DOPA Health Disclaimer

Version: v1.3 Effective Date: v1.0 release (TBD) Last Updated: 2026-08-20

This document is the authoritative full text of DOPA’s medical-device disclaimer, intended-use statement, and emergency guidance. Inside the App it is reachable from My → Health Disclaimer, and its key points are stated on the final onboarding screen.

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 (the Rhythm and Progress tabs, in today / weekly / monthly views)
3. Provide a short, guided breathing pacer (Phase B Breath Pacer) for unwinding breaks
4. Track session counts and a user-chosen goal (goal chip) across short sessions

The App is a tool that uses your brief measurement data to show you a recovery flow.

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 (10 seconds × 3 cycles, 30 seconds in total: inhale through the nose for 4s, then exhale slowly over 6s — there is no breath-holding step). 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: the general literature on how slow breathing (about 6 breaths per minute) and an exhale longer than the inhale affect autonomic activity — Laborde et al. 2022 (meta-analysis), Zaccaro et al. 2018 (systematic review)
• 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. Availability and Effect of This Disclaimer

• The App does not present a separate disclaimer-consent screen. It neither requires your agreement as a condition of use nor records whether you agreed.
• Instead, the final onboarding screen states the key points: “DOPA is not a medical device and is not for diagnosis or treatment. All data stays on this device.”
• This document is the authoritative full text and is available at any time from My → Health Disclaimer inside the App, and from this repository.
• The contents of this disclaimer apply to all use of the App regardless of whether any consent step exists.

9. Version History

Appendix: Related Documents

📌 Code-track note (updated 2026-08-20): The visual escalation of the in-app DisclaimerScreen emergency block, recommended in v1.2, is now moot — the screen itself was retired when onboarding was rebuilt around the opener beats. The App’s two remaining disclaimer touchpoints are (1) the key-points statement on the final onboarding screen and (2) the link to this document in the My tab; emergency and crisis information lives in §6 of this full text.

• In-App disclaimer touchpoints: My → Health Disclaimer (dopamine-app/src/screens/mypage/MyPageScreen.tsx) · final onboarding screen (onboarding.opener.beat5.legalFootnote — moved from beat 4 to beat 5 in onboarding v2, C6-1 2026-08-30; wording unchanged)
• Current breath-pattern SSOT: dopamine-app/src/constants/breathConfig.ts (4-6 ×3)
• Breath pacer decision (from the earlier 2-1-4 era): 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