Protecting Patient Safety: Medical Device Cybersecurity for Engineers and Manufacturers

John Price
Chief Executive Officer
January 6, 2023
4 minutes

In today's healthcare system, the use of medical devices is practically unavoidable, and it is anticipated that this trend will continue in the years to come. These devices, which range from heart monitors to pacemakers, are extremely important in the process of diagnosing and treating patients. On the other hand, similar to other forms of technology, medical devices are susceptible to cybersecurity risks. These dangers can range from harmless data breaches to attacks on the device itself that could put the user's life in danger. Engineers and manufacturers have a responsibility to ensure that patient safety is prioritized during the design and production of medical devices by keeping cybersecurity concerns front and center.

The fact that medical devices are frequently connected to other systems, such as hospital networks or the internet, is one of the primary causes for concern regarding these devices. Because of this connectivity, it is much simpler for cybercriminals to gain access to the device and potentially undermine its functioning. In addition, a lot of medical devices have software that can be updated remotely, and this can be another point of vulnerability for the device. It is the responsibility of engineers and manufacturers to take the necessary precautions to ensure that products are not connected to unneeded systems and that any connections that are made are safe.

Information security & secure lifecycle management

A further cause for concern is that medical technology typically has a lengthy shelf life, which can sometimes extend over several decades. Because of this, it is possible that they do not have the same level of protection against cyber threats as newer devices. Engineers and manufacturers have a responsibility to take this into consideration and make sure that product lifecycle is managed, and their products can be updated to provide protection against newly discovered dangers.

Medical devices physical security posture

Engineers and manufacturers of medical devices have an additional responsibility to consider the devices' physical security in order to ensure the safety of patients. This includes guarding the device against being tampered with or being accessed in an unauthorized manner. Protecting against unauthorized access can be accomplished, for instance, by making the housing of the device tamper-proof or by implementing secure boot processes during the engineering and manufacturing of the device.

Engineers and manufacturers are responsible not only for the design and production of secure devices, but also for ensuring that those devices are maintained and used in the correct manner. This includes instructing medical professionals in the proper and safe use of the device through the provision of training and educational materials. In addition to this, instructions will be provided on how to keep the device up to date and maintained, as well as the security aspects of the device, and how to react to any potential cybersecurity threats.

Compliance implications

Moreover, engineers and manufacturers are also responsible for ensuring the ongoing safety of patients through compliance with applicable regulations and standards. This includes adhering to any applicable cybersecurity standards, as well as ensuring that all devices are regularly tested to ensure they are protected against current and emerging threats. By taking these steps, engineers and manufacturers can help to ensure that medical devices are as secure as possible, and that patients are protected from any potential harm.

The Food and Drug Administration (FDA)  provides guidelines for the cybersecurity of medical devices. They have released a draft guidance for premarket cybersecurity in medical devices, and it is important for manufacturers to be aware of it. The FDA has also developed the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. This document serves as a guide for determining how to react when a cybersecurity incident occurs. Compliance with these guidelines is essential, as non-compliance can result in costly fines and potential legal action.

Medical devices play an essential part in today's healthcare system, but they also present their own set of challenges when it comes to cybersecurity. Engineers and manufacturers have a responsibility to take measures to protect the safety of patients by designing and producing secure devices, as well as providing instructions on how to use and maintain them in a secure manner. In addition, manufacturers should be aware that the FDA has issued guidance for ensuring the cybersecurity of medical devices. It is possible for us to ensure that medical devices will continue to be a useful tool for medical professionals by taking preventative measures regarding cybersecurity. This will also ensure that patients will not be put in danger.

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