November 26, 2025

The cybersecurity landscape for medical devices requires adherence to an integrated framework of international standards, regulatory expectations, and lifecycle security controls. Global regulatory agencies—including the FDA, EMA, MHRA, PMDA, and Health Canada—require manufacturers to incorporate cybersecurity risk management into design, development, testing, deployment, and post market surveillance.

Cybersecurity standards define requirements for device software architecture, secure development lifecycle, PHI protection, threat modeling, vulnerability management, and post market response coordination.

ISO 14971: Cyber Risk Integration into Medical Device Risk Management

ISO 14971 is the global foundation for medical device risk management.
Cybersecurity risk is included within:

  •  hazard identification related to cybersecurity failures
  •  threat modeling and vulnerability mapping
  •  analysis of cyber-harm severity and probability
  •  implementation of risk controls for data integrity, confidentiality, and availability
  •  residual cybersecurity risk justification
  •  integration with PMS, PMCF, and complaint handling
  •  alignment with AAMI TIR57 (cybersecurity risk concepts) and AAMI TIR97 (SBOM and lifecycle cybersecurity integration)

ISO 14971 requires end-to-end integration of cybersecurity throughout the device lifecycle.

IEC 62304: Secure Software Development Lifecycle Requirements

IEC 62304 establishes the regulatory foundation for safe and secure medical device software.

Key cybersecurity expectations include:

 • secure architecture design
 • classification into software safety classes A, B, C
 • secure coding practices
 • documentation of cybersecurity risk controls
 • interface security validation
 • patch and upgrade lifecycle planning
 • verification and validation of software security functions

IEC 62304 ensures software reflects security-by-design principles.

IEC 81001-5-1: Cybersecurity for Health Software & Health IT Ecosystems

IEC 81001-5-1 expands upon ISO 14971 with explicit cybersecurity expectations.

Requirements include:

 • secure development practices and configuration management
 • vulnerability identification, monitoring, and mitigation
 • continuous assessment of cybersecurity risks
 • documentation of cybersecurity controls and dependencies
 • secure deployment processes
 • validation of cybersecurity functions and error handling
 • lifecycle controls for updates and patches

Essential for hospital networking systems, AI-enabled platforms, and cloud-integrated digital health solutions.

ISO/IEC 27001: Information Security Governance for Connected Devices

ISO/IEC 27001 provides a structured information security management system (ISMS) essential for connected MedTech ecosystems.

Relevance includes:

 • confidentiality, integrity, and availability controls (CIA triad)
 • encryption governance for device data
 • access management and privilege control
 • secure cloud architecture for device integration
 • vulnerability scanning and incident response workflows
 • alignment with GDPR, Cyber Resilience Act, NIS2
 • enterprise cybersecurity risk mitigation

ISO/IEC 27001 is critical for digital health platforms and SaaS-connected devices.

FDA Cybersecurity Guidance: Design, Premarket, and Post market Requirements

The FDA mandates cybersecurity controls as part of regulatory submissions, design controls, and postmarked surveillance.

Key expectations include:


 • SBOM (Software Bill of Materials) documentation
 • secure design and architecture controls
 • authentication, authorization, and encryption
 • threat modeling and cyber-risk evaluation
 • update, patching, and vulnerability response plan
 • post market cybersecurity documentation
 • integration of cybersecurity within QMS and 21 CFR 820

FDA’s guidance ensures lifecycle cybersecurity readiness.

HIPAA Security Rule: PHI and ePHI Protection Requirements

HIPAA extends to any device for processing or transmitting PHI.

Required safeguards include:

 • administrative (policies, workforce controls)
 • technical (access control, audit logs, integrity validation)
 • physical (facility and hardware security)
 • encryption and secure data exchange
 • incident response and breach reporting
 • continuous cybersecurity monitoring

HIPAA governs all health data emerging from connected devices.

Conclusion

Cybersecurity standards and regulatory frameworks form the structural foundation for modern medical device safety and compliance. Integrating ISO 14971, IEC 62304, IEC 81001-5-1, ISO/IEC 27001, HIPAA, and FDA requirements ensures device security, protects PHI, reduces risk exposure, and strengthens lifecycle resilience. Maven Regulatory Solutions provides expert regulatory guidance for cybersecurity implementation and compliance across global MedTech markets.