Medical Device Cybersecurity Quick-Start Guide

Chapter 3: Planning and Architecting for Security

Security Management Plan

A security management plan establishes the foundation for all cybersecurity activities throughout the Total Product Life Cycle (TPLC). This plan should define how security risks will be identified, analyzed, and controlled.

Key Elements

• Security risk management process integration with safety risk management per ISO 14971
• Clear definitions of acceptable vs. unacceptable security risks
• Roles and responsibilities for security activities
• Documentation and review procedures

FDA Security Objectives

Security Architecture Views

The FDA recommends providing four specific types of architecture views:

Threat Modeling

Security Risk Assessment

Chapter 4: Secure Development

Secure Coding Practices

Third-Party Component Evaluation

Modern devices rely heavily on third-party software components. Comprehensive evaluation includes:

• Creating comprehensive Software Bill of Materials (SBOM)
• Assessing known vulnerabilities in CVE, NVD, and CISA KEV Catalog
• Evaluating vendor security practices and support timelines
• Planning for component lifecycle management

Security Testing

SBOM Management

Software Bill of Materials management is required for cyber devices under section 524B:

• Use standardized formats (SPDX, CycloneDX, SWID)
• Include component versions, suppliers, and dependency relationships
• Document known vulnerabilities and security status
• Maintain throughout the product lifecycle

Chapter 5: eSTAR Submission Artifacts

Required Documentation

Security Architecture Views

Security architecture views communicate the security design to FDA reviewers and demonstrate how security controls are implemented throughout the system. These views must scale based on the cybersecurity risk of the device.

FDA-Required Architecture Views

The FDA recommends providing, at minimum, the following four types of views:

Documentation Requirements for Architecture Views

• Clear, detailed diagrams with appropriate level of detail for system complexity
• Explanatory text describing security design decisions and rationale
• Identification of security-relevant system elements and their interfaces
• Definition of security context, domains, boundaries, and critical user roles
• Mapping to security requirements, controls, and threat model findings
• Traceability to risk assessment results and security objectives
• Consistency across all architectural views with cross-references where appropriate
• Alignment with security objectives and requirements to address identified threats
• Protocol details of communication pathways including authentication and session management
• Sufficient detail for engineers and reviewers to follow data, code, and commands through the system

Threat Model Documentation

The threat model demonstrates systematic identification and analysis of security threats specific to the device and its operating environment. This documentation provides the foundation for risk assessment and security control selection.

Data Flow Diagrams (DFDs)

• Complete system decomposition showing all processes, data stores, and external entities
• Trust boundaries clearly marked and explained with security implications
• Data flows labeled with security-relevant information and protection requirements
• Appropriate level of detail for the system complexity and attack surface
• Multiple diagram levels (high-level system view and detailed component views)
• Clear notation and legend explaining all symbols and conventions used
• Integration points with external systems and their security implications

Threat Identification and Analysis

• Systematic threat enumeration for each system element using structured methodologies
• Use of proven frameworks (STRIDE, attack trees, cyber attack lifecycle)
• Consideration of threats throughout the device lifecycle including development, deployment, operation, and decommissioning
• Documentation of threat sources, motivations, and capabilities
• Assessment of threat likelihood and potential impact using CVSS or similar frameworks
• Consideration of attacker capabilities, resources, and access levels
• Evaluation of existing security controls against identified threats
• Prioritization of threats based on risk level and potential patient safety impact
• Integration with vulnerability assessments of third-party components
• Regular updates to threat model as new threats emerge or system changes occur

Cybersecurity Risk Assessment

The risk assessment evaluates and prioritizes cybersecurity risks to guide security control implementation. This analysis forms the basis for all security-related design decisions and control selection.

Risk Analysis Methodology

• Clear description of risk assessment approach used (CVSS, NIST SP 800-30, OWASP, etc.)
• Detailed criteria for likelihood and impact evaluation with scoring rationale
• Risk scoring methodology with examples and consistency checks
• Integration with safety risk management processes per ANSI/AAMI SW96
• Consideration of intelligent adversaries and adaptive threats
• Assessment of cascading effects and system-wide impacts
• Evaluation of residual risks after control implementation

Risk Register and Documentation

• Comprehensive list of identified security risks with unique identifiers
• Risk likelihood and impact assessments with supporting rationale
• Current risk levels and risk treatment decisions
• Mapping to security controls, mitigations, and compensating measures
• Traceability to threat model findings and system vulnerabilities
• Risk ownership assignments and management responsibilities
• Risk monitoring and review processes with defined frequencies
• Application of risk acceptability criteria with approval documentation
• Documentation of risk treatment decisions and alternatives considered
• Identification and assessment of residual risks remaining after treatment

Security Controls Documentation

Document all implemented security controls and their effectiveness per the FDA's recommended security control categories. This documentation demonstrates how security objectives are achieved through specific technical and operational measures.

Required Security Control Categories

Per FDA 2023 guidance, security controls must address these eight categories:

• Authentication: Verifying identity of users, processes, and devices with specific mechanisms and protocols
• Authorization: Granting appropriate access privileges based on roles and least privilege principles
• Cryptography: Protecting data and communications using encryption with algorithm specifications
• Code, Data, and Execution Integrity: Ensuring software and data haven't been tampered with
• Confidentiality: Protecting sensitive information from unauthorized disclosure
• Event Detection and Logging: Monitoring and recording security-relevant events
• Resiliency and Recovery: Maintaining functionality and recovering from attacks
• Updatability and Patchability: Securely deploying software updates and security patches

Control Documentation Requirements

• Complete catalog of implemented security controls mapped to the eight categories
• Detailed control descriptions and implementation specifications
• Mapping to security requirements, risks, and threat model findings
• Control verification and testing evidence with test results
• Traceability to architecture views and system design decisions
• Performance impact assessment of security controls on device functionality
• Integration testing results showing controls work together effectively
• Configuration management procedures for security controls
• Monitoring and maintenance procedures for ongoing control effectiveness
• Failure mode analysis and backup procedures for critical security controls

Safety and Security Risk Integration Analysis

Demonstrates how security and safety risks have been properly integrated and managed throughout the development process. This analysis ensures that cybersecurity threats to safety are properly addressed and that safety controls don't inadvertently create security vulnerabilities.

Security-to-Safety Analysis

• Identification of security risks that could lead to safety hazards with impact assessment
• Transfer of appropriate risks to safety risk management per ISO 14971
• Integration of security considerations into safety analysis and FMEA processes
• Verification that safety controls adequately address security-related hazards
• Documentation of safety risk acceptability decisions for security-related hazards
• Traceability between security vulnerabilities and potential patient harm scenarios

Safety-to-Security Analysis

• Assessment of how safety controls might impact security (e.g., emergency overrides bypassing authentication)
• Evaluation of emergency override procedures and their security implications
• Analysis of fail-safe modes and their security implications
• Consideration of maintenance and service access impacts on security
• Assessment of physical safety features that might affect cybersecurity
• Documentation of compensating security measures for safety-required exceptions

Combined Risk Assessment

• Integrated view of safety and security risks with interaction analysis
• Analysis of risk interactions, dependencies, and cascading effects
• Overall risk evaluation and acceptability assessment
• Coordinated risk treatment strategies addressing both safety and security concerns
• Unified risk monitoring and review processes
• Cross-functional team coordination between safety and security risk management

Cybersecurity Management Plan

The management plan describes how cybersecurity will be managed throughout the Total Product Life Cycle (TPLC). For cyber devices, this plan is required under section 524B(b)(1) of the FD&C Act and must demonstrate ongoing commitment to device security.

Required Elements per FDA 2023 Guidance

• Personnel responsible for cybersecurity activities with roles and responsibilities defined
• Sources, methods, and frequency for monitoring and identifying vulnerabilities
• Process to identify and address vulnerabilities in the CISA Known Exploited Vulnerabilities Catalog
• Periodic security testing schedules and procedures with defined frequencies
• Timeline to develop and release patches based on vulnerability severity
• Update processes and delivery mechanisms with customer communication plans
• Patching capability assessment (rate at which updates can be delivered to devices)
• Description of coordinated vulnerability disclosure process following ISO 29147:2018
• Communication plans for remediations, patches, and updates to customers
• Integration with existing quality management and change control systems

Organizational and Process Elements

• Governance structure and decision-making authority for cybersecurity issues
• Resource allocation and budget considerations for ongoing cybersecurity activities
• Training and competency requirements for cybersecurity personnel
• Integration with quality management systems and design controls
• Incident response procedures and escalation processes
• Vendor and supplier security management requirements
• Customer support procedures for security-related issues
• End-of-life planning and secure device retirement procedures

SBOM Analysis and Documentation

Software Bill of Materials documentation provides transparency about software components and their security status. This is required for cyber devices under section 524B and must be maintained throughout the device lifecycle.

SBOM Content Requirements

• Complete inventory of software components including proprietary, COTS, and open-source
• Component version information and supplier details with contact information
• Dependency relationships and hierarchies showing transitive dependencies
• License information and usage rights with compliance requirements
• Known vulnerabilities and security status using CVE identifiers
• Integrity verification information (cryptographic hashes) for component authentication
• Component criticality assessment and impact on device functionality
• Update frequency and availability of security patches for each component

Vulnerability Analysis and Management

• Assessment of known vulnerabilities in components using CVE, NVD, and CISA KEV Catalog
• Evaluation of vulnerability impact on device security using CVSS or similar frameworks
• Risk assessment for vulnerable components with exploitability analysis
• Mitigation strategies for unpatched vulnerabilities with compensating controls
• Vendor response analysis and patch availability assessment
• Component replacement planning for end-of-life or unsupported software
• Continuous monitoring procedures for new vulnerabilities in existing components

Component Support Status and Lifecycle Management

• Supplier support commitments and service level agreements
• End-of-life schedules for components with transition planning
• Update and patching capabilities with deployment procedures
• Alternative components and migration plans for critical dependencies
• Vendor relationship management and communication procedures
• Budget and resource planning for component updates and transitions

Software Level of Support Assessment

Document the support status and implications for all software components throughout their lifecycle. This assessment helps identify risks associated with component support levels and plan for necessary transitions.

Support Classification and Assessment

• Categorization of all components by support level (supported, limited, end-of-life, community, custom)
• Vendor support commitments and service level agreements with contact procedures
• Community support assessment for open-source components including maintainer activity
• Internal support capabilities for custom components with knowledge management
• Support cost analysis and budget planning for ongoing maintenance
• Support quality assessment based on vendor track record and response times

Risk Assessment and Mitigation

• Security risks associated with each support level with impact analysis
• Impact of end-of-life components on device security and functionality
• Mitigation strategies for unsupported components with compensating controls
• Long-term sustainability planning with component roadmaps
• Risk acceptance decisions and approval documentation for unsupported components
• Monitoring procedures for security issues in unsupported components

Lifecycle Management and Transition Planning

• Component monitoring and update processes with defined procedures
• Transition planning for end-of-life components with timelines and milestones
• Vendor relationship management and communication strategies
• Budget and resource planning for component updates and migrations
• Change control procedures for component transitions
• Testing and validation procedures for component updates and replacements

Assessment of Unresolved Anomalies

Documentation of how security-relevant anomalies discovered during development have been evaluated and managed. This assessment demonstrates that all potential security issues have been properly considered and addressed.

Anomaly Documentation and Classification

• Complete list of unresolved anomalies with potential security relevance and unique identifiers
• Analysis of potential security impacts using structured methodologies and impact assessment
• Risk assessment for each anomaly using CVSS or similar frameworks
• Justification for leaving anomalies unresolved with supporting rationale and approval
• Classification by security relevance (security-relevant, safety-relevant, functional, performance)
• Traceability to discovery methods and original test cases or findings
• Impact analysis on overall system security posture

Compensating Controls and Risk Mitigation

• Compensating controls implemented to mitigate anomaly-related risks
• Monitoring procedures for detecting issues related to known anomalies
• Detection and response procedures for anomaly-related security events
• Customer communication about known limitations and required precautions
• User training recommendations for working around known anomalies
• Plans for future resolution including timelines and resource requirements
• Risk acceptance documentation and approval by appropriate authority

Cybersecurity Test Reports

Comprehensive documentation of all cybersecurity testing activities and their results. This report demonstrates that security controls have been properly implemented and validated through appropriate testing methodologies.

Testing Scope and Methodology

• Description of testing approach and objectives for all security testing performed
• Test environment configuration and any constraints or limitations
• Testing tools and techniques used (SAST, DAST, fuzzing, penetration testing)
• Test case development and execution procedures with traceability to requirements
• Testing team qualifications and independence considerations
• Testing schedule and integration with development milestones
• Test data management and privacy protection procedures

Test Results and Analysis

• Detailed results from all security testing activities with evidence
• Vulnerabilities discovered during testing and their resolution status
• Verification evidence that security requirements have been met
• Performance impact assessment of implemented security controls
• False positive analysis and validation of findings
• Regression testing results after vulnerability remediation
• Integration testing results showing security controls work together effectively

Test Coverage and Validation

• Test coverage analysis mapping tests to security requirements and threat model scenarios
• Coverage analysis for code, functional, and architectural testing
• Identification of any testing gaps with rationale and risk assessment
• Rationale for testing limitations and constraints
• Validation of test effectiveness and adequacy
• Comparison with industry best practices and standards
• Recommendations for ongoing testing and continuous improvement

Cybersecurity Metrics and Monitoring Plans

Establishment of metrics for ongoing cybersecurity monitoring and continuous improvement. These metrics provide measurable indicators of security program effectiveness and enable data-driven security decisions.

Security Performance Indicators

• Metrics for measuring security control effectiveness with baselines and targets
• Incident detection and response time metrics with performance thresholds
• Vulnerability management metrics (time to discovery, remediation, etc.)
• User security behavior metrics where applicable
• Security testing coverage and effectiveness metrics
• Patch deployment success rates and timelines
• Security training completion and effectiveness metrics
• Third-party security assessment and audit results

Monitoring and Reporting Procedures

• Data collection and analysis procedures for ongoing monitoring
• Automated monitoring tools and alert thresholds
• Reporting frequency, stakeholders, and escalation procedures
• Trend analysis and improvement identification processes
• Integration with quality management systems and continuous improvement
• Dashboard and visualization requirements for security metrics
• Data retention and archival procedures for security metrics
• Regular review and update procedures for metrics and thresholds

Cybersecurity Summary Report

A high-level summary that provides FDA reviewers with an overview of the device's cybersecurity posture. This executive summary ties together all cybersecurity documentation and demonstrates overall security adequacy.

Executive Summary and Overview

• Overview of device security architecture with key design decisions
• Key security controls and their rationale with effectiveness demonstration
• Major security risks and their mitigation strategies
• Compliance with relevant standards and guidelines (SW96, TIR97, etc.)
• Integration with safety risk management and overall device safety
• Summary of testing results and validation evidence
• Key assumptions and dependencies in the security design

Security Posture Assessment

• Overall assessment of device security with confidence levels
• Comparison to security best practices and industry benchmarks
• Residual risk evaluation and acceptability assessment
• Ongoing security commitments and lifecycle management plans
• Known limitations and required user/environment precautions
• Future security enhancement plans and roadmap
• Lessons learned and recommendations for similar devices

Cybersecurity Labeling

Information that must be provided to users to ensure secure device deployment and operation. This labeling enables healthcare facilities and users to properly integrate and maintain device security throughout its operational life.

Security Configuration Requirements

• Network security requirements and recommendations for deployment environments
• User authentication and access control requirements with role definitions
• Security monitoring and logging recommendations for healthcare facilities
• Incident response and reporting procedures with contact information
• Required security settings and configuration parameters
• Network segmentation and firewall recommendations
• Physical security requirements for device installation and access

User Security Information and Guidance

• Security features explanation and proper usage instructions
• Known security limitations and required compensating measures
• Security update and patching procedures with customer responsibilities
• Contact information for reporting security concerns or incidents
• User training recommendations and security awareness requirements
• Troubleshooting guidance for security-related issues
• Best practices for secure operation and maintenance

Technical Security Details

• Supported cryptographic algorithms and key lengths with compliance standards
• Network ports and protocols used with security implications
• Security certification and compliance information (FIPS, Common Criteria, etc.)
• Interoperability security considerations with other medical devices and IT systems
• Security logging and audit trail capabilities
• Backup and recovery procedures with security considerations
• End-of-life and secure disposal procedures

Interoperability Security Considerations

Documentation of security considerations for device interoperability with other systems and networks. This analysis ensures that security is maintained when the device operates as part of larger healthcare IT ecosystems.

Integration Security Requirements

• Security requirements for systems that will connect to or integrate with the device
• Trust establishment and authentication procedures for system integration
• Data protection measures during information exchange with external systems
• Security boundary management between the device and connecting systems
• Communication protocol security including encryption and integrity protection
• Session management and secure connection establishment procedures
• Error handling and failure mode security for integration scenarios

Standards Compliance and Testing

• Compliance with relevant interoperability security standards (HL7, DICOM, IHE, etc.)
• Security testing results with representative healthcare IT systems
• Known compatibility issues, workarounds, and security implications
• Certification and validation requirements for secure interoperability
• Third-party integration testing and validation procedures
• Ongoing monitoring and maintenance of interoperability security
• Documentation and communication of security requirements to integration partners

Chapter 6: Post-Market Responsibilities

Ongoing SBOM Monitoring

Continuous monitoring of software components for new vulnerabilities:

• Critical vulnerabilities: Monitor continuously (daily)
• High-severity vulnerabilities: Monitor weekly
• CISA Known Exploited Vulnerabilities: Monitor as updates are published
• Automated tools for CVE, NVD, and CISA KEV Catalog monitoring

Coordinated Vulnerability Disclosure

Inbound Vulnerability Reports

• Establish dedicated security reporting channels
• Respond with severity-based timelines (30-120 days based on criticality)
• Follow FDA-recognized standards ISO/IEC 29147:2018 and ISO/IEC 30111:2013

Response Timelines

• Critical vulnerabilities: Remediation within 30 days
• High-severity vulnerabilities: Remediation within 60 days
• Medium-severity vulnerabilities: Remediation within 120 days

Information Sharing

Active participation in cybersecurity information sharing organizations:

• Healthcare Sector ISAC (H-ISAC)
• Medical device security working groups
• Vendor-specific security communities

Security Testing and Updates

• Annual comprehensive penetration testing by external experts
• Quarterly focused testing of specific components
• Continuous fuzzing of critical interfaces
• Regular security update deployment with proper change control

Customer Communication

Effective communication during security events:

• 24-hour notification for critical vulnerabilities with active exploitation
• 5-day notification for high-severity vulnerabilities requiring customer action
• Clear instructions for security updates and patches
• Coordination with healthcare delivery organizations