These General Terms of Use (hereinafter the “GTU”) govern the User’s access to and use of Voice. The GTU constitute a document independent of the Agreement entered into between Gleamer and the Establishment; they apply directly to the User in their capacity as a healthcare professional User of Voice.

Access to Voice is made available to the User under the Agreement entered into between Gleamer and the Establishment in which the User carries out their professional activity. These GTU may only take effect provided that an Agreement is in force between Gleamer and said Establishment. The User’s use of Voice constitutes full and unreserved acceptance of these GTU.

For the purposes of these GTU, the following terms shall have the meanings set forth below:
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• “Agreement”: means all the contractual documents binding Gleamer and the Establishment, consisting of the General Terms of Service, the Special Terms and Conditions, and any potential amendments. The Agreement governs the relationship between Gleamer and the Establishment and constitutes a document separate from these GTU, the application of which is however conditional upon the existence of an Agreement in force.
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• “STC” or “Special Terms and Conditions”: means the special terms and conditions entered into between Gleamer and the Establishment, forming together with the GTS the Agreement and specifying in particular the services subscribed to and the associated usage costs.
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• “GTS” or “General Terms of Service”: means the general terms of service entered into between Gleamer and the Establishment.
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• “Documentation”: means the user manual(s) of Voice made available by Gleamer in accordance with its regulatory obligations, available on the dedicated website eifu.gleamer.ai.
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• “Personal Data”: means any information relating to an identified or identifiable natural person (hereinafter the “Data Subject”), within the meaning of Article 4(1) of the GDPR.
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• “Establishment”: means the healthcare establishment or institution that has entered into an Agreement with Gleamer for the purpose of making Voice available to the relevant healthcare professionals, and within which the User carries out a professional activity. The Establishment is the “Client” within the meaning of the GTS and the STC.
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• “Purpose”: has the meaning given to it in Article 1.2 of these GTU.
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• “Gleamer” or “Service Provider”: means the company Gleamer, a simplified joint-stock company registered with the Créteil Trade and Companies Register under number 834 105 470, with its registered office at 14 avenue du Général de Gaulle, 94160 Saint-Mandé, duly represented by DH AI INTERNATIONAL HOLDINGS, B.V, Chairman, publisher of Voice.
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• “GDPR” or “Regulations applicable to the protection of personal data”: means the French and European regulations applicable in the field of the protection of personal data: Regulation (EU) 2016/679 of April 27, 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, Law No. 78-17 relating to data processing, files and freedoms of January 6, 1978 as amended and any updates thereto, as well as its application texts.
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• “System” or “Voice”: means the artificial intelligence system, made available in SaaS mode, based on a general-purpose artificial intelligence (AI) model, for voice dictation and generation of medical reports, published by Gleamer.
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• “User”: means any healthcare professional, natural person, authorized by the Establishment to access the System, bound by professional secrecy and possessing the skills or qualifications necessary for the use of Voice.

1.1. Voice is an artificial intelligence system, made available in SaaS mode, based on a general-purpose AI model, for voice dictation and generation of medical reports. Voice constitutes neither a medical device within the meaning of Regulation (EU) 2017/745 nor a high-risk artificial intelligence system within the meaning of Regulation (EU) 2024/1689.

1.2. Voice is intended to be used as a documentation and reporting workflow tool, to assist healthcare professionals in the dictation and transcription of radiology reports (the “Purpose”). Voice is not intended to be used, and must under no circumstances be used, to establish a clinical diagnosis, recommend a treatment, make or guide a medical decision, or more generally for any purpose of a diagnostic or clinical nature.

1.3. The languages supported by Voice are indicated in the Documentation. Gleamer reserves the right to modify the list of supported languages at any time, subject to informing the User within a reasonable timeframe.

2.1. The User undertakes to ensure that any medical report generated by the System is reviewed, modified and finalized by the User of the System before being used in connection with the care of the patient concerned.

2.2. The User shall not use Voice for purposes other than the Purpose defined in Article 1.2. The User shall refrain, in particular and without limitation, from: (i) requesting Voice for the purpose of obtaining an interpretation, analysis or diagnostic guidance; (ii) using the outputs generated by Voice as an element of clinical decision-making without review and validation by a qualified healthcare professional; (iii) diverting Voice from its Purpose through any formulation, instruction, configuration or circumvention, including technical means, aimed at obtaining behavior not provided for in the Documentation.

Any diversion from the Purpose shall engage the exclusive liability of the User and may result in the immediate suspension of their access to Voice, under the conditions set forth in Article 9.

2.3. The User shall not use Voice in connection with their activity within an establishment other than the Establishment that has entered into the Agreement with Gleamer. The use of Voice is strictly limited to the scope of the contracting Establishment, as defined in the Agreement.

2.4. The User is strictly prohibited from introducing, in their voice dictations or in any other information provided to the System, Personal Data of patients, and in particular directly identifying health data, such as: surname, first name, NIR (social security number), full date of birth, address, telephone number, email address, or any other element enabling the direct or indirect identification of a Data Subject.

3.1. All elements comprising Voice, including, without limitation, the software, models, algorithms, interfaces, databases, documentation, trademarks and associated distinctive signs, are and remain the exclusive property of Gleamer, in accordance with the provisions of the French Intellectual Property Code.

These GTU do not confer upon the User any ownership rights over Voice. Consequently, the User shall refrain from any action or act likely to infringe, directly or indirectly, the intellectual property rights pertaining to Voice, the Documentation and, in general, the associated trademarks.

3.2. Subject to compliance with these GTU and the Agreement entered into between Gleamer and the Establishment, the User benefits from a non-exclusive, personal, non-assignable and non-transferable right to use Voice, solely for the purposes of the Purpose defined in Article 1.2 and for the duration during which they are authorized to access the System by the Establishment. This use is strictly limited to the geographical scope of the Establishment defined in the Agreement (including, where applicable, its sites and locations covered by the Agreement).

Any use of Voice not expressly authorized hereunder is unlawful, in accordance with the provisions of Article L. 122-6 of the French Intellectual Property Code.

3.3. In particular, the User is prohibited from: (i) using Voice or its results for the purpose of designing, producing, distributing or marketing a similar, equivalent or substitute solution; (ii) modifying, adapting, translating or creating derivative works based on all or part of Voice or the Documentation, including for error correction, without the prior written authorization of Gleamer; (iii) carrying out any reproduction, extraction, reuse, decompilation, reverse engineering or attempt to access the source codes of Voice, except to the extent permitted by applicable mandatory provisions of law; (iv) granting access to Voice to any person not authorized by the Establishment; (v) using Voice in another establishment or institution that is not bound by an Agreement in force with Gleamer for the use of the System.

4.1. Voice constitutes a documentation and voice dictation aid tool. Voice does not in any way substitute for the clinical judgment of the healthcare professional or their obligation to verify.

4.2. The use of Voice is carried out under the exclusive responsibility of the User, who remains responsible for the review, validation and final content of any medical report generated with the assistance of Voice.

4.3. The User acknowledges having been informed of the characteristics and limitations of Voice, including the risks of error inherent to the artificial intelligence technologies upon which the System relies. Gleamer cannot guarantee the reliability and accuracy of the reports and results generated in the course of the use of the System by Users.

4.4. Voice is provided “as is,” without any express or implied warranty, including as to its performance, reliability, uninterrupted availability, accuracy, fitness for a particular purpose, or ability to meet the specific needs of the User.

5.1. In the event the User introduces Personal Data of patients into Voice, in violation of Article 2.4, the User alone shall bear liability under these GTU.

5.2. The provisions of this article are without prejudice to the respective obligations and responsibilities of the Establishment (as data controller) and Gleamer (as processor, where applicable) under the GDPR, as well as the rights of data subjects and the powers of supervisory authorities. Consequently, the User acknowledges that Gleamer shall not be held liable towards them, under these GTU, for the consequences of the breach referred to in Article 5.1, without prejudice to the indemnification provided for in Article 5.3.

5.3. Any diversion from the Purpose shall engage the exclusive liability of the User and may result in the immediate suspension of their access to Voice, under the conditions set forth in Article 9.

5.4. Without prejudice to the provisions of the Agreement entered into between Gleamer and the Establishment, the User undertakes to indemnify and hold harmless Gleamer against any harmful consequence, cost, fine, sanction, damage and reasonable expense (including attorney’s fees) resulting directly from the breach referred to in Articles 5.1 and 5.3.

This indemnification shall not apply to the extent that such consequences result from a breach by Gleamer of its obligations under these GTU or the GDPR.

6.1. Voice is used by the User under their exclusive responsibility. The User is exclusively responsible for the verification and validation of the reports generated, for the proper care of patients, including in the event of a malfunction or interruption of the System.

6.2. Gleamer is subject to an obligation of means for the provision of Voice. The terms for engaging Gleamer’s liability and the limits applicable to its liability, in connection with the use of the System, are governed by the Agreement.

7.1. In connection with the provision of the Voice System, Gleamer acts as a processor within the meaning of Article 28 of the GDPR, on behalf of the Establishment, the data controller, in accordance with the provisions of the Agreement and the data processing agreement entered into between Gleamer and the Establishment.

7.2. Information relating to the processing of the User’s Personal Data in connection with Voice, including the technical architecture of the System, the categories of data processed, the purposes of the processing, the applicable legal bases, the retention periods, the security measures and the rights of data subjects, are detailed in the Voice Privacy Policy, accessible at the following address: gleamer.ai/voice-privacy-policy.

Gleamer reserves the right to modify these GTU at any time. The User will be informed of any substantial modification by any appropriate means (notification in the Voice interface, email). The modified GTU shall become applicable upon their being made available.

These GTU shall automatically terminate (i) on the date of termination, for any reason whatsoever, of the Agreement entered into between Gleamer and the Establishment, (ii) when the User is no longer authorized by the Establishment to access the System, or (iii) in the event of a breach by the User of these GTU or of any wrongful or non-compliant conduct by the User. In such case, Gleamer may suspend or withdraw the User’s access to Voice, without prejudice to any damages and remedies that Gleamer may be entitled to claim.

These GTU are governed by French law. In the event of a dispute, exclusive jurisdiction is attributed to the courts within the jurisdiction of the Paris Court of Appeal.