The Order In Which Permission To Use Patient Data In A Specific Study

Original Language Title: Kārtība, kādā atļauj izmantot pacienta datus konkrētā pētījumā

Read the untranslated law here:

Cabinet of Ministers Regulations No. 446 in Riga august 4, 2015 (pr. No 37 16) order in which permission to use patient data in the study Issued in accordance with the law on the rights of the patient in the eighth part of article 10 paragraph 2 of rule 1 defines the order in which the competent administrative authority to use medical record fixed patient data in the study. 2. the medical record of the patient's use of data recorded in a particular study (hereinafter permit) issued by the Center for disease control (hereinafter referred to as the Centre). 3. a Person who wishes to get permission (hereinafter person) shall provide the application Centre (annex 1). The application shall be accompanied by the following documents: 3.1. study Director and the principal investigator for a description of the dzīvesgait according to this provision, 2. the specimen in the annex; 3.2. the study Director and principal investigator educational copies of documents; 3.3. the research protocol, theoretically methodological precondition. 4. the Centre after this provision in the application referred to in paragraph 3 and the attached document receipt check that the application contains all the required items, and add all the rules referred to in paragraph 3 of the documents. If the application does not contain all the required information or not all these rules documents referred to in paragraph 3, the centre asked the person in writing to submit the required information or documents within the time limit. 5. the Centre shall assess the provisions referred to in paragraph 3, the application and the documents attached to it and within a month of receipt of the application, shall take a decision on the authorisation or refusal to issue the permit. The decision on issuing a permit or refusal to issue a permit, notify the person of Center notification in accordance with the procedure prescribed by law. At the same time with the decision on the permit Center person shall also permit. 6. the Centre shall take a decision on the permit if the following conditions occur simultaneously: 6.1. planned use of patient data necessary for the attainment of the objectives of the study and is proportionate; 6.2. study objectives cannot be achieved using an identifiable patient data in various databases and registers; 6.3. is designed for the planned publication of the results of the study; 6.4. a person has registered the processing of patient data or specific purposes designated by specialists on the protection of personal data, which are recorded in the data State Inspectorate; 6.5. the study Director and principal investigator of scientific qualification is appropriate to successfully carry out the study. 7. the Centre shall take a decision on the refusal to issue a permit if there is at least one of the following conditions: 7.1. personal documents submitted contain false or misleading information; 7.2. the party submitted all these rules the information referred to in paragraph 3; 7.3. failure to comply with any of the provisions referred to in paragraph 6. 8. Center the authorisation shall state: study objective 8.1; 8.2. research requires medical documentation; 8.3. list of treatment, of which it is intended to request research requires medical documentation; 8.4. the categories of data; 8.5. the persons who will be available in identifiable medical records; 8.6. the authorisation period. 9. In the event of changes in the information specified in the permit, the person needs to get a new permit. 10. the Centre within five working days after the decision on the authorisation of tīmekļvietn publishes information on licences issued, specifying: 10.1. first and last name of the person, where the holder is a natural person, the name and registration number, if the permit holder is a legal person; 10.2. the study name; 10.3. list of treatment, of which it is intended to request research requires medical documentation; 10.4. the term for which the licence is issued. 11. the Centre's decision on issuing a permit or refusal to issue a permit may be challenged in the Ministry of health of the administrative procedure law. The Ministry of health decision may appeal to the Court of Justice of the administrative procedure law. Prime Minister – Finance Minister John Minister of health Rare-Welfare Minister Uldis Augul annex 1 by Cabinet of Ministers of 4 august 2015 regulations no 446 application authorization medical documents fixed patient data for use in a specific trial date | ____ ____ | |. |____|____|. |____|____|____|____|.     (day) (month) (year)  

1. Applicant 1.1. natural personavārd, last name ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ _ _ ID code | | ___ ___ ___ | | | ___ ___ ___ | |-| | ___ ___ | | ___ ___ ___ | | 1.2. legal person name ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ _____ registration number __ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ 1.3. contact information for communication City/locality/Street name, home, House, apartment number postal code phone number e-mail address fax 2. information on the study 2.1. Study name 2.2. The objective and tasks of the research topic 2.3 2.4 Research actuality requires medical documentation (such as a patient's outpatient card, patient medical history) and the estimated number of units of the documentation Examined population characteristics 2.5 2.6. categories of data under study (for example , disease diagnosis, cause of death) 2.7. Treatment services, from which it is intended to request the research necessary medical documentation justification as to why 2.8 study necessary to use direct patient identifiable data 2.9. Reasons why it is not possible to get the patient or his legal representative's written consent for the use of medical data in particular study 2.10. Expected results of the study, their use and publication type 2.11. Research time schedule (start and end date) 3. Use of data and security 3.1. , which will be available in the patient medical information first name last name social security number | | ___ ___ ___ | | | ___ ___ ___ | |-| | ___ ___ | | ___ ___ ___ | | The to-do description 3.2. information on registration data State Inspectorate (mark with): registered the processing of personal data: the name _____ _____ _____ _____ _____ _____ _____ _____ processing registration number ___ ____ ____ ____ ____ ____ ____ ____ ____ ____ registered personal data protection professional: first name, last name _____ _____ _____ _____ _____ _____ _____ _____ _____ ___ licence number | | ___ ___ ___ | |

4. Mandatory documents mark to be added to the study Director and principal investigator of the study description of dzīvesgait Manager and principal investigator copies of education research protocol – theoretically methodological precondition outline 5. Authorization type note with, where the wish to receive the paper document in the form of a paper document in form 6. Proof by signing this application, the applicant represents that: 6.1 will use only such medical data that the patient or his legal representative is prohibited to put the researcher; 6.2. the patient's medical records will be used only for the research purpose; 6.3. in respect of data security, ethics and the principle of confidentiality 7. Signature of the applicant first name last name signature date | ____ ____ | |. |____|____|. |____|____|____|____|.       (day) (month) (year)    
Note the. Document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. Health Minister-Minister of welfare Uldis Augul 2. Annex Cabinet 2015 4. augustanoteikum no 446 Dzīvesgait description name contact details: address, phone e-mail address 1. Education (specify the education obtained in chronological order) of educational authority name education, degree 2 work experience (specify any position attributable to operations research and management science, projects, thesis and thesis) period of Employment job content 3. publications (specify all of the last three years has research publications related to the medical, pharmaceutical or public health and the author or co-author of is the study Manager or principal investigator) 4. attestation Certifying that the information provided is true and according to the nature of my qualifications and experience. Signature _____ _____ _____ _____ _____ _____ _____ _____ date ____ ____ ____ ____ ____ ____ ____ ____ ____ ___ Health Minister-Minister of welfare Uldis Augul States