A Blockchain Framework for Patient-Centered Health Records and Exchange (HealthChain): Evaluation and Proof-of-Concept Study

Background: Blockchain has the potential to disrupt the current modes of patient data access, accumulation, contribution, exchange, and control. Using interoperability standards, smart contracts, and cryptographic identities, patients can securely exchange data with providers and regulate access. The resulting comprehensive, longitudinal medical records can significantly improve the cost and quality of patient care for individuals and populations alike. Objective: This work presents HealthChain, a novel patient-centered blockchain framework. The intent is to bolster patient engagement, data curation, and regulated dissemination of accumulated information in a secure, interoperable environment. A mixed-block blockchain is proposed to support immutable logging and redactable patient blocks. Patient data are generated and exchanged through Health Level-7 Fast Healthcare Interoperability Resources, allowing seamless transfer with compliant systems. In addition, patients receive cryptographic identities in the form of public and private key pairs. Public keys are stored in the blockchain and are suitable for securing and verifying transactions. Furthermore, the envisaged system uses proxy re-encryption (PRE) to share information through revocable, smart contracts, ensuring the preservation of privacy and confidentiality. Finally, several PRE improvements are offered to enhance performance and security. Methods: The framework was formulated to address key barriers to blockchain adoption in health care, namely, information security, interoperability, data integrity, identity validation, and scalability. It supports 16 configurations through the manipulation of 4 modes. An open-source, proof-of-concept tool was developed to evaluate the performance of the novel patient block components and system configurations. To demonstrate the utility of the proposed framework and evaluate resource consumption, extensive testing was performed on each of the 16 configurations over a variety of scenarios involving a variable number of existing and imported records. Results: The results indicate several clear high-performing, low-bandwidth configurations, although they are not the strongest cryptographically. Of the strongest models, one’s anticipated cumulative record size is shown to influence the selection. Although the most efficient algorithm is ultimately user specific, Advanced Encryption Standard–encrypted data with static keys, incremental server storage, and no additional server-side encryption are the fastest and least bandwidth intensive, whereas proxy re-encrypted data with dynamic keys, incremental server storage, and additional server-side encryption are the best performing of the strongest configurations. Conclusions: Blockchain is a potent and viable technology for patient-centered access to and exchange of health information. By integrating a structured, interoperable design with patient-accumulated and generated data shared through smart contracts into a universally accessible blockchain, HealthChain presents patients and providers with access to consistent and comprehensive medical records. Challenges addressed include data security, interoperability, block storage, and patient-administered data access, with several configurations emerging for further consideration regarding speed and security

Prototype of running clinical trials in an untrustworthy environment using blockchain.

Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials

Harpocrates: Privacy-Preserving and Immutable Audit Log for Sensitive Data Operations

The audit log is a crucial component to monitor fine-grained operations over sensitive data (e.g., personal, health) for security inspection and assurance. Since such data operations can be highly sensitive, it is vital to ensure that the audit log achieves not only validity and immutability, but also confidentiality against active threats to standard data regulations (e.g., HIPAA) compliance. Despite its critical needs, state-of-the-art privacy-preserving audit log schemes (e.g., Ghostor (NSDI '20), Calypso (VLDB '19)) do not fully obtain a high level of privacy, integrity, and immutability simultaneously, in which certain information (e.g., user identities) is still leaked in the log. In this paper, we propose Harpocrates, a new privacy-preserving and immutable audit log scheme. Harpocrates permits data store, share, and access operations to be recorded in the audit log without leaking sensitive information (e.g., data identifier, user identity), while permitting the validity of data operations to be publicly verifiable. Harpocrates makes use of blockchain techniques to achieve immutability and avoid a single point of failure, while cryptographic zero-knowledge proofs are harnessed for confidentiality and public verifiability. We analyze the security of our proposed technique and prove that it achieves non-malleability and indistinguishability. We fully implemented Harpocrates and evaluated its performance on a real blockchain system (i.e., Hyperledger Fabric) deployed on a commodity platform (i.e., Amazon EC2). Experimental results demonstrated that Harpocrates is highly scalable and achieves practical performance.Comment: To appear at IEEE 4th International Conference on Trust, Privacy and Security in Intelligent Systems, and Applications (TPS-ISA) 202

A privacy-preserving design for sharing demand-driven patient datasets over permissioned blockchains and P2P secure transfer

Sharing patient datasets curated by health institutions is critical for the advance of monitoring, surveillance and research. However, patient data is sensitive data and it can only be released under certain conditions and with previous explicit consent. Privacy preserving data sharing provides techniques to distribute datasets minimizing the risk of identification of patients. However, the sharing of datasets is typically done without considering the needs or requests of data consumers. Blockchain technologies provide an opportunity to gather those requests and share and assemble datasets using privacy-preserving methods as data and requirements on anonymity match. The architecture and design of such a solution is described, assuming an underlying permissioned blockchain network where providers such as healthcare institutions deal with consent, patient preferences and anonymity guarantees, playing a mediator role to a network of organizations

An architecture for secure data management in medical research and aided diagnosis

Programa Oficial de Doutoramento en Tecnoloxías da Información e as Comunicacións. 5032V01[Resumo] O Regulamento Xeral de Proteccion de Datos (GDPR) implantouse o 25 de maio de 2018 e considerase o desenvolvemento mais importante na regulacion da privacidade de datos dos ultimos 20 anos. As multas fortes definense por violar esas regras e non e algo que os centros sanitarios poidan permitirse ignorar. O obxectivo principal desta tese e estudar e proponer unha capa segura/integracion para os curadores de datos sanitarios, onde: a conectividade entre sistemas illados (localizacions), a unificacion de rexistros nunha vision centrada no paciente e a comparticion de datos coa aprobacion do consentimento sexan as pedras angulares de a arquitectura controlar a sua identidade, os perfis de privacidade e as subvencions de acceso. Ten como obxectivo minimizar o medo a responsabilidade legal ao compartir os rexistros medicos mediante o uso da anonimizacion e facendo que os pacientes sexan responsables de protexer os seus propios rexistros medicos, pero preservando a calidade do tratamento do paciente. A nosa hipotese principal e: os conceptos Distributed Ledger e Self-Sovereign Identity son unha simbiose natural para resolver os retos do GDPR no contexto da saude? Requirense solucions para que os medicos e investigadores poidan manter os seus fluxos de traballo de colaboracion sen comprometer as regulacions. A arquitectura proposta logra eses obxectivos nun ambiente descentralizado adoptando perfis de privacidade de datos illados.[Resumen] El Reglamento General de Proteccion de Datos (GDPR) se implemento el 25 de mayo de 2018 y se considera el desarrollo mas importante en la regulacion de privacidad de datos en los ultimos 20 anos. Las fuertes multas estan definidas por violar esas reglas y no es algo que los centros de salud puedan darse el lujo de ignorar. El objetivo principal de esta tesis es estudiar y proponer una capa segura/de integración para curadores de datos de atencion medica, donde: la conectividad entre sistemas aislados (ubicaciones), la unificacion de registros en una vista centrada en el paciente y el intercambio de datos con la aprobacion del consentimiento son los pilares de la arquitectura propuesta. Esta propuesta otorga al titular de los datos un rol central, que le permite controlar su identidad, perfiles de privacidad y permisos de acceso. Su objetivo es minimizar el temor a la responsabilidad legal al compartir registros medicos utilizando el anonimato y haciendo que los pacientes sean responsables de proteger sus propios registros medicos, preservando al mismo tiempo la calidad del tratamiento del paciente. Nuestra hipotesis principal es: .son los conceptos de libro mayor distribuido e identidad autosuficiente una simbiosis natural para resolver los desafios del RGPD en el contexto de la atencion medica? Se requieren soluciones para que los medicos y los investigadores puedan mantener sus flujos de trabajo de colaboracion sin comprometer las regulaciones. La arquitectura propuesta logra esos objetivos en un entorno descentralizado mediante la adopcion de perfiles de privacidad de datos aislados.[Abstract] The General Data Protection Regulation (GDPR) was implemented on 25 May 2018 and is considered the most important development in data privacy regulation in the last 20 years. Heavy fines are defined for violating those rules and is not something that healthcare centers can afford to ignore. The main goal of this thesis is to study and propose a secure/integration layer for healthcare data curators, where: connectivity between isolated systems (locations), unification of records in a patientcentric view and data sharing with consent approval are the cornerstones of the proposed architecture. This proposal empowers the data subject with a central role, which allows to control their identity, privacy profiles and access grants. It aims to minimize the fear of legal liability when sharing medical records by using anonymisation and making patients responsible for securing their own medical records, yet preserving the patient’s quality of treatment. Our main hypothesis is: are the Distributed Ledger and Self-Sovereign Identity concepts a natural symbiosis to solve the GDPR challenges in the context of healthcare? Solutions are required so that clinicians and researchers can maintain their collaboration workflows without compromising regulations. The proposed architecture accomplishes those objectives in a decentralized environment by adopting isolated data privacy profiles