In an effort to update its health data standards, the French Supervisory Authority (CNIL) has launched a public consultation [c233755f]. The CNIL has previously issued health data standards, but some of them have become outdated and no longer align with industry practices. Interested stakeholders are encouraged to participate in the consultation by completing a questionnaire before July 12, 2024 [c233755f].
The public consultation covers a range of topics related to health data, including research activities, pharmacovigilance, adaptation due to the increasing use of artificial intelligence (AI), and specific documentation that the CNIL could provide. It also addresses participation in upcoming working groups [c233755f].
Additionally, the CNIL has provided guidelines on decentralized clinical trials, which cover electronic information notices, patient follow-up and monitoring at home, and remote quality control [c233755f].
The CNIL will analyze the responses received during the consultation and update the health data standards accordingly. Some updates are expected to be implemented in 2025 [c233755f].
In a separate development, the CNIL has published a new set of guidelines on the development of artificial intelligence (AI) systems from a data protection perspective [852fcd57]. The guidelines, called the July AI Guidelines, provide guidance on various aspects of AI system development, including the legal basis for legitimate interest, open-sourcing models, web scraping, informing data subjects, respecting data subjects' rights, annotating data, and ensuring the safe development of an AI system [852fcd57].
The CNIL has also published a questionnaire to gather input on the conditions under which AI models can be considered anonymous. The guidelines will be subject to public consultation until September 1, 2024 [852fcd57].