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Republic of Latvia

Cabinet
Regulation No. 446

Adopted 4 August 2015

Procedures for Using the Patient Data in a Specific Research

Issued pursuant to
Section 10, Paragraph eight, Clause 2 of
the Law On the Rights of Patients

1. This Regulation prescribes the procedures by which a competent State administrative institution allows the use of the patient data recorded in the medical documents in a specific research.

2. A permit for the use of the patient data recorded in the medical documents in a specific research (hereinafter - the permit) shall be issued by the Centre for Disease Prevention and Control (hereinafter - the Centre).

3. A person who wishes to receive the permit (hereinafter - the person) shall submit an application to the Centre (Annex 1). The following documents shall be appended to the application:

3.1. the curriculum vitae of the research manager and leading researchers in accordance with the sample provided in Annex 2 to this Regulation;

3.2. copies of the education documents of the research manager and leading researchers;

3.3. the research protocol - a layout of theoretically methodological preconditions.

4. After receipt of the application referred to in Paragraph 3 of this Regulation and the documents appended thereto the Centre shall verify whether all the requested information has been indicated in and all the documents referred to in Paragraph 3 of this Regulation have been appended to the application. If all the requested information has not been indicated in and all the documents referred to in Paragraph 3 of this Regulation have not been appended to the application, the Centre shall request in writing the person to submit the necessary information or documents within the specified time period.

5. The Centre shall evaluate the application referred to in Paragraph 3 of this Regulation and the documents appended thereto and, within one month after receipt of the application, take a decision to issue the permit or to refuse to issue the permit. The Centre shall notify the decision to issue the permit or to refuse to issue the permit to the person in accordance with the procedures laid down in the Law On Notification. Concurrently with the decision to issue the permit the Centre shall also send the permit to the person.

6. The Centre shall take a decision to issue the permit, if the following conditions exist concurrently:

6.1. the planned use of the patient data is necessary for achieving the objectives of the research and is commensurate;

6.2. the objective of the research cannot be achieved by using unidentifiable patient data in different databases and registers;

6.3. publishing of results of the planned research is intended;

6.4. the person has registered processing of the patient data for a specific objective or has appointed a personal data protection specialist registered with the Data State Inspection;

6.5. the scientific qualification of the research manager and leading researchers corresponds for successful conducting of the research.

7. The Centre shall take a decision to refuse to issue the permit, if at least one of the following conditions is in effect:

7.1. the documents submitted by the person contain false or misleading information;

7.2. the person has not submitted all of the information referred to in Paragraph 3 of this Regulation;

7.3. any of the conditions referred to in Paragraph 6 of this Regulation is not met.

8. The Centre shall indicate the following in the permit:

8.1. the objective of the research;

8.2. the medical documentation necessary for the research;

8.3. the list of medical treatment institutions, from which it is intended to request the medical documentation necessary for the research;

8.4. the categories of the data to be researched;

8.5. the persons who will have access to identifiable medical documentation;

8.6. the term of validity of the permit.

9. If the information indicated in the permit changes, the person must receive a new permit.

10. The Centre shall, within five working days after taking of the decision to issue the permit, publish information on the website regarding the permits issued, indicating:

10.1. the given name and surname of the person, if the recipient of the permit is a natural person, or the name and registration number, if the recipient of the permit is a legal person;

10.2. the name of the research;

10.3. the list of medical treatment institutions, from which it is intended to request the medical documentation necessary for the research;

10.4. the time period for which the permit is issued.

11. The decision of the Centre to issue the permit or to refuse to issue the permit may be contested to the Ministry of Health in accordance with the procedures laid down in the Administrative Procedure Law. The decision of the Ministry of Health may be appealed to a court in accordance with the procedures laid down in the Administrative Procedure Law.

Acting for the Prime Minister, Minister for Finance Jānis Reirs

Acting for the Minister for Health, Minister for Welfare Uldis Augulis

 


Translation © 2016 Valsts valodas centrs (State Language Centre)

 
Document information
Title: Kārtība, kādā atļauj izmantot pacienta datus konkrētā pētījumā Status:
In force
in force
Issuer: Cabinet of Ministers Type: regulation Document number: 446Adoption: 04.08.2015.Entry into force: 07.08.2015.Publication: Latvijas Vēstnesis, 152, 06.08.2015. OP number: 2015/152.5
Language:
LVEN
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