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14/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2
Chapter 1 - Get Started COSMED srl
Always consider data security aspects of the network topology and configuration when connecting the device to
shared networks through OMNIA SW. Your medical facility is responsible for the security of the network, where
sensitive patient data from the device may be transferred.
When a device is returned for repair, disposed of, or removed from your medical facility for other reasons, always
ensure that all patient data is removed from the device.
Log files generated by the device are used for system troubleshooting and do not contain protected health data.
About HIPAA Rules
If applicable, your facility’s security strategy should include the standards set forth in the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and
Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing
policies and procedures. For more information, please visit:
http://www.hhs.gov/ocr/privacy/
About the EU Directives
If applicable, your facility’s security strategy should include the practices set forth in the Regulation (EU) 2016/679
of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to
the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General
Data Protection Regulation).
COSMED Product Security Policy Statement
Additional security and privacy information can be required to COSMED when sending an inquiry to support@
cosmed.com .
Manufacturer Disclosure Statement for Medical Device Security – MDS2
You can get a copy of the document (MDS2) for a specific product sending an inquiry to support@cosmed.com .
Cyber Security Requirements and Controls
• Q-NRG cannot be connected directly to a Network.
• Q-NRG can be operated from a networked PC using the optional OMNIA SW.
As part of your security concept, you are responsible for establishing controls to protect your network and any
networked devices, including the PC where OMNIA SW is installed, against such cyber security threats.
Network Cyber Security Measures
Only connect COSMED devices operated from OMNIA SW to networks that are explicitly intended for that purpose.
If you connect the device to a network, it is therefore highly recommended that you deploy measures to protect
the network against cyber security threats. This includes the deployment of firewalls to limit remote access and
antivirus protection of standard computer systems.
Network Security Requirements
For managing risks in clinical network deployments, COSMED recommends that you apply a formal process such as
the IEC 80001 series of standards to address safety, effectiveness, and data and system security.