Why was the database created?
The FRESH registry "Observatoire Française de l'Insuffisance Cardiaque" (French Heart Failure Observatory) allows to know the number patients suffering from heart failure in France, and to improve knowledge about the treatments implemented and the patients' care pathways.
What data does the database contain?
- Population of interest
- Patients with chronic heart failure or hospitalized for acute heart failure, in a participating healthcare facility.
- Main inclusion criteria
- Any patient over 18 years of age with chronic heart failure, and any patient hospitalized for acute heart failure, whether de novo or not. The diagnosis of heart failure is under the responsibility of the cardiologist including the patient.
- Age group
- Older adult (65 and over) Adult (18 to 64)
- Data category
- Identification data (not directly identifying) Medical and administrative data Socio-professional data Treatments Biological data Clinical data
- Data collection methods
- eCRF
How is the data managed?
- Database documentation
Why is the database legal?
- Data controller
- Société Française de Cardiologie
- Legal basis
- The FRESH registyr is implemented by the French Society of Cardiology for the performance of a mission of public interest (art. 6.1.e of the GDPR). The processing of health data is based on the purpose of scientific research (art. 9.2.j GDPR).
- Data quality and completion
- Clinical data are collected directly from patients by physicians or under their responsibility, ensuring a first level of quality. A consistency check of these data is carried out under the control of the SFC. The SNDS data are kept up to date, on an annual basis. A data preparation pipeline makes it possible to carry out data quality work, in particular ensuring their consistency.
- Data transfer outside the EU
- The data are collected through an observation notebook hosted by IBM Cloud. These data are processed within the European Union. Maintenance operations on this platform are carried out by IBM teams located in the European Union. In exceptional cases where the European teams would not be able to solve an operating problem, access may be provided to IBM teams located outside the European Union for the sole purpose of this maintenance. In this situation, IBM undertakes to comply with data protection rules equivalent to European regulations, in accordance with the standard contractual clauses issued by the European Commission.