On May 16, 2024, the National Commission on Informatics and Liberties (CNIL) announced a very important public consultation alongside three critical updates impacting health research and clinical trials. These announcements are particularly significant as they address the rapidly evolving landscape of decentralized and dematerialized clinical trials. The CNIL's updates underscore its ongoing commitment to adapting regulatory practices to meet the current demands of health research and technological advancements in France.

3 updated guidelines on remote quality control, home monitoring, and electronic delivery of information:

1. Remote Quality Control for Clinical Trials: In the wake of the COVID-19 pandemic, the CNIL has updated its guidelines for remote quality control in clinical trials. These guidelines now require a CNIL authorization for any trials that began after January 1, 2022, and involve remote monitoring methods.
2. Home Monitoring in Health Research: The CNIL has clarified conditions for home monitoring of patients in health research. This practice is especially relevant for patients who cannot easily travel to research facilities due to their condition or study requirements. It underscores the need for robust data protection measures and patient consent when implementing home monitoring solutions.
3. Electronic Delivery of the ICF Data Protection Notice: Addressing the new communication methods in health research, the CNIL has provided guidelines for electronically sending ICF Data Protection Notice to study participants. This includes ensuring data security and confidentiality, particularly when sensitive health information is involved. The CNIL emphasizes the use of secure platforms and encrypted communications to protect participant data.

Urgent Call for Participation: Public Consultation on Health Binding Guidelines: The CNIL is actively seeking participation from stakeholders—including researchers, healthcare professionals, pharmaceutical companies, medical device manufacturers, and others—in a critical public consultation aimed at revising and enhancing its health data binding guidelines. This consultation, open until July 12, 2024, is a key opportunity to contribute insights that will help refine the guidelines and methodologies governing data processing operations in health research In France.

We recommend all stakeholders to make their voices heard in this significant process. Engage with the CNIL during the informative webinar scheduled for May 21 and contribute to the ongoing public consultation. Your input will directly influence the development of robust regulations that shape the future of health research.

For further details on how you can provide meaningful contributions and comments to the CNIL, and to participate in shaping these pivotal guidelines, do not hesitate to contact us.

Authored by Patrice Navarro.