The digital transformation of healthcare is accelerating: connected medical devices, artificial intelligence, remote monitoring, health data sharing… Innovations are multiplying and opening up considerable opportunities for both healthcare professionals and patients.

But this acceleration comes with growing responsibility. How can we ensure that these devices remain reliable, safe, and trustworthy throughout their lifecycle?

This is precisely the topic we had the pleasure of addressing during a webinar organized with AFNOR Certification, dedicated to the cybersecurity of medical devices (MDs), on June 2. (link to the recording).

Cybersecurity Is Not Just a Technical Issue

For a long time, cybersecurity was viewed as an IT issue. But given the potential impacts of cyberattacks, it can no longer be treated as a mere IT matter, left solely to IT professionals. Today, it has become a major challenge for the entire healthcare ecosystem.

A vulnerability can:

• compromise the availability of a medical device,
• expose sensitive health data,
• serve as a point of entry into a hospital information system,
• in some cases, have a direct impact on patient care.

In this context, the regulatory framework is evolving rapidly. The MDR, AI Act, NIS2, Cyber Resilience Act… all of these regulations share a common goal: to strengthen the security of digital healthcare solutions and support the maturation of all stakeholders.

Security is not a final check. It is a requirement that is built in from the design phase.

This is undoubtedly the most important message we wanted to share.

Many manufacturers still view cybersecurity audits as a final step, carried out just before a product is brought to market. In reality, this approach is no longer sufficient: cybersecurity must be integrated from the earliest stages of design.

Thinking in terms of *Security by Design* is not simply a list of “cybersecurity best practices.” It is an approach to managing cybersecurity risks that is integrated into the medical device’s lifecycle.

This approach leads, in particular, to:

• conducting a risk analysis from the very beginning of product design,
• reducing the attack surface by limiting the functions, interfaces, and access points that could be exploited,
• implementing defense in depth,
• planning for updates and vulnerability patches,
• planning for ongoing security maintenance.

Cybersecurity comes at a cost. It is still too often viewed as an additional expense on top of the costs of developing a medical device. However, the earlier cybersecurity considerations are addressed in the development cycle, the easier they are to integrate and the more effectively the associated costs can be managed. Discovering a vulnerability late in the process may require revising architectural choices or delaying a product’s launch. And that’s where the costs really add up!

Standards such as IEC 81001-5-1, IEC 62443, and IEC 62304 provide a recognized methodology for integrating cybersecurity throughout the software development process. They not only help meet regulatory requirements but, more importantly, enable the development of products that are more robust and easier to maintain over time.

Compliance remains essential, but it alone is not enough to guarantee that a device will withstand tomorrow’s threats.

Testing to Improve

When people hear the term “cybersecurity audit,” many immediately think of penetration testing, or “pentests.” In reality, an audit can cover a much broader scope depending on the needs and lifecycle of the medical device.

• Architecture audit: verifying how the device’s various components communicate with one another and identifying potential weaknesses in its design.
• Configuration audit: Verify that equipment, systems, or software are properly configured and that security settings are appropriate.
• Code audit: Examine the source code for security vulnerabilities that could be exploited.
• Organizational audit: Assess the manufacturer’s ability to address, manage, and maintain cybersecurity throughout the device’s lifecycle.
• Penetration test (pentest): Put oneself in the position of an attacker to attempt to actually exploit vulnerabilities in the device and verify the effectiveness of the protections in place.

The goal is not merely to detect vulnerabilities. Above all, it is to provide an objective view of the level of cybersecurity maturity and to support teams in a process of continuous improvement.

“What do I want to verify, at what point in the lifecycle, and to what level of depth?”

Cybersecurity is not a state that is achieved once and for all. It is a process that evolves at the same pace as the threats.

Building Digital Trust Beyond Cybersecurity

At Kereval, we have been supporting healthcare stakeholders for over twenty years in software quality, interoperability, and compliance for digital systems. Cybersecurity is now a natural extension of this work.

A trustworthy medical device is never based on a single area of expertise. It must be interoperable, secure, and robust throughout its entire lifecycle—all within a framework of regulatory compliance.

These aspects should not be considered in isolation. They all contribute to a single goal: ensuring that a medical device can be used reliably in its intended context.

This is the vision we uphold at Kereval. Because ultimately, the question is no longer simply whether a medical device works. The real question is: can it be trusted?

Would you like to assess the cybersecurity maturity of your medical device?

Contact our experts for a “Security by Design” assessment.