mala.dev
healthcare

AI Governance for
Healthcare & Life Sciences

When AI touches patient care, accountability isn't optional.

21 CFR
Part 11 Compliant
HIPAA
§164.312 Ready
Zero
PHI Exposure
The Challenge

The Healthcare AI Challenge

AI is assisting with diagnosis, treatment recommendations, and administrative decisions. FDA and CMS require complete audit trails. Patient safety demands it.

Regulatory Frameworks
21 CFR Part 11
FDA Electronic Records

Requires electronic signatures, audit trails, and system validation for software affecting patient safety.

HIPAA §164.312
Technical Safeguards

Mandates access controls, audit controls, and integrity controls for PHI.

CDS Rules
Clinical Decision Support

FDA guidance on AI/ML-based clinical decision support software.

HITECH
Health IT for Economic and Clinical Health

Strengthens HIPAA enforcement with breach notification requirements.

Use Cases
01

Clinical Decision Support

Document the reasoning behind AI-assisted diagnosis and treatment recommendations.

→ Defend clinical decisions with complete evidence chains

02

Claims Processing

Capture why claims were approved, denied, or flagged for review.

→ Reduce appeals and demonstrate fair claims handling

03

Prior Authorization

Seal the policies and precedents that informed authorization decisions.

→ Meet CMS interoperability requirements with full transparency

Security Features
VPC-native deployment - PHI never leaves your infrastructure
HIPAA BAA available
SOC 2 Type II certified
AES-256 encryption at rest and in transit
In Their Words

"Case study coming soon"

Regional Hospital Network
Chief Medical Information Officer
Private Alpha
Protect patients. Prove compliance.

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