Medical device cyber security

Why is the cyber security of medical devices important? 

There are regulatory, ethical and financial reasons to ensure the cyber security of medical devices and their accessories. For example:

• Regulatory requirements have to be met before medical products can be launched in different markets. This includes both European regulatory requirements such as the in vitro diagnostic regulation (IVDR), the medical device regulation (MDR), the in vitro diagnostic directive (IVDD), the medical devices directive (MDD) and the active implantable medical devices directive (AIMDD), as well as non-European regulatory requirements set by the United States Food and Drugs Administration (FDA), the Chinese National Medical Products Administration (NMPA), the Canadian Health Ministry (Health Canada) and the Japanese Ministry of Health, Labour and Welfare (MHLW).

• If unauthorised access is gained to a medical device, there can be severe consequences. That is why it's crucial for cyber security risks to be considered both during both the development phase as in the procurement and installation of medical devices.
• Patient privacy within the framework of the doctor-patient relationship is extremely important and could be compromised in a data breach.

Device manufacturers and health organisations that use unsecure technology and fail to guarantee the cyber security of their medical devices pay heavy penalties, both financially and in terms of their reputation.

Our services to test and assess the cyber security of medical devices

Globally, there is an increasing awareness of cyber security for medical devices from the regulatory organisations. For example, the FDA, the European Commission and Health Canada have published guidelines on how to meet cyber security regulations. These guidelines specify whether it is necessary to carry out vulnerability scans or penetration tests during the development of medical devices. It is better to implement the cyber security requirements early in the development process rather than having to include and integrate these requirements to the finished product.

We answer some of the most frequently asked questions to keep you up to date with the latest developments. 

Our testing labs offer a comprehensive range of services to test and assess the cyber security of your medical devices. These include: