As connectivity in medical devices increases, cybersecurity labeling has become both a regulatory expectation and a safety imperative. Done well, it empowers users, supports compliance, and mitigates cyber risks.
Why Cybersecurity Labeling Matters
Cybersecurity isn’t just a technical requirement—it’s a patient safety measure. A clear, actionable label helps users understand how a device protects sensitive data and what steps are needed to maintain its security.
- Patient Safety: Prevents harm due to unauthorized access or tampering.
- Transparency: Communicates device security features and limitations.
- Regulatory Compliance: FDA and international bodies now require cybersecurity information in labeling.
To meet these demands, labeling must include specific, verifiable information about the device’s security posture.
Core Labeling Elements (FDA + Industry Best Practices)
Labeling should provide a snapshot of the device’s security architecture and maintenance strategy. The following are the four critical elements recommended by the FDA and widely adopted in the industry:
1. Security Features
- Encryption: Example: “AES-256 for data at rest; TLS 1.3 for data in transit.”
- Authentication: MFA, certificate-based access, or biometric login.
- Access Controls: Role-based user profiles; lockout after failed attempts.
2. Software Update and Patch Policy
- Delivery method: e.g., OTA, USB
- Update frequency: e.g., quarterly or ad hoc
- User responsibilities: E.g., manually triggering updates or monitoring logs
3. SBOM (Software Bill of Materials)
- Definition: A complete inventory of all software components
- Format: Use standards like CycloneDX or SPDX
- Purpose: Enables tracking of vulnerabilities like CVEs
4. Vulnerability Management
- Monitoring: On-device logging, intrusion detection
- Reporting: Contact details or web portal
- Response: Timelines and procedures for fixes
Regulatory Context
Labeling isn’t just good practice—it’s required. The FDA’s latest guidance makes cybersecurity labeling part of the approval process.
FDA Guidance (2023) Highlights:
- Title: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
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Key Requirements:
- Describe security controls and configurations
- Disclose update and patch mechanisms
- Address known limitations or risks
This aligns with ISO 14971 (risk management) and AAMI TIR57 (lifecycle cybersecurity), pushing manufacturers to build transparency into every stage of development.
Actionable Labeling Strategies
To meet both user needs and regulatory standards, approach cybersecurity labeling with clarity and structure.
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✅ Be Clear, Not Vague:
✔️ “Encrypts data using AES-256, certified to FIPS 140-3.”
❌ “Data is secure.” - ✅ Keep SBOM Machine-Readable: Automate SBOM generation using CycloneDX or SPDX.
- ✅ Highlight Known Issues: “Wi-Fi disabled by default. No remote updates.”
- ✅ Document Update Policy: Include update frequency, delivery method, and OS dependencies.
Examples in Practice
These examples show how labeling varies depending on the device’s connectivity, criticality, and complexity.
| Device Type | Label Includes |
|---|---|
| Insulin Pump | SBOM with open-source libraries, OTA update instructions, CVE patch policy |
| Pacemaker | Bluetooth encryption protocols, manual update requirement, clinician access only |
| Imaging Scanner | Secure DICOM transmission, user roles, software support timeline |
Common Challenges
Creating a strong label means maintaining both accuracy and usability over time.
- Keeping Labels Updated: Use CI/CD tools to regenerate SBOMs and version-controlled labels.
- Over/Under-Sharing: Balance clarity for non-technical users with enough depth for IT teams.
- Global Requirements: Ensure compliance with EU MDR, IMDRF, and other local standards.
Conclusion
Cybersecurity labeling is a shared benefit: it protects patients, informs users, and streamlines compliance. To be effective, your label must:
- Provide clear, actionable cybersecurity information
- Align with FDA and global regulations
- Stay up-to-date as risks and software evolve
🔒 A transparent label = a safer device—and a more trusted brand.
