ToU Version 2-20230713
The app that you are about to download has been designed to work on a mobile phone. It is not suitable for tablet or computer use. This app belongs to "KYomed INNOV and MASK-air” (hereafter referred to as “the app owner”), responsible for processing the personal data in line with the European regulation (GDPR / EU Regulation 2016/679 of the European Parliament and of the Council of April 27, 2016). The app was developed by the legal manufacturer Peercode. The security and data valorisation of the collected data are ensured by KYomed INNOV.
- MASK-air: 273 avenue d'Occitanie, 34090 Montpellier, France
- Peercode: Oudenhof 4, 4191 NW Geldermalsen, The Netherlands
- KYomed INNOV : 1682 rue de la Valsière, 34184 Montpellier, France
Impact of installing the app on your phone
You are about to download (free of charge) an app. It has been developed in compliance with safety and performance rules.
Neither the app owner nor Peercode can be held responsible for any malfunction of your personal phone after installation of the app. Should you update the operating system of your phone (Android / iOS), it is your responsibility to update the app in order to keep it running smoothly. Do not switch off “automatic updates” to ensure that your app remains state of the art and that you receive the latest version updates. It is your responsibility to ensure that you are using the latest version of the app, as is available in the app store. In order to use all intended functionality, your phone must be sufficiently charged and have a camera. Should you encounter issues with the app store, you can contact the app owner or the manufacturer.
This app provides direct / indirect links to other information, such as information on websites hosted by third parties over which the app owner has no control. The app owner cannot be held responsible for the use or content of this information.
MASK-air is a medical device Class IIa according to European Regulation (EU) 2017/745 and Class I according to the European Council Directive 93/42/EEC. (https://www.ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/DM-classe-I-DM-sur-mesure-assemblage-Declaration/(offset)/4). Outside the EU the product may be regulated differently and not considered a medical device.
Scope of use, purpose of the app
This app is intended to help you monitor your allergy/allergies and/or asthma. It will enable you to register your allergic or asthma symptoms and your medical treatments as well as the impact of the symptoms on your daily life. You are recommended to share this information with a healthcare professional (HCP) in order to better understand and control your allergy/allergies/asthma. The use of this app is not a substitute for medical advice or medical treatment. Do not change your treatment or your medication yourself based on this app without consulting your HCP. This app is not intended to record the side effects of medical treatment. If you have medical complaints or questions related to the use of the app, discuss these with your HCP. Should you experience a serious incident, this needs to be reported to the manufacturer (who will report this to the competent authorities). If you enter incorrect data and are unable to correct them, do not use this data and inform your HCP to ensure that any decisions are not influenced by such data.
The calculating algorithm, cautioning for uncontrolled symptoms lasting for 3 or more days, is based on free available literature publications: Bousquet J, et al. J Allergy Clin Immunol. 2016 Aug:138(2):367-374 [DOI: 10.1016/j.jaci.2016.03.025]; Bousquet J, et al. J. Allergy Clin Immunol. 2020, Jan:145(1)70–80 [DOI:10.1016/j.jaci.2019.06.049].
Respecting your privacy
This app has been designed to help you track your condition while respecting your privacy. Only the minimum amount of information needed to monitor allergic rhinitis/asthma is collected by the app. If you send an email address and a password through the app, this information is stored on a database - separate from the one that collects your personal information - and is protected by irreversible encryption. The e-mail address and password are only used to restore the history of your data if necessary. Your information is collected in three ways:
- A general profile (gender, year of birth, country of residence, as well as a few parameters to roughly describe your allergy/asthma)
- A report indicating: (i) symptoms (via a visual analogue scale whereby the intensity of the symptom is converted into a number (0 to 100)), (ii) the impact that rhinitis/asthma has on your daily life (via answers to questions (yes / no / do not know)), (iii) medical treatments (via a pre-defined list of treatments with a free-text field)
- Complementary questionnaires (on scientifically-validated questionnaires: the response methods are the same as for the above-mentioned report)
The information stored in the app stems from a self-assessment process and can be used by a HCP for information purposes without any guarantee of accuracy or completeness. If you so wish, the report can be geolocated. This function is managed by your mobile phone. This feature can be turned off at any time and this will not affect the overall functioning of the app. According to the CNIL (French National Commission for Data Protection and Liberties), geolocation is considered as identifying information. This information is reprocessed in accordance with a scientifically-validated process which ensures that your geolocation is impossible to associate with your use of the app. The symptoms are recorded once a day in the database. Similarly, the geolocation data can be recorded at most once a day with the symptomatic data.
For information, the list of medications is the one officially proposed by the health authority in your country of residence and corresponds to over-the-counter and / or prescribed treatments for allergic rhinitis and asthma.
Through the app MASK-air, no advertising of any form whatsoever will be sent to you.
Use of the app by minors
The app owner does not collect or use any personal data concerning minors (children under 18). We do not allow minors whom we can identify as such to communicate with us or to use our services.
If you are a parent and learn that your child has provided us with information, please contact KYomed INNOV, using one of the methods below, so that we can handle this situation together.
Particular vigilance is given to the encryption of the data when they are sent from the phone to the host of the database. This database is secure, certified and is located in the European Community (in France: OVH https://www.ovh.com/fr/). When transferring all or part of the database to a third party, an encryption method is used along with an https protocol.
For the sharing of information between a patient and his/her HCP during a consultation, a transfer protocol has been developed using the image capture of a specific QR code - available on the site (https: www.mask-air.org/data/) - on the user's phone. This specific QR code can be viewed on the screen of the HCP's computer. Only the information concerning the physically-present patient scanning the QR code can be transferred temporarily to the HCP’s computer. The process of scanning the QR code is not without risk of security breach. Nevertheless, everything has been set up by Peercode to enable a regular check of the system. In case of doubt or fault in the app data management security system, the app owner must notify all users of the app within a maximum of 72 hours.
In accordance with the GDPR, an impact study on the consequences of a breach in the security of stored data has been carried out; revealing that this impact is negligible.
Although KYomed INNOV secures all of the personal data that you provide, we invite you to be cautious when sending this type of data over the internet, especially when it relates to personal data concerning your health.
In accordance with the EU General Data Protection Regulation (GDPR) (2016/679 of the European Parliament and of the Council of 27 April 2016), we have to inform you about your rights when using a mobile app that collects personal data:
- You may at any time demand access to the information that concerns you,
- You may also ask to modify, correct or delete your personal data, restrict their processing, or withdraw your consent to the processing of your data,
- You may at any time request an export file of your data in a usual format (for example .csv)
To do this, please contact KYomed INNOV. KYomed INNOV is committed to responding within two months of your request. Such a request regarding the processing of your personal data may, depending on the circumstances, prevent us from continuing to offer you the services offered previously.
The app owner reserves the right to alter the functionalities of the app and / or to update the information, products and services contained in the app at any time and without notice. All information that is essential for the medical purpose of this software product will be in your language.
Use of collected data and valorization of the app
All rights, including copyrights and other intellectual property rights within the app, the underlying databases and the data you provide belong to the app owner.
The app owner allows you to consult the app and the information contained therein as well as to make copies for your own personal use, for example by printing (screen shots) or recording. Any other use of the app or of the information contained therein, such as, for example, the storage or reproduction of all or part of the app in an external website or the creation of links, hyperlinks or deep links between the app and any other website, is prohibited without the express written consent of the app owner.
In order to sustain the app and maintain its free use and download in all countries where available, the collected data can be sold as anonymous data to public or private companies for commercial or research purposes. As mentioned previously, no data collected by the app can identify you. If the geolocation is registered, it is post-processed so as to prevent any identification of the users of the app. Thus, all the data transmitted to a third party are, as defined by the CNIL, anonymous. Data are kept by the app owner for a maximum of fifteen years.
Continuity of activity
In the event of the app owner becoming subject to acquisition, merge, sale or other transaction and of the database being acquired by a third party, you agree in advance to this third-party purchaser and his / her advisers having access to your personal data, both during and after the transaction, in order to facilitate and finalize the transaction. When the transaction is finalized, you will be informed of the transaction, as well as its impact on the ownership and control of the database and the personal data that you provided to the app owner. The personal data will be transferred to these third parties, in accordance with the provisions and limitations of this document. If the third party does not take control of the app owner appropriately, the app owner will obtain permission from the third party to stop using your personal data.