Comprehensive follow-up of patients with total hip replacements with dual mobility cups.

Collective information note relating to the post-registration SNDS study for the comprehensive follow-up of patients with total hip replacements with dual mobility cups (EPI PTH CDM).

In accordance with the provisions of Article 14 of the GDPR, this collective information notice describes the measures implemented in the context of studies that do not allow for individual information and require access to data from the National Health Data System (SNDS).

• Data controller:
  OSTEAL MEDICAL LABORATORIES (CERAVER – CERAVERBIOTECH), with registered office at 69 rue de la Belle Etoile, 95700 ROISSY EN FRANCE, SIREN registration number 339 487 969, is conducting a study assessed as being in the public interest by the Expert Committee for Research, Studies and Evaluations in the Field of Health (CESREES) on 10 December 2020 (for more information on this subject, please visit https://www.health-data-hub.fr/outil-de-visualisation). This study is delegated to IQVIA Opérations France, located at 17 bis Place des Reflets, 92400 Courbevoie, SIREN registration number 347 939 415, which is responsible for implementing the processing.

• Contact details of the DPO, representative of the Data Controller: eu.dpo@iqvia.com

• Purposes:
  The main objective is to quantify and compare the overall survival rates of total hip replacement patients (implantation duration without revision) and dislocation rates in the group with dual-mobility cups versus single-mobility cups, overall and according to revision risk factors, through a national post-registration study.
  Legal basis: In accordance with Article 6 of the GDPR and Article 5 of the French Data Protection Act, the processing carried out in the context of this study is based on the public interest in pursuing research, studies, evaluation and innovation in health. This joint study involving some twenty manufacturers was set up at the request of the CNEDiMTS (HAS, opinion of 24 January 2017) for the renewal of the registration of these products on the List of Reimbursable Products and Services.
  In accordance with Article 9 of the GDPR, the processing of this personal data concerning health is for scientific research purposes.
  On 2 April 2020, the Ethics and Scientific Committee for Research, Studies and Evaluations in Health (CESREES) ruled that the study was in the public interest (number 1502850).
  The study has been authorised by the CNIL in accordance with Article 66 of Law No. 78-17 of 6 January 1978, known as the ‘Data Protection Act’, as amended (Decision DR-2020-210; 10 July 2023).

• SNDS data categories used :
  Data extracted from databases Data extracted from the SNIIRAM (National Inter-Regime Health Insurance Information System) and PMSI (Medical Information Systems Programme) databases held by the National Health Insurance Fund (CNAM) between 1 January 2012 and 31 December 2023.
  The data processed in the SDNS relates to hospitalisations (illness responsible for hospitalisation and associated comorbidities) and/or reimbursed care provided in the community (medical consultations, dispensing of treatments, medical procedures, etc.), as well as socio-demographic data (age/year of birth, gender, etc.).
  In accordance with the Public Health Code (CSP), the personal data contained in these databases does not allow the individuals to whom it relates to be identified.

• Data retention period: 3 years after it has been made available.

• Responsible for processing implementation and data recipients:
  The data is made available by the CNAM on the CNAM’s secure IT portal for the designated implementation manager, IQVIA.

• Data transfer: This data will not be transferred outside the European Union.

• Exercising rights and making complaints:
  In accordance with the GDPR and the French Data Protection Act, you have the right to access, rectify, restrict and erase data concerning you that is processed as part of the Study, which you can exercise by contacting the Data Protection Officer of IQVIA Opérations France, Ms Barbara BRESSOLLES, at the following address: eu.dpo@iqvia.com.
  We remind you that for general opposition to any reuse of SNDS data, the provisions of Article R 1461-9 of the CSP relating to the exercise of rights stipulate that the rights of access, rectification and opposition may be exercised by contacting the Health Data Platform Directorate (Health Data Hub, https://www.healthdata-hub.fr/contact) or the director of the compulsory health insurance organisation to which you are affiliated.
  You also have the right to lodge a complaint with the Commission Nationale de l’Informatique et des Libertés (CNIL) online or by post at CNIL – Service des Plaintes – 3 Place de Fontenoy – TSA 80715 – 75334 PARIS CEDEX 07.