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

Dara Tith; Joong-Sun Lee; Hiroyuki Suzuki; W. M. A. B. Wijesundara; Naoko Taira; Takashi Obi; Nagaaki Ohyama

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자료유형: 학술저널

저자정보: Dara Tith (Institute of Innovative Research Tokyo Institute of Technology Yokohama Japan) Joong-Sun Lee (Tokyo Institute of Technology) Hiroyuki Suzuki (Tokyo Institute of Technology) W. M. A. B. Wijesundara (Institute of Innovative Research Tokyo Institute of Technology Yokohama Japan) Naoko Taira (Institute of Innovative Research Tokyo Institute) Takashi Obi (Tokyo Institute of Technology) Nagaaki Ohyama (Institute of Innovative Research Tokyo Institute of Technology Yokohama Japan)

저널정보: 대한의료정보학회 Healthcare Informatics Research Healthcare Informatics Research 제26권 제4호

발행연도: 2020.1

수록면: 265 - 273 (9page)

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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.

#Health Information Exchange #Electronic Health Records #Blockchain #Consent Forms #Access to Information

참고문헌 (24)

참고문헌 신청

World Health Organization / 2017 / Council for International Organizations of Medical Sciences. International ethical guidelines for health-related research involving humans / Council for International Organizations of Medical Sciences

World Medical Association / 2013 / World Medical Association Declaration of Helsinki : ethical principles for medical research involving human subjects / JAMA 310(20):2191~2194

Kaye J / 2015 / Dynamic Consent : a patient interface for twenty-first century research networks / Eur J Hum Genet 23(2):141~146

Budin-Ljosne I / 2017 / Dynamic Consent : a potential solution to some of the challenges of modern biomedical research / BMC Med Ethics 18(1):4

Giuseppe Albanese / 2020 / Dynamic consent management for clinical trials via private blockchain technology / Journal of Ambient Intelligence and Humanized Computing 11(11):4909~4926

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