French Public Health Code
In forceI. - An information system called "LABOé-SI" is hereby created, implemented under the responsibility of the Directorate-General for Health, the purpose of which is to contribute to epidemiological surveillance and health monitoring.
This processing is implemented as part of a mission of public interest in accordance with the provisions of e of 1. of Article 6 of Regulation (EU) 2016/679 of 27 April 2016 and for the reasons of public interest mentioned in i of 2 of Article 9 of the same Regulation.
It enables public and private medical biology departments and laboratories to report and transmit the data provided for in Articles R. 3113-1 to R. 3113-7. It also enables the regional health agencies and the National Public Health Agency to have access to the information and data required to carry out their health monitoring and epidemiological surveillance missions, as provided for in 1° of Article L. 1431-2 and 1° and 2° of Article L. 1413-1 respectively.
II. - The categories of data mentioned in article R. 3113-2 may be collected and recorded in the LABOé-SI data processing system.
In application of the provisions of articles L. 1413-7 and L. 1413-12-3, the categories of data mentioned in 1°, 2°, 4° and 5° of article R. 3113-2 relating to people who have undergone a negative biological screening test for one of the diseases mentioned in article R. 3113-1 may also, when this data is essential for epidemiological observation or monitoring of health risks threatening populations, or when the characteristics of the viral dynamics of the disease entail significant risks for the health of populations, be recorded in this processing for the purposes of making it available to the National Public Health Agency. An order by the Minister for Health sets the list of diseases giving rise to this registration and the list of data to be transmitted.
III. - Staff from medical biology departments and laboratories who have been individually authorised by the head of the department or laboratory are authorised to access the LABOé-SI processing system for the sole purpose of transmitting the data mentioned in II.
The only recipients of the data recorded in the LABOé-SI processing system, within the limits of their respective responsibilities, are :
1° Staff of the regional health agency with territorial jurisdiction, individually designated and specially authorised by the Director General;
2° Staff from the National Public Health Agency, individually designated and specially authorised by the Director General;
3° Where applicable and without prejudice to respect for medical confidentiality, any subcontractors that the data controller may use, in compliance with the conditions laid down in Article 28 of the aforementioned Regulation (EU) 2016/679 of 27 April 2016.
IV. - The data is kept in the LABOé-SI processing system for a period of one month from receipt by the competent regional health agency or by the National Public Health Agency. At the end of this period, the data is securely erased.
Any operation relating to data processing is recorded, including the identification of the user and traceability data, in particular the date, time and nature of the intervention in the processing.
V. - Medical biology departments and laboratories carrying out the alerts and data transmissions provided for in Articles R. 3113-1 to R. 3113-7 shall provide the data subjects with the information provided for in Article 14 of Regulation (EU) 2016/679 of 27 April 2016, as well as the information relating to the limitations on their rights provided for in this V. This information also appears on the websites of the regional health agencies and the National Public Health Agency.
Pursuant to Article 23(1)(e) of the Regulation referred to in the previous paragraph, the right to erasure and the right to object, provided for respectively in Articles 17 and 21 of the same Regulation, do not apply to LABOé-SI processing.
The rights of access, rectification and limitation of data, provided for respectively in Articles 15, 16 and 18 of the same Regulation, may be exercised with the Regional Health Agency or the National Public Health Agency to which the data in question has been transmitted via the LABOé-SI processing operation.
