Compliance & Standards
Labby X is built with compliance in mind. Learn about our alignment with healthcare and data protection standards.
Important Disclaimers
- • Labby X is NOT a medical decision-making system
- • Interpretation of results is the responsibility of qualified healthcare professionals
- • We are NOT HIPAA certified, but procedurally aligned
- • Compliance requirements vary by jurisdiction — consult legal counsel
- • Software is provided "as is" without warranties
HIPAA - Health Insurance Portability and Accountability Act
- •Administrative Safeguards: User authentication, access logs, role-based permissions
- •Physical Safeguards: Local data storage with device-level security
- •Technical Safeguards: AES-256 encryption at rest, TLS in transit, audit trails
- •Organizational Requirements: Business Associate Agreements available upon request
- •Important: Not HIPAA certified. For certified solutions, consult with HIPAA compliance specialists.
GDPR - General Data Protection Regulation
- •Data Minimization: We collect only necessary personal information
- •User Rights: Access, rectification, erasure, portability rights fully supported
- •Consent Management: Explicit opt-in for data collection and processing
- •Data Processing: Standard contracts for any third-party processors
- •Privacy by Design: Privacy considerations built into all features
- •Breach Notification: Procedures in place for timely breach notification
ISO 15189 - Medical Laboratories
- •Quality Management: Supports QC workflows and quality metrics
- •Competence: Role-based access ensures qualified personnel review results
- •Equipment Management: Integrates with analyzer connectors for data integrity
- •Document Control: Version history and audit trails for all records
- •Incident Management: Error tracking and anomaly detection capabilities
HL7/ASTM - Healthcare Data Standards
- •HL7 v2.5 Message Support: Lab result transmission and integration
- •ASTM Standards: Compatible with laboratory analyzer interfaces
- •Interoperability: Supports data exchange with EHR systems
- •Data Integrity: Standard protocols ensure accurate data transmission
India IT Act, 2000
- •Sensitive Personal Data: Protected with encryption and access controls
- •Reasonable Security Practices: Implementation of information security management
- •Data Breach Notification: Procedures for notifying affected individuals
- •Information Security: Regular audits and security assessments
- •Data Protection: Compliance with Section 72 penalties for data breaches
Our Security Practices
Encryption
AES-256 encryption at rest, TLS 1.3 in transit
Authentication
Multi-factor authentication support, role-based access
Audit Logging
Complete audit trails of all data access and modifications
Data Isolation
Each user's data is logically isolated and encrypted
Secure Development
Regular security audits and penetration testing
Incident Response
Documented procedures for security incident response
Data Processing Philosophy
Labby X follows a "local-first" data processing model:
- 1Default Local: All data is stored locally on your device by default
- 2User Controlled: Cloud backup is entirely optional and user-controlled
- 3Encrypted End-to-End: Any cloud data is encrypted before transmission
- 4No Third-Party Access: We never sell or share your data
Legal and Regulatory Consultation
While Labby X implements best practices aligned with healthcare standards, compliance requirements vary significantly by:
- • Geographic jurisdiction (country, state, region)
- • Type of healthcare facility (hospital, diagnostic lab, research center)
- • Type of data processed (PHI, genetic data, imaging, etc.)
- • Regulatory body oversight
We strongly recommend consulting with legal counsel and compliance specialists before deploying Labby X in your organization to ensure full compliance with your specific regulatory requirements.