Legal & Compliance Center

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

πŸ”’ HIPAA Compliant
πŸ‡ͺπŸ‡Ί GDPR Compliant
πŸ₯ Built by Physicians
πŸ“‹ Zero-PHI Design

πŸ“‹ 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.

πŸ›‘οΈ Privacy-First Architecture

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

βœ“ Implemented

πŸ” End-to-End Encryption

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

βœ“ Active

πŸ“Š Regular Auditing

Continuous compliance monitoring and third-party security assessments.

βœ“ Ongoing

πŸ“ 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.

πŸ”¬

Eligible4 - Clinical Trial Platform

AI-powered clinical trial recruitment and management

βœ“ HIPAA Compliant
βœ“ GDPR Compliant
βœ“ FDA 21 CFR Part 11
βœ“ ICH GCP Guidelines
⚑

LeanColab - Process Optimization

Healthcare workflow optimization and Lean Six Sigma tools

βœ“ HIPAA Compliant
βœ“ GDPR Compliant
βœ“ ISO 27001 Aligned
βœ“ SOC 2 Type II
πŸ›οΈ

WardControl - Bed Management

AI-powered hospital bed management and patient flow optimization

βœ“ HIPAA Compliant
βœ“ GDPR Compliant
πŸ”„ FDA 510(k) Preparation
βœ“ HL7 FHIR Compatible
🚨

ReanimaTech - Emergency Response

Real-time AI guidance for cardiac arrest and emergency response

βœ“ HIPAA Compliant
βœ“ GDPR Compliant
πŸ”„ FDA Class II Device
βœ“ IEC 62304 Medical Software
πŸ‘₯

PatientFlow - Elderly Care AI

AI-powered elderly care optimization and readmission prevention

βœ“ HIPAA Compliant
βœ“ GDPR Compliant
βœ“ Medicare Compliance
πŸ”„ CMS Quality Measures
πŸ’Š

Calc-o-mycin - Antimicrobial Stewardship

AI-powered antibiotic dosing optimization and stewardship tools

βœ“ HIPAA Compliant
βœ“ GDPR Compliant
πŸ”„ FDA Software as Medical Device
βœ“ Joint Commission Standards

πŸ† 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 βœ“ Compliant βœ“ Compliant βœ“ 21 CFR Part 11 πŸ”„ In Progress βœ“ Compliant πŸ”„ Type II
LeanColab βœ“ Compliant βœ“ Compliant β€” N/A β€” N/A βœ“ Compliant βœ“ Compliant
WardControl βœ“ Compliant βœ“ Compliant πŸ”„ 510(k) Prep πŸ”„ In Progress βœ“ Compliant πŸ”„ Type I
ReanimaTech βœ“ Compliant βœ“ Compliant πŸ”„ Class II πŸ”„ Medical Device βœ“ Compliant πŸ”„ Type II
PatientFlow βœ“ Compliant βœ“ Compliant β€” N/A β€” N/A βœ“ Compliant βœ“ Compliant
Calc-o-mycin βœ“ Compliant βœ“ Compliant πŸ”„ SaMD Review πŸ”„ In Progress βœ“ Compliant πŸ”„ Type I

Compliance Status Legend

βœ“
Compliant
Fully compliant with standards but not formally certified
πŸ”„
In Progress
Certification or compliance validation underway
β€”
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.

πŸ“‹ Platform-Specific Notes

  • Eligible4: Clinical trial platform compliant with ICH GCP guidelines
  • LeanColab: 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