Compliance & Regulatory

Meeting the highest healthcare regulatory standards with comprehensive compliance frameworks

Healthcare Compliance and Regulatory Framework - HIPAA, GDPR, FDA compliance for medical AI systems

Comprehensive Healthcare Compliance Framework

SynThera's compliance framework ensures adherence to the most stringent healthcare regulatory standards worldwide. Our platform is designed from the ground up to meet HIPAA, GDPR, FDA, HITECH, and international medical device regulations, providing healthcare organizations with the confidence to deploy AI solutions while maintaining full regulatory compliance and protecting patient privacy across all clinical workflows.

Core Compliance Domains

Data Privacy & Security

HIPAA, GDPR, CCPA compliance with end-to-end encryption

Medical Device Regulation

FDA 510(k), CE marking, ISO 13485 certification ready

Clinical Quality Standards

HL7 FHIR, DICOM, IHE compliance for interoperability

Audit & Documentation

Complete audit trails, validation documentation, GxP compliance

Compliance Status

HIPAA Compliance

✓ Administrative Safeguards

✓ Physical Safeguards

✓ Technical Safeguards

GDPR Compliance

✓ Data Subject Rights

✓ Privacy by Design

✓ Data Protection Impact Assessment

FDA Standards

✓ Software as Medical Device

✓ Quality System Regulation

Security Certifications

✓ SOC 2 Type II

✓ ISO 27001

Global Regulatory Framework Coverage

🇺🇸

United States

HIPAA, HITECH, FDA 21 CFR Part 11, FTC Health Breach Notification

🇪🇺

European Union

GDPR, Medical Device Regulation (MDR), eIDAS, NIS2 Directive

🇬🇧

United Kingdom

UK GDPR, Data Protection Act 2018, MHRA Software as Medical Device

🌏

Global Standards

ISO 27001, ISO 13485, IEC 62304, HL7 FHIR Security

Compliance API Integration

// Compliance Framework Integration
const complianceFramework = new SynTheraCompliance({
  apiKey: 'your-api-key',
  environment: 'production',
  auditLevel: 'comprehensive'
});

// Initialize compliance monitoring
await complianceFramework.initialize({
  regulations: ['HIPAA', 'GDPR', 'FDA_21CFR11'],
  
  privacySettings: {
    dataMinimization: true,
    consentManagement: true,
    rightToErasure: true,
    dataPortability: true
  },
  
  securityControls: {
    encryptionAtRest: 'AES-256',
    encryptionInTransit: 'TLS-1.3',
    accessControl: 'RBAC',
    auditLogging: 'comprehensive'
  },
  
  validation: {
    clinicalTrials: 'GCP',
    qualitySystem: 'ISO_13485',
    riskManagement: 'ISO_14971'
  }
});

// Process patient data with compliance checks
const result = await complianceFramework.processPatientData({
  patientId: 'patient-123',
  data: {
    demographics: { age: 45, gender: 'F' },
    clinicalData: { diagnosis: 'T2DM', medications: [...] },
    labResults: { hba1c: 7.2, glucose: 140 }
  },
  
  consentStatus: 'explicit',
  processingPurpose: 'clinical-decision-support',
  
  complianceChecks: {
    dataMinimization: true,
    lawfulBasis: 'vital-interests',
    retentionPeriod: '7-years',
    crossBorderTransfer: false
  }
});

// Generate compliance report
const complianceReport = await complianceFramework.generateReport({
  timeframe: '30-days',
  includeAuditTrail: true,
  includePolicyViolations: true,
  includeRiskAssessment: true
});

console.log('Processing compliant:', result.compliant);
console.log('Risk score:', result.riskScore);
console.log('Audit trail ID:', result.auditTrailId);

Privacy Protection Measures

1

Data Minimization

Collect and process only necessary patient information

2

Purpose Limitation

Use data only for specified clinical purposes

3

Consent Management

Granular consent controls with withdrawal options

4

Data Subject Rights

Access, rectification, erasure, and portability support

Security Controls

Technical Safeguards

  • • AES-256 encryption at rest and in transit
  • • Multi-factor authentication required
  • • Role-based access control (RBAC)
  • • Automated vulnerability scanning

Administrative Safeguards

  • • Security officer designation
  • • Workforce training programs
  • • Incident response procedures
  • • Business associate agreements

Physical Safeguards

  • • Secure data center facilities
  • • Biometric access controls
  • • Environmental monitoring
  • • Media disposal procedures

Continuous Audit & Validation

24/7

Continuous Monitoring

Real-time compliance monitoring and automated alerting

100%

Audit Trail Coverage

Complete logging of all system interactions and data access

<5min

Incident Response

Automated detection and response to compliance violations

Validation Documentation

  • • Installation Qualification (IQ)
  • • Operational Qualification (OQ)
  • • Performance Qualification (PQ)
  • • Risk Management File (ISO 14971)
  • • Clinical Evaluation Report
  • • Post-Market Surveillance Plan

Regulatory Submissions

  • • FDA 510(k) Pre-Submission
  • • EU CE Technical Documentation
  • • Health Canada Medical Device License
  • • TGA Therapeutic Goods Registration
  • • PMDA Software as Medical Device
  • • NMPA Medical AI Registration

Compliance Benefits & Outcomes

Zero

Data Breaches

Perfect security record with comprehensive protection

30-Day

Audit Readiness

Always prepared for regulatory inspections

99.99%

Compliance Score

Consistently meets all regulatory requirements

50+

Certifications

Global compliance certifications and attestations

Deploy with Complete Regulatory Confidence

Ensure full compliance across all healthcare regulations and standards