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Article R1413-68 of the French Public Health Code

November 5, 2023

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…

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Article R1413-69 of the French Public Health Code

November 5, 2023

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…

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Article R1413-70 of the French Public Health Code

November 5, 2023

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…

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Article R1413-72 of the French Public Health Code

November 5, 2023

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.

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Article R1413-73 of the French Public Health Code

November 4, 2023

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.

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Article R1413-75 of the French Public Health Code

November 4, 2023

The regional support structure for healthcare quality and patient safety helps the healthcare professionals concerned to analyse the reports of serious adverse events referred to in Article R. 1413-67 and thus contributes to informing the Director General of the Regional Health Agency about the conclusions to be drawn from them. It provides medical, technical and scientific expertise, particularly at the request of the Director General of the Regional Health Agency,…

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Article R1413-76 of the French Public Health Code

November 4, 2023

The Director General of the Regional Health Agency appoints one or more coordinated regional support structures for healthcare quality and patient safety in the region, following a call for applications, for a period of five years, tacitly renewable. These structures, which have legal personality, comply with a set of specifications defined by order of the Minister for Health, specifying in particular the criteria for professional competence, independence of their work…

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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396

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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396

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