Medical Disclaimer

Medical Disclaimer & Terms of Use

Important Notice: Not a Medical Device or Diagnostic Tool

The NIOMI app, portal, microbiome analysis services, and all associated content (collectively, "NIOMI Services") are provided for informational, educational, and wellness purposes only. NIOMI Services are not intended to diagnose, treat, cure, or prevent any disease or medical condition, and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Intended Use

NIOMI Services are designed to:

Provide personalized insights about your gut microbiome composition based on fecal sample analysis
Offer lifestyle and dietary guidance aimed at supporting general wellness and wellbeing
Help users understand potential connections between gut health and overall health indicators
Deliver evidence-based nutritional recommendations for health optimization

NIOMI is not a medical device and has not received regulatory clearance or approval from the FDA, EMA, or other medical regulatory bodies for diagnostic or therapeutic purposes.

Limitations and Disclaimers

1. Not for Medical Diagnosis or Treatment

NIOMI Services do not provide medical diagnoses or clinical assessments
Results should not be used to diagnose, monitor, or treat any medical condition
Do not use NIOMI Services to make medical decisions without consulting qualified healthcare professionals
If you have or suspect you have a medical condition, consult your physician immediately

2. Not a Replacement for Professional Healthcare

Always consult with a qualified healthcare provider before:
- Making dietary changes based on NIOMI recommendations
- Starting or stopping any medications or supplements
- Interpreting your results in the context of existing medical conditions
- Making any health-related decisions
NIOMI does not replace regular medical check-ups, screenings, or professional healthcare

3. Individual Results May Vary

Microbiome composition is highly individual and dynamic
Results represent a snapshot in time and may change due to diet, medications, stress, illness, and other factors
Personalized recommendations are based on current scientific literature and may not be suitable for everyone
The relationship between microbiome composition and health outcomes is an evolving area of research

4. Limitations of Current Science

While research supports connections between gut microbiome and health, the field is still developing
Not all microbiome-health relationships are fully understood or conclusively established
Individual responses to dietary and lifestyle interventions vary significantly
Scientific understanding of the microbiome continues to evolve

Scientific Foundation and Citations

NIOMI's recommendations are derived from:

Peer-reviewed scientific literature on gut microbiome research
Published clinical studies linking microbiome composition to health indicators
Evidence-based nutritional science and dietary guidelines
Current understanding of microbiome-host interactions

Key Scientific Sources Supporting NIOMI's Approach:

Users can access detailed citations and scientific references through:

NIOMI Website: https://www.niomihealth.com/scientific-references
Research Database: Published studies supporting gut health and nutrition recommendations

These resources include links to peer-reviewed journals, clinical studies, and established nutritional guidelines that inform NIOMI's algorithms and recommendations.

Data Privacy and Confidentiality

GDPR Compliance

NIOMI is fully compliant with the General Data Protection Regulation (GDPR) and all applicable data protection laws:

Your health data is strictly confidential and encrypted
Personal health information is never shared with third parties without explicit consent
You maintain full control over your data, including rights to access, modify, and delete
All data handling complies with GDPR Articles 6, 9, and 32

Confidentiality Requirements

Analysis results are confidential and for personal use only
Do not share your NIOMI account credentials with others
Results should not be shared with third parties without proper privacy considerations
Healthcare providers accessing your data (with your permission) must respect patient confidentiality

For complete privacy details, see our Privacy Policy at: https://www.niomihealth.com/policies/privacy-policy

Special Populations and Contraindications

Consult Your Healthcare Provider Before Use If You:

Are pregnant, nursing, or planning pregnancy
Have any diagnosed medical conditions (including but not limited to: IBD, IBS, celiac disease, diabetes, autoimmune disorders)
Are taking prescription medications
Are under 18 years of age
Have compromised immune function
Have a history of eating disorders
Are following a medically prescribed diet

Not Suitable For:

Active diagnosis or monitoring of gastrointestinal diseases
Emergency medical situations
Individuals requiring immediate medical attention
Replacement of medically necessary testing or monitoring

Dietary Recommendations and Supplements

Nutritional Guidance

NIOMI provides general nutritional guidance based on microbiome analysis
Recommendations are educational suggestions, not medical prescriptions
Always consider your individual health status, allergies, and dietary restrictions
Consult a registered dietitian or nutritionist for personalized medical nutrition therapy

Supplement Recommendations

Any supplement suggestions are for informational purposes only
Consult your healthcare provider before starting any supplement regimen
Supplements may interact with medications or medical conditions
NIOMI does not prescribe, sell, or endorse specific supplement products

Accuracy and Quality Assurance

NIOMI employs:

Validated laboratory testing methods for microbiome analysis
Quality control procedures to ensure result accuracy
Regular calibration and validation of testing equipment
Trained laboratory professionals following established protocols

However:

No test is 100% accurate
Results should be interpreted in context with other health information
Technical limitations may affect certain samples
Rare errors in sample collection, processing, or analysis may occur

Changes to Recommendations

As scientific understanding evolves:

NIOMI may update recommendations based on new research
Previous recommendations may be refined or modified
Users will be notified of significant changes affecting their health plans
Historical data and recommendations remain accessible in your account

Liability Limitations

To the fullest extent permitted by law:

NIOMI and Metaceutic ApS are not liable for decisions made based on NIOMI Services
Users assume full responsibility for health decisions and outcomes
NIOMI is not liable for indirect, incidental, or consequential damages
Maximum liability is limited to the amount paid for NIOMI Services

This disclaimer does not affect your statutory rights under applicable consumer protection laws.

Acceptance of Terms

By using NIOMI Services, you acknowledge that you have read, understood, and agree to this Medical Disclaimer. You confirm that:

You understand NIOMI is not a medical device or diagnostic tool
You will consult healthcare professionals for medical advice
You will not rely solely on NIOMI for health decisions
You accept responsibility for how you use NIOMI information

Contact Information

Medical Concerns: Contact your healthcare provider

NIOMI Services:

Email: niomi@metaceutic.com
Website: https://www.niomihealth.com/

Data Privacy:

Regulatory Information

Company: Metaceutic ApS
Product: NIOMI
Classification: Wellness and lifestyle information service (not a medical device)
Regulatory Status: Not FDA-cleared, not CE-marked as medical device

Last Updated: October 1st, 2025

This disclaimer is provided in compliance with Apple App Store Guidelines 1.4.1 and applicable consumer protection regulations. NIOMI is committed to providing transparent, science-based wellness information while clearly distinguishing our services from medical diagnosis and treatment.