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HealthClaw Guardrails

The security layer between AI agents and clinical data. A healthclaw.io open source project.

v1.3.0 | 288+ tests | 16 MCP tools | FHIR R4 US Core v9 + R6 v6.0.0-ballot3 | Fasten Connect | Open Wearables | Claude Code plugin

FHIR standardized how health data is structured. MCP standardized how AI connects to tools. Nobody standardized the guardrails in between. This project does.

What's new in v1.3.0 — Wearables

Heart rate, HRV, SpO2, steps, sleep, BP, glucose, body weight — from Garmin, Oura, Polar, Suunto, Whoop, Fitbit, Strava, Ultrahuman — flow into HealthClaw as FHIR Observations with correct LOINC codes and device Provenance. Compiled Truth timelines now include wearable-sourced data; SmartHealthConnect's healthy-habits + diet-exercise skills read them through the same fhir_search they already use.

  • Open Wearables sidecar (the-momentum/open-wearables, MIT) runs under a new wearables docker-compose profile. It owns per-provider OAuth; we own the FHIR mapping.
  • r6/wearables/mapper.py translates 13 metrics to LOINC + UCUM FHIR Observations. Unknown fields fall through with code.text — no data loss.
  • Daemon poller syncs every WEARABLES_POLL_INTERVAL (default 900s), posts through /Bundle/$ingest-context with step-up + X-Agent-Id: wearable-sync.
  • wearables_sync_status MCP tool (16 tools total) returns connection status + _meta.ui.resourceUri pointing at the new Connection Manager MCP App.
  • MCP App at /r6/fhir/mcp-apps/wearables/ — cards per provider: connect / re-auth / sync / view.

Quick start: OPEN_WEARABLES_URL=http://open-wearables:8000 docker-compose --profile wearables up -d.

What's new in v1.2.0 — Compiled Truth

Every other health tool shows you data. HealthClaw shows you the trail.

  • GET /<type>/<id>/$compiled-truth — returns current redacted resource + curation state + quality score + full Provenance timeline (newest first).
  • fhir_compiled_truth MCP tool — agents call this before making resource-specific claims; responses carry _meta.ui.resourceUri pointing to an embeddable review surface.
  • MCP App at /r6/fhir/mcp-apps/compiled-truth/<type>/<id> — focused HTML page: current data, evidence timeline, approve / re-evaluate actions. Zero install.
  • Activated schemacuration_state (raw → in_review → curated) and quality_score (0.0–1.0) now persisted on every resource.
  • .health-context.yaml — single declaration of jurisdiction, audience, regulations, defaults. Read by the guardrail stack; mirrored in SmartHealthConnect.

What It Does

This is a vendor-neutral guardrail proxy that sits between any AI agent and any FHIR server. Every request passes through:

  • PHI redaction — Names truncated to initials, identifiers masked, addresses stripped, birth dates truncated to year
  • Immutable audit trail — Every read/write logged with tenant, agent, timestamp
  • Step-up authorization — HMAC-SHA256 tokens required for writes
  • Human-in-the-loop — Clinical writes blocked until a human confirms (HTTP 428)
  • Tenant isolation — Every query scoped to tenant, cross-tenant access blocked
  • Medical disclaimers — Injected on all clinical resource reads
  • Compiled Truth — Current state + append-only evidence trail for every resource
AI Agent ──▶ MCP Server ──▶ Guardrail Proxy ──▶ Any FHIR Server
                              ↓                    (HAPI, Epic,
                         PHI redaction              Medplum, etc.)
                         Audit trail
                         Step-up auth
                         Human-in-the-loop

Install as a Claude Plugin

HealthClaw ships as a Claude Code plugin marketplace. Two plugins are available:

# Add the marketplace
claude plugin marketplace add aks129/HealthClawGuardrails

# Install the FHIR guardrail plugin (this repo)
claude plugin install healthclaw-guardrails@healthclaw-marketplace

# Install the personal-health companion plugin (SmartHealthConnect)
claude plugin install smarthealthconnect@healthclaw-marketplace
Plugin Skills Source
healthclaw-guardrails curatr, fasten-connect, fhir-r6-guardrails, fhir-upstream-proxy, healthex-export, phi-redaction aks129/HealthClawGuardrails
smarthealthconnect care-completion, diet-exercise, healthy-habits, kids-health, medication-refills, research-monitor aks129/SmartHealthConnect

Each skill is auto-discoverable — Claude loads it when your prompt matches the skill's trigger phrases (e.g. "check my care gaps", "redact this bundle", "run Curatr on my conditions").

Quick Start

# Install dependencies
uv sync

# Run (local mode with SQLite)
STEP_UP_SECRET=your-secret python main.py

# Run with upstream FHIR server
FHIR_UPSTREAM_URL=https://hapi.fhir.org/baseR4 STEP_UP_SECRET=your-secret python main.py

# Open browser
open http://localhost:5000            # Landing page with live demo
open http://localhost:5000/r6-dashboard  # Interactive dashboard

Docker

docker-compose up -d --build

# Services:
# - fhir-mcp-guardrails (Flask, port 5000)
# - agent-orchestrator (MCP server, port 3001)
# - redis (port 6379)

MCP Tools (14)

Tool names use underscores (not dots) for Claude Desktop / MCP client compatibility.

Read tools (no step-up required):

Tool Description
context_get Retrieve pre-built context envelopes
fhir_read Read a FHIR resource (redacted)
fhir_search Search with patient, code, status, date filters
fhir_validate Structural validation
fhir_stats Observation statistics (count/min/max/mean)
fhir_lastn Most recent N observations per code
fhir_permission_evaluate R6 Permission access control evaluation
fhir_subscription_topics List available SubscriptionTopics
curatr_evaluate Evaluate a FHIR resource for data quality issues

Write tools (require step-up token):

Tool Description
fhir_propose_write Validate + preview without committing
fhir_commit_write Commit with step-up auth + human-in-the-loop
curatr_apply_fix Apply patient-approved fixes with Provenance tracking

Utility tools:

Tool Description
fhir_get_token Issue a 5-minute step-up token (call before any write)
fhir_seed Seed a tenant with demo Patient + Observations + Condition

All tools add _mcp_summary with reasoning, clinical context, and limitations.

Guardrail Demo

The 6-step demo at /r6/fhir/demo/agent-loop shows the full guardrail sequence:

  1. PHI Redaction — Agent reads a patient, receives redacted data
  2. $validate Gate — Agent proposes an Observation, validated before write
  3. Permission Deny — No Permission rule exists, access denied with reasoning
  4. Permission Permit — Permit rule created, re-evaluation succeeds
  5. Step-up + Human-in-the-loop — Write requires both token and human confirmation
  6. Commit + Audit — Write succeeds, full audit trail generated

Comparison

Feature This Project AWS HealthLake MCP Medplum MCP Raw FHIR API
Works with any FHIR server Yes HealthLake only Medplum only N/A
PHI redaction on reads Yes No No No
Immutable audit trail Yes CloudTrail (separate) Partial No
Step-up auth for writes Yes IAM (separate) Medplum auth No
Human-in-the-loop Yes No No No
Permission $evaluate (R6) Yes No No No
Setup time 10 seconds 30+ minutes 15+ minutes Varies

FHIR Version Support

Version Profile Status Resources
R4 US Core v9 Stable Patient, Condition, AllergyIntolerance, Immunization, MedicationRequest, Procedure, DiagnosticReport, CarePlan, CareTeam, Goal, DocumentReference, Coverage, ServiceRequest, Location, Organization, Practitioner, PractitionerRole, RelatedPerson, Specimen, FamilyMemberHistory
R6 v6.0.0-ballot3 Experimental Permission, SubscriptionTopic, DeviceAlert, NutritionIntake, DeviceAssociation, NutritionProduct, Requirements, ActorDefinition

Both R4 and R6 resources flow through the same guardrail stack (PHI redaction, audit, step-up auth, tenant isolation). R6 ballot resources may change before final release.

Testing

# Python tests (266 tests)
uv run python -m pytest tests/ -v
uv run python -m pytest tests/test_r6_routes.py::test_name -v   # single test

# MCP server tests
cd services/agent-orchestrator && npm ci && npm test

# Playwright end-to-end tests (UI + API, requires Flask on :5000)
cd e2e && npm ci && npx playwright install --with-deps chromium && npm test
cd e2e && npm run test:headed    # headed browser
cd e2e && npm run test:ui        # interactive UI mode

API Endpoints

Endpoint Method Description
/r6/fhir/metadata GET CapabilityStatement
/r6/fhir/health GET Liveness probe (reports upstream status)
/r6/fhir/{type} POST Create resource (requires step-up)
/r6/fhir/{type} GET Search resources
/r6/fhir/{type}/{id} GET Read resource (redacted)
/r6/fhir/{type}/{id} PUT Update resource (requires step-up + ETag)
/r6/fhir/{type}/$validate POST Validate resource
/r6/fhir/{type}/{id}/$deidentify GET HIPAA Safe Harbor de-identification
/r6/fhir/Observation/$stats GET Observation statistics
/r6/fhir/Observation/$lastn GET Most recent observations
/r6/fhir/Permission/$evaluate POST R6 access control evaluation
/r6/fhir/SubscriptionTopic/$list GET Subscription topic discovery
/r6/fhir/Bundle/$ingest-context POST Bundle ingestion + context envelope
/r6/fhir/context/{id} GET Retrieve context envelope
/r6/fhir/AuditEvent GET Search audit events
/r6/fhir/AuditEvent/$export GET Export audit trail (NDJSON/Bundle)
/r6/fhir/demo/agent-loop POST 6-step guardrail demo
/r6/fhir/oauth/* * OAuth 2.1 + PKCE + SMART discovery
/r6/fhir/{type}/{id}/$curatr-evaluate GET Evaluate resource data quality (Curatr)
/r6/fhir/{type}/{id}/$curatr-apply-fix POST Apply patient-approved fixes with Provenance

Upstream Proxy

Connect to real FHIR servers while keeping all guardrails active:

FHIR_UPSTREAM_URL=https://hapi.fhir.org/baseR4 python main.py
  • Reads: Fetched from upstream, then redacted + audited + disclaimers added
  • Searches: Forwarded with all query params, results redacted per entry
  • Writes: Validated locally first, then forwarded with step-up auth check
  • URL rewriting: Upstream URLs never leak to clients

Tested with: HAPI FHIR R4/R5, SMART Health IT, Epic Sandbox.

Curatr — Patient-Owned Data Quality

Curatr is a patient-facing data quality skill that evaluates FHIR health records for coding issues and lets the patient decide how to resolve them.

1. Patient connects data → HealthClaw Guardrails deidentifies and loads it
2. OpenClaw calls curatr.evaluate → checks codes against live terminology APIs
3. Issues presented in plain language with impact and fix suggestions
4. Patient approves fixes → curatr.apply_fix updates resource + creates Provenance
5. Optional: generate a structured correction request for the source provider

What Curatr checks on a Condition:

Check Service Example
Deprecated code system Local lookup (no network) ICD-9-CM → critical
ICD-10-CM code validity NLM Clinical Tables API Invalid code → warning
SNOMED CT / LOINC validity tx.fhir.org (HL7 public) Unknown code → warning
RxNorm drug code RXNAV API (NLM) Missing RXCUI → warning
Display name accuracy Cross-checked with canonical term Mismatch → suggestion
Missing required fields Structural No clinicalStatus → warning

Every fix creates a linked Provenance resource recording patient intent, field changes, and agent attribution. All changes are audited in the immutable trail.

OpenClaw skill: skills/curatr/SKILL.md

R6-Specific Resources (Experimental)

These resources are part of the FHIR R6 ballot3 specification and may change before final release.

Resource What's New in R6
Permission Access control (separate from Consent), $evaluate operation
SubscriptionTopic Restructured pub/sub (introduced R5, maturing R6)
DeviceAlert ISO/IEEE 11073 device alarms
NutritionIntake Dietary consumption tracking
DeviceAssociation Device-patient relationships
NutritionProduct Nutritional product definitions
Requirements Functional requirements tracking
ActorDefinition Actor role definitions

US Core v9 R4 Resources (Stable)

Standard FHIR R4 resources conforming to US Core Implementation Guide v9. These are widely deployed in US healthcare and stable for production use.

AllergyIntolerance, Immunization, MedicationRequest, Medication, MedicationDispense, Procedure, DiagnosticReport, CarePlan, CareTeam, Goal, DocumentReference, Location, Organization, Practitioner, PractitionerRole, RelatedPerson, Coverage, ServiceRequest, Specimen, FamilyMemberHistory

Environment Variables

Variable Required Default Description
STEP_UP_SECRET Production HMAC-SHA256 signing secret
FHIR_UPSTREAM_URL No Upstream FHIR server (enables proxy mode)
SQLALCHEMY_DATABASE_URI Production sqlite:///mcp_server.db Database connection
SESSION_SECRET No (dev key) Flask session secret
FHIR_UPSTREAM_TIMEOUT No 15 Upstream request timeout (seconds)
FHIR_LOCAL_BASE_URL No Local URL for response URL rewriting

Project Structure

main.py                         Flask app entry point
app.py                          Web UI routes (landing, dashboard)
r6/
  routes.py                     R6 FHIR REST Blueprint (1,732 lines)
  models.py                     R6Resource, ContextEnvelope, AuditEventRecord
  validator.py                  FHIR R6 structural validation
  redaction.py                  PHI redaction (names, identifiers, addresses, DOB, telecom)
  audit.py                      Immutable AuditEvent recording
  stepup.py                     HMAC-SHA256 step-up token management
  oauth.py                      OAuth 2.1 + PKCE + SMART-on-FHIR discovery
  health_compliance.py          Disclaimers, HITL, HIPAA Safe Harbor, audit export
  context_builder.py            Bundle ingestion + context envelopes
  rate_limit.py                 Per-tenant rate limiting
  fhir_proxy.py                 Upstream FHIR server proxy with URL rewriting
  curatr.py                     Curatr data quality engine (terminology lookups + fix application)
services/agent-orchestrator/
  src/index.ts                  MCP server (Streamable HTTP + SSE)
  src/tools.ts                  12 tool definitions + executor (incl. curatr.evaluate, curatr.apply_fix)
e2e/                            Playwright end-to-end tests
templates/                      Jinja2 (landing page, dashboard)
static/                         CSS + JS for interactive dashboard
skills/curatr/                  Curatr OpenClaw skill definition
tests/                          266 pytest tests (8 files, incl. test_us_core_r4.py)

Personal FHIR data store — patient import flow

This walkthrough shows how to go from a raw HealthEx export to querying your own records through Claude Code's MCP tools.

1. Start the stack

uv sync
uv run python main.py                         # Flask on :5000
cd services/agent-orchestrator && npm ci && npm start  # MCP on :3001

2. Import your HealthEx / Flexpa / generic FHIR bundle

# Dry-run first to preview without writing
python scripts/import_healthex.py \
  --bundle-file ~/Downloads/my-records.json \
  --dry-run

# Real import — prints context_id on success
python scripts/import_healthex.py \
  --bundle-file ~/Downloads/my-records.json \
  --tenant-id my-patient \
  --step-up-secret "$STEP_UP_SECRET"

3. Connect Claude Code via MCP

.mcp.json in this repo auto-configures Claude Code when you open the project. Update X-Tenant-ID to match your --tenant-id:

{
  "mcpServers": {
    "healthclaw-local": {
      "type": "http",
      "url": "http://localhost:3001/mcp",
      "headers": { "X-Tenant-ID": "my-patient" }
    }
  }
}

Then in Claude Code:

Use fhir_search to find all my Conditions
Use context_get with context_id <ctx-id> to get my full context envelope
Use curatr_evaluate on Condition/<id> to check data quality

4. Set up Fasten Connect (optional)

# .env additions
FASTEN_PUBLIC_KEY=<key>
FASTEN_PRIVATE_KEY=<key>
FASTEN_WEBHOOK_SECRET=<secret>
FASTEN_CURATR_SCAN=true    # auto-run Curatr after each import

Records arrive via webhook at /r6/fasten/webhook and are stored under the patient's canonical tenant ID.

5. Deidentify for sharing

# HIPAA Safe Harbor
curl -H "X-Tenant-ID: my-patient" \
  http://localhost:5000/r6/fhir/Patient/pt-1/\$deidentify

# Patient-controlled (preserves birthDate, strips institutional identifiers)
curl -H "X-Tenant-ID: my-patient" \
  "http://localhost:5000/r6/fhir/Patient/pt-1/\$deidentify?mode=patient-controlled&patient_id=my-patient"

6. Telegram bot (optional)

TELEGRAM_BOT_TOKEN=<token> TENANT_ID=my-patient \
FHIR_BASE_URL=http://localhost:5000/r6/fhir \
python openclaw/bot.py

Commands: /health, /conditions, /labs, /curatr, /curatr fix, /approve.

Or via Docker Compose:

docker-compose --profile openclaw up -d

7. Use Medplum as the backing FHIR store (optional)

Set in .env (leave FHIR_UPSTREAM_URL empty):

MEDPLUM_BASE_URL=https://api.medplum.com/fhir/R4
MEDPLUM_CLIENT_ID=<id>
MEDPLUM_CLIENT_SECRET=<secret>

All guardrails apply to Medplum responses identically to local SQLite mode. Access tokens are cached in Redis (key medplum:access_token; falls back to in-process cache when Redis is unavailable).


Known Limitations

  • Local mode: JSON blob storage with table-scan search (no indexed fields)
  • Structural validation only (no StructureDefinition conformance or terminology binding)
  • SubscriptionTopic stored but notifications not dispatched
  • Human-in-the-loop is a header flag, not cryptographic confirmation
  • OAuth endpoints implemented but not enforced on routes (demonstration only)
  • No historical versioning (version_id increments but old versions not retrievable)
  • Upstream proxy: no response caching, no cross-version translation

License

MIT

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The security layer between AI agents and clinical data. A healthclaw.io open source project.

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