Although Cybersecurity Awareness Month in October has passed, the need to spotlight critical vulnerabilities in healthcare systems remains as pressing as ever. While attention often centers on securing traditional medical devices like implants and surgical equipment, diagnostic services and their associated devices remain a critical yet often overlooked component of healthcare security.

The Synnovis cyberattack in the UK illustrates the devastating potential of such oversight. The attack highlights how a single point of failure in a complex healthcare ecosystem can disrupt patient care at scale, shedding light on the urgent need for robust cybersecurity measures across all diagnostic services.

A Wake-Up Call from Synnovis’ Cyberattack

In 2024, Synnovis, a diagnostic services provider in the UK, suffered a ransomware attack that exposed patient data and disrupted blood testing services for six months. This incident crippled diagnostic workflows, delayed essential tests, and created a ripple effect across the National Health Service (NHS), highlighting the vulnerabilities in interconnected healthcare systems.

The attackers even published sensitive patient information, presumably to increase ransom payment pressure. This raised ethical and operational questions about the readiness of diagnostic services to handle cyber threats that go beyond traditional IT network breaches.

While diagnostic services are distinct from standalone medical devices, they share the critical function of enabling accurate and timely healthcare decisions. Many industry professionals acknowledge that the cybersecurity needs of diagnostic systems are different from those of traditional devices because these systems often involve interconnected networks and third-party services. Additionally, diagnostic devices can be developed with an analyzer or instrument from one medical device manufacturer that is validated to operate with assays to evaluate analytes from one or many other manufacturers, and other developers can add on feature sets to expand the original analyzer capabilities including automated sample loading systems and new software that expands feature sets to accommodate new assays.This uniqueness makes diagnostics both crucial and challenging to secure.

A Complex Healthcare Ecosystem at Risk

Synnovis is not an isolated case. Other high-profile incidents, such as ransomware attacks on major healthcare organizations, illustrate the broader implications of these threats. For example, the recent breach of a major U.S.-based diagnostic imaging provider highlighted how vulnerabilities in imaging systems could compromise sensitive patient data and disrupt hospital workflows.

These examples demonstrate how disruptions to diagnostic services don’t just delay results; they threaten patient safety, erode public trust, and create cascading failures across healthcare operations. Whether it’s diagnostic lab equipment, imaging systems, or blood screening devices, these technologies form the backbone of precision medicine and care delivery. When compromised, they become vectors for operational chaos and patient harm, all while presenting cybercriminals with opportunities to access sensitive health data.

Stronger Cybersecurity for Diagnostic Systems

The industry’s growing reliance on diagnostic devices calls for enhanced cybersecurity standards comparable to those enforced for other medical devices. While regulatory frameworks like the FDA’s premarket cybersecurity guidance and the EU’s In Vitro Diagnostic Regulation (IVDR) exist, their implementation can vary widely. Additionally, many incidents attributed to diagnostic services result from traditional IT network vulnerabilities, blurring the lines between device and network security.

Here’s what diagnostic systems must demonstrate in a robust and proactive cybersecurity strategy:

• Data Integrity: Diagnostic devices process critical patient information. Inaccurate test results caused by compromised systems can lead to improper diagnoses or treatments. In some cases, these test results are considered “STAT,” or needed immediately (for example, complete blood count (CBC), blood glucose, electrolyte panels, Troponin and arterial blood gas (ABG).)
• Operational Continuity: As seen in the Synnovis and OneBlood cases, disrupted diagnostic services paralyze healthcare workflows, delaying critical treatments.
• Patient Safety: Delayed or erroneous diagnostics can have life-threatening consequences, from misdiagnosed conditions or incorrect treatment decisions, to incorrect transfusion matches.

What Needs to Change?

The attack on Synnovis shows us that diagnostic devices need to be treated with the same cybersecurity vigilance as other medical devices. To safeguard diagnostic services, healthcare organizations, device manufacturers, and policymakers must take action:

• Unified Cybersecurity Standards: Ensure diagnostic devices comply with cybersecurity regulations like FDA’s premarket guidance or IVDR, aligning them with traditional medical devices.
• SBOMs and Vulnerability Management: Maintain accurate Software Bills of Materials (SBOMs) to monitor and address vulnerabilities in diagnostic systems proactively.
• Incident Response Protocols: Develop robust response plans tailored to diagnostic workflows, ensuring rapid recovery and continuity of care.
• Interoperability Testing: Evaluate how diagnostic devices interact with other systems to identify and mitigate potential cascading failures.

Conclusion

The Synnovis cyberattack underscores the critical importance of securing diagnostic services and the devices they utilize against cyber threats. As interconnected healthcare systems grow more complex, protecting these foundational services and devices becomes a matter of patient safety and operational reliability.

At Medcrypt, we advocate for a cybersecurity-first approach across all healthcare technologies. When it comes to patient care, no system is too integral — or too peripheral — to protect.

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