Medical Disclaimer
1. Intended Use Statement
Gluchol is a general wellness and nutritional awareness application that analyzes food images and generates non-clinical, population-level estimates of potential dietary impact related to:
- Blood sugar response (general glycemic load estimation)
- Cholesterol-related nutritional risk factors
- Sodium-related blood pressure impact
The application is intended solely to support general dietary awareness and lifestyle education.
The application is not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any disease or medical condition, including but not limited to diabetes, hyperlipidemia, hypertension, or cardiovascular disease.
2. Explicit Non-Medical Device Declaration
Gluchol:
- Does not measure physiological parameters
- Does not connect to medical devices
- Does not interpret laboratory values
- Does not analyze individual medical history
- Does not provide patient-specific clinical risk scoring
- Does not generate treatment recommendations
- Does not recommend medication changes
- Does not provide insulin dosing guidance
- Does not provide sodium restriction thresholds for diagnosed hypertensive patients
- Does not calculate ASCVD risk or other clinical cardiovascular risk scores
The application operates solely as an AI-driven dietary content estimation tool based on visual food analysis.
3. Population-Level Modeling Clarification
All outputs are derived from:
- Food recognition algorithms
- Publicly available nutritional databases
- Generalized macronutrient and sodium estimations
- Statistical dietary modeling frameworks
Outputs do not account for:
- Individual insulin sensitivity
- Diagnosed metabolic disorders
- Medication use
- Clinical blood lipid panels
- Personal blood pressure readings
- Genetic predisposition
- Physician-prescribed dietary plans
Therefore, results represent generalized dietary impact tendencies and not individualized clinical predictions.
4. No Physiological Monitoring
The app:
- Does not monitor real-time glucose levels
- Does not monitor blood pressure
- Does not measure cholesterol levels
- Does not replace laboratory testing
- Does not replace glucometers or sphygmomanometers
It analyzes food characteristics only — not user biometrics.
5. High-Risk User Advisory
Users who:
- Have diabetes (Type 1 or Type 2)
- Have prediabetes
- Have diagnosed hyperlipidemia
- Have diagnosed hypertension
- Are pregnant
- Are under physician-supervised dietary plans
Should consult a licensed healthcare provider before making dietary decisions based on app outputs.
6. No Clinical Decision Support (CDS)
The application does not:
- Integrate with Electronic Health Records (EHRs)
- Provide clinical decision support
- Generate diagnostic alerts
- Flag medical emergencies
- Trigger escalation protocols
It is not intended for use by healthcare professionals as a clinical decision-making tool.
7. Emergency Disclaimer
The app is not designed to detect medical emergencies.
If you experience symptoms such as:
- Chest pain
- Severe headache
- Shortness of breath
- Severe dizziness
- Extremely high or low blood sugar symptoms
Seek immediate medical attention.
8. Algorithm Transparency Statement
AI-generated outputs:
- Are probabilistic
- May contain recognition errors
- May misestimate portion sizes
- May not detect hidden ingredients
- Should not be interpreted as precise nutritional analysis
No guarantee of accuracy or clinical reliability is provided.
9. Regulatory Jurisdiction Positioning
This application is intended to fall under:
- "General Wellness Products" guidance per the U.S. Food and Drug Administration
- Lifestyle and well-being software under EU Medical Device Regulation
- Non-medical software under Medicines and Healthcare products Regulatory Agency interpretation frameworks
The app does not claim compliance as a certified medical device and is not CE marked or FDA cleared unless explicitly stated.
Gluchol