How Should Healthcare Organizations Secure Legacy Systems and Connected Medical Devices?
Short answer: Healthcare organizations should manage legacy system and medical device risk through network segmentation; continuous monitoring; and a prioritized inventory of which devices carry the most risk, since many of these systems cannot be patched or replaced the way a standard IT asset can. The FDA now requires manufacturers to treat cybersecurity as an ongoing obligation across a device's lifecycle, not just at the time of approval, but that requirement does not retroactively secure the legacy devices already deployed in hospitals and clinics today.
Legacy systems and connected medical devices occupy a uniquely difficult position in healthcare security. They cannot always be patched, replaced, or secured the way a laptop or server can, and they often remain in clinical use for years or decades after the software running them stops receiving support. This guide covers why this gap persists, what has changed on the regulatory side, and what healthcare organizations can actually do about the devices already in service.
Why Are Legacy Systems and Connected Medical Devices Such a Persistent Security Gap in Healthcare?
Legacy systems and connected medical devices persist as a security gap because they are often expensive, clinically essential, and difficult to replace on a normal IT refresh cycle. This means an organization may knowingly operate a device years past the point its software stops receiving security updates. Unlike a workstation that can be replaced every few years without disrupting operations, a piece of imaging or monitoring equipment may represent a significant capital investment that a healthcare organization simply cannot justify replacing purely for security reasons while it remains clinically functional.
This dynamic creates a structural mismatch between IT security best practice, which generally assumes systems can be patched or retired on a predictable schedule, and the reality of a clinical environment where equipment lifecycles are driven by capital budgets and clinical need rather than security considerations alone.
What Makes Patching or Replacing a Medical Device Different From Patching a Standard IT System?
Patching a medical device is different because many devices require manufacturer validation before any software change can be applied. This is because an unauthorized update could affect the device's clinical performance or void its regulatory clearance, which means a healthcare organization often cannot simply apply a patch the way it would on a standard workstation. This validation requirement can add significant delay between when a vulnerability becomes known and when a fix can actually be safely applied.
Some devices cannot be patched at all, either because the manufacturer no longer supports them or because the underlying hardware cannot run an updated operating system. For these devices, patching is not a delayed option; it is not an option at all, which shifts the entire security strategy toward isolation and monitoring rather than remediation.
What Does the FDA Now Require from Device Manufacturers, and What Does That Mean for Healthcare Providers?
The FDA finalized guidance in June 2025 making cybersecurity a mandatory lifecycle obligation for manufacturers rather than a one-time premarket consideration, building on Section 524B of the FD&C Act as amended by the Consolidated Appropriations Act of 2023. (Federal Register, June 27, 2025) FDA has since issued a further updated version of this guidance, "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions," (FDA guidance document page) which supersedes the June 2025 version and aligns it with FDA's Quality Management System Regulation, though the core lifecycle obligation established in 2025 remains intact.
For healthcare providers, this regulatory shift matters most for future purchasing decisions. It does not retroactively secure devices already deployed. An organization operating a fleet of devices approved before this guidance took effect is still responsible for managing the security of those devices under the older, less prescriptive standard they were originally built to meet.
What Compensating Controls Actually Work for Devices That Cannot Be Patched or Replaced?
Network segmentation is the most consistently effective compensating control for devices that cannot be patched. This effectively isolates them onto a separate network segment where their traffic can be monitored and restricted, limiting what an attacker could reach even if the device itself were compromised. This does not eliminate the underlying vulnerability, but it significantly reduces what that vulnerability can actually be used to do.
Enhanced monitoring specifically tuned to detect unusual behavior from these devices provides a second layer of defense, since an unpatchable device that suddenly begins communicating with unexpected destinations or generating unusual traffic patterns is a strong signal worth investigating immediately, even without the ability to patch the underlying flaw.
How Should Healthcare Organizations Inventory and Prioritize Their Legacy and Device Risk?
Healthcare organizations should build and maintain a specific inventory of every legacy system and connected device, noting which ones cannot be patched; which carry known critical vulnerabilities; and which have access to the most sensitive systems or data, so that limited security resources can be directed toward the highest-risk devices first. A general awareness that "we have some older equipment" does not support this kind of prioritization. A specific inventory does.
This inventory should be treated as a living document, updated as new vulnerabilities are disclosed and as devices are added, retired, or reach end-of-life status, rather than a one-time project completed and then left unreviewed for years.
What Should an Incident Response Plan Account for When a Compromised System Is a Medical Device, not a Workstation?
An incident response plan needs a specific process for a compromised medical device, since isolating or taking the device offline may have direct clinical consequences that isolating a workstation does not, which means the decision to contain a compromised device often requires clinical staff input, not just an IT security decision made independently. A response plan written only with standard IT systems in mind can create dangerous ambiguity about who has authority to make this call and how quickly it needs to happen.
This is exactly the kind of gap that a tabletop exercise, if it specifically includes a medical device compromise scenario, will surface before a real incident forces the organization to work through it under pressure and without clear precedent.
Legacy System and Device Risk Categories and Compensating Controls
| Risk Category | Compensating Control | Key Consideration |
|---|---|---|
| Unpatchable operating systems | Network segmentation and isolation from general traffic | Segmentation limits blast radius; it does not close the underlying vulnerability |
| End-of-life devices with no vendor support | Enhanced monitoring for unusual behavior | Requires a documented baseline of normal device behavior to detect anomalies |
| Devices requiring manufacturer validation before updates | Prioritized patching schedule aligned with vendor validation timelines | Delay between disclosure and safe patching can be significant |
| High-risk, high-access legacy systems | Specific inventory tracking and priority remediation or replacement | General awareness of "old equipment" does not support real prioritization |
| Incident response involving a compromised device | Predefined process requiring clinical input on containment decisions | Isolating a device can carry direct clinical consequences unlike a workstation |
What Do Healthcare Organizations Get Wrong About Legacy System and Device Security?
The most common mistake is treating legacy device risk as a single, undifferentiated category rather than building a specific inventory that identifies which devices carry the greatest risk. Without this specificity, security resources tend to spread thin across the entire legacy fleet rather than concentrating on the devices that matter most.
A second common mistake is assuming that network segmentation alone fully resolves the risk from an unpatchable device. Segmentation meaningfully reduces exposure, but it does not eliminate it, and organizations that treat segmentation as a complete solution rather than a partial mitigation can develop a false sense of security about devices that remain genuinely vulnerable.
A third mistake is writing an incident response plan that does not specifically address what happens when the compromised system is a medical device rather than a standard workstation. This gap often goes unnoticed until an actual incident forces a rushed decision about containment without a clear, predefined process for clinical input.
What the Data Shows About Medical Device and Legacy System Risk
The FBI's Internet Crime Complaint Center reported in a 2022 cybersecurity advisory that 53 percent of connected medical devices and other IoT devices in hospitals had known critical vulnerabilities, that approximately one-third of healthcare IoT devices had an identified critical risk potentially affecting device operation, and that more than 40 percent of medical devices at end-of-life status offered little to no available security patches (FBI IC3, 2022). This remains the most current, directly verifiable government advisory specific to this figure, though it is now several years old, and no more recent FBI advisory with an updated percentage appears to have been published.
On the regulatory side, the FDA finalized cybersecurity guidance for medical device manufacturers in June 2025, making cybersecurity a required, ongoing lifecycle obligation rather than a premarket-only consideration, under authority established by Section 524B of the FD&C Act. FDA has since replaced that guidance with a further updated version aligning it with its Quality Management System Regulation, though the underlying lifecycle obligation remains in place. This regulatory shift addresses future devices going forward. It does not change the security posture of the legacy devices already deployed across most healthcare organizations today.
Frequently Asked Questions
Does the FDA's guidance require hospitals to replace their existing legacy medical devices?
No. The guidance applies to manufacturers and new premarket submissions going forward. It does not create a retroactive requirement for healthcare organizations to replace devices already in clinical use.
Is network segmentation enough to fully secure an unpatchable medical device?
No. Segmentation significantly reduces what an attacker could reach if a device were compromised, but it does not eliminate the underlying vulnerability. It should be treated as a meaningful mitigation, not a complete solution.
Who should be involved in deciding whether to isolate a compromised medical device during an incident?
Both IT security and clinical leadership. Isolating or disconnecting a device can carry direct clinical consequences, which means the decision should not rest with IT security alone.
How often should a legacy device and system inventory be updated?
Continuously, as new vulnerabilities are disclosed and as devices are added, retired, or reach end-of-life status, rather than treated as a static, one-time project.
Are all legacy medical devices equally risky?
No. Risk varies significantly based on what data or systems a device can access and whether it carries a known critical vulnerability, which is why a specific, prioritized inventory matters more than a general awareness that older equipment exists.
Related Reading
- What Does Ransomware Readiness Actually Look Like for a Healthcare Organization?
- How Should Healthcare Organizations Manage Third-Party Vendor Cybersecurity Risk?
- What Does the Proposed HIPAA Security Rule Update Change, and What Should Healthcare Organizations Do Now?
- Cybersecurity for Healthcare Organizations
- Request a Free Security Assessment
What to Do Next
If your organization cannot currently produce a specific inventory of which legacy systems and devices carry known critical vulnerabilities, that gap is worth closing before an incident forces the question under pressure.
Request a legacy system and medical device security assessment from Badger Fortress. We help healthcare organizations build a prioritized inventory, implement effective segmentation and monitoring, and prepare an incident response process that accounts for the clinical realities a standard IT plan often misses.