Addressing US Medical Device Cyber Integrity and Protecting Patients

Medical device interconnectivity is now the norm, providing patients with essential treatment and monitoring both inside and away from healthcare centers. But with these significant technical and medical innovations comes exposure to cybercrime.

Hacking and the loss of patient data, let alone the risk of a medical compromise, is a real and growing problem. According to GlobalData, 22.5 million patient records were breached in the first half of 2022 alone. And with each significant facility attack costing $10 million, the sector must fight back.

Making Medical Devices Cyber Secure

The need for medical device manufacturers to tighten security is clear. The US Food and Drug Administration published its Playbook for Threat Modeling Medical Devices in 2021. But while the report suggests why threat modeling in the design and production phase is critical, it does not give manufacturers a definitive path to take.

That’s where IriusRisk becomes your perfect partner, providing unequivocal automated threat modeling that identifies security risks through each phase of your design and development process. The company’s platform is used by federal organizations, financial institutions, and increasingly by medical device manufacturers. They all recognize that threat modeling is recommended by The Open Web Application Security Project (OWASP) and the National Institute of Standards and Technology (NIST), among many other notable bodies.

IriusRisk can be delivered on-premises or in the cloud, meaning cybersecurity analysis is done from the start of a project rather than at the end of a development cycle. The threat modeling platform has significant benefits for manufacturers:

Time and Cost-saving

The cost of a data breach can do untold damage to your company. There are the punitive costs for causing a breach, plus the cost of researching and fixing the leak across all devices. It’s hard also to put a number on the reputational damage, but, in the worst case, it could bring a company down.

Why wouldn’t any company want to prevent this from the very start? NIST estimates that correcting code once an application is in production can take 30 times longer than if identified in the design phase. So, not only can threat modeling save costs, it will help speed up a manufacturer’s route to market.

As more medical device manufacturers put cybersecurity at the forefront of development, significant healthcare breaches will occur. This is critical because the threat is higher than ever. Only a few months ago, the FBI smashed a ransomware hacking group that has been threatening healthcare systems, saving $130 million in ransom payments.

Collaboration

Multiple departments can view our threat modeling platform in real-time, encouraging “agile” behavior during the development process. It bonds security with Dev Ops, creating DevSecOps, the best proponent of Shift Left testing you can get.

Regulatory compliance

A robust threat modeling platform automatically creates complete reports and auditing trails, both highly prized in sectors like healthcare that are heavily regulated. Cyber resilience reports also reassure healthcare facilities looking to purchase medical equipment.

What next?

If you prefer some additional reading, download our eBook Protecting the IoMT and Your Business.

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