Meeting the highest healthcare regulatory standards with comprehensive compliance frameworks
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.
HIPAA, GDPR, CCPA compliance with end-to-end encryption
FDA 510(k), CE marking, ISO 13485 certification ready
HL7 FHIR, DICOM, IHE compliance for interoperability
Complete audit trails, validation documentation, GxP compliance
✓ Administrative Safeguards
✓ Physical Safeguards
✓ Technical Safeguards
✓ Data Subject Rights
✓ Privacy by Design
✓ Data Protection Impact Assessment
✓ Software as Medical Device
✓ Quality System Regulation
✓ SOC 2 Type II
✓ ISO 27001
HIPAA, HITECH, FDA 21 CFR Part 11, FTC Health Breach Notification
GDPR, Medical Device Regulation (MDR), eIDAS, NIS2 Directive
UK GDPR, Data Protection Act 2018, MHRA Software as Medical Device
ISO 27001, ISO 13485, IEC 62304, HL7 FHIR Security
// 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);
Collect and process only necessary patient information
Use data only for specified clinical purposes
Granular consent controls with withdrawal options
Access, rectification, erasure, and portability support
Real-time compliance monitoring and automated alerting
Complete logging of all system interactions and data access
Automated detection and response to compliance violations
Perfect security record with comprehensive protection
Always prepared for regulatory inspections
Consistently meets all regulatory requirements
Global compliance certifications and attestations
Ensure full compliance across all healthcare regulations and standards