Cybersecurity Note - GE Voluson Swift Instructions For Use Manual

Safety

2.13 CyberSecurity Note

2-28
network such as those listed below, which could introduce new risks and require additional
analysis.
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changes in network configuration
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connection of additional items to the network
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disconnection of items from the network
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update of equipment connected to the network
•
upgrade of equipment connected to the network
In order to reduce the vulnerability of the system with respect to attacks from the internet, it is
not recommended to connect to the public internet. Note that when using the UMTS terminal
the provider usually acts as a filter to the public internet. The upload of data to an internet-
based service requires an internet connection between the ultrasound system and the internet-
based server. It is strongly recommended to use a firewall to restrict network access from and
to the ultrasound system when features requiring internet access ( e.g. trice, service remote
access, Email) are installed. Other precautions like a secure network segment are
encouraged. It is the user's responsibility to ensure a secure internet connection, e.g. to
prevent patient data leaks.
Since the Voluson™ systems are integrated into your IT-network, GE wants to make sure that
you are aware of the proactive measures we are taking to secure the systems. Below are
measures we have implemented to secure the Voluson™ systems. Refer to Voluson™
SWIFT / Voluson SWIFT+ Privacy & Security Manual for a detailed description of the Privacy
& Security capabilities included in Voluson™ scanners.
•
The operating system is locked down to prevent a user from loading software, opening
email, or using a web browser and introducing viruses or Trojan horses to the system.
•
All operating system services that are not used by the system software are disabled to
help ensure that the source of security vulnerabilities is minimized.
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Disable, or make inaccessible, functionality that is typically used as malware vectors for
spreading viruses (e.g. email services, web browsers).
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The "auto run" feature is disabled on the system. For instance, when a DVD or USB
memory stick that has a program that runs automatically is inserted, the system will not
open or run the program. On top of that, access to USB storage devices for reading and
writing can be disabled in the system configuration.
•
Close network entry points that are not in use by the Voluson™ scanner software by
strict firewall configuration and by disabling Services. The only Internet connection
needed is an outbound port to GE's remote service platform (InSite™ ExC), Tricefy™
and Voluson Update, which uses a secure HTTPS connection (port 443). Inbound
connections are used for DICOM connectivity only (port 104, configurable) within the
local network .
•
To control scanner access the system offers a built-in user management that can be
configured individually by the device administrator. This user management can be linked
to a central user management system (LDAP/AD).
•
Use secure integration and communication between systems (Scanners, Workstations
and Servers).
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Enable encryption of patient data stored on the internal hard drive to ensure
confidentiality.
•
Monitor public security bulletins from software vendors and news services, analyze for
applicability to the Voluson™ scanner, and include third party software security patches
as necessary within GE software.
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4