General Conditions of Use (GCU) of the AudiWin® Software

Version: V01.00.00 – last updated on 07/29/2025

1.Purpose

These General Conditions of Use (GCU) define the conditions for using the AudioWin® software (hereinafter referred to as “the software”) intended for healthcare professionals for the screening of hearing disorders. Using the software implies the user’s unconditional acceptance of these GCU.

2.Definitions

Data Controller: A legal (such as a joint company) or natural person who determines the purposes and means of processing, that is, the objective and the way to achieve it. In this case, the data controller is the legal entity using the software.

Personal Data: Any information that identifies or makes a person identifiable.

Health Data: A particular type of personal data related to a person’s health.

EMR (Electronic Medical Record) Software: An application that enables healthcare professionals to manage and access patient records in digital form, facilitating the documentation, monitoring, and secure sharing of health data.

Processor: A natural or legal person (company or public body) that processes data on behalf of another organization (the data controller) as part of a service or provision. In this case, the processor is FIM Medical.

User: The user is the data controller (the legal entity using the software).

3.Use of the Software

The software is intended for use by healthcare professionals for the screening of hearing disorders. It allows the collection and analysis of data related to the auditory function of patients. The purpose for using this data is at the sole discretion of the data controller. The software must be used in accordance with the instructions described in the user manual. This document describes the technical prerequisites, installation, update, and backup procedures, as well as best practices for use. FIM Medical shall not be held liable for malfunctions, data loss, misinterpretation, or security breaches resulting from improper use or incorrect configuration of the software. The user manual is accessible directly within the software, as well as in the device’s mass storage. It can also be obtained upon request or downloaded from FIM Medical’s website using the password provided in the device’s information sheet.

4.Collection and Use of Personal Data

In accordance with Regulation (EU) 2016/679 (GDPR), the software may collect and store personal data relating to patients, such as identification information, health data, and screening results. This data is stored in a local database under the user’s responsibility, in compliance with the aforementioned regulations.

5.User Responsibility

The user is fully responsible for the security and confidentiality of the data stored in the local database. The user agrees to take all necessary measures to protect personal data against unauthorized access, alteration, disclosure, or destruction. The user is also responsible for managing login credentials, including their creation, maintenance, and protection, to prevent unauthorized access. Credentials must not be shared or disclosed to unauthorized third parties. The data controller must ensure compliance with local recommendations on password length and complexity.6.Use from Third-party Software (EMR)

If the software is interoperable with third-party software such as EMR (Electronic Medical Record) or an electronic patient record system (DPI), the security and confidentiality of data exchanges between the software and the third-party software are the exclusive responsibility of the data controller. The latter must ensure that the third-party software complies with all applicable legal and regulatory obligations, including those related to the protection of personal data.

The software allows data to be exported in formats whose security level is left to the discretion of the data controller. The controller is fully responsible for the security of exported data in terms of availability, integrity, or confidentiality.

The data controller must ensure the proper integration of data imported by third-party software.

6. Use with Third-Party Software (EMR)

If the software is interoperable with third-party software, such as an EMR or EHR (Electronic Health Record), the responsibility for securing and ensuring the confidentiality of data exchanged lies entirely with the data controller. The data controller must ensure that the third-party software complies with applicable legal and regulatory obligations, including those regarding data protection. The software enables data export in formats whose security level is determined by the data controller. The controller is fully responsible for the security of exported data in terms of availability, integrity, and confidentiality. The data controller must ensure the proper integration of data imported by the third-party software.

7.Patient Information

In accordance with GDPR requirements, the user must inform patients clearly and precisely about the collection and use of their personal data. This information must include, but is not limited to:

  • The identity and contact details of the user (healthcare professional) as the data controller.
  • The purposes for which the data is collected and processed.
  • The legal basis for data processing.
  • The recipients or categories of recipients of the personal data.
  • The data retention period.
  • Patients’ rights regarding their personal data (access, rectification, deletion, restriction of processing, objection to processing, data portability).
  • Patients’ right to lodge a complaint with a supervisory authority.

Information templates for medical record management can be proposed by the local data protection authority.

8.Data Security

The user commits to implementing appropriate technical and organizational measures to ensure a security level adapted to the risk, including accidental or unlawful destruction, loss, alteration, or unauthorized disclosure of personal data. The software includes built-in security mechanisms to restrict access to personal and health data. It is the user’s responsibility to activate and configure them as instructed in the user manual. The software can be used without a local database, in which case no personal or health data is stored. This mode is intended for interoperable use where data is processed exclusively by third-party software. FIM Medical shall not be liable for any breach of availability, integrity, or confidentiality of data collected and stored by the software.

9.Intellectual Property

The software and all its components, including but not limited to content, text, graphics, user interfaces, visual interfaces, photos, trademarks, logos, sounds, music, illustrations, and source code (collectively “Content”), are the property of FIM Medical or its licensors and are protected by intellectual property laws, including copyright and trademark laws. The right to use the software is personal, non-exclusive, non-transferable, and limited to internal professional use, in accordance with these GCU. The user is prohibited from reproducing, copying, modifying, creating derivative works, distributing, publicly displaying, republishing, downloading, storing, transmitting, selling, or reselling all or part of the software or its Content without prior written authorization from FIM Medical. Any unauthorized use of the software or Content in violation of these GCU may constitute an infringement and lead to legal proceedings.

10.  Modifications to the GCU

These GCU may be modified at any time by FIM Medical to reflect technical or regulatory changes or for any other reason deemed necessary. Changes will take effect upon publication on the website or integration into the software. The data controller is responsible for regularly reviewing the GCU to stay informed of any changes. Use of the software after a GCU update implies acceptance of the new conditions without requiring individual notification.

11. Software Updates

The software may be subject to technical, corrective, or functional updates. An automatic update detection and installation mechanism is integrated and configurable by the user in the software settings. This mechanism requires a working Internet connection. FIM Medical disclaims any liability for failure of the automatic update mechanism, particularly in the absence of connectivity, server access, or technical compatibility. It is the user’s responsibility to regularly check for updates and ensure proper installation.

12.  Legal Information about the Publisher

The software is published by FIM Medical SAS with a share capital of 166,000 euros, registered in the Lyon Trade and Companies Register under number 391 853 090 00044.

For any questions or assistance regarding the software or these GTU, please contact FIM Medical at the following contact details:

13. Activity Logs and Technical Support

The software automatically records activity logs related to its internal operations. These logs are solely intended to facilitate maintenance, incident diagnosis, stability monitoring, and continuous improvement of the software. Logged events include, but are not limited to: startup sequences, database connections, device manager operations, interoperability exchanges, and other technical processes. No personal or health data is recorded in these strictly technical logs. Logs are stored locally in the software installation folder. They are never transmitted automatically to FIM Medical. The user may consult or send them manually to technical support when requesting assistance.

14. Governing Law and Jurisdiction

These Terms of Use shall be governed by and construed in accordance with French law. In the event of any dispute relating to the interpretation or performance of these Terms, the parties shall endeavor to reach an amicable settlement prior to initiating any legal proceedings. Failing an amicable resolution, exclusive jurisdiction shall lie with the Commercial Court of Lyon.