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Why CIRISMedical Uses CML

CIRIS Medical License - Protecting Patients, Practitioners, and Progress

⚠️ Critical: Medical Software Cannot Be Fully Open Source

Unlike general AI, medical AI carries life-or-death responsibility. Open source licenses like MIT or Apache cannot adequately address medical liability, FDA compliance, or patient safety requirements. This is why we created the CIRIS Medical License (CML).

The Liability Challenge

Why Standard Open Source Fails for Medical AI

  • No Liability Protection: MIT/Apache licenses disclaim all liability - impossible for medical software where errors can be fatal
  • No Supervision Requirements: Anyone could deploy it without physician oversight, creating massive risk
  • No Compliance Tracking: FDA requires 7-year audit trails - open source can't enforce this
  • No Usage Restrictions: Could be used for unauthorized autonomous diagnosis or prescription

The CML Solution

CIRIS Medical License Requirements

  • Mandatory Physician Supervision: Cannot operate without verified medical professional oversight
  • Liability Assignment: Clear chain of responsibility from AI to supervisor to medical facility
  • Audit Requirements: Enforces FDA-compliant logging and 7-year retention
  • Usage Restrictions: Prohibits autonomous diagnosis, requires human verification for critical decisions
  • Insurance Requirements: Deployments must have medical malpractice coverage

What This Means

✅ You CAN:

  • • Deploy with proper medical supervision
  • • Use in clinical settings with oversight
  • • Modify for your medical facility's needs
  • • Integrate with existing medical systems
  • • Train local health workers to use it
  • • Deploy in humanitarian missions

❌ You CANNOT:

  • • Deploy without physician supervision
  • • Use for autonomous diagnosis
  • • Remove safety checks or audit logs
  • • Claim it replaces doctors
  • • Use without liability insurance
  • • Deploy without regulatory compliance

The Bigger Picture

CIRISAgent remains fully open source under the CIRIS Covenant for general AI applications. The medical capabilities are completely separated into CIRISMedical with CML licensing.

This separation ensures:

  • • General AI remains freely available to all
  • • Medical AI has proper safeguards
  • • Clear liability boundaries
  • • No medical code in the open source version

We believe healthcare is a human right, but patient safety must come first. The CML ensures CIRISMedical saves lives without risking them.

Comparison Table

AspectOpen Source (MIT/Apache)CML (CIRIS Medical License)
LiabilityCompletely disclaimedAssigned to supervisor/facility
SupervisionOptionalMandatory physician oversight
FDA ComplianceNot addressedBuilt-in requirements
Audit TrailOptional7-year retention required
InsuranceNot requiredMalpractice coverage required
DeploymentAnyone, anywhereLicensed medical facilities only
ModificationsUnrestrictedAllowed with safety preservation
Commercial UseAllowedAllowed with compliance

For NGOs and Humanitarian Use

Special provisions exist for humanitarian deployments:

  • • Reduced licensing fees for qualified NGOs
  • • Expedited approval for crisis response
  • • Support for training local health workers
  • • Partnership programs with medical schools

Contact humanitarian@cirismedical.ai for humanitarian licensing.

Legal Framework

International Compliance

CML is designed to meet requirements in multiple jurisdictions including FDA (USA), CE marking (EU), PMDC (Pakistan), and WHO guidelines.

Liability Chain

1. AI provides recommendation → 2. Physician reviews → 3. Medical facility implements → 4. Clear accountability at each step

Insurance Requirements

Deployments must maintain medical malpractice insurance appropriate to their jurisdiction and scope of practice.

Ready to Deploy Responsibly?

Join medical facilities worldwide in bringing AI-assisted healthcare to those who need it most.