Assess platform changes for compatibility before production and maintain security settings to support access protection, malware defenses, network protection, logging, and timely updates.
Platform changes and security settings
Changes to hardware and software platforms
NeuroCenter EEG has been validated for use on the hardware and software platforms specified by the manufacturer. The user and/or the responsible organization shall assess any changes to the platform, including operating system updates, antivirus or firewall updates, changes to system libraries, firmware updates, or other configuration changes, for compatibility with NeuroCenter EEG before implementation in the production environment.
Platform settings shall be selected and maintained such that the security goals and security capabilities of the system are supported. This includes, as applicable, user access protection, malware protection, network protection, logging availability, and timely installation of approved security updates. If compatibility of a platform change is uncertain, the change should first be evaluated in a controlled environment or discussed with the manufacturer before deployment.
Hazardous situations resulting from IT-network failure
Hazardous situations related to failure of the IT-network
When NeuroCenter EEG is used in connection with an IT-network, failure of that IT-network to provide the characteristics and services required for the intended use may result in one or more of the following hazardous situations:
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delay or loss of access to online functions, including online help or documentation;
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delay or failure of data transfer between system components;
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incomplete, delayed, or unavailable access to examination data;
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disruption of user authentication or access control where dependent on network services;
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delay in clinical workflow due to unavailability of network-dependent functions.
The responsible organization shall ensure that the IT-network used with NeuroCenter EEG provides appropriate availability, integrity, and security for the intended use of the software.