Legal & Compliance Center

Comprehensive legal documentation and regulatory compliance information for all Reconquering Medicine healthcare technology platforms

🔒 HIPAA Compliant
🇪🇺 GDPR Compliant
🏥 Built by Physicians
📋 Zero-PHI Design

📋 Compliance Overview

All Reconquering Medicine platforms are designed from the ground up with healthcare compliance at their core. Our physician-founded team ensures each solution meets the highest standards of privacy, security, and regulatory adherence across multiple jurisdictions.

🛡️ Privacy-First Architecture

Zero-PHI approach minimizes patient data exposure while maximizing operational insights.

✓ Implemented

🔐 End-to-End Encryption

AES-256 encryption for all data transmission and storage across all platforms.

✓ Active

📊 Regular Auditing

Continuous compliance monitoring and third-party security assessments.

✓ Ongoing

📁 Platform-Specific Legal Documentation

Each platform has comprehensive legal documentation tailored to its specific use case and regulatory requirements. Click on any document to access the full legal text.

🔬

Eligible4 - Clinical Trial Platform

AI-powered clinical trial recruitment and management

✓ HIPAA Compliant
✓ GDPR Compliant
✓ FDA 21 CFR Part 11
✓ ICH GCP Guidelines
⚡

SLean - Process Optimization

Healthcare workflow optimization and Lean Six Sigma tools

✓ HIPAA Compliant
✓ GDPR Compliant
✓ ISO 27001 Aligned
✓ SOC 2 Type II
🛏️

WardControl - Bed Management

AI-powered hospital bed management and patient flow optimization

✓ HIPAA Compliant
✓ GDPR Compliant
🔄 FDA 510(k) Preparation
✓ HL7 FHIR Compatible
🚨

ReanimaTech - Emergency Response

Real-time AI guidance for cardiac arrest and emergency response

✓ HIPAA Compliant
✓ GDPR Compliant
🔄 FDA Class II Device
✓ IEC 62304 Medical Software
👥

PatientFlow - Elderly Care AI

AI-powered elderly care optimization and readmission prevention

✓ HIPAA Compliant
✓ GDPR Compliant
✓ Medicare Compliance
🔄 CMS Quality Measures
💊

Calc-o-mycin - Antimicrobial Stewardship

AI-powered antibiotic dosing optimization and stewardship tools

✓ HIPAA Compliant
✓ GDPR Compliant
🔄 FDA Software as Medical Device
✓ Joint Commission Standards

🏆 Compliance Framework & Validation

Our comprehensive compliance framework ensures adherence to healthcare regulations. While formal third-party certifications are in progress, we maintain full compliance with all applicable standards and undergo regular validation assessments.

Platform HIPAA GDPR FDA CE Mark ISO 27001 SOC 2
Eligible4 ✓ Compliant ✓ Compliant ✓ 21 CFR Part 11 🔄 In Progress ✓ Compliant 🔄 Type II
SLean ✓ Compliant ✓ Compliant — N/A — N/A ✓ Compliant ✓ Compliant
WardControl ✓ Compliant ✓ Compliant 🔄 510(k) Prep 🔄 In Progress ✓ Compliant 🔄 Type I
ReanimaTech ✓ Compliant ✓ Compliant 🔄 Class II 🔄 Medical Device ✓ Compliant 🔄 Type II
PatientFlow ✓ Compliant ✓ Compliant — N/A — N/A ✓ Compliant ✓ Compliant
Calc-o-mycin ✓ Compliant ✓ Compliant 🔄 SaMD Review 🔄 In Progress ✓ Compliant 🔄 Type I

Compliance Status Legend

✓
Compliant
Fully compliant with standards but not formally certified
🔄
In Progress
Certification or compliance validation underway
—
N/A
Not applicable for this platform type
ℹ️
Important Note on Compliance Status

All platforms marked as "Compliant" have been designed and built to meet the specified regulatory standards and have undergone internal compliance validation. While we maintain full compliance with these standards, formal third-party certification processes are ongoing as part of our growth strategy. Healthcare institutions can request detailed compliance documentation and validation reports for due diligence purposes.

📋 Platform-Specific Notes

  • Eligible4: Clinical trial platform compliant with ICH GCP guidelines
  • SLean: Process optimization tool, no medical device classification required
  • WardControl: Bed management system preparing for FDA 510(k) submission
  • ReanimaTech: Resuscitation audit and debriefing coach for training programs (educational software)
  • PatientFlow: Elderly care management platform; ML decompensation detection in development
  • Calc-o-mycin: Digital twin simulation platform for antimicrobial stewardship education (classification under regulatory review)

Need detailed compliance documentation?

Contact our compliance team: compliance@reconqueringmed.com