Health Disclaimer

Vaely is a personal wellness journal designed to help you log your own symptoms, medications, and observations, and to summarize them back to you in your own words. It is not a medical device. It does not provide medical advice. The sections below say so in the specific terms that the App Store, Apple's review team, and global health regulators expect.

1. Vaely is a personal wellness journal, not a medical device

Vaely is intended for general health-and-wellness journaling. It is not a medical device under the United States Food and Drug Administration's interpretation of the Federal Food, Drug, and Cosmetic Act, not a medical device under the European Union Medical Device Regulation 2017/745, not a Class I, II, or III device under any jurisdiction's regulatory framework, and not a Software as a Medical Device (SaMD) under the IMDRF guidance.

Vaely's category on the Apple App Store is Health & Fitness, not Medical. Vaely relies on the wellness exclusion under EU MDR Article 1, the wellness framing under FDA general-wellness policy guidance, and equivalent positions in jurisdictions where the Service is offered.

2. What Vaely does not do

Specifically, Vaely does not:

• Diagnose any disease, condition, or disorder.
• Predict the onset, progression, or recurrence of any disease, condition, or disorder.
• Recommend, prescribe, or substitute for any medication, dosage, treatment, therapy, or clinical procedure.
• Generate quantified risk assessments (such as "your headache risk tomorrow is N percent") or any clinical scoring system.
• Replace the judgment of any licensed healthcare professional.
• Provide telemedicine, remote monitoring of vital signs for clinical purposes, or any other clinical service.
• Issue codes from the International Classification of Diseases (ICD-10, ICD-11) or any formal diagnostic terminology.
• Claim to be clinically validated, medical-grade, or any equivalent.

3. AI-generated outputs are summaries of your own entries

The App includes features powered by an on-device language model that summarizes the journal entries you have written. These summaries are framed as "your journal shows…" — they are descriptions of what you logged, not independent analyses. They are retrospective. They are conservative. They are sometimes wrong, because language models are sometimes wrong; the confirmation step in the App is the trust step. Review every extraction before saving.

Doctor-ready PDFs generated by the App are headed "Personal Wellness Journal Summary — Not a Medical Document." This heading is mandatory and cannot be removed. It is intended to communicate to your healthcare provider that the document is your record of your own observations, not a clinical assessment.

See the AI Disclosure for the EU AI Act Article 50 transparency notice and the Article 6(3) exemption assessment.

4. Always consult a licensed healthcare professional

Decisions about your health — including but not limited to whether to start, stop, or change a medication, whether to seek further care, whether a symptom warrants investigation, and whether a pattern in your journal is clinically significant — are decisions for you and your licensed healthcare provider. Do not delay seeking medical advice, disregard medical advice, or change medical care because of anything Vaely has summarized for you.

If a Vaely-generated PDF or pattern observation surfaces something that surprises you, the appropriate next step is a conversation with a clinician, not a self-directed intervention.

5. Safety reminders inside the App

The App detects, on your device, certain words in your entries that may indicate a medical emergency or a self-harm risk. When such words appear, the App may present a safety reminder suggesting that you contact emergency services, a crisis line, or a trusted person. These reminders are produced by simple keyword matching on your device. They are over-inclusive on purpose: they err toward suggesting help even when help may not be needed.

A safety reminder is not a clinical assessment, a diagnosis, or a triage decision. It is a prompt to consider professional support. The App does not contact emergency services on your behalf, does not transmit any data when a safety reminder is shown, and does not record that the reminder was shown.

6. Limitations of natural-language extraction

The App's natural-language extraction transforms a sentence you spoke or typed into structured fields. This process can mishear, misinterpret, or miscategorize your intent. The confirmation step in the App is your opportunity to correct the extraction. We strongly encourage you to review the confirmation card before saving every entry, especially entries that contain medication names, dosages, time-sensitive information, or anything you might later show a clinician.

7. Pregnancy, fertility, reproductive, and sensitive health information

If you choose to log information related to pregnancy, fertility, reproductive health, sexual health, mental health, gender-affirming care, or substance use in the App, that data stays on your device subject to the same architectural protections that apply to every other entry. The App does not transmit this category of data, does not flag it for additional handling, and does not change behavior based on its presence. See the Privacy Policy and the Consumer Health Data Privacy Policy for the full data-handling treatment.

8. Children

The App is intended for adults aged 18 and over. The App is not designed for the diagnosis or care of pediatric conditions, pediatric mental-health conditions, or any pediatric clinical use. Caregivers logging on behalf of a minor should consult their pediatrician about the appropriateness of any health-tracking tool for the child's specific situation.

9. Jurisdictions

This disclaimer applies wherever the App is available. Where applicable law in your jurisdiction provides additional protections to consumers using a wellness app, those protections apply. Where applicable law in your jurisdiction requires additional disclosure to be made before you may use the App, that disclosure is made here. If you believe a particular jurisdiction's law requires a different or additional statement, please write to tezaapps@gmail.com and we will address it.

10. Acknowledgment

By using Vaely, you acknowledge that you have read this disclaimer, that you understand Vaely is not a medical device or a substitute for professional care, and that you are responsible for seeking appropriate care for any health concern.

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Effective 6 May 2026. Version 1.0.0. This is the first version of this disclaimer.