Title I: Institutions

In the event of risks to public health or to the health of a person due to an abnormality arising during investigations, treatments or preventive actions, the administrative authority may give formal notice to the professionals, bodies or establishments which carried out these investigations, treatments or preventive actions to inform the persons concerned if it appears that this information was not provided in accordance with article L. 1111-2.

Any healthcare professional, healthcare establishment or medico-social establishment or service having observed either a healthcare-associated infection, including a nosocomial infection, or any serious adverse event associated with healthcare, in the context of care provided during investigations, treatments, medical procedures, including cosmetic procedures, or preventive actions, shall report it to the Director General of the Regional Health Agency. The healthcare professionals concerned analyse the causes of these infections and undesirable events….

State services and local authorities, their public establishments, public and private health establishments, the armed forces health service, social and medico-social establishments and services, emergency services and all health professionals are required to notify the Director General of the Regional Health Agency immediately of any imminent threats to the health of the population of which they are aware, as well as situations in which they believe there is a serious…

The procedures for applying this section shall be determined by decree of the Conseil d’Etat, in particular the nature and seriousness of the events mentioned in article L. 1413-14 which must be reported, the procedures for collecting this information or data, the procedures for analysing these events and the rules guaranteeing respect for medical confidentiality.