PRIVACY STATEMENT

PRIVACY STATEMENT (for USA)

Canada below - English

Canada below - French

This Privacy Statement governs Corcym S.r.l.’s ("Corcym", "Company", "we" or "us") collection, use and disclosure of Personal Information in compliance with applicable US federal and state personal information and personal health information protection legislation, GDPR (EU) 2016/679 and other applicable legislation.
Our Privacy Statement is designed to provide transparency regarding our privacy practices with respect to the use and disclosure of the Personal Information we collect, as manufacturer of medical devices, from the hospital for device tracking according to Title 21 of Code of Federal Regulations, Part 821 "Medical Device Tracking Requirements" that implement section 519(e) of Federal Food, Drug and Cosmetic Act (21 CFR821) through a specific web-based platform (Platform) and for your registration to the Platform.

We collect, from you or from the hospital you performed surgery at, Personal Information about you like contact information (first name, last name, address, phone number) and hospital information related to the implant surgery you provided or assisted, under the authority of 21 CFR821 (Personal Information). We may also collect form you Personal Information in order for you to register to the Platform. (Personal Information).

Personal Information collected include the following classes of information:

• Your Information as implanting physician, including first name, last name, phone number, and email address;
• Information about the hospital, including Hospital file number, Hospital name, Hospital address, Country, State, City;
• Patient information, including information about the patient that has been implanted with a medical device manufactured by Corcym: i.e. first name, last name, date of birth, address, phone number;
• Information about the medical device, including serial number, reference number, device model, and device status information (if the device was implanted, reason for not implant);
• Information about the implant, including implant type, implant date, implanting physician name;
• Your information as a registered user of the Platform, including e-mail address.

We will use your Personal Information received, from you or from the hospital you performed surgery at, for the purposes described above and rely on our activity of manufacturer of medical devices, especially to implement and manage the Platform for device tracking with regard to implantable devices based in accordance with 21 CFR821. As a result of that, we process your Personal Information based on a lawful basis of legal obligation.

We will use your Personal Information received from you in order to register to the Platform. As a result of that, we process your Personal Information based on a lawful basis of contract.

We may also use Personal Information to comply with any laws, regulations, court orders, subpoenas, or other legal process or investigation and to protect ourselves and other individuals from harm. As a result of that, we process your Personal Information based on a lawful basis of legal obligation and legitimate interest.

Your Personal Information is processed and stored via the Platform managed by the Company to efficiently comply with our legal obligation as manufacturer of medical devices. The Platform is managed by and hosted on our behalf by a subcontractor whose data center is located in the European Union. Our subcontractor is bound to process Personal Information based on our instructions by way of a specific data processing agreement.

Your Personal Information is only processed via the Platform by our employees, who have been expressly authorized to process them and who have received appropriate operating instructions, through administration profile to manage the Platform and by you or hospital’s employees through authentication credentials to insert your Personal Information into the Platform.

Your Personal Information may be disclosed to the competent regulatory authority for the purpose of our legal obligations according to 21 CFR821 and to other authorities and supervisory and control bodies and, in general, public or private entities entitled to request Personal information.

We will retain and use your Personal Information as needed to fulfill the purpose described above and for which it was collected and as necessary to comply with our legal obligations as manufacturer of medical devices or other legal obligations according to the applicable regulations.

We will retain your Personal Information for registration purposes until you revoke your registration to the Platform.

We also will retain and use your Personal Information as needed to resolve disputes and enforce our agreements under applicable laws.

We will take steps to destroy or render anonymous such Personal Information when it is no longer necessary.

We will provide you with access to your Personal Information stored in our Platform or system, subject to certain exceptions, including data that is referenced to another individual’s personal information that we cannot sever or other legal restrictions that may prevent us from fulfilling your access request.

• to update your Personal Information;
• to ask that we delete your information. We may continue to keep your information if we’re entitled or required to keep it;
• in some circumstances, to obtain from us restriction of the processing;
• in some circumstances, to receive certain information you have provided to us in an electronic format and/or ask that we send it to a third party;
• in some circumstances, to object to the processing your Personal Information.

You may also direct complaints regarding compliance with information protection legislation to the relevant local authority of the jurisdiction in which you reside or to the relevant supervisory authority, according with the EU law.

Should you have questions or comments related to this statement or wish to access or correct Personal Information held by Corcym about you, please contact us here:

email: privacy@corcym.com
address: Via Giovanni Spadolini 7, 20141, Milan, (Italy)

We may update this Statement as necessary from time to time, so be sure to check this Privacy Statement regularly. Any changes to this Privacy Statement will be communicated promptly on the Platform or on our website.

PRIVACY STATEMENT (for Canada)

USA above

Canada below - French

This Privacy Statement governs Corcym S.r.l.’s ("Corcym", "Company", "we" or "us") collection, use and disclosure of Personal Information in compliance with Canadian Provincial and Federal personal information and personal health information protection legislation, GDPR (EU) 2016/679 and other applicable legislation.
Our Privacy Statement is designed to provide transparency regarding our privacy practices with respect to the use and disclosure of the Personal Information we collect, as manufacturer of medical devices, from you or from the hospital for device tracking according to Canadian "Medical Devices Regulations" (SOR 98-282) through a specific web-based platform (Platform) and for your registration to the Platform.

We collect, from you or from the hospital you performed surgery at, Personal Information about you like contact information (first name, last name, address, phone number) and hospital information related to the implant surgery you provided or assisted, under the authority of SOR 98-282. We may also collect form you Personal Information in order for you to register to the Platform. (Personal Information).

Personal Information collected include the following classes of information:

• Your Information as implanting physician, including first name, last name, phone number, and email address;
• Information about the hospital, including Hospital file number, Hospital name, Hospital address, Country, State, City;
• Patient information, including information about the patient that has been implanted with a medical device manufactured by Corcym: i.e. first name, last name, date of birth, address, phone number;
• Information about the medical device, including serial number, reference number, device model, and device status information (if the device was implanted, reason for not implant);
• Information about the implant, including implant type, implant date, implanting physician name;
• Your information as a registered user of the Platform, including e-mail address.

We will use your Personal Information received, from you or form the hospital you performed surgery at, for the purposes described above and rely on our activity of manufacturer of medical devices, especially to implement and manage the Platform for device tracking with regard to implantable devices in accordance with SOR 98-282. As a result of that, we process your Personal Information based on a lawful basis of legal obligation.

We will use your Personal Information received from you in order to register to the Platform. As a result of that, we process your Personal Information based on a lawful basis of contract.

We may also use Personal Information to comply with any laws, regulations, court orders, subpoenas, or other legal process or investigation and to protect ourselves and other individuals from harm. As a result of that, we process your Personal Information based on a lawful basis of legal obligation and legitimate interest.

Your Personal Information is processed and stored via the Platform managed by the Company to efficiently comply with our legal obligation as manufacturer of medical devices. The Platform is managed and hosted on our behalf by a subcontractor whose data center is located in the European Union. Our subcontractor is bound to process Personal Information based on our instructions by way of a specific data processing agreement

Your Personal Information is only processed via the Platform by our employees, who have been expressly authorized to process them and who have received appropriate operating instructions, through administration profile to manage the Platform and by you or hospital’s employees through authentication credentials to insert your Personal Information into the Platform.

Your Personal Information may be disclosed to the competent regulatory authority for the purpose of our legal obligations according to SOR 98-282 and to other authorities and supervisory and control bodies and, in general, public or private entities entitled to request Personal information.

We will retain and use your Personal Information as needed to fulfill the purpose of device tracking described above and for which it was collected and as necessary to comply with our legal obligations as manufacturer of medical devices or other legal obligations according to the applicable regulations.

We will retain your Personal Information for registration purposes until you revoke your registration to the Platform.

We also will retain and use your Personal Information as needed to resolve disputes and enforce our agreements under applicable laws.

We will take steps to destroy or render anonymous such Personal Information when it is no longer necessary.

We will provide you with access to your Personal Information stored in our Platform or system, subject to certain exceptions, including data that is referenced to another individual’s personal information that we cannot sever or other legal restrictions that may prevent us from fulfilling your access request

• to update your Personal Information;
• to ask that we delete your information. We may continue to keep your information if we’re entitled or required to keep it;
• in some circumstances, to obtain from us restriction of the processing;
• in some circumstances, to receive certain information you have provided to us in an electronic format and/or ask that we send it to a third party;
• in some circumstances, to object to the processing your personal data

You may also direct complaints regarding compliance with information protection legislation to the privacy commissioner of the jurisdiction in which you reside or to the relevant supervisory authority, according with the EU law.

Should you have questions or comments related to this statement or wish to access or correct Personal Information held by Corcym about you, please contact us here:

email: privacy@corcym.com
address: Via Giovanni Spadolini 7, 20141, Milan, (Italy)

We may update this Statement as necessary from time to time, so be sure to check this Privacy Statement regularly. Any changes to this Privacy Statement will be communicated promptly on the Platform or on our website.

DÉCLARATION DE CONFIDENTIALITÉ (pour le Canada)

USA above

Canada above - English

La présente Déclaration de confidentialité régit la collecte, l’utilisation et la divulgation par Corcym S.r.l. (« Corcym », la « Société », « nous » ou « notre ») de Données personnelles conformément à la législation provinciale et fédérale canadienne de protection des données personnelles et informations médicales personnelles, au RGPD (UE) 2016/679 et aux autres législations applicables.
Notre Déclaration de confidentialité est prévue pour apporter de la transparence sur nos pratiques en matière de confidentialité pour ce qui est de l’utilisation et de la divulgation des Données à caractère personnel que nous collectons, en tant que fabricant de dispositifs médicaux, sur vous ou l’hôpital pour le suivi de dispositif(s) conformément aux « Réglementations relatives aux dispositifs médicaux » canadiennes (SOR 98-282) par le biais d’une plateforme spécifique basée sur le Web (la Plateforme) et pour votre inscription sur la Plateforme.

Nous collectons, sur vous ou l’hôpital dans lequel vous pratiquez vos interventions chirurgicales, des Données personnelles vous concernant telles que des coordonnées de contact (prénom, nom patronymique, adresse, numéro de téléphone) et des informations concernant l’hôpital et liées aux actes d’implantation chirurgicaux que vous avez pratiqués ou auxquels vous avez assisté, sous l’autorité du SOR 98-282. Nous pouvons également collecter des Données personnelles sur vous pour vous enregistrer sur la Plateforme. (Données Personnelles).

Les Données personnelles collectées incluent les classes d’informations suivantes:

• Vos données en tant que médecin pratiquant l’implantation, dont le prénom, le nom patronymique, le numéro de téléphone et l’adresse e-mail;
• Les Informations concernant l’hôpital, dont le numéro d’inscription de l’Hôpital, le nom de l’Hôpital, son adresse, et le Pays, l’État, la Ville;
• Les Informations relatives au Patient, dont les informations concernant le patient qui a subi l’implantation d’un dispositif médical fabriqué par Corcym : le prénom, le nom patronymique, la date de naissance, l’adresse, le numéro de téléphone par ex.;
• Les Informations concernant le dispositif médical, dont le numéro de série, le numéro de référence, le modèle du dispositif et les informations sur le statut du dispositif (si le dispositif a été implanté, raisons de la non implantation);
• Informations concernant l’implantation, à savoir le type d’implantation, la date d’implantation, le nom du médecin responsable de l’implantation;
• Vos informations en qualité d’utilisateur inscrit sur la Plateforme, dont l’adresse e-mail.

Nous utiliserons vos Données personnelles reçues, vous concernant vous ou l’hôpital où vous avez pratiqué les actes chirurgicaux, aux fins décrites ci-dessus et nous nous appuierons sur notre activité de fabricant de dispositifs médicaux, surtout pour mettre en œuvre et gérer la Plateforme pour le suivi de dispositif en ce qui concerne les dispositifs implantables conformément au SOR 98-282. En conséquence, nous traiterons vos Données personnelles sur la base juridique d’une obligation légale.

Nous utiliserons les Données Personnelles reçues de vous pour vous inscrire sur la Plateforme. En conséquence, nous traiterons vos Données personnelles sur la base légale d’un contrat.

Nous pouvons également utiliser vos Données Personnelles pour respecter les lois, réglementations, ordonnances de tribunal, citations à comparaître ou autres procédures ou investigations légales et pour nous protéger nous et les autres de tout préjudice. En conséquence, nous traiterons vos Données personnelles sur la base juridique d’une obligation légale et d’un intérêt légitime.

Vos Données personnelles sont traitées et stockées via la Plateforme gérée par la Société pour respecter efficacement notre obligation légale de fabricant de dispositifs médicaux. La Plateforme est gérée et hébergée pour nous par un sous-traitant dont le data center se situe en Union Européenne. Notre sous- traitant est tenu de traiter les Données personnelles suivant nos instructions sur la base d’un contrat spécifique de traitement des données.

Vos Données Personnelles ne sont traitées que via la Plateforme par nos employés qui disposent de l’autorisation expresse de traiter ces données et qui ont reçu les instructions de service appropriées, de gérer par profil d’administration la Plateforme et d’insérer par vous ou des employés de l’hôpital avec des références d'authentification vos Données personnelles dans la Plateforme.

Vos Données personnelles peuvent être divulguées à l’autorité réglementaire compétente dans le cadre de nos obligations légales conformément au SOR 98-282 et aux autres autorités et organismes de supervision et de contrôle et, en général, aux entités publiques ou privées ayant le droit de demander des Données personnelles.

Nous conserverons et utiliserons vos Données Personnelles si nécessaire pour satisfaire à l’objectif du suivi de dispositif décrit ci-dessus et pour lequel elles ont été collectées et qui sont nécessaires pour respecter nos obligations légales de fabricant de dispositifs médicaux ou autres obligations légales conformément aux réglementations applicables.

Nous conserverons vos Données personnelles aux fins d’inscription jusqu’à ce que vous révoquiez votre inscription sur la Plateforme.

Nous conserverons également et utiliserons vos Données Personnelles si nécessaire pour résoudre des litiges et faire appliquer nos accords en vertu des lois applicables.

Nous prendrons des mesures pour détruire ou rendre anonymes ces Données personnelles lorsqu’elles ne seront plus nécessaires.

Nous vous donnerons accès à vos Données Personnelles stockées sur notre Plateforme ou notre système, sous réserve de certaines exceptions, dont les données référencées comme données personnelles d’un autre individu que nous ne pouvons pas séparer ou d’autres restrictions légales qui peuvent nous empêcher de satisfaire votre demande d’accès

• pour mettre vos Données personnelles à jour;
• pour demander à ce que nous détruisions vos données. Nous pouvons continuer de conserver vos données si nous avons le droit de le faire ou si on nous le demande;
• dans certaines circonstances, pour obtenir de nous une restriction de leur traitement;
• dans certaines circonstances, pour recevoir certaines données que vous nous avez fournies au format électronique et/ou pour demander à ce que nous les envoyons à un tiers;
• dans certaines circonstances, pour s’opposer au traitement de vos Données personnelles

Vous pouvez aussi adresser des plaintes concernant la conformité à la législation sur la protection des données au commissaire à la protection de la vie privée de la juridiction dans laquelle vous résidez ou auprès de l’autorité de supervision en charge, conformément à la législation européenne.

Si vous avez des questions ou des commentaires concernant la présente Déclaration ou si vous souhaitez accéder ou corriger des Données Personnelles détenues par Corcym vous concernant, veuillez nous contacter ici:

email: privacy@corcym.com
adresse: Via Giovanni Spadolini 7, 20141, Milan, (Italy)

Nous pouvons mettre la présente Déclaration de confidentialité à jour si nécessaire de temps à autre, veillez donc à la contrôler régulièrement. Les modifications apportées à la présente Déclaration de confidentialité seront communiquées rapidement sur la Plateforme ou sur notre site Internet.