#AFSP1706241ADecree on Automated Processing of Personal Data for Adverse Health Event Reporting
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This French decree establishes a system for automated processing of personal data related to adverse health event reporting. It aims to promote public access to report health incidents, guiding users to relevant forms and ensuring that reports are evaluated by health professionals. The decree sets categories of data collected and ensures confidentiality, while exceptions to data access rights are clarified.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Introduction of an automated system for reporting adverse health events
- Guidance for public and professionals on how to access reporting forms
- Establishment of data confidentiality and specific access rights
Obligations
What this law requires
Implement an automated processing system (adverse health event reporting portal) to collect and manage personal data related to health incidents, with the stated purposes of promoting reporting, directing users to appropriate forms, transmitting reports to health professionals, and informing declarants of their report status.
Ensure that only specifically designated and authorized agents of public health establishments and regional surveillance networks access personal data, and only to the extent necessary for their assigned missions.
Maintain separate storage of data identifying the subjects of declarations and authentication data for authorized users from all other data in the system.
Retain declaration form data and declarant identification data only for the duration necessary to transmit them to evaluation professionals. Retain RPPS number, declaration type, declaration date, and evaluation service information for one year to allow declarants to access their declaration history.
Preserve technical audit traces of actions on personal data for no longer than six months.