PATIENT INFORMATIONS – CLINICAL STUDIES
Individual Information Notice regarding the processing of your personal data in the context of retrospective study for the validation of electrophysiological signal analysis algorithms and the performance of medical devices for the acquisition and analysis of electrophysiological signals.
1.WHAT IS THE VALIDATION OF ELECTROPHYSIOLOGICAL SIGNAL ANALYSIS ALGORITHMS AND THE PERFORMANCE OF MEDICAL DEVICES ?
The purpose of using your personal data is to carry out a retrospective study called “Validation of electrophysiological signal analysis algorithms and the performance of medical devices for the acquisition and analysis of electrophysiological signals”.
The purpose is to validate automatic analysis algorithms and to ensure the performance of medical devices for signal analysis, in order to help physicians better detect and analyze neurological disorders (such as epilepsy or sleep apnea) and to facilitate medical diagnosis.
2. WHO IS CONDUCTING THE RESEARCH ?
An organisation has decided to conduct this research and to provide the means to carry it out: BioSerenity Medical Devices Group, a private entity located at 6/8 rue Jean Antoine de Baïf, 75013 Paris.
The implementation of this research is in line with the legitimate interests of BioSerenity Medical Devices Group relating to the development of new medical devices and the improvement of diagnostic care for patients.
Furthermore, BioSerenity processes your health data for scientific research purposes in accordance with GDPR Article 9.2.j.
3. WHAT DATA IS PROCESSED AS PART OF THE RESEARCH ?
This study is retrospective.
The data is drawn from your medical record compiled during you receive medical care by BioSerenity Life.
The categories of personal data required are:
- Identification data: Age (truncated to year and month), sex, and registration number or alphanumeric code;
- Administrative data: Electronic contact details (email) for individual information;
- Health data: Weight, height, medical history, treatments (medications), electrophysiological signals (EEG, ECG, polysomnography), examination results and diagnoses;
- Lifestyle habits: Sleep-related behaviors and lifestyle habits recorded in routine questionnaires;
- Video data: Video recordings during polysomnography and long-term at-home video.
4. WHO WILL SPECIFICALLY HAVE ACCESS TO MY DATA ?
Only authorized persons may access it:
- BioSerenity’s DataScience, clinical and regulatory teams;
- The scientific coordinator
- Healthcare professionals (physicians and technicians) employed by BioSerenity or external, responsible for annotating signals to validate the algorithms;
- Staff responsible for quality control and auditing;
- Legally authorized health and regulatory authorities.
Your data is hosted on servers certified as “health data host provider” (HDS).
5. IN THE CONTEXT OF THIS STUDY, CAN MY DATA BE TRANSFERRED OUTSIDE THE EUROPEAN UNION ?
Your personal data is not transferred outside the European Union in the context of this study.
6. HOW LONG IS MY DATA RETAINED ?
Data will be made available for research for up to 3 years after the last publication of results or the signing of the final report. It will then be archived for a maximum of 20 years.
7. WHAT ARE MY RIGHTS REGARDING MY DATA USED IN THE STUDY ?
Your participation in this study is entirely voluntary and any objection on your part would not affect the quality of your care or the quality of your relationship with the care team.
The processing of your data for research purposes is not mandatory. Furthermore, you have several rights regarding this data :
- The right to object allows you, if you do not wish your health data to be reused for this research, to object. The right to object may be exercised at any time and will not affect your care or the relationship with the medical team at your healthcare facility. You do not need to justify your decision;
- The right of access allows you to request access to your data and to obtain a copy of it;
- The right to rectification allows you to request that your data be corrected if you find that it contains an error;
- The right to erasure allows you to request that your data be erased. However, certain data may not be erased if such deletion is likely to make it impossible or seriously compromise the achievement of the research objectives;
- The right to restrict the use of data relating to you, which temporarily prevents their inclusion in the research, in specific circumstances.
To exercise these rights, you must contact the Data Protection Officer at BioSerenity. Here are the contact details you need:
| Organisation | Email adress | Postal adress |
|---|---|---|
| BioSerenity Medical Devices Group | dpo@bioserenity.com | Data Protection Officer BioSerenity Medical Devices Group, 6/8 rue Jean Antoine de Baïf 75013 Paris |
If you believe that your rights regarding the use of your data have not been respected, you may contact the Commission Nationale de l’Informatique et des Libertés (CNIL) to file a complaint (https://www.cnil.fr/plaintes ou CNIL – Service des Plaintes – 3 Place de Fontenoy – TSA 80715 – 75334 PARIS CEDEX 07). CNIL is the supervisory authority responsible for monitoring compliance with data protection rules, in order to protect the fundamental rights and freedoms of individuals with regard to data processing.