HYGIE is a health data warehouse authorized by the Informatic and Freedom National Commission (CNIL Decision DT2023-015 from Authorization requirement n°2230868).
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Purpose of processing your personal data
The purpose of the processing is to create ahealth data warehouse, i.e. a database designed to bring together data from different sources, which will be reused to conduct studies and research ininterventional 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. The legal basis for this warehouse is 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 (Article 9.2 j) of the GDPR and to ensure high standards of quality and safety of medical devices (Article 9.2 i) of the GDPR.

Our ambition:
All research and studies carried out using this warehouse will be described in this Transparency Portal.
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Definition:
A personal data processing operation is an operation or set of operations involving personal data (e.g. collection, storage of your data, use for research purposes, etc.).

Identification of the data controller:
The data controller for the creation of the health data warehouse is Quantum Surgical SAS, a simplified joint stock company with 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, i.e. the purpose of the processing and how it is carried out.

Categories of personal data
As part of our health data warehouse, we collect and process the following personal data:
- Identification data: age (month + year ofbirth), gender
- Personal life, lifestyle habits and quality of life: weight, height
- Health data: organ treated; medical history; types of intervention; number, type, location and size of lesions treated, serious adverse events, local tumor recurrence, etc.

These pieces of data are non-nominative (pseudonymized), i.e. they do not include any information enabling you to be directly identified (surname, first name, e-mail address, etc.).

The collection of this data in our health datawarehouse is not compulsory. If you object, this will have no impact on your treatment by your healthcare establishment.

Definition: Personal data is any information enabling a natural person to be identified directly or indirectly, from a single item of data (for example, your first and last names, your e-mailaddress, etc.) or from a combination of data.

Data sources
The Health Data Warehouse gathers the data entered in your medical file and the data generated when using the Epione robot.
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Retention period: 20 years

Data recipients
Your personal data is used by Quantum Surgical's authorized teams to conduct studies and research designed to meetour regulatory obligations and improve the Epione robot.

Our employees involved in research are bound by a strict obligation of confidentiality.

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 on Quantum Surgical's premises in France.
Data is encrypted at rest and in transit.
Our employees must be authorized to access you rdata, and are bound by a strict obligation of confidentiality.
They are also made aware of the importance of security and personal data protection.

Your rights
You have the following rights:
- Access, to find out whether your data is used or not
- rectification: correction of inaccurate, incomplete or ambiguous data
- deletion of your data- limitation, to define directives concerning the conservation, deletion and communication of your data
- oppose 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).
He will also be able to answer any questions you may have concerning the protection of personal data. Likewise, you may object at any time to the data being fed into the health data warehouse, without this in any way modifying the medical care provided by your doctor. Data that has already been fed may still be used, unless you explicitly 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 is not being processed in accordance with the regulations governing personal data, you may you may lodge a complaint with the CNIL(www.cnil.fr).