Roche Diagnostics
cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0
21Safety precautions
Network security Malicious software and hacker attacks may impair IT
security. The laboratory is responsible for the IT security
of their IT infrastructure.
r To protect and separate Roche systems from other
laboratory infrastructure, the Roche-provided firewall
must be used.
r Secure all devices and services used in the lab
infrastructure against malicious software and
unauthorized access.
r Secure the network environment to be resilient
against traffic redirection and eavesdropping.
Data entry and data transfer Writing patient sensitive information in comment fields
can violate protection laws for protected health
information.
r Do not write any patient sensitive information into
comment fields.
r Do not download patient identifiers from any host
system (e.g., LIS, middleware, or HIS) onto the system.
Data transfer using any host protocol (e.g., HL7,
ASTM) is not encrypted; data is transferred as plain
text and readable with packet analyzer tools such as
Sniffer.
Secure data storage Unauthorized access to data backups and archive files
can violate data protection laws.
r Any data backup or data archive that has been
exported from the system must be physically stored in
a secured location.
r Ensure only authorized persons may access the
secure data storage. This includes the data transfer to
remote storage locations and disaster recovery.Data
backups must not be taken from the secure data
storage. Do not take storage media outside the lab
environment.
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