Section 6: Reporting serious adverse events associated with healthcare

A serious undesirable event associated with care provided during investigations, treatments, cosmetic medical procedures or preventive actions is an unexpected event with regard to the person’s state of health and pathology, the consequences of which are death, life-threatening conditions or the probable occurrence of a permanent functional impairment, including a congenital anomaly or malformation.

Any healthcare professional, regardless of where or how they practice, or any legal representative of a healthcare establishment, medico-social service establishment or independent cosmetic surgery facility, or the person they have appointed for this purpose, who observes a serious adverse event associated with healthcare, must report it to the Director General of the Regional Health Agency using the form provided for in article R. 1413-70. A healthcare professional who informs…

I.-The declaration mentioned in article R. 1413-68 consists of two parts. II-The first part is sent without delay by one of the persons mentioned in the same article. It includes : 1° The nature of the event and the circumstances in which it occurred or, failing that, was observed ; 2° A statement of the initial measures taken locally for the benefit of the patient and to prevent the recurrence…

An order of the Minister for Health specifies the form and content of the two parts of the declaration form and the procedures for electronic transmission. This declaration is made under conditions which guarantee the anonymity of the patient(s) and professionals concerned, with the exception of the declarant. In particular, the form does not include patients’ full names, addresses, dates of birth or the full names of the professionals involved…

The Director General of the Regional Health Agency will acknowledge receipt to the declarant of the declaration received in application of articles R. 1413-68 and R. 1413-69.

Both parts of the form for reporting a serious adverse event associated with healthcare are sent by the Director General of the Regional Health Agency to the Haute Autorité de santé, in accordance with the procedures defined by order of the Minister for Health. This transmission does not include the full name of the reporter or the address of the place where the event occurred.

The Haute Autorité de santé shall draw up an annual report on the declarations it has received in application of the provisions of the present section, together with recommendations for improving patient safety. This report is sent to the Minister for Health and is made public on the Haute Autorité de santé website.