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xSpecimen: Biobank Specimen Protection

XorIDA splits biobank specimen data across independent research institutions. Reconstruction requires threshold cooperation. Configurable quorum sizes protect donor privacy permanently.

Healthcare / Biobanking COMING SOON XorIDA Powered
Section 01

The Problem

Biobank genetic marker data stored at single institutions creates permanent exposure risk. A single breach exposes donor identities and genetic information that can never be changed.

Biobanks store biological specimens alongside genetic markers, phenotype data, and donor identifiers. This data is stored at a single institution with centralized access control. A breach at that institution permanently compromises every donor -- genetic data cannot be rotated or revoked like a password.

Multi-institution research collaborations compound the problem. When biobanks share data for collaborative studies, complete datasets are copied to each participating institution, multiplying the attack surface proportionally.

The Old Way

University Lab Hospital Lab Central Biobank DB Genetic markers + Donor IDs + Phenotype data BREACH Permanent exposure
Section 02

The PRIVATE.ME Solution

XorIDA splits specimen data across independent research institutions. Reconstruction requires threshold cooperation between independently governed institutions.

Each donor's specimen data is split into N shares distributed across independent biobank institutions. No single institution holds enough data to identify any donor or reconstruct their genetic profile. Collaborative research proceeds through threshold reconstruction with configurable quorum sizes.

The quorum size is configurable per study. A rare disease study across 5 institutions might require 3-of-5 cooperation, while a sensitive population study might require 4-of-5. The donor's consent record specifies the minimum quorum for each authorized use.

The New Way

Specimen Data + Genetic Markers XorIDA K-of-N Split Institution A Institution B Institution C HMAC Verify
Section 03

How It Works

A consent-aware pipeline distributes specimen data across independent institutions with configurable quorum requirements per study.

SPECIMEN DATA CONSENT VALIDATE XorIDA SPLIT INSTITUTION 1 INSTITUTION 2 INSTITUTION N RECONSTRUCTION PATH HMAC VERIFY QUORUM MET RECONSTRUCT OUTPUT
Key Security Properties
Configurable quorum: Each study defines its own threshold based on sensitivity level. Donor consent: Consent records specify authorized uses and minimum quorum requirements. Permanent protection: Genetic data protected by information-theoretic security that never weakens.
Section 04

Use Cases

🏥
Multi-Institution
Multi-Institution Biobank Collaboration

Connect biobanks across universities and hospitals with threshold-based access. Each institution holds shares, not complete genetic profiles.

Federated Research
🛡
Donor Privacy
Donor Privacy Protection

Protect donor identities with information-theoretic security. No institution -- even under legal compulsion -- can identify donors without threshold cooperation.

Privacy-First
📈
Longitudinal Studies
Longitudinal Study Data

Protect multi-decade longitudinal studies with threshold security that never weakens. Data collected over 30 years remains equally protected at year one and year thirty.

Long-Term
🔗
Chain of Custody
Specimen Chain of Custody

Track specimen provenance across institutions with HMAC-verified share chains. Every handoff is independently verifiable and tamper-evident.

Provenance
Section 05

Developer Experience

xSpecimen provides real-time progress tracking and structured error codes to help biobank developers build reliable, auditable specimen management systems.

Progress Callbacks

Both splitSpecimen() and reconstructSpecimen() operations support onProgress callbacks for tracking long-running operations, especially useful when distributing specimen data across multiple biobank institutions.

Progress tracking example
const shares = await splitSpecimen(specimenData, {
  institutions: ['mit', 'stanford', 'oxford'],
  k: 2,
  n: 3,
  onProgress: async (event) => {
    switch (event.stage) {
      case 'validating':
        console.log('Validating consent requirements...');
        break;
      case 'splitting':
        console.log('Splitting specimen data via XorIDA...');
        break;
      case 'distributing':
        console.log(`Distributing share ${event.current}/${event.total}...`);
        break;
      case 'complete':
        console.log('Specimen data distributed successfully');
        break;
    }
  }
});

// Reconstruct with progress tracking
const result = await reconstructSpecimen({
  studyId: 'rare-disease-2026',
  institutions: ['mit', 'stanford'],
  onProgress: async (event) => {
    if (event.stage === 'verifying') {
      console.log(`Verifying HMAC for share ${event.current}...`);
    }
    if (event.stage === 'reconstructing') {
      console.log(`Reconstructing from ${event.current} shares...`);
    }
  }
});

Structured Error Handling

xSpecimen uses a Result<T, E> pattern with detailed error structures. Every error includes a machine-readable code, human-readable message, actionable hint, and documentation URL.

Error detail structure
interface ErrorDetail {
  code: string;         // e.g., 'CONSENT_NOT_FOUND'
  message: string;      // Human-readable description
  hint?: string;        // Actionable suggestion
  field?: string;       // Field that caused the error
  docs?: string;        // Documentation URL
}

Error Categories

xSpecimen organizes error codes across multiple categories for systematic handling:

Category Example Codes Description
Consent CONSENT_NOT_FOUND, CONSENT_EXPIRED, QUORUM_NOT_MET Donor consent validation failures
Specimen INVALID_SPECIMEN_ID, SPECIMEN_NOT_FOUND, CHAIN_OF_CUSTODY_BROKEN Specimen data and provenance errors
Institution INSTITUTION_NOT_AUTHORIZED, INSTITUTION_OFFLINE, SHARE_DELIVERY_FAILED Multi-institution coordination failures
Crypto HMAC_VERIFICATION_FAILED, SHARE_RECONSTRUCTION_FAILED Cryptographic operation failures
Compliance CLIA_VALIDATION_FAILED, CAP_AUDIT_REQUIRED, HIPAA_VIOLATION Regulatory compliance errors
Viral Growth

Viral Onboarding: < 2 Minute Multi-Site Setup

Zero-config biobank discovery and viral invite flow enable exponential multi-site adoption. Setup time: < 2 minutes (vs 4-8 weeks for manual biobank integration). Target viral coefficient: 1.3 → exponential consortium growth.

The 2-Minute Biobank Onboarding Flow

Traditional biobank integration requires 4-8 weeks per institution: IRB approval process, data use agreement negotiation, HIPAA business associate agreement, technical integration planning, VPN setup, database schema alignment, access control configuration, chain-of-custody documentation, CLIA/CAP compliance verification, security audit, pilot data transfer, and production rollout. xSpecimen reduces initial technical setup to under 2 minutes through zero-config biobank discovery and automatic trust establishment:

Complete biobank setup: < 2 minutes
// Step 1: Initialize institutional identity (< 30 sec)
$ xspecimen init --name stanford-biobank --type research-institution
{
  "status": "initialized",
  "did": "did:key:z6MksBiobank7sP...",
  "name": "stanford-biobank",
  "type": "research-institution"
}

// Step 2: Connect to a biobank consortium (< 90 sec)
$ xspecimen connect cancer-genomics-consortium
{
  "status": "connected",
  "consortium": "cancer-genomics-consortium",
  "coordinator": "did:key:z6MksCancer...",
  "institutions": ["mit", "oxford", "mayo-clinic"],
  "quorum_requirement": "3-of-5",
  "elapsed_seconds": 1.4
}

// Step 3: Start collaborating immediately
const { connectBiobank } = require('@private.me/xspecimen');
const connection = await connectBiobank('cancer-genomics-consortium');
await splitSpecimen(specimenData, {
  institutions: connection.value.institutions,
  k: 3,
  n: 5,
  studyId: 'melanoma-trial-2026'
});

Zero-Config Biobank Discovery (3-Tier Lookup)

The connectBiobank() function accepts consortium names, institution domains, or URLs and automatically discovers connection details through a 3-tier lookup system:

Method Example Lookup
Public Registry connectBiobank('cancer-genomics-consortium') Query biobank.registry.io for registered consortium
.well-known connectBiobank('biobank.stanford.edu') Fetch https://biobank.stanford.edu/.well-known/xspecimen.json
Direct URL connectBiobank('https://biobank.mayo.edu/xspecimen') Use URL directly
AUTOMATIC TRUST ESTABLISHMENT
The first connection to a biobank consortium automatically adds institution public keys to your local trust registry. Subsequent specimen transfers verify HMAC signatures against stored keys (TOFU: Trust On First Use). For CLIA/CAP-certified labs, admins can pre-populate the trust registry with certified institution keys.

Viral Invite Flow (< 10 sec creation, < 60 sec acceptance)

The invite system enables exponential consortium growth through effortless institution-to-institution invitations. Creating an invite takes < 10 seconds, accepting takes < 60 seconds, and the invite recipient automatically becomes a potential inviter themselves.

Create biobank invite (< 10 sec)
$ xspecimen invite mayo-clinic-biobank --email biobank@mayo.edu
{
  "status": "created",
  "invite_url": "https://xspecimen.to/invite/b8Np2y...",
  "qr_code": "data:image/svg+xml,...",
  "expires_at": "2026-04-19T...",
  "consortium": "cancer-genomics-consortium",
  "message": "Share this link: https://xspecimen.to/invite/b8Np2y..."
}

When the recipient clicks the invite link, they see a one-click acceptance page with the consortium's study info, quorum requirements, and participating institutions. Accepting the invite automatically establishes the connection, adds the institution to the consortium trust registry, and enables specimen data sharing.

Viral Coefficient Model: VC = 1.3

Viral coefficient (VC) measures how many new institutions each existing institution brings. The formula: VC = (collaborations per institution) × (invite rate) × (acceptance rate). xSpecimen targets VC > 1.0 for exponential consortium growth:

Metric Target Rationale
Collaborations per institution 4 Multi-site biobanks typically partner with 4-6 institutions per study
Invite rate 100% Zero-click invite creation, consortium coordinators invite all partners
Acceptance rate > 32% One-click acceptance, 7-day expiry, trusted research network
Viral Coefficient > 1.0 1.3 (4 × 1.0 × 0.32)
EXPONENTIAL GROWTH MODEL
With VC = 1.3, starting from 10 biobanks in Month 1 projects to 1,392 biobanks by Month 12. Each institution invites 4 collaborators, 32% accept within 7 days (driven by consortium coordinator outreach + trusted research networks), and the cycle repeats.

Zero-Downtime Migration (Dual-Mode Adapter)

For existing biobank integrations using VPN tunnels, SFTP transfers, or legacy APIs, xSpecimen provides a DualModeBiobankAdapter that runs xSpecimen and legacy transfer mechanisms simultaneously. This enables zero-downtime migration with gradual rollout and usage tracking:

Zero-downtime biobank migration
const { DualModeBiobankAdapter } = require('@private.me/xspecimen');

// Create dual-mode adapter (tries xSpecimen first, falls back to legacy)
const adapter = new DualModeBiobankAdapter({
  xspecimen: xspecimenClient,   // Optional: add when ready
  fallback: {
    type: 'sftp',
    host: process.env.BIOBANK_SFTP_HOST,
    credentials: process.env.BIOBANK_SFTP_KEY,
  },
});

// Transfer specimen data (automatically tries xSpecimen → legacy)
const result = await adapter.transferSpecimen(specimenData, {
  institutions: ['mit', 'stanford'],
  studyId: 'lung-cancer-2026'
});

// Track migration progress
const metrics = adapter.getMetrics();
console.log(`xSpecimen usage: ${metrics.xspecimenPercentage}%`);
// Output: "xSpecimen usage: 81%"

// Remove fallback when 100% migrated
adapter.removeFallback();

Comparison: xSpecimen vs Traditional Biobank Integration

Aspect Traditional Integration xSpecimen
Setup Time 4-8 weeks (IRB + DUA + BAA + VPN + schema + audit) < 2 minutes (init + connect + use)
Data Protection Single-site centralized database K-of-N threshold splitting, no single point of exposure
Discovery Manual consortium coordinator contact list Zero-config 3-tier lookup
Invite Mechanism Email contact details + 4-8 week onboarding One-click invite link, < 10 sec creation
Acceptance Manual setup (4-8 weeks) One-click acceptance (< 60 sec)
Growth Linear (manual outreach + lengthy approvals) Exponential (VC = 1.3)
Compliance Per-site CLIA/CAP audits + separate chain-of-custody HMAC-verified provenance + automatic audit trails
SUCCESS CRITERIA
Biobank onboarding is considered successful when: (1) Technical setup < 2 min, (2) Invite creation < 10 sec, (3) Invite acceptance < 60 sec, (4) Acceptance rate > 32%, (5) Viral coefficient > 1.0. Note: IRB approval and legal agreements remain separate processes governed by institutional policy.

Use Cases for Viral Growth

🧬
CANCER RESEARCH
Multi-Site Cancer Genomics Consortium

Connect 12 NCI-designated cancer centers for rare variant discovery. Each biobank invites 3-4 partner institutions. Threshold: 4-of-7 for reconstruction.

NCI MATCH Trial Pattern
🏥
PRECISION MEDICINE
Regional Tissue Repository Network

Hospital biobanks invite affiliated research labs and pathology centers. Each hospital brings 5-6 partners. Chain-of-custody verified via HMAC.

CLIA/CAP Compliant
🔬
RARE DISEASE
Global Rare Disease Biobank Federation

Cross-border biobank sharing for ultra-rare diseases. Each biobank invites international partners. Threshold: 3-of-5 balances access with donor privacy.

GDPR + HIPAA
💊
PHARMA TRIALS
Pharma-Sponsored Multi-Site Trials

Pharmaceutical companies invite CRO biobanks for Phase II/III trials. Sponsor holds 1 share, each CRO holds 1 share. Threshold: 3-of-N.

21 CFR Part 11
Section 07

Integration

Quick Start
import { splitSpecimen, collaborateSecure } from '@private.me/xspecimen';

// Split specimen data across 5 institutions (3-of-5)
const shares = await splitSpecimen(specimenData, {
  institutions: ['mit', 'stanford', 'oxford', 'eth', 'tokyo-u'],
  n: 5,
  k: 3
});

// Collaborate with quorum-based reconstruction
const result = await collaborateSecure({
  studyId: 'rare-disease-2026',
  institutions: ['mit', 'stanford', 'oxford']
});
splitSpecimen(data: SpecimenData, institutions: string[], config: { n: number, k: number }): Promise<BioShare[]>
Splits biobank specimen data into N shares distributed across specified research institutions with K-of-N threshold reconstruction. Each share is HMAC-signed and tagged with institution metadata. Consent validation and quorum requirements enforced before every operation.
Section 08

Security Properties

PropertyMechanismGuarantee
Configurable QuorumPer-study K-of-N thresholdSensitivity-appropriate access control
Donor AnonymityXorIDA threshold splittingNo institution can identify donors alone
Tamper DetectionPer-share HMAC-SHA256Any modification detected before reconstruction
Quantum ResistanceInformation-theoretic security (GF(2))Security never weakens over time
Chain of CustodyHMAC-verified handoff recordsEvery specimen transfer independently verifiable
<1ms
Typical payload
K-of-N
Configurable quorum
0 bytes
Exposed per breach
GF(2)
Quantum-proof algebra
VERIFIED BY XPROVE

Verifiable Data Protection

Every operation in this ACI produces a verifiable audit trail via xProve. HMAC-chained integrity proofs let auditors confirm that data was split, stored, and reconstructed correctly — without accessing the data itself.

XPROVE AUDIT TRAIL
Every XorIDA split generates HMAC-SHA256 integrity tags. xProve chains these into a tamper-evident audit trail that proves data was handled correctly at every step. Upgrade to zero-knowledge proofs when regulators or counterparties need public verification.

Read the xProve white paper →
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© 2026 StandardClouds Inc. dba PRIVATE.ME. All rights reserved.

VERIFIABLE WITHOUT CODE EXPOSURE

Ship Proofs, Not Source

xSpecimen generates cryptographic proofs of correct execution without exposing proprietary algorithms. Verify integrity using zero-knowledge proofs — no source code required.

XPROVE CRYPTOGRAPHIC PROOF
Download proofs:

Verify proofs online →

Use Cases

🏛️
REGULATORY
FDA / SEC Submissions
Prove algorithm correctness for distributed systems without exposing trade secrets or IP.
Zero IP Exposure
🏦
FINANCIAL
Audit Without Access
External auditors verify secure operations without accessing source code or production systems.
FINRA / SOX Compliant
🛡️
DEFENSE
Classified Verification
Security clearance holders verify distributed systems correctness without clearance for source code.
CMMC / NIST Ready
🏢
ENTERPRISE
Procurement Due Diligence
Prove security + correctness during RFP evaluation without NDA or code escrow.
No NDA Required

Deployment Options

📦

SDK Integration

Embed directly in your application. Runs in your codebase with full programmatic control.

  • npm install @private.me/xspecimen
  • TypeScript/JavaScript SDK
  • Full source access
  • Enterprise support available
Get Started →
🏢

On-Premise Upon Request

Enterprise CLI for compliance, air-gap, or data residency requirements.

  • Complete data sovereignty
  • Air-gap capable deployment
  • Custom SLA + dedicated support
  • Professional services included
Request Quote →

Enterprise On-Premise Deployment

While xSpecimen is primarily delivered as SaaS or SDK, we build dedicated on-premise infrastructure for customers with:

  • Regulatory mandates — HIPAA, SOX, FedRAMP, CMMC requiring self-hosted processing
  • Air-gapped environments — SCIF, classified networks, offline operations
  • Data residency requirements — EU GDPR, China data laws, government mandates
  • Custom integration needs — Embed in proprietary platforms, specialized workflows

Includes: Enterprise CLI, Docker/Kubernetes orchestration, RBAC, audit logging, and dedicated support.

Contact sales for assessment and pricing →