for healthcare professionals, HHPs and administrative staff

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1. Preamble 

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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 (the "Patients") manage their disease and to enable healthcare professionals to access and remotely monitor their Patients' data (the "Platform").

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

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1. Purpose

The purpose of these General Terms and Conditions is to define the terms and conditions under which the services of the myDiabby Healthcare medical device platform, hereinafter referred to as "the Service", developed by MDHC, are made available and the conditions under which the Service is used by healthcare professionals, HHPs and administrative staff, hereinafter referred to as "the User", in the management of Patient care.

The GTCU apply to the contract entered into between MDHC SAS, 66 avenue des Champs Elysées, 75008 Paris, France and the 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 services are available on the website and on the platform. If the User has any prior questions about the Service, 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 User and the Patient (the User) and should not be considered as a healthcare professional itself or a healthcare establishment. The contract entered into for the use of the Service 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.

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.

- Any legal entity acting through a natural person who has the legal capacity to contract in the name and on behalf of the legal entity.

If the User does not wish to accept all or part of these General Terms and Conditions, he/she is asked to refrain from using the Service.

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2. Definitions

• User: Healthcare Professional and other Professionals (HHP, etc.) involved in the patient care, as well as administrative staff involved in the patient record management who use the "Service". 

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

• Administrator user: Healthcare professional in charge of a healthcare team.

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

• Administrative user: Administrative staff skilled in patient record management who use the "Service". 

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

• Login: The term "Login" covers 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.

 

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. 

When creating and setting up your account, you must ensure that all the information about you transmitted on the platform is correct, relevant, complete and up-to-date and, where applicable, that your right to practice complies with the ethics and the rules defined by the regulations and/or regulatory authorities governing your profession. The use of a User account is strictly individual. The login and password may not be shared under any circumstances.

You agree to update the User Data in your account or notify the MDHC support immediately if your circumstances change in a way that affects the User Data you have previously submitted to MDHC. 

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3.1 Administrator User registration

The Administrator User of his/her healthcare team registers by completing the registration form provided for this purpose. He/she must provide all the compulsory information concerning him/herself and his/her healthcare team. Any incomplete registration will not be accepted by MDHC.

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3.2 Registration of Users (Healthcare professionals)

The professional administrator assigns accounts to the other professionals involved in the patient's care and remote monitoring, explaining the roles of each of them and the data to which they have access according to their role. Once these accounts have been created, MDHC sends the professionals concerned the link enabling them to finalise their registration.

MDHC recalls that the Administrator User, who invites other professionals to create an account, is entirely responsible for selecting only those persons authorised to carry out remote monitoring or involved in the management of the patient's care.  

 

3.3 Registration of other Users (excluding Healthcare Professionals)  

The Administrator User may assign accounts to other users only if they are involved in managing the Patient's care and remote monitoring. The Administrator User must then justify the roles of each of them and the need for Users to have access to the Patient's health data. Once these accounts have been created, MDHC sends the Users concerned the link enabling them to finalise their registration.  

 

3.4 Registration of Patients on the Solution by Healthcare Professionals

Users (healthcare professionals) can create an Account on behalf of the Patient using the form provided for this purpose. They must provide all the compulsory information, as well as any other useful information such as the Patient's medical history and care pathway. Patients may also register on the advice of a healthcare professional by entering a monitoring code. Any incomplete registration will not be validated by MDHC. Any registration carried out by a Healthcare professional User on behalf of a patient requires the patient's consent. 

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3.5 Service access and logins 

Access to the Service requires the use of a login (professional e-mail address) and a password. 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 steps to protect the personal data provided against any breach. MDHC is not responsible for any harm caused by the transfer of information, including the Login and/or password, via the Service.

The User is solely responsible for the loss, theft or unauthorised use of his/her identification data, as well as the consequences thereof. In this case, the User must notify MDHC without delay, who will then immediately cancel and/or update the Logins concerned. In this respect, if the subscribed User pre-saves his/her Logins on a device, thus allowing automatic connection to the Services, he/she is required to ensure that at the end of each session he/she effectively disconnects from the Service, in particular when he/she accesses the Service from a public computer.

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

The list of equipment compatible with our platform is available in the myDiabby Healthcare user manual. In order to improve the information system, MDHC may keep a register of accesses to ensure compliance with these conditions.

To find out more about how to create an account and access the Service, please see www.mydiabby.com/notice-pds.

 

4. Access to and sharing of healthcare data between healthcare professionals

The User acknowledges that any sharing of Health Data with other healthcare professionals, HHPs and Administrative Users via the Service used must be done in accordance with article L1110-4 of the French Public Health Code.

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4.1 General terms and conditions

When sharing a patient's medical record and other documents, the User is responsible for complying with the rules relating to medical confidentiality and for managing access rights, as well as for obtaining the authorisations required to comply with the laws and regulations in force. MDHC recalls that in the event of sharing of the Patient record containing Health Data and/or Documents, these are fully accessible by default by each authorised User in the healthcare structure managing the patient and other healthcare structures, subject to the authorisations which are subsequently granted or refused.

MDHC recalls that the User is responsible for complying with the rules relating to the collection of prior consent or information from Patients in the context of patient care and the exchange of Health Data. The User expressly acknowledges and accepts that, in accordance with the regulations in force, each Patient may decide at any time to modify or refuse access to his/her shared medical record to the Healthcare Professionals and other professionals in his/her healthcare team concerned.

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4.2 Remote consultation
As part of the platform's functionalities, medical healthcare professionals are able to carry out remote consultations by videoconference with the Patients under their care. To do this, the Patient and the Healthcare Professional coordinate the day and time of the consultation directly. When the Professional starts the remote consultation, on the date and at the time agreed, the Patient, logged into his/her myDiabby account, is informed by receiving a notification as soon as the remote consultation has started. He/she can then join or decline the call from the healthcare professional. The professional can write a report at the end of the remote consultation, which will be stored in the shared space. MDHC does not record remote consultations in any way, including by camera or audio recording.

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4.3 Messaging service
Users have access to a messaging service, via which Patients may communicate with the Healthcare Professionals, HHPs and administrative staff responsible for their medical care. Users are required to exercise reasonable care and discretion in their communications with other users when using the messaging service, and to observe the usual standards of decency and politeness.
 

4.4 Unsubscribing 

If a User wishes to stop using their account and deactivate it, they may unsubscribe from the Service at any time by sending an email and proof of identity to MDHC at support@mydiabby.com.

As part of the use of the Service, your data will be stored in accordance with the following archiving procedure:

- in active mode, until your user account is closed;

- then, in an intermediate archive as part of a separate information system with restricted access, for ten (10) years, plus the duration of any litigation, if any;

- at the end of this period, your personal data will be permanently deleted in accordance with the French Data Protection Act no. 78-17 of 6 January 1978.

 

If your user account is inactive for more than two (2) years, it may be manually 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 unsubscribed user will no longer have access to his/her account. 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. In the event that the User has patients being monitored on myDiabby Healthcare, MDHC reserves the right to ask the User for the name of the healthcare professional authorised to ensure continuity of care for the Patients in order to redirect the attached Patients. 

 

5. Obligations and Responsibilities

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5.1 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 platform's General Terms and Conditions and to use the Services 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, the code of ethics and the Public Health Code to which the user is subject. 

In this respect, he/she undertakes to comply with all the provisions of the Public Health Code applicable to him/her, including in particular:

- research involving human subjects, as referred to in Articles L.1121-1 et seq. of the French Public Health Code;

- patients' rights, as set out in article L.1110-1 et seq. of the French Public Health Code;

- medical confidentiality and the sharing of patient information, as referred to in Articles L.1110-4 and R.1110-1 of the French Public Health Code;

- the conditions of access to shared medical records, as set out in Articles L.1111-14 et seq. of the French Public Health Code;

- the rules applicable to telemedicine, as described in articles R.6316-1 to R.6316-10 of the French Public Health Code;

- the following laws and regulations designed to prevent fraud, corruption and money laundering, in particular the prohibition on offering advantages to healthcare professionals, as set out in articles L.1453-3 et seq. of the French Public Health Code.

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2) MDHC recalls that the User involved in the management of patient care is solely responsible for its interactions with Patients and their monitoring as part of their medical monitoring. It is the User's responsibility to ensure that Patients are eligible and that they have given written consent to the sharing of their Patient Data prior to their medical monitoring. In this respect, the User expressly accepts that MDHC reserves the right to request any additional documents and information deemed necessary, in particular for the purposes of verifying the prior written consent of Patients. The User shall send MDHC the requested documents and information as soon as possible.

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3) MDHC recalls that the User undertakes to access only the data strictly necessary for the care of the patient and the management of his/her medical record, and that he/she is authorised to access such data after obtaining the consent of the patient concerned. The Administrator User undertakes to restrict access and observe the utmost confidentiality in general and to secure these access methods in order to prevent unauthorised use of the Services.

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4) All administrative, fiscal and/or social procedures which may be necessary in connection with the use of the Services are the sole responsibility of the User. MDHC may not be held liable in this respect.

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5) 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.

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6) The User must check that the system and Infrastructure necessary for the use of the Service comply with the technical requirements communicated to him/her. MDHC cannot be held responsible for any network or server failure, or any other unforeseeable circumstance making access to the Service difficult or impossible.

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7) 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. The use of virus protection software is recommended. We do not guarantee that the application will be free of bugs or viruses.

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8) The User agrees to contribute to the improvement of the application, by reporting any malfunctions and, where appropriate, by suggesting any improvements to the following e-mail address: support@mydiabby.com

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9) 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 and its use by the User, his/her Assistants and/or Patients; (iii) the infringement of MDHC's or any third party's Intellectual Property rights as a result of the use of the Services by the subscribing User and his/her Assistants; and (iv) the content and quality of the information and Documents stored on the myDiabby Healthcare Platform. 

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• 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 application 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.

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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.

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

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

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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.

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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. 

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

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5.2 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 Services 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.

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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.

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5.3 Commitment and Responsibilities of MDHC 

1. MDHC undertakes to: 

• administer the Platform in order to ensure the proper functioning of the Services and to provide access to the Platform, including the possibility for a diabetic patient to be managed under remote monitoring with a subscribed User, and the services associated with remote monitoring, in particular the storage of information provided by Users 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 Users 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 Agence du numérique en santé 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" must be understood in its broadest sense, i.e. any use of the site whatsoever, whether lawful 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 Subscribing Users (Healthcare Professionals, HHPs, administrative staff and other relevant professionals) and Patients, 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 User's profile. The accuracy and updating of such information is the sole responsibility of such User. MDHC is not responsible for access authorisations by Users of the same service to patient health data. 

• MDHC is not responsible for errors caused by the Subscribing 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 Service. MDHC's liability is in all circumstances limited to direct and proven damages. MDHC is not liable for any consequential loss, lost profits or expected savings or any indirect 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.

 

6. Intellectual property

MDHC is the owner, or holder of the rights, to all the elements that make up this site, in particular the data, graphics, photos and soundtracks. The brands and logos appearing on the mydiabby.com site 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 site without the express authorisation of MDHC is therefore prohibited, within the meaning of article L 713 - 2 of the Intellectual Property Code.

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7. Personal data

In accordance with the legislation on the respect of the privacy of its Users, 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-praticiens for detailed information on how we process your personal data, including clear instructions on your rights and how you can exercise these rights. Each subscribed User acknowledges that he/she has read the Privacy Policy. 

 

8. 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.

 

9. Modification of the GTCU

We reserve the right to change the scope and function of the User Account, the Site and the Service 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.

 

10. Termination

In the event of a breach or violation 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 Service.

 

11. 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.

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

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