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.
Appendix
Data use and sharing by the Data Holder (Samsung)
Agreed use of non-personal Data by the Data Holder
The Data Holder undertakes to use non-personal Data only for the purposes agreed with the User as follows:
(a) performing any agreement with the User or activities related to such agreement;
(b) providing support, warranty, guarantee or similar services or to assess User’s, Data Holder’s or third party’s claims (e.g. regarding malfunctions of the Product) related to the Product or Related Service;
(c) monitoring and maintaining the functioning, safety and security of the Product or Related Service and ensuring quality control;
(d) improving the functioning of any Product or Related Service offered by the Data Holder;
(e) developing new products or services, including artificial intelligence (AI) solutions, by the Data Holder, by third parties acting on behalf of the Data Holder (i.e., where the Data Holder decides which tasks will be entrusted to such parties and benefits therefrom), in collaboration with other parties or through special purpose companies (such as joint ventures);
(f) aggregating these Data with other data or creating derived data, for any lawful purpose, including with the aim of selling or otherwise making available such aggregated or derived data to third parties, provided such data do not allow specific data transmitted to the Data Holder from the connected product to be identified or allow a third party to derive those data from the Dataset.
The use of the Data for the above purposes is necessary for the full enjoyment of the Product and Related Service by the User, for instance in respect of maintenance, diagnostics and repair, and the provision of automation, smart home monitoring services and in-product features. Certain Product features require Data Holder to hold Data in order for the feature to be available.
The Data Holder undertakes not to use the Data: to derive insights about the economic situation, assets and production methods of the User, or about the use of the Product or Related Service by the User in any other manner that could undermine the commercial position of the User on the markets in which the User is active. None of the Data uses agreed to may be interpreted as including such Data use, and the Data Holder undertakes to ensure, by appropriate organisational and technical means, that no third party, within or outside the Data Holder’s organisation, engages in such Data use.
Data use by the User
Permissible use and sharing of data
The User may use the Data made available by the Data Holder upon their request for any lawful purpose and/or share the Data freely subject to the limitations below.
Unauthorised use and sharing of data
The User shall not:
(a) use the Data to develop a connected product that competes with the Product, nor share the Data with a third party with that intent;
(b) use Data to derive insights about the economic situation, assets and production methods of the Product manufacturer or, where applicable, the Data Holder;
(c) use coercive means to obtain access to Data or, for that purpose, abuse gaps in the Data Holder’s technical infrastructure which is designed to protect the Data;
(d) share the Data with a third-party considered as a gatekeeper under article 3 of Regulation (EU) 2022/1925;
(e) use the Data they receive for any purposes that infringe EU law or applicable national law.
Making Data available to a Data Recipient
The Data must be made available to a third party nominated by the User (a ‘Data Recipient’) by the Data Holder, free of charge for the User, upon request presented by the User or a party acting on its behalf. The request can be made using the EUDA Service, in the same way as the User requests access to the Data themselves.
The Data Holder shall make the Data which is personal data available to a third party following a request of the User, when the User is not the data subject, only when there is a valid legal basis for making personal data available under Article 6 of Regulation (EU) 2016/679 (GDPR) and only, where relevant, the conditions set out in Article 9 of that Regulation and of Article 5(3) of Directive 2002/58/EC (Directive on privacy and electronic communications) are met.
In that respect, when the User is not the data subject, the User must indicate to the Data Holder, in each such request for third-party access, the legal basis for processing under Article 6 of Regulation (EU) 2016/679 (and, where relevant, the applicable derogation under Article 9 of that Regulation and Article 5(3) of Directive (EU)2002/58) upon which the making available of personal data is requested.
The Data Holder must make the Data available to a Data Recipient with at least the same quality as they become available to the Data Holder, and in any case in a comprehensive, structured, commonly used and machine-readable format, easily and securely.
Where the User submits such a request, the Data Holder will agree with the Data Recipient the arrangements for making the Data available under fair, reasonable and non-discriminatory terms and in a transparent manner in accordance with Chapter III and Chapter IV of the Data Act.
The User acknowledges that a request cannot benefit a third party considered as a gatekeeper under Article 3 of Regulation (EU) 2022/1925.
