Rx360 Wellness Lexicon & Claims Audit v1¶
Date: April 15, 2026
Prepared by: Gene Lang, PharmD | Director of Pharmacy Operations
Purpose: Canonical reference for the claim language that keeps Rx360 inside FDA General Wellness enforcement discretion. Used as a linter for every user-facing, marketing, and pilot material under Track A (Wellness) (Consumer Wellness Self-Service Track).
Status: v1 — working draft, anchored to verified primary sources
Reference: Rx360_Shared_Drive/02_Clinical_Data_and_Risk_Analysis/FDA_2026_Guidance_and_Enforcement_Research_2026-04-15.md
Classification: Confidential — Internal Strategy
01 How to use this document¶
- Before any user-facing content goes out (marketing copy, app UI, onboarding script, kiosk display, printed handouts, social media, pilot recruitment material, press releases) — sweep it against Section 03 (the red-flag → safe-equivalent table) and Section 05 (the claim pattern audit). Count hits. Target: zero red-flag hits in any member-facing Track A (Wellness) material.
- For Track B (Clinical) material (pharmacist-facing, IRB documents, clinical protocol, staff training): red-flag language is PERMITTED and often clinically appropriate. Those audiences are healthcare professionals, not consumers. The lexicon applies only to consumer-facing surfaces.
- When in doubt, rewrite. If a claim might be a red flag, it is a red flag. FDA's intended-use analysis looks at how a reasonable consumer would read the claim, not what the author meant.
- Primary sources for all red-flag designations are in the research file referenced at the top. Every row in Section 03 that's marked with a citation can be traced back to the FDA's own language in the Sep 2019 / Jan 2026 General Wellness guidance, the WHOOP warning letter (Jul 14, 2025), or the SeniorLife Technologies warning letter (Aug 21, 2025).
02 The core test — four questions¶
Before approving any claim, ask:
- Does the claim describe a clinical outcome the product causes? ("Improves adherence," "reduces hospitalizations," "prevents falls") — RED FLAG. These are outcome claims requiring clinical evidence and almost always trigger device classification.
- Does the claim name a specific disease or condition? ("Manages diabetes," "detects Alzheimer's," "tracks hypertension") — RED FLAG. Disease-specific language almost always fails the wellness test.
- Does the claim imply the product makes clinical decisions? ("Recommends interventions," "alerts caregivers to missed doses," "flags at-risk patients") — RED FLAG. This is CDS (Clinical Decision Support), which is separately regulated.
- Does the claim use "medical-grade," "clinical," "diagnostic," or equivalent hedging? — RED FLAG. The WHOOP case established that these words alone can trigger device classification.
If the answer to any of the four is yes, rewrite.
03 Red-flag phrases → Safe wellness equivalents¶
Medication / adherence claims¶
| ❌ Red flag | ✅ Safe equivalent | Source |
|---|---|---|
| "Improves medication adherence" | "Helps you stay on top of your routine" | FDA General Wellness 2026; implied outcome claim |
| "Increases adherence rates" | "Supports daily consistency" | Outcome claim — requires clinical evidence |
| "Reduces missed doses" | "A gentle nudge at the right time" | Outcome claim |
| "Prevents medication errors" | "Keep your list in one place" | Outcome + safety claim |
| "Monitors adherence" | "Your routine at a glance" | "Monitor" implies clinical surveillance |
| "Clinically validated adherence tool" | "Simple daily reminders" | WHOOP precedent — "clinically validated" language |
| "Tracks compliance" | "See your check-ins this week" | "Compliance" is a clinical QA term |
| "Alerts you to drug interactions" | (not permitted in Track A (Wellness) — this is CDS) | Explicit CDS trigger |
| "Flags dangerous medications" | (not permitted in Track A (Wellness)) | CDS + disease-specific risk |
Fall + mobility claims (SeniorLife red lines)¶
| ❌ Red flag | ✅ Safe equivalent | Source |
|---|---|---|
| "Proactively identifies fall risk" | "Track your daily movement" | SeniorLife warning letter 8/21/2025 |
| "Recommends interventions" | (not permitted — implies CDS/therapy) | SeniorLife warning letter |
| "Continuously tracks patient mobility" | "See your weekly activity summary" | SeniorLife warning letter — "patient" + "continuously tracks" |
| "Fall prevention" | "Activity support" | FDA 2026 — "prevention" = device territory |
| "Reduces fall risk" | "Celebrate your active days" | Outcome claim |
| "Detects gait abnormalities" | (not permitted in Track A (Wellness)) | Diagnostic function |
| "Balance assessment" | "Movement trends" | "Assessment" = clinical term |
| "Postural sway analysis" | (not permitted in consumer UI) | Clinical measurement |
Disease + cognitive claims (SeniorLife red lines)¶
| ❌ Red flag | ✅ Safe equivalent | Source |
|---|---|---|
| "Detects early signs of Alzheimer's" | (not permitted in Track A (Wellness)) | SeniorLife warning letter |
| "Cognitive decline monitoring" | (not permitted) | Disease-specific diagnostic |
| "Dementia screening" | (not permitted) | Diagnostic screening |
| "Heart health monitoring" | "Daily heart rate trends" | Disease-specific framing |
| "Diabetes management" | "Your daily routine" | Disease-specific therapy claim |
| "Hypertension tracking" | "Daily wellness trends" | WHOOP warning letter — BP-related |
| "Blood pressure insights" | (not permitted without extensive 2026 guidance review) | WHOOP warning letter — core trigger |
| "Preventive health" | "Healthy aging support" | "Preventive" + "health" = clinical framing |
Clinical oversight + CDS claims¶
| ❌ Red flag | ✅ Safe equivalent | Source |
|---|---|---|
| "Clinical decision support" | (not a consumer-facing claim at all) | Explicit CDS — separately regulated |
| "Doctor-approved" | "Designed with input from pharmacists" | Implies clinical validation |
| "Medical-grade accuracy" | (not permitted) | WHOOP precedent |
| "FDA-cleared" | (not permitted unless actually cleared) | Misbranding risk |
| "Pharmacist-verified medication list" | (Track B (Clinical) only — not a consumer-facing claim under B) | Crosses B/A boundary |
| "Caregiver alerts for missed doses" | "Share updates with your circle (opt-in)" | Auto-alerts imply clinical surveillance |
| "Real-time health monitoring" | "Daily summary of your activity" | "Monitoring" + "real-time" = clinical |
Study / research language (not wellness-safe)¶
| ❌ Red flag | ✅ Safe equivalent | Notes |
|---|---|---|
| "Participant" | "Member," "user," "you" | "Participant" is HSR language |
| "Study" | "Pilot program," "early access" | "Study" implies research |
| "Subject" | "Member" | Common Rule HSR term |
| "Enrollment" | "Sign-up," "getting started" | Research framing |
| "Informed consent" | "Terms of service," "sign up" | Research framing |
| "Inclusion/exclusion criteria" | "Who it's for" | Research framing |
| "Investigator" | "Our team," "product team" | Research framing |
| "Principal Investigator" | (not used in Track A (Wellness) consumer materials) | Research framing |
| "IRB" | (not used in Track A (Wellness) consumer materials) | Research framing |
| "Protocol" | "How it works" | Research framing |
| "Research" | "Early feedback," "what we're learning" | Research framing |
| "Clinical trial" | "Early access program" | Device classification trigger |
Marketing + outcome claims¶
| ❌ Red flag | ✅ Safe equivalent | Notes |
|---|---|---|
| "Reduces hospitalizations" | "Supports confidence and independence" | Classic outcome claim |
| "Improves quality of life" | "Makes daily routines easier" | QoL is a clinical trial endpoint |
| "Evidence-based" | "Built with pharmacist input" | Implies clinical research |
| "Scientifically proven" | (avoid entirely) | Outcome claim |
| "Prescribed" | "Recommended by your pharmacist" (still conservative — prefer "added by you") | Rx language = device territory |
| "Treatment" | (not used for Rx360) | Therapy claim |
| "Therapy" | (not used for Rx360) | Therapy claim |
| "Diagnose / Treat / Cure / Mitigate / Prevent" | (avoid the entire verb family) | FDCA §201(h) — definition of device |
04 Safe wellness vocabulary — the approved lexicon¶
Use these words freely in Track A (Wellness) user-facing material:
Routine / daily living: - routine, daily rhythm, consistency, habits, rituals, flow - at a glance, on track, on your schedule, in one place
Support / empowerment: - support, help, simplify, organize, keep track, stay on top - confidence, independence, peace of mind, reassurance
Activity / movement: - activity, movement, steps, active days, daily wins, your energy - celebrate, momentum, progress, streaks
Community: - your circle, support circle, family, friends, loved ones - share, connect, stay in touch, updates (always opt-in)
Wellness / aging well: - healthy aging, aging well, wellness, well-being, daily wellness - lifestyle, daily life, your day
Emotional tone: - gentle, simple, friendly, thoughtful, helpful, kind - welcome, ready when you are, your pace
Product description: - companion, tool, helper, sidekick, pocket buddy - wearable, device, app, kiosk
Verbs that are safe: - track, log, see, view, organize, remember, notice - check in, confirm, mark, celebrate, share (opt-in)
05 Claim pattern audit — common constructions to avoid¶
Beyond single words, these sentence patterns are red flags even if every individual word is technically neutral:
-
"[Product] + [outcome verb] + [clinical metric]" Example: "Rx360 improves medication adherence rates by 23%." Problem: outcome claim with clinical metric. Rewrite: "Members tell us Rx360 helps them stay on track."
-
"[Product] + [detects/identifies/predicts] + [condition]" Example: "Rx360 identifies signs of medication non-adherence." Problem: SeniorLife pattern — "identifies" + clinical condition. Rewrite: "Rx360 shows you your daily routine at a glance."
-
"[Product] + monitors + [patient/user] + [clinical parameter]" Example: "Rx360 continuously monitors patient mobility." Problem: Direct SeniorLife warning letter pattern. Rewrite: "Rx360 celebrates your active days."
-
"[Product] + alerts + [caregiver/healthcare team] + [clinical event]" Example: "Rx360 alerts caregivers when a dose is missed." Problem: Automated CDS + clinical surveillance. Rewrite: "Rx360 helps you share opt-in updates with your circle."
-
"[Product] + recommends + [intervention/action]" Example: "Rx360 recommends calling your pharmacy for a refill." Problem: SeniorLife pattern — "recommends interventions." Rewrite: "Rx360 gives you a gentle heads-up when your refill is coming."
-
"[Product] + FDA-cleared / medical-grade / clinically validated" Problem: WHOOP precedent — these words alone trigger classification. Rewrite: "Rx360 is designed with pharmacist input."
-
"[Research framing] + [pilot]" Example: "Participants in our study reported..." Problem: Research language. Rewrite: "Early members told us..."
-
"Prevents / reduces / improves + [clinical outcome]" Example: "Prevents adverse drug events." Problem: Classic device outcome claim. Rewrite: "Keeps your med list in one place."
06 Edge cases and judgment calls¶
"Adherence" — is the word itself a red flag?¶
Yes, in consumer-facing material. "Adherence" is a clinical QA term used in CMS Star Ratings (PDC measures), pharmacy benefit management, and clinical research. In Track A (Wellness) consumer surfaces, replace with "routine," "consistency," or "keeping up with your day." It is FINE to use "adherence" in Track B (Clinical) pharmacist-facing material, internal docs, and conversations with payers — that's a professional audience.
"Reminder" — safe?¶
Yes, explicitly. FDA's 2019 and 2026 General Wellness guidance both identify "user-configured reminders for improved medication management" as safe-harbor wellness functions. The word "reminder" is one of the clearest-safe terms in the lexicon. But note the phrase "user-configured" — reminders that are pushed from a pharmacy system without user configuration may cross into clinical oversight territory.
"Medication" vs. "med" vs. "prescription"¶
- "Medication" — safe. Generic term, used in consumer context freely.
- "Med" — safe and friendly. Preferred in UI for space efficiency.
- "Prescription" — cautious. Implies a clinical Rx relationship. Preferred alternative: "your meds" or "your list."
- "Rx" — avoid in consumer UI. Clinical shorthand. OK on pharmacist-facing surfaces.
"Your doctor" / "your pharmacist"¶
Safe, and actually helpful. Directing users to their own HCP is permitted under wellness guidance — it's the opposite of making clinical recommendations yourself. Use phrases like "talk to your pharmacist" or "check with your doctor" freely. DO NOT use phrases like "we've notified your pharmacist" or "your care team has been alerted" (auto-communication implies clinical oversight).
"Wellness" — can we call ourselves a wellness product?¶
Yes, and we should. "Wellness product," "wellness program," "wellness device," and "wellness app" are all approved. Use these as the primary product descriptors. Avoid "health tech," "digital health," "clinical tool," "medical app."
"Caregiver" — OK?¶
Yes, as long as the caregiver flow is opt-in and passive. "Caregiver," "family member," "support circle member" are all safe in consumer material. The danger is in what the caregiver receives — if the system automatically sends missed-dose alerts, that's clinical surveillance. If the user manually shares a weekly summary, that's social. Keep the Support Circle feature on the social side of the line.
"SOS" / emergency button¶
Safe if framed as emergency communication, not health monitoring. The button sends a location to a chosen contact or to 911. That's a safety feature, not a medical device feature. Avoid phrases like "medical emergency," "health crisis," "clinical emergency response." Prefer: "get help fast," "reach your circle," "call for help."
Passive logging of dose confirmations¶
Safe if framed as personal reflection, not clinical tracking. - ✅ "You checked in 24 out of 28 days last month" - ✅ "Your longest streak: 14 days in a row" - ❌ "You missed 4 doses — alert sent to caregiver" - ❌ "Adherence rate: 86%"
07 Audit targets — documents to sweep¶
This lexicon must be applied as a linter to every document on the following list. As of v1, the sweep is NOT YET DONE — this is the next action.
Priority 1 — member-facing (must be zero red flags)¶
- PP-85B Consumer Onboarding Script (Step 6 — not yet built)
- PP-18B Self-Service Kiosk Flow (Step 6 — not yet built)
- Consumer ToS template (Step 6 — not yet built)
- Consumer Privacy Policy (Step 6 — not yet built)
- App UI copy (coordinate with Ryan/Faraz)
- Kiosk display copy (coordinate with Ryan/Faraz)
- Marketing / landing page copy (coordinate with Ryan)
Priority 2 — external-facing non-consumer (should minimize red flags)¶
- Press releases / social media (future)
- Venue partnership pitches (for community centers, clinics, non-pharmacy sites)
- Recruiting material for pilot enrollment
Priority 3 — internal/professional audience (red flags permitted in context)¶
- Architecture Brief v6 DualTrack — separated A vs B sections, B section must be clean
- Existing 13 Jira tickets — sweep for accidental consumer-facing leakage
- Peyman dual-track briefing — professional audience, clinical language OK, but note which language won't translate to consumer surfaces
Priority 4 — do not sweep¶
- FDA Boundary Analysis PDF (academic/legal — clinical language is expected)
- Architecture Brief v5 (superseded; marked as historical)
- Research files (professional audience)
08 Sweep results — v1 dry run (placeholder)¶
To be filled in as sweeps are performed.
| Document | Audience | Red-flag count | Priority fixes | Sweep date |
|---|---|---|---|---|
| PP18_Testing_Schedule.md | Professional (A) | TBD | TBD | TBD |
| PP85_Onboarding_Guide.md | Professional (A) | TBD | TBD | TBD |
| Email_Response_Ryan_Faraz_Wireframe_Feedback.md | Professional | TBD | TBD | TBD |
| RX360_Clinical_Product_Architecture_Brief_v5.md | Professional | TBD (expected high — has "patient," "study," "PharmD verification") | To be superseded by v6 | TBD |
09 Update history¶
- v1 (2026-04-15) — Initial draft. Anchored to Jan 2026 FDA General Wellness guidance update, WHOOP warning letter (Jul 14, 2025), and SeniorLife Technologies warning letter (Aug 21, 2025). All red-flag designations traceable to primary sources.
10 Primary sources¶
- FDA — General Wellness: Policy for Low Risk Devices
- FDA — SeniorLife Technologies, Inc. Warning Letter 707021 (Aug 21, 2025)
- Rx360 internal — FDA 2026 Guidance and Enforcement Research (Apr 15, 2026)
- Rx360 internal — Medication Risk Tools and FDA Boundary Analysis for Rx360's Tiering System (existing PDF)