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Hello everyone, this is Manon DURAND, health lawyer at Pharmaspecific. We meet again to talk about the General Data Protection Regulation (the GDPR), which is the reference text in terms of personal data protection, and which came into force in the European Union on May 25, 2018.

The question of the day is who should file a data breach notification with the CNIL. As a reminder, a personal data breach is a breach of security resulting in the accidental or unlawful destruction, loss, alteration or unauthorized disclosure of or access to personal data. When such a personal data breach occurs and it entails a risk to the rights and freedoms of the persons concerned, it must be notified to the CNIL within 72 hours.

In practice, how does this happen? If the clinical research associate (CRA) realizes that a personal data breach has occurred, he/she informs the project manager who will contact the sponsor – or its DPO, if one has been designated – directly so that the latter can notify the CNIL of the breach. It is therefore the sponsor or its DPO who will be responsible for this breach notification.

When a subcontractor works with the controller, with the developer, the same applies: if there is a personal data breach at the subcontractor’s premises, it must directly inform the developer or its DPO, who will be responsible for notifying the data breach to the CNIL.

In conclusion, the person in charge of making this data breach notification to the CNIL, within the 72-hour time limit, is the sponsor or his DPO if he has been appointed.

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Get in touch with the CNIL website to find out how to notify a data breach to the CNIL, knowing that when the breach does not entail any risk for the rights and freedoms of the persons concerned, you simply have to document it internally, if the breach entails a risk, you have to document it internally and inform the CNIL within 72 hours, and finally, if the risk is high, you have to document it internally, notify it to the CNIL and inform the persons concerned as soon as possible

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