Making Medical Devices More Secure

While the relentless advance of technology in medical devices is improving and saving lives globally, it has created a new problem that is robbing patients of their personal data, exposing them to risk and costing healthcare providers millions.

Cybercrime is a hidden peril, but an ever-present one, thanks to the online nature of modern medical devices and how they interact with healthcare facility networks, and patients’ own mobile apps.

Hacking and the loss of patient data, let alone the risk of a medical compromise, is a real and growing problem. Across Europe alone in the last few years, there have been significant ransomware attacks on:

Two French Hospitals (2022)¹
The UK’s National Health Service (2022)²
The Irish Health Service Executive (2021)³
A Finnish mental health facility (2020)⁴

These attacks are just the tip of the iceberg but are presented here to show the scale and breadth of the problem across the continent.

The problem is just as acute in the United States, where 22.5 million patient records were breached in the first half of 2022 alone, according to GlobalData⁵. With experts suggesting each healthcare facility security breach costs $10 million, the sector is under huge pressure to plug the leaks.

Tightening Medical Security

The EU and USA have taken a tougher stances on Medical Device Regulation. With so many devices now connected online, each poses a potential network entry point for hackers. As a result, new rules from 2021 state devices must use a more robust cyber-secure approach.

Unfortunately, just like the US Food and Drug Administration’s (FDA) Playbook For Threat Modeling Medical Devices report published in 2021, there is little previous advice about exactly what path medical device manufacturers should take.

This is precisely where IriusRisk becomes your best partner, issuing automated threat modeling that identifies cyber security risks through every phase of the design and development process.

The platform is used across various sectors, including public authorities and financial institutions, and now increasingly by medical device manufacturers.

IriusRisk analysis happens from the start of a new project, during the development phase (even before code is written), identifying and eliminating harmful security holes before any product is ever made. Available on-premise or in the cloud, the platform works in real-time and allows for collaboration between teams.

The benefit for any medical device manufacturer includes:

Money saving

Becoming a cause of a data breach costs untold damages. There are potential punitive costs for causing a breach, then there are the in-house costs of finding and fixing the source of the breach. Reputational damage is also significant, perhaps fatally so.

But all of this can be prevented from the start with IriusRisk. Some experts also estimate it takes 30 times longer to rectify an issue than if it had been identified in the design phase. Speed to market is, therefore, another consideration.

Collaboration

Many departments can review the IriusRisk threat modeling platform in real-time, at the same time. This supports “agile” behavior during any project, bonding security with Dev Ops, creating DevSecOps.

Regulatory compliance

Being able to produce robust reports and auditing trails throughout the development process is invaluable in heavily regulated markets like healthcare. Cyber resilience reports from IriusRisk data will reassure the EU and European national health bodies, while also giving confidence to healthcare facilities when they purchase medical equipment.

It’s Time to Trust IriusRisk

There’s no better time to learn more about IriusRisk and how our platform can transform your organization's medical device development processes, highlighting risks and informing mitigation before any market deployment.

Simply click on the button below to get started with a platform demonstration. Schedule a demo

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

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FAQs

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