N° F20221214115412

PMCF Study of Virage OCT spinal system 2023

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Objectif(s) de la recherche et intérêt pour la santé publique

Objectifs poursuivis

Autre

Domaines médicaux investigués

Autre

Bénéfices attendus

This processing of health data is authorized because it is necessary for scientific research purposes (article 9 of the GDPR) and meets the legitimate interests pursued by LDR Médical SAS as industrial sponsor. Indeed, this study is carried out within the framework of the Post-Market Clinical Follow-up activities of the studied device. The objective of this study is to obtain clinical data in order to maintain the CE mark of the device and not to demonstrate scientific hypotheses for the development of biological or medical knowledge. The objectives of maintaining the CE marking of the device and keeping the device on the market are of public interest for orthopaedic professionals and patients who will continue to benefit from this technology.

Données utilisées

Catégories de données utilisées

Informations relatives aux pathologies des personnes concernées
Autre

Source de données utilisées

Autres sources

Variables sensibles utilisées

Année et mois de naissance
Date de soins
Date de décès (le cas échéant)

Acteurs finançant et participant à l'étude

Responsable(s) de traitement

Type de responsable de traitement 1

Entreprise du médicament

Responsable de traitement 1

LDR Médical SAS

5 rue de Berlin 10300 Sainte-Savine

Calendrier du projet

Terminé
Date de début : 01/03/2022 – Date de fin : 01/10/2023 Durée de l'étude : 18 mois
Etape 1 : Dépôt du projet
14/12/2022

Base légale pour accéder aux données

Destinataire(s) des données

Destinataire des données 1

Zimmer Biomet Spine Inc.

Westminster 10225 Westmoor drive 80021

Destinataire des données 2

Multihealth/Statitec

Velizy Villacoublay Velizy Espace- Bat. Santos Dumont,13 avenue Morane Saulnier 78140

Durée de conservation aux fins du projet (en années)

15

Fondement juridique

Article 6 du RGPD (Licéité du traitement)

(1)(f) intérêts légitimes du responsable de traitement

Article 9 du RGPD (Exception permettant de traiter des données de santé)

(2)(j) archives, recherche scientifique ou historique, ou statistiques

Transfert de données personnelles vers un pays hors UE

  Oui

The transfer outside the European Union of indirectly identifiable data of patient and directly or indirectly identifiable data of professionals involved in the research is strictly necessary for the implementation of the research or the exploitation of its results, under the conditions provided for in Chapter 5 of the GDPR.. . The transfer is carried out with appropriate safeguards, listed in Article 46, paragraph 2, of the GDPR (in particular: standard contractual clauses approved by the European Commission, binding corporate rules, code of conduct, certification mechanism).. . The sponsor has previously informed the data subjects of the fact that the controller intends to transfer personal data to a third country or international organisation and the existence or absence of an adequacy decision by the Commission, or appropriate or suitable safeguards and the means by which to obtain a copy of these suitable safeguards or where they have been made available in accordance with Article 13(1)(f) of the GDPR.. . To adequately protect personal data in accordance with European data protection laws, Controller has (i) entered into an internal data transfer agreement with all subsidiaries, which is based on the EU Standard Contractual Clauses [SCCs] (and makes the EU SCCs binding on third parties where personal data is transferred to them); and (ii) carried out a transfer impact assessment in relation to each international transfer to duly assess that the SCCs will be complied by data importer taking into account local laws and practices of local authorities.

Droits des personnes

In accordance with the French Data Protection Act n°78-17 of January 6, 1978, as amended, and Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (GDPR: General Data Protection Regulation), the Data subject shall have the right of access, to rectification, to erasure, to restriction of processing and to data portability.. All of these rights must be exercised with the surgeon participating in the study or directly with the Sponsor LDR Médical SAS (privacy.emea@zimvie.com or by mail to Hogan Lovells International LLP, Paseo De la Castellana 36-38, 28046 Madrid, Spain), and this, with proof of identity.. . Any rectification or erasure of personal data or restriction of processing carried out in accordance with Article 16, Article 17(1) and Article 18 of GDPR should be communicated to each recipient to whom the personal data have been disclosed, unless being impossible or involves disproportionate effort.

Délégué à la protection des données

Hogan Lovells International LLP

Paseo De La Castellana 36-38 28046 Madrid

privacy.emea@zimvie.com