Patient Consent Management by a Purpose-Based Consent Model for Electronic Health Record Based on Blockchain Technology.

OBJECTIVES: Currently, patients' consent is essential to use their medical records for various purposes; however, most people give their consent using paper forms and have no control over it. Healthcare organizations also have difficulties in dealing with patient consent. The objective of this research is to develop a system for patients to manage their consent flexibly and for healthcare organizations to obtain patient consent efficiently for a variety of purposes. METHODS: We introduce a new e-consent model, which uses a purpose-based access control scheme; it is implemented by a blockchain system using Hyperledger Fabric. All metadata of patient records, consents, and data access are written immutably on the blockchain and shared among participant organizations. We also created a blockchain chaincode that performs business logic managing patient consent. RESULTS: We developed a prototype and checked business logics with the chaincode by validating doctors' data access with purpose-based consent of patients stored in the blockchain. The results demonstrate that our system provides a fine-grained way of handling medical staff 's access requests with diverse intended purposes for accessing data. In addition, patients can create, update, and withdraw their consents in the blockchain. CONCLUSIONS: Our consent model is a solution for consent management both for patients and healthcare organizations. Our system, as a blockchain-based solution that provides high reliability and availability with transparency and traceability, is expected to be used not only for patient data sharing in hospitals, but also for data donation for biobank research purposes.

Application of Blockchain to Maintaining Patient Records in Electronic Health Record for Enhanced Privacy, Scalability, and Availability.

OBJECTIVES: Electronic Health Record (EHR) systems are increasingly used as an effective method to share patients' records among different hospitals. However, it is still a challenge to access scattered patient data through multiple EHRs. Our goal is to build a system to access patient records easily among EHRs without relying on a centralized supervisory system. METHODS: We apply consortium blockchain to compose a distributed system using Hyperledger Fabric incorporating existent EHRs. Peer nodes hold the same ledger on which the address of a patient record in an EHR is written. Individual patients are identified by unique certificates issued by a local certificate authorities that collaborate with each other in a channel of the network. To protect a patient's privacy, we use a proxy re-encryption scheme when the data are transferred. We designed and implemented various chaincodes to handle business logic agreed by member organizations of the network. RESULTS: We developed a prototype system to implement our concept and tested its performance including chaincode logic. The results demonstrated that our system can be used by doctors to find patient's records and verify patient's consent on access to the data. Patients also can seamlessly receive their past records from other hospitals. The access log is stored transparently and immutably in the ledger that is used for auditing purpose. CONCLUSIONS: Our system is feasible and flexible with scalability and availability in adapting to existing EHRs for strengthening security and privacy in managing patient records. Our research is expected to provide an effective method to integrate dispersed patient records among medical institutions.