What are the Risks, Contraindications and Adverse Side Effects of CoLumbo

The software itself does not pose a danger to either doctors or patients, but it can contribute
to dangerous situations. There are two main reasons for this – errors in software
specifications and incorrect coding. The risk analysis shows that after the measures taken to
reduce the risk, the residual risk is minimal.


Key Risk Categories Identified
Risk Control Measures Implemented

Wrong input data (e.g.,
unsupported studies, missing
files, etc.)
– The study does not load;
– A warning appears and study is loaded without
CoLumbo analysis.
Wrong analysis (e.g., incorrect
segmentation or measurement,
incorrect findings or modifiers,
etc.)

– CoLumbo asks users to review and modify (or
correct) the results of the analysis in 3 ways:
o In the list of findings,
o Through the visualizations, and
o In the draft report.
– Users independently review the original study in
addition to CoLumbo analysis, modify and approve
the report, and therefore are fully responsible for the
diagnosis.
Missed analysis (e.g., missed
segmentation or measurement,
missed finding, etc.)

– Users independently review the original study in
addition to CoLumbo analysis, modify and approve
the report, and therefore are fully responsible for the
diagnosis
Issues with operating
environment (e.g., loss of
power, lack of network
connection, etc.)

– Study is not processed and can be loaded again upon
power or network connectivity resumption;
– User settings are stored on non-volatile memory;
– Automatic switching to local hardware resources to
continue the analysis if server connection is lost.

Data security breach (e.g.,
unauthorized users, unsecured
access, data tempering, etc.)
– User access controls and authentication;
– All transferred data is encrypted.
Misuse of software (i.e.,
radiologist users overly rely on
the software)

– Present UI reminders, warnings for users to review,
correct and approve displayed information and
report;
– CoLumbo creates summary tables that contain
information about what changes the user made for
each study. These tables can be generated weekly,
monthly and annually and reviewed by the lead
radiologist of the medical center/hospital.