Cybersecurity in healthcare is about more than protecting data — it’s about protecting patients. As medical devices become increasingly connected to hospital networks, cloud platforms, and even patients’ homes, they also become prime targets for cyber threats. A single vulnerability could delay treatment, disrupt diagnosis, or cause direct harm. This makes cybersecurity assessments an essential part of medical device design, approval, and postmarket management.
This checklist provides manufacturers, developers, and healthcare organizations with a practical framework for conducting cybersecurity assessments that align with FDA guidance, international standards, and industry best practices.
Why Cybersecurity Assessments Matter
Cybersecurity assessments are not just regulatory checkboxes — they are fundamental to patient safety and trust. The FDA’s 2025 premarket guidance emphasizes that cybersecurity must be built into devices throughout the Total Product Lifecycle (TPLC). Without proper assessment, risks go undetected, leaving devices vulnerable to exploitation. Past advisories involving insulin pumps, cardiac implants, and ransomware attacks like WannaCry illustrate how quickly cybersecurity lapses can impact care delivery. In the WannaCry case, hospitals across the UK had to turn away patients because their systems were locked down — a powerful reminder of why strong device cybersecurity is critical.
Key Elements of a Medical Device Cybersecurity Assessment
A robust cybersecurity assessment covers three areas: identifying vulnerabilities across hardware, software, and communication pathways; evaluating the effectiveness of existing controls such as authentication, encryption, and monitoring; and assessing risk based on both likelihood and potential harm to patients.
This patient-centered approach extends traditional confidentiality, integrity, and availability (CIA) to also include harm (CIAH), ensuring safety is at the core of every evaluation.
The Cybersecurity Assessment Checklist
1. Gather Device Specifications and Threat Models
Start by documenting the device’s architecture, software, communication protocols, and intended use. Develop threat models to anticipate potential attack vectors. For example, applying STRIDE can highlight whether an attacker could spoof a clinician’s login or tamper with wireless communication.
2. Conduct Vulnerability Scanning and Code Review
Scan for known vulnerabilities in both custom code and third-party components. Use static and dynamic code analysis to uncover weaknesses. Maintaining a Software Bill of Materials (SBOM) is vital for tracking and responding to vulnerabilities in open-source and third-party libraries. The Log4j crisis showed how difficult it is to react quickly if you don’t know what’s inside your devices.
3. Perform Penetration Testing
Simulate real-world attacks to identify how an adversary could exploit device weaknesses. Testing should cover wireless interfaces, APIs, cloud integrations, and hospital network connections. Think of it as a rehearsal for what an attacker might try in the wild.
4. Review Authentication and Access Controls
Check that strong password policies are enforced, unique credentials are required, and multi-factor authentication is enabled where feasible. Hardcoded or default passwords have been at the heart of several FDA recalls — a mistake that can be avoided with careful design.
5. Evaluate Encryption and Secure Communication
Confirm that patient data at rest and in transit is encrypted using modern standards. Verify secure communication protocols like TLS and DTLS, and ensure encryption keys are managed safely. Without encryption, devices remain exposed to interception and manipulation.
6. Validate Logging, Monitoring, and Audit Trails
Ensure the device records meaningful security events such as failed login attempts, firmware updates, and network anomalies. Logs should be tamper-resistant and exportable to hospital security teams. In practice, good logging reduces response times when an incident occurs.
7. Assess Update and Patch Management Processes
Verify that the device supports secure software and firmware updates. Updates should be digitally signed, delivered through secure channels, and validated before installation. This ensures that patches can be deployed quickly when new vulnerabilities emerge without disrupting patient care.
8. Evaluate Supplier and Third-Party Risks
Review dependencies on third-party software and hardware. Require SBOMs from vendors and evaluate their security maturity. Incidents like URGENT/11 and SweynTooth highlight how flaws in common components can ripple across entire device categories.
9. Review Labeling and User Instructions
FDA guidance stresses the importance of clear labeling. Provide instructions for secure configuration, maintenance, and updates, along with contact details for reporting vulnerabilities. This helps healthcare providers keep devices safe in the field.
10. Develop an Incident Response and Recovery Plan
Check whether the manufacturer has a defined incident response process. This should cover detection, containment, remediation, and communication with healthcare providers and regulators. Backup and recovery mechanisms should also be tested to confirm resilience.
Postmarket Considerations
Cybersecurity assessment doesn’t end with FDA clearance. Ongoing activities should include continuous threat monitoring, a coordinated vulnerability disclosure (CVD) program, regular penetration testing, and open communication with customers about updates and risks.
Embedding cybersecurity assessments into the TPLC ensures devices remain secure and trusted throughout their operational life.
Final Thoughts
Cybersecurity assessments are no longer optional for medical devices — they are essential for patient safety, regulatory compliance, and market trust. A thorough assessment identifies vulnerabilities, validates safeguards, and ensures risks are managed across the lifecycle.
At Blue Goat Cyber, we partner with medical device manufacturers to conduct comprehensive cybersecurity assessments that align with FDA expectations, international standards, and patient safety goals. From threat modeling to penetration testing and SBOM analysis, we ensure devices are secure by design and safe for patients.