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Keryx safety claims, delivery limitations, and regulatory position
Approved: 25 August 2026
This document is the P1-10 claims packet for Keryx for SafeCall. It locks approved safety and reliability language, delivery limitations, Critical Alerts strategy, category/medical posture, and escalation/acknowledgment wording.
It does not claim that Apple Critical Alerts entitlement was requested or granted, that counsel reviewed or published live legal pages, that store listings already use these sentences, or that the physical delivery matrix is complete.
Purpose and non-goals
Purpose
- Approve truthful product claims for listings, legal drafts, client onboarding, and support.
- Align delivery-limitation language with Android delivery and iOS delivery.
- Record regulatory/category answers consistent with P0-02.
- Assign handoffs for copy surfaces that still need implementation.
Non-goals
- Applying for iOS Critical Alerts entitlement.
- Rewriting App Store / Play listing assets — approved in store-listing-copy.md (P2-02); console paste #125.
- Publishing live legal pages or obtaining counsel sign-off — publication packet public-web-pages.md (P2-04); HTTPS deploy and counsel deferred.
- Completing the physical-device delivery matrix (#117).
- Writing full support/troubleshooting runbooks (#120 / #121).
Approved decisions
| Topic | Approved position |
|---|---|
| Owner and approver | Thomas Minitsios, 25 August 2026 (P0-05 RACI) |
| Product role | Supplemental administrator companion notifications — not a substitute for on-site procedures, phone/radio escalation, or SafeCall web/ops monitoring |
| Client fallback | Clients must retain non-Keryx operational paths (SafeCall admin UI, phone/radio, site SOPs). Keryx alone is not the sole alarm channel |
| Critical Alerts | Not sought at launch; no Critical Alerts entitlement in the launch IPA |
| Categories / medical | Business; no Health & Fitness / Medical; not a regulated medical device; no diagnose/treat/cure/prevent/clinical-monitor claims (P0-02) |
| Delivery | Not guaranteed; subject to the limitations catalog below |
| External counsel | Mandatory if health/medical claims or Critical Alerts scope change (P0-05) |
Approved claim language (English source)
Reusable sentences for listings, support, legal, and client materials. Czech parity remains #108.
- Keryx is a free SafeCall administrator companion that shows supplemental operational alerts on your phone.
- Keryx notifications are supplemental. They are not a substitute for on-site emergency procedures, phone escalation, or SafeCall monitoring.
- Keryx is not a medical device and does not diagnose, treat, cure, or prevent any condition.
- Alert delivery is not guaranteed. Focus modes, Do Not Disturb, denied notification permission, mute, force-stop, OEM battery limits, network or ntfy outages, push latency, and pause mode can delay or suppress alerts.
- Clients must keep non-Keryx operational paths (for example SafeCall admin UI, phone/radio, and site SOPs). Do not rely on Keryx as the only alarm channel.
- Keryx uses ordinary system notifications. The launch build does not use Apple Critical Alerts.
- Marking an alert read in Keryx is a local device action. It is not a guaranteed receipt confirmation to SafeCall or other administrators.
Prohibited claims
Do not use (or imply) in public, store, sales, or support copy:
- Guaranteed, always-on, or “never miss” delivery
- Certified emergency dispatch, life-safety system, or sole alarm channel
- Medical device, clinical monitoring, diagnose/treat/cure/prevent language
- Critical Alerts capability or bypass of Focus/DND via Critical Alerts
- Independent consumer emergency product (Keryx is a SafeCall companion only)
- Guaranteed remote acknowledgment of alerts by SafeCall when an administrator opens or marks an alert in the app
Delivery limitations catalog
Document these limits wherever honesty is required (listings footnotes, support, legal, client onboarding). Detail lives in the delivery architectures.
| Factor | Effect |
|---|---|
| Notification permission denied or revoked | No banners; limited or no alerts |
| Focus / Do Not Disturb / scheduled mute | OS may suppress or silence alerts |
| User mute / volume / silent mode | Audible cues may be absent |
| Force-stop / force-quit | Background wake may not resume until app reopen |
| OEM battery / autostart restrictions | Delayed or blocked background work (Android) |
| Network offline or captive portal | Poll and push wakes fail until connectivity returns |
| Client ntfy outage or misconfiguration | No messages or failed subscribe/poll |
| Message cache miss / expiry | Missed alerts if device was offline beyond cache |
| FCM / APNs absence, delay, or misconfig | Delayed or no killed-state wake (P1-03 / P1-04) |
| In-app pause | Notifications suppressed while paused |
| Lock-screen / notification privacy settings | Preview may be hidden by OS settings (full preview is the launch app posture per P1-05; OS can still redact) |
Physical proof of behavior on devices remains #117; this packet does not claim that matrix is complete.
Critical Alerts strategy
- Launch decision: do not request or ship Apple Critical Alerts entitlement.
- Rationale: Keryx is a supplemental Business companion; Critical Alerts imply elevated interrupt priority inappropriate for the approved launch claims and would require entitlement review and claim changes.
- Launch IPA: ordinary notifications only; Focus/DND limits apply.
- Revisit: only if product scope explicitly changes to require Critical Alerts; then reopen regulatory/claims review with external counsel per P0-05.
Regulatory and category record
Reaffirm P0-02 for store questionnaires and metadata:
| Surface | Approved answer |
|---|---|
| Apple category | Business (not Health & Fitness or Medical) |
| Apple medical device | Not a regulated medical device; no health functionality |
| Apple audience | Adult administrators; not Kids |
| Expected Apple age result | 4+ (content suitability — not a child-directed product) |
| Play category | Business |
| Play target age | 18+ only; not for children / Families |
| Expected IARC | Everyone (return to P0-02 if questionnaire differs) |
| Play health | No health functionality; not a medical device |
Final console checkboxes must still be filled from the release candidate (#125).
Incident severity, escalation, communication, acknowledgment
Align with support draft and P0-05:
| Topic | Approved wording |
|---|---|
| Support channel | Existing SafeCall support path; no standalone Keryx 24/7 emergency desk |
| Hours / response | Czech business hours; next-business-day first response for ordinary contacts; same-business-day acknowledgment for supported-tier core-path incidents by the go/no-go owner when reported through SafeCall |
| Support vs delivery | Support process targets are not alert-delivery SLAs |
| Severity (administrator ops) | Treat missed/delayed Keryx alerts as supplemental-channel degradation; escalate via site SOP and SafeCall ops — not “Keryx emergency dispatch” |
| Severity (product/support) | Use SafeCall/GitLab intake; redact secrets per support draft |
| Communication | Prefer SafeCall account path; no public Keryx status page at launch |
| In-app acknowledgment | Local UI only; does not guarantee SafeCall or peer administrators received confirmation |
Copy surfaces and evidence handoffs
| Surface | Owner |
|---|---|
| Normative claims (this packet) | Approved here |
| Legal drafts cross-link | legal/ + public-web-pages.md; remain DRAFT until counsel/deploy |
| Store listing / marketing copy | store-listing-copy.md (P2-02); console paste #125 |
| Live legal pages + counsel | public-web-pages.md (P2-04); HTTPS deploy + counsel |
| Support / troubleshooting runbooks | #120 / #121 |
| Physical delivery evidence | #117 |
| Store console claim consistency | #125 |
| Czech parity of public claims | #108 |
Explicit non-claims
Closing #103 approves this packet. It does not:
- claim Critical Alerts entitlement was requested or granted;
- claim counsel reviewed or live legal pages exist;
- claim store listings or in-app copy already use the approved sentences;
- claim the physical-device delivery matrix (#117) is complete;
- claim Keryx is a certified emergency or medical system.
Review record
- Status: approved as the P1-10 safety claims and regulatory position packet.
- Date: 25 August 2026.
- Approver: Thomas Minitsios under the P0-05 RACI.
- Depends on: P0-02 categories, P0-05 ownership/support, android-delivery-architecture.md, ios-delivery-architecture.md, legal/.
- Evidence sources: P0–P1 roadmap decisions, delivery architectures, legal drafts, publishing runbook category rules.