Balancing Connectivity and Compliance in the Next Generation of Healthcare Devices
Medical devices that connect to a network share the risk of any other networked device. Any connected device has a possibility of being a vector for a cybersecurity attack – and a device designed to be implanted in a human body for years poses considerable risks if compromised.
Secure-By-Design Isn’t a Philosophy, It’s a Product Decision
Many medical device manufacturers are small companies who have never had security engineers on staff, much less medical device security engineers. What’s more, no small company has slack in its development budget. They’re not going to bother designing a feature that’s not necessary – and security has been optional until recently.
So we’re not just raising awareness. We’re providing guidance and templates to integrate security into a design process, and ongoing feedback as we jointly navigate this new territory.
Compliance Is Moving Faster Than Most Manufacturers Expected
Regulatory expectations for medical technology, in particular, have changed dramatically. Under the FDA’s current Refuse to Accept policy, devices lacking this kind of premarket risk assessment and assurances of post-market monitoring will not even make it to the official submission process. Patching is even more critical; the agency’s published framework on managing medical device cybersecurity in the post-market requires manufacturers to monitor and address vulnerabilities on an ongoing basis – and to provide evidence that they have the appropriate mitigations in place.
Especially after recent attacks spanned the globe in hours – for MedTech cybersecurity system operators (like hospitals), “no known exposure” is the strongest possible protection for those systems that can’t be isolated in an air-gapped network. For device manufacturers, it’s the strongest proactive defense from entangling your company in widespread lawsuits over defects.
The UX Problem That Gets Overlooked
There is a sensitive aspect to security design that is not emphasized enough: authentication measures that are too strict can actually put lives at risk. For instance, a doctor treating a patient with a life-threatening condition in an emergency room cannot be delayed by a complex login procedure. Security measures that hinder the provision of care are simply not feasible in a medical context. People will resort to alternative methods, and these will most likely be less secure than the original process.
This does not mean that strong authentication is not needed. It means that the authentication process should be tailored to the medical workflow. Access based on the role of the user, automated authentication based on the proximity of the user to the device, and permissions based on the context in which the device is being used can all offer good security solutions without causing unnecessary friction that leads to password notes stuck to the monitor.
The trade-off is important. If clinicians cannot use a device, then no amount of security will help patients.
Why This Is a Competitive Issue, Not Just a Compliance Issue
The healthcare industry has the most expensive data breaches of any industry with an average cost of $10.93 million per incident (IBM Cost of a Data Breach Report 2023). For a medical device manufacturer, a patient data breach is not solely a financial cost. It is a hit to hospital purchasing decisions, clinician confidence, and regulatory reputation all at once.
And the manufacturers who get this right aren’t just avoiding penalties – they’re making something that their customers can depend on. Hospitals are asking tougher questions of vendors before a purchase is made. If this device is compromised, is a physical recall required for a software update? What is the end-of-life commitment for software support? How do we implement network segmentation with this device?
Companies that have convincing answers to those prompts have a real edge over those who still view cybersecurity as a box-ticking exercise. Having a clear, papered concept for vulnerability management and post-market surveillance is now a differentiator, in a way that it simply wasn’t five years ago.
Legacy Devices And The Gap That Won’t Close Itself
Underneath all of this lies a more difficult problem. Many hospitals are still using medical devices that were invented before today’s security framework even existed. These “legacy” devices are often unable to be patched, running on old software, and although they have now been connected, were never designed to be connected to a network in the first place. Manufacturers of the latest devices may not be able to directly solve this problem, but they can prevent it by designing products that don’t inherit it.
By building devices that gracefully isolate failures, that don’t expose the rest of the network when they are compromised, and that provide clear guidelines on what clinicians can expect when a device reaches the end of its life, companies will ensure that the next wave of healthcare technology will be defined by how well they balance openness and protection. The ones that can solve this puzzle won’t just be trusted by regulators, they’ll be trusted long-term in the healthcare space. And in healthcare, trust is the long-term competitive asset that everything else is built on.
Further Reading
