Essential Cybersecurity Practices to Protect Medical Devices

Author: Derek Silva, VP Marketing, Intertek

As the medical device landscape evolves with increased connectivity and technological advances, cybersecurity has become a key priority. Regulators around the world are implementing rigorous guidelines that require manufacturers to integrate robust cybersecurity measures into their products. This guide explores the latest developments in medical device cybersecurity, providing engineers, quality managers, and compliance officers with practical information to ensure their devices meet regulatory requirements and are safe from emerging threats.

Navigating the Changing Regulatory Landscape

The regulatory environment for medical device cybersecurity has changed significantly in recent years, making it critical for manufacturers to stay informed. In October 2023, the FDA published final guidance titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Pre-Market Notifications.” This guidance emphasizes the need for a comprehensive cybersecurity bill of materials (CBOM), thorough threat modeling, and ongoing vulnerability management throughout the device lifecycle. Notably, the guidance also emphasizes the importance of post-market cybersecurity vigilance, ensuring that manufacturers remain proactive in identifying and mitigating new threats as they emerge.

The International Medical Device Regulators Forum (IMDRF) has also played a key role in shaping global standards. In late 2023, IMDRF published a guidance document focused on managing cybersecurity risk in legacy devices. This guidance is essential for manufacturers dealing with devices that may no longer receive regular software updates but are still in use. IMDRF emphasizes the importance of end-of-life planning and risk assessment to ensure ongoing patient safety and data security.

National regulations are also tightening. Japan’s PMDA introduced mandatory penetration testing and detailed documentation requirements under IEC 62443. Similarly, China’s NMPA introduced new cybersecurity guidelines in early 2024, emphasizing local threat assessments and integrating Chinese standards with international guidelines. These changes reflect a global trend toward stricter cybersecurity requirements, underscoring the need for manufacturers to take a comprehensive, proactive approach.

Cybersecurity Essentials for Medical Device Engineers

Given the complexity of regulations, engineers must consider a number of important cybersecurity issues when designing their products.

A solid cybersecurity plan is the foundation of any secure medical device, spanning the entire product lifecycle from design to end of life. A key element of this plan is the creation of a detailed cybersecurity bill of materials (CBOM) that inventories all software and hardware components, including third-party and open source components. This inventory is essential for understanding potential vulnerabilities and ensuring that the device’s security posture is thoroughly documented and managed.

In addition to comprehensive planning, threat modeling plays a key role in the design phase. This process involves anticipating potential security threats and developing safeguards to protect the device. Engineers must consider worst-case scenarios, such as device hacks that could compromise patient safety, data security, or intellectual property. By treating cybersecurity as an integral part of the device design—like any critical hardware component—manufacturers can build security into the device from the ground up, rather than adding it as an add-on.

Risk management is another important aspect of cybersecurity. Engineers must conduct thorough risk assessments that go beyond technical vulnerabilities to address broader issues related to patient safety and data integrity. This includes assessing potential threats and their impact on both the device and the broader healthcare environment. By understanding these risks, manufacturers can implement measures that mitigate potential harm and ensure regulatory compliance.

Given the dynamic nature of cybersecurity threats, ongoing security testing and documentation is essential. Regular penetration testing is essential, especially after significant updates to a device’s software or hardware. While annual testing is usually sufficient, more frequent assessments may be necessary if significant changes have been made. In addition, cybersecurity documentation should be treated as a living document that evolves with the product. This includes maintaining up-to-date records of security assessments, vulnerability reports, and actions taken to address identified issues.

Cooperation with regulators is also key. Engaging with regulators early and often can help ensure that your device meets all necessary cybersecurity requirements. Pre-application reviews of security documentation or test plans can identify potential issues early, preventing costly delays in the approval process. Maintaining an open line of communication with regulators also helps manufacturers stay up to date on the latest requirements and expectations, which is especially important as new regulations and standards continue to emerge.

Looking ahead, the rapid pace of technological advances, particularly in areas such as AI and connected medical devices, means that cybersecurity will become even more complex. Engineers must be prepared to address specific cybersecurity issues related to AI, such as protecting AI models from manipulation and ensuring transparency into AI decisions. Additionally, devices used in remote patient monitoring and other connected medical device applications require special attention to cybersecurity, with a focus on protecting these devices from network threats and securing patient data.

Key conclusions

The intersection of healthcare and technology offers incredible potential to improve patient outcomes, but it also presents new challenges, particularly in the area of ​​cybersecurity. By taking a proactive, comprehensive approach to cybersecurity, engineers can ensure that their devices are not only safe and effective, but also compliant with the latest regulatory requirements. Staying current with the latest developments, integrating robust security measures into the design process, and maintaining an ongoing dialogue with regulators are essential steps in this process.

As this environment changes, these best practices will help ensure the safety and effectiveness of your medical devices, paving the way for the next generation of healthcare technologies.

To learn more, check out “Connected Technologies” section on www.intertek.com/medical/resources.

Content sponsored by Intertek