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Article D1413-58 of the French Public Health Code

I.-A website, developed and implemented by the consortium mentioned in article L. 1111-24, is made available to the public, healthcare professionals and professionals in the health and medico-social sectors to facilitate, promote and collect the declaration or reporting of undesirable health events appearing on a list drawn up by the Minister for Health. This website enables declarations or reports to be transmitted to the authorities and establishments responsible for processing…

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Article R1413-58-1 of the French Public Health Code

I. – 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…

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