Skip to content

Intended Use & Claims Control

This document controls what IINTS-AF may and may not claim.

Approved Intended Use

IINTS-AF is an open-source research and education SDK for pre-clinical simulation of diabetes technology concepts. It can be used to:

  • simulate virtual glucose-insulin scenarios;
  • test candidate algorithms in a sandbox;
  • generate reproducible research artifacts;
  • explore physiology-inspired models and glucose forecasting;
  • inspect data quality using MDMP-style contracts;
  • run local AI review of simulation outputs for research discussion.

Excluded Intended Use

IINTS-AF must not be used for:

  • diagnosis;
  • treatment decisions;
  • insulin or glucagon dosing for a person;
  • real-time patient care;
  • clinical monitoring of a patient;
  • autonomous or semi-autonomous therapy;
  • claims of CE marking, MDR conformity, clinical safety, or clinical performance.

Approved Public Claim Pattern

Use wording like:

IINTS-AF is a research-only educational simulator for diabetes technology experimentation. It helps generate reproducible simulations, reports, and evidence artifacts. It is not a medical device and must not be used for treatment decisions.

Forbidden Claim Patterns

Do not use wording like:

  • "clinically validated insulin dosing";
  • "safe for patient use";
  • "approved medical AI";
  • "CE marked";
  • "doctor replacement";
  • "predicts patient glucose for treatment";
  • "connect this to a real pump for therapy".

Review Triggers

Stop and perform a formal regulatory review before any change that:

  • connects SDK output to real insulin or glucagon delivery;
  • markets the SDK for a clinical workflow;
  • adds patient-specific recommendations;
  • uses identifiable patient data outside local research processing;
  • enables remote cloud processing of health data;
  • adds automatic app updates without signed release verification;
  • adds broad Tauri filesystem, shell, network, or updater permissions.

Maintainer Checklist

Before release, confirm:

  • README contains the research-only boundary.
  • Desktop app header contains the medical-device boundary.
  • Reports and AI outputs do not produce treatment advice.
  • Release notes do not claim regulatory approval.
  • Screenshots and demo scripts avoid suggesting clinical deployment.