Connected medical devices depend on more than the security of the device itself. They operate within clinical networks, software ecosystems, remote access arrangements, data exchange workflows, and postmarket support processes. That broader environment is where many cybersecurity threats begin: not as a failure of the device’s clinical function, but as a weakness in the systems and connections that allow the device to collect, transmit, update, or use patient data.
For manufacturers, that makes medical device cybersecurity a life-cycle discipline. Devices need to be designed, configured, updated, monitored, and evaluated with real clinical environments in mind. A standards-based assessment process can help organize that work, which is why IEEE’s Medical Device Cybersecurity Certification Program focuses on evaluating connected devices against defined cybersecurity requirements and documenting evidence of secure design and testing.
Those requirements matter because many common threats exploit the same dependency: a connected device is only as resilient as the systems, software, access points, and data pathways around it.
Ransomware and Disrupted Device Environments
Ransomware shows why medical device cybersecurity cannot be separated from the clinical environment around the device. An incident may begin in an identity system, network segment, electronic health record, imaging platform, scheduling system, or third-party service. Even when the device is not the attacker’s first target, the disruption can affect the systems a device relies on to exchange data, receive updates, or support clinical workflows.
In that setting, the risk is not limited to stolen information. Cyber threats targeting medical devices can delay critical patient care, reveal sensitive patient data, shut down health care operations, and require costly recovery efforts. For connected devices, cybersecurity is therefore also a question of availability and operational continuity.
Legacy Devices and Long Technology Life Cycles
Legacy devices raise a related but different problem: Medical devices often operate for many years, and that long service life can create cybersecurity challenges when operating systems, libraries, embedded components, or communication protocols are no longer maintained in the same way current enterprise systems are.
The issue is not simply that a device is older. It is that security expectations, attacker techniques, and vulnerability disclosure practices continue to evolve while deployed devices may remain relatively fixed.
Legacy devices, by definition, cannot always be reasonably protected against current cybersecurity threats in the same way as newer systems. That does not mean legacy devices cannot be used safely, but it does mean manufacturers and health care delivery organizations may need compensating controls such as segmentation, inventory management, access restrictions, monitoring, and coordinated risk planning.
Remote Access, Credentials, and Configuration Weaknesses
Legacy risk is often difficult because older systems can be hard to change. Remote access risk is different: it often comes from how a device or support pathway is configured. Connected medical devices may require remote access for maintenance, monitoring, troubleshooting, updates, or data exchange. Those capabilities can support service continuity and patient care, but they also create risk when authentication, authorization, and monitoring are weak. A remote access pathway built for support can also become an entry point. Shared credentials, default passwords, broad vendor access, and poor activity logging all increase that risk.
This category of risk is especially important because device compromise does not always begin with an advanced exploit. It may begin with an exposed service, a misconfigured interface, a weak password, or excessive permissions. From there, an attacker may seek access to device data, connected systems, or the broader clinical network.
Manufacturers can help reduce this risk by designing devices with secure default configurations, strong authentication options, limited service exposure, and clear logging capabilities. Health care organizations also have a role in how devices are deployed and managed. Network segmentation, credential governance, access review, and asset inventory are practical controls that help reduce the chance that one weak point becomes a broader operational issue.
Data Exposure Across Interoperable Systems
Connected devices rarely hold data in only one place. Patient data may move from a device to a gateway, a mobile application, a cloud service, a hospital interface, or an electronic health record. That movement is central to interoperability, but it also increases the number of places where data confidentiality and integrity must be protected.
Medical device interoperability refers to the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. That framing matters because it ties interoperability to safety and security, not just to connectivity. A device that exchanges data successfully still requires attention to encryption, authentication, authorization, auditability, and data handling across connected systems.
For manufacturers, the data question should be specific: what data does the device collect, where does it travel, how is it protected in transit and at rest, who can access it, and what happens if it is altered or unavailable? These questions are especially relevant for devices that support remote patient monitoring, imaging workflows, medication delivery, or other use cases where device data may inform clinical decisions.
Software Supply Chain and Component Visibility
The same complexity that affects data movement also affects the software inside and around the device. Connected medical devices rely on software components, firmware, libraries, operating systems, development tools, and third-party services. A vulnerability in one component may affect multiple products, and a newly disclosed vulnerability may require manufacturers to determine quickly whether a device, model, or software version is exposed.
A Software Bill of Materials, or SBOM, can help manufacturers, health care organizations, and other stakeholders identify the software components used in a device and assess whether a disclosed vulnerability may affect deployed products. This visibility is especially important when devices remain in service for long periods or when software components are reused across product lines.
Supply chain risk is not limited to software inventory. It can also involve development practices, update mechanisms, third-party remote access, vendor support processes, and the security of cloud or mobile components connected to the device. A device may meet its clinical function while still depending on external systems that require separate security review.
Building Security Into Connected Device Design
Taken together, these threats point to the same conclusion: medical device cybersecurity is not one control or one checklist. It requires attention across design, deployment, monitoring, and postmarket support.
The Medical Device Cybersecurity Certification Program helps manufacturers approach these issues through a defined conformity assessment process. The program includes pre-assessment by an IEEE-recognized laboratory, testing using IEEE 2621 test plans and checklists, standardized reporting, and inclusion of certified products in the IEEE Medical Device Registry.
For health care organizations and patients, the goal is not to eliminate every possible cyber risk. No connected system can do that. The goal is to make connected medical devices more resilient, more transparent to evaluate, and better aligned with recognized cybersecurity expectations.
