Information for Healthcare providers
1. Device instructions for use and product specifications related to recommended cyber security controls appropriate for the intended use environment are provided in Install manual section “Summary: Minimum relevant IT security requirements” and User manual section “IT security measures”.
2. System is working even when the device’s cyber security has been compromised, but it is recommended to log-off from the system and inform person responsible for system administration.
3. System backups should be created by system administrator, based on internal rules of healthcare provider.
4. Manufacturer provides requirements for minimal server side (please see Install manual). Healthcare provider is responsible for required infrastructure support.
5. Manufacturer provides requirements for secure configuration, as well as typical network port and other interfaces (please see Install manual).
6. List of network ports and other interfaces that are expected to receive/send data, and a description of port functionality and whether the ports are incoming or outgoing (Unused ports should be disabled).
7. Typical network diagrams for end-users are provided in MedDream integration documents. If integration documents are required, please contact to firstname.lastname@example.org.
8. In case of personal data breach (including but not limited to cyber security breach) please immediately (but not later than during 24 hours) inform medical software Manufacturer Softneta UAB by using below mentioned contacts: SOFTNETA Data Protection Officer: Raimundas Mikalauskas Tel. +370 630 06808 Mail: email@example.com.
9. Any serious incident that has occurred in relation to the device should be reported to the manufacturer (via email: firstname.lastname@example.org) and the competent authority of the Member State in which the user and/or patient is established.
10. Residual risks which could influence medical device functionality are provided in Release notes.
Safety and performance information for MedDream distributors and users
MedDream can be downloaded from Softneta website Downloads page together with Install manual, User manual and other information intended for users or can be reached in Softneta website. If integration documents are required, please contact to email@example.com. Please not that specific trainings for users are not required. Software About window is treated as a device label and could be found in User manual.