Medical device cyber security information for users v1.2

Medical devices are used in various environments and cyber security risks depend on the knowledge and approach of medical device users. Manufacturers and sponsors are responsible for supplying compliant medical devices, whereas users share responsibility for providing a cyber secure environment in which to use for these devices.

This document describes cyber security practices and protocols for the medical device sector and aims to help medical device users manage cyber security risk. It also helps support the Australian Government’s cyber security strategy.

This document is for groups or individuals who represent users of medical devices, including in-vitro diagnostic medical devices.

Main sections:

· Report potential cyber security issues

· Guidance for different users

· Guidance for patients and consumers

· Guidance for health and medical professionals

· Guidance for small business operators

· Guidance for large-scale service providers

· Cyber security intelligence and threat sharing

· Known vulnerabilities

· The evolving cyber security landscape