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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of July 21, 2021 No. 91

About procedure for development, forming, maintaining, operation of information systems in health care

Based on the paragraph of the seventh of part three of article 8 of the Law of the Republic of Belarus of June 18, 1993 No. 2435-XII "About health care", subitem 9.1 of Item 9 of the Regulations on the Ministry of Health approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446, the Ministry of Health of the Republic of Belarus DECIDES:

1. Approve the Instruction about procedure for development, forming, maintaining, operation of information systems, information resources, bases (banks) of data and (or) registers (registers) in health care which are part of centralized information system of health care, requirements to them, procedure for their interaction with centralized information system of health care it (is applied).

2. This resolution becomes effective after its official publication.

Minister

D.L.Pinevich

It is approved

Ministry of Communications and Informatization of the Republic of Belarus

 

Operational analytical center in case of the President of the Republic of Belarus

 

 

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of July 21, 2021 No. 91

The instruction about procedure for development, forming, maintaining, operation of information systems, information resources, bases (banks) of data and (or) registers (registers) in health care which are part of centralized information system of health care, requirements to them, procedure for their interaction with centralized information system of health care

Chapter 1. General provisions

1. This Instruction determines procedure for development, forming, maintaining, operation of information systems, information resources, bases (banks) of data and (or) registers (registers) in health care which are part of centralized information system of health care (further - information system), requirements to them, procedure for their interaction with centralized information system of health care (further - TsISZ).

2. For the purposes of this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus "About health care", the Law of the Republic of Belarus of November 10, 2008 No. 455-Z "About information, informatization and information security", the Presidential decree of the Republic of Belarus of December 16, 2019 No. 460 "About the nation-wide automated information system", the resolution of Council of Ministers of the Republic of Belarus of May 13, 2021 No. 267 "About procedure for functioning and use of centralized information system of health care are used".

Chapter 2. Procedure for development and forming of information systems

3. Coordination of works on development of information systems is performed by the Ministry of Health in coordination with the Ministry of Communications and Informatization.

4. Forming of information system is performed taking into account requirements of the resolution of Council of Ministers of the Republic of Belarus of May 26, 2009 No. 673 "About some measures for implementation of the Law of the Republic of Belarus "About information, informatization and information security", and also Regulations on procedure for functioning and use of centralized information system of the health care approved by the resolution of Council of Ministers of the Republic of Belarus of May 13, 2021 No. 267.

5. Documentation of process of forming of information system is the compulsory provision of its inclusion in structure of TsISZ.

Chapter 3. Procedure for maintaining and operation of information systems

6. During the maintaining and operation of information system the following conditions are complied:

the information system is located on the servers located in the territory of the Republic of Belarus and is registered according to the legislation on information, informatization and information security;

placement of information on one at least from state languages of the Republic of Belarus is provided;

the means of technical and cryptographic information security having the certificate of conformity of National system of confirmation of conformity of the Republic of Belarus or the positive expert opinion by results of the state examination which is carried out by Operational analytical center in case of the President of the Republic of Belarus are used;

the automated maintaining online magazines of accounting of transactions with fixing of placement, change and removal of information, the exact time of making of such transactions is provided;

the possibility of information exchange of information system with TsISZ is provided;

identification and authentication of users of TsISZ with use of single system of identification of physical persons and legal entities, other means of identification and authentication is provided.

7. In case of operation of information system the unity of the used normative reference information used in TsISZ is provided.

Chapter 4. Order of interaction of information systems with TsISZ

8. The information systems operated in the organizations of health care provide provision of access of TsISZ to information in the amount necessary for forming of the electronic medical record of the patient, other electronic medical documents and operation of subsystems of functional purpose of TsISZ.

9. In case of information exchange with TsISZ the information systems operated in the organizations of health care provide use of normative reference information of TsISZ.

10. Information exchange with TsISZ of the information systems operated in the organizations of health care is performed based on the agreement between the operator of TsISZ and the owner (owner) of information system.

11. The information systems operated in the organizations of health care, conforming to requirements of the legislation on information, informatization and information security, and also requirements of this Instruction are allowed to information exchange with TsISZ.

 

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