Adequate information security for medical devices
Adequate information security for medical devices is essential for protecting patients. In this presentation, we will consider two key points: information security and patient safety, consisting of freedom from risk (“safety“) and effectiveness (“performance”).
Adequate information security for medical devices is essential for protecting patients. A “safe” medical device takes into account several, sometimes conflicting aspects.
In this presentation, we will consider two key points: information security and patient safety, consisting of freedom from risk (“safety“) and effectiveness (“performance”).
Technical aspects, but also the responsible and targeted operation of a product, are of central importance for the information security of a product.
This often conflicts with the goal of patient safety: Many functional features, such as the increased interconnectivity of a medical device, have a positive effect on safety and performance and offer additional relief for medical staff.
At the same time, however, a new target is created that could potentially be exploited by attackers.
In order to weigh up these protection goals in borderline cases, this presentation argues that patient safety should be regarded as the dominant technical criterion for medical devices.
This is explained in a summary comparison of relevant European/national laws.
Please note: The lecture will be held in German.
Supported by: ZVEI e.V.
Speakers (1)
Dr. Georg Heidenreich
Quality Management, Regulatory Affairs & Process Management, Standards and Special Expertise, Siemens Healthineers AG