Legal & Clinical Policy

Medical Disclaimer & Terms of Use

Last Updated: September 2026 • FDA Non-Device Clinical Decision Support (CDS) Status

1. Not a Substitute for Professional Medical Advice

Important

AskZeni and its AI persona "Zeni" are educational, consumer-facing health navigation tools. The contents, multi-model comparisons, consensus points, and doctor visit prep summaries provided on AskZeni are for informational and preparatory purposes only. They do not constitute formal medical advice, clinical diagnoses, treatment recommendations, or medical prescriptions.

Always seek the direct guidance of your physician or qualified healthcare provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read or generated on AskZeni.

2. Emergency Notice & Urgent Medical Situations

Emergency Protocol

If you are experiencing a life-threatening medical emergency—including but not limited to severe crushing chest pain, sudden shortness of breath, numbness on one side of your face/body, slurred speech, or uncontrollable bleeding—do not use this website.

In the United States, immediately contact emergency services (call 911) or go to the nearest hospital emergency department. Outside the U.S., contact your local emergency medical response service.

3. FDA Non-Device Clinical Decision Support (CDS) Compliance

21st Century Cures Act

AskZeni operates in full compliance with the 21st Century Cures Act Section 520(o)(1)(E) and the U.S. Food and Drug Administration (FDA) Guidance on Non-Device Clinical Decision Support Software:

Transparent Literature Citations: We display the underlying rationale, citations, and medical source literature for all consensus conclusions.

Independent Clinical Review: We enable health consumers and licensed clinicians to independently review the basis for every AI model output.

No Closed-Loop Device Control: We do not process continuous physiological signals or trigger automated device interventions.

Multi-Model Conflict Flagging: Disagreements between frontier models are explicitly highlighted in red to eliminate single-AI hallucination risks.

4. Regulatory Notice for EU / EEA Citizens

EU MDR Scope

Educational Information Service Only - Not a CE-Marked Medical Device. AskZeni does not market diagnostic software within the European Economic Area under EU Medical Device Regulation (EU MDR 2017/745). European users access AskZeni solely as an informational search comparator for health and wellness inquiries.

5. Bringing AskZeni Reports to Your Doctor Visit

Our 1-page printable Doctor Visit Prep Guides and topic-by-topic question checklists are specifically engineered to facilitate productive, high-efficiency conversations with your licensed healthcare provider during standard 15-minute consultations. Always hand your generated summary directly to your physician for diagnostic review.

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