Samsung EU Data Act (EUDA) Pre-Sales Information
As a manufacturers of connected products, Medical Device Business Division of Samsung Electronics Co., Ltd. and Samsung Medison Co., Ltd. (collectively “Samsung” or “we”) are committed to ensuring transparency about how those products generate data about their use and performance, and how our customers can access that data or share it with third parties, in accordance with the Data Act (EU Regulation 2023/2854).
Some of the information contained in this notice applies to all product types. Other information may vary by product category. Samsung updates this EUDA pre-sales information notice from time to time to reflect the launch of new products and features.
Data Generation
Samsung offers connected products to enhance user experience and enable efficient troubleshooting. The types of data generated may vary by product type. The volume of data generated by connected products varies based on the type of device, usage patterns, and the granularity of data collection.
Location of Data
Remote Server Storage: Data is primarily stored on Samsung’s secure remote servers for analysis, product improvement, and customer support. Retention periods vary based on data type and purpose but are designed to comply with applicable data protection regulations.
On-Device Storage: Some data may be stored on the device itself for diagnostic purposes or immediate access.
Data Access
The Samsung Healthcare EU Data Act Service (“EUDA Service”) provided at samsunghealthcare.com is the primary means by which users can access data about their connected products and related services.
Samsung Healthcare EUDA Service
To meet our obligations under the Data Act, and to allow users to access and share information, Samsung has created the EUDA Service. This serves as a centralized platform where customers can submit, track, and manage their data access requests.
The Samsung EUDA Service is the primary means by which users can access data about their connected products and related services.
Using the EUDA Service
The EUDA Service is linked to a user account created through http://samsunghealthcare.com . It enables access to data for any connected products registered under that account. Using the EUDA Service is easy – simply locate your product’s unique serial number on its label and register it in the EUDA Service.
Once you have registered your product on the EUDA Service, you will be able to see a list of the data held by Samsung each of your products. If you cannot see a particular product on the EUDA Service once you have logged in, please verify that its serial number has been entered correctly.
Access Requests
Once you have registered a product, you can select it within the EUDA Service and request to access its data. You will need to accept EUDA Service Terms of Use and Access Terms to be able to download and access the data. Enterprise users can also use the same registration to request process to access data.
Once a ticket has been raised, you can track its progress, and access and download the data via the EUDA Service once the ticket is completed.
Sharing Requests
The process for data sharing requests is slightly different. At data request stage, you can nominate a third-party recipient by entering the third-party’s email address which will serve as your consent for Samsung to share data with them. You must separately agree with the third party on how they may use your data – this may occur in advance of your data sharing request, for example when you sign up to their service.
The third-party recipient will need to accept the EUDA Sharing Terms before they can download and access the data. These Sharing Terms form an agreement between us and the third-party, defining their rights and obligations in receiving, using, and safeguarding your data.
Data Structure
The EUDA Service brings together data from different sources and systems, relating to different types of product, and with different functions.
When making a data access request, you will select the product you wish to access data for. Once selected and request is made, all available data for that product across applicable datasets will be provided to you.
The available datasets for our digital radiography devices and ultrasound systems are:
(a) Error Code Data: When a failure occurs or is predicted, and a warning is issued, the related data (error/warning code, occurrence time, product serial number) is collected and/or transmitted to us. Example of error/warning code: Error 8802 (A type of battery failure error)
(b) Issue Report Data: When a failure occurs, the customer may press the issue report transmission button on the product screen to send the issue report data (such as error code, occurrence time, product serial number, error content entered by the customer, etc.) to Samsung
(c) QR Data: When a service engineer determines that an immediate on-site failure repair is not possible, engineers operate the product to enter the service mode. In the service mode, a QR code appears on the screen. The service engineer takes a picture of this QR code with their phone while running our service app, and the product log data (such as bumper collision count, battery total cycle, shot count, etc.) is transmitted to Samsung.
Please note that Samsung does not hold any imaging data generated by medical devices and there cannot provide them through the EUDA Service.
All images and resulting information and analysis can be accessed directly from the medical devices themselves.
Data Volumes
The volume of data generated varies by product and related service and depends on usage. While it is not possible to complete detailed estimates for each product, we have provided some estimated approximate volume per user per day below to give users a sense of how much data their products generate.
| Type of Data |
Estimated approximate volume per user per day |
Duration of retention |
| Ultrasound Systems |
275.3 Bytes |
1 year |
| Digital Radiography Systems |
275.3 Bytes |
1 year |
Payment
Users can access data about their own connected products and related services for free. Samsung may impose a fee on third party data recipients which as our users to share their connected product and related service information with them (i.e. in order to provide their own related service). As an end user, you will never have to pay anything to Samsung for using the Samsung EUDA Service.
The Samsung EUDA Service is designed so that all requests are processed in a secure and transparent manner, adhering to the principles of data protection and user rights.
Should you have any questions or require further assistance regarding data access or the use of the Data Service, please do not hesitate to contact our support team at https://samsunghealthcare.com/en/support/contact.
How can I make a complaint relating to the EUDA Service or the Data Act in general?
In the first instance, you can contact our support team at https://samsunghealthcare.com/en/support/contact.
You also have a right to lodge a complaint alleging Samsung's infringement of the Data Act with the relevant "competent authority". Each EU Member State has designated one or more competent authorities to be responsible for the enforcement of the Data Act. You may lodge a complaint with the relevant competent authority in the EU Member State of your habitual residence, place of work or establishment if you consider that your rights under the Data Act have been infringed.
EUDA Service Terms
In order to request access to your own connected product data or to share it with third parties, you are first required to agree to the Samsung EUDA Terms of Use found at https://previous.samsunghealthcare.com/en/notice/37. These terms will apply to all request tickets using the Samsung EUDA Service.
There is also a privacy notice for the EUDA Service – set out in the EUDA Service homepage and also provided at https://previous.samsunghealthcare.com/en/privacy.
Should you have any questions or require further assistance regarding data access or the use of the Data Service, please do not hesitate to contact our support team at https://samsunghealthcare.com/en/support/contact.
