From 97a632310884c9c7af81c7c3c8656967114c8a7e Mon Sep 17 00:00:00 2001 From: MP2EZ <182439403+MP2EZ@users.noreply.github.com> Date: Mon, 25 May 2026 18:14:54 -0700 Subject: [PATCH] fix(features): remove SaMD-adjacent claims + clinical framing MIME-Version: 1.0 Content-Type: text/plain; charset=UTF-8 Content-Transfer-Encoding: 8bit The /features page made detection / auto-trigger / clinical claims that compliance + crisis agents both flagged as inconsistent with Being's consumer-wellness positioning per regulatory-applicability.md §FDA. Apple/TestFlight reviewers may visit the live site; "Auto-detects severe depression (PHQ-9 ≥20)" + "Crisis support triggered automatically" is exactly the language FDA uses to define a Software as a Medical Device. Rewrites (19 + 2 follow-ups from agent re-review): # Removed: SaMD-adjacent detection / trigger claims - "Auto-detects severe depression (PHQ-9 ≥20)" → "Flags elevated scores (PHQ-9 ≥20) and surfaces crisis resources" - "Auto-detects severe anxiety (GAD-7 ≥15)" → same for GAD-7 - "Crisis support triggered automatically" / "Integrated with crisis protocols" → "Always one tap from 988 and Crisis Text Line" - "Auto-triggered on PHQ-9 ≥20 or GAD-7 ≥15" (Crisis Support section) → "Surfaced immediately when self-assessment scores are elevated" # Shifted: clinical register → consumer wellness register - Section title: "Mental Health Self-Monitoring" → "Mood & Wellbeing Tracking" - "Standardized self-assessments" / "mental health patterns" → "Research-based reflection tools" / "mood and wellbeing patterns" - Card headers: "PHQ-9 (Depression)" → "PHQ-9 Mood Self-Assessment" (same pattern for GAD-7) - "monitoring depression symptoms" → "tracking mood patterns over time" - "monitor anxiety symptoms" → "tracking anxious thought and feeling patterns" - Privacy: "mental health data" → "wellbeing data" (consistency) - "Military-grade encryption" → "AES-256 encryption" (drop empty-marketing phrase, keep concrete claim) - Hero: "modern mental health science" → "modern wellbeing research" - CTA: "evidence-based self-monitoring tools" → "research-based self-reflection tools" # Safety additions - Crisis Text Line added: previously the 988 callout said "One tap to connect" implying only the call mode. Now: "Call 988 or text HOME to 741741" — both modes named explicitly. - 988 callout restyled from solid bg-info (bright blue + white text) to bg-crisis-bg + crisis-text + crisis-border tokens (muted, on-brand, consistent with the design system's crisis token family — matches what the audit recommended for cross-site unification of 988 treatment). - Section title "24/7 Crisis Support" → "24/7 Crisis Resource Access" (Being surfaces links to 24/7 resources; doesn't itself provide support — precision per crisis-agent re-review). - PHQ-9 description: dropped "scores remain comparable to those you might see from a healthcare provider" — both agents flagged this as a new SaMD-adjacent claim on the rewrite. Now: "self-reported scores stay consistent, letting you track your own patterns." # Out of scope (raise with app team) - Verify the app actually surfaces crisis resources at PHQ-9 ≥20 / GAD-7 ≥15 (else FTC §5 issue). - Handle PHQ-9 item 9 ≥1 independently of total score (real product safety design concern: total-only thresholds miss self-harm ideation at lower totals). - Verify "Crisis button always visible in app" + "Less than 3 seconds from any screen to 988" are literally true. Co-Authored-By: Claude Opus 4.7 (1M context) --- app/(main)/features/page.tsx | 69 ++++++++++++++++++++---------------- 1 file changed, 38 insertions(+), 31 deletions(-) diff --git a/app/(main)/features/page.tsx b/app/(main)/features/page.tsx index 8b8c4b7..d64437c 100644 --- a/app/(main)/features/page.tsx +++ b/app/(main)/features/page.tsx @@ -1,7 +1,12 @@ /** * Features Page - Being app capabilities * Professional SaaS Design - * Showcases daily check-ins, wellness self-assessments, crisis support, privacy + * Showcases daily check-ins, mood/wellbeing reflection tools, crisis-resource + * access, and privacy-first design. + * + * Copy is intentionally consumer-wellness register (not clinical). The + * page uses PHQ-9 and GAD-7 self-reflection tools but does NOT make + * detection or diagnostic claims — Being is not a SaMD. */ import BrainIcon from '@/components/shared/BrainIcon'; @@ -20,8 +25,9 @@ export default function FeaturesPage() { App Features

- Being combines ancient Stoic wisdom with modern mental health science. Daily check-ins, - wellness self-assessments, and crisis support, with privacy-first design and AES-256 encryption. + Being combines ancient Stoic wisdom with modern wellbeing research. Daily check-ins, + mood and anxiety reflection tools, and crisis-resource access, with privacy-first + design and AES-256 encryption.

@@ -127,26 +133,27 @@ export default function FeaturesPage() { - {/* Mental Health Self-Monitoring */} + {/* Mood & Wellbeing Tracking */}

- Mental Health Self-Monitoring + Mood & Wellbeing Tracking

- Standardized self-assessments help you track your mental health patterns over time. - All data encrypted and stored locally on your device. + Research-based reflection tools help you track your mood and wellbeing patterns + over time. All data encrypted and stored locally on your device.

{/* PHQ-9 */}
-

PHQ-9 (Depression)

+

PHQ-9 Mood Self-Assessment

- The Patient Health Questionnaire-9 is a widely-used self-assessment questionnaire - for monitoring depression symptoms. Being uses exact PHQ-9 wording and scoring. + The Patient Health Questionnaire-9 is a widely-used self-reflection tool for + tracking mood patterns over time. Being uses the standard PHQ-9 wording so your + self-reported scores stay consistent, letting you track your own patterns.

  • @@ -159,21 +166,21 @@ export default function FeaturesPage() {
  • ✓ - Auto-detects severe depression (PHQ-9 ≥20) + Flags elevated scores (PHQ-9 ≥20) and surfaces crisis resources
  • ✓ - Crisis support triggered automatically + Always one tap from 988 and Crisis Text Line
{/* GAD-7 */}
-

GAD-7 (Anxiety)

+

GAD-7 Anxiety Self-Assessment

- The Generalized Anxiety Disorder-7 scale helps you monitor anxiety symptoms over time. - Self-assessment tool with standardized scoring. + The Generalized Anxiety Disorder-7 scale is a widely-used self-reflection tool + for tracking anxious thought and feeling patterns over time.

  • @@ -182,15 +189,15 @@ export default function FeaturesPage() {
  • ✓ - Monitor anxiety trends + Track anxious feelings over time
  • ✓ - Auto-detects severe anxiety (GAD-7 ≥15) + Flags elevated scores (GAD-7 ≥15) and surfaces crisis resources
  • ✓ - Integrated with crisis protocols + Always one tap from 988 and Crisis Text Line
@@ -203,27 +210,27 @@ export default function FeaturesPage() {

- 24/7 Crisis Support + 24/7 Crisis Resource Access

Your safety is our top priority. Immediate access to crisis resources from every screen.

-
-

988 Suicide & Crisis Lifeline

-

- One tap to connect with trained crisis counselors. Available 24/7/365. - Completely confidential. +

+

988 Suicide & Crisis Lifeline

+

+ Call 988 or text HOME to 741741 to + connect with trained crisis counselors. Available 24/7/365. Completely confidential.

-
+

✓ Less than 3 seconds from any screen to 988

✓ - Auto-triggered on PHQ-9 ≥20 or GAD-7 ≥15 + Surfaced immediately when self-assessment scores are elevated

✓ @@ -239,10 +246,10 @@ export default function FeaturesPage() {

- Privacy & Security + Privacy & Security

- Your mental health data is yours. We protect it with AES-256 encryption + Your wellbeing data is yours. We protect it with AES-256 encryption and local-first storage.

@@ -259,7 +266,7 @@ export default function FeaturesPage() {

AES-256 Encryption

- Military-grade encryption protects your check-ins, assessments, and journal entries. + AES-256 encryption protects your check-ins, self-assessments, and journal entries. Even if your device is compromised, your data remains secure.

@@ -267,7 +274,7 @@ export default function FeaturesPage() {

No Data Selling

- We don't sell, share, or monetize your mental health data. Ever. + We don't sell, share, or monetize your wellbeing data. Ever. Your privacy is not for sale.

@@ -290,7 +297,7 @@ export default function FeaturesPage() { Ready to begin?

- Experience Stoic Mindfulness with evidence-based self-monitoring tools. + Experience Stoic Mindfulness with research-based self-reflection tools. Start your 1 month free trial today.