Cybersecurity: a shared responsibility

In recent years, cybersecurity in medical devices has become a critical issue. While it was often overlooked in the past, the growing number of cyber incidents targeting medical technology has forced industry to address this challenge head-on.

Regulatory bodies, such as the FDA and EU via the MDR, have responded by tightening their requirements. At Zentis Medical, we recognize the importance of these developments and have been actively working to help our clients navigate the complex world of cybersecurity for medical devices.

Recently, we discussed our experiences and provided recommendations on cybersecurity for medical devices. This process reflects the latest regulatory expectations and addresses the evolving cybersecurity landscape. Here are the key takeaways:

The increasing importance of cybersecurity in medical devices

Cybersecurity is no longer an optional consideration in the design and deployment of medical devices. With incidents of data breaches and compromised equipment becoming more frequent, regulators are placing greater emphasis on cybersecurity. Medical devices are increasingly connected to networks, making them vulnerable to attacks. Now, more than ever, manufacturers are expected to account for security risks across the entire lifecycle of a product, from initial concept to decommissioning.

A lifecycle approach to cybersecurity

One of the most important aspects of cybersecurity is that it must be integrated throughout the   entire lifecycle of a medical device. This means considering security from the early planning stages, through design, architecture, and validation, all the way to the end of a device’s life. During the design phase, Zentis Medical performs threat modeling to identify potential vulnerabilities and attack vectors, and we implement controls to mitigate these risks.

Managing both safety and security risks

In the medical device industry, we’re already familiar with safety risk management, which ensures devices don’t pose physical harm to patients. Now, we’ve expanded this to include security risk management. Often, security issues overlap with safety concerns, especially when a security breach could lead to a device malfunction that affects patient safety. By integrating security risk management into our process, we ensure that both risks are addressed comprehensively.

Cybersecurity as a shared responsibility

One of our key messages is that cybersecurity is a shared responsibility. It’s not just the manufacturer who needs to stay proactive. Suppliers, integrators, healthcare providers, and even patients have roles in maintaining the security of medical devices. This requires collaboration and information sharing   among all parties involved. For instance, suppliers need to provide vulnerability information, while healthcare providers must follow security guidelines for safe use.

What lies ahead for cybersecurity in medical devices

At Zentis Medical, we’re committed to leading the way in medical device security. This means continually improving our processes, staying ahead of regulatory changes, and working closely with our partners. By focusing on secure design, performing detailed risk assessments and fostering a culture of collaboration, we aim to create a safer and more secure healthcare environment.

In today’s world, cybersecurity isn’t just a technical issue, it’s a fundamental part of ensuring patient trust and safety. Together, through shared responsibility, we can protect the future of medical technology.