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TERMS AND CONDITIONS

LEGAL NOTICE FOR THE 'NEWCARD' APPLICATION
Patients are kindly requested to read the following Terms of Service for the 'Newcard' application carefully. We recommend that users refer back to these legal notices regularly, as they are subject to change.

 ARTICLE 1 – GENERAL TERMS OF USE" 

The purpose of the 'Newcard' application is to collect measurements taken by patients at home and transmit them via 3G or Wi-Fi to the platform developed by Newcard, which is accessible to healthcare professionals involved in telemonitoring. Its use is strictly reserved for patients suffering from heart failure who have been enrolled in the program by a physician and on whose device the application has been installed.

Particularly for the purpose of improvement, Newcard may modify or adapt the application. In such cases, an update by the patient may be required. The patient is required to perform this update as soon as possible.

Newcard also reserves the right to modify the application's terms of use at any time (by adding, changing, or removing elements). In this case as well, an update to the application by the patient may be necessary. Following each update, users are advised to review the legal notice.

ARTICLE 2 – INTELLECTUAL PROPERTY 

This 'Newcard' application is published by Newcard, located at 236 avenue Clément Ader, 59118 Wambrechies, and is hosted by ATE (Avenir Télématique), 21 Avenue de la Créativité, 59650 Villeneuve-d’Ascq.

The elements created for this application are the exclusive property of Newcard or, where applicable, of third parties that have authorized their citation by the company. All elements (including trademarks, logos, images, graphics, icons, audio, software, and domain names) displayed on the 'Newcard' application are protected by applicable intellectual property laws and belong to Newcard or are subject to an authorization for use.

The user is granted only a right to use the information displayed (texts, logos, designs, images, etc.) on the application. This right is limited to personal and private use; the user has no right of reproduction, representation, modification, publication, or adaptation of all or part of the application's elements, except for a single copy intended strictly for private use, and subject to compliance with intellectual property rights and any other property rights mentioned. Any other use is subject to the prior agreement of Newcard. Consequently, any unauthorized use will constitute infringement, for which Newcard reserves the right to pursue legal remedies.

ARTICLE 3 – CONTACT INFORMATION 

The owner and publisher of the 'Newcard' application is the company NEWCARD.

Newcard

 236 Avenue Clément Ader
59118 Wambrechies,
France contact@newcard.io +33 (0)3 20 14 71 14
Registered with the Lille Métropole Trade and Companies Register (RCS) under number 821 766 961
SAS with a share capital of 3,511.00 euros
Managing Director: Pierre Emmanuel BONNET

Hosting Provider: Avenir Télématique (ATE) 

21 Avenue de la Créativité
59650 Villeneuve d’Ascq, France
SAS  with a share capital of 60,000 €
Lille Trade and Companies Register (RCS) No. 347 607 764
www.ate.info
+33 (0)3 28 800 300
Managing Director: Maxence ROUSSEAU 

Questions or requests for information regarding the application may be sent to the company via the aforementioned postal or email addresses, or by phone using the contact details provided. 

ARTICLE 4 – APPLICABLE LAW 

The 'Newcard' application is an application created in France. Any dispute arising in connection with its use shall be governed by French law, and the French courts shall have exclusive jurisdiction.

For any questions regarding personal data or liability, users are invited to read the application's Terms of Service, which they have accepted.

TERMS OF SERVICE FOR THE 'NEWCARD' APPLICATION Please find attached the Terms of Service that you accept / accepted during your first log-in to the application. For any withdrawal, please contact NEWCARD using the contact details provided.

Between NEWCARD, a Simplified Joint-Stock Company (SAS) registered under identification number 821 766 961 with the Lille Métropole Trade and Companies Register, having its registered office located at 391 avenue Clément Ader, 59118 Wambrechies, represented by its legal representative (hereinafter referred to as the 'Service Provider' or 'NEWCARD')

And the patient, defined herein as a user of the Telemonitoring Software prescribed by their physician in accordance with the legal and regulatory requirements of the Social Security (hereinafter referred to as the 'Patient'). NEWCARD and the Patient are hereinafter collectively referred to as the 'Parties' or individually as a 'Party'.

1. ACCEPTANCE AND UPDATES 

Important : Any use of the Logiciel in any capacity whatsoever implies the unreserved acceptance by the end user (the Patient) of these TOU.

1.1 The Patient acknowledges that he/she has read, understood and accepted these TOU without limitation or condition, initially by giving his/her free and unreserved consent to his/her physician to be tele-surveilled and use the "Newcard" Application, then by accepting these TOU on the Application (i.e. the "System" or the "Software"). These TOU constitute the complete and exclusive agreement between the Patient and NEWCARD concerning the use of the Logiciel.

1.2 NEWCARD reserves the right to change, modify all or part of these TOU. The Patient is informed of these modifications and of the date of updating of the TOU.

If the Patient does not accept these GTU or any updated version of these GTU, he must not use the System.

1.3 The Patient hereby warrants and confirms that he/she is of legal age to consent to these TOU and that he/she is fully capable of (i) concluding the contract that these TOU constitute, and (ii) complying with them.

2. PURPOSE 

2.1 NEWCARD makes the Application available to Patients under the Decree of June 22, 2023, concerning the registration of medical telemonitoring activities on the list provided for in Article L. 162-52 of the French Social Security Code, on the basis of Article 36 of Law No. 2021-1754 of December 23, 2021, on social security financing for 2022.

2.2 NEWCARD makes the Application available to the Patient and grants them a non-exclusive, personal, and non-transferable license to use the System solely within the French territory.

2.3 The System offers the following main features:

  • Weight tracking using a connected scale;
  • Blood pressure and heart rate measurement using a connected blood pressure monitor;
  • Symptom reporting through a questionnaire consisting of five (5) questions;
  • Information logging for biological data;
  • Application on a digital tablet or smartphone allowing the retrieval and visualization of measurements taken, as well as notification of absence;
  • A 3G system for sending measurements, particularly for patients who do not have an internet connection;
  • An algorithm allowing data processing and the triggering of alerts in the event of a variance;
  • A telephone service to answer technical questions, on business days from 9:00 AM to 5:00 PM.

3.  FREE SERVICE AND CONNECTION CONDITIONS 

3.1 The provision and use of the System are free of charge for eligible patients under the Decree of June 22, 2023, concerning the registration of medical telemonitoring activities on the list provided for in Article L. 162-52 of the French Social Security Code, on the basis of Article 36 of Law No. 2021-1754 of December 23, 2021, on social security financing for 2022, and to whom the telemonitoring service has been medically prescribed.

3.2 The Patient acknowledges that they possess the necessary means and skills to use the System. Consequently, the Patient accepts and understands that the performance of the System may be affected by the means they choose to use. Furthermore, if the Patient uses their own internet connection to send their data, they are responsible for their internet subscription, and NEWCARD shall not be held liable for the billing terms of any third-party operator.

3.3 In accordance with Article L.221-28 of the French Consumer Code, the Patient does not benefit from a right of withdrawal once they validate their registration to the System, thereby accessing the System's digital content. In any event, the Patient may withdraw their consent at any time by contacting NEWCARD using the contact details provided to request the closure of their account on the System.

4. OBLIGATIONS OF NEWCARD 

4.1 The Service Provider makes the System available at the Patient's home and offers telephone support in the event of a technical issue, available from Monday to Friday from 9:00 AM to 5:00 PM.

4.2 The Service Provider undertakes to host the Patient's data within the System through a hosting provider certified to store health data (HDS certified hosting provider).

4.3 The Service Provider undertakes to comply with the provisions of 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, and repealing Directive 95/46/EC (General Data Protection Regulation).

4.4 The Service Provider undertakes, within the framework defined by these Terms of Service, to use all reasonable means to ensure the performance and continuity of access to the System. However, the Patient accepts and acknowledges that maintenance and update operations on the System may occur, and the Service Provider will use its best efforts to notify the Patient in advance.

4.5 The Service Provider undertakes to comply with the applicable regulatory provisions relating to its status as a regulated Medical Device and, as such, bears the CE marking.

5.  MEDICAL DISCLAIMER 

5.1 The Software provides and publishes informative content based on the results of the measurements taken by the Patient and is solely intended to assist them and provide information required by the System for the proper conduct of telemonitoring. NEWCARD is not a medical organization or a healthcare professional. NEWCARD offers a System for transmitting and organizing information sent by the Patient. In this regard, the System informs physicians of the data sent. None of the content on the Software shall be interpreted to mean otherwise. Consequently, the information accessed on the Software shall not be considered a substitute for (a) a personal and professional medical consultation provided by a physician, and/or (b) a diagnosis, interpretation, or evaluation made by the physician either remotely or in person.

5.2 THIS SYSTEM IS NOT AN EMERGENCY SYSTEM. Its purpose is the daily monitoring of data sent in order to notify the physician in the event of a significant variance in the data. Telemonitoring follow-up does not exempt the Patient from their usual care routines. In the event of any medical difficulty or emergency, entirely left to their own judgment, the Patient must contact healthcare professionals as they normally would (for example, their general practitioner or emergency medical services).

5.3 NEWCARD shall not be held liable:

  • If data fails to reach it, for any reason whatsoever, or if the data received is illegible or impossible to process;
  • If the user is unable to access or use the application, for any reason whatsoever;
  • If, for any reason whatsoever, the connection is interrupted.

6. PATIENT OBLIGATIONS 

6.1 The Patient undertakes to allow NEWCARD to create an account for them and to train them on how to use the System if necessary. They then undertake to take their measurements regularly and in accordance with the recommendations made by Newcard for their telemonitoring follow-up. This is an essential condition for the proper functioning of the telemonitoring system.

6.2 The Patient, as a user, acknowledges that they possess the necessary means and skills to use the Software. Consequently, the Patient accepts and understands that the performance of the Software may be affected by the chosen connection means.

6.3 The Patient undertakes to make strictly personal use of the equipment provided to them, in accordance with its intended purpose. They shall follow the instructions provided during installation and/or the information included in the user guide. They are aware that they have custody and responsibility of the equipment, and notably the tablet equipped with the Application. They are also aware that the trend curves of their data can be visualized when connected to the internet or a 3G server. In this respect, they are solely responsible for any use of the tablet and the Application by third parties, and must therefore take the necessary security measures. On their own initiative, they may notably lock the tablet or smartphone on which they use the Application with a confidential code of their choice. In the event that the tablet provided by Newcard is locked by a confidential code, they must imperatively remove this code before returning the equipment to Newcard.

6.4 The Patient undertakes to use their best efforts to enter their data into the System in a reliable, complete, accurate manner, and in accordance with the formats agreed upon between the Parties. In case of doubt or difficulty, the Patient may contact Newcard for assistance with data entry.

6.5 The Patient undertakes to comply with the technical prerequisites and hardware configurations recommended by the Service Provider.

6.6 At the end of their telemonitoring follow-up or upon termination of the Contract by either Party, for any reason whatsoever, the Patient or their beneficiaries (ayants droit) undertake to return the equipment to NEWCARD within the following 30 days, by sending it to the address provided to them. The Patient also undertakes to return the equipment to NEWCARD in the event of defective equipment or any other reason requiring a kit replacement.

6.7 The Patient undertakes to comply with the provisions of these Terms of Service and the requirements of the guidelines set by the Social Security.

6.8 The Patient undertakes to comply with applicable laws and regulations in force.

7. COMMON OBLIGATIONS

7.1 Each Party undertakes to inform the other Party of any event or information brought to its knowledge that would be likely to have any effect whatsoever on the Software and these Terms of Service.

7.2 Each Party undertakes to respect the confidentiality of these presents and not to harm the image and reputation of the other Party.

8. INTELLECTUAL PROPERTY

8.1 NEWCARD remains the sole owner of all its intellectual and material property rights regarding trademarks, photographs, computer programs, distinctive signs, know-how, methods, and all documents used or implemented during the use of the Software, and notably its algorithm (all such rights and elements hereinafter referred to as the "Elements").

8.2 The Patient undertakes not to infringe upon, or challenge in any manner whatsoever, the Service Provider's rights over the Elements belonging to it.

8.3 The Contract does not imply any transfer of ownership over the Software, and notably over the data, methods, or development tools for which the Service Provider holds proprietary or licensing rights and which may have been made available to the Patient for the purposes hereof.

8.4 The Patient undertakes not to make any modification to the Software. The Patient acknowledges that the Software is protected by intellectual property rights and declares that they have not entered into this contract with the intent to infringe upon them in any manner whatsoever. In particular, the Patient undertakes not to copy it, disclose it in any way whatsoever, and not to commit or allow any action to be committed that is likely to infringe upon these rights.

9. LICENSE FOR USE

9.1 The Service Provider hereby grants to the Patient, who accepts it, a personal, non-transferable, non-assignable, and non-exclusive license to use the Software for a term of 2 years, tacitly renewable. This license shall terminate at the end of their telemonitoring follow-up.

9.2 The granting of the right of use, as provided for in the Contract, is consented solely to the Patient. This grant is validly attributed solely for the French territory from the moment a session is opened on the Software.

9.3 The Patient is prohibited from any type of exploitation not explicitly authorized by these Terms of Service, and notably from:

  • Making a backup copy for any reason other than preserving the use of the Software;
  • Correcting or having a third party correct any potential errors or bugs in the Software without the prior written consent of the Service Provider;
  • Granting a loan or making the Software or its documentation available by any means whatsoever, including via the Internet;
  • Adapting, arranging, or modifying the Software.

10. ENTRY INTO FORCE / TERM

10.1 This document enters into force as of the date of acceptance of these Terms of Service.

10.2 The duration of the Contract is 2 years.

10.3 The Contract shall be tacitly renewed for successive periods of two years, except in the event of (a) termination by either Party notified by registered letter with acknowledgment of receipt subject to one (1) month's notice, or (b) the end of the medical telemonitoring follow-up and non-renewal of the prescription by the Cardiologist.

11. CONFIDENTIALITY

11.1 The term "Confidential Information" hereinafter refers to any information, whether materialized or not, that is strategic, financial, technical, or commercial. This confidential nature may notably result from the presence of any appropriate marking, from the very nature of the document, or from an express oral indication.

11.2 The Parties undertake to ensure that Confidential Information is kept confidential by taking all useful and reasonable security measures, and used solely for the purposes hereof.

11.3 The provisions of this article shall remain valid throughout the term of the Contract and for 4 years thereafter.

12. PERSONAL DATA

12.1 Identity of the Data Controller

The collection and processing of personal data are carried out by the Company Newcard, responsible for the application made available to patients. Newcard is domiciled at the following address: 391 avenue Clément Ader, 59118 Wambrechies. It can be contacted at +33 (0)3 20 14 71 14 or by email at info@newcard.io.

Newcard has appointed a Data Protection Officer (hereinafter "DPO"), duly declared to the French National Commission for Information Technology and Civil Liberties (hereinafter "CNIL"). The DPO can be contacted at +33 (0)3 60 85 06 86 or by email at mes-données-personnelles@newcard.io.

12.2 Purposes of Personal Data Processing

The data collected is processed for specific purposes. Consequently, it cannot be used for purposes other than those specified in these Terms of Service. In this case, these purposes are of several types:

  • Conducting the telemonitoring of patients suffering from chronic pathologies;
  • Providing therapeutic support; and
  • Conducting analyses and data studies on patient populations. The objective is to contribute to scientific research on chronic pathologies and their management, telemonitoring, and its medico-economic benefits.

12.3 Legal Basis for Processing

The collection and processing of data are carried out in accordance with the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (GDPR), and Law No. 78-17 of January 6, 1978, relating to information technology, files, and civil liberties. The legal basis for processing is the consent of the data subject.

12.4 Categories of Processed Data

Only the data necessary for the patient's telemonitoring within the framework of the tele-follow-up application is required.

This includes the patient's identity data (last name and first name, gender, date of birth), their social security number, their daily vitals (weight, height, blood pressure, heart rate, symptom questionnaire), connection data, and the software usage history.

12.5 Recipients of Personal Data

The collected information is secured and hosted by an HDS certified hosting provider ("Hébergeur de données de santé"). Our data host is ATE, whose contact details are as follows:

Avenir Télématique (ATE)

21 avenue de la créativité

59650 Villeneuve d’Ascq

https://ate.info / contact_web@ate.info / +33 (0)3 28 80 03 00

Several persons, whether belonging to Newcard or not, are authorized to access the patient's personal data:

  • The cardiologist and their medical team have access to the patient's personal data (sensitive and non-sensitive) in order to ensure their telemonitoring;
  • Internal healthcare professionals at Newcard also have access to the data (sensitive and non-sensitive) to ensure the efficiency of the patient's follow-up; and
  • Newcard's administrative staff also has access to the patient's non-sensitive personal data (identity, contact details, etc.).

12.6 Retention Period of Personal Data

All data collected and processed by Newcard within the framework of the application is retained:

  • For patients followed by a private practice cardiologist: 5 years after the end of their follow-up;
  • For patients followed by a healthcare institution (hospital or private clinic): 20 years after the end of their follow-up.At the end of the retention period, the data will be irreversibly anonymized.

12.7 Rights of Data Subjects

Regarding the collection and processing of personal data, data subjects possess numerous rights necessary to guarantee fair and transparent processing. To exercise these rights, they may contact Newcard at the contact details mentioned in paragraph 12.1. Thus, they have a right to:

  • Access to personal data: The data subject has the right to obtain from Newcard confirmation as to whether or not personal data concerning them is being processed, and, where that is the case, access to said data.
  • Rectification of personal data: The data subject has the right to obtain from Newcard the rectification of inaccurate and/or incomplete personal data.
  • Erasure of personal data: The data subject has the right to obtain from Newcard the erasure of personal data concerning them without undue delay.
  • Restriction of processing: The data subject has the right to obtain from Newcard the restriction of processing of their personal data.
  • Objection to processing: The data subject has the right to object, at any time, to the processing of personal data concerning them.
  • Data portability: The data subject has the right to receive the personal data concerning them, which they have provided to Newcard, in a structured, commonly used, and machine-readable format.
  • Withdrawal of consent: The data subject has the right to withdraw their consent to the processing of their personal data at any time, without affecting the lawfulness of processing based on consent before its withdrawal.
  • Lodging a complaint with a supervisory authority: The data subject has the right to lodge a complaint with the competent supervisory authority. They may address their remarks to the Commission Nationale de l’Informatique et des Libertés (CNIL), whose contact details are as follows:Commission Nationale de l’Informatique et des Libertés3 Place de Fontenoy – TSA 8071575334 Paris Cedex 07

12.8 Transfer Outside the European Union

The data collected and processed within the framework of telemonitoring is hosted by ATE – an HDS certified data host – based in Villeneuve d’Ascq.

Our host certifies that the data is hosted within the European Union and that no transfer outside the European Union is carried out. Newcard undertakes to provide any interested person, upon request, with the hosting certificate issued by ATE.

13. TERMINATION - EXPIRATION

13.1 Under the conditions provided for in Article 10.3, the Parties may terminate the Contract. This termination shall take effect 30 calendar days from the receipt of the termination notice.

13.2 The prescription by the Physician of the Newcard service under the Decree of June 22, 2023, concerning the registration of medical telemonitoring activities on the list provided for in Article L. 162-52 of the French Social Security Code, on the basis of Article 36 of Law No. 2021-1754 of December 23, 2021, on social security financing for 2022, is an essential condition of these Terms of Service. In the event of the end of the medical telemonitoring follow-up, the Contract shall terminate automatically, except for authorized out-of-framework follow-ups, which require the express agreement of Newcard.

13.3 In the event of non-performance of their obligation to return the equipment, the Patient will be served a formal notice to pay the sum of two hundred (200) euros to NEWCARD, representing the buyback price of the equipment, by check or bank transfer using the details provided to them by mail.

13.4 Upon expiration or termination of the Contract for any reason whatsoever, the obligations of the Parties shall survive regarding intellectual property and copyright, confidentiality, and those clauses which by their nature must remain in force shall remain in force, such as the "Liability" clause.

14. SUSPENSION – TERMINATION OF ACCESS

14.1 The Service Provider may automatically suspend access to the Software and remove the Software from online availability, without compensation to the Patient and without prior formal notice, in the following cases: (1) upon the Patient's request, (2) due to non-compliance with the Patient's obligations, (3) the Patient's death, (4) discontinuance of the Software, (5) when the Patient's actions endanger the Software in any manner whatsoever, (6) in the event of a material breach of this Contract, (7) in the event of the end of a follow-up semester and non-re-inclusion of the patient by their cardiologist. This decision shall be brought to the Patient's attention by the Service Provider within a reasonable timeframe.

14.2 In the event of suspension of access or termination of the Contract, the Patient has the possibility to extract their data in accordance with applicable regulations.

15. LIABILITY

15.1 The Service Provider shall not be held liable in any manner whatsoever for the consequences resulting from (i) the Patient's lack of diligence in taking their vitals, (iii) the incorrect use of the Software by the Patient, (iv) the use by any third party of the equipment under the sole custody of the Patient, (v) any delay, inaccuracy, or malfunction due to a failure, fault, negligence, or omission of the Patient, their physician, their subcontractors, or any third party over whom the Service Provider has no power of control or supervision.

15.2 Neither Party shall be held liable for the consequences of indirect damages. In particular, data losses are considered indirect damages.

15.3 It is up to the Patient to inform the Service Provider of any defect or non-conformity observed, and to provide proof of the Service Provider's failure.

15.4 The Service Provider shall not be held liable in any manner whatsoever for (v) total or partial unavailability to access the Software, notably for technical maintenance operations or updating of published information, (vi) viral attacks, (vii) incomplete or erroneous information provided by a user, (viii) the processing or lack of processing of alerts by the Physician.

16. FORCE MAJEURE

Neither Party shall be held liable for any breach of its obligations under the Contract if such breach results from a situation constituting force majeure as defined by the case law of the French Cour de Cassation on the date of its occurrence. Each Party shall immediately inform the other Party of the occurrence of a force majeure event likely to prevent it from executing its obligations. The Parties shall then endeavor to take appropriate measures to mitigate the consequences of the event. However, if the event persists beyond 30 calendar days, the Contract may be terminated by the most diligent Party, without compensation.

17. MISCELLANEOUS

17.1 If any of the clauses of the Contract were to be declared null and void, the remaining provisions of the Contract shall remain in full force and effect.

17.2 The failure of either Party to invoke a breach by the other Party of any of the obligations referred to in the Contract shall not be construed for the future as a waiver of its right to invoke said breach or to enforce the obligation in question.

18. GOVERNING LAW – JURISDICTION

18.1 The Contract is governed by French law.

18.2 UNLESS CONTRARY TO PUBLIC POLICY PROVISIONS, ANY DISPUTE RELATING TO THE APPLICATION, PERFORMANCE, OR INTERPRETATION OF THE CONTRACT SHALL, BY EXPRESS AGREEMENT, BE BROUGHT BEFORE THE COURTS OF LILLE.