Compliance & Safety
Enterprise-grade security, clinical safety protocols, and comprehensive regulatory compliance for healthcare's most critical workflows
Industry Certifications & Attestations
Our comprehensive compliance framework is validated by independent third-party auditors and meets the highest industry standards
HIPAA Compliant
Full compliance with Health Insurance Portability and Accountability Act
- Administrative safeguards with workforce training
- Physical safeguards for all infrastructure
- Technical safeguards including encryption
- Executed Business Associate Agreements
- Regular compliance audits and assessments
SOC 2 Type II
Audited controls for security, availability, and confidentiality
- Annual independent third-party audits
- Continuous monitoring and reporting
- Comprehensive risk assessment protocols
- 24/7 incident response procedures
- Change management controls
HITRUST CSF Certified
Healthcare industry's most comprehensive security framework certification
- Risk-based approach to compliance
- 156 prescriptive security controls
- Independent third-party validation
- Continuous improvement framework
- Annual recertification requirements
ISO 27001 Certified
International standard for information security management systems
- Systematic security risk management
- Comprehensive security controls
- Regular internal and external audits
- Continuous monitoring and improvement
- Global recognition and trust
Clinical Safety & Quality Assurance
Rigorous clinical validation, continuous safety monitoring, and ethical AI practices ensure the highest standards of patient care
Clinical Validation
Evidence-Based Algorithms
All clinical algorithms validated against peer-reviewed research and clinical guidelines from APA, SAMHSA, and WHO
Clinical Advisory Board
Continuous oversight by board-certified psychiatrists, psychologists, and behavioral health specialists
Outcome Tracking
Real-time monitoring of clinical outcomes with automated alerts for adverse events or deterioration
Regular Clinical Audits
Quarterly reviews of all clinical decisions and recommendations by independent medical professionals
Patient Safety Protocols
Crisis Detection Systems
AI-powered detection of crisis indicators with immediate escalation to emergency protocols
Suicide Risk Assessment
Validated Columbia Suicide Severity Rating Scale integration with automated provider alerts
Medication Safety Checks
Real-time drug interaction screening and contraindication alerts with FDA database integration
Mandatory Reporting Compliance
Automated workflows for mandatory reporting requirements including child/elder abuse detection
AI Safety & Ethics
Bias Detection & Mitigation
Continuous monitoring for algorithmic bias across demographics with quarterly fairness audits
Explainable AI
All clinical recommendations include transparent reasoning paths and confidence scores
Human-in-the-Loop Design
Clinician oversight required for all treatment decisions with clear escalation pathways
Ethical AI Framework
Adherence to WHO Ethics & Governance of AI for Health guidelines and AMA AI principles
Quality Assurance
Continuous Quality Monitoring
Real-time tracking of system performance, accuracy metrics, and clinical outcomes
Provider Feedback Integration
Systematic collection and integration of clinician feedback for continuous improvement
Clinical Decision Auditing
100% audit trail of all clinical decisions with quarterly third-party reviews
Performance Benchmarking
Regular comparison against industry standards and clinical best practices
Security Infrastructure
Defense-in-depth security architecture with multiple layers of protection for your most sensitive data
Data Encryption & Protection
AES-256 Encryption at Rest
Military-grade encryption for all stored data including backups and archives
TLS 1.3 in Transit
End-to-end encryption with perfect forward secrecy for all data transmissions
Hardware Security Module (HSM)
FIPS 140-2 Level 3 certified key management with automatic rotation every 90 days
Zero-Knowledge Architecture
Patient data encrypted at the edge before transmission to our servers
Access Control & Authentication
Multi-Factor Authentication (MFA)
FIDO2/WebAuthn support with biometric authentication and hardware security keys
Role-Based Access Control (RBAC)
Granular permissions with principle of least privilege and regular access reviews
Session Security
Automatic timeouts, secure session tokens, and device fingerprinting
Privileged Access Management
Just-in-time access with approval workflows and comprehensive audit logging
Infrastructure & Network Security
Multi-Cloud Architecture
Redundant deployment across AWS, Azure, and Google Cloud with automatic failover
Network Segmentation
Micro-segmentation with zero-trust networking and east-west traffic inspection
DDoS Protection
Multi-layer DDoS mitigation with 15 Tbps capacity and <1 second response time
Web Application Firewall
OWASP Top 10 protection with custom rules and real-time threat intelligence
Monitoring & Incident Response
24/7 Security Operations Center
Round-the-clock monitoring by certified security analysts with 15-minute response SLA
SIEM & Threat Detection
AI-powered threat detection with behavioral analytics and anomaly detection
Incident Response Plan
NIST-based incident response with defined playbooks and regular tabletop exercises
Forensic Capabilities
Complete audit trails with tamper-proof logging and chain of custody procedures
Data Governance & Privacy
Transparent data handling practices with comprehensive privacy controls and regulatory compliance
Data Minimization
Collection limited to minimum necessary for treatment, payment, and operations
- Automatic data purging after retention period
- Anonymous analytics with differential privacy
- Opt-in for non-essential data collection
Purpose Limitation
Strict controls on data usage with explicit consent requirements
- Granular consent management
- Purpose binding enforcement
- Third-party data sharing restrictions
Data Subject Rights
Full compliance with GDPR, CCPA, and state privacy laws
- Right to access within 30 days
- Right to rectification and erasure
- Data portability in standard formats
Cross-Border Transfer
Secure international data transfers with appropriate safeguards
- EU-US Data Privacy Framework certified
- Standard Contractual Clauses
- Data localization options available
Vendor Management
Rigorous third-party risk management program
- Annual vendor security assessments
- Contractual security requirements
- Continuous vendor monitoring
Breach Response
Comprehensive breach notification and response procedures
- 72-hour notification commitment
- Credit monitoring services provided
- Transparent communication protocols
Global Regulatory Compliance
Comprehensive compliance with healthcare regulations across multiple jurisdictions
| Regulation | Jurisdiction | Status | Details |
|---|---|---|---|
| HIPAA (Health Insurance Portability and Accountability Act) | United States | Fully Compliant | Complete implementation of Administrative, Physical, and Technical Safeguards with annual risk assessments |
| GDPR (General Data Protection Regulation) | European Union | In Progress | Data Protection Officer appointed, Privacy by Design implementation, and comprehensive data subject rights |
| CCPA/CPRA (California Consumer Privacy Act) | California, USA | In Progress | Consumer rights implementation including opt-out, deletion, and non-discrimination provisions |
| FDA Software as Medical Device (SaMD) | United States | In Progress | Following FDA guidance for clinical decision support software with quality management system |
Security-First Healthcare Innovation
Have questions about our compliance and safety practices? Our security team is here to help.
For security vulnerabilities, please email security@medera.ai using our PGP key