Tag: medical device cybersecurity

NIS2: One year to go  

Attaining NIS2 compliance is a standard process that requires around 12 months for completion. With non-compliance carrying severe penalties, it’s crucial for businesses, particularly MDMs, to pay attention to the essential components of this Directive, prepare adequately and act before the approaching deadline arrives.
Check out our compliance checklist and actionable steps for MDMs and see how well-prepared your business is

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The implication of NIS2 on medical device cybersecurity

The healthcare industry has made great efforts over the past few years to prevent and mitigate the risks of cyberattacks targeting connected medical devices and healthcare systems. The alarming numbers indicating an increase in cyberattacks against healthcare institutions sadly show that there are still problems to tackle, particularly on the part of MDMs.
The introduction of the NIS2 Directive marks one of the latest and most important attempts to address these challenges. What’s the meaning of NIS2 to the healthcare sector and how do MDMs get started?

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The complexity of medical device cybersecurity requirements: How to cope 

Mitigating cybersecurity risks for medical devices is increasingly a core focus area for regulators, who are driving the establishment of a consistent cybersecurity framework to better facilitate coordination among all parties involved. This emphasizes the importance of Medical Device Manufacturers (MDMs) being aware of and familiar with the latest requirements. The intertwining of requirements, however, creates significant complexity in the medical device cybersecurity ecosystem. How can you cope with this?

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Exposing medical devices: Alarming statistics in the last 3 years

Moving away from static offline devices and paper notetaking, to having the full system and communication done online was a breakthrough for the healthcare industry. This however introduced new challenges for medical device cybersecurity. This article explores some of the most alarming statistics on how the industry has been affected by cybersecurity threats over the past few years. 

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Medical device cybersecurity: Conformity assessments 

The ongoing digitization in healthcare has brought not only new opportunities to improve patient care, but also challenges in cybersecurity. To address the issue and ensure the security of new medical devices, state-of-the-art regulatory frameworks are mandatory. Let’s discover some of the new industry developments, discuss the best practice documents and the implementation of the guidance.

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Medical device cybersecurity management – what you need to know

There is little doubt that the future of healthcare will rely more on always-connected devices, Software as a Medical Device (SaMD), cloud computing and vast amounts of data processing. However, moving medical devices outside of the security provided within a managed hospital network and placing them at our homes increases the risk of cyberattacks. So, how manufacturers can face the ongoing challenge of ensuring security of their devices and the ever-increasing pressure by the regulatory bodies?  

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