Lifecycle Management for Medical Device Security
Post Summary
Medical devices are increasingly connected, which improves healthcare but also exposes them to cyber threats. U.S. hospitals average 10–15 connected devices per patient bed, and between 2021–2025, healthcare cybersecurity attacks rose 44%, exposing over 50 million patient records. These attacks often disrupt care, and 30% of device breaches pose patient safety risks.
Effective lifecycle management secures devices from design to decommissioning, addressing risks like outdated systems (used by 73% of providers) and unpatched vulnerabilities. Key strategies include:
- Secure-by-design development: Threat modeling, encryption, and access controls.
- Regulatory compliance: FDA requirements like SBOMs (Software Bill of Materials) and premarket cybersecurity plans.
- Ongoing security: Continuous monitoring, timely patching, and incident response.
- Decommissioning: Secure data wiping and planning for end-of-support devices.
Tools like Censinet RiskOps™ automate risk tracking and help manage vulnerabilities across the device lifecycle. Protecting medical devices is critical to patient safety and healthcare operations.
Medical Device Cybersecurity Statistics and Lifecycle Security Phases
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Security During Design and Development
Incorporating security into the design and development of medical devices isn’t just a good idea - it’s expected. With 83% of organizations reporting multiple breaches and the average U.S. breach costing a staggering $9.44 million [5], manufacturers must prioritize security from the very beginning. It’s not just about compliance; it’s about protecting lives and avoiding financial fallout.
Threat Modeling and Risk Assessments
Threat modeling is the backbone of secure medical device development. It’s a proactive way to identify critical medical device security risks before they turn into full-blown security issues. As MedCrypt points out:
"Threat modeling is a cornerstone of 'secure by design' development. As connected medical devices become more complex and integrated, manufacturers must move beyond reactive cybersecurity measures and systematically identify risks before they become vulnerabilities" [6].
This process ties directly into secure-by-design principles, helping to address risks early in development.
One widely used framework is STRIDE, which categorizes threats into six areas: Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege [6]. To make this actionable, manufacturers use Data Flow Diagrams (DFDs) to map how information moves through their devices, pinpointing weak spots where attackers could strike [6]. This ensures that cybersecurity measures are aligned with clinical safety goals [6].
Regulators like the FDA, Health Canada, and Australia’s TGA now require threat modeling in premarket submissions [6]. They expect manufacturers to answer four key questions: What are we building? What could go wrong? How will we address these risks? And, did we do a thorough enough job? [8]. Risk prioritization often depends on qualitative assessments of exploitability and impact, with tools like CVSS scores helping to rank threats [6].
By addressing these risks early, manufacturers can build stronger, more secure devices from the outset.
Secure-by-Design Principles
Once threats are identified, secure-by-design practices help embed protections into the device from the start. Key safeguards include:
- Data encryption to protect patient information during storage and transmission.
- Strict access controls to ensure only authorized users can interact with the device.
- Secure boot processes to verify software integrity and block unauthorized code from running [5].
The FDA also emphasizes the importance of a Zero Trust Architecture, which requires verification at every access point [2]. This is especially important given that identity-based attacks account for 30% of recorded data breaches, often exploiting valid credentials [3]. To balance security with clinical functionality, manufacturers should involve cross-functional teams that include cybersecurity experts alongside medical device developers [5][6].
Another critical aspect is ensuring devices can receive updates and patches throughout their 10–20 year lifespan [4]. Given that the average time to detect a breach is about 200 days [7], having mechanisms in place for rapid response is essential to maintaining long-term security.
Creating a Software Bill of Materials (SBOM)
An SBOM acts like an ingredient list for medical device software, detailing all components, including third-party libraries and open-source tools. Under the PATCH Act and Section 524B of the FD&C Act, the FDA now requires SBOMs for "cyber devices" in premarket submissions [9][10]. Since October 1, 2023, submissions lacking an SBOM risk being rejected outright [9].
To meet these requirements, SBOMs must include NTIA minimum elements, such as supplier name, component name, version, unique identifiers (like Package URL or CPE), dependency relationships, author, and timestamps [10]. These documents must be continuously updated throughout the device’s lifecycle to reflect changes in software and component support [10]. Viktor Petersson, CEO of sbomify, highlights the importance of this:
"The FDA may refuse to accept premarket submissions that do not provide adequate SBOM and related cybersecurity information" [10].
SBOMs allow manufacturers to quickly identify vulnerabilities by cross-referencing components with national vulnerability databases [9]. With projections showing at least 299 hospitals could face ransomware attacks in 2025 [9], this transparency is vital for patient safety. To streamline this process, manufacturers should automate SBOM generation within CI/CD pipelines and use standardized formats like SPDX or CycloneDX for automated vulnerability scanning [9][10].
Taking these steps during the design phase ensures a solid foundation for the secure manufacturing and operational practices to follow in the next stages.
Security During Manufacturing and Deployment
When a medical device transitions from the design stage to production, the focus shifts from planning security measures to putting them into action. This is the stage where devices are assigned their cryptographic identities, access controls are solidified, and deployment settings are standardized. With identity-based attacks on the rise, ensuring robust security during manufacturing and deployment is not just a priority - it’s a necessity.
Secure Provisioning and Authentication
Every medical device must leave the factory with a secure, verifiable identity. The best practice is to provision each device with a unique X.509 certificate and private key during production. This cryptographic identity makes forgery extremely difficult. To safeguard these credentials, manufacturers use HSMs (Hardware Security Modules), Secure Elements, or TPMs (Trusted Platform Modules), which isolate keys from the device’s firmware, keeping them secure even if the software is compromised.
Manufacturers typically choose between two provisioning methods. One option involves creating a unique firmware image for each device, offering tight control but increasing both complexity and cost. The other option uses a "golden image", where a standard firmware is applied, and unique credentials are added later through secure interfaces like SSH or serial connections. While the golden image approach is more efficient for large-scale production, it requires a secure process to inject credentials during the device’s first boot or through in-system programming.
The provisioning environment must be tightly controlled. Credential injection should occur only in secure facilities managed by trusted personnel. Using HSMs, manufacturers can pre-provision credentials at the component level, ensuring that private keys are never exposed during production. For situations where in-factory provisioning isn’t feasible, automated onboarding services can assign identities once the device is deployed. However, provisioning during manufacturing remains the more secure option.
Once a device has a secure identity, the next step is to enforce strict access controls to protect its functionality.
Least-Privilege Access and Secure Communication
After provisioning, access controls play a crucial role in maintaining device security. Role-Based Access Control (RBAC) assigns permissions based on specific roles, while "just-in-time" privileges grant temporary access for specific tasks. These practices align with the FDA’s emphasis on Zero Trust Architecture, which requires thorough verification at every access point rather than relying on network location [2].
Jeff Crume, IBM Distinguished Engineer and Master Inventor, underscores a critical vulnerability:
"Some of the biggest vulnerabilities happen in those bridge points between two different things where the interfaces are. My component may be perfect, and your component may be perfect, but our interface is not" [3].
To mitigate such risks, healthcare organizations should implement micro-segmentation using VLANs and automated network tools like service meshes and firewalls to isolate medical devices from the broader network [3][4]. Given that around 50% of medical devices in healthcare facilities are network-connected [4], this isolation is essential. Secure communication protocols like TLS should be standard, and sensitive credentials - such as API keys, certificates, and tokens - must be automatically created, rotated, and stored in secure vaults. Credential injection should be automated, eliminating the need for manual handling by users [3].
Automated Configuration for Deployment
Automated configuration tools are key to maintaining security during deployment. By applying security policies consistently across thousands of devices, these tools reduce the risk of misconfigurations that could leave devices exposed.
Healthcare delivery organizations (HDOs) should document IT and security details - such as MAC addresses, VLANs, operating systems, and firmware versions - in their Computerized Maintenance Management System (CMMS) during the onboarding process. This helps reconcile inventory and manage risks effectively [4]. During procurement, HDOs should require manufacturers to provide a Manufacturer Disclosure Statement for Medical Device Security (MDS2), a Software Bill of Materials (SBOM), and detailed security configuration guidelines [4]. Contracts should also specify terms for remote access and service-level agreements for timely vulnerability patching [4].
Ali Youssef, Director of Medical Device and IoT Security at Henry Ford Health, highlights a critical risk:
"The act of scanning a given device can affect its core functionality... In some cases, MDMs will void the warranty on a device if it is scanned by a vulnerability scanner without the MDM's knowledge or approval" [4].
To avoid disrupting device functionality, healthcare organizations should rely on passive network monitoring platforms that analyze traffic without directly interacting with devices [4]. These platforms verify configurations and detect anomalies while keeping medical equipment operational and warranties intact. By following these manufacturing and deployment security practices, organizations lay the groundwork for ongoing monitoring and vulnerability management throughout the device’s lifecycle.
Security During Operations: Monitoring and Maintenance
Keeping medical devices secure during their operational phase involves ongoing monitoring, timely updates, and swift responses to incidents - all aimed at safeguarding patient safety.
Continuous Monitoring and Anomaly Detection
Real-time monitoring is at the heart of operational security. Many modern systems rely on AI and machine learning to establish a "normal" behavior pattern for each device. When something deviates - like unusual communication, unauthorized access attempts, or unexpected data transfers - it raises a red flag [11][14]. This proactive approach helps catch potential breaches or malfunctions early.
To make informed security decisions, healthcare organizations should collect and monitor at least 100 data points per device. These include details like the device's manufacturer, OS version, serial number, port numbers, and network location [11]. A detailed inventory like this ensures that when new vulnerabilities surface, affected devices can be quickly identified and addressed.
Vulnerability Management and Patching
Patching is a critical part of keeping Internet of Medical Things (IoMT) devices secure, but it comes with challenges - especially in environments where devices must operate continuously. A notable example involves an organization that left critical vulnerabilities unpatched, resulting in the exposure of millions of patient records [11].
To manage patches effectively, organizations should prioritize risks using tools like the KEV catalog and EPSS. They can also implement compensating controls such as micro-segmentation and device hardening [11][12][13]. Before rolling out patches widely, testing them on a smaller group of devices helps identify compatibility issues. Additionally, having a rollback plan ensures any problematic updates can be quickly reversed. Documenting each patch installation is also key for compliance [11].
Incident Response and Post-Market Surveillance
Even with strong preventive measures, security incidents can happen. That’s why having a clear incident response plan is essential. This plan should outline roles, communication channels, and escalation procedures. Effective coordination between IT teams, biomedical engineers, and clinical staff is crucial, especially when scheduling maintenance during low-use periods [14].
Manufacturers play a role, too, by monitoring devices for new threats and issuing timely security advisories. However, regulatory testing requirements can sometimes delay these updates [11][12]. To stay ahead, organizations should adopt closed-loop remediation. This involves matching an up-to-date vulnerability database with a real-time inventory of devices, automating risk assessments, and tracking progress on fixes [14].
As Medcrypt highlights:
"The consequences of a security breach in a medical device can be life-threatening, demanding a more rigorous and proactive approach to vulnerability management than in other industries" [12].
Decommissioning and Legacy Device Management
The final steps in a medical device's lifecycle - secure decommissioning and managing legacy devices - are just as crucial as the earlier phases. These processes ensure data security and help mitigate risks tied to outdated equipment.
When devices reach the end of their usefulness, secure decommissioning is essential to prevent data breaches or unauthorized access. Meanwhile, many healthcare organizations still rely on legacy devices that manufacturers no longer support, presenting ongoing security challenges that demand careful attention.
Secure Data Wiping and Certificate Revocation
Simply deleting files or performing a factory reset isn’t enough to protect sensitive information like PHI, network credentials, or configuration settings. These methods leave data recoverable, creating potential vulnerabilities [15][18]. The FDA underscores the importance of safeguarding PHI throughout a device's lifecycle, including its disposal, in line with HIPAA regulations [17].
The most secure method involves physically destroying storage media - shredding hard drives, SD cards, or USB drives. If devices are being repurposed or sold, software-based tools that overwrite data multiple times provide a higher level of security. Factory resets, while convenient, offer limited protection, and deleting files through the device interface leaves data easily accessible [18].
Devices must also be disconnected from cloud services and management servers, with all digital certificates revoked to prevent unauthorized reactivation. As Chad Waters, ECRI's Senior Cybersecurity Engineer, explains:
"If the device isn't disassociated from the cloud service, the device could potentially rejoin the cloud management system if it's reactivated later, providing an unaffiliated user with access to data from the original facility" [15].
This process includes removing IP addresses, wireless settings (like Pre-Shared Keys), Active Directory accounts, and DICOM configurations that could otherwise provide valuable information for cyberattacks [18].
When working with third-party salvage companies, it’s essential to secure a Business Associate Agreement (BAA) and a signed Certificate of Destruction to confirm complete data removal [15][18]. These steps ensure that decommissioning is thorough and secure, paving the way for proper end-of-support planning.
End-of-Support (EOS) Planning
The FD&C Act Section 524B now requires manufacturers to document support timelines and end-of-support dates for all software components. This makes lifecycle planning a regulatory obligation rather than an optional best practice. Once a device reaches its EOS date, the responsibility for its security shifts to the healthcare organization - provided the manufacturer has delivered the necessary documentation, training, and tools for implementing external controls.
Healthcare providers should maintain an updated inventory of devices in a Computerized Maintenance Management System (CMMS) or Configuration Management Database (CMDB), tracking EOS milestones for each device [15][18]. This proactive approach allows organizations to plan upgrades or replacements before support ends. The Manufacturer Disclosure Statement for Medical Device Security (MDS2) is a valuable resource, offering details about data storage and sanitization methods that aid in both decommissioning and replacement planning [15].
Failing to plan for EOS can have serious consequences. For example, during the 2017 WannaCry ransomware attack, 81 of 236 NHS hospitals in the UK were affected, leading to over 20,000 canceled appointments and procedures - a direct result of legacy systems running outdated software [16].
Legacy Device Risk Mitigation Strategies
Even after manufacturer support ends, healthcare organizations must take steps to secure legacy devices. This is especially important given that 73% of healthcare providers still use medical equipment running on outdated systems, with 10–15 million such devices in U.S. hospitals alone [1]. Medical devices often have lifecycles exceeding 15–20 years, far outlasting the pace of modern cyber threats [1].
When patches are no longer available, network segmentation becomes the first line of defense. Isolating legacy devices from critical systems limits the potential damage in case of a breach. Additional measures, like "virtual patching" through firewall rules or intrusion prevention systems, can block known vulnerabilities [1].
Compensating controls can also offer protection when a device lacks built-in security features. These include continuous monitoring and AI-based anomaly detection to flag unusual activity on medical device networks. To make informed decisions about whether to keep legacy devices in operation, cross-disciplinary committees - including clinical, IT, and security teams - should use formal risk assessment frameworks like ISO 14971 to evaluate both the security risks and the clinical importance of the devices [1].
As Chad Waters puts it:
"Creating a structured decommissioning process now will help assure that the protections you need are in place when you dispose of medical devices in the future" [15].
Using Censinet RiskOps for Lifecycle Security
Securing medical devices throughout their entire lifecycle - from design to decommissioning - is no small task. With the growing number of connected devices in today’s healthcare systems, coupled with evolving threats and regulatory demands, managing these risks manually is nearly impossible. That’s where Censinet RiskOps™ steps in, offering a platform designed to handle these challenges with automation and intelligence.
Censinet RiskOps™ provides a centralized hub for healthcare organizations and medical device manufacturers to manage cybersecurity risks at every stage. From processing manufacturer security documents to monitoring vulnerabilities and coordinating remediation, the platform ensures that IT, Risk, Cybersecurity, and BioMedical teams stay aligned.
Automated Risk Assessments and Vulnerability Tracking
Censinet RiskOps™ simplifies vulnerability management by automating critical processes. For example, it can automatically parse MDS2 forms (2013 and 2019 versions), which is especially useful for older devices lacking updated security documentation. This automation eliminates the need for manual data entry, speeding up the process of identifying device-specific risks.
The platform also maintains a machine-readable SBOM (Software Bill of Materials) for each device, listing all third-party components and dependencies. This allows for continuous tracking of vulnerabilities, with automated alerts when a CVE impacts any component in your inventory [22]. Unlike traditional SBOMs, which are often treated as static documents, Censinet RiskOps™ integrates SBOMs into ongoing workflows. It tracks the status of vulnerabilities - whether they’re under review, scheduled for patching, or already resolved [22].
Another standout feature is delta-based reassessments, which focus only on changes since the last review. This approach reduces the time needed for reassessments to less than a day [19]. When security gaps are found, the platform generates Corrective Action Plans (CAPs) with recommended solutions, assigns tasks to the right experts, and monitors progress until completion [19].
AI-Powered Threat Analysis and Collaboration
The platform doesn’t stop at automation - it also uses AI to supercharge threat analysis and enhance teamwork. Censinet AI™ speeds up risk assessments by enabling vendors to complete security questionnaires in seconds. It summarizes vendor documentation, highlights key product integrations, and identifies fourth-party risks. The result? Concise risk reports that help healthcare organizations address vulnerabilities faster.
The Digital Risk Catalog™, which includes data on over 50,000 pre-assessed vendors and products, allows organizations to tap into existing risk scores and intelligence instead of starting from scratch [19]. This shared network, utilized by more than 100 healthcare providers and payers, reduces redundant assessment work and speeds up procurement decisions [19].
Collaboration is another key focus. Medical device security often requires input from multiple teams - clinical engineers who understand device lifecycles and security experts who grasp the threat landscape. The platform’s Cybersecurity Data Room™ ensures everyone stays on the same page. It allows vendors to keep their risk data updated and supports activities like vulnerability triage, disclosure, remediation, and ongoing communication [22][19].
Security Support Across the Device Lifecycle
Censinet RiskOps™ ensures security isn’t an afterthought - it’s baked into every stage of the device lifecycle. From initial threat modeling during design to secure decommissioning and end-of-support planning, the platform provides continuous oversight. Its centralized inventory makes it easy to pinpoint legacy systems and prepare for transitions when devices reach the end of their support.
Real-time risk scoring and automated alerts keep organizations informed about breaches, ransomware incidents, and other threats across their entire portfolio [19]. The platform even monitors nth-party risks, such as cloud providers that medical device vendors depend on for data storage or processing [19].
For legacy devices that can no longer be patched, Censinet RiskOps™ suggests and tracks compensatory controls, like isolating devices on segmented networks. Risk tiering features group devices based on factors like clinical importance and PHI exposure, automatically scheduling reassessments for high-risk devices. This ensures that even older devices remain under surveillance throughout their operational life [19].
Conclusion
Securing medical devices isn’t a one-and-done task - it’s an ongoing process that spans the entire lifecycle, from design to decommissioning. Each phase of this lifecycle plays a critical role in addressing the ever-changing landscape of cyber risks. By adopting a lifecycle-focused strategy, security measures can adapt to evolving threats, ensuring devices remain protected over time.
Medical devices often remain in use for 15–20 years or more, far outlasting the typical evolution of cybersecurity threats [1]. Without a well-defined lifecycle approach, healthcare organizations are left vulnerable to risks like outdated legacy devices, supply chain compromises, and unpatched third-party components. Lifecycle traceability doesn’t just enhance security - it can also save manufacturers up to $30 million by enabling rapid responses to defective products [21]. More importantly, it helps safeguard patient safety by preventing potential exploits that could disrupt clinical care.
Industry experts emphasize the importance of a comprehensive strategy that includes practices like threat modeling, maintaining a Software Bill of Materials (SBOM), and coordinated vulnerability disclosure [20][23][24]. Organizations like the FDA and IMDRF recommend combining pre-market security controls with proactive post-market monitoring to address emerging threats throughout a device’s operational life. This approach not only supports compliance with regulations but also prioritizes protecting lives.
To meet these challenges, manufacturers and healthcare organizations need to take proactive steps. These include designing devices with security in mind, keeping SBOMs up to date, implementing continuous monitoring and patching, and planning for secure decommissioning when devices reach the end of their lifecycle. Tools such as Censinet RiskOps™ can simplify this process by automating risk assessments, tracking vulnerabilities, and fostering collaboration between IT, cybersecurity, clinical engineering, and vendor teams. These efforts ensure that security remains a priority at every stage of the device lifecycle.
As connected medical devices become more prevalent and cyber threats grow increasingly complex, adopting a lifecycle-based security strategy is no longer optional. It’s essential for protecting patients, ensuring regulatory compliance, and maintaining the integrity of healthcare operations for years to come.
FAQs
What should a medical device security lifecycle plan include?
A medical device security lifecycle plan needs to address every phase, from the initial design to decommissioning. It starts with defining security requirements right from the beginning and incorporating cybersecurity measures into the overall risk management process. Using secure development frameworks that align with FDA standards is a critical step.
Once the devices are in use, post-market activities become essential. These include monitoring for vulnerabilities, applying patches promptly, and having a solid incident response plan in place. Tools like the Software Bill of Materials (SBOMs) are especially helpful for tracking vulnerabilities and ensuring compliance with changing regulations.
How can hospitals reduce risk when a device can’t be patched or scanned?
Hospitals can lower risks by implementing network segmentation, which isolates devices that cannot be patched, reducing their exposure to potential threats. Pairing this with strict access controls ensures that only authorized individuals can interact with these devices, adding an extra layer of protection. On top of that, having strong monitoring systems and well-prepared incident response plans allows for quick detection and containment of threats, limiting potential damage. These approaches align closely with FDA recommendations for managing vulnerabilities and maintaining patient safety in situations where patching or scanning isn't feasible.
What’s the fastest way to use SBOMs to find impacted devices and CVEs?
The quickest way to use SBOMs for pinpointing affected devices and CVEs is by integrating continuous vulnerability monitoring and risk assessments, with the SBOM serving as a central resource. After compiling a thorough and precise SBOM, you can use it to monitor vulnerabilities over time. Automated solutions, such as those offered by Censinet RiskOps™, simplify this process, allowing for faster identification of impacted devices and linked CVEs.
