Background

Following the occurrence in the United States of cases of severe lung disease among users of e-cigarettes or other vaping devices and the alert issued by the Centers for Disease Control and Prevention (CDC) in late August 2019, Santé publique France, in collaboration with its partners, is establishing a system for reporting cases of severe lung disease among users of electronic vaping devices (e-cigarettes, vaporizers) or those who engage in “dabbing.”

The collection of reports relies on all hospital departments likely to treat patients with severe pneumonia (emergency departments, inpatient wards, including intensive care units).

Objectives of the survey

The objectives of this investigation are to:

• detect the possible emergence in France of an outbreak of severe lung disease linked to vaping, similar to that observed in the United States,

• describe the epidemiological, clinical, and toxicological characteristics of the cases, and, if possible, the composition of the products consumed, in order to identify the cause(s) of these lung diseases.

This specific surveillance initiative is not intended to monitor potential risks associated with vaping.

Conduct of the investigation

In accordance with Article L. 1413-7 of the Public Health Code, physicians diagnosing a case (see below) must report it as soon as possible (if possible within 24 hours).

The reporting form includes the clinical and epidemiological data necessary to describe the case, as well as data identifying the patient and the reporting physician.

Healthcare professionals: report a case via the Ministry of Health’s reporting portal.

The reporting form will be automatically sent to the ARS’s surveillance, alert, and health management unit. Santé publique France, in collaboration with institutional partners, will follow up with the reporting physician and the patient to conduct further investigations. In this context, the clinician informs each patient, as soon as their condition permits, that they may be interviewed, with their consent, about their vaping habits.

This reporting system will be adjusted based on the epidemiological situation in France and the international epidemiological situation (particularly in the U.S.).

Data Privacy

Santé publique France is responsible for the processing of personal data carried out by this system and based on the performance of a public service mission. The agency ensures compliance with the provisions of Law No. 78-17 of January 6, 1978, on information technology, files, and civil liberties (hereinafter the “Data Protection Act”), and implements technical and organizational measures to ensure the security and confidentiality of the personal data collected.

Data collected that allows for the identification of the patient and the physician will be deleted no later than 3 months after the conclusion of the case investigation. Other data will be retained in a pseudonymized form until the end of the investigation. It will then be anonymized and retained in this form for up to 5 years after the conclusion of the investigation.

The results of these investigations, which will not allow for the identification or re-identification of patients or physicians, may be included in reports or publications.

Rights of data subjects regarding the collected data (reporting physician and patient)

In accordance with the provisions of Article 56 of the French Data Protection Act, you may exercise your right to object to the processing of your personal data by contacting Santé publique France, Data Protection Officer of Santé publique France, 12 rue du Val d’Osne, 94415 Saint-Maurice Cedex, or by email at dpo@santepubliquefrance.fr. In accordance with the provisions of Articles 49 et seq. of the French Data Protection Act, you may exercise your rights of access, rectification, restriction of processing, and erasure of your data by contacting the same address.

The exercise of these rights is reserved for the data subject, except in the case of minors and adults lacking legal capacity, for whom the holders of parental authority or legal representatives are authorized to exercise these rights.

You may exercise these rights upon verification of your identity, and such rights remain available until Santé publique France deletes your identifying data.

For any questions regarding the processing of your data, you may contact the Data Protection Officer at Santé publique France: dpo@santepubliquefrance.fr.

In the event of a complaint, you may file a claim with the CNIL. We recommend that you first contact the Data Protection Officer at Santé publique France, who is available to answer any questions you may have.