How has the medical device regulatory landscape evolved in recent years and how do MDMs cope with the changes? The insightful discussion between Irdeto’s and QBD Group’s experts will provide all you need to know.
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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?
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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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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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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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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Looking for expert insights to enhance your cybersecurity? Get it for FREE: download The Business Value of Cybersecurity in MedTech Report now.
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