User's Manual

INTRODUCTION
CYBERSECURITY
KleeYa - User Manual - Version 2 1-27
If for whatever reason network administrators decide to install security patches of
the Operating System without known consent of STRATEC, the administrator bears
full responsibility for the further correct functionality of the KleeYa System. STRATEC
will not take over any responsibility for a System that was modified without consent.
1.7.10 PRIVACY OF DATA ON THE KLEEYA
SYSTEM
The KleeYa System generates analytical results in accordance with its intended use.
This data is exposed to the risk of being spread through the following personnel,
which are directly or indirectly involved in technical activities on the KleeYa System
in a laboratory environment:
• STRATEC specialists
• STRATEC’s contractual distributions partners
• Distribution partners of STRATEC’s contractual distributions partners
These groups might get in contact during customer support or maintenance
activities.
The KleeYa System does not store any specific patient information like last and
surname. A sample identifier (SID), an anonymous sequence of alphanumeric
characters is used instead and stored on the system. End-users are obliged only to
use SIDs not referring to the patient; such traceability shall be kept on the laboratory
tracing systems.
Therefore, there will not be the option to go back on the KleeYa System itself from
health data to the SID and from the SID.
1.7.11 INCIDENT RESPONSE
STRATEC recommends to implement Cybersecurity structures (Cybersecurity
incident management/process) as defined below.
Cybersecurity incident management is the process of identifying, managing,
recording and analyzing security threats or incidents in real-time if applicable.
Security incident management seeks to give a robust and comprehensive view of
any security issues (Cybersecurity event and or a Cybersecurity incident) within an
IT infrastructure. A Cybersecurity incident can be policy violations and unauthorized
access to data that have a significant probability of compromising business
operations and threatening information security. Whereas a Cybersecurity event is
an identified occurrence of a system, service, or network state, indicating a possible
breach of information security, failure of controls, or a previously unknown situation
that may be security relevant
Cybersecurity incident management process typically starts with an alert that an
incident has occurred and engagement of the incident response team, a team of
appropriately skilled and trusted members of the organization that handles
incidents during their life-cycle. From there, incident responders will investigate and
analyze the incident to determine its scope, assess damages, and develop a plan for
mitigation.