IEC 82304

IEC 82304-1:2016 "Health software - Part 1: General requirements for product safety" is an international standard that specifies requirements for the safety and security of health software products throughout their entire lifecycle. It applies to standalone health software that is not already covered by IEC 62304 as part of a medical device.

Scope and applicability:

IEC 82304-1 applies to:
- Standalone health software products not embedded in medical devices
- Software as a Medical Device (SaMD) that is not part of a hardware medical device
- Health and wellness apps
- Clinical decision support software
- Electronic health records (EHR) systems
- Health information management systems
- Software that processes health information

Key differences from IEC 62304:

IEC 62304:
- Covers medical device software lifecycle processes
- Applies to software that is part of or used in manufacturing medical devices
- Focuses on software development lifecycle
- Detailed process requirements for software engineering

IEC 82304-1:
- Covers standalone health software product safety
- Applies to health software products sold or distributed separately
- Focuses on product lifecycle and user safety
- Includes requirements for content, deployment, maintenance, and retirement
- Addresses health information processing and privacy

Relationship between the standards:
Many software products fall under both standards. When both apply, organizations must comply with both IEC 62304 (for software development processes) and IEC 82304-1 (for product safety requirements).

Software safety classification:

IEC 82304-1 requires classification based on the potential for the software to harm users or patients:

Class A - No harm possible:
- Software incapable of causing injury
- Minimal safety requirements
- Example: General health information apps with no personalized advice

Class B - Non-serious injury possible:
- Software that could cause non-serious injury
- Moderate safety requirements
- Example: Diet and fitness tracking apps

Class C - Serious injury or death possible:
- Software that could cause serious harm
- Highest safety requirements
- Example: Insulin dosage calculators, clinical decision support

Key safety requirements:

1. Health software product specification:
- Define intended use and intended users
- Document essential performance requirements
- Identify health data processed
- Specify operating environment and platforms
- Define data security and privacy measures

2. Safety and security requirements:
- Conduct risk management per ISO 14971
- Identify hazards related to health software use
- Implement risk controls for identified hazards
- Address cybersecurity risks and vulnerabilities
- Ensure data integrity and confidentiality
- Validate health software algorithms and calculations

3. Health information processing:
- Ensure accuracy and reliability of health information
- Maintain data integrity throughout processing
- Implement backup and recovery procedures
- Protect against unauthorized access or modification
- Support audit trails for critical operations
- Comply with privacy regulations (HIPAA, GDPR)

4. User interface and usability:
- Design user interface to minimize use errors
- Provide clear instructions for use
- Include appropriate warnings and precautions
- Support accessibility for intended users
- Conduct usability testing and validation
- Address human factors engineering

5. Validation and verification:
- Validate software in intended use environment
- Verify correct implementation of requirements
- Test with representative users
- Validate health information processing accuracy
- Test on all supported platforms and configurations
- Document validation results

6. Software release and deployment:
- Define release criteria and approval process
- Prepare user documentation and training materials
- Establish installation and configuration procedures
- Verify successful deployment
- Provide technical support resources
- Document known limitations and anomalies

7. Maintenance and updates:
- Monitor software performance in field
- Collect and analyze user feedback and complaints
- Investigate adverse events and safety issues
- Develop and distribute software updates and patches
- Maintain compatibility with evolving platforms
- Document maintenance activities

8. Retirement and data migration:
- Plan for product retirement or replacement
- Preserve user health information
- Provide data export and migration tools
- Notify users of retirement timeline
- Ensure continuity of care during transitions

Post-market requirements:

Surveillance and monitoring:
- Collect real-world performance data
- Monitor adverse events and near misses
- Analyze user complaints and feedback
- Track software errors and malfunctions
- Assess ongoing safety and performance
- Report serious incidents to authorities

Updates and patches:
- Maintain software security through regular updates
- Address newly discovered vulnerabilities
- Fix bugs and performance issues
- Enhance features based on user needs
- Validate updates before release
- Communicate update information to users

Periodic safety reviews:
- Regularly review accumulated safety data
- Re-evaluate risk assessments
- Update risk management file
- Assess need for design changes
- Document review findings and actions

Regulatory considerations:

FDA recognition:
- IEC 82304-1 is recognized by FDA as a consensus standard
- Applicable to Software as a Medical Device (SaMD)
- Supports premarket submissions (510(k), De Novo, PMA)
- Demonstrates product safety approach

EU MDR/IVDR compliance:
- Applicable to standalone software medical devices
- Supports conformity assessment for CE marking
- Addresses General Safety and Performance Requirements
- May be referenced in technical documentation

Integration with other standards:
- ISO 14971 - Risk management for medical devices
- IEC 62304 - Software lifecycle processes (when both apply)
- ISO 27001 - Information security management
- ISO 9241 - Usability and ergonomics
- IEC 62366 - Usability engineering for medical devices

Documentation requirements:

Key documents required by IEC 82304-1:
- Health software product specification
- Safety and security requirements specification
- Risk management file (per ISO 14971)
- Validation and verification reports
- User documentation and instructions for use
- Installation and deployment procedures
- Maintenance and support procedures
- Post-market surveillance reports
- Periodic safety update reports

Cybersecurity and data protection:

IEC 82304-1 requires specific attention to:
- Authentication and access controls
- Encryption of health information
- Protection against malware and attacks
- Secure communication protocols
- Data privacy compliance (GDPR, HIPAA)
- Vulnerability management
- Incident response procedures

Common compliance challenges:

• Balancing user convenience with security requirements
• Maintaining compatibility across diverse platforms and devices
• Managing frequent software updates while ensuring validation
• Addressing evolving cybersecurity threats
• Complying with varying international privacy laws
• Demonstrating clinical validity of health information processing
• Establishing adequate post-market surveillance for software

Best practices for IEC 82304-1 compliance:

• Start with clear product specification and intended use
• Integrate security and privacy considerations from design phase
• Conduct comprehensive risk analysis covering all potential hazards
• Implement automated testing for continuous validation
• Establish robust change control for updates and patches
• Monitor real-world performance and user feedback systematically
• Maintain living documentation that evolves with product
• Ensure cross-functional team involvement (engineering, clinical, regulatory, privacy)

IEC 82304-1 provides a comprehensive framework for ensuring the safety of standalone health software products, addressing the unique challenges of software that operates independently while processing sensitive health information and supporting clinical decisions.