#SFHP2609259AFrance Updates Health Incident Reporting Portal to Include Mandatory Disease Notifications
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order expands France’s health incident reporting portal so it can also be used for mandatory disease notifications. It updates the official list of health-related adverse events and reporting categories that can be submitted through the national portal. The change mainly affects healthcare professionals, health institutions, and certain regulated professionals who must report serious care-related incidents, infections, vigilance issues, and listed mandatory diseases. Businesses and organizations in healthcare, cosmetics, medical devices, blood products, assisted reproduction, tattoo products, and related sectors should check that their reporting processes match the updated categories.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Adds mandatory disease notifications to the scope of the national health incident reporting portal
- Replaces the previous table of reportable health incident categories with an updated list
- Clarifies which groups can report each category through the portal, including healthcare professionals, individuals, and other regulated professionals
Obligations
What this law requires
Healthcare professionals must report mandatory notifiable diseases listed in Articles D.3113-8 and D.3113-9 of the French Public Health Code, and the national health adverse-event reporting portal may be used for these reports.
Healthcare professionals and other professionals involved in care must report serious adverse events associated with healthcare through the applicable reporting process, including via the national health adverse-event reporting portal.
Healthcare professionals must report healthcare-associated infections through the applicable reporting process, including via the national health adverse-event reporting portal.
Healthcare professionals must report significant radiation-protection events under the cited Public Health Code provisions, with reporting possible through the national health adverse-event reporting portal.
Healthcare professionals must report pharmacovigilance cases involving suspected adverse effects of medicinal products under the applicable Public Health Code provisions, with reporting possible through the national portal.