Data Act Notice

In accordance with the EU Data Act (the “Data Act”), Abbott is committed to ensuring fair access to and use of data generated by our connected products and related services. As a user, you have certain rights provided by the Data Act to access data generated by your use of our connected products and related services. Please see below for information required to be disclosed pursuant to the Data Act regarding each of our connected products and related services.

A. Connected Products – Meters and Readers

FreeStyle Freedom Lite Meter

FreeStyle Optium Neo Meter

Freestyle Libre Reader

FreeStyle Libre 2 Reader

FreeStyle Libre 3 Reader

What types of product data is this product capable of generating?

The products are capable of generating certain personal data (e.g. glucose measurements) as well as certain non-personal data concerning the product’s performance (e.g. product status/fault codes), use (e.g. duration and timing of use), and environment (e.g. temperature) that is generated from the use of the product.

What formats of product data is this product capable of generating?

Data generated by the products is stored digitally in memory within the meter/reader. Data is stored in time-stamped samples and organised in a format which can readily be transferred to Abbott’s LibreView cloud-based data management system via USB.

What is the estimated volume of product data this product is capable of generating?

The products have fixed memory sizes and allow data to be housed for specific amounts of time. Maximum storage and features vary by model. For example, the FreeStyle Optium Neo meter can store up to 1000 events which include glucose readings. Please consult your user’s manual for specific storage capabilities of your device.

Is this product capable of generating data continuously and in real-time?

No, the meter/reader products only generate or collect data when initiated by the user, such as when a scan of the sensor is performed.

Is this product capable of storing data on-device or on a remote server?

No, however the user can transfer the data to Abbott’s LibreView cloud-based data management system via USB (note that this requires users to create a LibreView account).

Where applicable, for how long will the data be stored on-device or on a remote server?

The data stored on devices remains on the device for disposal by the user.

How can a user access or retrieve the data? 

The Home screen of the meters/readers displays the user’s most recent data. Consult your User Manual for product-specific steps to access all readily available data collected by your current meter or reader.

How can a user erase the data, where relevant?

Consult your reader/meter’s user manual for information on deleting saved data.

B. Connected Products – Sensors

Freestyle Libre Sensor

FreeStyle Libre 2 Sensor

FreeStyle Libre 2 Plus Sensor

FreeStyle Libre 3 Sensor

FreeStyle Libre 3 Plus Sensor

FreeStyle Libre Pro iQ Sensor

FreeStyle Libre Select Sensor

What types of product data is this product capable of generating?

The products are capable of generating certain personal data (e.g. glucose measurements) as well as certain non-personal data concerning the product’s performance (e.g. product status/fault codes), use (e.g. duration and timing of use), and environment (e.g. temperature) that is generated from the use of the product.

What formats of product data is this product capable of generating?

Data generated by the products is stored digitally in memory within the sensor and/or meter. Data is stored in time-stamped samples and organised in a format which can readily be transferred to compatible related services or product wirelessly.

What is the estimated volume of product data this product is capable of generating?

The sensor products have fixed memory sizes and allow data to be housed for specific amounts of wear time. Maximum storage varies by model and features available in each market. For example, the FreeStyle Libre 3 sensor has will retain glucose readings for the entire wear duration of the product

Is this product capable of generating data continuously and in real-time?

Yes, the connected sensor products are continuously measuring data while in use but will only send data to the related services a maximum of once per minute or immediately if there is a triggering event (such as an alarm condition) or when a scan of the sensor is performed.

Is this product capable of storing data on-device or on a remote server?

The products store data within the sensor only and do not interface directly with remote servers. Connected products only interface with compatible related services. Data transmitted to related services may be stored in Abbott’s LibreView cloud-based data management system if you choose to create a LibreView account.

Where applicable, for how long will the data be stored on-device or on a remote server?

The data stored on devices remains on the device for disposal by the user.

How can a user access or retrieve the data? 

Users can access data only after it is transferred to a compatible related service (mobile app) or another connected product (readers/meters). The Home screen of the mobile apps, meters, and readers displays your most recent data. Consult your User Manual for product-specific steps to access readily available data collected by your current sensor or meter.

Note: You can refer to www.freestylelibre.com for information about all the compatible related services for your specific sensor model.

How can a user erase the data, where relevant?

Users cannot erase data generated by and stored within the connected sensor products. They are designed to be disposed of after use.

C. Related Services – Mobile Apps

FreeStyle LibreLink App

FreeStyle Libre 3 App

To which connected product(s) does this service relate?

Each related service can connect to at least one compatible connected product. Refer to your User Manual or visit www.freestylelibre.com for the latest compatible products listing.

What is the nature of the connected product data that Abbott is expected to obtain in connection with a user’s use of this service?

The connected products are capable of generating certain personal data (e.g. glucose measurements) as well as certain non-personal data concerning the product’s performance (e.g. product status/fault codes), use (e.g. duration and timing of use), and environment (e.g. temperature) that is generated from the use of the product.

In connection with your use of the service, the related services (mobile apps) will receive relevant data the connected product generates in addition to any data you provide.

What is the estimated volume of connected product data that Abbott is expected to obtain in connection with a user’s use of this service?

The volume of data collected in connection with the use of our related services varies depending upon the connected product type (real-time or "streaming” systems generate more data), usage patterns (actively engaging in logging generates more data), and how long you have been using the systems.

The physical size of the data collected will vary but could be as much as 10MB, which allows several months of historical data to be viewed on the related service.

What is the collection frequency for product data that Abbott is expected to obtain in connection with a user’s use of this service?

When not interacting with your chosen related service and not experiencing alarms and/or alerts, your connected sensor is sending data to the related service at a prescribed frequency of one-minute or five-minute intervals depending on which connected product you are using.

Where relevant, how and for how long will Abbott store this product data?

The related services (mobile apps) other connected products that interact with sensors (readers/meters) will store data for an extended period of time (minimally 90 days) to provide you with access to relevant recent data.

Please note: Abbott does not have access to data stored on your chosen mobile app, meter, or reader until you create a LibreView account and allow Abbott to collect it. Data will be stored in your LibreView account as described in the Privacy Notice displayed on www.libreview.com.

Where relevant, how can a user access or retrieve product data generated in connection with use of the connected product?

Users can access sensor data only after it is transferred to a compatible related service (mobile app) or another connected product (reader/meter). The Home screen of the mobile apps display your most recent readily available product data.

Consult your User Manual for product-specific steps to access relevant readily available product data collected by your current sensor or meter.

What is the nature of the related service data generated through a user’s use of the related service?

In addition to the product data described above, when using a mobile app, non-personal data related to your interactions with the mobile app (“Analytics Data”) may be collected. Analytics Data is used to maintain product quality or customise the user’s experience. This occurs even when you have elected to not create a LibreView account.

The personal and non-personal data collected by the related services (described above) allows Abbott to maintain product quality or customise your experience.

This data can help Abbott verify your identity if you contact Customer Service, change your data collection preferences, or make changes to your account. For additional details on how your data is managed, please consult the Privacy Notice provided with your product or on www.freestylelibre.com.

What is the estimated volume of related service data generated through a user’s use of the related service?

The volume of data collected varies by product type and with the frequency in which you engage with the related services, but typically is less than 10MB.

How can a user access or retrieve this data?

The Home screen of the mobile apps displays your most recent relevant readily available product data.

Consult your User Manual for product-specific steps to access relevant readily available product data collected by your current sensor or meter.

If you have a LibreView account and have connected it to your mobile app, you can download available product data from www.libreview.com.

You can request to receive or ask for deletion of  personal and non-personal data by contacting Customer Service using one of the methods described below.

In what format will related service data be made available upon request?

Data will generally be provided in CSV or similar file format that is able to be opened with widely available software products, e.g. Microsoft Excel.

How and for how long will Abbott store related service data?

If you have a LibreView account, your data will be stored in accordance with local laws and regulations for data retention.

For additional details on how your data is managed please consult the Privacy Notice included with your product or on www.freestylelibre.com

For what purposes might Abbott use readily available data generated from a user’s use of the connected products or related services?

Abbott may use this data for the purposes described in our contract with you, including any applicable Terms of SaleTerms of Use and Privacy Policy

Will any third parties be permitted to use the readily available data for the purposes described above?

Abbott may disclose the data to affiliates and third parties in accordance with, and for the purposes described in, our contract with you, including any applicable Terms of SaleTerms of Use and Privacy Policy

Who will be the data holder and other data processing parties for this data?

Data Holders:

Abbott Diabetes Care Inc. of 1420 Harbor Bay Parkway, Alameda, CA 94502, USA

If you received your connected products or related services from a healthcare provider, or if you share your data with a healthcare provider for healthcare purposes, your healthcare provider (e.g. a hospital or clinic) may also be a data holder. Information regarding how any non-Abbott data holders use, share, store, or make available data should be obtained directly from those data holders.

Additional data processing parties include:

Amazon Web Services and its applicable sub-processors

EMEA SARL 38 Avenue John F. Kennedy L- 1855 Luxembourg

Braze, Inc. and its applicable sub-processors

63 Madison Building, 28 East 28th Street, 12th Floor, New York, NY 10016, USA

How can a user communicate with Abbott regarding this notice and the data described in this notice?

You can contact Abbott by calling Customer Service.

Please see relevant contact information for your specific location on www.freestylelibre.com.

You can reach our customer service from Monday to Friday between 8:00 AM and 8:00 PM, Saturday, Sunday & Bank Holidays 9:00 AM to 5:00 PM.

Call us at 0800 032 1016

How can a user request that the data be shared with a third party?

See contact details above.

How can a user request to end data sharing with a third party with whom the user previously requested that data be shared?

See contact details above.

How can a user lodge a complaint alleging an infringement of any of the provisions of Chapter II of the Data Act with a competent authority designated pursuant to Article 37 of the Data Act?

You may lodge a complaint with the relevant competent authority, as defined in the Data Act. If you are unsure about which competent authority to address in a specific case, you should first contact the data coordinator in your Member State. The name and contact details for the data coordinator in your Member State are made available online through the European Commission.

Who are the relevant trade secret holders for any trade secrets?

Abbott Diabetes Care Inc. and its affiliates.

What is the duration of the contract between you and Abbott, and how can you terminate that contract?

Contracts for related services may be terminated at any time, in accordance with the relevant terms of service applicable to the related services.

Kindly note that not all products (devices and mobile apps) are available in your country.
 

ADC-121500 v1.0

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