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General Terms and conditions of use 

of the myDiabby Healthcare platform

for Patients

 

  1. Preamble 

MDHC is the developer of the diabetes telemedicine platform known as myDiabby Healthcare, which is, as at the date of this document, a Class IIa medical device under Regulation UE 2017/745 with UDI number 3770026228MYDIABBYXQ, and which is intended to help patients with type 1, type 2 and gestational diabetes manage their disease and to enable healthcare professionals to access and remotely monitor their Patients' data (the "Platform"). 

 

    2. General terms and conditions of use for the myDiabby Healthcare Platform and Application 

1. Purpose

The purpose of these General Terms and Conditions is to define the terms and conditions of the services of the myDiabby Healthcare platform, hereinafter referred to as "the Service", developed by MDHC, as well as the rights and obligations of MDHC and the user.

The GTCU apply to the contract entered into between MDHC SAS, 66 avenue des Champs Elysées, 75008 Paris, France and the Patient (“User”) when the latter registers and creates a user account for access to the Service.

The GTCU, the applicable data protection policies and various instructions and information relating to the Service are available on the website and on the platform. If the user has any prior questions about our “Services”, he/she can contact our technical support : support@mydiabby.com

 

MDHC is solely a technological service provider, manufacturer and operator of a medical device, which acts as an intermediary between the Healthcare Professional and the Patient. MDHC should not be considered as a healthcare professional itself or a healthcare establishment. The contract entered into between us is a simple service contract. MDHC is not responsible for the content, the quality of the medical examinations, or the advice provided in the context of Remote Patient Monitoring.

 

1.1 Description of Services 

The Service is accessible to all user Patients using the myDiabby Healthcare solution. 

The platform offers:

(i) A simple, intuitive mobile application that allows you to collect all your monitoring data (blood sugar levels logbook, treatment monitoring, diet logbook, etc.) in one place, using connected objects or by manual input.

(ii) a messaging service between the healthcare professionals and users.

(iii) a presentation of the various Services offered on the Platform, such as remote monitoring, Document sharing and Remote Consultation. 

 

1.2 Accessibility of the Service

The service is accessible to any natural person who has full legal capacity to enter into a commitment under these General Terms and Conditions. Individuals who do not have full legal capacity may only access the Service with the agreement of their legal representative.

In the event that the user does not wish to accept all or part of these general conditions, they are asked to refrain from using the Service. 

 

2. Definitions

  • Contents: The term "content" refers to the data transmitted by the User in the various sections of the platform.

  • User: The User is any person who uses the platform or the Application.

  • Patient: refers to a user identified on the platform and receiving care from a Healthcare Professional.

  • Healthcare Professional: any person who practises a healthcare profession and whose skills lead them to treat or care for diabetic patients, or to contribute to maintaining or improving patients' state of health.

  • Administrative staff: Administrative staff with the ability to access certain identification and health data as part of the management of the patient record. 

  • Care Team: Healthcare Professional and other Professionals who have access to the Patient's health data as part of his/her care programme. 

  • Login: the term “Login” is the information required to identify a user on the site in order to access areas reserved for members.

  • Password: The "Password" is a confidential piece of information, which the User must keep secret, enabling him/her, when used in conjunction with his/her Login, to prove his/her identity.

  • Platform: refers to the myDiabby Healthcare Platform, including its web interfaces, mobile application, desktop application, cloud and database.

  • Site:  refers to the Website: https://www.mydiabby.com/

 

3. Creating an account and accessing the service

Any access to and/or use of the Service constitutes unequivocal acceptance of and compliance with all the terms of these Terms and Conditions. They therefore represent an agreement between the Service and the User.  

When creating and setting up an account, the User must ensure that all information concerning him/her transmitted on the platform is correct, relevant, complete and up to date. Where applicable, the User undertakes to inform MDHC support without delay if his/her situation changes. 

The User is responsible for all actions relating to the use of his/her account and must ensure that the account is used in accordance with these GTCU as well as the various terms and conditions communicated on our website and our platform.

The list of equipment compatible with our platform is available in the myDiabby Healthcare user manual. To find out more about how to create an account and access the Service, please see the instructions : https://www.mydiabby.com/notice-patients

 

3.1 Service access and logins 

Access to the Service calls for the use of a login and a password. MDHC recalls that the User's account is strictly individual and must not be shared with any other user. The password, chosen by the User, is personal and confidential. The User is entirely responsible for the use made of his/her Logins. It is the User's responsibility to take all necessary measures to protect the personal data provided against any attack, loss, theft or unauthorised use of his/her identification data. In this case, the User must notify MDHC without delay, who will then immediately cancel and/or update the Logins concerned. MDHC is not responsible for any harm caused by the transfer of information, including the Login and/or password, via the Service.

In the event that the User provides information that is false, inaccurate, out of date, incomplete, misleading or fraudulent, MDHC may suspend or terminate the User's Account and deny him/her access, temporarily or permanently, to all or part of the Services, without affecting its liability to MDHC. 

In order to improve the information system, MDHC may keep a register of accesses to ensure compliance with these conditions.

 

3.2 Patient Data Management
The User has access, via their Patient account, to their Personal Data, as well as to the history of the treatment followed and their care pathway in the context of remote monitoring. He/she can enter new or updated Data on the Solution. 

 

3.3 Messaging service and sharing of documents with the Professionals
The User has access to a messaging service, through which they can communicate with the Healthcare Professionals and other Professionals responsible for their medical monitoring and their administrative file as part of remote monitoring.  Within this framework, the User may contact the healthcare team for any question relating to their medical monitoring. It is the User's responsibility to exercise appropriate caution and discernment in their dealings with Healthcare Professionals, and to respect the usual rules of politeness and courtesy.

 

3.4 Remote consultation
Healthcare Professionals have the option of carrying out remote consultations by videoconference with the Patient for whom they are responsible as part of the Patient's care.
To this end, the Patient and the Professional plan the date and time of the consultation directly between themselves, outside of the Solution. When the Professional starts the remote consultation, on the date and at the time agreed, the Patient is informed by receiving a notification on his/her myDiabby account as soon as the remote consultation has started. He/she can then join or decline the call from the healthcare professional. At the end of the remote consultation, the Professional can enter a report which will be kept in the Shared Space. MDHC does not make any recordings, either video or audio, of remote consultations.

 

3.5 Other Services
MDHC reserves the right to offer any other service it deems useful, in a form and according to the functionalities and technical means it deems most appropriate to provide said service.

 

3.6 Unsubscribing 

If a User no longer wishes to use their account and wishes to deactivate it, they can unsubscribe from the Service at any time by accessing their account and then going to the menu for deleting their account. Their account will be deleted in accordance with the account deletion process available in the myDiabby Healthcare medical device user manual. 

In any event, if your User account is inactive for more than two (2) years, it may be closed. We will alert you to the e-mail address provided prior to this closure to allow you to object to it, or to allow us to archive your data for a specific and reasonable period not exceeding two (2) years, with a view to reactivating your account in the future.

The User's personal data and health data will be stored in accordance with the current legislation and MDHC's personal data protection policy. For more information, please consult the following link: https://www.mydiabby.com/politique-donnees-patients.

 

In order to ensure that the User is effectively unsubscribed, MDHC will update the data every 36 months and will ensure that obsolete login data is deleted.

4. Obligations and Responsibilities

4.1 Responsibilities of the User

These general terms and conditions, the obligations arising therefrom and the rights arising therefrom may not be transferred to a third party.

 

  • Commitment by the User 

1) The user undertakes to comply with all the terms of the General Terms and Conditions and to use the Service in accordance with the current French legislation, in particular with regard to communication on the Internet, the protection of personal data, the protection of Intellectual Property and image rights.

2) All the costs relating to access the Service, whether material, software or internet access costs are at the exclusive expense of the User. They alone are solely responsible for the correct operation of their IT equipment as well as their internet access.

 

  • Commitment by the patient 

1) MDHC recalls that the Healthcare Professionals and the Professionals involved the management of patient care are solely responsible for their interactions with Patients and their monitoring as part of their medical monitoring. It is their responsibility to ensure that Patients are eligible and that they have given written consent to the sharing of their personal data prior to their medical monitoring. 

2) The User agrees to provide MDHC with all information necessary for the provision of the Service within the agreed time and to update such information in writing. The consequences of failure to update or delay in updating such information shall be the sole responsibility of the User.

3) MDHC recalls that the User must use frequently updated anti-virus software to guard against the risks of data loss or program piracy. Hardware, software and Internet access costs, as well as all other costs associated with access to the service, are the sole responsibility of the User. The User is entirely responsible for the functionality of his/her computer hardware and Internet connectivity. MDHC cannot be held responsible for any network or server failure, or any other unforeseeable circumstance making access to the Service difficult or impossible.

4) The Users agree to contribute to the improvement of the Platform, by reporting any malfunctions and, where appropriate, by suggesting any improvements to the following e-mail address: support@mydiabby.com

5) where applicable, the User indemnifies MDHC, its representatives against all costs (including legal fees, costs and expenses) and damages relating to claims and legal actions relating to (i) the use of the Service by the User and its third parties in an illegal or fraudulent manner, or in a manner which does not comply with the Contract or with the User's code of ethics where applicable; (ii) User Data; (iii) the infringement of MDHC's or any third party's Intellectual Property rights as a result of the use of the Service by the User and his/her Assistants; and (iv) the content and quality of the information and Documents stored on the myDiabby Healthcare Platform. 

  • Prohibited behaviour by the User when using the Service

Any behaviour likely to interrupt, suspend, slow down or prevent the continuity of the Service or likely to damage the reputation of MDHC in the following list is prohibited: 

1) abusing the Platform by knowingly introducing viruses, Trojan horses, worms, logic bombs, a "denial-of-Service" attack or a "distributed denial-of-service" attack, or any other malicious or technologically harmful material or any activity of a nature to harm, control, interfere with, or intercept all or part of a third party's computer system, violate its integrity or security.

2) attempting to obtain unauthorised access to the application, to the server on which the application is stored or to any server, computer or database connected to the application.

3) any intrusion or attempted intrusion into the platform's systems, (iii) any misappropriation of the Site's system resources, (iv) any action likely to impose a disproportionate burden on the Site's infrastructure, (v) any breach of security and authentication measures, (vi) any act likely to infringe the financial, commercial or moral rights and interests of MDHC or the users of the Service.

 

4) using the service to disseminate information or links redirecting users to a third-party site.

5) copying and/or misappropriating for their own purposes or those of third parties the concept, technologies, all or part of the data or any other element of the Solution.

6) monetising, selling or granting all or part of the access to the Services or the Site, as well as to the information hosted and/or shared therein, engaging in illegal or fraudulent activities or activities that infringe the rights or security of third parties, infringe public order or violate the laws and regulations in force. 

By breaching this provision, the User is committing a criminal offence under Articles 323-1 to 323-7 of the French Penal Code. MDHC will report this breach to the competent authorities and cooperate with these authorities by disclosing the identity of the User concerned to them.

4.2 Penalties for breaches

If a User breaches any of the terms of these General Terms and Conditions or, more generally, the laws and regulations in force:

1) MDHC reserves the right to take any appropriate measure and in particular to (i) suspend access to the Service of the User who is the author of the breach or infringement, or who has participated in it, (ii) publish on the platform any information message that MDHC deems useful to warn any authority concerned and (iii) initiate any legal action.

 

2) MDHC also reserves the right to terminate the User's access to the Services (i) either ipso jure, fifteen (15) days from receipt by the User of formal notice declaring the intention to enforce this article which has remained without effect and sent by registered letter with acknowledgement of receipt; (ii) or in the event of repetition of a breach previously notified by registered letter with acknowledgement of receipt; in this case, termination shall take effect immediately on the date on which the registered letter with acknowledgement of receipt declaring the repeated breach is sent; (iv) without prejudice to any damages that may be claimed from the User.

Without prejudice to any other consequences that may arise from the application of these General Terms and Conditions, termination automatically results in deactivation of the User's account.

4.3 Commitment and Responsibilities of MDHC 

  1. MDHC undertakes to: 

  • administer the Platform in order to ensure the proper functioning of the Service and to provide access to it, including the possibility for a diabetic patient to be managed under remote monitoring with a health professional, and the services associated with remote monitoring, in particular the storage of information provided by the User and MDHC. Access to the Service and to the personal account is provided in accordance with the GTCU, subject to authorised service interruptions, in particular for planned maintenance or work on the application system. 

  • ensure that the Service complies with the regulations in force relating to medical devices, in particular Regulation (EU) 2017/745 of 5 April 2017 as soon as it comes into force, i.e. 26 May 2020, and Regulation (EU) 2016/679 on the protection of personal data.

  • ensure that the data is hosted by an approved health data host (HDS) that has been approved by the Minister for Health, in accordance with Articles L.1111-8 and R.1111-9 of the French Public Health Code.

  • enable communications and exchanges of health documents between the User and Healthcare Professionals and other professionals in accordance with the regulations and standards in force for the sharing of health data, to store and give you access to the information associated with your account.

  • expressly undertakes to comply with the guidelines established by the ANS as part of the Politique Générale de Sécurité des Systèmes d'Information de Santé (PGSSI-S 5general security policy for health information systems-), in order to guarantee the accuracy and confidentiality of personal health data. 

 

MDHC reserves the right to sub-contract the performance of its undertakings and obligations under these General Terms and Conditions.

 

    2. Limitation of MDHC's liability

  • MDHC may not under any circumstances, within the limits of applicable law, be held liable for damages and/or prejudice, direct or indirect, material or immaterial, or of any nature whatsoever, resulting from the unavailability of the Service or from any Use of the Service. The term “Use” shall be understood in the broad sense, i.e. any use of the Platform whatsoever, whether legal or not.

  • MDHC's involvement is limited solely to the provision of the Service provided herein, to the exclusion of all others. As such, MDHC does not interfere in any way with the relationship between the Professionals and the Patient, to which MDHC is not a party. MDHC is not responsible for the care, information or recommendations provided by healthcare professionals to the User in writing, via messaging or during remote consultations. MDHC is not responsible for the accuracy of the information contained in each Healthcare Professional's profile. The accuracy and updating of such information is the sole responsibility of such healthcare professional.

  • MDHC is not responsible for errors caused by the User or any use for which the User is responsible. In addition, MDHC is not responsible for personal damages or consequences that may result, directly or indirectly, from the use or misuse of information provided, presented or addressed from the Platform. MDHC's liability is in all circumstances limited to direct and proven damages.

  • MDHC does not exclude or limit in any way its liability where it would be illegal to do so. This includes liability for death or personal injury caused by its negligence or the negligence of its employees, agents or sub-contractors; for fraud or fraudulent misrepresentation; for breach of your consumer rights in relation to the services it has promised to provide to you.

5. Intellectual property

MDHC is the owner, or holder of the rights, to all the elements that make up this platform, in particular the data, graphics, photos and soundtracks. The brands and logos appearing on the mydiabby.com site and the Platform are registered trademarks. In accordance with Article L 713 - 2 of the Intellectual Property Code, any total or partial reproduction of these trademarks or logos, made from elements of the platform without the express authorisation of MDHC is therefore prohibited, within the meaning of article L 713 - 2 of the Intellectual Property Code.

6. Personal data

In accordance with the legislation on the respect of the privacy of the User, MDHC undertakes that the collection and processing of personal information, made within this site, are carried out in accordance with Act 78-17 of 6 January 1978 on data processing, data files and individual liberties.

We refer you to our Privacy Policy https://www.mydiabby.com/politique-donnees-patients  for detailed information on how we process your personal data, including clear instructions on your rights and how you can exercise these rights. Each User acknowledges that he/she has read the personal data protection policy. 

 

7. Force majeure 

We do not pay any compensation for damages due to unforeseeable and unavoidable events such as strikes, fires, government measures, labour disputes, accidents, closures or problems with public communication systems, as well as other events and results beyond our control that we were unable to prevent or control.

 

8. Modification of the GTCU

We reserve the right to change the scope and function of the User Account, the site and the Services offered on the site. These General Terms and Conditions may be amended as a result of product and service development, which may involve, but is not limited to, changes in layout, content or functionality. These changes will be announced on the platform or by e-mail.

 

9. Termination

In the event of breaches or violations by the User of his/her obligations herein, MDHC may terminate ipso jure the Contract thirty (30) days after notice has been sent to the User and remained without effect.

The User whose contract is terminated is no longer authorised to use the Services.

10. Applicable law and jurisdiction

French law governs the legal rules applicable to the transmission of data and information on and around the site.

In the event of a dispute that cannot be settled amicably, the French courts within the jurisdiction of the Paris Court of Appeal shall have sole jurisdiction.

These General Terms and Conditions of Use come into force on 17/08/2023. 

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