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Category
Supplementary Resource
Access
Open
Status
Active
Created
May 2011
This document addresses the problem of increasing risk of cyber attacks on medical devices, specifically the risks of malware outbreaks and breaches of protected health information. The unique regulatory status, general use scenario, and patient care aspects make medical devices difficult to protect and manage. This document reviews the problem and provides a risk management–based approach to solving it.

Main sections:

• Objective

• IHE role

• Why is cyber security an issue for medical devices?

• Regulatory environment and the role of regulation

• Medical device types and risk considerations

• Privacy vs security problems

• Roles and responsibilities

• Example discussion / threat vectors

• Guidance on countermeasures

• IHE’s role in the framework of existing guidance and standards

• Conclusion

• References
Access IHE Patient Care Device (PCD) White Paper - Medical Equipment Management (MEM): Cyber Security

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