The Internet of Things (IoT) brings with it endless opportunities – and, quite a few security challenges. The U.S. Food & Drug Administration’s (FDA) recent guidance on handling medical device vulnerabilities follows closely on the heels of its more general medical device cybersecurity guidance.
IoT-connected devices are a growing security concern, and the FDA has focused on general IoT device security and, specifically, medical IoT device security. This once again brings too close to home the overriding message to vendors and consumers alike that no Internet-connected device is 100% secure. If it is connected to the Internet, it can be hacked. Of course, the risk and impact multiplies manifold when the IoT product is a medical device.
Medical devices, and the systems they connect to, can seriously impact patient health. Thankfully, software patches are now addressing vulnerabilities presenting the biggest risk, and are combatting a number of threats, says Mathieu Baissac, vice president of Product Management at Flexera Software.
The unthinkable is now very thinkable…
The fact that traditional hackers are now moving beyond mere desktop computers to medical devices, demonstrates how cybersecurity is hitting home in a very personal way – even going as far as critically impacting our loved ones.
Medical device manufacturers need to manage any risks related to software vulnerabilities within their own code, as well as monitor and react on vulnerabilities of any third-party or open source software components they might be using in their devices. They should also have a strategy in place to get updates out to the right customers.
A vulnerability is an error in software, which can be exploited with security impact and gain. If hackers launch an attack against Internet-connected products, it can cause enormous damage to the medical manufacturer and patients – either because the products are controlled by the hackers, or because the user data is extracted and abused by those hackers.
Consequently, medical manufacturers need to increase focus on the security of the device itself, as well as the software that controls the device. This includes careful code testing, continuous maintenance, careful mapping of bundled software and verified intelligence about software vulnerabilities in that software – as well as ample resources to react promptly and effectively as soon as a vulnerability in the product is reported.
Reducing risks in five simple steps
One of the primary concerns associated with Internet-connected devices is the risks from hackers exploiting vulnerabilities, and using applications on medical devices as a vector for viruses and malware.
Today, more than ever, it is up to medical device manufacturers to be vigilant, and mitigate the exposure associated with connected devices, and they can do so in five simple steps:
- For medical applications that sit at the operating-system level, adopt tamper-resistance technology to protect software applications from hackers.
- Protect embedded software on the medical device from reverse engineering, and make changes at the machine level to strengthen protections.
- Ensure that the applications on medical devices and mobile-device management systems have an easy, automated mechanism for getting the latest security patches and updates out as fast as possible.
- Proactively monitor medical devices for application issues.
- Provide a reliable and secure ecosystem with clear traceability through the supply chain – from initial software delivery to subsequent firmware/software updates on the device – as well as the ability to pro-actively disable devices at mandated end-of-life, or during product recalls.
Recently, much attention has been paid to potential security threats facing smart, Internet-connected appliances – thermostats, TVs, wireless speaker systems, refrigerators, cars, etc. As the news progresses from the advantages of the IoT to the associated risks of exposure, it is more important than ever to discuss how device manufacturers can embrace these products while keeping risks at bay, especially when it comes to medical devices.
Doing so will stop making the unthinkable so thinkable.
The author of this blog is Mathieu Baissac, vice president of Product Management at Flexera Software
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