Privacy Policy Research and Clinical Trials

Privacy policy applicable to individuals participating in our research and clinical trials (physicians and/or subjects whose data are used for research and/or trial purposes)

This Privacy Policy describes all the data processing that we may carry out within the framework of our research and clinical trial activities. For complete information on the nature of the processing we carry out, and also on your rights and how to exercise them, please also consult the information contained in Volta Medical's General Data Protection Policy.

What categories of personal data are we likely to collect and process in our capacity as Data Controller?

The categories of data we collect depend on the type of research/clinical trial we are conducting and your role in the concerned research/trial (patient, professional involved, etc.). In this context, the data we are likely to collect includes the following:

With regard to natural persons whose data enables us to carry out our research and/and clinical trials

For data on persons participating in or concerned by a research project/clinical trial (excluding research carried out on the basis of data relating to "PMSI", the French program for the medicalization of information systems)
Please note: The data collected varies based on the intended type of research/clinical trial. Through a specific information notice issued by the doctor in charge of the study/clinical trial, you will be informed of the specific data collected as part of the research or trial concerned and of all the essential characteristics of the processing carried out on such data. The data listed below may include the following:

Identification data: Age or date of birth (month, year, or even day if the latter is required for conducting research/trial), place of birth, sex, country and department of residence, serial number or alphanumeric code excluding surname(s), first name(s) (i.e. directly identifying data)
Health data: Data strictly necessary for the implementation of research and clinical trial (such as: weight, height, medical history, therapies followed, test results, medical imaging, data relating to adverse effects and events occurring during the research or clinical trial, health data relating to a health status likely to influence the results or make participation in the research impossible.
photographs and/or videos and/or voice recordings that do not allow the identification of the data subjects of the research/clinical trial (e.g. with masking of the face, eyes, distinguishing features) and collected under conditions compliant with the applicable provisions on image and voice rights
dates relating to the conduct of the research/clinical trial (specifically, date of inclusion and dates of visits or data collection)
ethnic background
genetic data strictly necessary to meet the objectives or purposes of the research/clinical trial, which may under no circumstances be used to identify or re-identify individuals
family status
level of education (such as primary, secondary, higher)
socio-professional category (such as INSEE classification)
career history (such as current and previous employment, unemployment, business travel and commuting, occupational exposure)
social security affiliation (excluding the registration number in the French national register for the identification of natural persons), supplementary insurance (mutual insurance, private insurance)
participation in other research, studies and clinical trial, to ensure compliance with inclusion criteria
travel (such as to the care or research/clinical trial site: mode of transport, duration, distance)- use of tobacco, alcohol, drugs
lifestyle and behavioral habits, such as: dependence (individual, institution, independent, bedridden), assistance (home care, family), physical exercise (intensity, frequency, duration), dietary habits, leisure activities;
lifestyle, such as urban, semi-urban, nomadic, sedentary; housing (detached house or apartment building, floor, elevator, etc.)
sex life
vital status, when this information appears in the source document or is known to the professional involved in the research
reimbursement of expenses incurred by the research subject in conjunction with the research
quality of life scale, or other information on the person's quality of life

For data relating to professionals involved in research/clinical trial: As part of this research or clinical trial, we also collect personal data concerning the professionals involved, such as scientific officers, participating physicians, and, where applicable, staff involved in the research/trial

First and last name, status, telephone number, professional contact information (email, address, landline and cell phone numbers), department, unit and address of the unit in which you practice, your professional identification number (RPPS), URSSAF number (if applicable), professional background (résumé), contract(s) entered into with us if any. University practitioner: Institute, first and last name of the dean and/or director of the institute with internal responsibility/Department director, head of commission, signature, position, date of signature, hospital stamp, professional correspondence. Where applicable: Bank details, remuneration, hospitality, date of interactions with us, technical data relating to the use of medical devices developed by us.

For clinical research assistants: First and last name, status, telephone number, professional contact details (email, address, landline and mobile telephone numbers), department, unit and addresses of the unit in which you practice. Where applicable: Bank details and remuneration, hospitality, dates of interaction with us.

With regard specifically to studies conducted on the basis of data originating from the French medical-based information system (also called "PMSI"):

The PMSI is a summarized, standardized collection of administrative and medical data compiled from public and private healthcare facilities in France. The data compiled in this set is collected by the French government agency known as "L’Agence Technique de l’Information sur l’Hospitalisation" [Agency for Information on Hospital Care], hereinafter referred to as ATIH.

The French government has two main objectives in compiling this set: Specifically, to organize hospital care in France and its territories, and to fund healthcare facilities on the basis of their activity.

However, the data contained in the PMSI can also be made available to those who manufacture or sell healthcare products for re-use under certain conditions.

These conditions for reusing PMSI data are outlined in Reference Methodology MR-006 (Deliberation no. 2018-257 of June 7, 2018 approving a reference methodology relating to data processing requiring access on behalf of persons manufacturing or selling products mentioned in II of Article L. 5311-1 of the French Public Health Code) for PMSI data centralized and made available by ATIH via a secure solution (MR006).

The PMSI data that can be made available to us includes data centralized and made available by the ATIH for the following activities:
- medicine, surgery, obstetrics, and dentistry (MCO)
- follow-up and rehabilitation care (SSR)
- collection of medical information in psychiatry (RIM-P)
- home hospitalization

The data relevant to each study is listed in the scientific protocol, the summary of which has been declared to the public directory maintained by the Institut National des Données de Santé [National Institute for Health Data] (INDS). Studies registered with the INDS can be consulted here: https://www.health-data-hub.fr/projets.

With regard to the processing of data relating to the persons responsible for carrying out the study (staff of the research office/laboratory in question), the categories of data that we are likely to process are as follows: first and last name, job title, access profiles, business telephone, postal, and email address where applicable, employer's organization, training, degrees and qualifications, elements required for the assessment of knowledge in order to carry out the study.

What do we use this data for? What are our objectives?

We may process your data for the purpose of fulfilling the objectives set out below:

Purpose no. 1: Data processing carried out as part of our research activities involving or not involving the human person

The use we make of this data depends on our research/clinical trial objectives.

Volta Medical conducts several types of research and trial involving or not involving the human person as defined by the French Public Health Code. Data is collected in application of a research protocol validated by the study's scientific director as part of a research contract signed with the relevant healthcare facility, a research laboratory, or a research firm.

A specific information notice is distributed to any person likely to be part of research and/or trial. This information notice presents the information required by law, including the specific purposes of the data processing.

For data processing carried out as part of studies requiring access to PMSI data, the data subjects of the studies are notified by the notice available here and available for consultation on our website at any time.

If you wish to receive additional information, we encourage you to contact us using the contact information given in the "Contact " tab of Volta Medical's General Data Protection Policy.

In the context of these research and clinical trials, we also collect personal data concerning the professionals involved, such as scientific officers, participating physicians, and, where applicable, staff involved in the research.

In the context of these research and clinical trials, we are data controllers, and the healthcare facilities/physicians, research labs, or firms that process data on our behalf are our data processors as defined by the GDPR.
In some cases, other entities may also be considered as joint data controllers; in such cases you will be informed in the information notice communicated to you by appropriate means.

Purpose n°2 : Data processing carried out as part of our statutory obligations concerning transparency and the avoidance of conflicts of interest

In strict compliance with applicable regulation, we may compensate, pay, or award hospitality to healthcare professionals. We may also make donations for research or for organizations, or fund training in the field of healthcare. Consequently, we collect information needed for completing procedures required by regulations concerning transparency and the avoidance of conflicts of interest.

What is the legal basis under which we operate?

The legal basis for processing depends on the purpose of the intended processing. Please refer to the section corresponding to your situation.

Purpose no. 1: Processing of data carried out as part of our research activities involving or not involving the human person (including research carried out on the basis of data originating from the PMSI)

With regard to the processing of the personal data of data subjects of research sponsored by Volta Medical, the legal basis is the legitimate interests of Volta Medical, without, however, infringing on the interests or fundamental rights and freedoms of the data subjects. An information notice is communicated to data subjects detailing the applicable legal basis and specifying what legitimate interests we are pursuing.

With regard to the processing of the data of professionals involved in these research and clincial trials, the legal basis is our legitimate interest or the performance of the contract entered into with the professionals concerned, or Volta medical’s compliance with its legal obligations (e.g. With regard to declarations of interest and the management of potential conflicts of interest). A specific information notice is sent to these professionals within statutory timeframes, indicating the legal basis applicable to the intended processing.

Purpose n°2 : Data processing carried out as part of our statutory obligations concerning transparency and the avoidance of conflicts of interest

The legal basis for this processing is compliance with our legal obligations. A GDPR-compliant notice is provided in this regard to the healthcare professionals and data subjects by appropriate means.

How long do we keep your data?

The data retention period depends on the purpose for which it is processed. Please refer to the section corresponding to your situation.

Purpose no. 1: Data processing carried out as part of our research activities involving or not involving the human person

With regard to the data of persons participating in research/clinical trials conducted by Volta Medical: Data are stored throughout the period needed for the research/clinical trial, plus the various periods authorized by regulations. At the end of this data retention period, personal data are either anonymized or destroyed in a securely manner. Exact information on data retention periods is given in the specific information notice for the research or clinical trial concerned.

Exact information on data retention periods is given in the specific information notice for the research concerned.

With regard specifically to research conducted on the basis of data originating from PMSI: Access to data and its storage within the secure solution are strictly limited to the duration of the study. When Volta Medical demonstrates the need, this period may be extended up to a maximum of two years from the last publication of the results. The data of persons in charge of research for PMSI studies is retained for a maximum of 5 years after the end of the research, or for a period in accordance with applicable regulations.

Purpose n°2 : Data processing carried out as part of our statutory obligations concerning transparency and the avoidance of conflicts of interest

Data is kept for the period during which we are in contact with the person for whom the declarations/authorizations are required by law. At the end of this period, the data is securely archived for a period of 5 years so we can protect ourselves against any litigation.

Who receives the data?

Data recipients will differ depending on the intended processing. Please refer to the section corresponding to your situation.

Purpose no. 1 : Data processing carried out as part of our research activities and clinical trials involving or not involving the human person

The recipients of identifying data of persons concerned by research and clinical trials sponsored by Volta Medical may include the following :

the data controller and natural or legal persons acting on the controller's behalf, when they are strictly authorized to access the data and when their participation is necessary for data processing in the context of research or a clinical trial
the principal investigator
professionals involved in the research or trial, and personnel acting under their oversight and authority
persons in charge of data collection, quality control, processing, and analysis of data
persons responsible for regulatory affairs and for registering the research/clinical trial with the competent authorities
personnel of health authorities and public supervisory authorities legally authorized in the context of a specific procedure or mission, or the exercise of a right of communication
authorized personnel acting under the oversight of the insurance organization guaranteeing Volta Medical's civil liability, specifically in application of article L.1121-10 of the French Public Health Code
independent experts responsible for re-analysis of data to verify research or clinical trial results.

The recipients of directly identifying data of the subjects of research and clinical trials sponsored by Volta Medical may include the following:

the professionals involved in the research and the personnel acting under their oversight or authority, concerning the people for whose care they are responsible in the context of the research or clinical trial (in particular your doctors and their staff)
the persons responsible for quality control and quality assurance during visits to the investigating sites to monitor and assess the quality and authenticity of the data collected, specifically by comparing the data recorded with the content of the source documents (an Agence Régionale de Santé [Regional Health Agency] known as "ARS", and its foreign equivalents). Under Volta Medical's oversight, these individuals also ensure compliance with provisions relating to the privacy and protection of subjects
members of independent supervisory committees, as defined in article L.1123-7 of the French Public Health Code
Volta Medical's DPO, only when contacted directly by the data subject
authorized personnel acting under the oversight of the insurance organization guaranteeing Volta Medical's civil liability, specifically in application of article L.1121-10 of the French Public Health Code
personnel of health authorities and public supervisory authorities legally authorized in the context of a specific procedure or mission, or the exercise of a right of communication

Recipients of the data of the professionals involved in the research and/or clinical trial may include the following:

the data controller and its data processors
the principal investigator and their collaborators
the professionals involved in the research or clinical trial, and personnel acting under their oversight
the persons managing regulatory affairs and registration of research/clinical trial with the competent authorities acting on behalf of Volta Medical or belonging to one of the companies in its group
employees of companies in the group to which Volta Medical belongs
personnel of health authorities and public supervisory authorities legally authorized in the context of a specific procedure or mission, or the exercise of a right of communication
authorized personnel acting under the oversight of the insurance organization guaranteeing Volta Medical's civil liability, specifically in application of article L.1121-10 of the French Public Health Code

These categories of persons, who are bound by professional secrecy, may also originate from organizations or structures outside Volta Medical (in particular the ARS [Regional Health Agency], professional bodies such as the French National Board of Physicians ["Conseil de l'ordre des médecins], the French Transparency Register or their international equivalents). You are encouraged to consult the privacy policies of these organizations.

Purpose n°2 : Data processing carried out as part of our statutory obligations concerning transparency and the avoidance of conflicts of interest

The necessary data are processed by authorized staff internally and are also disclosed to certain authorized third parties (in particular regulatory bodies, such as the Council of the Order of Physicians, the French Transparency Register, and their foreign equivalents, etc.). You are encouraged to consult the confidentiality policies of these bodies.

Is collection and processing of your data mandatory?

With regard to subjects of research and clinical trials sponsored by Volta Medical: Since participation in the research or trial is optional, individuals participating in such research or trial are notified by means of a specific information notice to ensure they understand what it entails and are aware of their rights. They are free to either participate in the research/trial or refrain from doing so without any impact on the healthcare they receive. If the research or trial in question allows it, they are free to withdraw their consent at any time.

In the case of research on data originating from PMSI (i.e. the French program for the medicalization of information systems), healthcare facilities and health insurers notify individuals of the potential re-use of data concerning them, by any means enabling the data subjects to be informed of the re-use of their data.
With regard to data processed as part of PMSI research sponsored by Volta Medical, information is provided to data subjects in accordance with the applicable reference methodology (also known as "MR-006"). Information is available here.

With regard to professional involved in the research or clinical trials : Participation in research/trial is not mandatory, but the collection and processing of data is necessary for the participation of the professional in question.

With regard to the fulfillment of our obligations concerning transparency and the prevention of conflicts of interest: The provision of data by the concerned person or by a third party is mandatory.

How do we collect your data?

With regard to individuals whose data is processed in the course of our research and clinical trials: Direct collection from individuals or indirect collection in the context of retrospective studies or studies conducted on the basis of PMSI data.

With regard to healthcare professionals in the course of their participation in our research or clinical trials: Direct collection from the data subjects or via their employer.

With regard to the fulfillment of our obligations concerning transparency and the prevention of conflicts of interest: Direct collection from individuals or indirect collection from third parties (including the individual's superiors).

Do we transfer your Data outside the EU ?

We may carry out data transfers to a country outside of the European Union in the framework of our operations. In this case, we will take all appropriate measures to ensure compliance with applicable regulations within the European Union. You may obtain a copy of these safeguards from our Data Protection Officer, whose contact details are specified in the “Contact ” section of Volta Medical’s General Data Protection Policy.

How do you exercise your rights?

For studies involving PMSI data, rights of access, rectification, and opposition may be exercised with the director of the organization managing the mandatory health insurance scheme with which you are affiliated, in accordance with the provisions of article R. 1461-9 of the French Public Health Code.

For other research and trials, you can exercise your rights through the study physician or through Volta Medical's Data Protection Officer, whose contact details can be found here under the "Contact" tab of Volta Medical's General Data Protection Policy.

However, health data processed by us is pseudonymized. Volta Medical does not know your identity; if you choose to contact our Data Protection Officer, the confidentiality of your identity therefore cannot be maintained.
If you decide to exercise your rights or submit questions about the processing of your personal data through the study physician, your identity can be kept confidential.

As with all other data processing carried out by Volta Medical, if at any time during the study or trial you feel that you have not been sufficiently informed of your rights, or that your rights have not been properly respected, you can contact the supervisory authority at the Commission Nationale de l’Informatique et des Libertés [National Commission on Data Privacy] (Mailing address: 3 Place de Fontenoy – TSA 80715 – 75334 PARIS CEDEX 07).

Can we modify this Policy ?

We may modify the content of this Policy at any time, following the evolution of our activities and/or in order to comply with our legal obligations. In the event of any amendments, these will be made and posted on the relevant pages of this Policy on our website. We recommend that you refer to these pages each time you visit our website. However, if the amendments to this Policy are substantial, we will draw your attention to this by publishing a disclaimer on our website.

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Privacy policy applicable to individuals participating in our research and clinical trials (physicians and/or subjects whose data are used for research and/or trial purposes)