Study Application powered by Hyfe - Privacy Notice

As part of the study you have joined, this Study Application, which includes the cough monitoring device and software platform (collectively the “App”) is being provided to help share information with your study doctor. This privacy notice describes how your personal information is used by the App. 

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For details about the study itself, including what other information is collected by your study doctor and how it is used, please refer to the study Informed Consent Form. This will be provided to you by your study doctor before you decide whether to join the study.

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Who is Providing the App?

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GlaxoSmithKline or its Affiliate (defined below) (‘GSK’) is the sponsor of the study. GSK is working with Hyfe (via ICON), here in after called Supplier, to provide the App, so you and your study doctor can share information more easily. Supplier will keep your information confidential and will only use it to manage your use of the App. Supplier will not share your personal information directly with GSK. 

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Affiliate means each Affiliate of GSK which has the benefit of the Study-related services as a third party (a list of which can be provided on request).

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What data do we collect about you?

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Account Data 

You create an account via a code provided by your study doctor, Supplier will only collect:

• Your patient ID, provided by your study doctor

Health Data 

Some studies will ask you to use the App to submit your health information to your study doctor.  The health information you input into the App or that is collected automatically from the App will be sent to your study team to be used in the study as described in the study Informed Consent Form. Supplier will not use that health information for any other purposes. 

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Data Collected Automatically by the App 

Supplier may collect certain information about your device to provide the App services. The following information may be collected:

• Device ID and battery status, if you use a device which was provided by Supplier
• Metadata: Data on the OS version, device model and screen size of the device using the app.
• App usage and activity information, including when the app has been opened, which app screens have been used, and when the app has synchronised with the cough monitoring device.
• Sensor data, if the study requires this data
• IP Address
• Time zone

This data is collected automatically from your device and may be then sent to Supplier and used to deliver and improve the App services. No personal data will be shared with the smartphone manufacturers or the smartphone OS providers.

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How long will we keep your personal information?

Your data will be used only as long as it is specified in the informed consent form. . It may be stored for longer, where required by law. Supplier, on behalf of GSK, will retain the data in line with the retention period stipulated in the relevant agreement between GSK and Supplier.

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Who has access to your data?

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‍Your data will be maintained by Supplier and trusted third parties working on behalf of Supplier, who are required to keep your data secure and confidential. Supplier will share your Health Data with your study doctor. Your data may be shared with regulatory authorities as required. 

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GSK may receive information, including your Health Data collected via the App, from your study doctor, but it will not identify you directly. More information can be found in the study Informed Consent Form.

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As described above, data that is collected automatically from your device may be shared with Supplier so that they can analyse your data pursuant to GSK’s instructions and provide it to the appropriate study personnel.  

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Transfers of your personal information outside of your home country

Your data may be stored by Supplier outside of your home country such as in the United States of America. GSK and Supplier use appropriate safeguards to protect your data when it is transferred outside your home country. Safeguards include written agreements which commit Supplier and any third parties working for Supplier to keep your information confidential and to put in place appropriate security measures to keep your information secure.

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Your rights

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At any time, you may ask the study doctor to look at your data. You may request:

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• To learn more about what is done with your data. 
• A copy of your data.
• To correct and/or delete your data. 
• To transfer your data to a third party (such as your personal doctor) for re-use.

You may also:

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• Object to what is done to your data.
• Complain to your local data protection authority, if your privacy rights are violated.
• Claim compensation for damages caused due to unlawful use of your data, through the courts.

Some rights may be limited by law or regulatory requirements. If you object to Supplier processing your personal information, you may no longer have access to the App, and this could impact your participation in the study. 

If you want to make a request about your information that is held by Supplier, you can submit your request to roccport@coughmonitor.com. All other questions should be directed to your study doctor first. 

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Contact GSK

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GlaxoSmithKline, as sponsor of the study, is the controller of the data collected or generated through this App. A data controller determines why and how data is processed, even if the controller never sees or uses the data.

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Some of your data may be processed within the European Union. European Union law states that GSK should state the legal basis for processing your data. GSK’s legal basis is in the company’s legitimate interests of scientific research to provide you with access to the App to support your participation in the study.

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You can contact GSK’s Data Privacy Officer at EU.DPO@gsk.com. However, it is best to contact your study doctor first to retain your anonymity.