Patient Consent Management by a Purpose-Based Consent Model for Electronic Health Record Based on Blockchain Technology
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Objectives: Currently, patients’ consent is essential to use their medical records for various purposes; however, most peoplegive their consent using paper forms and have no control over it. Healthcare organizations also have difficulties in dealingwith patient consent. The objective of this research is to develop a system for patients to manage their consent flexibly and forhealthcare organizations to obtain patient consent efficiently for a variety of purposes. Methods: We introduce a new e-consentmodel, which uses a purpose-based access control scheme; it is implemented by a blockchain system using HyperledgerFabric. All metadata of patient records, consents, and data access are written immutably on the blockchain and shared amongparticipant 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 withpurpose-based consent of patients stored in the blockchain. The results demonstrate that our system provides a fine-grainedway of handling medical staff ’s access requests with diverse intended purposes for accessing data. In addition, patients cancreate, update, and withdraw their consents in the blockchain. Conclusions: Our consent model is a solution for consentmanagement both for patients and healthcare organizations. Our system, as a blockchain-based solution that provides highreliability 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.
Abstract
Objectives: Currently, patients’ consent is essential to use their medical records for various purposes; however, most peoplegive their consent using paper forms and have no control over it. Healthcare organizations also have difficulties in dealingwith patient consent. The objective of this research is to develop a system for patients to manage their consent flexibly and forhealthcare organizations to obtain patient consent efficiently for a variety of purposes. Methods: We introduce a new e-consentmodel, which uses a purpose-based access control scheme; it is implemented by a blockchain system using HyperledgerFabric. All metadata of patient records, consents, and data access are written immutably on the blockchain and shared amongparticipant 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 withpurpose-based consent of patients stored in the blockchain. The results demonstrate that our system provides a fine-grainedway of handling medical staff ’s access requests with diverse intended purposes for accessing data. In addition, patients cancreate, update, and withdraw their consents in the blockchain. Conclusions: Our consent model is a solution for consentmanagement both for patients and healthcare organizations. Our system, as a blockchain-based solution that provides highreliability 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.
참고문헌 (24)
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