The foundation of cybersecurity: How we can protect medical devices in the digital era

by Sebastian Wittor

In times of rapid technological progress and digital transformation, the topic of cybersecurity is becoming increasingly important. Medical devices and medical treatment environments are also increasingly becoming the focus of hackers, as the annual situation report of the german Federal Office for Information Security (BSI) shows.

But what about the security of medical devices? Here, studies such as ManiMed and eCare show a frightening picture. It is to be feared that it is only a matter of time before direct attacks on medical devices claim their first victims.

In this article, I aim to emphasize the key reasons why the following elements—overview, skills, communication, security by design, documentation, and efforts —are vital for effective cybersecurity processes during product development:

Overview

Digital medical products are becoming increasingly complex, which also increases the chances for potential cyber-attacks. A comprehensive understanding of one’s own system, including its components, interfaces, and data flows, is essential to identify and address potential vulnerabilities before they can be exploited by potential attackers.

SBOMs also enable automated security vulnerability assessments of implemented components. Only those who know their product can secure it.

Skills

To successfully address the challenges of cybersecurity, appropriate resources are required in the project. Cybersecurity experts with an understanding of current threat possibilities, attack methods, and preventive measures are indispensable to proactively respond to potential risks in medical product development and to develop effective security strategies. Because complex countermeasures are not synonymous with secure countermeasures.

Communication

When it comes to cybersecurity, fast and direct communication within product development is of great importance. Knowledge about the medical device is scattered, especially when it is a medical treatment unit with several different components. Cybersecurity must be thought of across systems and requires appropriate clarification. The development of a secure product can only be successful if the development teams work together with cybersecurity experts and cybersecurity is implemented in the overall context of the product.

Security by design

The form of security measures is already of fundamental importance in the development phase of applications, products and services. Security by design ensures that security aspects are considered in the design from the outset in order to minimize vulnerabilities and avoid potential security gaps for cyber-attacks.

Documentation

Careful, complete and structured documentation of all identified vulnerabilities and countermeasures is essential for clean documentation. There is always a way to counter identified risks. But what was not documented was never discussed.

Efforts

Cybersecurity is not a one-time activity, but a continuous process that spans the entire product lifecycle. And with product lifecycles in the medical environment of more than 15 years, there is a lot to consider. Just think about the state of the art at the time. The first iPhone was just coming to market. Cybersecurity must be planned and managed as an effort in the project, because if you invest in cybersecurity, you invest in the future of your product.

In summary, cybersecurity is a holistic approach that requires a combination of factors to be effective. Overview, skills, communication, security by design, documentation and effort form the foundation of a medical device’s security and prepare it for an increasingly connected and digitalized world.

Let’s continue the dialogue on cybersecurity and shape a future for safe medical devices together.

About Sebastian Wittor

Cybersecurity Expert

Sebastian Wittor is cybersecurity expert at BAYOOMED and has been supporting our customers in the secure development of their medical devices as Project Manager Medical Engineering for over three years.