Version in force: 21st November 2022
The purpose of these general terms and conditions of use (hereinafter the “GTU”) is to define the terms and conditions of access and use of the Applications (as defined below), provided by TWERIS, a company duly organized and construed under the laws of France (Grasse B 913 568 069), having its registered office at 1047 route des Dolines, 06560 VALBONNE (France) (hereinafter “TWERIS”).
ARTICLE 1. DEFINITIONS
The following terms, when starting with a capital letter, used in singular or in plural form in the GTU, shall always have the following definition:
i. Applications: refers to the software applications developed and published by TWERIS, their features, functionalities and application services described in Section 2.1 below, as subscribed by the Client, and more generally all the software components and Web servers exclusively owned by TWERIS, which are provided to the Client in SaaS (Software as a Service) mode, i.e. deployment and delivery of the Applications whereby they are hosted on remote servers operated by TWERIS;
ii. Client: refers to the healthcare professional, acting for the purposes of its activity, client of TWERIS, subscribing to the provision of the Applications and using them in accordance with these GTU;
iii. Data concerning health: refers to all data relating to the Patient, constitutive of the Patient’s medical records (Cardiotocographs, date of birth, previous medical history, treatments, medical decisions undertaken, ultrasound reports, mother and neonates/child medical outcomes, collected by the User as part of the Patient’s care, as well, integrated and/or generated on the Applications by the User. Data concerning health shall not contain any Personal Data relating to the Patient, as mentioned in Section 10.2 below;
iv. Data Protection Legislation: refers to all applicable data protection legislation, including the Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (the “GDPR”), as amended from time to time, the French Law No 78-17 of 6 January 1978 as modified, called “Loi Informatique et Libertés”and any other national data protection legislation applicable in the country of the processing and/or the Patients concerned by the processing of their Personal Data, and any regulations, guidelines or any other documents issued by a competent data protection Authority, each as amended from time to time;
v. Patient: refers to the individual, patient of the Client, and her (un)born baby, whose Data concerning health are processed through the Applications, in the context of her personal care during childbirth;
vi. Personal data: refers to any data which, within the meaning of the Data Protection Legislation, identify, directly or indirectly, a natural person (here, the Patient), in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person;
vii. User: refers to the natural person who benefits from the services provided by the Applications granted to the Client and who is either (i) the Client operating individually, (ii) employed by or (iii) contractors of the Client, authorized by the latter to use all or part of the Applications.
ARTICLE 2. Acceptance
Access and use of the Applications are subject to the express and unreserved consent of the GTU by the Client and the User. The User (and, as the case may be the Client) acknowledges having read the GTU and having fully understood their terms, prior to accessing the Applications. The User (and, as the case may be the Client) declares that he/she concludes the GTU in his/her name, on his/her behalf and for his/her professional needs.
ARTICLE 3. Description of the Applications
3.1. Services
The Applications are aimed to collect mother and fetal data during childbirth in particular extracts of cardiotocographs (CTG), in order to improve the prediction model of fetal hypoxia during delivery and help the medical team to manage the labor.
The Applications are constitutive of two mobile applications dedicated to:
– Application #1: The collection of Data: the User is invited to capture, with the camera of his/her smartphone, directly on the Application, the cardiotocographs (output of the sensors connected to the Patient (mother and baby) and to label it with a list of items;
– Application #2: The decision support application: this Application enables the User to submit a picture of the CTG during the labor and to visualize temps real time labeled, analyzed and enriched Data.
The Applications are prototypes, under research and development phase. TWERIS does not warrant their accuracy, quality, as further mentioned in Article 7 below.
3.2. Equipment
The Applications are free to download on mobile download platforms (ios, Android).
Access to the Applications requires the User to have a smartphone and a high-speed internet connection. All costs relating to access to the Applications and their use, whether hardware, software or internet access costs, are the sole responsibility of the User. The User is solely responsible for the proper functioning and appropriate security of his/her equipment and information system.
3.3. Hosting – Security
TWERIS implements and maintains security and confidentiality measures for the Applications, which take into account the principles of protection of personal data and are adapted to the risk generated by their processing on the rights and freedoms of the persons concerned, in accordance with the requirements of the Data Protection Legislation.
All access to the Applications, as well as the actions carried out by the User on the Data are traced and recorded daily in database. TWERIS carries out scheduled, daily backups of the Data.
The Applications and the Data are hosted on dedicated servers made available to TWERIS by the company Microsoft Azure, having the HDS certification (health data hosting). This host is bound by professional secrecy. In accordance with the Data Protection Legislation, this host acts as a processor of TWERIS, and only under the contractual conditions signed between the host and TWERIS which cannot derogate from the General Conditions. It has no access to the Data, nor any right to use it, the processing carried out by the host being strictly limited to the technical services of hosting and database management.
TWERIS will use its reasonable efforts to ensure:
– the host has implemented appropriate physical and logical security measures ensuring, in particular, the integrity of the network and servers against any external malicious act or any computer attack;
– the confidentiality, integrity, availability and traceability of Data, and in particular Personal Data and Data concerning health, in order to prevent breaches of Data and/or minimize their impacts on the Patients in case of a breach;
– the detection, resolution and notification of security incidents and personal data breaches within the time limits required by the Data Protection Legislation;
– the possibility of restoring the availability and access to the Data in a timely manner in the event of a physical or technical security incident;
– robust and flawless end-to-end encryption of Data in accordance with industry best practices, without any breakage. As such, access to the Applications, servers, features and databases is done via protocols incorporating encryption protocols (e.g. SSH, HTTPS) that comply with market standards. The versions of the cryptographic algorithms used are kept at the state of the art;
– the Data, excluding Data concerning health, is only accessible and readable by duly authorized employees of TWERIS, within the strict limits of what is necessary for the performance of their duties; TWERIS will provide the Client upon request with a list of duly authorized persons;
– the persons authorized to access the Data have undertaken in writing to confidentiality and security obligations as protective as those contained herein.
TWERIS implements a procedure aimed at regularly testing, analyzing and evaluating the effectiveness of the aforementioned security measures.
In the event of server failure, TWERIS will make its best efforts to restore the service as soon as possible, within the limits of the service level commitments made by the hosting provider.
3.4. Availability
TWERIS will use its commercially reasonable efforts to ensure the operation and availability of the Applications (within the limits of the commitments made by the hosting provider), as well as its accessibility 24 hours a day, 7 days a week, subject to the occurrence of a case of force majeure or an event beyond the control of TWERIS and except interruption, suspension or limitation within the framework of maintenance operations and /or updates necessary for the proper functioning of the Applications. TWERIS reserves the right to interrupt, suspend or limit access to all or part of the Applications, in particular due to legal or technical constraints, without these interruptions/suspensions giving rise to any right or remedy to the benefit of the Client and/or the User.
ARTICLE 4. License grant
The User acknowledges and accepts that the Applications (including their software, architecture and documentation) are protected by intellectual property rights (including right of authorship, patent, trademarks) and are the exclusive property of TWERIS. The GTU do not confer to the User (and, as the case may be, the Client) any right or interest on them, but only a limited right to access and use the Applications under the conditions set out below.
TWERIS grants to the User, for the duration of the GTU, a non-exclusive, non-assignable, non-transferable, license to use the Applications, for his/her own needs and for the sole purpose of his/her care activity.
This license is strictly personal, and the User may not assign, transfer or delegate the rights or obligations hold hereunder without the prior written consent of TWERIS.
The User expressly refrains from any other use or exploitation of the Applications, notably:
– Practicing reverse engineering, decompiling or disassembling the Applications, the computer program(s) and software solution(s);
– Modifying, altering, adapting or making any change whatsoever to the presentation and content of the Applications, computer program(s) and software solution(s), trademark, trade name, logos etc., The Applications’ presentation, or removing the identification and ownership labelling of the Applications;
– Performing any reproduction, translation, adaptation or arrangement of all or part of the Applications;
– Rent, sublicense, sell or transfer the Applications to a third party or allow a third party to access and use all or part of them without the prior written consent of TWERIS.
ARTICLE 5. Access and use of the Applications
5.1. Creation of a User account
Access to the Applications requires the creation of an account by the User. For this, the User must have a valid e-mail address.
The User may create his/her account directly on the Applications, by completing the forms. Before validating the creation of his/her account, the User is invited to read and carefully read these GTU, by clicking on the corresponding hypertext link. The User will tick, if he/she accepts, the corresponding boxes, thus acknowledging that he/she has read the GTU and fully accepts all of their provisions, without restriction or reservation.
The User agrees to provide and maintain his/her Personal Data accurate, up-to-date and complete. TWERIS cannot be held liable under any circumstances in the event of delay or impossibility of accessing the Applications due to incorrect or incomplete information in the entry of information concerning the User when requesting the creation of an account. As such, the User may at any time modify his/her Personal Data and password directly from his/her account.
5.2. Access to the Applications
Access to the Applications is made via a strong authentication system. At each connection, the User is first prompted to enter his/her connection identifiers (username and password).
With the exception of a previous authentication by enrollment of the browser as a trusted browser (browser enrollment), at each connection to the Applications, the User is then invited to choose a second authentication factor from a proposed list, then to follow the selected authentication procedure.
5.3. Confidentiality of login details
The login details (username and password) of the User are personal and confidential. The User must keep his/her login details in a secure manner and undertakes not to disclose them to third parties for any reason, in any way and in any form whatsoever. The User also undertakes to ensure that at the end of each session of use of the Applications, he/she disconnects correctly.
In the event of loss or theft of his/her authentication details, the User must modify his/her password as soon as possible by clicking on the “Forgotten password” on the Applications. The User is then invited to create a new password.
Under no circumstances shall TWERIS be held liable for the loss or theft of the his/her authentication details or their fraudulent use. The User is solely responsible for accessing and using the Applications with his/her login details.
5.4. Proper use of the Applications
Given the nature and purpose of the Applications, the User undertakes to use the Applications in a professional context solely for his/her professional needs.
The Applications shall be used solely under the Client’s control, direction and liability and the Client shall bear all the risks that may arise therefrom. The User undertakes to use the Applications in accordance with the GTU, in compliance with the laws and regulations applicable in France and in the European Union.
The User must have all the skills, knowledge and expertise necessary to use the Applications correctly, to process the Data, interpret and analyze them and make all decisions relating thereto, with all the professional judgment, diligence and care required.
TWERIS may suspend or terminate the User’s access to the Applications in the event of non-compliance with this article, without prejudice to any damages that TWERIS may request.
5.5. Prohibited behaviors
It is strictly prohibited to use the Applications for the following purposes:
– Producing interference with the Applications or accessing it using a method other than that provided for in the GTU and the instructions made available to him/her;
– The exercise of illegal, discriminatory, fraudulent actions or actions that infringe the rights or the safety of third parties;
– The breach of public order or the violation of the laws and regulations in force, in particular the Public Health Code;
– Aiding or inciting, in any form and in any way whatsoever, to one or more of the acts described above;
– And more generally any practice diverting the Applications for purposes other than those for which they were designed.
TWERIS may suspend or terminate the access of the User to the Applications in the event of non-compliance with this article, without prejudice to any damages that TWERIS may request.
ARTICLE 6. Warranties
TWERIS declares and warrants it has all the titles, licenses and authorization to enter the GTU and provide the Applications. TWERIS also represents and warrants that the Applications comply with the state of the art existing on the day of the last version in force of the GTU and that it has all necessary intellectual property rights for the purposes hereof.
TWERIS cannot guarantee the accuracy, completeness, timeliness or other quality of the Data integrated and processed by the User on the Applications. The User is solely responsible for the integrity, accuracy and quality of the Data that he/she integrates and processes on the Applications.
The User declares and warrants he/she has all the titles, licenses and authorizations to process and exploit the Data on and through the Applications. The User shall indemnify and hold TWERIS harmless against any claim or action from a Patient or another third party regarding the process of the Data.
The User also ensures that the Data is free of viruses or any other component likely to cause damage to the Applications. The User acknowledges that the lack of security, integrity and/or quality of the Data is likely to seriously harm the interests of TWERIS. The User (and as the case may be the Client) guarantees TWERIS in this respect and will indemnify it for any damage that may be suffered by TWERIS as a result.
TWERIS does not grant any other express or implicit guarantee, including, without this enumeration being exhaustive, as to the continuity, performance and/or durability of the Applications and/or as to the suitability for a particular use or the suitability of the Applications to the User’s needs, nor does it guarantee that it is free from anomalies, errors or bugs or that it will operate without failure or interruption. The Applications are provided “as is” and according to their availability.
Access to the Applications implies knowledge and acceptance of the characteristics and limits of the Internet, in particular with regard to technical performance, response times for consulting, querying or transferring information, risks of interruption, and more generally, the risks inherent in any connection and transmission on the Internet, the lack of protection of certain data against possible misappropriation and the risks of contamination by possible viruses circulating on the network. TWERIS does not guarantee that the Applications will at all times be free of viruses, worms, Trojan horses or any other component likely to cause damage. It is up to the User and/or the Client to take all appropriate measures to protect their own hardware, Data, and/or software stored on their computer equipment against any attack.
ARTICLE 7. Limitation of liability
The User expressly acknowledges having received from TWERIS all necessary information, allowing to assess the adequacy of the Applications to his/her needs and to take all the precautions necessary for its use. The User expressly acknowledges that the use of the Applications is under his/her sole responsibility. No advice or information, whether oral or written, obtained by the User is likely to create guarantees not expressly provided for in these GTU, nor to entail the liability of TWERIS for damages, of any kind whatsoever, caused to the User or a third party due to the misuse of the Applications, in violation of the provisions of this article and more generally of non-compliance with the GTU.
The User is solely liable to third parties, with respect to the nature and content of information and Data processed through the Applications.
To the fullest extent permitted by applicable law, TWERIS expressly excludes its liability for any damage, direct or indirect, resulting from or in connection with access to the Applications, their use, malfunction or unavailability whatever the nature and duration.
TWERIS is only liable for direct damages that may be caused to the User as a result of the poor performance and/or non-performance of its obligations under the GTU.
ARTICLE 8. Insurance
Each party undertakes to take out with a reputably solvent insurance company and to maintain throughout the duration of the GTU professional civil liability insurance intended to guarantee the risks relating to the performance of the GTU. At the request of the other party, each party must be able to justify the subscription of this insurance.
ARTICLE 9. Personal data protection
TWERIS undertakes to comply at all times with the Data Protection Legislation.
9.1. User’s Personal Data
For the purpose of executing its contractual obligations and managing the Applications, TWERIS process the Personal Data (surname, first name, professional email, professional certification reference) of the User.
The User has a right of access, rectification, limitation and portability of his/her Personal Data. He/she also has the right to object to the processing by TWERIS of his Personal Data for commercial prospecting purposes, the right to the erasure of his/her Personal Data under the conditions of Article 17 of the GDPR and the right to introduce a complaint to the Data Protection Authority if he/she considers that the processing carried out by TWERIS constitutes a violation of his/her Personal Data. The User’s rights over his/her Personal Data may be exercised at any time by sending an e-mail to TWERIS at the following address: [to be completed].
9.2. No other Personal Data processed
It is expressly acknowledged and agreed that no Personal Data of the Patient is processed through the Applications. The Applications do not need any Personal Data to properly operate, but only anonymized Data concerning health.
The User is required to collect, upload and process only Data concerning health that are anonymized, that is to say, that do not include any Personal Data relating to the Patient (e.g. the name of the mother, her date of birth, etc.).
The User warrants that the Patients have been informed of the use of the Applications and their purpose, and that none of their Personal Data will be processed through the Applications, but only anonymized Data concerning health.
9.3. Use of Data concerning health by TWERIS
The User acknowledges that TWERIS will use the Data concerning health processed through the Applications, in constant compliance with the Data Protection Legislation, in order to improve the performance and features of the Applications, for clinical research purposes, and for statistical purposes.
To that end, the User grants TWERIS a right to use such Data for that purposes.
ARTICLE 10. Duration, suspension and termination
The GTU will take effect on the first connection of the User to the Applications and will remain in force as long as the User uses the Applications.
The User may terminate these GTU whenever he/she wants, by closing his/her account on the Applications.
In the event of use of the Applications by the User that does not comply with the GTU, in the event of the User’s breach of the GTU, or more generally in the event of violation of applicable laws and regulations, TWERIS may suspend or terminate, without prior notice or compensation, all or part of the User’s access to the Applications. TWERIS may pronounce this suspension or termination without prejudice to any other rights, actions and remedies that TWERIS may have with a view to repairing the damage it may have suffered as a result of these breaches.
TWERIS will archive a copy of the Data under conditions of security and confidentiality in accordance with the Data Privacy Legislation, for the purposes of (i) enabling their use for clinical research, under the conditions provided for in these GTU and (ii) for evidence purposes for the establishment, exercise or defense of legal claims.
ARTICLE 11. General provisions
Subcontracting. TWERIS may at its own discretion, use one or more subcontractors to perform its obligations under these GTU. TWERIS will remain jointly and severally liable for the proper performance of its obligations hereunder.
Force majeure. The parties may not be held liable for the late performance or breach of their obligations due to a force majeure event as defined by applicable law. If a force majeure event occurs, the affected party shall immediately inform the other party and the parties shall take all reasonable measures to mitigate the consequences of such an event. If the occurrence of a force majeure events makes it temporarily impossible for one of the parties to fulfil its obligations, the breach of its obligations by the affected party shall be tolerated for the duration of the force majeure event and at least during a continuous period of thirty (30) calendar days. After that time, the parties may terminate the GTU, without any other formality.
Tolerance. It is expressly agreed that any tolerance or waiver by one of the parties in the implementation of all or part of the obligations under these GTU, whatever the frequency and duration, shall not amount to an amendment of these GTU, nor generate any right.
No waiver. No failure or delay by a party to exercise any right or remedy provided under these GTU or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy.
Severability. If any provision of these GTU is partially or fully cancelled, the validity of the other clauses shall not be affected.
ARTICLE 12. Applicable law and jurisdiction
The GTU are subject to French law, to the exclusion of any other legislation.
The parties declare their intention to find an amicable solution to any difficulty that may arise concerning the validity, interpretation or performance of these GTU. Failing to do so, the dispute will be submitted to the exclusive jurisdiction of the competent courts of Grasse, France.