My Dose Coach Global App Privacy Policy

Effective Date: 23 JUL 2020

WHY THIS DOCUMENT?

METEDA s.r.l, via Silvio Pellico 4, San Benedetto del Tronto, 63074 Italy (“METEDA”) – the legal manufacturer of My Dose Coach App (the “App”), and Sanofi India Limited, Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai – 400072, India (“SANOFI”) – the local entity of the Sanofi Group marketing and promoting the App in the country in which you are established – are fully committed to the protection of your Personal Data and intend to provide you with relevant information regarding the way in which SANOFI and METEDA process your Personal Data on the App and to whom it is or may be disclosed.

For residents of the United States, it is hereby specified that neither SANOFI nor METEDA qualify as a “healthcare professional”, or a “Business Associate” under HIPAA regulations. While METEDA is making the App available, as legal manufacturer, and although your healthcare professional enters information that is used in the App, this does not result in making METEDA a healthcare professional.

This App Privacy Policy does not address, and we are not responsible for, the privacy, information or other practices of any third parties, including any third party operating any site or web property that is available through the App or to which the App frames or contains references or links not operated or controlled by SANOFI and/or METEDA (“the Third Party Services”). This App Privacy Policy does not apply to Third Party Services. The availability of, or inclusion of links to, any such site or web property on the App does not imply our review or endorsement of the Third Party Services. We suggest contacting those sites or web properties directly for information on their privacy policies.

SANOFI and/or METEDA have reasonable security practices and procedures in place for securing your Personal Data.

You will therefore find below all relevant information regarding the processing of Personal Data conducted on this App. Please note that the content of this App Privacy Policy may change from time to time, for instance in case of evolution of our processes or as a result of applicable law. METEDA and/or SANOFI reserve the right to amend this App Privacy Policy without prior notice. If METEDA and/or SANOFI change this App Privacy Policy, an updated version will reflect those changes. You are advised to consult this App Privacy Policy regularly for any changes. By using this App, you consent to any material changes to this App Privacy Policy and any new practices that may affect your previously collected Personal Data.

REMINDER: WHAT IS PERSONAL DATA & PROCESSING?

For the purposes of this App Privacy Policy, Personal Data is any information relating to an identified or identifiable natural person. SANOFI, METEDA and their respective contractors (including without limitation call centers, data hosting providers) and/or your healthcare professional will use the information you provide, including Personal Data, in connection with the objectives and purposes defined in this App Privacy Policy.

To make things clear, Personal Data is any information that relates to an individual. Such Personal Data can take the form of:

• Basic identification information such as your name or date of birth;
• Information that can be attributed to you directly or indirectly – such as notes provided to your healthcare professional;
• Information which can be associated to you or your device such as, for instance, an IP address (i.e. the network address of your machine);

In this respect, the notion of “processing” designates any action that is undertaken on your Personal Data such as, for instance:

• Collection;
• Storage;
• Access;
• Analysis

WHAT PERSONAL DATA DOES THIS APP COLLECT?

When operating, this App may collect the following categories of Personal Data:

• Identification data: any information provided directly from you while using the App or by your healthcare professional as part of the App onboarding which allows your identification, whether directly or indirectly such as your name, gender, date of birth, or contact details (email address, telephone number) or medical record/patient identification number
• Messages: you may send your healthcare professional notes while using the App
• Health Data: any information pertaining to your dose plan sent by your healthcare professional, medication or blood glucose data input by you manually or collected from connected devices, health status information such as weight or A1C, and other similar information
• Usage data : any information regarding your connection, access and usage of this App (e.g. type of mobile device you use, your mobile device’s unique ID, the IP address of your mobile device, your mobile operating system, and information about the way you use the App)

FOR WHAT PURPOSES DOES THIS APP COLLECT PERSONAL DATA?

Any processing of Personal Data must be implemented for a defined purpose. In this respect, the collection and processing of Personal Data on this App is conducted for the following purposes:

• User registration and app functioning & data display: to ensure that the App functions adequately, notably by ensuring users (patients and healthcare professionals) are registered and can access and visualize their data through their individual accounts;
• App user / patient support & guidance: to allow the App to send you notifications, reminders and advice in consideration of the information inputed in the App;
• Therapeutical support: to enable healthcare professionals to prescribe an individual dose plan based on data entered into the App;
• Product and service improvement: identify usage trends, develop new products and services, and understand how you and your device interact with our services through use of analytics technologies that support IP anonymization, never disclosing your full IP address to SANOFI and/or METEDA; track and respond to safety concerns; conduct surveys; and to investigate application crashes: collection and sending of crash reports that include technical information from the App at the time of the crash, the App log, basic metrics such as App launches and session length, and low resolution videos of use of the App before and at the time of a crash, in order to help troubleshoot service problems;
• Patient protection and safety (pharmacovigilance & materiovigilance): identify and investigate any safety-related events or product complaints in accordance with legal obligations;
• Further scientific research : Sanofi may reuse the data collected and processed in this app after de-identifying them to carry out further scientific research in healthcare.

ON WHAT GROUNDS DOES THIS APP PROCESS YOUR PERSONAL DATA?

For the purposes of this App, your Personal Data is only processed on the following basis, according to the above-described purposes of processing:

• User registration and app functioning & data display: the processing of personal data is based on the End User License agreement (EULA) i.e., the agreement between you and METEDA pursuant to which you are able to access and use the services of the App;
• App user / patient support & guidance: the processing of personal data is based on your consent and, where this purpose requires the processing of health data, your specific consent to the processing of your health data;
• Therapeutical support: the processing of personal data is based on the fact that the processing is necessary for the purposes of preventive medicine, medical diagnosis, the provision of health care or treatment pursuant to contract with a health professional who is subject to an obligation of professional secrecy;
• Product and service improvement: the processing of personal data is based on the legitimate interests of METEDA and SANOFI;
• Patient protection and safefy: the processing of personal data is based on the compliance with METEDA and SANOFI’s legal obligations to monitor the safety and efficiency of this App;
• Further scientific research : the processing of personal data is based on your consent, that you can withdraw at any moment, without impeding the use of this App.

HOW LONG IS THE PERSONAL DATA COLLECTED IN THIS APP RETAINED?

Through our respective contractors, SANOFI and/or METEDA may retain Personal Data for as long as you use the App and for a reasonable time thereafter. Please note that some or all of the Personal Data may be required in order for the App to function properly, and we may be required to retain certain information by the law. Your Personal Data shall be retained for the specific duration as described below and in any case only for the duration that is necessary to fulfil the above mentioned purposes, unless further retention is necessary to meet any legal or regulatory requirements or to the protection of SANOFI or METEDA’s interests.

Specifically, your identification and health related data shall be retained until (i) your treating healthcare professional believes that you should benefit from using the App to manage your therapy, or (ii) the App is available for use, whichever comes earlier.

• User registration and app functioning & data display: data processed for this purpose will be retained for the entire term of your use of this App / until your decision to delete your account increased by ten (10) years to allow you to re-instate your account should you change your decision to delete.
• App user / patient support & guidance: data processed for this purpose will be retained for the entire term of your use of this App.
• Therapeutical support: data processed for this purpose will be retained by your healthcare professional in accordance with his/her own retention policy – please contact him/her to obtain details on such applicable term of retention ;
• Product and service improvement: data processed for this purpose will be retained for three (3) years;
• Patient protection and safety: data processed for this purpose will be retained for ten (10) years.
• Further scientific research : once de-identified, the personal data no longer qualifies as personal data and can therefore be retained for an undetermined period of time.

WHO HAS ACCESS TO PERSONAL DATA?

Unless you contact us directly, neither SANOFI nor METEDA will have access to your Personal Data through the App. SANOFI and/or METEDA’s respective contractors, which are helping to provide the App services may have access to your Personal Data; however, such contractors are subject to confidentiality requirements and have committed not to disclose any identifiable information to SANOFI and/or METEDA or any third party unless legally required. SANOFI may have access to de-identified information of users of the App, upon prior consent as described in this App Privacy Policy. Other individuals downloading and using the App will not have access to your information at any time.

SANOFI and/or METEDA may disclose the Personal Data provided by you or your healthcare professional or automatically collected by the App, for the purpose of:

• With their affiliated entities, contracted third parties of our global affiliates, group companies, etc. in order to ensure the correct usage and functioning of the App services;
• As required by law, such as to comply with a subpoena, or similar legal process, or to report adverse events;
• When we believe in good faith that disclosure is necessary to protect our rights, protect your safety or the safety of others, investigate fraud, respond to a government request or otherwise exercise our legal rights or defend against legal claims;
• When we believe it is necessary to share information in order to assist in an investigation regarding, or to prevent, illegal activities, suspected fraud, or situations involving potential threats to the safety of any person;
• To third parties with whom SANOFI is jointly marketing a product or service or jointly conducting a program or activity, upon collection of prior separate consent;
• If SANOFI and/or METEDA are respectively involved in a merger, acquisition, or sale of all or a portion of its assets, you will be notified via email and/or prominent notice on our website of any change in ownership or uses of this information as well as any choices you may have regarding this information;
• To analytics companies as described in this App Privacy Policy.

Where Personal Data are transferred outside of their country of origin, such transfer will be covered by appropriate safeguards, notably the EU Standard Contractual clauses. SANOFI and/or METEDA will ensure that the Personal Data is only transferred to a person or a body corporate that ensures the same level of data protection that is adhered to by SANOFI and/or METEDA and SANOFI and/or METEDA will take reasonable steps to ensure that the Personal Data is treated securely and in accordance with applicable Indian laws and this App Privacy Policy.

YOUR RIGHTS: SANOFI WILL ENSURE THAT YOU CAN EXERCISE YOUR RIGHTS PERTAINING TO YOUR PERSONAL DATA

You can exercise your rights as provided by applicable data protection laws.

As such, you are entitled to:

• object to the processing of your Personal Data. You may opt-out of all collection of information by uninstalling the App from your mobile device. You may use the standard uninstall processes as may be available as part of the mobile device or via the mobile application marketplace or network. You must uninstall the App for data entry and data collection directly collected from you to stop. If you choose to delete the app, we cannot stop your healthcare professional from entering additional Personal Data into the healthcare professional portal. You are responsible for letting your healthcare professional know to stop entering information on the portal or to delete your account.
• access by simple request to your Personal Data – in which case you may request to receive a copy of your personal data, unless such personal data is made available to you directly;
• request a rectification of your Personal Data if such data is inaccurate, incomplete or obsolete;
• obtain the deletion of your Personal Data in the specific cases provided for by law;
• obtain a limitation of the processing of your data in the specific cases provided for by law;
• if applicable, receive your data in a standard format for transmission to another data controller;
• lodge a complaint with the SANOFI Grievance Officer or your data protection authority.

By further using the App:

• You confirm that you are 18 years of age or older;
• You acknowledge and agree having read this App Privacy Policy in its entirety, you understand it, and you agree to the collection, use, and processing of information as described in this App Privacy Policy, which may be amended by SANOFI at any time effective upon its posting. Your continued use of this App constitutes your acceptance to this App Privacy Policy and any updates.
• You have provided your healthcare professional with your unambiguous authorization to enter your Personal Data into the portal so you can use this App;

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