Privacy Notice

Last Updated: May 28, 2025

At Fasikl, Inc., data security, transparency, and regulatory compliance form the cornerstone of our Neuro-AI medical technology platform. This Privacy Notice details our enterprise standards regarding the handling, processing, and protection of personal data and Protected Health Information (PHI) acquired through our global digital infrastructure, clinical portals, and the Felix NeuroAI Wristband app.

1. Global Compliance Framework & Scope

Fasikl operates under international medical data security protocols. As an entity delivering FDA-cleared AI therapeutics and advanced nerve-computer interfaces, our operational frameworks strictly adhere to HIPAA regulations, GDPR compliance principles, and relevant international data privacy laws. This ensures clinical partners, healthcare distributors, and patients operate within a certified, audit-ready bioelectronic ecosystem.

2. Data Collection Categories

To provide high-fidelity closed-loop neuromodulation and secure institutional procurement services, we categorize data collection into two distinct streams:

3. Purpose & Legal Basis of Data Utilization

Data acquired by Fasikl is strictly utilized to fulfill medical, operational, and research parameters, including:

• Closed-Loop Algorithm Optimization: Real-time neuromuscular sensor readings are algorithmically analyzed to dynamically adjust peripheral nerve stimulation parameters.
• Clinical Verification & Account Management: Secure authentication pathways prevent unauthorized access to prescription device controls.
• Enterprise Support & Technical Diagnostics: Telemetry logs allow engineering teams to troubleshoot hardware and cloud interactions efficiently.
• Regulatory Quality Systems: System data supports post-market surveillance required by international medical device regulatory authorities.

4. Data Sharing & Institutional Governance

Fasikl enforces strict access boundaries. We do not sell, rent, or commercialize personal data or PHI under any circumstances. Information sharing is bounded strictly to authorized clinical entities:

• Certified Cloud Infrastructure: Data is hosted within SOC 2 Type II and ISO 27001-certified enterprise environments (e.g., Google Cloud Platform Medical Infrastructure).
• Fulfillment & DME Operations: Authorized fulfillment partners receive necessary logistics information under signed Business Associate Agreements (BAAs).
• Prescribing Healthcare Clinicians: Authorized movement disorder specialists receive user consent-based therapy performance metrics to guide longitudinal treatment decisions.

5. Enterprise Security Safeguards

Fasikl implements multi-layered technical and organizational cybersecurity controls designed for medical-grade platforms:

• End-to-End Encryption: All data in transit utilizes TLS 1.3 encryption protocols, while stored data is protected using AES-256 standard encryption.
• Role-Based Access Control (RBAC): Administrative access to cloud databases requires multi-factor authentication (MFA) and zero-trust verification.
• Continuous Monitoring: Real-time threat detection systems monitor infrastructure for unauthorized access attempts or system anomalies.

6. International Data Rights & Regulatory Contacts

Depending on geographical location, enterprise partners and clinical users possess specific statutory rights regarding data access, rectification, restricted processing, and account deletion. To exercise data governance rights, or to submit formal compliance queries, organizational representatives can contact our Data Protection Officer directly at [email protected] or via written communication to:

Fasikl Data Protection & Compliance Office
8500 Normandale Lake Blvd, Suite 400A
Bloomington, MN 55437, United States