Conditions générales de vente

  • ✓ La fourniture d’un Casque et/ou de ses Accessoires ;
  • ✓ L’installation d’un logiciel dans les Casques ;
  • ✓ La mise à disposition du Logiciel;
  • ✓ La mise à disposition de la Plateforme ;
  • ✓ La mise en service et la formation à l’utilisation du Casque et du Logiciel

  • ✓ Son identité : carte d’identité ;
  • ✓ Ses coordonnées : nom, prénom, adresse e–mail, adresse postale, numéro de téléphone ;
  • ✓ Ses informations professionnelles : SIRET/SIREN ;
  • ✓ Ses informations bancaires (empreinte bancaire)  ;
  • ✓ Attestation responsabilité civile professionnelle.

  • ✓ Ne pas exposer les lentilles optiques du Casque à la lumière directe du soleil. Le Client reconnaît que l’exposition à la lumière directe du soleil pendant moins d’une minute peut causer des dégâts sous forme de tache jaune sur l’écran. Le Client s’engage à prendre des précautions supplémentaires lors des conditions de forte luminosité (utilisation proche d’une fenêtre ou d’une forte source d’éclairage direct);
  • ✓ Protéger les lentilles optiques pendant l’utilisation et le stockage du Casque afin d’éviter que des objets ne rayent les lentilles ;
  • ✓ Recharger le casque régulièrement (y compris lorsqu’il n’est pas utilisé pendant une période de plus d’un mois), et dès l’apparition du message d’alerte de niveau de batterie faible ;
  • ✓ Ne pas faire fonctionner le Casque à un volume trop élevé pendant une période prolongée. Le Client reconnaît qu’un volume trop élevé peut endommager l’ouïe du Patient ;
  • ✓ Faire une pause toutes les 30 minutes en cas d’utilisation prolongée et ne pas faire plus d’une session par jour par Patient. Une utilisation prolongée peut causer des étourdissements ou de la fatigue oculaire ;
  • ✓ Arrêter immédiatement d’utiliser le Casque en cas d’anomalies visuelles (diplopie et distorsion de la vue, inconfort ou douleur oculaire, etc.), transpiration excessive, nausées, vertiges, palpitations, désorientation, perte d’équilibre, etc ;
  • ✓ S’assurer d’avoir suffisamment d’espace pour éviter les accidents, en particulier en cas d’utilisation du Casque en intérieur ;
  • ✓ Ne pas utiliser le Casque près des escaliers, des fenêtres, des sources de chaleur ou d’autres zones dangereuses ;
  • ✓ Utiliser le Casque en position assise et sur une assise stable ;
  • ✓ Utiliser les exercices de fusion uniquement sur les Patients en correspondance cortico–rétinienne normale ;
  • ✓ Ne pas utiliser sur les Patients atteints d’épilepsie.
  • ✓ Une casse ou panne liée à un non–respect des conditions d’utilisation du Casque par le Client et les Patients,
  • ✓ La modification du Casque,
  • ✓ Le Casque n’a pas été installé, rechargé, utilisé, réparé ou entretenu conformément aux instructions fournies.

  • ✓ La configuration du Casque et mise à niveau du firmware ;
  • ✓ L’installation et la configuration du Logiciel ;
  • ✓ Les vérifications de sécurité et de bon fonctionnement du Logiciel
  • ✓ La création d’un compte client permettant d’utiliser le Logiciel en lien avec la Plateforme.

  • ✓ Mettre tout ou partie du Logiciel à la disposition de tiers, même gratuitement, et ce, de quelque manière que ce soit,
  • ✓ Permettre l’utilisation du Logiciel par toute personne autre que les Patients,
  • ✓ Divulguer tout ou partie du Logiciel à toute personne autre que les Patients,
  • ✓ Traiter les données de tiers au moyen du Logiciel à l’exclusion des données des Patients,
  • ✓ Imprimer, transférer, transmettre ou afficher tout ou partie du Logiciel sauf pour les besoins du Client,
  • ✓ Modifier/adapter le Logiciel et/ou fusionner tout ou partie du Logiciel dans d’autres programmes informatiques, notamment en vue de le rendre conforme à sa destination, dans la mesure où Oculera se réserve expressément le droit de procéder aux corrections, adaptations et modifications nécessaires,
  • ✓ Compiler le Logiciel, le décompiler, le désassembler, le traduire, l’analyser, procéder au reverse–engineering ou tenter d’y procéder,
  • ✓ écrire, faire écrire, créer, faire développer, tout programme informatique dérivé du Logiciel,
  • ✓ Altérer, enlever, dissimuler ou modifier toute information indiquant le titulaire des droits de propriété intellectuelle afférents au Logiciel.

  • ✓ Consulter et modifier ses informations personnelles (nom, prénom, profession, adresse e– mail, rôle, adresse postale) ;
  • ✓ Réinitialiser son mot de passe ;
  • ✓ Gérer les fonctionnalités de mesure du champ visuel
  • ✓ Gérer les fonctionnalités de suivi des évolutions des mesures de champ visuel ;
  • ✓ Gérer les Patients et en particulier leur suivi (séances, évolutions, durée…).
  • ✓ Ne pas perturber le fonctionnement de la Plateforme ;
  • ✓ Ne pas extraire, réutiliser, stocker, reproduire, représenter ou conserver, directement ou indirectement, sur un support quelconque, par tout moyen, et sous quelque forme que ce soit, tout ou partie de la Plateforme qui constitue une base de données protégée par la loi.

  • ✓ Régler toutes les sommes dues à Eyesoft ou à l ‘organisme de leasing partenaire en contrepartie de la fourniture des Services, toute créance devenant immédiatement exigible ;
  • ✓ Cesser toute utilisation du Casque et du Logiciel,
  • ✓ Régler le cas échéant les frais de résiliation anticipée qui sont immédiatement exigible ;
  • ✓ Restituer le Casque dans les conditions définies ci-après ;
  • ✓ Cesser toute utilisation de la Plateforme. En conséquence, il appartient au Client de sauvegarder les données stockées sur la Plateforme préalablement à la cessation de l’Abonnement. Toutefois, le Client pourra contacter Eyesoft afin d’exporter et transmettre les données stockées sur la Plateforme au plus tard avant la fin de la cessation de l’Abonnement.

  • ✓ D’autres faits que ceux relatifs à la fourniture des Services ;
  • ✓ D’une inexécution d’une obligation à la charge d’Eyesoft au titre des présentes CGV causée par un manquement d’un prestataire du Client, du Client ou d’un Patient ;
  • ✓ Le Logiciel est un dispositif médical de classe II.a au sens du Règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux,
  • ✓ L’utilisation du Logiciel a pour seul objet d’aider le Client à assister les Patients dans l‘évaluation de leur champ visuel.
  • ✓ Dommages indirects tels que le manque à gagner, la perte de chance, le préjudice commercial ou financier,
  • ✓ La perte ou la corruption de données ou interruption ou perte d’activité,
  • ✓ L’augmentation de frais généraux la perte de revenus, de bénéfices, de clientèle ou de ventes ou d’économies prévues trouvant leur origine ou étant la conséquence de l’exécution des présentes CGV.

  • ✓ L’information était en sa possession avant qu’elle la reçoive de l’autre Partie,
  • ✓ L’information était dans le domaine public avant qu’elle la reçoive de l’autre Partie,
  • ✓ L’information a été légalement reçue d’un tiers qui ne la tenait pas directement ou indirectement de l’autre Partie,
  • ✓ L’information a été développée indépendamment par la Partie.

  • ✓ Coordonnées du Client : nom, prénom, adresse e–mail, adresse postale, numéro de téléphone, carte d’identité
  • ✓ Informations professionnelles : SIRET/SIREN
  • ✓ Coordonnées bancaires : Carte bancaire ou RIB ;
  • ✓ Autre : attestation responsabilité civile professionnelle.

  • ✓ La mise à disposition du Logiciel embarqué dans le Casque pendant toute la durée de l’Abonnement ;
  • ✓ La mise à disposition de la Plateforme pendant toute la durée de l’Abonnement ;
  • ✓ L’installation du Logiciel dans le Casque ;
  • ✓ L’assistance technique pendant toute la durée de l’Abonnement ;
  • ✓ La mise en service et la formation à l’utilisation du Casque et du Logiciel
  • ✓ Casque PICO :
  • ✓ Série Neo 3 Pro Eye ;
  • ✓ Modèle A7H10

  1. This DPA consists of two parts: the main body of the DPA, and Schedules 1, 2 and 3.
  2. This DPA has been pre-signed on behalf of Oculera. Please note that the contracting entity under the Agreement may be a different entity to Oculera.
  3. To complete this DPA, Customer must:
    1. Complete the information in the signature box and sign (with wet signature or e-signature) on page ten (10).
    2. Send the signed DPA to Oculera by e-mail to privacy@oculera.health indicating, if applicable, the Customer’s Account Number (as set out on the applicable Oculera Order Form or invoice).

  1. Customer Personal Data. Oculera will Process Customer Personal Data as Customer’s Processor in accordance with Customer’s instructions as outlined in Section 3.4.
  2. Account Data. Oculera will Process Account Data as a Controller for the following purposes: (i) to provide and improve Oculera’s Software Product; (ii) to manage the Customer relationship (communicating with Customer and Users in accordance with their account preferences, responding to Customer inquiries and providing technical support, etc.), (iii) to facilitate security, fraud prevention, performance monitoring, business continuity and disaster recovery; (iv) to carry out regulatory requirements and (v) to carry out core business functions such as accounting, billing, and filing taxes.
  3. Usage Data. Oculera will Process Usage Data as a Controller for the following purposes: (i) to provide, optimize, secure, and maintain Oculera’s Software Products; (ii) to optimize user experience; and (iii) to inform Oculera’s business strategy.

  1. Any valid transfer mechanism pursuant to Chapter V “Transfers of personal data to third countries or international organizations” of the GDPR permitting transfer of EU Personal Data outside the EU to which Oculera would subscribe, certify or participate in.
  2. The Standard Contractual Clauses (hereinafter “SCC”) are hereby incorporated into this DPA by reference as follows:
    1. Customer is the “data exporter” and Oculera is the “data importer”.
    2. Module One (Controller to Controller) applies where Oculera is Processing Account Data or Usage Data.
    3. Module Two (Controller to Processor) applies where Customer is a Controller of Customer Personal Data and Oculera is Processing Customer Personal data as a Processor.
    4. Module Three (Processor to Processor) applies where Customer is a Processor of Customer Personal Data and Oculera is Processing Customer Personal Data as another Processor.
    5. By entering into this DPA, each Party (including the Authorized Affiliates) is deemed to have signed the SCCs as of the commencement date of the Agreement.
  3. For each Module, where applicable:
    1. In Clause 7, the optional docking clause does not apply.
    2. In Clause 9, Option 2 applies, and the time period for prior notice of Sub-processor changes is stated in Section 6 (Sub- processors) of this DPA.
    3. In Clause 11, the optional language does not apply.
    4. In Clause 17, Option 1 applies, and the EU SCCs are governed by the laws of France.
    5. In Clause 18(b), disputes will be resolved before the courts of Paris, France
    6. The Appendix of SCCs is populated as follows:
      • ✓ The information required for Annex I(A) is located in the Agreement and/or relevant Orders.
      • ✓ The information required for Annex I(B) is located in Schedule 1 (Details of Processing) of this DPA.
      • ✓ The competent supervisory authority in Annex I(C) will be determined in accordance with the Data Protection Laws; and
      • ✓ The information required for Annex II is located here.
  4. In the event of any conflict or inconsistency between this DPA and the SCC, the SCC shall prevail.
  5. Schedule2 of this DPA represents Customer’s express consent regarding existing and new Sub-processors.

  • ✓ Schedule 1: Details of Processing
  • ✓ Schedule 2: List of Sub-Processors as of the Effective Date
  • ✓ Schedule 3: Oculera’s Technical and Organizational Security Measures
CUSTOMER Signature:

Full Name:

Print Name:

Title:

Date:
OCULERA Signature:

Full Name:

Print Name:

Title:

Date:
DescriptionDetails
Categories of Data Subjects whose Personal Data is Processed:Customer may submit Personal Data to the Services, the extent of which is determined and controlled by Customer in its sole discretion, and which include Personal Data relating to the Users (patients).
The frequency of the Transfer:Continuous.
Categories of Personal Data Processed:(i) Account Data, (ii) Usage Data and (iii) Customer Personal Data
Nature of the Processing:Oculera will Process Customer Personal Data in order to provide the Software Products and related support and advisory Services in accordance with the Agreement, including this DPA. Customer Personal Data, therefore, may be subject to the following Processing activities: (i) Collection, storage, and other Processing necessary to provide, maintain and improve the Services provided to Customer pursuant to the Agreement. (ii) Making available of Personal Data by automated means in accordance with the Agreement (including this DPA) and/or as compelled by applicable laws. (iii) Controller may disclose patient data to Oculera when receiving technical support and from time-to-time Oculera’s technical team may have access to patient data when they are fixing a technical issue for example via remote support, which may include screen sharing. (iv) Compilation of anonymized statistics about the use of Oculera’s platform, such as the use of its functions by its Users/patients. These statistics may be used for Oculera’s own analytics and improvement purposes.
Purpose(s) of the Processing:(i) Customer Personal Data: Oculera will Process Customer Personal Data as Processor in accordance with Customer’s instructions as set out in Section 3.4 (Customer Instructions). (ii) Account Data and Usage Data: Oculera will Process Account Data and Usage Data for the limited and specified purposes outlined in Section 1.1 (Roles of the Parties).
Duration of Processing:(i) Customer Personal Data: Oculera will Process Customer Personal Data for the term of the Agreement as outlined in Section 6 (Deletion and Return of Customer Personal Data). (ii) Account Data and Usage Data: Oculera will Process Account Data and Usage Data only as long as required (a) to provide Products and related support and advisory Services to Customer in accordance with the Agreement; (b) for Oculera’s legitimate business purposes outlined in Section 1.1 (Roles of the Parties); or (c) by applicable Law(s).
Type of Personal DataPersonal Data (relating to Users (patients) of the Controller): Patient demographic details (name; date of birth; gender) Mobile phone number Email address ‍Personal Data (relating to healthcare and/or social care professionals): Name Email address Mobile phone number Affiliated organisations Job role Sensitive Personal Data Content of the communications with – or regarding – User (patients) sent via the Services (which may contain data concerning health). Social security number relating to the user. Other types of data, including third party data, (which may include data concerning health that may from time to time be required to provide the Services) Account Data and Usage Data as described in the Section 1 (Definitions).
Transfers to (Sub-) processors:Oculera will transfer Customer Personal Data to Sub-processors as permitted in Section 6 (Sub- processors).
NameNature and PurposeGeographical LocationApplicable Features
Amazon Web ServicesOculera controls access to the infrastructure that uses to store and Process the data on the platform. Oculera use AWS’s secure cloud hosting service to securely store and process Customer Personal Data. AWS regions used are located in the Frankfurt Germany, for both live and backup environments. AWS is certified as Health Data Hosting provider.Germany, FrankfurtAll
Google LLCGoogle is Oculera’s email provider. All requests Oculera receive or address via @oculera.health email addresses are processed through their services.USE-mail, video, infrastructure

  • ✓ Access management policy addressing access control standards, including the framework and the principles for user provisioning.
  • ✓ User provisioning for the access to Oculera systems and infrastructure based on the relevant job role and on the least privilege principle that is enforced through the authentication processes.
  • ✓ Strict role-based access controls for Oculera staff, allowing access to Customer Data only on a need-to-know basis.
  • ✓ Use of technical controls such as virtual private network (VPN) and multi-factor authentication (MFA) where relevant based on information classification.
  • ✓ Oculera’s HR onboarding and off-boarding processes handle provisioning and de-provisioning of accounts and access.
  • ✓ API IP Whitelisting – Defines the range of IP addresses from which a customer’s users can access the Oculera API to prevent unauthorized third parties from accessing the Oculera Services.
  • ✓ All requests on the Oculera Dashboard have cross-site request forgery (CSRF) protection. All web services use encrypted HTTPS for all traffic and disallow all HTTP traffic via HTTP Strict Transport Security (“HSTS”).
  • ✓ Failed login attempts are recorded and an account is locked out with the owner notified after multiple failed attempts.

  • ✓ User passwords are never transmitted or stored in clear text.
  • ✓ Oculera uses industry-standard methods to determine password validity.
  • ✓ Oculera keeps audit logs for all access to production servers.
  • ✓ Server access is controlled via Amazon Web Services Identity and Access Management.
  • ✓ Logs are stored in a secure centralized host to prevent tampering.
  • ✓ Passwords are not logged under any circumstances.
  • ✓ All access to Customer dashboard accounts by Oculera employees must be done through an internal service that is accessible via a 2-factor VPN only.
  • ✓ As part of Oculera’s Security Policy, employees may not store any Customer Data on removable media.

  • ✓ Comprehensive logging standards as part of Oculera’s policy management framework, with annual reviews and senior management approvals.
  • ✓ Secure forwarding and storage of relevant system logs to a centralized log platform of the cloud infrastructure with read-only access.
  • ✓ Monitoring of security audit logs to detect unusual activity, with established processes for reviewing and addressing anomalies.
  • ✓ Regular updates to the logging scope of information and system events for Software Products and related infrastructure in order to address new features and changes.
  • ✓ Utilizing time sync services from relevant cloud service providers (e.g. AWS) for reliable timekeeping across all deployed instances.

  • ✓ Change management policies covering the risk management for all internal and external asset changes, reviewed annually.
  • ✓ Standard procedures for change management applicable to encryption and cryptography for the secure handling of data (e.g. encryption keys) according to its security classification.
  • ✓ A centralized internal policy program categorising the global policies into different domains including annual review, and senior management approval of the program.
  • ✓ Stringent policies encompassing (i) encryption, (ii) cryptography, (iii) endpoint management, and (iv) asset tracking inline with industry standards.
  • ✓ Established baselines and standards for change control that require testing documentation prior to implementation and authorized approval.
  • ✓ A strict post-implementation testing and approval process for emergency changes to the code.

  • ✓ A comprehensive risk management program for identifying, assessing, and addressing various risks to support informed risk management decisions.
  • ✓ A policy program aligning company-wide policies with ISO 27001 and other relevant standards to mitigate associated risks.
  • ✓ Oculera’s infrastructure and applications are continuously scanned by a Vulnerability Management System. Alerts are monitored by our Security Team and addressed at least monthly by the Oculera Security Team. Oculera also maintains a list membership to various CVE vulnerability mailing lists. Patches and ‘critical’ and ‘high’ vulnerabilities are remediated no later than 30 days following discovery. Oculera also uses static code analysis tools during the build process to perform static security analysis.
  • ✓ Processes and metrics for reporting vulnerability management activities.
  • ✓ Thorough security evaluations, including independent external and internal audits
  • ✓ Oculera undergoes a third-party penetration test of the Oculera Services on an annual basis.

  • ✓ Using reliable 3rd party services (e.g. AWS) to operate the physical infrastructure for processing Customer Data as a Sub-processor.
  • ✓ Sanitization and degaussing of used equipment by the 3rd party cloud service providers, including hard drives with Customer Data in line with industry standards (e.g. ISO 27001).
  • ✓ Full disk encryption using industry standards (e.g. AES-256) employed for data drives on servers and databases storing Customer Data, and on endpoint devices.
  • ✓ Unattended workspaces are required to have no visible confidential data, aligning with the secure workplace guidance.

  • ✓ Active monitoring and documentation by legal and compliance teams on regulatory obligations.
  • ✓ A detailed system security plan with comprehensive documentation on system boundaries and product descriptions.
  • ✓ Communication to internal users and customers about significant changes to key products and services.
  • ✓ Periodic reviews and updates of the security management program.

  • ✓ A global privacy compliance program for reviewing and adapting to data protection laws including necessary safeguards and processes.
  • ✓ Maintaining an internal personal data processing policy with clear definitions of personal data categories, processing purposes, and processing principles.
  • ✓ Detailed standards for processing of various categories of personal data covering the topics such as processing principles, applicable legal basis, retention, destruction etc.
  • ✓ An established method to create pseudonymised data sets using industry standard practices and appropriate technical and organisational measures governing the systems capable of remapping pseudonymous identifiers.
  • ✓ Transparent privacy policies for its users and customers, as well as internal guidelines for employees.
  • ✓ Comprehensive compliance documentation, including but not limited to (i) processing activities, (ii) privacy impact assessments, (iii) transfer impact assessments, (iv) consents, and (v) data processing agreements with customers and vendors.
  • ✓ Secure development practices across all development lifecycle stages, focusing on security and data protection from the initial design phase.
  • ✓ Respecting the individual’s rights to access, correct, and delete their personal data in line with relevant data protection laws.