General conditions of use of Orthense for healthcare professionals

Effective as of October 10, 2021

The purpose of these general conditions of use (called "T & Cs") is the legal framework for the provision of the Orthense service (hereinafter referred to as "the Service") by the company DIGIKARE (hereinafter referred to as " DIGIKARE "," we ") and to define the conditions of access and use of the said service by the user (hereinafter referred to as "the User", "you").

Introduction

Welcome

Thank you for choosing us. DIGIKARE is a French processing company data (“Data company”) in the service of health. We provide you with a patient-centric real-life data platform. The Orthense service, created by and for orthopedics, is based on this platform. By digitizing your supported, the Service extends your medical talk to the patient for the whole episode of care, equips the evaluation of your practice and assists clinical investigation. You have the ability to position a patient in relation to your patient base, or that of all users of the service.

Our leitmotif is “Better measurement for better care”. Our goal is to equip a full valuation of the quality of care.

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

In case of non-acceptance of the general conditions of use stipulated in this contract, you must renounce access to the Service.

The definitions

Below is a list of definitions that we have found relevant to you share for a better understanding of the T & Cs. Don't hesitate to us contact electronically ([[email protected]] (mailto: [email protected])), if you want to participate to their improvement.

| Title | Definitions | | ---------------------------------------------- | - -------------------------------------------------- -------------------------------------------------- -------------------------------------------------- -------------------------------------------------- -------------------------------------------------- -------------------------------------------------- -------------------------------------------------- -------------------------------------------------- -------------------------------------------------- ------------------- | | Order Form | Document signed by the Client, describing in particular the characteristics of the service provided to the Client under these General Conditions | | Client | Any natural or legal person designated in the Order Form | | Documentation | All the information relating to the use of the Service including in particular the user guide and the list of prerequisites necessary for its use | | Username | Refers to both the User's own identifier (username, email address, "login") and the connection password (password, "password") chosen by the latter after registration | | SEPA Direct Debit Mandate | Authorization given by the Customer to DIGIKARE to withdraw it from his bank account for the amount in euros and the agreed schedule, within the Order Form | | Personal data regulations | Together refers to Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 applicable from May 25, 2018 (hereinafter, "the General Data Protection Regulation") and the "Data Protection Act" »N ° 78-17 of January 6, 1978 modified Law n ° 78-17 of January 6, 1978 relating to data processing, files and freedoms, and modified by law n ° 2004-801 of August 6, 2004; | | GDPR | Said General Data Protection Regulation, is a regulation of the European Union which constitutes the reference text in matters of personal data protection. | | Saas | Software as a service, or software as a service (SaaS), is a commercial operating model of software in which software is installed on remote servers rather than on the User's machine. Customers pay for a subscription to the Service in lieu of a physical acquisition of the software and the inherent need to install and maintain it. | | Service or Orthense | Refers to the Orthense service, developed and published by DIGIKARE, for which the Customer has chosen to take out a subscription when signing the Order Form. 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 Customer by a connection via the Internet network. The Service and the functionalities are described by the Documentation and the Order Form | | User | Any natural person authorized by the Customer to use the Service (himself, his patients, or his authorized collaborators) |

Legal mentions

The Service is edited 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 hosting of the Service is provided by the companies: CLARANET and MICROSOFT.

All health data is hosted by the company CLARANET, accredited host of Health Data (HDS) since 2010, and HDS certified since 2018 (Infrastructure host and HDS outsourcer).

However, the company MICROSOFT having obtained HDS certification since 2019, any data collected, whether medical or not and processed by the service Orthense is located in an environment that strictly respects the framework regulations associated with personal data and, moreover, health.

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 treatment and use digital data.

The object

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

• DIGIKARE grants the Customer, who accepts it, a right of use in mode SaaS of the Service

• DIGIKARE provides the Customer with associated services

• The Customer agrees to pay the contractual fee

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

These T & Cs are applicable to all services provided by DIGIKARE, that they are part of the digitization of support, and therefore in the digitization of the patient relationship, or in the management dematerialized data collected, including their archiving and processing.

The Customer declares to have read these General Conditions Use before ordering.

The applicable T & Cs are those in effect on the date of the order.

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

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

Enjoying Orthense

The Orthense service collects and processes data perioperative procedures of your patients. The service is designed to be used in online and cannot be downloaded. You must register to access and use this Service. This use remains unique and personal, to be to do this will be based on the couple formed by your username and your password. past. So you understand the care you need to pay to them.

Your comments are an important part of the information used for the improvement of our services. As such, beyond the various means customary to contact us, you can at any time report an idea, a unexpected behavior directly from the service's online interface, the details of the mechanics are presented in the Documentation.

To best meet the needs of each user, the Orthense service is multifaceted. It thus consists of an interface for your patients and an interface to your destination (and to healthcare professionals skills that you will select).

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

• https://pro.orthense.com (Healthcare professionals)

• https://suivi.orthense.com (Patients)

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

Maintenance periods will be communicated to users by mail electronic or informational messages published within the Service.

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

Access to the Service is made from an Internet browser regardless of the device chosen by the User (computer, tablet or smartphone). We 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 him by means of tailored notifications such as a visible notice or page referral Dedicated Internet.

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

In addition, in order to guarantee optimum safety, a double authentication can be enabled 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 T & Cs which contracts your arrival at among our Service subscribers. It is based on an online process, whose first advantage is the saving of time, and results in the affixing of your electronic signature on the present document.

Once this step is completed, we will create a User account based on the email address associated with your signature. You will therefore receive a email confirming this creation, reminding you that the associated rights of use are only granted to you in a personal capacity.

At your first connection, you will have to choose a password which we will not know.

No right of use is granted without the approval of DIGIKARE, and without that DIGIKARE means it to you. Apart from the registration of your patients which is based upon automatic approval from DIGIKARE.

The registration of a patient is based on a series of regulatory information (first name, last name, date of birth…) and his email address. As soon as you have entered this information, the latter will be notified by electronic means of the creation of his account, and he will be invited to choose a password which he only will know.

These steps are enough to collect your first health data.

Service options

The Service Documentation describes the different options. Purchase order list exhaustively the Service options of which you are beneficiaries. Some options are available to you free of charge. Other options require a payment before you can benefit from it. You can also be beneficiary of special promotional subscriptions co-constructed with third parties parts. We are not responsible for any components that will be supplied by these.

In fact, we reserve the right to modify or terminate subscriptions and promotional offers that we offer at any time, in accordance with these T & Cs.

The "Cabinet" option

The "Cabinet" option gives you the possibility to share the use of the Service with your collaborators. These must in fact be people authorized to exchange or share information covered by secrecy medical under Articles L. 1110-4 and L. 1110-12 of the French Health Code public and texts taken for their application.

If you are subscribed to the "Firm" option, you are invited to send us track the email addresses of employees who will work together with you, once their acceptance of the T & Cs, they will each have their own user account.

Payments, cancellations and cooling off period

Billing

You can purchase a subscription to the Orthense service from DIGIKARE or by through a third party.

Two payment options are available to you:

• A payment due (i.e. in advance) of the subscription fees on a monthly or any other period that was communicated to you before your purchase.

• A prepayment covering a predetermined period (prepaid card subscription).

We are the only ones able to offer you the payment due. the prepayment of a subscription is based on the acquisition of so-called cards subscriptions. Using such a card automatically gives you access to the Service under the conditions associated with the card (including an enumeration explicit of the activated options). If you purchase a subscription card from third party, special conditions may apply to your access to the Service, in addition to these T & Cs.

Some paid options of the Service do not benefit from billing monthly, they will be billed to you at once upon purchase.

The effective payment of your purchases is based on the creation of a SEPA direct debit to our credit. You will be able to perform this action online. You will be informed of any payment due.

Renewal and cancellation

If your subscription is not the result of a prepaid card, it will be automatically renewed at the end of its period on a monthly basis, unless to terminate it before the end of this period.

You can cancel your subscription by contacting us (electronically : [[email protected]] (mailto: [email protected])). The cancellation will take effect effective the day after the last day of the current subscription period. Stopping your subscription does not automatically end your account. You will no longer be able to register a patient, but we leave it to you possibility of monitoring all registered patients before stopping your subscription. Thus, the latter and the contract linked to it will end on last day of the last active follow-up of one of your patients. You keep the possibility of canceling all ongoing follow-ups, potentially shortening how long your account will remain active. Even though we regret your departure, we remain committed to accompanying you until it is effective.

Using our service

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

The license granted is personal and is not tacitly granted to a your colleagues, partner, or employer, parent or daughter company, subsidiary, or another third party.

Our obligations

We have implemented security measures required by law and respecting industry standards, to ensure the protection of the data you and your patients provide information through the Service. DIGIKARE carried out the audits of security and data protection imposed by GDPR directives: please contact us if you would like a copy of the minutes of these audits to [[email protected]] (mailto: [email protected]).

DIGIKARE uses the services of a health data host ("HDS") which has the CNIL approvals necessary to store data personal health care. We guarantee that this host has provided us with the documents demonstrating that it complies with the legal constraints in terms of of healthcare data hosting: our host is ISO 27001 certified. 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 be able to change hosting provider at any when and without special notification. If we change host, we will make sure that the new provider respects the same level of data security, or the level of security required by applicable law.

We do not control communications between secure servers of DIGIKARE or its partners, and your equipment that you use for you connect to our Service. So we can not have any responsibility in the event of loss or theft of data during communication between these materials.

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

You acknowledge, and you agree, that your data will be anonymized by DIGIKARE, automated procedure consisting in deleting all information personal, such as last name, first name, establishment, address whatsoever from you or your patients, initial health data. This process does not requires no human intervention on identifying data.

By becoming anonymous, you understand, and you agree, that these data become free of rights. You agree that we develop, control and maintain the anonymous database thus constituted in full respect of the provisions of Article L. 4113-7 of the Public Health Code.

You are the first beneficiary of our anonymization process, you allows you to project your data onto all anonymized data and consolidated by our Service, as it is carried out for the follow-up of the pain felt by the patient during the postoperative period. Within a same graph, the service presents three pain development curves postoperative:

• A first curve is based on the values ​​entered by your patient

• A second curve is based on the average of the values ​​entered by your patient (except your patient) subject to the same treatment.

• A third curve is based on the average of the values ​​entered by all patients (except your patient) registered with the service and subject to the same treatment.

If a User expressly requests it, we will delete all his personal data. Any request for permanent deletion of data must be made explicitly by the user, by email to the service termination of DIGIKARE, [[email protected]] (mailto: [email protected]).

We will then be relieved of all responsibility on the securing this data or its archiving. If this is a patient, we inform the surgeon who registered him for the Orthense service.

Finally, we recognize you as the owner of your medical monitoring protocols. which we digitize. You are free to share them, or not, to other subscribers to the Service.

Your obligations

We respect intellectual property rights and we expect that you do the same. So, for example, you need to make sure to have licenses to use the measurement tools (scores, etc.) that you implement digitally using our service. We remain at your disposition if you are concerned about using a score.

You are a healthcare professional and if we ensure that our Service complies with the laws and regulations in force relating to health data, once it is in your hands, we leave it to you. If you copy to a medium outside the IT infrastructure of the service, you will then be solely responsible for their security and confidentiality.

However, for the sake of support to the endian, we have developed functionalities to assist you in communication information, beyond the use of anonymized data. We you invite you to refer to the Documentation to take cognizance of these.

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

You recognize that Orthense, in its structure, its organization, its flow information, as well as its source code, contain secrets and confidential business know-how. You must not, nor authorize third party to: (a) modify, adapt, alter, translate or create products derivatives of Orthense; (b) merge Orthense with any other software; (vs) 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) delete or alter copyright, paragraphs mentioning patents and other notices relating to the intellectual property of Orthense; (f) disseminate or publish, whether orally or in writing, any information relating to the performance of Orthense unless DIGIKARE gives you express authorization; (g) of a in general, exercise rights other than those specified in these T & Cs.

Finally, Orthense being a service in Saas mode, you grant us the use the hardware resources of the device from which you are accessing the service.

You and your patients are solely responsible for the accuracy and qualification of the data that are collected through the Service.

The use of anonymized data

Faithful to our values ​​and our policy of transparency, it appeared to us relevant to dedicate a chapter to our use of our law use of anonymized medical data. We didn't want to be the only person to exercise this right, you yourself are the beneficiary. You have a right to use anonymized data for which you have participated in collection.

Whether it is you or us, the marketing of this data is permitted under conditions.

Thus, if a purchase request from Digikare identifies you explicitly, or mobilizes data whose precision would allow you to indirectly identify, the company Digikare undertakes to:

• Inform you of the request, including the economic conditions

• Obtain your prior agreement to the sale

You agree to respond to us within 20 working days, after this deadline, we consider your non-response to be a refusal and we will decline the purchase request.

As for you, you are not required to inform us of the future of the operation of its anonymized data, as you will have noted in the previous chapter, you then take responsibility for full compliance with the regulatory framework in force.

If the data is collected in a research context, it is the regulations associated with the research methodology that applies before anything else. Thus, your patient included in a search could be invited to formalize again explicitly his consent to the exploitation of his medical data even once anonymized.

We have drawn up a document dedicated to the questions that may arise from right to use data. This chapter is the synthesis, the case if necessary, do not hesitate to dispose of it by writing a simple letter to the address : [[email protected]] (mailto: [email protected]).

Violation and reporting of illegal content

We are supported by a medical committee. However, you yourselves are a health professional. If you think that content violates rights author, or violates medical ethics, do not hesitate to contact us: [[email protected]] (mailto: [email protected]).

Limitations and modifications of the Service

For the sake of continuous improvement of our service or respect for new regulatory requirements, we may have to interrupt temporarily the service. Everything will be done to ensure that the duration of these interruptions are reasonable and carried out in such a way as to minimize their impact. The updates day of service will not lead to any regression in terms of performance and features.

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

The cost of connecting to the Internet is also your responsibility.

Customer and user support

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

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

Duration and termination

The Order Form and the T & Cs constitute the Contract which binds us. It will remain in force until its termination, at your initiative, or that of DIGIKARE.

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

You can terminate this Contract at any time, you will then endorse it in full responsibility for the consequences of the termination of the Contract.

In the event of termination of the Contract, or if we suspend your access to the Service, DIGIKARE will not assume any responsibility towards you, will not reimburse the sums that you have already paid and the sums not yet paid will become immediately payable.

With the exception of prepaid subscriptions, the Contract is subject to a renewal by tacit agreement, unless terminated by the Customer, in respecting a notice of one (1) month before the anniversary date.

Guarantee and disclaimer

You acknowledge the entire Contract and its exclusive character in the sense that it supersedes any other proposal or previous contract, written or oral, regarding the use of the Service. If you have acquired access to the Service at from a third party, the latter may not engage in anything in the name of DIGIKARE.

You can use Orthense in your daily professional life with your patients. However, you agree to use Orthense as is, and you understand that Orthense may not work the way you want it to or you deliver the results you desire. Your use of Orthense is carried out under your sole responsibility.

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

A clause of these T & Cs that has become illegal does not completely bring them into cause.

Applicable law, compulsory arbitration and place

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

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

Contact us

If you have any questions about the Orthense Service or its conditions general terms of use, please contact us by phone: +33678456065 or by electronic means: [[email protected]] (mailto: [email protected]).

Thank you for reading our terms of use. We are now eager to count you among our subscribers.