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TransTrack

Transplant Waitlist & Operations Management

HIPAA Aligned 21 CFR Part 11 Aligned Platform

TransTrack is an offline-first desktop application for transplant centers and pre-transplant coordination teams. It is architected to support HIPAA Security Rule controls and designed for alignment with FDA 21 CFR Part 11 electronic-records requirements; formal certification is the responsibility of the deploying organization and its auditors. It provides secure, cloud-independent data management and operational risk intelligence to help reduce the risk of patient inactivation before transplant.

Important: "HIPAA aligned" and "Part 11 architected" describe the product's design controls — they are not certifications. SOC 2 / HITRUST / 21 CFR Part 11 validation, and any FDA determinations, must be performed by the deploying organization with qualified auditors.

Licensing Notice: TransTrack is proprietary software. Use, operation, and deployment require a valid license activation issued by TransTrack Medical Software. Unauthorized use, redistribution, or rebranding is prohibited.

Impersonation and Safety Warning: The project has identified unaffiliated third-party pages impersonating TransTrack. Do not download installers, archives, or updates from unofficial pages. Use only the official repository and releases listed below.

Known Unaffiliated Page (Do Not Use): https://the-vishal-gupta.github.io/ is not an authorized TransTrack channel. Treat downloads or links from that page as unsafe.

TransTrack Dashboard

Demo

Watch or download the demo video — a short overview of TransTrack's offline workflow, operational risk intelligence, and readiness tracking.


Why TransTrack Exists

TransTrack addresses a gap in transplant operations: operational risk intelligence outside of national allocation systems. It helps coordination teams identify and act on readiness risks — expiring evaluations, missing documentation, frequent status changes — before they cause unnecessary candidate inactivation.

TransTrack does not perform allocation decisions or replace UNOS/OPTN systems. It provides operational prioritization and readiness tracking only.

The Problem

Transplant centers face operational failures that impact patient readiness:

  • Missing or delayed evaluations
  • Unresolved non-clinical barriers (insurance, logistics)
  • Coordination gaps across teams

These lead to candidate inactivation, delayed transplants, and increased compliance risk.

System Positioning

TransTrack operates between EHR systems and transplant registries.

  • Does not replace UNOS/OPTN
  • Does not perform organ allocation
  • Focuses on operational readiness and coordination

Who This Is For

  • Transplant operations and coordination teams — workflow visibility and readiness tracking
  • Clinical informatics and healthcare IT — secure, offline-first data management
  • Compliance and audit staff — immutable audit trails and validation artifacts

TransTrack is not intended for allocation or listing authority functions, or as a national registry replacement (UNOS, OPTN).


Core Value: Operational Risk Intelligence

The core of TransTrack is proactive detection of operational risks that can delay or jeopardize patient readiness:

  • Expiring Evaluations — detect upcoming expirations automatically
  • Documentation Gaps — identify missing or outdated records
  • Status Churn Detection — track frequent candidate status changes
  • Readiness Barriers — manage non-clinical obstacles (insurance, transport, support, etc.)
  • Risk-Level Indicators — highlight high-risk cases before they cause inactivation
  • Inactivation Risk Engine v2 — deterministic, explainable per-patient inactivation scoring with 30 / 60 / 90-day calibrated probabilities, full per-factor decomposition, and counterfactual intervention simulation ("if you resolve this insurance barrier, the score drops from 78 to 41"). See docs/INACTIVATION_RISK_ENGINE.md for the technical specification.
  • Transplant Clock — real-time operational pulse and activity rhythm monitoring

Operational Risk Intelligence Dashboard

Transplant Clock

The Transplant Clock provides real-time operational awareness for coordination teams:

  • Time Since Last Update — visual indicator showing system activity freshness (green/yellow/red status)
  • Operational Pulse — aggregated view of open barriers, aHHQ issues, lab gaps, and at-risk patients
  • Average Resolution Time — track how quickly the team resolves operational tasks
  • Next Expiration — countdown to the nearest expiring document or evaluation
  • Team Load Indicator — monitor coordinator workload distribution (Light/Moderate/Heavy)
  • Pulse Rate (Hz) — dynamic rhythm that increases with more open tasks

Transplant Clock - Real-Time Operational Awareness

All metrics are computed locally from the encrypted SQLite database. No cloud, API, or AI inference required.


Features

Patient Waitlist Management

  • Candidate demographics and evaluation tracking
  • Configurable readiness indicators and internal prioritization
  • Search, filter, and status-based workflow visibility

Readiness Barriers (Non-Clinical)

  • Track operational barriers (insurance, logistics, caregiver support)
  • Assign tasks to staff roles (Social Work, Financial, Coordinator)
  • Integrated into the risk intelligence dashboard

Transplant Clock (Real-Time Monitoring)

  • Visual system activity rhythm with color-coded freshness indicators
  • Operational pulse showing open barriers, aHHQ issues, and lab gaps
  • Team workload monitoring and task resolution metrics
  • Computed 100% locally — no cloud dependencies

EHR & Registry Integration

  • FHIR R4 data import/export
  • HL7 v2.x message ingestion (ADT^A01/A03/A04/A08, ORU^R01) with ACK generation
  • OPTN-style CSV exports (TCR/TRR/TRF-shaped extracts) — for internal review and reconciliation; not an OPTN/UNet submission
  • Validation rule configuration and history tracking

Transplant Clinical Calculators (reference values)

Every calculator constant is traceable to a controlled source recorded in docs/compliance/CLINICAL_SOURCES.md. All values are reference-only: allocation and listing decisions are made in OPTN/UNet, not here.

Calculator Status Notes
MELD, MELD-Na, MELD 3.0 Available Coefficients traced to the published equations; verified against reference vectors in tests/calculatorReferenceVectors.test.cjs.
PELD Unavailable — fails closed OPTN Policy 9.1.E Table 9-1 publishes its coefficients only as an image, which could not be verified against a controlled source. Rather than compute from a secondary source that contradicts OPTN's own narrative, TransTrack returns no value. Pediatric liver candidates have no PELD reference score in TransTrack; use the OPTN calculator. See residual risk RR-01.
TransTrack Lung Triage Index (TTLI) Available — internal instrument This is not the OPTN Lung Allocation Score. It is an internal 0–100 ordinal triage indicator for ordering a centre's own lung worklist. Its constants are expert-set, not fitted, and it has no published derivation or external validation. It is flagged isPublishedInstrument: false on every result. The OPTN LAS was retired for allocation in March 2023 and the Composite Allocation Score is computed centrally in UNet; a centre needing either must obtain it from UNet and store it as an opaque value. See residual risk RR-07.
KDPI / KDRI Available, with approximation flag Deceased-donor kidney donor profile index. The percentile map is a piecewise approximation of the OPTN mapping table and is flagged as an approximation on every result. See residual risk RR-03.
EPTS Available, with approximation flag Estimated post-transplant survival (Rao 2009). Percentile map is a piecewise approximation, flagged on every result. See residual risk RR-03.

Operational Workflows

  • Organ Offer Management — auditable state machine (PENDING → ACCEPTED_PROVISIONAL → ACCEPTED_FINAL / DECLINED / EXPIRED / RESCINDED) with structured decline-reason codes
  • Post-Transplant Follow-up — transplant events, immunosuppression regimens, rejection episodes, biopsies, and post-tx readmissions
  • Living Donor Workflow — separate donor record, evaluation steps, status state machine, and auto-generated 6/12/24-month OPTN Policy 14-style follow-ups

Compliance posture (design controls — not certifications)

  • HIPAA Security Rule alignment: AES-256 at-rest encryption (SQLCipher), role-based access control, account lockout, immutable audit logs, audit-log immutability enforced at the database trigger level
  • 21 CFR Part 11 alignment: timestamped audit trail, electronic-record integrity controls, application-level electronic signature records binding signer identity, meaning, payload hash and timestamp, password complexity & history, session controls. Known gaps — including the absence of re-authentication at signing — are stated in docs/compliance/PART_11_CONTROL_MAPPING.md
  • Local-first data handling: in the default configuration no PHI leaves the workstation unless an authorized user exports it. This is a default, not a structural guarantee — see "What can leave the workstation" below
  • Validation package: see docs/compliance/. Vendor Installation and Operational Qualification for this release are executed and recorded in docs/compliance/executed/; Performance Qualification is the deploying organization's responsibility and has not been executed by the vendor. Start with docs/compliance/VALIDATION_SUMMARY_REPORT.md

What can leave the workstation

TransTrack performs its core function with no network connection. It is not, however, a system with no external network dependencies. Every egress path below is optional and off unless configured:

Path Default What leaves
Remote log sink (SENTRY_DSN / TRANSTRACK_REMOTE_LOG_URL) Off Error-level log lines, truncated, with PHI redacted at the sink and metadata restricted to an allow-list
SIEM forwarder (RFC 5424 syslog / CEF) Off — no destinations configured PHI-redacted audit events; plaintext transport refused unless explicitly overridden
Optional server tier (Fastify / FHIR / SMART) Not deployed PHI, by design — this is an integration tier, and it is early access
HL7 v2 MLLP listener Bound to 127.0.0.1 Inbound only
Auto-update via GitHub Releases On in packaged builds Version metadata and the update download; no PHI

Configure for zero egress by leaving those variables unset, creating no SIEM destinations, not deploying the server tier, and blocking the update endpoint. See SECURITY.md and residual risk RR-12.

Local-First Architecture

  • No internet connection required for core operation (see the egress table above)
  • AES-256 local encryption
  • Secure backup/restore and data sovereignty

Enterprise Features

  • Role-based access and justification
  • Disaster recovery and validation documentation
  • Read-only compliance view for auditors

Screenshots

Dashboard Overview

Dashboard Overview

Patient Waitlist Management

Patient Management

Donor-Recipient Matching

Donor Matching

Risk Intelligence & Barriers

Readiness Barriers

Transplant Clock & Operational Pulse

Transplant Clock - Operational Pulse

Patient Documentation & Workflow Tracking

Patient Documentation and Workflow Tracking

Compliance Center

Compliance Center

Disaster Recovery

Disaster Recovery

Compliance Center & Audit Trail

Audit Trail


Technology Stack

  • Frontend: React 18, Tailwind CSS, Radix UI, Framer Motion, TanStack Query
  • Desktop runtime: Electron 39
  • Database: Encrypted SQLite via SQLCipher (AES-256-CBC, PBKDF2-SHA512 ≥256 000 iterations)
  • Build: Vite 6, electron-builder, CycloneDX SBOM
  • Languages: TypeScript / JavaScript (CommonJS in Electron main, ESM in renderer)
  • Optional server tier: Fastify + PostgreSQL + FHIR R4 + SMART on FHIR v2 + CDS Hooks 1.1 + MLLP/TLS HL7 v2 listener (see server/, currently early-access; the desktop client can run fully offline or in thin-client mode against the server)

Installation

Pre-built Installers

Download from the Releases page.

Only this GitHub Releases page is an authorized download channel.

Two build configurations exist. The standard build is produced from the build block in package.json; the enterprise build is produced from electron-builder.enterprise.json, which sets productName to TransTrack Enterprise and adds Windows signing and macOS notarization steps. Filenames follow electron-builder's artifactName patterns, so substitute the release version for ${version} (for example 1.3.0):

Platform Standard build Enterprise build
Windows (x64) TransTrack-${version}-x64.exe TransTrack-Enterprise-${version}-x64.exe
macOS (Intel) TransTrack-${version}-x64.dmg TransTrack-Enterprise-${version}-x64.dmg
macOS (Apple Silicon) TransTrack-${version}-arm64.dmg TransTrack-Enterprise-${version}-arm64.dmg
Linux (AppImage) TransTrack-${version}.AppImage TransTrack-Enterprise-${version}.AppImage
Linux (deb) TransTrack-${version}.deb TransTrack-Enterprise-${version}.deb

Code signing. Windows Authenticode signing and macOS notarization are wired into the enterprise configuration but the signing credentials have not yet been procured, so published artifacts may be unsigned. Verify a download against the SHA-256 digest published with the release before installing. Tracked as residual risk RR-10 in docs/compliance/RESIDUAL_RISK.md.

Build from Source

# Clone the repository
git clone https://github.com/NeuroKoder3/TransTrackMedical-TransTrack.git
cd TransTrack

# Install dependencies
npm install

# Development mode
npm run dev:electron

# Build for production
npm run build:electron

Quick Start

  1. Launch TransTrack.

  2. On first launch a one-time setup token for the seeded administrator account admin@transtrack.local is written to:

    • userData/INITIAL_ADMIN_PASSWORD.txt (mode 0o600 on POSIX), and
    • the application's stdout / log (a delimited "first-launch administrator setup" banner).

    No build-time default password ships with the product. For scripted installs, set TRANSTRACK_INITIAL_ADMIN_PASSWORD before first launch and the file in userData will not be written.

  3. Sign in at the login screen with admin@transtrack.local and the setup token. You will be required to change the password immediately (must_change_password = 1). Delete the token file after rotation.

  4. Begin entering or importing data — all features are immediately available.

See Contact if you need assistance.

Trust and Anti-Impersonation Notice

  • Official repository: https://github.com/NeuroKoder3/TransTrackMedical-TransTrack
  • Official releases: https://github.com/NeuroKoder3/TransTrackMedical-TransTrack/releases
  • Official support address: support@transtrack.example (see Contact for provisioning status)
  • Any lookalike page claiming to be "official TransTrack" outside these channels should be treated as untrusted.
  • If you suspect malware, impersonation, or fraud linked to TransTrack branding, report it to security@transtrack.example following the procedure in SECURITY.md.

Compliance & Security (Design Controls)

HIPAA Security Rule alignment

  • Encryption at rest (AES-256, SQLCipher)
  • Role-based access control with justification logging
  • Automatic session timeouts and idle lockout, plus immediate session end on OS screen lock or suspend
  • Immutable audit trails enforced at the database trigger level
  • Multi-factor authentication (TOTP with backup codes)
  • Optional SIEM forwarding (RFC 5424 syslog / CEF)

21 CFR Part 11 alignment

  • Timestamped, immutable audit trail (append-only with DB-level UPDATE/DELETE blocks)
  • Strong password policy with history and expiration
  • Session controls and re-authentication for sensitive operations
  • Application-level electronic signature records (identity + meaning + payload hash + timestamp), immutable at the database trigger level. Not PKI digital signatures, and not re-authenticated at the point of signing — see docs/compliance/PART_11_CONTROL_MAPPING.md
  • Validation documentation package (see docs/compliance/)

Validation status

Stage Status Where
Validation Plan Approved and in force docs/compliance/VALIDATION_PLAN.md
Installation Qualification Executed by the vendor for the build-and-install steps that can be evidenced without a target host; host-specific steps are the site's docs/compliance/executed/IQ_TT-IQ-001.md
Operational Qualification Executed by the vendor for the automated portion; the interactive portion is the site's docs/compliance/executed/OQ_TT-OQ-001.md
Performance Qualification Not executed. PQ requires clinical users and site data; it is the deploying organization's responsibility. The protocol to execute is provided docs/compliance/executed/PQ_TT-PQ-001.md
Risk analysis FMEA and formal residual-risk statements complete FMEA.md, RESIDUAL_RISK.md

Vendor software verification is complete for this release. Site qualification is not, and no claim is made that it is. The single document to read is docs/compliance/VALIDATION_SUMMARY_REPORT.md.

Server tier maturity

The optional server tier (server/) is early access. It is versioned with the desktop application but is not covered by the vendor Operational Qualification beyond unit-level verification: its integration suites require a live PostgreSQL instance, which was not available in the vendor verification environment, so row-level security and cross-tenant isolation are evidenced at the DDL and application-query level rather than by execution against a running database. A site deploying the server tier must extend its own OQ and PQ to cover it. Recorded as residual risks RR-04 and RR-14.

Security architecture

  • Local-only operation by default; all network egress paths are opt-in (see the table above)
  • Local AES-256 encryption with key rotation support
  • Secure, encrypted backups and disaster-recovery tooling
  • Hardened Electron renderer: sandbox: true, contextIsolation: true, nodeIntegration: false, strict CSP, no renderer permissions
  • Every IPC call is sender-validated and argument-validated before any handler runs
  • Audit trail is tamper-evident on two layers: SHA-256 hash chain plus a keyed HMAC held in OS secure storage
  • Plaintext databases, database temp copies, rotated backups (including WAL sidecars), and the first-launch setup token are overwritten in multiple passes before being unlinked, rather than simply unlinked. This reduces exposure; it is not a guarantee of erasure. On SSDs, copy-on-write filesystems (APFS, Btrfs, ZFS), snapshotted volumes and thin-provisioned storage, an overwrite writes to new blocks and the original data can survive in unreferenced blocks beyond the application's reach. electron/services/secureDelete.cjs documents this directly. The effective control against media-level recovery is full-disk encryption plus cryptographic erase of the key at decommissioning — the deploying organization's responsibility. See residual risk RR-08
  • Independent penetration test and SOC 2 Type II are the responsibility of the deploying organization; neither has been performed (RR-09)

Compliance overview · Validation package · Hardening & residual risk

Running the test suites

npm test                # all Node suites (security + hardening + functional)
npm run test:security   # compliance-critical suites only
npm run test:hardening  # Electron/IPC/audit hardening suites
npm run test:list       # show every suite group
npm run test:e2e        # Playwright, against the real Electron app

Suite membership lives in scripts/run-test-suites.cjs. See the hardening document for what each suite covers.


Important Notice

  • Not intended for clinical decision-making
  • Not connected to national transplant systems (UNOS/OPTN)
  • Designed for operational workflow management and readiness tracking

Contact

Purpose Address
Security vulnerability disclosure security@transtrack.example — see SECURITY.md for the response SLA and escalation path
Deployment help and technical inquiries support@transtrack.example

These are role-based placeholders on the reserved .example domain and are not yet provisioned; mail sent to them will not be delivered. Provisioning monitored role addresses on the production product domain is a prerequisite for commercial release, tracked as residual risk RR-15 in docs/compliance/RESIDUAL_RISK.md. Until then, use the repository's private vulnerability reporting facility on GitHub for security issues, and open a GitHub issue for everything else.

About

TransTrack - offline-first Electron desktop app for transplant centers. Inactivation Risk Engine v2 (calibrated 30/60/90-day scoring) + Transplant Clock (operational pulse). FHIR R4 / HL7 v2 ingest, SQLCipher encryption. HIPAA Security Rule aligned, 21 CFR Part 11 architected. Authoritative source: NeuroKoder3.

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