docs(shield): v2 — HIPAA+GDPR global scope, user's pricing model (free print, $49 PMS integration), Signal Tier 3 bundle, Shield MVP first

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# STTIL Shield — Product Architecture # STTIL Shield — Product Architecture v2
**Design date:** 2026-06-22 **Design date:** 2026-06-22
**Design by:** Pi **Design by:** Pi
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## 1. Product Definition ## 1. Product Definition
**What Shield is:** **What Shield is:**
A standalone compliance automation platform for small healthcare operations and SaaS companies that engage with PHI and AI and need compliance — without paying enterprise prices. 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:** **What Shield is NOT:**
- Not DMEPOS-specific (that's Signal's lane) - Not DMEPOS-specific (that's Signal's lane)
- Not a replacement for Vanta/Drata (different tier — Shield targets smaller orgs)
- Not a consulting service (self-serve compliance tooling) - Not a consulting service (self-serve compliance tooling)
- Not limited to the US market
**Target customer:** **Target customer:**
- **Small healthcare ops** — clinics, therapy practices, home health agencies, DME suppliers of any type who handle PHI and need HIPAA compliance - **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** — startups building AI tools for healthcare, digital health apps, telemedicine platforms, patient communication tools - **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 PHI** — any company building AI/ML products that touch protected health information and need to prove compliance to customers - **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 who need both documentation readiness (Signal) and overall compliance (Shield) - **Shield + Signal bundle** — DMEPOS suppliers on Signal Tier 3 get Shield included
**Core value proposition:** **Core value proposition:**
"Get HIPAA compliant in days, not months. Pre-built policies, automated evidence collection, audit-ready reporting, and a free open-source AI Consent Engine — starting at less than any competitor." "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 ## 2. Competitive Positioning
| Competitor | Price | Frameworks | Target | Shield Advantage | | Competitor | Price | Coverage | Global? | Shield Advantage |
|-----------|-------|-----------|--------|-----------------| |-----------|-------|---------|---------|-----------------|
| **Vanta** | $10K-$100K+/yr | SOC 2, HIPAA, ISO, PCI | Enterprise | Overkill for small ops | | **Vanta** | $10K-$100K+/yr | SOC 2, HIPAA, ISO, PCI | Partial | Overpriced for small ops |
| **Drata** | $7.5K-$100K+/yr | SOC 2, HIPAA, ISO, PCI | Mid-market | Overkill 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 | Mid-market | Overkill 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 | Small teams | **Direct competitor** | | **Dash ComplyOps** | **$3K/yr flat** | HIPAA, SOC 2, PCI, ISO, NIST | **US only** | **Direct competitor but US-only** |
| **Shield** | **TBD (target $1.2K-$2.4K/yr)** | HIPAA-first, SOC 2, expand | **Small healthcare ops + AI SaaS** | Cheaper + Consent Engine lead magnet | | **Shield** | **TBD** | **HIPAA + GDPR native** | **Global** | Global by design, cheaper, Consent Engine |
**Differentiation strategy:** **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.
- Price under Dash (target $100-200/mo instead of $250)
- AI Consent Engine is a unique open-source lead-gen asset no competitor has
- Purpose-built for small healthcare operations and AI companies — not enterprise compliance repackaged
- Optional Signal bundle for DMEPOS suppliers who also need documentation readiness
--- ---
## 3. Feature Set (MVP) ## 3. Shield MVP — Core Feature Set
### Core Features (v1) ### MVP Scope (v1.0)
| Feature | Description | Why | The MVP focuses on what small healthcare ops and AI SaaS need most: proving HIPAA and GDPR compliance with minimal effort.
|---------|-------------|-----|
| **Policy Templates** | 12+ pre-built admin policies (HIPAA-focused) | Instant compliance documentation |
| **Evidence Collection** | Manual upload + API integrations for cloud infra | Prove controls are active |
| **Audit Reports** | One-click SOC 2 / HIPAA evidence bundles | Answer auditor requests fast |
| **Risk Assessment** | Simple asset register + risk scoring | Foundational HIPAA requirement |
| **User Management** | Unlimited users (team collaboration) | Match Dash's offering |
| **Framework Support** | HIPAA v1, SOC 2 v2, expand to PCI/ISO | Start narrow, grow |
### AI Consent Engine (Open-Source Lead Magnet) **HIPAA + GDPR Overlap:**
Both frameworks require:
**What it does:** - Data mapping and classification
An open-source tool that lets any healthcare organization generate HIPAA-compliant AI/healthcare consent forms for their patients or end-users. A client (clinic, SaaS, AI company) takes the Consent Engine, brands it with their logo and custom language, and serves it to their own patients so patients can generate consent documents. - Risk assessments
- Access controls
- Breach notification procedures
- Vendor/subprocessor management
- Training documentation
- Policy adoption and review cadence
**How the client uses it:** Shield's architecture treats these as shared controls, then layers jurisdiction-specific requirements on top rather than building separate modules.
1. Fork or clone the open-source GitHub repo | Feature | HIPAA | GDPR | Shared |
2. Edit a config file (JSON or YAML) with their logo URL, company name, clinic name, custom consent clauses, and branding colors |---------|-------|------|--------|
3. Deploy via one-click to Vercel/Netlify, or self-host | Policy templates (12+) | ✓ | ✓ | ✓ |
4. Their patients visit their branded consent page, fill in AI tool name and data types, and receive a formatted HIPAA-compliant consent PDF | Data mapping / ROPA | ✓ | ✓ | ✓ |
5. The footer includes: "Powered by STTIL Shield — Need full compliance? Learn more." | Risk assessment | ✓ | ✓ | ✓ |
| Breach notification playbook | ✓ | ✓ | ✓ |
| Subprocessor tracking | ✓ | ✓ | ✓ |
| Evidence collection | ✓ | ✓ | ✓ |
| Audit reports | ✓ | ✓ | ✓ |
| Consent management reference | ✓ | ✓ | ✓ |
**Why open source on GitHub:** **Key MVP deliverables:**
- Builds community trust and brand credibility 1. **Policy Library** — 12+ pre-built admin policies with HIPAA and GDPR variants. User picks their jurisdiction at onboarding.
- SEO magnet for "AI consent form healthcare HIPAA GitHub" 2. **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.
- Low friction — any developer can try it in 5 minutes 3. **Risk Assessment** — Simple asset register + control mapping. Pre-populated with common healthcare SaaS controls.
- GitHub stars = social proof for Shield 4. **Evidence Collection** — Manual uploads first (MVP). API integrations later (Phase 2).
- PR contributions from the community improve the tool 5. **Audit Reports** — One-click evidence bundles formatted for HIPAA audits and/or GDPR supervisory authority requests.
- Client owns their instance, no data flows through STTIL 6. **Subprocessor Register** — Track vendors, BAAs, and data processing agreements.
--- ---
## 4. Consent Engine — Delivery Options ## 4. AI Consent Engine
### Option A: GitHub Template Repo (User's Suggestion) — RECOMMENDED ### Purpose
Create a GitHub template repository that clients can use with one click. 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.
**How it works:** ### Pricing Model
1. Client clicks "Use this template" on the GitHub repo | Use case | Price | What they get |
2. Their own copy is created with all the code |----------|-------|---------------|
3. They edit a single `config.yaml` or `config.json` file: | **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. |
```yaml ### How it Works
organization:
name: "City Family Clinic"
logo_url: "https://clinic.com/logo.png"
primary_color: "#2563eb"
website: "https://clinic.com"
consent:
jurisdiction: "US-HIPAA"
custom_clauses:
- "I consent to my data being used for AI-assisted diagnosis"
- "I understand I can revoke consent at any time"
footer_text: "This consent form is managed by City Family Clinic"
```
4. Deploy button (Vercel/Netlify) — one click to production 1. **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.
5. Client gets a live, branded consent form at `consent.clinic.com` or a Vercel subdomain 2. **Hosted version** (optional, later) — `consent.sttilsolutions.com` for non-technical users.
6. The form is ready for their patients to use 3. **$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.
**Pros:** ### README Requirements (to get it right)
- True open source — client owns the code and deployment The GitHub README must answer, in order:
- Developer-friendly — uses familiar GitHub workflow
- No data flows through STTIL — privacy advantage
- Community contributions via PRs
- Huge SEO value for "HIPAA consent form GitHub"
**Cons:** 1. **What is this?** — One-sentence: "Generate HIPAA and GDPR-compliant AI/healthcare consent forms for your patients or end-users."
2. **Quick start (60 seconds)** — "Click 'Use this template,' edit config.yaml, deploy to Vercel" — with screenshots
- Requires some technical ability (fork, edit config, deploy) 3. **Config reference** — Every field in `config.yaml` documented with examples
- No usage analytics for STTIL (can't track how many consents are generated) 4. **Custom domains** — How to point `consent.yourclinic.com` to your deployment
- Client self-manages hosting costs (usually free on Vercel/Netlify free tier) 5. **Practice management system integration** — "Want one-click install into DrChrono/PointClickCare? $49 — [Buy now](link)"
6. **Compliance notes** — What makes this form HIPAA-compliant and/or GDPR-compliant. Legal disclaimer.
### Option B: Hosted Multi-Tenant (SaaS) 7. **Contributing** — How to submit PRs, report issues
8. **License** — MIT
A hosted version at `consent.sttilsolutions.com` where clients log in, upload their logo, customize language through a UI, and get a branded page. 9. **Shield upsell** — "Need full compliance automation for your organization? Check out Shield."
**How it works:**
1. Client signs up (no payment needed)
2. Uploads logo, sets colors, writes custom clauses in a WYSIWYG editor
3. Gets a branded URL: `consent.sttilsolutions.com/city-family-clinic`
4. Links their patients to that URL
5. Or embeds via iframe on their own website
**Pros:**
- Zero technical skills required
- STTIL controls the full experience
- Can track usage, collect emails, measure conversion to Shield paid
- Can A/B test CTAs and optimize lead generation
**Cons:**
- STTIL hosts the service (potential PHI adjacency concerns)
- More operational overhead
- Less open/community feel
- Client doesn't own their instance
### Option C: Hybrid (Recommended as Final State)
Start with Option A (GitHub template) for the developer audience and open-source community. Later add Option B (hosted) for non-technical clients who want a simpler setup.
**Phased rollout:**
1. **Phase 0a:** GitHub template repo — config-driven, deploy button
2. **Phase 0b (later):** Hosted version at consent.sttilsolutions.com — for clinics without developers
3. Both share the same rendering engine (the GitHub repo is the source of truth)
**Best of both worlds:**
- Developers and open-source community get the GitHub experience
- Non-technical clinics get the hosted experience
- The rendering engine is MIT-licensed on GitHub regardless
--- ---
## 5. Technical Architecture ## 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) ### Standalone Codebase (Not Signal Module)
Build Shield as a new, independent codebase. No shared infrastructure with Signal. Same reasoning as v1 — clean separation enables independent pricing, global scaling, and future spinout.
**Stack:** **Stack:**
- Frontend: Vite/React (same stack as Signal — reuse patterns) - Frontend: Vite/React
- Backend: Python/FastAPI (same stack — reuse patterns) - Backend: Python/FastAPI
- Database: Supabase (separate project from Signal's DB) - Database: Supabase (separate project)
- Auth: Clerk (separate instance or same with org separation) - Auth: Clerk (global-ready — supports multiple identity providers)
- Hosting: Railway (separate project) + Vercel (separate deployment) - Hosting: Railway + Vercel
**Why standalone:** ### Global-Ready Architecture Decisions
- Clean separation — Signal issues never affect Shield or vice versa | Decision | Why |
- Independent pricing and scaling |----------|-----|
- Can sell standalone without bundling concerns | Multi-jurisdiction from day one | User selects "HIPAA," "GDPR," or "Both" at onboarding. Policies, risk templates, and reports adjust accordingly |
- Easier to spin out or sell separately later | 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 Architecture (GitHub Template) | Consent Engine supports both standards | Config toggle between HIPAA, GDPR, or combined consent language |
```
shield-consent-engine/
├── README.md # Quick start, config guide
├── config.yaml # THE config file — client edits this
├── template/ # HTML/CSS/JS rendering engine
│ ├── index.html # Main consent form page
│ ├── style.css # Uses CSS variables from config
│ ├── script.js # Form logic, PDF generation
│ └── preview.png # Screenshot for GitHub social
├── CNAME # Custom domain support
├── vercel.json # One-click deploy config
├── netlify.toml # Netlify deploy config
├── LICENSE # MIT license
└── .github/
└── CONTRIBUTING.md # How to contribute
```
**Key technical decisions:**
- Client-side PDF generation only (jsPDF or pdf-lib) — no backend needed
- CSS custom properties driven by config — instant branding
- Zero data storage — forms generate PDF in-browser, nothing is sent to a server
- Deploy preview on every PR via Vercel/Netlify
- GitHub Actions for CI (validate config, build preview)
--- ---
## 6. Pricing Tiers (Suggested) ## 7. Pricing Tiers (Shield Standalone)
| Tier | Price (monthly) | Features | Target | | Tier | Price (monthly) | Features | Target |
|-----|----------------|---------|--------| |-----|----------------|---------|--------|
| **Free** | $0 | AI Consent Engine (GitHub template, self-hosted) | Lead gen, community | | **Starter** | **$99/mo** | HIPAA or GDPR (pick one), 12 policies, data mapping, risk assessment, evidence upload | Solo practitioners, tiny teams |
| **Starter** | **$99/mo** | 12 policies, evidence upload, audit reports | Solo practitioners, tiny teams | | **Growth** | **$199/mo** | HIPAA + GDPR (both), audit reports, subprocessor register, unlimited users | Growing healthcare ops, AI SaaS |
| **Growth** | **$199/mo** | Starter + API integrations, risk assessments, unlimited users | Growing healthcare ops, SaaS | | **Enterprise** | Custom | Growth + dedicated support, custom frameworks, API integrations, Signal Tier 3 bundle | DMEPOS suppliers, larger orgs |
| **Enterprise** | Custom | Growth + dedicated support, custom frameworks, Signal bundle | DMEPOS suppliers, larger orgs |
**Rationale:** **Key pricing principles:**
- Undercut Dash ($250/mo) at both Starter ($99) and Growth ($199) - Dash costs $250/mo for US-only HIPAA + SOC 2
- Free tier = Consent Engine (zero cost to STTIL, drives organic traffic and SEO) - Shield at $199/mo for HIPAA + GDPR is cheaper AND broader in geographic scope
- Signal bundle upsell to $299/mo for suppliers who need both Signal + Shield - Signal Tier 3 covers Shield — creates a bundle upsell for DMEPOS suppliers
- Consent Engine generates organic leads that convert to Shield Starter
--- ---
## 7. Go-to-Market ## 8. Build Phases (Prioritized)
### Consent Engine as Growth Engine | Phase | Scope | Est. | Depends on |
|-------|-------|------|-----------|
1. Developer or clinic ops person discovers "HIPAA consent form" via search | **Phase 1: Shield MVP** | Policy library, data mapping/ROPA, risk assessment, evidence upload, audit reports, auth, HIPAA + GDPR frameworks | 4-5 sessions | Nothing |
2. Finds the open-source GitHub repo — stars, forks, tries it | **Phase 2: Consent Engine** | GitHub template repo, config-driven, deploy button, MIT license | 1 session | Phase 1 (or parallel) |
3. Impressed by quality → sees Shield CTA in the footer | **Phase 3: $49 PMS Integrations** | Pre-built connectors for 3-5 major practice management systems | 1-2 sessions | Phase 2 |
4. Signs up for Shield Starter ($99/mo) | **Phase 4: API Integrations** | Evidence collection via API (AWS, GCP, Railway, Supabase) | 2-3 sessions | Phase 1 |
5. Upgrades to Growth when they need audit prep and evidence collection | **Phase 5: Signal Tier 3 Bundle** | Shared dashboard + billing integration | 1 session | Phase 1 + Signal coordination |
### Channels
- **GitHub:** Stars, trending, HN posts about the open-source Consent Engine
- **SEO:** "HIPAA consent form generator," "AI consent template GitHub," "HIPAA compliance for startups"
- **Content:** Blog posts: "How we built an open-source HIPAA consent engine," "Shield vs Dash ComplyOps"
- **Signal cross-sell:** When a DMEPOS supplier signs up for Signal, offer Shield bundle
- **Direct outreach:** Small clinics, digital health startups, AI healthcare companies
---
## 8. Build Phases
| Phase | Scope | Est. |
|-------|-------|------|
| **Phase 0a: Consent Engine GitHub** | Template repo, config-driven, deploy button, MIT license | 1 session |
| **Phase 0b: Consent Engine Hosted** | Multi-tenant hosted version for non-technical users | 1 session (later) |
| **Phase 1: Shield MVP** | Policy templates, evidence upload, audit reports, user auth | 3-4 sessions |
| **Phase 2: Risk + Integrations** | Risk assessment module, API integrations (AWS, GCP, Railway) | 2-3 sessions |
| **Phase 3: Signal Bundle** | Shared dashboard for suppliers using both products | 1 session |
--- ---
## 9. Open Questions (For Kisa) ## 9. Open Questions (For Kisa)
1. **Pricing:** Does $99/$199 feel right for small healthcare ops? Too low/high vs Dash at $250? 1. **Frameworks:** Start with HIPAA + GDPR as described? Or add SOC 2 at launch too?
2. **Frameworks:** Start with HIPAA-only and add SOC 2 later? Or launch with both? 2. **Practice management systems:** Which ones should we target first for the $49 integration? (DrChrono? PointClickCare? PracticeFusion? Kareo?)
3. **Consent Engine name:** "AI Consent Engine" vs "STTIL Consent Builder" vs "Open Consent"? 3. **Consent Engine name:** "Open Consent" vs "AI Consent Engine" vs "STTIL Consent Builder" vs something else?
4. **Consent Engine approach:** Go with Option A (GitHub template only), Option C (hybrid with hosted later), or something else? 4. **Build order:** Shield MVP first, then Consent Engine? Or start Consent Engine in parallel?
5. **Signal bundle:** A shared login/dashboard, or just a discount code for Shield customers? 5. **Signal Tier 3 pricing:** What's the price of Tier 3 relative to Tier 1/2? Does Shield inclusion justify a premium?
6. **Build order:** Consent Engine first (fast win) or Shield MVP first? 6. **Data residency:** MVP just documents where data lives, or do we need EU hosting from day one?
7. **PHI concerns with hosted:** If we offer Option B (hosted), does the consent form itself generate PHI? (Patient name + health info in a form = potentially PHI)
--- ---