No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments combine a robust cyber security post-market release plan with software applications to support data safety along with prioritizing an intuitive and functional user experience. Below the experts at Veranex weigh in on today’s top concerns within software and cyber security and cover our unique approach.
Beyond the Instrument
Point-of-care, at-home and central laboratory diagnostics instruments are part of a digital ecosystem that supports clinical workflows, caretakers, and patients. Touchpoints for these instruments often pose vulnerabilities that can be exploited by criminals, therefore requiring heightened security measures. APIs, wireless access, process automation software, and the use of third-party applications open up the system to a wide range of users with no or limited IT backgrounds. Users are concerned with getting their results with speed and are naturally focused on patient care rather than cyber security. Our approach generates an end-to-end solution that combines cyber security with robust software applications to support best-in-class user experience.
Mitigating Risk
Cyber security continues to make headlines in the news with major companies reporting ransomware attacks in which criminals encrypt important files and won’t unlock them until a substantial ransom is paid. Critical services like hospitals aren’t immune to these attacks. As recently as June 2024, a Russian cybercriminal group attacked pathology services at several British hospitals, disrupting more than 3,000 hospital and general practitioner appointments as well as risking the privacy of thousands of patients.
Diagnostics companies are working to increase the resilience of their instruments against these kinds of attacks and software needs to be continually updated to prevent external attacks that reach instruments (even small, point-of-care instrumentation) via the hospital’s software management system. Additionally, an attack on the software of diagnostics instruments distributed across the world would affect the lives of millions of patients.
Our Experience
We implemented cyber security solutions during recent medical device and diagnostics instrument development projects. From that experience our team is up to date on professional standards and has the expertise to implement those security standards successfully during development as well as plan ahead for the necessary monitoring of cyber security post-market release.