Healthcare Compliance Made Simple

Protect patient data, ensure HIPAA compliance, and meet FDA requirements with AI-powered scanning across all your healthcare systems.

HIPAA Certified Scanning
FDA 21 CFR Part 11 Ready
Healthcare SOC 2 Audited

Healthcare Compliance Crisis

The cost of non-compliance in healthcare is at an all-time high

714
Healthcare Data Breaches
in 2023
+15%
$10.9M
Average Breach Cost
per incident
+13%
$5.1M
HIPAA Violations
in fines (2023)
+22%
312%
Compliance ROI
average return
+8%

Healthcare Compliance Frameworks We Cover

Comprehensive coverage of healthcare-specific regulations

HIPAA
critical

Health Insurance Portability and Accountability Act - Protecting patient health information

Fines: $100 - $1.9M per incident
FDA 21 CFR Part 11
critical

Electronic Records and Electronic Signatures in clinical trials and medical devices

Fines: $15K - $500K per violation
Medical Device Regulation (MDR)
high

EU regulation for medical device safety and compliance

Fines: €5M - 4% of global turnover
GDPR (Healthcare)
critical

Special healthcare provisions under EU data protection law

Fines: €20M - 4% of global turnover
HIPAA Requirements
Secure patient health information (PHI)
Access controls and audit trails
Employee training and policies
Risk assessments and breach notification

Common Healthcare Compliance Challenges

We solve the most critical healthcare compliance issues

Patient Data Protection

Securing sensitive health information across digital platforms

Critical - Direct patient safety and legal liability

Our Solutions:

Automated PHI scanning
Access control auditing
Breach detection
Multi-Regulatory Compliance

Meeting HIPAA, FDA, MDR, and GDPR simultaneously

High - Complex overlapping requirements

Our Solutions:

Unified compliance dashboard
Framework mapping
Gap analysis
Clinical Trial Data Integrity

Ensuring accurate and tamper-proof research data

Critical - FDA approval and patient safety

Our Solutions:

Electronic signature validation
Audit trails
Data integrity checks

Built for Healthcare Organizations

Specialized features for healthcare compliance needs

PHI Detection & Protection

Automatically identify and secure Protected Health Information across all systems

Clinical Trial Compliance

Ensure FDA 21 CFR Part 11 compliance for electronic records and signatures

Multi-Site Management

Centralized compliance monitoring across hospitals, clinics, and research facilities

Real-Time Breach Detection

Instant alerts for potential HIPAA violations and security incidents

Audit-Ready Documentation

Generate comprehensive compliance reports for regulatory audits

Enterprise Integration

Seamless integration with EMRs, PACS, and healthcare management systems

Protect Your Patients and Your Organization

Join hundreds of healthcare organizations using our AI-powered compliance platform to protect patient data and avoid costly violations.

Trusted by 150+ healthcare organizations • 99.7% uptime • SOC 2 Type II certified
Embodier.ai - AI Act Compliance Scanner | Norwegian Gold Standard