Patient Consent

About

Use Case Patient Data in Clinical Trials Automation with focus of Patient Consent. This prototype includes two versions developed with Sawtooth and Fabric

Sawtooth

Features

Functional

• Create mandatory participants (like Hospital, Patient and Investigator)
• Patient grants permission to Hospital to process his/her EHR
• Hospital registers new EHRs
• Hospital grants permission to Investigator to read data
• Hospital applies certain exclusion/inclusion criteria to the retrieved EHRs
• Investigator contacts to Patients whose EHRs match the criteria
• Investigator requests Patient to sign Inform Consent document
• Patient signs the document
• Investigator is allowed to import the patient's data and harmonize it.
• Investigator finally identifies if the data is eligible

Technical

• Private key to store/read data (private key of every participant is stored on server side)
• Private data access management (every participant has a role assigned with corresponding permissions)
• Docker compliance (every component of this project has separate docker image and fully isolated)
• Various network representation (blockchain network has few options (1 node/Dev-Mode consensus, 3 nodes/PoET consensus/single VM, 3 nodes/PoET consensus/3 separate VMs)

Components

• Consent/Identity/Authorization Management smart contract (responsible to operate with identity/permission related data as well as patients' consent)
• Data Management smart contract (responsible to handle EHR patient’s data)
• Investigator Management smart contract (responsible to operate with investigator related data)
• Hospital REST-API service (provides interface between Hospital, Patient and blockchain network)
• hospital Web client (web page where a participant can operate as one of predefined roles such as hospital, patient etc)
• Investigator REST-API service (provides interface between Investigator and blockchain network)
• Investigator Web client (web page where a participant can operate as one of predefined roles such as investigator etc)

Architecture

The whole use case is divided on 3 isolated blockchain networks:

• The 1st one (green) is dedicated for hospitals. They store there all EHR data related to patient
• The 2nd one (blue) is dedicated for investigators. They store there all Clinical Trial data
• The 3rd one (orange) is shared between both types of participants: hospital and investigator. It stores accounts for any participant, their roles and corresponding permissions. Also it includes requested and signed by patients inform consent documents

Technology stack

Python/Hyperledger Sawtooth/Docker/Docker-Composer/Protobuf/Setuptools/Sanic/Shell/Webpack

How to setup and run infrastructure (1 node/Dev-Mode consensus)

• Go to root project’s directory
• Clone this repo (if not cloned yet))
• Ensure all containers stopped: “docker-compose down -v --remove-orphans”
• Get recent data from the repo: “git pull”
• Start new containers: “docker-compose up”