HIPAA Compliance & Security

1. Business Associate Role

OmniWound EMR operates as a HIPAA Business Associate, providing electronic medical records services to healthcare providers (Covered Entities). This means we:

• Handle PHI on behalf of healthcare providers - We process, store, and transmit protected health information as directed by our customers
• Execute Business Associate Agreements (BAAs) - Every customer relationship includes a comprehensive BAA that outlines our responsibilities and protections
• Maintain HIPAA compliance standards - We implement all required administrative, physical, and technical safeguards
• Support customer compliance - We provide tools and documentation to help healthcare providers meet their own HIPAA obligations

2. HIPAA Security Safeguards

We implement comprehensive security measures across all three categories of HIPAA safeguards:

3. Certifications & Standards

3.1 ONC Health IT Certification

OmniWound EMR is certified by the Office of the National Coordinator for Health Information Technology (ONC), which means our platform:

• Meets federal standards for electronic health records functionality
• Supports meaningful use and quality reporting requirements
• Enables interoperability with other certified health IT systems
• Provides required clinical decision support and reporting capabilities
• Maintains data portability and patient access requirements

3.2 ISO 9001 Quality Management System

Our ISO 9001 QMS certification demonstrates our commitment to:

• Consistent quality in software development and customer service
• Continuous improvement of processes and systems
• Customer satisfaction through reliable service delivery
• Risk management and preventive action procedures
• Documented processes for all critical business functions

4. Data Protection Measures

4.1 Encryption Standards

All patient data is protected using industry-leading encryption:

• Data at Rest: AES-256 encryption for all stored data
• Data in Transit: TLS 1.3 encryption for all data transmission
• Database Encryption: Field-level encryption for sensitive data elements
• Backup Encryption: All backups are encrypted using the same standards

4.2 Data Storage and Backup

• Secure Cloud Infrastructure: Data stored in HIPAA-compliant cloud environments
• Automated Backups: Regular, encrypted backups with geographic redundancy
• Disaster Recovery: Comprehensive business continuity and disaster recovery plans
• Data Retention: Configurable retention policies to meet regulatory requirements

4.3 Network Security

• Firewalls and Intrusion Detection: Multi-layer network security monitoring
• VPN Access: Secure remote access for authorized personnel
• Network Segmentation: Isolated environments for different security zones
• DDoS Protection: Advanced protection against distributed denial of service attacks

5. Access Controls & Authentication

5.1 User Authentication

We implement robust authentication measures to ensure only authorized users can access patient data:

• Multi-Factor Authentication (MFA): Required for all user accounts
• Strong Password Policies: Enforced complexity and regular updates
• Single Sign-On (SSO): Integration with healthcare organization identity systems
• Session Management: Automatic timeouts and secure session handling

5.2 Role-Based Access Control

• Principle of Least Privilege: Users only access data necessary for their role
• Customizable User Roles: Flexible permissions based on job functions
• Audit Trails: Comprehensive logging of all access and actions
• Regular Access Reviews: Periodic review and certification of user access rights

5.3 Administrative Controls

• User Provisioning: Formal processes for granting and revoking access
• Identity Verification: Verification of user identity before account creation
• Terminated User Processing: Immediate access revocation upon employment termination
• Privileged Account Management: Enhanced controls for administrative accounts

6. Incident Response & Breach Notification

6.1 Security Incident Response

We maintain a comprehensive incident response program that includes:

• 24/7 Security Monitoring: Continuous monitoring for security threats and anomalies
• Incident Response Team: Dedicated team trained in healthcare security incident response
• Response Procedures: Documented procedures for different types of security incidents
• Forensic Capabilities: Tools and expertise for incident investigation and analysis

6.2 Breach Notification Process

In the event of a security incident involving PHI, we follow strict notification procedures:

• Immediate Assessment: Rapid evaluation to determine if a breach has occurred
• Customer Notification: Healthcare providers notified within 60 days as required by HIPAA
• Breach Documentation: Detailed documentation of the incident and response actions
• Regulatory Reporting: Assistance with required breach notifications to HHS and affected individuals
• Remediation Support: Help implementing additional safeguards to prevent future incidents

6.3 Business Continuity

• Disaster Recovery Plan: Comprehensive plan for service restoration after incidents
• Backup Systems: Redundant systems and data backups for rapid recovery
• Communication Plan: Clear communication procedures during incidents
• Regular Testing: Periodic testing of incident response and recovery procedures

7. Business Associate Agreement Process

7.1 BAA Requirements

Every healthcare provider using OmniWound EMR must execute a Business Associate Agreement that includes:

• Permitted Uses and Disclosures: Clear definition of how we may use and disclose PHI
• Safeguard Requirements: Our obligations to implement appropriate safeguards
• Subcontractor Management: Requirements for any subcontractors who may access PHI
• Individual Rights: Support for patient rights under HIPAA
• Breach Notification: Procedures for notifying covered entities of breaches
• Termination Procedures: Data handling requirements upon contract termination

7.2 BAA Execution Process

Our streamlined BAA process ensures rapid onboarding while maintaining compliance:

1. Standard BAA Review: We provide a comprehensive, standard BAA for review
2. Customization if Needed: Accommodation of reasonable healthcare provider-specific requirements
3. Legal Review Period: Adequate time for legal review and negotiation
4. Electronic Execution: Secure electronic signature process for efficiency
5. Documentation: Proper filing and documentation of executed agreements

8. Compliance Contact Information

For questions about HIPAA compliance, security measures, or to request compliance documentation:

Compliance Documentation Requests

We can provide the following compliance documentation upon request:

• Business Associate Agreement Template: Standard BAA for review and execution
• Security Assessment Reports: Third-party security assessments and certifications
• Compliance Attestations: Formal attestations of HIPAA compliance
• Incident Response Procedures: Overview of our security incident response capabilities
• Data Processing Addendum: Additional privacy protections and data handling procedures

Security Incident Reporting

For urgent security concerns or to report suspected security incidents:

• Emergency Contact: security@omniwound.com
• 24/7 Security Hotline: (201) 270-9103 (ask for security team)
• Incident Reporting Portal: Secure online portal for detailed incident reporting

---

This compliance information is current as of September 17, 2025. OmniWound EMR continuously monitors regulatory changes and updates our compliance program accordingly. For the most current compliance documentation, please contact our compliance team.