The Challenge

The increasing connectivity of medical devices prompts concerns about cybersecurity threats. In 2020, the FDA issued a safety communication regarding vulnerabilities in certain insulin pumps, emphasizing the importance of addressing cybersecurity risks to protect patient safety and privacy.

Medical devices are increasingly connected to digital networks and collect sensitive patient data, raising valid concerns about cybersecurity threats and data privacy breaches. Ensuring robust cybersecurity measures and compliance with data protection regulations is essential to safeguard patient information.

The Solution

Capsifi offered the capability to map out industry-endorsed cybersecurity frameworks and align them with both the projects introducing and maintaining necessary controls and the impacted components of the operating model.

This provides an immediate and dynamic view to track progress, assess overall risk, and understand potential weaknesses in the organization’s cybersecurity response to safeguard patient safety and privacy.

Here’s some practical ways the Capsifi platform can address and resolve these industry-wide challenges:

Establish a clear line of sight from legislation and policy to controls, business rules, and operating model elements
Establish a clear line of sight from legislation and policy to controls, initiatives, or projects, and epics (including costs)
Use data object risk classification based on various risk frameworks, with calculated attributes used to deduce the risk associated with operating model elements handling that data
Use business outcomes to suggest technology innovations to address risk pain points