PERSONAL DATA

PROTECTION POLICY

GLEAMER is committed to protecting the personal information and privacy of website visitors and anyone using its services in general. The purpose of this Personal Data Protection and Cookies Policy is to inform you about:

• The types of personal data we collect about you

• How your personal data is processed by GLEAMER and its potential partners and subcontractors

• The terms and conditions of use of your personal data and your rights in this regard, in compliance with applicable European and French legislation

• All operations involving your personal data are carried out in compliance with the regulations in force, notably Regulation (EU) 2016/679 of the European Parliament and of the Council 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 (hereinafter referred to as the “GDPR”), and any applicable national legislation related to data protection.

ARTICLE 1 – DEFINITION

• The “website” refers to the infrastructure developed by GLEAMER in Internet-compatible computer formats, comprising data of various types, including texts, sounds, still or moving images, videos, databases, intended to be viewed and accessible at the address: www.gleamer.ai;

• “Internet” refers to various networks of servers located in different places around the world, interconnected through communication networks and communicating using a specific protocol known as TCP/IP;

• “File” refers to any structured and stable set of personal data accessible based on specific criteria;

• “Personal data”, “special categories of data”, “processing / processing” have the same meaning as in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data;

• The “Data Controller” is the entity that collects and processes personal information (personal data);

• The “Processor” : any person who agrees to process personal data on behalf of the Data Controller or access personal data in the course of their duties, in accordance with the Data Controller’s instructions;

• The “Recipients” refer to any person authorized to receive communication of data other than the Data Controller, the Processor, and individuals who, due to their roles, are responsible for processing the data;

• The “Authorized Third Parties”: refer to authorities legally empowered, within the scope of a specific mission or the exercise of a right to request, to ask the Data Controller to provide them with personal data;

• “Data Subject”: refers to an individual to whom the processed data pertains;

• A “processing of personal data” means any operation or set of operations which is performed upon personal data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

ARTICLE 2 – SCOPE

This Personal Data Protection Policy ( hereinafter the “Policy”) aims to inform the data Subjects about how their personal data is collected and processed by GLEAMER.

ARTICLE 3 – IDENTITY OF THE DATA CONTROLLER

Personal data is collected by GLEAMER , whose registered office is located at 5 avenue du Général de Gaulle 94160 Saint Mandé, France, registered with the RCS under the number 834 105 470, represented by Christian ALLOUCHE, in his capacity as President.

ARTICLE 4 – PROCESSING OF PERSONAL DATA

GLEAMER is committed to protecting the privacy of its users in compliance with current regulations, particularly the amended law “Informatique et Libertés” (Data Protection Act) No. 78-17 of January 6, 1978, and the European Regulation 2016/679 on data protection.

1. Personal data collected, purposes, and legal bases.

As part of the operation of the website www.gleamer.ai, GLEAMER collects data about you. These data are processed in accordance with the purposes specified during collection, namely:

Categories of collected data: Contact (identity and contact details)

Purposes: Management of information requests and contact requests

Legal basis: Legitimate interest

Retention period: Duration necessary for processing requests

Categories of collected data: Personal data from demo requests (name, first name, email)

Purposes: Management of solution demonstration requests and contact requests, management of commercial prospecting

Legal basis: Legitimate interest and consent

Retention period: 3 years after the last contact initiated by you or as part of your objection

Categories of collected data: Cookies (tracking cookies) and other trackers

Purposes: Compile statistics on site traffic based on analyses

Legal basis: Consent

Retention period: 13 months

The data identified by an asterisk within the forms is mandatory. Failure to provide them will make it impossible for the data subject to access and use the Services or fulfill a request related to a form.

Other data is optional, and their non-provision will not affect the delivery of promised services or responses to inquiries, although it may limit their relevance.

Furthermore, GLEAMER may collect personal data for other purposes, ensuring to obtain the prior consent of the individuals concerned. In particular, GLEAMER may collect the following data :

• Identity: name, first name, email address;

• Personal life data: client’s company;

• Contact data: messages sent on the site via contact forms, correspondence that might be sent to us.

b) Recipients of the Collected Data

The database created during the registration for the Services is strictly confidential. GLEAMER undertakes to take all necessary precautions, organizational and technical measures appropriate to preserve the security, integrity, and confidentiality of the Data, and in particular, to prevent them from being distorted, damaged, or accessed by unauthorized third parties.

c) Data transferred to authorities and/or public bodies

In accordance with current regulations, data may be transmitted to competent authorities upon request, particularly to public bodies, exclusively to meet legal obligations, legal auxiliaries, ministerial officers, and organizations responsible for debt collection.

ARTICLE 5 – RIGHTS OF CONCERNED INDIVIDUALS

In accordance with Regulation (EU) 2016/679 regarding the protection of personal data, you have the right to request the controller to access your personal data, as well as the rectification or erasure of such data, and the limitation of the processing of your personal data.

You also have the right to object to the processing of your personal data for legitimate reasons, as well as the right to object to the use of your data for commercial prospecting purposes.

Finally, you have the right to establish general and specific guidelines defining how you intend your rights to be exercised after your death.

If you believe, after contacting us, that your rights regarding your personal data are not being respected, you can file a complaint with the CNIL or the Supervisory Authority in your place of residence.

To exercise these rights or for any questions regarding the processing of your data in this system, you can contact our Data Protection Officer (DPO), providing proof of your identity by referencing your customer number or any element that can identify you; otherwise, please attach a copy of your identity document.

To exercise your rights, you can contact GLEAMER’s Data Protection Officer (DPO) :

• by a simple request via email to the following address: DPO@gleamer.ai

• by postal mail: 5 avenue du Général de Gaulle - 94160 Saint Mandé, France

GLEAMER undertakes that the collected data will be kept in a form allowing the identification of the Data Subjects for a period not exceeding the time necessary for the purposes for which they are collected and processed.

ARTICLE 6 – TRANSFER OF PERSONAL DATA

The personal data collected on the website is exclusively reserved for GLEAMER. GLEAMER is the sole recipient of this data. No transfer is made outside the European Union. However, GLEAMER reserves the right to transmit your personal data to fulfill its legal obligations, especially if required by a court order.

ARTICLE 7 – COMMERCIAL PROSPECTING

GLEAMER enables you to receive commercial offers and information via email.

Individuals concerned may, at any time, object to targeted advertising on the website and inform GLEAMER that they no longer wish to receive commercial offers or information. You can opt out of receiving these messages at any time by clicking the link at the end of each email message.

ARTICLE 8 – SECURITY

GLEAMER implements all necessary technical and organizational measures to ensure the security and confidentiality of the personal data collected and processed. This includes preventing data from being distorted, damaged, or disclosed to unauthorized third parties, ensuring a level of security appropriate to the risks associated with the processing and the nature of the data to be protected, considering the technological state of the art and the cost of implementation.

GLEAMER has established a policy for the protection of personal data and informs all individuals acting under its authority who access this information about its confidential nature.

Furthermore, GLEAMER ensures that its technical service providers who may have access to personal data adhere to the same confidentiality standards.

However, it is the responsibility of each user to ensure the security of personal data transmissions over the internet. GLEAMER cannot be held responsible for personal data transmissions over the internet.

ARTICLE 9 – UPDATE

This policy comes into effect on June 4. 2024 To check for updates to our Policy, it is advisable to regularly visit this page.

For questions:

The Data Protection Officer (DPO) of GLEAMER is at your disposal for any further information regarding the use of your data :

By email: DPO@gleamer.ai

By postal mail: 5 avenue du Général de Gaulle - 94160 Saint Mandé, France

Product Mentions

In Europe:

BoneView and ChestView are Class IIa medical devices manufactured by GLEAMER and whose conformity assessment has been carried out by the notified body BSI CE 2797 relative to the 2017/745 regulation. It is software using deep learning techniques intended to provide preliminary data for helping clinicians’ diagnosis of X-ray radiographs.

Instructions for use are available here.

In the US:

BoneView is a class II medical device that has been cleared by the FDA under K212365. BoneView is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs. For more information on precise indications for use, warnings, and limitations of the software, refer to the 510(k) summary available on FDA’s website. Please read the instructions for use carefully.

Instructions for use are available here.

Other Quality Management information

Our company is certified with ISO 13485:2016