure of service of electronic recipes (further – the SIR), their regulation, determination of the minimum amount of information for implementation of stages SIRS, the statement of the recipe, realization of medicine and products of medical appointment according to the recipe, the notification on issue of medicines and products of medical appointment;

2) safety the SIR concerning identification of the parties providing support of delivery of health care, establishment of their authenticity and the consent of the patient.

3. In this Standard terms and concepts are used:

1) the recipe of repeated action – the recipe according to which numerous leave of medicine is performed;

2) medicines – the means representing or containing pharmacological the active agents intended for prevention, diagnostics and treatment of diseases, and also change of condition and functions of organism, medicinal substance, medicinal raw materials of natural origin medicinal angro-and balk-products, medicines, medical immunobiological supplies, parapharmaceutics;

3) subjects in the field of drug circulation, products of medical appointment and medical equipment (further – subjects) – the physical persons or legal entities performing pharmaceutical activities;

4) the State register of medicines, products of medical appointment and medical equipment - the document of accounting of the medicines registered and allowed for medical application in the Republic of Kazakhstan, products of medical appointment and medical equipment;

5) the international unlicensed name of medicine - the name of medicine recommended by the World Health Organization;

6) medicine – medicine in certain dosage form;

7) the national identifier of medicines – identification code of certain medicine in the national registry of medicines, available to the statement or use in the Republic of Kazakhstan;

8) the valid recipe – the recipe which is written out by the health worker having the right and powers to the statement of the recipe;

9) the national identifier of products of medical appointment – identification code of certain product of medical appointment in the national registry of products of the medical appointment available to the statement or use in the Republic of Kazakhstan;

10) the recipe – the purpose of medicine performed by the health worker by means of EPZ concerning leave of medicines and/or products of medical appointment in electronic format or its printed-out version;

11) the recipe on medicine of prescription dispensing – the recipe which is issued by the supplier of medical services for realization of medicines of prescription dispensing to certain patient;

12) medicine of prescription dispensing – medicine which is implemented by objects in the field of drug circulation products of medical appointment and medical equipment only on presentation by the patient of the recipe which is written out by the health worker in form 130/at of the Republic of Kazakhstan approved by the order of the acting minister of health care of November 23, 2010 No. 907 (it is registered in the Register of state registration for No. 6697);

13) the accompanying information on the recipe – information concerning privileges on acquisition of medicines, the clinical record and other data describing drugs and health of the patient according to this Standard;

14) maintaining recipes in electronic format – transfer of the recipe or any other information connected with the recipe by means of the SIR, between the parties of health care directly or through EPZ;

15) person which is writing out recipes – the supplier of medical services performing the statement of the recipes according to this Standard according to regulatory legal acts of the Republic of Kazakhstan existing in the field of drug circulation, products of medical appointment and medical equipment;

16) registration number – registration number which is assigned to medicines, products of medical appointment and medical equipment in case of state registration in the national register of medicines, products of medical appointment and medical equipment;

17) pharmaceutical activities – the activities performed in the field of health care on production, production (except for medical equipment), wholesale and retail sale of medicines, products of medical appointment and medical equipment, connected with purchase (acquisition), storage, import, export, quality control, registration, distribution, use and destruction of medicines, products of medical appointment and medical equipment, and also ensuring their safety, efficiency and quality;

18) pharmaceutical workers – the physical persons having pharmaceutical education and performing pharmaceutical activities;

19) service of electronic recipes – the complex of actions providing maintaining recipes in electronic format for the purpose of creation, administration, sending, obtaining, cancellation or redirection of electronic recipes;

20) third-party medical information system – medical information system which is developed and is used by the third parties;

21) the magazine of logging – the file with records about events in chronological procedure.

4. The statement of recipes is performed according to the subitem 83) of Item 1 of article 7 of the Code.

5. Maintaining recipes in electronic format includes bilateral information transfer between the supplier of medical services and subjects in the field of drug circulation, products of medical appointment and medical equipment, and also the bilateral information transfer connected with drug treatment and the accompanying information to the recipe.

6. Bilateral information transfer is performed and controlled with the help of EPZ which also provides communication between the parties involved in process of maintaining recipes in electronic format. Activities for maintaining recipes in electronic format and process of exchange of the relevant information are registered in EPZ.

7. The recipes created in third-party medical information systems are divided into two types:

1) the recipes issued as a result of rendering out-patient or stationary medical care;

2) registration of drug treatment during rendering stationary medical care.

8. In case of registration of drug treatment during rendering stationary medical care creation of the electronic recipe in the form of the attached special record (further – PSZ) is not required.

9. Data on medicines are presented in EPZ in type of information containing in clinically significant elements of contact of electronic medical supplier record of medical services.

10. The data set for medicines and products of medical appointment described in appendix 1 to the Standard (further – application 1) is automatically updated by means of EPZ in case of registration of drug treatment during rendering stationary medical care.

11. In case of the statement of the recipe with use of third-party medical information system, as a result of out-patient or hospitalization, for registration of the recipe in EPZ PSZ in the form of kliniko-administrative records which contain the electronic recipe are generated and stored under the EMZ corresponding element of the supplier of medical services in EPZ.

12. The national registry of medicines provides access to the reference information determined according to the State register of medicines, products of medical appointment and medical equipment for the medicines identified by means of the national identifier of medicines.

13. The national registry of products of medical appointment provides access to the reference information determined according to the State register of medicines, products of medical appointment and medical equipment for the products of medical appointment identified by means of the national identifier of products of medical appointment.

2. Procedure for exchange of electronic recipes

14. The following procedures are applied to recipes which are registered, stored and controlled on a centralized basis in EPZ:

1) the subjects in the field of drug circulation, products of medical appointment and medical equipment who expressed requirements of receipt of access to the SIR for the purpose of accomplishment of transactions on use of electronic recipes make the corresponding request for access to the SIR;

If necessary the patient requests 2) and receives the paper version of the recipe which is valid for any subject in the field of drug circulation, products of medical appointment and medical equipment from EPZ;

3) subjects in the field of drug circulation, products of medical appointment and medical equipment which have access to the SIR of certain patient bear responsibility for proper accomplishment of transactions on issue of medicines with observance of the actions determined by Chapter 3 of this Standard;

4) subjects in the field of drug circulation, products of medical appointment and medical equipment and the pharmaceutical workers receiving paper recipes within the guaranteed amount of free medical care submit the report on these recipes in EPZ by means of the SIR.

3. Transactions of service of electronic recipes

15. The SIR includes transactions on the statement, maintaining and exchange of electronic recipes according to summary information on specifications of transactions according to appendix 2 to the Standard (further – appendix 2) which regulate the access level and the carried-out role of the parties of health care using this service.

16. The statement the health worker of the new recipe, involves the following actions:

1) the EPZ updating of the patient by addition of relevant information on medicines in relevant element of contact of EPZ according to appendix 1;

2) updating of the register of medicines, products of medical appointment for the purpose of monitoring, accounting and assessment of use of medicines, products of medical appointment according to set of the administrative data determined in appendix 3 to the Standard (further – appendix 3);

3) automatic creation of the electronic recipe in the form of PSZ the SIR and his storage in EPZ.

17. The written-out new recipe is temporary record before its check. The description of the status of the recipe is determined according to line 3.1 of appendix 3.

18. If necessary, the recipes expecting confirmation change person which is writing out recipes. The recipes which underwent testing introduced in EPZ are not subject to change.

19. The elements of data provided for electronic recipes and which are stored in the corresponding PSZ are determined in appendix 1.

4. Standards of data

20. Requirements to standards of data in the released electronic recipes, are regulated by appendix 4 to this Standard.

21. Sources of reference information are determined in appendix 5 to this Standard.

22. Control of information access public is exercised according to appendix 6 to this Standard.

23. All transactions determined in this Standard are registered logging of EPZ according to requirements to EPZ.

Appendix 1

to the Standard of regulation of maintaining recipes in electronic format

 See Appendix 1 (9Kb In original language)

Appendix 2

to the Standard of regulation of maintaining recipes in electronic format

Summary information on specifications of transactions

№	Name of transaction	Authorized supplier of medical services	Person which is writing out recipes	System of compensation of medical expenses
1	The short statement from the electronic passport of health of the patient	Creation	-	-
2	History of recipes	Creation	Yes, if there is consent of the patient	-
3	The list of the medicines accepted now	Creation	Yes, if there is consent of the patient	-
4	Consent of the patient to collection, storage and information transfer	Creation	Provide to the pharmaceutical worker	-
5	Statement of the new recipe	-	Create and send the notification	Receive the notification
6	Cancellation of the recipe	-	Consider condition of the recipe and execute	Receive the notification
7	Viewing status of the recipe	-	Viewing	-
8	Updating of the status of the recipe;	-	Receive the notification	-
9	Change of the recipe	-	Receive the notification	Receive the notification
10	Recipe of repeated action	-	Create and send the notification	Receive the notification
11	Verification of the recipe	-	-	Receive the notification
12	Change of the password	-	-	-
13	Request for provision of information on criteria	-	Viewing	Receive the notification

Description of transactions:

"the consent of the patient to collection, storage and information transfer" - provides provision of access rights to the parties of health care concerning the summary information connected with recipes for the purpose of implementation of pharmaceutical activities. In case of lack of consent of the patient, pharmaceutical workers get access only to the recipe;

"cancellation of the recipe" - removal of temporary record of the electronic recipe. This transaction is possible until drawing of the status "verification of the recipe";

"viewing of the status of the recipe" - provision of information on condition of the electronic recipe according to appendix 3;

"updating of the status of the recipe" - provides updating of information on the status of the electronic recipe according to appendix 3. Information on updating of the status of the recipe is part of information on medicines and is registered in EPZ;

"change of the recipe" - provides modification of the electronic recipe expecting check according to appendix 3. Changes are made to the recipe only by person which wrote out the recipe. Change of the recipe does not imply replacement of the written-out medicine by other medicine, and implies change of trademark, or package size according to appendix 1;

"the recipe of repeated action" - allows to reuse the recipe;

"verification of the recipe" - provides updates of the status of the electronic recipe;

"change of the password" - result of change of the password used by druggists for access to the SIR;

"request for provision of information on criteria" - verification of the recipe on belonging to preferential categories.

Appendix 3

to the Standard of regulation of maintaining recipes in electronic format

 See Appendix 3 (7Kb In original language)

Appendix 4

to the Standard of regulation of maintaining recipes in electronic format

Standards of data

№	The field with the product description	Code classification	Terminology
1	Identification and description of commercial product	National identifier of medicines, products of medical appointment and medical equipment	Registration number – registration number which is assigned to medicines, products of medical appointment and medical equipment in case of state registration in the State register of medicines, products of medical appointment and medical equipment. More detailed information is in the single qualifier of medicines, products of medical appointment and medical equipment
2	Substances	MHH (WHO)	Application of MNN in the state
		ATX (WHO)	SNOMED CT

Appendix 5

to the Standard of regulation of maintaining recipes in electronic format

Sources of reference information

№	Element of data	Service of reference information	National standard of management of service of reference information
1. Identification of the parties of health care
1.1	Identification number of the patient	National registry of patients	Standard requirements to identification of the operating parties of health care used in systems of electronic health care
1.2	Contact information of the patient
1.3	Identification number of person which wrote out the recipe	National registry of health workers
1.4	Contact information of person which wrote out the recipe
1.5	Identification number of the pharmaceutical worker
1.6	Contact information of the pharmaceutical worker
2. Commercial identification of product
2.1	National identifier of medicines, products of medical appointment and medical equipment	National registry of medicines, products of medical appointment and medical equipment	This standard
3. Clinical identification of product
3.1	Active ingredient	National registry of medicines	This standard
3.2	Code of active ingredient

Appendix 6

to the Standard of regulation of maintaining recipes in electronic format

 See Appendix 6 (4Kb In original language)

Appendix 2

to the Order of the Minister of health and social development of the Republic of Kazakhstan of July 20, 2015 No. 600

Standard of management of electronic processes of diagnostic testings and medical procedures

1. General provisions

1. The standard of management of electronic processes of diagnostic testings and medical procedures (further – the Standard) is developed according to the subitem 6 of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" for the purpose of quality assurance and specifics (properties) of information collected by means of the electronic passport of health (further - EPZ) and other interacting third-party medical information systems concerning the appointed diagnostic testings and medical procedures (further – medical services) at all levels of delivery of health care taking into account requirements of the international standard DIN EN 13940 "System of the concepts providing continuity of delivery of health care".

2. Tasks of this Standard are:

1) determination of additional requirements and provisions on regulation of the following processes:

collection of clinical data;

the electronic directions on diagnostic testings and medical procedures;

2) determination of qualifiers and identifiers for normalization of clinical data in the course of the direction on medical services, and also receipts of results of diagnostic testings by means of EPZ.

3. In this Standard terms and concepts are used:

1) collection of clinical data – process of normalization of clinical data with use of the international and national standards, reference books and qualifiers for ensuring interoperability and possibility of electronic data processing by means of the mechanisms and tools which are available in EPZ;

2) medical services – the actions of subjects of health care having preventive, diagnostic, medical or rehabilitation orientation in relation to the specific person;

3) the electronic catalog of medical services and resources (further - the electronic catalog) – the service of reference information providing access to the standardized information on medical services and suppliers of medical services;

4) third-party medical information system – any medical information system which is developed and is used by the third parties.

4. Options of the direction are the medical services available to the health workers using EPZ for the direction of the patient on further treatment, and also documentation and registration of such cases according to this Standard. Options of the directions are divided into 3 types:

1) the direction on consultation of the specialist;

2) the direction on diagnostic medical services;

3) the direction on medical medical services.

5. Information on direction options – information provided to health workers by means of the electronic catalog which is used for collection of the clinical data concerning the appointed medical services. Information on options of the direction comprises the information about suppliers of medical services which are provided by necessary resources for rendering specific medical service.

6. Services of reference information provide processes of electronic health care implemented by means of EPZ and with the interacting medical information systems of electronic health care (internal and external).

2. Choice of medical service and supplier of medical services

7. In this Standard the following transactions are determined:

1) request and receipt of information on direction options;

2) new direction.

8. Information on direction options concerning subitems 2) and 3) of item 4 of this Standard, is provided to the health worker by means of EPZ by means of the electronic catalog, for ensuring data collection and issue of record about the new direction.

9. Options of the direction and information on options of the direction are regulated by provisions of Chapter 3 of this Standard.

10. The new directions, are issued by health workers, the rendering medical services to the patient.

11. The new directions involve creation of new records.

3. National electronic catalog of medical services and resources

12. EPZ and third-party medical systems interacting with EPZ provide access to the database of the electronic catalog by means of services of reference information for the purpose of the choice of medical services for which record of the direction according to Chapter 2 of this Standard is created.

13. Implementation of the database of the electronic catalog and services of reference information are regulated by this Standard.

14. Systematics (taxonomy) and terminology realized in the electronic catalog corresponds to the systematized nomenclature of medico-clinical terms on the basis of international standards (SNOMED-CT).

15. The system of coding realized in the electronic catalog for assignment of specification symbol to the medical services chosen by means of the electronic catalog and system of the terminology determined in Item 14 of this Standard is based on MKB-10 SKP (ICD-10 Procedure Coding System).

16. The system of coding realized in the electronic catalog for assignment of specification symbol of medical services in the diagnostic and laboratory testings chosen by means of the electronic catalog and system of the terminology determined in Item 14 of this Standard is based on names and codes of identifiers of logical observation on the basis of international standards (LOINC).

17. Changes of codes and amendments to codes it is performed on the basis of system of the terminology determined in Item 14 of this Standard and by means of the electronic catalog of service of reference information.

18. For the purpose of classification of the medical services rendered based on the directions issued by means of EPZ in category "for compensation", the electronic catalog provides grouping of medical services for reference of medical services in the above-stated categories.

19. Reference of medical services to the category "for compensation" determined in Item 18 of this Standard is performed according to tasksetter of medical services.

20. The codes of the medical services MKB-10 SKP appointed by means of the direction in EPZ are enlarged in codes according to tasksetter of medical services for payment for the rendered services.

4. Results of diagnostic testings

21. Results of diagnostic testings are transferred and kept in EPZ in the form of the attached special records.

22. The electronic catalog realizes set of specification symbols on the basis of MKB-10 SKP which expands the detail level.

23. The specification symbols determined according to Item 22 of this Standard, based on the terminology of international standards (SNOMED-CT) realized in the electronic catalog.

Appendix 3

to the Order of the Minister of health and social development of the Republic of Kazakhstan of July 20, 2015 No. 600

Standard of regulation of electronic prevention of diseases

1. General provisions

1. The standard of regulation of electronic prevention of diseases (further – the Standard) is developed in compliance with the subitem 6 of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" and determines conditions for participation of suppliers of medical services in system of electronic prevention of diseases (further - service of electronic prevention) taking into account requirements of the international standard DIN EN 13940 "System of the concepts providing continuity of delivery of health care".

2. Task of the Standard is determination of functional requirements and the principles for regulation of interaction of the electronic passport of health with external information systems (national or third-party) for realization of processes of electronic prevention.

3. In this standard terms and concepts are used:

1) the party of health care – physical persons and legal entities which interact in health care system, including patients, suppliers of the medical services and the parties providing support of delivery of health care;

2) third-party medical information system – any medical information system which is developed and is used by the third parties.

4. Service of electronic prevention are the activities performed by means of the electronic passport of health (further - EPZ) which provide planning, accomplishment and registration of primary, secondary and tertiary preventive medical services concerning the patient. Data source for service of electronic prevention is EPZ.

5. Information obtained in result or for the purpose of realization of the actions specified in items 4 and 7 these Standards is subject of regulation of this Standard.

6. For the purpose of planning, accomplishment and registration of primary, secondary and tertiary preventive medical services concerning the patient, electronic procedures are divided into three types:

1) management of vaccination;

2) management of screening;

3) management of lists of patients.

7. Actions of service of electronic prevention and the corresponding electronic procedures begin and controlled by means of EPZ.

2. Management of vaccination

8. Management of vaccination is part of functions of service of the electronic prevention and electronic procedures performed by means of EPZ for the purpose of the prevention of emergence of diseases, and also prevention of their effects and complications.

9. Information on medical services in vaccination of patients and information on results of vaccination including disease against which vaccination, data on vaccination, collateral reactions, the used medicines is carried out gathers, conducted and organized by means of EPZ.

10. Viewing, assessment and management of the status and history of vaccination of the patient is performed by means of EPZ.

11. The subjects of health care requesting information, stipulated in Item 10 Standards obtain information in full on any patient.

12. The parties of health care which get direct information access determined in Item 10 of this Standard, are the doctors of primary health care (further – PSMP) appointed for each patient.

13. Vaccination is appointed both for the specific patient, and for group of patients, by means of lists of the patients determined in Item 21 of the Standard.

14. Each purpose of vaccination is registered the organization of health care, by means of EPZ and according to Standard provisions.

3. Management of screening and routine medical examinations

15. Management of screening and routine medical examinations is part of functions of service of the electronic prevention and electronic procedures performed by means of EPZ for the purpose of carrying out surveys of the target groups of the population directed to detection of diseases at early stages and the prevention of development of diseases, the risk factors promoting emergence of diseases, forming and strengthening of health of the population, professional suitability, the admission to work and other activities.

16. Information on the diagnostic medical services rendered according to certain algorithms of staging of performing screening and routine medical examinations of target groups of the population gathers and organized in EPZ.

17. For the purpose of implementation of certain screening programs or algorithms of staging of performing screening and routine medical examinations, only authorized suppliers of medical services have access for viewing and information analysis, containing in EPZ for determination of target groups of the population, subjects to screening and routine medical examination.

18. Diagnostic testings within screening and routine medical examinations are appointed both for the specific patient, and for group of patients, by means of lists of the patients determined in Item 21 of the Standard and according to the standard of management of electronic processes of diagnostic testings and medical procedures.

19. Purpose of screening surveys for certain patients or groups of patients is determined automatically by means of EPZ without the consent of the authorized party of health care on the basis of certain algorithms of staging of carrying out screening surveys. Accomplishment of the appointed diagnostic testing within screening survey according to Item 19 of the Standard requires authorization of the authorized supplier of medical services, according to Item 18 of the Standard. For this purpose, EPZ uses protocols for monitoring and automatic detection of screening indicators.

4. Management of lists of patients

20. Based on information containing in EPZ lists of the patients who are subject to vaccination are kept. The patients who are subject to vaccination are notified by the authorized doctor of PHC who receives the adequate notice from the EPZ system on vaccination of patients.

21. Based on information containing in EPZ lists of the patients who are subject to screening surveys are kept. The patients who are subject to screening surveys are notified by the authorized supplier of medical services which receive adequate notices from the EPZ system on carrying out screening surveys. Notifications on carrying out screening surveys are transferred to third-party medical information systems.

5. Obligations of suppliers of medical services at the level of primary health care and hospital

22. Suppliers of medical services at the level of PHC and hospital which interact with service of electronic prevention or the national EPZ system provide continuous communication with service of electronic prevention for receipt of notifications on screening surveys and the notifications connected with service of electronic prevention.

23. The third-party medical information system interacting with EPZ performs the following functions:

1) checks updates in the corresponding register on observation of diseases;

2) based on the metadata received from the corresponding register on observation of diseases is notified by EPZ in case of the arrival of patients with the diagnosis specified in this register;

3) interacts with service of electronic prevention on permanent basis concerning the arriving appointments to diagnostic testings which are transferred by means of EPZ.

24. Results of diagnostic testings within screening survey which are appointed according to the procedure established by the subitem 3) of Item 24 of the Standard, are transmitted back to EPZ according to provisions of Item 5 of the Standard.

6. Connected kliniko-administrative data EPZ

25. In addition to data sets, determined in this Standard, for the purpose of realization and regulation of service of electronic prevention, kliniko-administrative data are included in the corresponding data sets of EPZ.

 

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