General conditions of use of Orthense for patients

Effective from December 5, 2024

The purpose of these general terms and conditions of use (hereinafter referred to as "GTC") is to provide a legal framework for the terms and conditions for making the Orthense service (hereinafter referred to as "the Service") available by the company DIGIKARE (hereinafter referred to as "DIGIKARE", "we") and to define the conditions of access and use of said service by the user (hereinafter referred to as "the User", "you").

The terms "you" or "your" used in this contract mean you or any person acting on your behalf, such as someone close to you, your family or a home caregiver.

Introduction

Welcome to Orthense

DIGIKARE is a French data processing company serving healthcare.

Are you scheduled for orthopedic surgery?

The Orthense service, created by and for orthopedics, is made available to you in partnership with your surgeon and his team. It will support you during your treatment, informing the medical team about your state of health and guiding you on the conduct to adopt with regard to this state.

Our motto is "Better measurement to better care". This translates into the desire to offer you the best possible experience. As such, you agree that we may contact you directly by telephone or electronically as part of your digital support.

Beyond your episode of care, you participate in improving medical care, where it can be most significant while you live your daily life and are distant from any medical team.

The relationship with the patient, when nourished and constructive, has a significant impact on the patient's health (KELLEY JM, 2014)

Your data is only used for one purpose: the success of your care. Once anonymized, it only serves one purpose, improvement, whether it be care, care pathways or medical devices.

DIGIKARE has a medical committee composed exclusively of orthopedic surgeons whose primary mission is to ensure the ethics and professional conduct of its decisions.

Are you participating in a clinical study?

The Orthense service, initially created for orthopedics, was requested by doctors from all specialties to assist them in conducting large-scale clinical studies. This is in line with our leitmotif "Better measurement for better care". We agreed to open the Orthense service for this purpose.

Your data is only used for one purpose, the carrying out of the study, and it is only once anonymized that it can serve the objective of the study.

You become a user

Use of our Service implies your acceptance of these T&Cs. We invite you to read them carefully.

In the event of non-acceptance of the general conditions of use stipulated in this contract, you must renounce access to the Service, but this access, of course, is not a condition for benefiting from any medical treatment. Refusal of these general conditions will not modify your care pathway or your medical treatment.

Our service should not be used for medical emergencies, you should always seek the advice of your doctor, surgeon, their team, or any other qualified healthcare professional, regarding any questions relating to your health.

Your acceptance of these terms

By clicking the "I Agree" button or using our Service, you acknowledge that you have read these terms and conditions, that you understand them and that you therefore agree to be legally bound by their terms and conditions. These terms are a license agreement between you and DIGIKARE. If you do not agree with its terms or conditions, you should not click "I Agree" and you should not use our Service.

Finally, access to our Service is subject to compliance with all the terms of our data protection charter accessible at this address: https://account.orthense.com/home/privacy . The confidentiality and security of your personal data is, and will remain, one of our most important priorities.

The definitions

Below is a list of definitions that we considered relevant to share with you for a better understanding of the CGU. Do not hesitate to contact us electronically ( [email protected] ), if you want to participate in their improvement.

Titled Definitions

Documentation All information relating to the use of the Service including in particular the user guide and the list of prerequisites necessary for its use

Identifier Refers to both the User's own identifier (username, email address, "login") and the connection password (password, " password ") chosen by the latter after registration.

Personal data Together means Regulation (EU) 2016/679 of the European regulations Parliament and of the Council of 27 April 2016 applicable from 25 May 2018 (hereinafter, "the General Data Protection Regulation") and the "Informatique et Libertés" law n°78-17 of 6 January 1978 amended Law n° 78-17 of 6 January 1978 relating to information technology, files and freedoms, and amended by Law n° 2004-801 of 6 August 2004;

GDPR The General Data Protection Regulation is a European Union regulation that constitutes the reference text for the protection of personal data.

Saas Software as a service (SaaS) is a business model for software in which software is installed on remote servers rather than on the User's machine. Customers pay a subscription fee for the Service in lieu of physically purchasing the software and the inherent need to install and maintain it.

Service or Refers to the Orthense service, developed and published Orthense by DIGIKARE. It is specified that the Service is available in SaaS mode for all its Users, offering them the same functionalities. The Service is made available to the User by a connection via the Internet network. The Service and the functionalities are described in the Documentation

User Any natural person authorized to use the Service (the patient, their surgeon or authorized employees, a healthcare professional)

Legal notices

The Service is provided by us, that is to say, by the company DIGIKARE SAS whose head office is located at 2 avenue de l'Escadrille Normandie Niémen, 31700 BLAGNAC .

The Service is hosted by the companies: CLARANET and MICROSOFT.

All health data is hosted by the company CLARANET, an approved Health Data Host (HDS) since 2010, and HDS certified since 2018 (HDS Infrastructure Host and IT Manager ).

That being said, since MICROSOFT has obtained HDS certification since 2019, all data collected, whether medical or not, and processed by the Orthense service is in an environment that strictly complies with the regulatory framework associated with personal data and, more importantly, health data.

Securing your data is a given, our duty and your right. We wanted to go further, so on May 13, 2019, the Orthense service obtained ADEL certification, guaranteeing the ethics of its processing and use of digital data.

The object

DIGIKARE grants you a personal, non-transferable, non-exclusive, royalty-free license to use its ORTHENSE service. It allows you to inform your medical team of the status and progress of your convalescence. It also allows you to be informed of the conduct to be adopted with regard to your recovery following your surgical operation.

The purpose of these T&Cs is to define the contractual conditions under which:

DIGIKARE grants the user, who accepts it, a right to use the Service in SaaS mode
DIGIKARE provides the user with associated services

These T&Cs apply, without restriction or reservation, to Users of the Orthense service.

These T&Cs apply to all services provided by DIGIKARE, whether they relate to the digitalization of care, and therefore to the digitalization of the patient relationship, or to the paperless management of the data collected, including their archiving and processing.

In view of its commitment to the continuous improvement of the quality of its Service (security, operational guarantee, legal or regulatory reasons), DIGIKARE reserves the right to modify these T&Cs by publishing a new version online. Users will be notified by email of such a modification.

If you do not wish to continue using the Service under the new version of the T&Cs, you may terminate your access by contacting us (electronically: [email protected] ).

Enjoy Orthense

The Orthense service allows you to collect and process your perioperative data . The service is designed to be used online and cannot be downloaded. You must register to access and use this Service. This use remains unique and personal, to do so it will be based on the pair formed by your username and password. You therefore understand the attention you must pay to them.

You can use Orthense from your home, or from anywhere you have an Internet connection.

Your comments constitute an important part of the information used to improve our services. As such, beyond the usual means of contacting us, you can at any time report an idea or unexpected behavior directly to us by sending an email to [email protected] .

To best meet the needs of each user, the Orthense service is multifaceted. It is composed of an interface for you and an interface for your medical team.

These interfaces are accessible through websites (individually and collectively referred to as the "Site"):

https://suivi.orthense.com (Patients)
https://pro.orthense.com (Healthcare professionals)

Users will be able to connect to these interfaces at any time (except during maintenance periods), namely: 24 hours a day, 7 days a week, including Sundays and public holidays. They will benefit from our assistance during business hours (Monday to Friday inclusive, from 9 a.m. to 6 p.m.).

Maintenance periods will be communicated to users via email or information messages published within the Service.

The Service is provided in SaaS mode, users do not have to install anything specific on their computer or on any other device used to access this service.

Access to the Service is via an Internet browser regardless of the device chosen by the User (computer, tablet or smartphone). We strive to support a large number of browsers, if this is not the case for the one chosen by a user, we will inform them by means of appropriate notifications such as a visible notice or a referral to a dedicated Internet page.

The User's identification when accessing the Service is based on their Identifiers. The user is entirely responsible for their use and archiving. Of course, if he forgets his password, or if he wishes to change it, he can reset it from the Service.

In addition, in order to ensure optimal security, a double authentication mechanism can be activated for all users in order to provide a unique code, in addition to the username/password pair, at each connection. This option can be activated from the Service.

Getting started

It is the acceptance of these present T&Cs which formalizes your arrival among our users. It is based on an online process, the first advantage of which is saving time, and results in the association of your electronic signature on the present document.

The first time you log in, you will need to choose a password that we will not know.

Your right of use is based on automatic approval by DIGIKARE, following your registration by a healthcare professional within our Service.

Your registration is based on a series of regulatory information (first name, last name, date of birth, etc.) and your email address. This registration is carried out by a health professional, ensure that the information entered is correct. However, you will be the only one who can define and therefore know your password.

Once you have accepted these general conditions, you will be able to receive assistance in your care from the Service.

Payments, cancellations and cooling-off period

Are you scheduled for orthopedic surgery?

The Orthense service is offered to you by your orthopedic surgeon and his medical team. This service is free. If a third party were to ask you for payment, refuse and notify us as soon as possible by sending a simple email to the following address: [email protected]

Are you participating in a clinical study?

The Orthense service is free. If a third party asks you for payment, refuse and notify us as soon as possible by sending a simple email to the following address: [email protected]

Cancelation

You may cancel your subscription, inherent to your registration to the Service, at any time by contacting us electronically: [email protected] .

The cancellation will come into effect no later than one (1) month after the request.

Using our service

We grant you a non-exclusive, revocable, non-transferable, personal, non-sublicensable license to use the Service.

The license granted is personal and is not granted tacitly to any of your relatives, colleagues, partners, or employer, parent or subsidiary company, subsidiary, or other third party.

Our obligations

We have implemented security measures required by law and in compliance with industry standards, to ensure the protection of the data you provide through the Service. DIGIKARE has carried out the security and data protection audits required by the GDPR directives: please contact us if you wish to have a copy of the minutes of these audits at [email protected] .

DIGIKARE uses the services of a health data host ("HDS") that has the CNIL approvals necessary to store personal health data. We guarantee that this host has provided us with the documents demonstrating that it complies with the legal constraints regarding the hosting of health data: our host is ISO 27001 certified. The certificates relating to the data security of this host are available at the following address: https://www.claranet.fr/certifications . We reserve the right to change hosting providers at any time and without specific notification. If we change hosts, we will ensure that the new provider complies with the same level of data security, or the level of security required by the law in force.

We do not control communications between DIGIKARE's or its partners' secure servers and your equipment that you use to connect to our Service. Thus, we cannot be held responsible for any loss or theft of data during communication between these equipment.

DIGIKARE and its employees or representatives do not under any circumstances access personal health data, directly or indirectly identifying, of patients or doctors (in order to respect medical confidentiality).

You acknowledge and agree that your data will be anonymized by DIGIKARE, an automated procedure consisting of deleting all personal information, such as the name, first name, establishment, address of either you or your doctor, from the initial health data. This process does not require any human intervention on identifying data.

By becoming anonymous, you understand and agree that this data becomes royalty-free. You agree that we develop, control and maintain the anonymous database thus created in full compliance with the provisions of Article L. 4113-7 of the Public Health Code.

We insist on the fact that personal medical data, therefore identifying you, is only intended for you and the healthcare professional who registered you for the service.

Anonymized data is used exclusively to improve medical practices, care pathways, or medical devices.

Are you scheduled for orthopedic surgery? You are the first beneficiary of our anonymization process, it allows us to present your data to your surgeon in relation to the average of his patient base and in relation to the average of all patients using Orthense. This visualization allows any user surgeon to analyze his care and identify areas for improvement.

Please note that you have permanent and independent access to all your data via our Service. In cases where information has been entered or modified with your consent by a healthcare professional, this information remains fully accessible to you, guaranteeing transparency and traceability. At the end of your follow-up, you will be able to download all the information in a dedicated report for a complete view of your journey.

If you make an express request, we will delete your account and thus all of your personal data. Any request for permanent deletion of data must be made explicitly by you, by email to the DIGIKARE termination service, [email protected] . We will inform the healthcare professional who registered you for the Service.

You can also exercise your right of access, namely ask us to communicate to you all the data concerning you. Again, sending a simple email to this address [email protected] is enough . We will then be discharged from any responsibility for securing this data or archiving it.

Your obligations

We respect intellectual property rights and we expect you to do the same.

While we ensure that our Service complies with applicable laws and regulations regarding health data, once it is in your hands, we rely on you. If you copy it to a medium outside the Service's IT infrastructure, you will then be solely responsible for its security and confidentiality.

You agree to keep your username and password confidential and not share them with any third party.

You acknowledge that Orthense, in its structure, organization, information flow, and source code, contains confidential trade secrets and know-how. You must not, nor authorize any third party to: (a) modify, adapt, alter, translate or create derivative works of Orthense; (b) merge Orthense with any other software; (c) sublicense, rent, lend or transfer your access rights to Orthense to any other third party; (d) attempt to reverse engineer, decompile, disassemble or derive the source code of Orthense; (e) remove or alter the copyright, patent and other intellectual property notices of Orthense; (f) distribute or publish, whether orally or in writing, any information relating to the performance of Orthense unless DIGIKARE gives you express permission to do so; (g) generally, exercise rights other than those specified in these T&Cs.

Finally, Orthense being a SaaS mode service, you grant us the use of the hardware resources of the device from which you access the service.

You and the healthcare professional who registered you are solely responsible for the accuracy and qualification of the data that is collected through the Service.

illegal content

We are supported by a medical committee. However, if you think that a content does not respect copyright, or flouts medical ethics, do not hesitate to contact us: [email protected] .

Limitations and Modifications of the Service

In order to continuously improve our service or to comply with new regulatory requirements, we may be required to temporarily interrupt the service. Everything will be done to ensure that the duration of these interruptions is reasonable and carried out in such a way as to minimize their impact. Service updates will not result in any regression in terms of performance and functionality.

It is understood that we cannot be held responsible for technical malfunctions of the telecommunications network that the user uses to access the Internet, or of any software necessary for this access.

The cost of connecting to the Internet network also remains your responsibility.

Customer and User Support

We provide support to both our customers and our users (healthcare professionals or patients). We provide them with telephone or electronic support from Monday to Friday inclusive, from 9 a.m. to 6 p.m.

This assistance responds equally well to a user's request for help or the discovery of a malfunction.

Duration and termination

The T&Cs constitute the Contract that binds us. It will remain in force until terminated, at your initiative, or that of DIGIKARE.

This Agreement, and the rights of use attached to it, will become effective on the date, called the anniversary, on which it is signed and approved by you and us.

You may terminate this Agreement at any time.

The termination will take effect at the end of the inherent suspension of your registration or after a period of a priori 10 years with regard to the regulation targeting the archiving of medical data within the framework of the shared medical record.

Warranty and exemption

You acknowledge the entire Agreement and its exclusive nature in the sense that it supersedes any other prior proposal or agreement, written or oral, concerning the use of the Service. If you have acquired access to the Service from a third party, the latter cannot commit to anything on behalf of DIGIKARE.

You agree to use Orthense as is, and you understand that Orthense may not work as you expect or provide you with the results you desire. Your use of Orthense is at your sole risk.

This document grants rights only to you and DIGIKARE, even if access to the Service has been distributed by a third party.

A clause of these T&Cs that becomes illegal does not call them into question entirely.

Applicable Law, Mandatory Arbitration and Venue

These T&Cs are governed by French Law. You and we consent to the exclusive jurisdiction of the Courts of Toulouse and to the holding of trials before these courts.

If a dispute arises during the interpretation of the execution of these conditions, you and we will endeavour to settle it amicably prior to any legal action. In the event of a persistent disagreement, the dispute will be brought before the Toulouse Commercial Court, the only competent jurisdiction.

Contact us

If you have any questions regarding the Orthense Service or its general conditions of use, please contact us by telephone: +33678456065 or by email: [email protected] .

Thank you for reading our Terms of Use. We look forward to having you as a subscriber.

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