Data Confidentiality and Individual Rights

Entred 3 is a public interest survey classified as non-interventional research involving human subjects that received approval from the South East 1 Human Subjects Protection Committee (CPP) on July 10, 2017 (internal CPP reference: 2017-43; RCB ID No.: 2017-A01337-46).

The Entred 3 study (National Representative Control Sample of People with Diabetes) involves the processing of personal data based on public interest and authorized by the National Commission for Information Technology and Civil Liberties (CNIL) on December 20, 2018, No. 918004 (DR-2018-325). This processing is carried out under the responsibility of Santé publique France, the National Health Insurance Fund (CNAM), and Social Security for the Self-Employed (SSI), partners in this study, which aims to better understand the needs and the way in which the 3 million people with diabetes in France are monitored, in order to improve the quality of care and, consequently, the health and quality of life of these individuals.

Processing of Personal Data

The Entred 3 study is based on the collection of health-related data from:

• participants selected from among CNAM and SSI policyholders;

• their treating physicians;

• and their health insurance providers.

Data is collected and analyzed under conditions that guarantee confidentiality and respect for the privacy of individuals involved in the Entred 3 study.

Thus, the data processed is pseudonymized for the purposes of collection and analysis: data that could directly identify you (last name, first name, address) is separated from the data required for analysis. A random number assigned by Santé publique France allows, if necessary (for the exercise of your rights or for the data collection provided for in the study protocol), for a link to be established between your identifying data and the data required for analysis.

During data collection, only Santé publique France staff and the personnel of its subcontractors will have access—to the extent strictly necessary for performing the task assigned to them—to the identifying data and the data collected from participants and their treating physicians.

Data analysis will be conducted by Santé publique France and its partners (CNAM, SSI, HAS, ANSM, research teams) using pseudonymized data (data linked to a random number with no reference to the identity of the individual concerned).

All data will be collected for a period of 20 years.

Your rights

Participation in the Entred 3 study is voluntary, and you may withdraw your consent at any time, for any reason, without having to provide an explanation.

Furthermore, you have the right to object to the processing of your data, which may be exercised at any time by sending a signed letter accompanied by a copy of your ID¹ to: Santé publique France – Attention: Entred Project Manager – 12 rue du Val d’Osne – 94415 St Maurice Cedex.

You may exercise your right to access, correct, and delete your data, or even restrict its processing, under the same conditions.

Under no circumstances may the attending physician have access to information provided by their patient, or vice versa.

You may also contact the Data Protection Officer (DPO) of Santé publique France with any questions regarding the processing of your data by Santé publique France: dpo@santepubliquefrance.fr

If you believe that your data rights have not been respected, you may file a complaint with the CNIL. However, we recommend that you first contact the DPO of Santé publique France, who is available to assist you with these matters.