10 KiB
STTIL Shield — Product Architecture v2
Design date: 2026-06-22 Design by: Pi Status: Draft — review by Kisa before sharing with Claude Code
1. Product Definition
What Shield is: A global compliance automation platform for small healthcare operations and SaaS companies that handle PHI and/or personal data and need to prove compliance across jurisdictions. Think "Dash ComplyOps, but built for a global audience from day one — US HIPAA + EU GDPR, with an open-source AI Consent Engine as the lead-gen engine."
What Shield is NOT:
- Not DMEPOS-specific (that's Signal's lane)
- Not a consulting service (self-serve compliance tooling)
- Not limited to the US market
Target customer:
- Small healthcare ops globally — clinics, therapy practices, home health agencies, DME suppliers who handle PHI and need HIPAA and/or GDPR compliance
- Healthcare-adjacent SaaS globally — startups building AI/health tools, digital health apps, telemedicine platforms, patient communication tools serving US and/or EU markets
- AI companies handling personal data — any company building AI products that touch health or personal data and need to prove compliance to customers worldwide
- Shield + Signal bundle — DMEPOS suppliers on Signal Tier 3 get Shield included
Core value proposition: "One platform to prove HIPAA and GDPR compliance. Pre-built policies, automated evidence collection, audit-ready reporting — starting at less than any US-only competitor."
2. Competitive Positioning
| Competitor | Price | Coverage | Global? | Shield Advantage |
|---|---|---|---|---|
| Vanta | $10K-$100K+/yr | SOC 2, HIPAA, ISO, PCI | Partial | Overpriced for small ops |
| Drata | $7.5K-$100K+/yr | SOC 2, HIPAA, ISO, PCI | Partial | Overpriced for small ops |
| Secureframe | $7.5K-$80K+/yr | SOC 2, HIPAA, ISO, PCI | No | Overpriced for small ops |
| Dash ComplyOps | $3K/yr flat | HIPAA, SOC 2, PCI, ISO, NIST | US only | Direct competitor but US-only |
| Shield | TBD | HIPAA + GDPR native | Global | Global by design, cheaper, Consent Engine |
Key insight: No major competitor in the sub-$3K/yr space offers HIPAA + GDPR in one platform. Dash is US-only. Vanta/Drata add GDPR as an afterthought at enterprise prices. Shield's global-first approach is a genuine moat.
3. Shield MVP — Core Feature Set
MVP Scope (v1.0)
The MVP focuses on what small healthcare ops and AI SaaS need most: proving HIPAA and GDPR compliance with minimal effort.
HIPAA + GDPR Overlap: Both frameworks require:
- Data mapping and classification
- Risk assessments
- Access controls
- Breach notification procedures
- Vendor/subprocessor management
- Training documentation
- Policy adoption and review cadence
Shield's architecture treats these as shared controls, then layers jurisdiction-specific requirements on top rather than building separate modules.
| Feature | HIPAA | GDPR | Shared |
|---|---|---|---|
| Policy templates (12+) | ✓ | ✓ | ✓ |
| Data mapping / ROPA | ✓ | ✓ | ✓ |
| Risk assessment | ✓ | ✓ | ✓ |
| Breach notification playbook | ✓ | ✓ | ✓ |
| Subprocessor tracking | ✓ | ✓ | ✓ |
| Evidence collection | ✓ | ✓ | ✓ |
| Audit reports | ✓ | ✓ | ✓ |
| Consent management reference | ✓ | ✓ | ✓ |
Key MVP deliverables:
- Policy Library — 12+ pre-built admin policies with HIPAA and GDPR variants. User picks their jurisdiction at onboarding.
- Data Mapping / ROPA — Wizard-style interface to document data flows, classify data types, identify processors. Outputs a GDPR-compliant Record of Processing Activities (ROPA) or HIPAA-compliant data flow map.
- Risk Assessment — Simple asset register + control mapping. Pre-populated with common healthcare SaaS controls.
- Evidence Collection — Manual uploads first (MVP). API integrations later (Phase 2).
- Audit Reports — One-click evidence bundles formatted for HIPAA audits and/or GDPR supervisory authority requests.
- Subprocessor Register — Track vendors, BAAs, and data processing agreements.
4. AI Consent Engine
Purpose
An open-source lead-generation tool. Not the core product. Builds trust, drives organic traffic, and serves as a low-friction entry point to Shield.
Pricing Model
| Use case | Price | What they get |
|---|---|---|
| Print a consent PDF | Free | Visit the hosted tool or use the GitHub repo. Fill in fields, get a HIPAA/GDPR-compliant consent PDF. Done. |
| DIY integration | Free | Fork the GitHub repo, copy/paste the HTML into their website or practice management system. Supports themselves. |
| One-click PMS integration | $49 one-time | We provide a pre-built integration connector for major practice management systems (DrChrono, PointClickCare, etc.) that installs the consent form with one click. No coding. |
| Custom integration | Contact us | We build a custom connector for their specific PMS/EHR. |
How it Works
- GitHub template repo — "Use this template," edit
config.yaml(logo, company name, jurisdiction [HIPAA/GDPR/both], custom clauses), deploy to Vercel/Netlify with one click. - Hosted version (optional, later) —
consent.sttilsolutions.comfor non-technical users. - $49 PMS integration — A script that auto-installs the consent form into the practice management system via their API or embed mechanism. One-time purchase, no subscription.
README Requirements (to get it right)
The GitHub README must answer, in order:
- What is this? — One-sentence: "Generate HIPAA and GDPR-compliant AI/healthcare consent forms for your patients or end-users."
- Quick start (60 seconds) — "Click 'Use this template,' edit config.yaml, deploy to Vercel" — with screenshots
- Config reference — Every field in
config.yamldocumented with examples - Custom domains — How to point
consent.yourclinic.comto your deployment - Practice management system integration — "Want one-click install into DrChrono/PointClickCare? $49 — Buy now"
- Compliance notes — What makes this form HIPAA-compliant and/or GDPR-compliant. Legal disclaimer.
- Contributing — How to submit PRs, report issues
- License — MIT
- Shield upsell — "Need full compliance automation for your organization? Check out Shield."
5. Signal Tier 3 Bundle
Signal pricing tiers (proposed):
| Tier | Features | Shield included? |
|---|---|---|
| Tier 1 | Core Signal (documentation readiness worklist) | No |
| Tier 2 | Signal + Advanced Analytics | No |
| Tier 3 | Signal + Shield (compliance automation) | Yes — Shield included at no extra cost |
This makes Tier 3 the premium offering for DMEPOS suppliers who need both documentation readiness AND overall compliance. Shield also sells standalone to non-DMEPOS customers (clinics, AI SaaS, etc.).
6. Technical Architecture
Standalone Codebase (Not Signal Module)
Same reasoning as v1 — clean separation enables independent pricing, global scaling, and future spinout.
Stack:
- Frontend: Vite/React
- Backend: Python/FastAPI
- Database: Supabase (separate project)
- Auth: Clerk (global-ready — supports multiple identity providers)
- Hosting: Railway + Vercel
Global-Ready Architecture Decisions
| Decision | Why |
|---|---|
| Multi-jurisdiction from day one | User selects "HIPAA," "GDPR," or "Both" at onboarding. Policies, risk templates, and reports adjust accordingly |
| Data residency awareness | MVP: document where data lives. Phase 2: EU hosting option |
| Language-ready UI | i18n from day one (English + EU languages as we grow) |
| Consent Engine supports both standards | Config toggle between HIPAA, GDPR, or combined consent language |
7. Pricing Tiers (Shield Standalone)
| Tier | Price (monthly) | Features | Target |
|---|---|---|---|
| Starter | $99/mo | HIPAA or GDPR (pick one), 12 policies, data mapping, risk assessment, evidence upload | Solo practitioners, tiny teams |
| Growth | $199/mo | HIPAA + GDPR (both), audit reports, subprocessor register, unlimited users | Growing healthcare ops, AI SaaS |
| Enterprise | Custom | Growth + dedicated support, custom frameworks, API integrations, Signal Tier 3 bundle | DMEPOS suppliers, larger orgs |
Key pricing principles:
- Dash costs $250/mo for US-only HIPAA + SOC 2
- Shield at $199/mo for HIPAA + GDPR is cheaper AND broader in geographic scope
- Signal Tier 3 covers Shield — creates a bundle upsell for DMEPOS suppliers
- Consent Engine generates organic leads that convert to Shield Starter
8. Build Phases (Prioritized)
| Phase | Scope | Est. | Depends on |
|---|---|---|---|
| Phase 1: Shield MVP | Policy library, data mapping/ROPA, risk assessment, evidence upload, audit reports, auth, HIPAA + GDPR frameworks | 4-5 sessions | Nothing |
| Phase 2: Consent Engine | GitHub template repo, config-driven, deploy button, MIT license | 1 session | Phase 1 (or parallel) |
| Phase 3: $49 PMS Integrations | Pre-built connectors for 3-5 major practice management systems | 1-2 sessions | Phase 2 |
| Phase 4: API Integrations | Evidence collection via API (AWS, GCP, Railway, Supabase) | 2-3 sessions | Phase 1 |
| Phase 5: Signal Tier 3 Bundle | Shared dashboard + billing integration | 1 session | Phase 1 + Signal coordination |
9. Open Questions (For Kisa)
- Frameworks: Start with HIPAA + GDPR as described? Or add SOC 2 at launch too?
- Practice management systems: Which ones should we target first for the $49 integration? (DrChrono? PointClickCare? PracticeFusion? Kareo?)
- Consent Engine name: "Open Consent" vs "AI Consent Engine" vs "STTIL Consent Builder" vs something else?
- Build order: Shield MVP first, then Consent Engine? Or start Consent Engine in parallel?
- Signal Tier 3 pricing: What's the price of Tier 3 relative to Tier 1/2? Does Shield inclusion justify a premium?
- Data residency: MVP just documents where data lives, or do we need EU hosting from day one?
This is a design draft. Please review and adjust before sharing with Claude Code for build.