Roche Diagnostics
Urisys 1100® · ≥5.7 · Operator's Manual · 9.0
2. About the protection of personal data and software security 11
Network security Malicious software and hacker attacks may impair IT
security. The laboratory is responsible for the IT security
of their IT infrastructure.
• Secure all devices and services used in the lab
infrastructure against malicious software and
unauthorized access.
• 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.
• Do not write any patient sensitive information into
operator ID or patient ID fields.
Secure data storage Unauthorized access to archive files can violate data
protection laws.
• Any data archive that has been transfered from the
instrument must be physically stored in a secured
location.
• Ensure only authorized persons may access the
secure data storage. This includes the data transfer to
remote storage locations.
Cybersecurity and privacy awareness Insufficiently informed employees can endanger security.
• Perform regular cybersecurity and privacy awareness
trainings for staff handling personal data. Instruct staff
how to handle data in a compliant way and according
to the privacy principles as mandated by customer
regulations.
• Check your instrument for suspicious activity and
report any suspected compromise to your local Roche
representative immediately.
• Update to the latest software versions provided by
Roche as soon as possible.