The purpose of the GTU is to define the rights and obligations of the parties with regard to the use of the Application provided by iHealth.
Prior to any use of the Application, the User acknowledges having read and accepted all of the GTU, by ticking the checkbox provided for this purpose when first logging in to the Application.
- Changes to the GTU
The GTU may be updated at any time by iHealth, to take into account changes to the service or any evolution of the applicable law or for any other legitimate reason. The User shall be notified of any changes to the GTU so that he/she may then be informed of the version of the GTU applicable between iHealth and the User.
- Description of the Application
a) General Information
iHealth manufactures and distributes innovative connected healthcare products both for professionals and individuals: wellness products, medical devices, and applications for monitoring health data.
In the framework of these GTU, the User is informed that the Application is intended to operate with connected iHealth medical devices only (the "Products").
In addition, the User is informed that the Application is currently only compatible with the iOS operating system, and is therefore intended to be installed on Apple tablets only.
Users are also reminded that the information provided by the Application and all iHealth connected Products may not substitute for a medical diagnosis by a healthcare professional.
Lastly, Users are reminded that the use of the iHealth Application and of the connected Products is the responsibility of each User.
b) iHealth CardioPro
The iHealth CardioPro Application allows the use of:
- theiHealth CardioMed medical device (Ambulatory Blood Pressure Monitor, hereinafter referred to as "ABPM"), a Class IIa device,
- the iHealth CardioLab medical device (BP5(ABI)), a Class IIa device.
The iHealth CardioMed medical device is a connected ambulatory blood pressure monitor enabling to take measurements at regular intervals for 24 h or 48 h, day and night. It is installed by a health professional User (doctor, pharmacist, nurse) on a patient, who will keep it for 24 h or 48 h, as determined by the User.
The User initially configures on the Application the duration of the intervals between blood pressure measurements.
Upon expiration of the period prescribed by the User, the User removes the iHealth CardioMed device from the patient, and can analyse the measurements taken by consulting the Application.
The iHealth CardioLab medical device is a wireless cardiovascular monitoring system that measures or calculates blood pressure, but also a host of other cardiovascular vectors such as Ankle Brachial Index (ABI), Pulse Pressure (PP), Mean Arterial Pressure (MAP), Cardiac Output (CO) and Stroke Volume (SV).
- Use of the Application
a) General Information
The use of the Application is reserved for adults, being healthcare professionals as defined by the French Public Health Code (medical professions, pharmaceutical professions, medical assistants).
The use of the Application requires an Internet connection and equipment with reasonable performance. The User's material must be configured to allow the operation of the Application.
The Application only operates on an iPad (Apple brand tablet, under iOS) and is controlled by User accounts for each healthcare professional. Each healthcare professional has access only to his/her own User account and to information on his/her own patients. New patients are created by the healthcare professional in the Application. The information provided or entered in the User account is stored securely, in accordance with regulations applicable to health data.
- User Account
Access to the Application is provided through identification by a user name and a password entered during the creation of a User account. The use of the account is strictly personal.
When creating their account, Users must fill in all fields truthfully and accurately to ensure the proper operation of the Products and iHealth Application. A valid email address and mobile number are required to the proper functioning of the service.
The User warrants to iHealth that he/she is the only person that shall access the data stored in his/her account. The User must maintain the confidentiality of his/her user name and password. iHealth shall not be liable for any damage caused by a fraudulent use of the User's account as a result of the misuse of such account.
The User agrees to immediately notify iHealth of any unauthorised use of his/her account. Any lost password shall be reset by iHealth at the request of the User. iHealth reserves the right to deny abusive requests for password changes by the User.
The registered User may request the deletion of their account at any time by e-mail at the following address: firstname.lastname@example.org. The User is hereby informed that any request to delete his/her account may prevent the recovery of data provided in connection with the use of the Application. As a result, the User shall take any steps required to preserve the data contained in their account, prior to any request for its deletion. In particular, the User may exercise his/her right to data portability allowing him/her to transfer the personal data from his/her User account to another data controller. Otherwise, iHealth shall not be held responsible for any damages suffered by the User as a result of such loss of data.
In the event of non-compliance with the GTU and/or fraud by the User detected by a third party, a court authority or iHealth services, iHealth reserves the right to suspend or delete the User's account.
Any new request for registration following the deletion of a User Account under the aforementioned conditions shall be subject to iHealth’s express agreement.
The Application is available continuously, 7 days a week, 24 hours a day.
However, iHealth reserves the right to change, modify or suspend access to the Application without notice for maintenance reasons or for any other legitimate reason.
Unavailability of the Application shall not entitle the User to any compensation.
In the event of the unavailability of an Application, the User shall be informed by any appropriate means.
b) iHealth CardioPro
The iHealth CardioPro Application provides the following main features:
- Creation of a profile per patient and management of the list of patients attached to the User account;
- Measurements with the iHealth CardioMed:
o Configuration of the iHealth CardioMed device measurement settings for each patient;
o Launch of the acquisition of measurements for a given patient;
o Retrieval of measurements from the iHealth CardioMed device;
o Publication of a report containing the measurements and an interpretation of the results to assist in the diagnosis;
- Measurements with the iHealth CardioLab:
o Launch of the acquisition of measurements for a given patient;
o Retrieval of measurements from the iHealth CardioLab device;
o Publication of a report containing the measurements;
- Synchronisation of data to the approved cloud dedicated to the connected healthcare devices.
The data contained in each User account are saved to an approved Cloud dedicated to connected healthcare devices: CloudSanté, a HDS (health data hosting system) approved since 20 December 2013 (approval valid until 2021).
The transmission of data between the iHealth Products used by the User and the corresponding Application is performed by encrypted Bluetooth. The transmission of data between the Application and their host is secured through the https protocol (secure connection).
- Warranties and Responsibilities
iHealth shall not be held liable, either directly or indirectly, for damages sustained by Users or their equipment, in relation to:
- a temporary suspension or unavailability of the Application;
- a suspension of the Application justified by any User behaviour, whether or not the User is at fault;
- any incident or suspension of the Application caused by a malfunction and/or inadequate equipment, hardware and/or software and infrastructure of the User;
- a case of force majeure as defined by the case law of the French Court of Cassation;
- the unauthorised intrusion by a third party into iHealth's computer system resulting in the release of harmful software.
The data displayed by the Application are as accurate as possible, but are nonetheless for reference purposes only and depend in part on the configuration by the User or the use of the corresponding iHealth Product. iHealth shall not be held responsible for any inaccuracies, inconsistencies or errors in the Application and the displayed data.
Similarly, iHealth shall not be held liable for the use of data, including Personal Data, by applications developed by third parties used by the User.
It should be noted that the configuration of mobile devices and applications is under the exclusive control of the User and under his/her sole responsibility.
- Intellectual Property
The User is informed that the service associated with the Application, the software, the documentation related thereto and all Application’s components, including the interfaces made available to the User, the methods, diagrams, data bases, graphic chart, logos, distinctive signs and trademarks are protected by an intellectual property right in France or any other similar rights in other countries, notably through the protection provided by international conventions to works, trademarks and patents. iHealth is the sole holder of such intellectual property rights and/or has the rights required exploit such protected elements.
iHealth hereby grants to the User with a non-exclusive, non-transferable, personal, private and non-commercial licence which grants him/her the right to use and access the Application, excluding all other authorisations, including the right to reproduce the creations contained in the Application, regardless of their nature (software, source code, database, images, sounds, texts, graphics, audio-visual sequences and others).
Except with the prior written consent of the iHealth Marketing Team (email@example.com), the User shall thus refrain, under civil and criminal applicable to infringement, from reproducing any of the abovementioned elements or from having them reproduced, in whole or in part, in a temporary or definitive manner, by any means, known or unknown, in any medium, including, but not limited to, any website, Intranet network, messaging service, removable media, decentralised and peer to peer exchange network, weekly publications, journals, magazines, catalogues, brochures, leaflets, flyers, package inserts, mailings, advertising and promotional files including press and training files, posters, notices, cards, signs, containers and packaging for all products, publications and works of any kind.
This prohibition also extends to any reproduction or distribution on electronic media and, notably, via the Internet, mobile telephone networks, ADSL, radio, cable or satellite networks as well as on personal mobile devices such as digital music players, telephones and touch screen tablets.
- Personal Data
As data controller, iHealth collects certain information from the User in order to provide him/her with the services of relating to its Application.
iHealth also provides the User with the means for collecting and processing their patients' personal data, some of which are related to health and are considered sensitive and subject to special protection.
iHealth and the User hereby undertake, in this regard, to comply with applicable regulations on the protection of personal data, and in particular the law of 6 January 1978, referred to as the "Loi Informatique et Libertés" ("French Data Protection Act"), as amended, and Regulation (EU) 2016/679 of 27 April 2016, referred to as the "GDPR" (the "Applicable Regulations").
In accordance with the Applicable Regulations, the User has rights of access, rectification and deletion of his/her Personal Data. The User also has the right to request the limitation of the processing of his/her Personal Data and to object to such processing, as well as the right to the portability of their Personal Data. Lastly, the User may file a complaint with the competent supervisory authority (the CNIL in France).
These rights may be exercised by sending a letter to: iHealthLabs Europe, 36 rue de Ponthieu, 75008 Paris, or an email to the following email address: firstname.lastname@example.org, with an attached copy of the User's identity document.
- Applicable Law and Jurisdiction
iHealth and the User hereby agree to apply French law to any dispute that may arise regarding the interpretation or performance of these GTU. iHealth and the User shall submit their dispute in the context of the performance of these GTU to competent French courts.