Do you sell or share patient data?
Never. Data is not sold or used for marketing.
Privacy & Compliance
Overview
MultiOmics Inc. maintains strict privacy, consent, and data‑security practices to protect patient and clinical information associated with LiquidMammo™, our microRNA‑based supplemental screening test.
LiquidMammo is being developed as a CLIA Laboratory Developed Test (LDT). It is not yet FDA‑cleared or FDA‑approved.
HIPAA alignment
- All Protected Health Information (PHI) is handled under HIPAA‑aligned workflows.
- PHI is encrypted at rest and in transit.
- Access is restricted to authorized clinical and laboratory staff.
- Audit logs track all PHI access and modifications.
- No PHI is shared externally without authorization.
Consent & data use
All patient samples and associated information follow informed‑consent pathways that specify permitted uses and data‑sharing restrictions.
- Consent scopes are respected without exception.
- Secondary use must align with original consent language.
- De‑identified data may be used for internal validation and QA.
- External collaborators receive only de‑identified datasets.
Data protection safeguards
- Industry‑standard encryption and access controls.
- SOP‑driven lab and data workflows.
- Segregated environments for PHI vs. de‑identified datasets.
- Regular internal and external security reviews.
- Retention and deletion based on regulatory guidelines.
CLIA LDT compliance
LiquidMammo is developed and validated under CLIA Laboratory Developed Test practices.
- CLIA‑certified laboratory environment.
- Analytical accuracy, precision, and reproducibility validation.
- Quality management and proficiency testing.
- Comprehensive documentation and SOPs.
Data access requests
Researchers requesting data access must submit a brief concept note outlining study aims. Only de‑identified datasets are eligible for release.
Frequently asked
Do research partners receive PHI?
No. Only de‑identified datasets may be shared following review and approval.
How long is data retained?
Retention follows CLIA, HIPAA, and state regulatory requirements.