Privacy And Security Environment Requirements - GE Vscan Air Manual

Privacy and Security Environment Requirements

Privacy and Security Capabilities
Access Controls
Viewing images in the presence of others
Patient Privacy Consent Management
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Vscan Air User Manual
Direction GP092020-1EN Rev 18
The GEHC Vscan Air ultrasound product has been designed for
an intended use with the following expectations of Privacy and
Security protections included in the environment where this
product will be used:
1. The device should be connected to a secured network, not
open to unintended users.
2. The Vscan Air CL should be physically secured in a way that
it is not accessible for unintended users.
3. The display of the Vscan Air should be placed in a way
limiting the visibility to the user only.
The GEHC Vscan Air incorporates a broad assortment of
capabilities to enable Privacy and Security. This section
describes the capability and use of these Privacy and Security
capabilities.
The access control features may be used to help control access
to sensitive information. User-based access controls are
provided by iOS and Android OS. Vscan Air product is based on
a bring-your-own mobile device to be used with our app and
probe. Vscan Air app software leverages device encryption and
authentication. Ensure that you set a device password or PIN
which is sufficiently complex. The Vscan Air app will only start
and run if the device is secured with a PIN, passcode, or
biometric protection such as FaceID or fingerprint.
GEHC is not responsible for image data if the owner of Vscan
Air views images in the presence of unauthorized individuals.
Patient Privacy Consent Management is the process to support
the patient to express their privacy requirements. This is
different from other forms of consent such as the consent to
treat.
There is no integrated functionality in the system for Patient
Privacy Consent Management. If needed, operational routines
must be established.
Introduction
7-3