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Digits Health × myLaminin — Integration Architecture

How myLaminin's regulated-research substrate (FHIR, verifiable credentials, CTMS, ledger audit) could layer underneath Digits Health to unlock trial-grade workflows.

Integration Architecture

Digits stays the data-generating clinical edge. myLaminin becomes the regulated-research substrate underneath — FHIR mapping, verifiable credentials, 21 CFR Part 11 audit, and CTMS for trial-grade workflows.

Digits surfaceIntegration bridgemyLaminin platformExternal actors

1 — Capture (Digits clients)

Edge / IoMT
Web app
Next.js 16 + MediaPipe hand pose, ROM / dexterity / pain / arthritis
Android (Kotlin + Compose)
Native ROM assessments, on-device pose inference
Voice agent
Gemini Live STT + Google TTS Neural2 coaching

2 — Digits API (Fastify)

Business logic
/assessments
ROM, dexterity, pain-v2, arthritis save handlers
/reports
PDF generation, AI summarization, email
/ai-orchestrator
Gemini 2.5-flash + MedGemma (Vertex AI)
/billing
Stripe — adds RESEARCH tier for trial-grade pipeline

3 — Local store (Postgres + Prisma)

Authoritative cache
contacts · patient_info
PHI, Auth0-linked identity
rom / dexterity / pain / arthritis
Per-joint, per-finger validated metrics
assessment_records
Becomes a pointer to myLaminin credential id
hand_journal_entries
Voice transcripts + AI summaries (sensitive PHI)

4 — Integration bridge (new)

Adapter
FHIR serializer
ROM/dexterity → Observation, DeviceMetric, QuestionnaireResponse
Credential issuer client
Issues verifiable credential per finalized assessment
Audit anchor
Hashes report + signatures to myLaminin ledger
Outbox queue
Async, retried; Digits never blocks on the bridge

5 — myLaminin platform

SOC 2 · 21 CFR Part 11
FHIR repository
IoMT-mapped Observations, ResearchSubject linkage
Verifiable credentials
Patented issuer / holder / verifier model
CTMS + Randomization
Block / Stratification, ethics-board, consent
Distributed-ledger audit
Immutable, e-signature backed, regulator-ready

6 — External actors

Verifiers
Patient (credential holder)
Controls who sees what, no public-code leaks
Clinician / specialist
Verifies a referral without Digits exposing rows
Trial sponsor
Reads FHIR endpoints in real time for live monitoring
FDA / Ethics board
Audits ledger-anchored signatures & consent
Today

Digits only

  • AssessmentRecord.code — 6-char public links, no holder control
  • No FHIR exporter; metrics live only in app-shaped Postgres rows
  • No e-signature, no audit trail, no 21 CFR Part 11 controls
  • No randomization, CTMS, or sponsor-grade real-time stream
  • Clinical-trials landing page sells capability the stack lacks
With myLaminin

Digits as edge, myLaminin as substrate

  • Verifiable credentials replace public codes; patent-backed sharing
  • Every assessment is also a FHIR Observation in the trial repository
  • Reports e-signed by clinician, hash anchored on ledger
  • Randomization + CTMS unlock sponsor & FDA pilot motion
  • New RESEARCH Stripe tier monetizes the upgraded pipeline

Where the bridge plugs into the existing code

Digits surfacemyLaminin roleWhat changes
apps/api/src/routes/assessments.tsFHIR repositoryAfter local persist, emit Observation / DeviceMetric via the outbox.
prisma/schema.prisma — AssessmentRecordVerifiable credentialRow becomes a pointer to a credential id; isPublic deprecated.
apps/api/src/routes/reports.ts + services/report-ai.service.tsE-signature + ledger anchorClinician signs; report hash anchored to ledger; share link is credential-based.
hand_journal_entriesHolder-controlled sharingSensitive PHI never goes public — patient grants per-verifier access.
subscriptions (Stripe)Pricing surfaceNew RESEARCH tier gates the myLaminin-backed pipeline.
(marketing)/clinical-trials/page.tsxCTMS + randomizationReplace aspirational copy with a real enrollment form backed by Block/Stratification.

Lifecycle of a single trial-grade assessment

  1. 1
    Enroll
    Patient consents in Digits; myLaminin randomizes them into an arm and returns a ResearchSubject id.
  2. 2
    Capture
    MediaPipe ROM + dexterity run on web/Android. Voice coach guides the session.
  3. 3
    Persist
    Fastify writes per-joint metrics to Postgres — local source of truth.
  4. 4
    Translate
    Outbox emits FHIR Observations tagged with the ResearchSubject.
  5. 5
    Sign
    Clinician reviews the AI-generated report and e-signs in myLaminin; hash anchored on ledger.
  6. 6
    Share
    Patient releases a verifiable credential to specialist, insurer, or sponsor — no public links.
  7. 7
    Monitor
    Sponsor's live dashboard + FDA pilot view stream from the FHIR repository.

Proposed integration, generated for research. Visualization only; no code changes wired.