Product Data Access & Use Disclosures Policy
Pursuant to Regulation (EU) 2023/2854 (“EU Data Act”)
1. Purpose
This information policy document establishes the framework under which B Medical Systems Luxembourg Sarl, registered address at: 17, Op der Hei, L-9809 Hosingen Grand Duchy of Luxembourg, R.C.S. Luxembourg: B 91535, including its affiliated companies (“BMS”) ensures adherence to Regulation (EU) 2023/2854 (“EU Data Act”), by providing information to end users and relevant third parties concerning digital data generated by the products manufactured and sold by BMS in the EU, the product collected and processed information by BMS, information to end users about their rights to access such data or request the transfer of the data in accordance with the EU Data Act.
2. Scope
This information policy issued by BMS is applicable to a connected product. Connected products means physical item or device that obtains, generates, or collects data about its use or environment and can communicate those data through (a) an electronic communications service, (b) a physical connection, or (c) on-device access (“Connected Products”). Connected Products may also include accompanying digital platforms providing digital infrastructure that supports, extends, or enhances the functionality of the Connected Products by enabling data visualization, storage, and management (“Related Services”).
BMS, as the manufacturer, service provider and the data holder of the Connected Products and Related Services is obligated to comply with the requirements of the EU Data Act and provide the product data and related service data to the User ( means the natural or legal person that owns or uses the Connected Product or the Related Services) and to the relevant third parties (as may be specified by the User).
BMS reserves the right to amend the terms of this information policy document from time to time. All such amendments shall be published.
3. Data Access for Users
Direct data access- Connected Products or associated interfaces allow users to access data directly from the device and export data in a structured and machine readable format. This data can be retrieved directly from the relevant device.
Indirect data access – in case direct access is not technically possible, Users may request access to data through: customer portals and customers service request. Requests will be fulfilled as soon as reasonable possible. This data can be retrieved via the below online form, stating your customer name, address, device number and email address. You can choose to receive the report in PDF or CSV format; media function files can also be provided in JPEG format. The data provided is considered to be personal, any sharing of the data is subject to providing to BMS the details of the scope of the data, the third party name and the purpose of the sharing with third party. Any such sharing shall be subject to the terms and conditions agreed between BMS and the User.
4. Generated Data, Storage Location, Usage, Retention Period, Volume and Method
Depending on the Connected Product, the table below provides details about the Connected Products and Related Services :
| Device | Data Category | Readily Available Data | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Direct access | Indirect access | ||||||||
| Method | Storage location | Retention period | Volume (estimated) | Method | Storage location | Retention period | Volume (estimated) | ||
| Precision line | Operational status data (e.g. temperature) | Through USB export in CSV file | On device | 30 days | Approx. 1MB / month | Using RS485 interface (additional tools and related services required) | At the customer’s premises (local server) | Depends on user’s server settings (up to device lifetime) | Approx. 40MB / month |
| Premium line | Operational status data (e.g. temperature, failure and functionality events) | Through USB or SD card export in CSV file | On device | 3 months | Approx. 2MB / month | Using Ethernet interface (additional tools and related services required) | At the customer’s premises (local server) | Depends on user’s server settings (up to device lifetime) | Approx. 40MB / month |
| CSF | Operational status data (e.g. temperature, failure and functionality events) | Through USB or SD card export in CSV file | On device | 3 months | Approx. 2MB / month | Using Ethernet interface (additional tools and related services required) | At the customer’s premises (local server) | Depends on user’s server settings (up to device lifetime) | Approx. 50MB / month |
| VCC equipped with RTMD | Operational status data (e.g. temperature, failure and functionality events) | NA | NA | NA | NA | Using mobile network (additional tools and related services required) | Cloud (Bmedical server) | 1 year (direct access), older data is archived and can be accessed upon request (up to device lifetime) | Approx. 1MB / month |
| VCC with integrated EMS | Operational status data (e.g. temperature, failure and functionality events) | USB connection to a PC or laptop to transfer reports in PDF or JSON format | On device | 60 days (PDF/JSON), device lifetime (JSON) | Approx. 5MB / month | Using mobile network (additional tools and related services required) | Cloud (Bmedical server) | 1 year (direct access), older data is archived and can be accessed upon request (up to device lifetime) | Approx. 5MB / month |
| DCU | Operational status data (e.g. temperature, failure and functionality events) | Through USB export in CSV file | On device | 3 months | Approx. 2MB / month | Using Ethernet interface (additional tools and related services required) | At the customer’s premises (local server) | Depends on user’s server settings (up to device lifetime) | Approx. 40MB / month |
| GTmini | Operational status data (e.g. temperature) | NA | NA | NA | NA | Using Bluetooth interface (additional tools and related services required) | Cloud (Bmedical server) | Device lifetime | Approx. 1MB / month |
5. Usage Purpose and Licensing
BMS and its affiliated companies are using the Connected Products data for the following purposes:
- Fulfilling with the terms and conditions of BMS’ obligations under agreements,
- Providing various maintenance and repair services,
- Improving the functionality and quality of the devices and improving the provisions of the services,
- Marketing activities,
- Developing new and better technology and devices.
BMS, BMS’ affiliates and BMS’ designated third parties may use and make available to other third parties, any data generated in connection with the Connected Products with no limitation of time.
Any data that qualifies as direct data access, the User (or any future User) of the device grants BMS and its affiliates, an irrevocable, non-exclusive, transferable, worldwide, royalty free, and time-unlimited license to use such data and to sublicense it to third parties (including the right to further sublicense the data).
6. Data transfer and Personal data
The product and service data may be collected and processed by either BMS and its affiliates or by its third-parties service providers or by distributors and agents. Data may also be shared with relevant authorities to conform with legal obligations and with various certification bodies.
Any transfer, processing and storage of personal data is in accordance with the applicable data protection laws and regulations. The data processing is governed by the data protection privacy policy.
7. Confidentiality and Trade Secrets
Certain data may be considered as trade secrets or confidential information. According to the EU Data Act, BMS has the right to preserve its trade secrets and confidential information against a likelihood of economic damage due to the exposure of trade secrets and confidential information.
Accordingly, BMS has the right to:
- Ask Users and third parties to preserve the confidentiality of data that is confidential and/or is q trade secret; and/or
- Impose appropriate contractual, technical and organizational safeguards to preserve the confidentiality and the trade secrets; or
- Withold or suspend or refuse to share the partial or the complete data in case of the likelihood of serious economic damage, whereby in this case the user shall be informed in writing by BMS; or
- BMS may consider to share redacted access to the data, whereby in this case the User shall be informed in writing.
8. Storage and Deletion
The data may be stored locally in the device storage capability or on a cloud. The data is usually stored for the life time of the device. The data can be deleted upon request via the contact option in section 6. [AS3.1]Personal data will be deleted in accordance with the Privacy Policy.
9. Rights and Contacts
In case of any additional information request in relation to this information policy document or a specific request, please contact us and provide details of your request.
Any person can lodge a complaint with the relevant competent authority about any issue relating to the handling of the data of the Connected Product.
Please fill out the form below to request access to your Connected Product (only valid for EU and EEA countries):
