Last update 10/04/2024
PROTECTION AND PROCESSING OF YOUR PERSONAL DATA IN THE CONTEXT OF OUR HEALTH DATA WAREHOUSES (HDW)
Quantum Surgical SAS places the utmost importance on protecting your personal data and complying with the General Data Protection Regulation.
The purpose of this Transparency Portal is to provide you with clear and transparent information on how we process and use your personal data in the context of our health data warehouse authorized by the French Data Protection Authority (CNIL Decision DT2023-015 of Application for Leave No. 2230868).
Updates
The Transparency Portal is regularly updated to take account of new research we carry out. We invite you to consult it regularly.
Purposes of processing your personal data
The aim of the processing is to create a health data warehouse, in other words a database designed to bring together data from different sources that will be reused to conduct studies and research in interventional radiology to assist in the treatment of cancer patients, and in particular :
- identifying potential technical improvements in the use of the device ;
- the study and development of new functionalities for the device.
This warehouse is constituted on the basis of Quantum Surgical’s legitimate interest in carrying out such projects (Article 6.1 f) of the GDPR). The processing of health data is necessary for the purposes of scientific research (Art. 9.2 j) of the GDPR) and to ensure high standards of quality and safety of medical devices (Art. 9.2 i) of the GDPR).
Our ambition:
All research and studies carried out from this warehouse will be described in this Transparency Portal. We are not currently conducting any research here.
Definition: A personal data processing operation is an operation or set of operations involving personal data (for example collecting, storing your data, using it for research purposes, etc.).
Identification of the data controller
The data controller for the creation of the health data warehouse is Quantum Surgical SAS, simplified joint stock company, with a capital of €105,273.00 euros, registered with the Montpellier Trade and Companies Register under number 824393003, whose registered office is located at 1000 Rue du Mas de Verchant 34000 Montpellier (France).
Definition: A data controller determines the purposes and means of personal data processing, namely the objective of this processing and how it is implemented.
Categories of personal data
As part of our health data warehouse, we collect and process the following personal data:
- Identification data: age (month + year of birth), gender
- Personal life, lifestyle habits and quality of life: weight and height
- Health data: Organ affected, Medical history, Types of intervention, Number of lesions treated, Types of lesions (primary or metastatic tumors), Location of lesions treated, Size of lesions treated, Serious adverse events, Local tumor recurrence.
These data are non-nominative (pseudonymized), i.e. they do not include any information that could directly identify you (surname, first name, e-mail address…).
The collection of these data in our health data warehouse is non-obligatory. If you object, this will have no impact on your treatment by your healthcare establishment.
Definition: Personal data is any information that directly or indirectly identifies a natural person, based on a single piece of data (e.g. your first and last name, your e-mail address, etc.) or a combination of data.
Data sources
The health data warehouse brings together :
- Data entered in your medical record and data generated when using the Epione robot;
Shelf life: 20 years
Data recipients
Your personal data is used by authorized Quantum Surgical teams to conduct studies and research, intended to meet our regulatory obligations and improve the Epione robot.
Our collaborators involved in research are subject to a strict obligation of confidentiality and cannot directly identify you. Indeed, your first and last names are not collected in our health data warehouse.
Security
Quantum Surgical SAS maintains and implements technical and organizational measures to ensure the security of your personal data.
As such, our health data warehouse is hosted in France within Quantum Surgical’s premises. Data is encrypted at rest and in transit.
Our employees must be authorized to access your data and are subject to a strict obligation of confidentiality. They are also trained in security and personal data protection.
Your rights
You have :
- the right to access your personal data
- the right of rectification: correction of inaccurate, incomplete or ambiguous data
- the right to delete your data
- the right to define directives concerning the conservation, deletion and communication of your personal data after your death
- the right to object to the re-use of your data for research purposes.
You can exercise these rights by contacting Quantum Surgical’s Data Protection Officer (dpo@quantumsurgical.com).
They will also be able to answer any questions you may have concerning the protection of personal data. Likewise, you may withdraw your consent to the supply of data to the health data warehouse at any time, without this in any way modifying the medical care provided by your doctor. The use of data already given prior to the withdrawal of your consent for research purposes will remain legitimate unless you object.
If, after contacting us, you feel that your rights with regard to information technology and civil liberties have not been respected, or that your data has not been processed in accordance with the regulations governing personal data, you may lodge a complaint with the Commission nationale de l’informatique et des libertés (www.cnil.fr).
Research list
Name of project |
Description of project |
Date of project |
Status |
| Epibone – NCT06376682 ClinicalTrials.gov ID: NCT06376682
|
Pre-market study for bone percutaneous procedures | September 2024 – On going |
|