DOPA Health Disclaimer

Version: v1.2 Effective Date: v1.0 release (TBD) Last Updated: 2026-06-14

This document is the authoritative full text of the in-App medical-device disclaimer presented on first launch (src/screens/onboarding/DisclaimerScreen.tsx). By tapping “Agree” on that screen, you confirm that you have read and accept the summary; this document is the complete version.

1. Medical-Device Status

DOPA is not a medical device.

The App does not qualify as:

• A medical device under the U.S. Federal Food, Drug, and Cosmetic Act §201(h) and related U.S. FDA regulations
• A medical device under the EU Medical Device Regulation (MDR), nor a regulated product under the EMA framework
• A medical device under the Republic of Korea Medical Devices Act
• A digital therapeutic (DTx) under the Republic of Korea Digital Medical Products Act (DMPA)
• A medical device under analogous regulations in other jurisdictions

The App is not intended to diagnose, treat, mitigate, cure, or prevent any disease. The App is a consumer wellness tool — a non-medical self-observation and cognitive-practice tool intended to complement, not replace, professional medical care.

2. Intended Use

The App is intended to:

1. Measure short cognitive-performance metrics (reaction time, working-memory accuracy, task-switching cost, digit-symbol substitution)
2. Visualize trends in your own metrics over time (Weekly Mirror)
3. Provide a short, guided breathing pacer (Phase B Breath Pacer) for unwinding breaks
4. Track session counts and a user-chosen goal (focus chip) across short sessions

The App is “a tool that uses your brief measurement data to show you a recovery flow” (as stated on the in-App disclaimer screen).

3. The App is Not Intended For

• ❌ Diagnosing any disease or disorder (e.g., ADHD, depression, anxiety, dementia, cognitive impairment)
• ❌ Treating any disease or disorder (e.g., as a clinical cognitive-training intervention or psychiatric treatment adjunct)
• ❌ Preventing any disease or disorder
• ❌ Providing medical, psychological, or psychiatric advice in lieu of a licensed professional
• ❌ Serving as a medical-emergency resource or substitute

The App’s measurement outputs are informational self-observation, not medical findings.

4. Interpreting the Numbers

The cognitive-performance numbers shown by the App (reaction time, accuracy, weekly trends) do not indicate:

• Your absolute cognitive ability or any “normal / abnormal” classification
• The presence or absence of any disease
• Equivalence with clinical scales (e.g., MoCA, MMSE, RBANS, CERAD)

The values the App shows are behavioral changes in cognitive-task scores (trends in reaction time and accuracy during the tasks) only. The App does not measure or diagnose your dopamine levels, dopamine deficiency, or dopamine-receptor state. (The word “dopamine” in the App’s name is a motivational frame for behavior change, not a neurochemical-measurement claim.)

Do not use these numbers to make medical decisions for yourself or anyone else. If you have concerns about your cognition or mental health, consult a qualified medical professional (physician, clinical psychologist, neurologist).

5. Breath Pacer — Use With Caution

The App provides a brief breath-pacer (7 seconds × 3 cycles: inhale 2s + assist 1s + extended exhale 4s). It is for light relaxation by healthy adults.

Consult a medical professional before using the breath pacer if you have:

• Diagnosed respiratory conditions (asthma, COPD, etc.)
• Diagnosed cardiovascular conditions (arrhythmia, angina, etc.)
• Low blood pressure (including orthostatic hypotension)
• A history of epilepsy or seizures
• Pregnancy
• A history of panic disorder or hyperventilation episodes
• Any diagnosed mental-health condition

Stop immediately if you feel light-headed, faint, or otherwise unwell. The breath pacer is not a clinical breathing-therapy intervention.

Note also that the App’s cognitive-measurement accuracy depends on your device (hardware performance, touch latency, screen refresh rate, etc.) and does not guarantee precision equivalent to clinical measurement equipment.

6. Emergencies

The App is not an emergency tool.

🚨 EMERGENCY — ACT NOW. If you or someone near you is experiencing:

• Altered consciousness, loss of consciousness
• Chest pain or shortness of breath
• Thoughts of self-harm or suicide
• Rapid worsening of physical or psychiatric symptoms

…contact local emergency services immediately. Do not use the App or delay emergency care.

Mental-Health Crisis Resources

Do not delay seeking emergency care to use the App.

7. Scientific Basis — What the App Claims and Does Not Claim

The App draws on the following scientific work as general inspiration:

• Breath pacer pattern: Balban & Huberman, 2023, Cell Reports Medicine (physiological sigh)
• Cognitive measurement paradigms: standard academic task-switching, N-back, digit-symbol substitution tasks

The App does not claim that these studies establish clinical efficacy of this particular App. No clinical trials of the App itself have been conducted.

Claims the App Will Never Make (across marketing, store listing, onboarding, and all channels)

Nowhere — in marketing, the app-store listing, onboarding, or in-app copy — does the App claim to:

1. ❌ Improve real-world performance (academic, work, athletic, etc.)
2. ❌ Prevent or delay age-related cognitive decline, dementia, or mild cognitive impairment (MCI)
3. ❌ Mitigate or treat clinical conditions such as ADHD, PTSD, depression, or addiction
4. ❌ Frame itself as “scientifically/clinically proven” or otherwise efficacy-validated

In-app and marketing copy describes scores only as change / trend — never as improvement / enhancement.

⚠️ A disclaimer does not cure a marketing efficacy claim. The existence of this disclaimer does not legitimize any headline, store description, or onboarding copy that implies the claims above. Regulators judge the net impression a user receives, not isolated disclaimer sentences.

8. Consent Records

• Your acknowledgment is recorded locally on your device in the SQLite column disclaimer_accepted. The record does not leave your device.
• The full text of this disclaimer is reachable from the App’s settings screen and from this repository.

9. Version History

Appendix: Related Documents

📌 Code-track separation note (L2): To mirror the visual escalation of the §6 emergency block in this authoritative text, the in-app DisclaimerScreen.tsx emergency / crisis-hotline block should also be visually escalated (bold, boxed, multi-jurisdiction hotlines). This is a code change and is therefore out of scope for this legal document; it will be handled via a separate FC/ADR.

• In-App disclaimer screen: dopamine-app/src/screens/onboarding/DisclaimerScreen.tsx
• Breath pacer decision: dopamine/decisions/011_phase_b_breath_pacer.md
• Privacy Policy (English): dopamine/legal/privacy_policy_v1.en.md
• Privacy Policy (Korean): dopamine/legal/privacy_policy_v1.md
• Terms of Service (English): dopamine/legal/terms_of_service_v1.en.md
• Breathing research source: dopamine/research/acute_cognitive_reset_evidence.md