Distributed Health Conference

Securing Clinical Trials with the Blockchain

Clinical Trials need:

  • A better way to recruit patients
  • A better way to ensure and capture informed consent
  • A better way to monitor and govern compliance with HIPAA


Blockchain Health can help

Blockchain

A New Global Utility

The Bitcoin network:

  • Allows anyone to initiate a transaction
  • Gossips about transactions
  • Runs a game to allow one player to build a block
  • Orders the block permanently in a chain

Creating:
the world's first decentralized timestamp server

Public Key Infrastructure

  • Certificate Authorities register certificates publicly
  • Past history is permanently recorded
  • Certificates are easy to register
  • Cost effective (~$0.10)

Notary Services

  • Publicly register any fact
  • Easy to tie to identity services
  • History unchangeable
  • Central registry of facts

Clinical Identity Service

Features

  • Blockchain tracks credentialing and decredentialing devices
  • Friends can restore access
  • Devices authenticate humans
  • Identity is linked to FHIR profiles

Consent Management

Features

  • Patients go through consent flows on their own devices
  • Authenticate consent events using identity registered on blockchain
  • Notarize e-signatures using Chainpoint standard
  • Communicate consent via FHIR

Event Tracking &
Chain of Custody

Features

  • Consume and produce FHIR Resources
  • Track, authenticate and notarize every access event
  • Trigger consent flows for needed permissions

Private Beta

Current:

  • Merck & Co.

Next:

  • Pharmaceutical Companies
  • Contract Research Organizations
  • Clinical IT Companies

Long term vision

  • Recruit qualified trial participants globally
  • Acquire targeted health data directly from users
  • Ecosystem of Apps creating/collecting health-relevant data
  • Aggregation per project/query instead of per institution

Market Potential

  • The outsourced Contract Research Organization industry has annual revenues of ~$25bn
  • Does not conduct any actual clinical treatment or direct research, but instead recruits patients and sites, manages consent and compliance and enforces guidelines related to data handling
  • E/ID will allow a more direct relationship between patients and researchers, dramatically reducing costs while improving science