Healthcare-Grade Security & Compliance
SOC 2, HIPAA, 510(k) cleared. Your data, protected. Enterprise-grade security so you can focus on patient care.
Meeting the highest regulatory standards in healthcare
HIPAA
In Progress via Vanta
SOC 2 Type II
In Progress via Vanta
FDA
510(k) Cleared
Samsung Knox
Enterprise Secured
GDPR
Compliant
California AI
AB 2013 & AB 3030
Comprehensive protection for healthcare data and operations
Encryption
End-to-end encryption for data in transit and at rest
- \u2713 AES-256 encryption
- \u2713 TLS 1.3 protocols
- \u2713 Key management
- \u2713 Zero-trust architecture
Monitoring
24/7 security monitoring and threat detection
- \u2713 Real-time monitoring
- \u2713 Threat detection
- \u2713 Incident response
- \u2713 Security analytics
Audit Trails
Comprehensive logging and audit capabilities
- \u2713 Complete audit logs
- \u2713 User activity tracking
- \u2713 Compliance reporting
- \u2713 Data lineage
Data Protection
Advanced data protection and privacy controls
- \u2713 Data anonymization
- \u2713 Access controls
- \u2713 Backup & recovery
- \u2713 Retention policies
Privacy by Design
Our platform is built with privacy and security as core principles, not afterthoughts. Every component is designed to protect patient data while enabling clinical excellence.
- Data minimization and purpose limitation
- Consent management and patient rights
- Secure multi-tenancy and isolation
- Regular penetration testing and audits
- Incident response and breach notification
- Staff security training and background checks
AI Governance & Transparency
In compliance with California's AI transparency laws (AB 2013 and AB 3030), we maintain comprehensive documentation and governance of our AI systems.
- AI Training Data Transparency — Detailed disclosure of data sources, collection methods, and processing procedures per AB 2013
- Healthcare AI Disclosures — All AI-generated clinical communications include required disclosures per AB 3030
- 5-Layer Governance Framework — Human oversight for all clinical decisions with documented audit trails
- Transparent AI decision-making with explainable outputs
AB 2013 Compliant
AI Training Data Transparency Act
AB 3030 Compliant
Healthcare AI Disclosure Requirements
Is digitalhumanOS™ HIPAA compliant?
Yes. digitalhumanOS™ is HIPAA-native by architecture, not just by policy. Infrastructure is powered by Vanta with AES-256 encryption at rest, TLS 1.3 in transit, zero-trust access controls, and tamper-proof audit logging for all patient data. Business Associate Agreements are executed with every clinical deployment.
What security certifications does Scienza Health have?
SOC 2 Type II certification verified through Vanta, HIPAA compliance across clinical and corporate channels, 510(k) clearance for GIA®, GDPR compliance for international deployments, and Samsung Knox enterprise security on all Health Grade Galaxy devices. Quarterly bias audits and tamper-proof audit trails across every screening session.
How does Samsung Knox protect healthcare data?
Samsung Knox provides hardware-level security on every Health Grade Galaxy device running GIA® by Scienza Health. Secure boot verifies system integrity before the device starts. Real-time kernel protection monitors for tampering during operation. Containerization isolates patient data so it remains protected even if the device is physically compromised.
What is SOC 2 Type II certification for healthcare?
SOC 2 Type I confirms security controls are properly designed. SOC 2 Type II confirms those controls are operating effectively over an extended audit period. The distinction matters in healthcare: Type II validates that security, availability, processing integrity, confidentiality, and privacy controls work consistently under real clinical conditions, not just on paper.
How is patient data encrypted?
All patient data processed by GIA® by Scienza Health is encrypted with AES-256 at rest and TLS 1.3 in transit. Zero-trust architecture ensures no single access point can expose data. Hardware security modules manage encryption keys. Samsung Knox adds a hardware-level encryption layer on every deployed device. No unencrypted patient data exists at any point in the screening pipeline.
What 510(k) clearances does Scienza Health have?
GIA® by Scienza Health is 510(k) cleared for multimodal clinical screening across 46 cognitive, behavioral, and neurological conditions. Peer-reviewed accuracy: Depression 81.6%, PTSD 80.0%, Anxiety 77.5%, Parkinson’s AUC 0.97. Clinician review is required before any result enters the clinical record.
How does the platform maintain data privacy?
Privacy by design across every layer. Data minimization limits collection to what the screening requires. Purpose limitation prevents data from being used beyond its clinical intent. Consent is recorded before every session. Multi-tenancy isolation ensures complete data separation between facilities. In corporate deployments, no protected health information is returned to the employer.
What are the data retention policies?
Data retention follows healthcare regulations and individual customer agreements. Comprehensive audit logs document every screening interaction. Automated backup and recovery ensure data integrity and availability. Retention periods are configurable per deployment. When data deletion is requested, it is executed across all systems and confirmed with a tamper-proof deletion record.
Is Scienza Health compliant with California AI laws?
Yes. Scienza Health complies with California AB 2013 (AI Training Data Transparency Act) by publishing detailed documentation of training data sources and methodology. AB 3030 (Healthcare AI Disclosure) compliance is maintained through clear disclosures on all AI-generated healthcare communications. GIA® by Scienza Health operates as a screening tool. All results require clinician review before any clinical action.
Is AI clinical screening HIPAA compliant?
HIPAA compliance requires architecture, not just policy. GIA® by Scienza Health encrypts all patient data with AES-256 at rest and TLS 1.3 in transit. Zero-trust access controls and tamper-proof audit trails cover every session. Business Associate Agreements are executed with every clinical deployment. For corporate channels, no protected health information is returned to the employer. SOC 2 Type II certified. GDPR compliant.
Trust in Every Interaction
Learn more about our comprehensive security and compliance framework.
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