DOPA Health Disclaimer
Version: v1.1 Effective Date: v1.0 release (TBD) Last Updated: 2026-06-10
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)
- A medical device under the Republic of Korea Medical Devices Act
- A medical device under analogous regulations in other jurisdictions
The App is a consumer wellness tool.
2. Intended Use
The App is intended to:
- Measure short cognitive-performance metrics (reaction time, working-memory accuracy, task-switching cost, digit-symbol substitution)
- Visualize trends in your own metrics over time (Weekly Mirror)
- Provide a short, guided breathing pacer (Phase B Breath Pacer) for unwinding breaks
- 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)
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.)
- Pregnancy
- A history of panic disorder or hyperventilation episodes
Stop immediately if you feel light-headed, faint, or otherwise unwell. The breath pacer is not a clinical breathing-therapy intervention.
6. Emergencies
The App is not an emergency tool.
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.
Mental-Health Crisis Resources
| Region | Hotline |
|---|---|
| United States | 988 (Suicide and Crisis Lifeline, 24/7) |
| United States | 911 (general emergency) |
| Canada | 988 (Suicide Crisis Helpline, 24/7) |
| United Kingdom | 116 123 (Samaritans, 24/7) / 999 (general emergency) |
| Republic of Korea | 1393 (Suicide Prevention, 24/7) / 1577-0199 (Mental Health Crisis, 24/7) / 1388 (Youth, 24/7) / 119 (general emergency) |
| Other regions | Please consult your local crisis-line directory |
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.
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
| Version | Date | Change |
|---|---|---|
| v1.0 | 2026-05-29 | Initial — authoritative version of the in-App disclaimer + emergency contacts + breath-pacer cautions + scientific-basis honesty |
| v1.1 | 2026-06-10 | Record of in-app DISCLAIMER_VERSION bump v1.0 → v1.1 (ONB-A2, commit d8218b7) — dataLocal summary copy no longer promises unimplemented in-app deletion; replaced with OS fact (deleting the app deletes the data), consistent with privacy_policy v1.x deferral. Full-text body unchanged. |
Appendix: Related Documents
- 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