Privacy Statement

1. Definitions

Capitalised terms used in the present Privacy Statement shall have the following meanings:

Axiles Bionics : means the entity referred to under article 3.1 of this Privacy Statement;

GDPR : means the General Data Protection Regulation 2016/679 of 27 April 2016;

Service Provider : means the entity to which Axiles Bionics outsources its processing activities, for example through the provision of IT systems or databases in which Personal Data are processed;

End User : means the natural person who purchases the Product from the Manufacturer or a Certified Prosthetist for exclusive personal use; 

Certified Prosthetist : the entity which has sold the Product to the End User, and which has obtained the Manufacturer's express written permission to do so;

Personal Data : means any information relating to an identified or identifiable person;

Privacy Statement : means the present privacy statement;

Product : any medical device manufactured by the Manufacturer for the purpose of sale;

Regulation : means European Parliament and Council Regulation 2017/745 of 5 April 2017 on medical devices.

2. General / Scope

Your privacy is important to us.

The present Privacy Statement relates to the processing of Personal Data of End Users of the Products. Any Personal Data we receive from you as an End User will be processed in accordance with applicable data protection regulations, in particular the GDPR, as well as the present Privacy Statement.

The present Privacy Statement provides you with more information regarding what Personal Data we process, why we process it, how we obtain it, how long we keep it and whom we share it with. It also provides you with more information regarding exercising your rights.

The present Privacy Statement supplements our website privacy statement, which covers specific processing activities on our website www.axilesbionics.com. 

3. Identity and Contact Details

3.1. Controller

The following legal entity is the controller of your Personal Data:

Axiles Bionics BV, having its registered office at Raketstraat 64, 1130 Brussels and registered in the CBE under number 0719.695.854.

3.2. Contact details

In case you have any questions about the processing of your Personal Data, you can always contact us:

• by mail: to the address above, with the indication "Privacy"
• by e-mail: info@axilesbionics.be

4. Personal Data

4.1. General

In the event of purchase of a Product by the End User, Axiles Bionics will process the Personal Data listed below. We will process sensitive data about you in accordance with applicable data protection rules and only as required for the relevant purposes set out in article 5. The data will be retrieved and processed only by the relevant personnel, under the responsibility of one of our representatives bound by professional secrecy or confidentiality.

4.2. Personal and contact details:

Personal and contact details concern:

• name of the End User;
• address of the End User; 
• contact details of the End User (including e-mail address, telephone number, etc.);
• date of birth of the End User;
• gender of the End User;
• dimensions (including weight, length and foot circumference of the End User);
• patient identification data of the End User.

4.3. Medical data:

The medical data concern:

• description and background of the End User's disability (including condition of the stump, degree of amputation, details of surgery and rehabilitation, level of amputation, prosthesis used, etc.);
• medical reporting through to the prosthetist and any other caregivers;
• health data (such as treatments administered, examination results, personal or family history, diseases or related events, risk factors, etc.) necessary or relevant for the production and installation of the Product.

4.4. Usage data:

The usage data refers to data relating to the End User's use of the Product, generated by connecting the Product to the designated 'IO Charger'. 

4.5. Other data:

We may process any other data to the extent that its processing is necessary in view of the processing purposes set out in article 5.1:

• occupational data: current and previous occupations;
• Information on consumption of tobacco, alcohol, drugs;
• information on lifestyle, habits and behaviour, including in particular physical activity (intensity, frequency, duration), leisure time and interests; 
• housing features;
• recordings of kinematic and biomechanical data during trials (needed for research on customised bionics);
• video recordings for research and development (the recordings can also be used during contacts with prosthetists).

5. Processing / Purposes

5.1. Processing purposes

We process your Personal Data for one or more of the following purposes:

• the production of the Product according to your needs and profile, the preparation and setting up of the Product in view of the use of it, the installation and fitting of the Product;
• ensuring compliance with the agreement with the End User;
• maintenance and repairs, monitoring, and any recalls of the Product;
• monitoring the safety of the Products, including detecting, assessing and preventing side effects or malfunctions and reporting to health authorities;
• providing information on the installation and correct use of the Product, as well as on any malfunctions;
• respond to medical queries, such as on the availability of a Product, clinical data, installation and use, composition and stability, interaction with other devices, or questions regarding our Products or services;
• dealing with quality complaints relating to our Products such as in relation to any failure of quality and/or effectiveness, stability, reliability, safety, performance or use;
• improving our Products and services;
• training or educational purposes;
• biomechanical research: recording and examining kinematic, biomechanical and physical data during trials;
• direct marketing; 
• market research & statistics: determining the viability of a new service or Product, discovering target markets;
• compliance with applicable regulations, in particular the Regulation, in our capacity as 'manufacturer', as defined in Articles 2) - 30) of the Regulation, including Article 10 of the Regulation;
• for the assessment or implementation of an acquisition or restructuring of Axiles Bionics, in going concern, or as part of a bankruptcy, liquidation or similar proceeding, when Personal Data is transferred as assets.

5.2. Processing grounds

5.2.1. We will not process your Personal Data if we do not have a legal basis for that purpose as provided by law. Accordingly, we will only process your Personal Data on the following legal bases:

• the useful performance and ensuring compliance with the Product purchase agreement, the maintenance agreement and the product warranties;
• Our legal obligations under the Regulation and other relevant legislation;
• the performance of a public health task;
• protecting the vital interests of the End User or any other person;
• safeguarding of our legitimate interests, provided that this does not compromise the interests and fundamental rights and freedoms of the End User. We shall always strive to maintain a balance between our legitimate interests and the End User's privacy when processing Personal Data on the latter basis. Examples of such "legitimate interests" include data processing activities carried out:
• to provide the End User and Prosthetists with accurate and timely information about our Products or facilitate their communication; and
• to prevent misuse of our services and products;
• the End User's consent, insofar as the processing does not take place on the basis of one of the aforementioned legal grounds.

5.2.2. These legal bases support our processing purposes as follows:

Execution of the agreement

• production, preparation and setting up, installation and application of the Product
• maintenance and repairs, monitoring, and any recalls of the Product
• monitoring the safety of Products, detecting, assessing and preventing side effects or malfunctions and reporting to health authorities
• ensuring compliance with the agreement with the End User
• providing information on installation and correct use of the Product, as well as on possible malfunctions
• responding to medical queries
• dealing with quality complaints relating to the Products

Legal obligations

• maintenance and repairs, monitoring, and any recalls of the Product
• monitoring the safety of Products, detecting, assessing and preventing side effects or malfunctions and reporting to health authorities
• dealing with quality complaints relating to the Products
• compliance with applicable regulations, in particular the Regulation, in our capacity as 'manufacturer'

Public health interests

• maintenance and repairs, monitoring, and any recalls of the Product
• production, preparation and setting up, installation and application of the Product
• monitoring the safety of Products, detecting, assessing and preventing side effects or malfunctions and reporting to health authorities
• providing information on installation and correct use of the Product, as well as on possible malfunctions
• responding to medical queries
• dealing with quality complaints relating to the Products
• improving our products and services
• training or educational purposes
• biomechanical research
• market research & statistics
• compliance with applicable regulations, in particular the Regulation, in our capacity as 'manufacturer'
• the resale or provision of Personal Data to third Parties

Safeguarding our legitimate interests

• improving our products and services
• training or educational purposes
• biomechanical research
• direct marketing
• market research & statistics

Consent

• direct marketing
• market research & statistics
• assessment or the implementation of an acquisition or restructuring of Axiles Bionics
• the resale or provision of Personal Data to third Parties

5.3. Retention period

We process your personal data for as long as necessary to fulfill the aforementioned processing purposes (e.g. during the period you use one or more Products or the period required by law).

We may indefinitely keep track of data, on an aggregated and anonymised (or pseudonymised) basis. As soon as such data is aggregated and anonymised, it loses its status of 'Personal Data'.

6. Acquisition / Communication of Personal Data

6.1. Acquisition

We acquire your data:

• directly from you, through the purchase of a Product, the connection of the Product to the designated 'IO Charger', through a visit to our website, through social media, through your subscription to our newsletter, through direct contact with one of our employees, representatives, etc;
• from your Prosthetist or any other caregiver (rehabilitation doctor);
• from orthopedic centers;
• from research partners and patient organisations.

6.2. Communication

We shall not sell, share or otherwise transfer your Personal Data to third parties not identified in the present Privacy Statement. In the course of our business and for the same purposes as those stated in the present Privacy Statement, your Personal Data may be made available or disclosed to the following persons (who are contractually obligated to protect the confidentiality and security of your Personal Data, in accordance with applicable law):

• companies related with Axiles Bionics (within the meaning of Article I.20 of the Companies and Associations Code);
• the Prosthetist;
• the competent national or international authorities (legislative, executive, public, judicial) to the extent required by law;
• Service Providers; 
• parties involved in an acquisition or restructuring of Axiles Bionics, who acquire your personal data as part of this acquisition or restructuring (of which you will always be informed in advance);
• parties to whom we would resell or permit the use of your Personal Data, in accordance with the processing purpose listed in article 5.1, provided that such parties provide the same level of protection as provided for in the present Privacy Statement.

6.3. Other jurisdictions

Your Personal Data may potentially be processed by parties (listed above) that are not based in your country of residence or jurisdiction, and are hence subject to different privacy legislations. Axiles Bionics will take all steps reasonably necessary to ensure that your Personal Data is processed in accordance with the present Privacy Statement, and is subject to a similar level of protection as afforded to you in your jurisdiction.

7. Security

We have implemented appropriate technical and organisational measures to ensure the confidentiality of your Personal Data and to protect your data against accidental or unlawful destruction, loss, alteration, unauthorised disclosure or access. Personal Data is stored in secure databases and any exchange of Personal Data takes place through secure systems. 

We have appropriate contractual arrangements with the third parties we work with and do not transfer your Personal Data outside the European Economic Area without ensuring that your data enjoys an equivalent level of protection there.

8. Rights

8.1. The End User’s rights

You can always contact us to exercise the following rights:

• a request for access to your Personal Data;
• a request for access or rectification of your Personal Data;
• a request for erasure of your Personal Data, insofar as we cannot invoke any legal grounds other than your consent;
• a request to restrict the processing of your Personal Data;
• an objection to the processing of your Personal Data;
• a request to transfer your Personal Data;
• an opposition to fully automated individual decision-making without any human intervention that significantly affects you;
• a complaint if you consider that we are not acting in accordance with applicable data protection legislation. You can also file a complaint with the Belgian Data Protection Authority.

8.2. Exercise of rights

If you wish to exercise the aforementioned rights, we may ask you to justify your request and/or provide us with proof of identity, e.g. by sending a copy of the front side of your identity card by post or e-mail.

You can always contact us to exercise your rights in accordance with article 3.2.

8.3. Questions and objections

We respect all rights in relation to your Personal Data which you are entitled to under applicable law.

For those processing purposes for which the legal basis for the processing of Personal Data is a legitimate interest, you can always ask us for more information about the balancing of interests carried out in that context.

For those processing purposes for which the legal basis for processing Personal Data is a task of public interest or legitimate interest, you may at any time exercise your right to object to the processing of your Personal Data, specifying the reasons pertaining to your particular situation. We will stop processing your Personal Data unless we consider that there are compelling legitimate grounds which outweigh the interests, rights and freedoms you bring forward.

9. Updates

The present Privacy Statement may be amended from time to time, within the limits of the applicable data protection regulations. Through our usual communication channels (in particular the website www.axilesbionics.com or e-mail) you will always have access to the most up-to-date version.