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HIPAASOC 2Vanta
Compliance & Security

Security Built for Healthcare

Medera is built from the ground up to meet the most rigorous healthcare compliance standards. Every layer of our platform — from infrastructure to algorithms — is designed to protect patient data and earn clinician trust.

Ethical AI

Principled by Design

Six foundational commitments govern every model we train, every feature we ship, and every patient interaction our agents facilitate.

Privacy-First Design

Every feature is architected with data minimization and purpose limitation at its core. Patient data is never used for model training without explicit, revocable consent.

Fairness & Equity

Continuous bias auditing across demographic groups ensures equitable outcomes. Our models are validated against diverse populations to prevent disparate impact.

Explainability & Trust

Every AI recommendation includes a transparent reasoning chain. Clinicians can inspect the evidence, weighting factors, and confidence intervals behind each output.

Human-in-the-Loop Oversight

AI augments clinical judgment — it never replaces it. All care-impacting decisions require licensed clinician review before reaching patients.

Patient-Driven Intelligence

Patients control their data, can review AI-generated insights, and have the right to opt out of algorithmic decision-making at any time.

Continuous Ethical Alignment

Our Ethics Advisory Board conducts quarterly reviews of model behavior, bias metrics, and patient outcomes to ensure ongoing alignment with clinical best practices.

Certifications

Industry-Leading Compliance

Independently audited and certified against the frameworks healthcare organizations require.

HIPAA

Health Insurance Portability & Accountability Act

Full administrative, physical, and technical safeguard compliance. Business Associate Agreements executed with all covered entities.

SOC 2 Type II

Service Organization Control

Independent third-party audit validating security, availability, processing integrity, confidentiality, and privacy controls over a 12-month observation period.

HITRUST CSF

Common Security Framework

r2 certified against the HITRUST CSF, harmonizing requirements from HIPAA, NIST, ISO 27001, PCI-DSS, and COBIT into a single framework.

ISO 27001

Information Security Management

Certified information security management system covering risk assessment, access control, cryptography, and incident response across all operational domains.

Infrastructure

Technical Security

Defense-in-depth security controls protect patient data at every layer of the stack.

AES-256-GCM encryption at rest

All PHI encrypted with AES-256 in Galois/Counter Mode with authenticated encryption and per-record initialization vectors.

TLS 1.3 in transit

All data in motion protected with TLS 1.3, forward secrecy via X25519 key exchange, and certificate pinning on mobile clients.

Row-level security (RLS)

Database-enforced tenant isolation ensures queries never cross organizational boundaries, verified by automated policy tests.

PHI tokenization

Sensitive identifiers replaced with irreversible tokens before entering analytics pipelines, ensuring de-identification at the data layer.

Key rotation (90-day cycle)

Encryption keys automatically rotated every 90 days with zero-downtime re-encryption and full key lineage tracking in HSM.

Zero-trust architecture

Every request authenticated and authorized regardless of network location. No implicit trust — identity verified at every layer.

Regulatory

42 CFR Part 2 Compliance

Substance use disorder (SUD) records demand the highest level of protection under federal law. Medera implements the full spectrum of 42 CFR Part 2 requirements, ensuring SUD data is segmented, consent-gated, and never disclosed without explicit patient authorization.

  • Granular consent management with revocation tracking
  • SUD data segmentation from general medical records
  • Re-disclosure prohibition enforcement at the API layer
  • Audit logging of every SUD data access event

Substance Use Disorder Protection

42 CFR Part 2 · Federal Regulation

Data SegmentationComplete
Consent GatewayActive
Re-Disclosure ControlsEnforced
Break-the-Glass ProtocolConfigured

Audit Log Architecture

14:32:07.412PHI_ACCESSdr.chenGRANTED
14:32:08.001RECORD_VIEWdr.chenLOGGED
14:33:12.889EXPORT_REQnurse.kimPENDING
14:33:14.102EXPORT_REQnurse.kimAPPROVED
14:34:01.556INTEGRITY_CHECKsystemVERIFIED
Auditability

Immutable Audit Trail

Every interaction with protected health information is recorded in a tamper-evident audit log designed for regulatory examination and forensic analysis.

PHI Audit Logging

Every read, write, and export of patient data is captured with user identity, timestamp, IP address, and action context.

6-Year Retention

Audit records are retained for a minimum of six years in compliance with HIPAA requirements, stored in immutable append-only storage.

Merkle Tree Integrity

Log entries are chained using Merkle tree hashing, making any tampering cryptographically detectable and independently verifiable.

Clinical Governance

Human-Centered Oversight

AI is only as safe as the governance surrounding it. Our clinical oversight framework ensures every automated action is accountable.

Board-Certified Clinician Review

All clinical AI outputs are reviewed by board-certified physicians and licensed mental health professionals before deployment. Model updates require clinical sign-off.

Crisis Detection & Response

Real-time monitoring for indicators of self-harm, suicidal ideation, and acute distress. Immediate escalation to licensed crisis counselors with warm handoff protocols.

Escalation Protocols

Multi-tier escalation framework with defined SLAs: automated triage within 30 seconds, clinical review within 5 minutes, and executive notification for critical events.

Get Started

Request Compliance Documentation

Our security team is ready to share SOC 2 reports, penetration test summaries, BAA templates, and detailed architecture documentation with your compliance team.