Study French PArADIsE :

Management of acute dyspnea in French emergency departments

 

Data controller :

Nancy University Hospital

29, Avenue du Maréchal de Lattre de Tassigny

54035 NANCY Cedex

Scientific coordinator :

Pr Nicolas GIRERD, CHRU de Nancy, Hôpitaux de Brabois

Scientific manager co-coordinator :

Pr Tahar CHOUIHED, CHRU de Nancy, Hôpital Central

 

 

Information

 

Dear Sir/Madam,

 

Your establishment is taking part in a new observational research project, "French PARADISE", which will be carried out using personal data collected as part of routine medical care.

You are concerned by this research if you have been treated for acute dyspnea (breathing difficulties) by an emergency department medical team in one of the healthcare establishments participating in the present research over the period below :

Establishments Period of care
CHRU de Nancy, coordinating center 2010-2021
Hospices civiles de Lyon, associate center 2018-2021
Dijon University Hospital, associate center 2010-2021
Besançon University Hospital, associate center 2010-2021

 

The aim of "French PARADISE" is to assess the risk factors associated with changes in the health status of patients treated for acute dyspnea.

This research is part of the public interest mission of the Nancy CHRU, which is to ensure and contribute to research and innovation.

The public interest of this study, its scientific quality and its ethical relevance were assessed by an ethical and scientific committee for research, studies and evaluations in the health field, independent of the data controller. The public interest has been validated by the CNIL.

Who is responsible for processing the " French Paradise" study ?

The organization that decided to carry it out, and which is legally responsible for it, is the CHRU de Nancy. If you have any questions or specific requests, please contact the scientific manager by e-mail at cic@chru-nancy.fr

What data will be used in the " French Paradise" study ?

  • - health data (age, gender, pathologies, care data, management, health history, biological results, diagnoses, treatments, medical X-rays, co-morbidities, hospitalizations, healthcare consumption, etc.);
  • - vital status data ;
  • - medico-administrative data ;
  • - hospital activity data.

This data, which is strictly necessary for research purposes, concerns your hospitalization and your follow-up up to the date of the last news. The data will come from the health establishments where you were hospitalized, and from the National Health Data System (SNDS). We will use the social security number to match the databases with the SNDS data. The social security number will only be used for this purpose.

The SNDS (https://www.snds.gouv.fr) brings together several national databases (Assurance Maladie data, hospital data, medical causes of death, etc.), under the responsibility of Assurance Maladie. Its purpose is to make these data available for studies, research or evaluation in the public interest. In this context, it can be used by the facility's healthcare professionals, who can also cross-reference it with the facility's own care data.

Who will have access to the data in " French Paradise" ?

Data will be accessed by those responsible for carrying out the study: data controller and subcontractors, scientific managers, professionals responsible for carrying out the study, professionals responsible for data processing and analysis.

Who will host your personal data for the " French Paradise" study ?

Your personal data will be stored in a secure project area of the Health Data Hub (HDH: https: //www.health-data-hub.fr/ ) for an estimated period of 7 years. It will then be archived for a period of one year.

The HDH secure project space is hosted in Microsoft data centers located in the French zone, certified as a "health data host". No health information will be transferred outside the European Union.

All your data will be processed in coded form (randomly assigned sequence number) to guarantee confidentiality.

How can you exercise your rights regarding your personal data?

The use of your data in this study is not obligatory.

You have a number of rights with regard to the personal data used for the study. You can object to the use of this data, or request access, rectification or restriction:

To exercise your rights, you can contact the Data Protection Officer (DPO) of the CHRU de Nancy by e-mail or by post:

  • - dpo@chru-nancy.fr
  • - CHRU de Nancy- Hôpital Marin, 92 Avenue du Maréchal de Lattre de Tassigny, 54035 NANCY Cedex.

If, after contacting us, you feel that your rights with regard to data processing, data files and individual liberties have not been respected, the Commission Nationale de l'Informatique et des Libertés - CNIL (the French data protection authority) may receive your complaint on its website: https: //www.cnil.fr/fr/webform/adresser-une-plainte.