Coordination of the GIHSN, supervision of implementation and data management/data hosting are supported by Impact Healthcare, an independent organization based in Paris, France, specializing in the strategic and operational management of large innovative projects in Digital Health and the use of Health data, both in France and internationally.
To comply with regulations on data access and privacy, the Foundation for Influenza Epidemiology set up a data access framework. Impact Healthcare is the Data Controller for the GIHSN (jointly with Fondation de France). Impact Healthcare is proposing an online data collection tool to ensure timely data sharing on the GIHSN platform.
The GIHSN database is hosted in a secured environment (certified secured hosting for health personal data). Data are processed in full accordance with the European General Data Protection Regulation (GDPR) and French data protection regulations.
Sites implementing the GIHSN protocol should be compliant with their ethical and national regulations for conducting the surveillance. Any obligation related to data protection and data transfer to Impact Healthcare platform should be anticipated.
With respect to existing WHO surveillance capacities, all data collected through the GIHSN Study questionnaires will be shared with corresponding National Influenza Centres and/or with WHO Collaborating Centres for Reference and Research on Influenza. Influenza strain genetic sequencing data will be shared via GISAID.
Data collected by sites receiving funding remains the proprietary of the site. There is no commercial use of the data. Donors of the Foundation for Influenza Epidemiology, who include, as of May 2023, Sanofi, Seqirus, Illumina, Abbott Diagnostics, do not have access to the data. The data are transferred through a secured channel and the site has full access to the data through a secured platform managed by Impact Healthcare.
Impact Healthcare is given access to the GIHSN data for epidemiologic research fulfilling the three following conditions:
- Analyses can only be performed for research purposes in line with the mandate of the Foundation (i.e. surveillance and monitoring of influenza and other respiratory viruses).
- Analyses are exclusively performed with pseudonymised data.
- Any analyses plan will need to be approved beforehand by the Independent Scientific Committee of the Foundation.
Analysis results will be submitted for publication. Scientific publications and communications will mention contributing sites, with investigators names in the authorship, in line with the ICMJE rules.
Sites will be informed upfront for any planned data analysis beyond the routine annual pooled analysis, and they have the possibility to opt-out.
