The lack of accessibility to medical records for both patients and clinicians has long been recognised as a barrier to transparent and efficient healthcare.[1][1] While electronic health record (EHR) systems help address this issue somewhat, many of these systems are heterogeneous, demonstrate
BACKGROUND: Clinical decision support (CDS) is a tool that helps clinicians in decision making by generating clinical alerts to supplement their previous knowledge and experience. However, CDS generates a high volume of irrelevant alerts, resulting in alert fatigue among clinicians. Alert fatigue is the mental state of alerts consuming too much time and mental energy, which often results in relevant alerts being overridden unjustifiably, along with clinically irrelevant ones. Consequently, clinicians become less responsive to important alerts, which opens the door to medication errors. OBJECTIVE: This study aims to explore how a blockchain-based solution can reduce alert fatigue through collaborative alert sharing in the health sector, thus improving overall health care quality for both patients and clinicians. METHODS: We have designed a 4-step approach to answer this research question. First, we identified five potential challenges based on the published literature through a scoping review. Second, a framework is designed to reduce alert fatigue by addressing the identified challenges with different digital components. Third, an evaluation is made by comparing MedAlert with other proposed solutions. Finally, the limitations and future work are also discussed. RESULTS: Of the 341 academic papers collected, 8 were selected and analyzed. MedAlert securely distributes low-level (nonlife-threatening) clinical alerts to patients, enabling a collaborative clinical decision. Among the solutions in our framework, Hyperledger (private permissioned blockchain) and BankID (federated digital identity management) have been selected to overcome challenges such as data integrity, user identity, and privacy issues. CONCLUSIONS: MedAlert can reduce alert fatigue by attracting the attention of patients and clinicians, instead of solely reducing the total number of alerts. MedAlert offers other advantages, such as ensuring a higher degree of patient privacy and faster transaction times compared with other frameworks. This framework may not be suitable for elderly patients who are not technology savvy or in-patients. Future work in validating this framework based on real health care scenarios is needed to provide the performance evaluations of MedAlert and thus gain support for the better development of this idea.
Chang Lu, Danielle Alves Batista, Hoda Hamouda, Victoria L. Lemieux
BACKGROUND: Although researchers are giving increased attention to blockchain-based personal health records (PHRs) and data sharing, the majority of research focuses on technical design. Very little is known about health care consumers' intentions to adopt the applications. OBJECTIVE: This study aims to explore the intentions and concerns of health care consumers regarding the adoption of blockchain-based personal health records and data sharing. METHODS: Three focus groups were conducted, in which 26 participants were shown a prototype of a user interface for a self-sovereign blockchain-based PHR system (ie, a system in which the individual owns, has custody of, and controls access to their personal health information) to be used for privacy and secure health data sharing. A microinterlocutor analysis of focus group transcriptions was performed to show a descriptive overview of participant responses. NVivo 12.0 was used to code the categories of the responses. RESULTS: Participants did not exhibit a substantial increase in their willingness to become owners of health data and share the data with third parties after the blockchain solution was introduced. Participants were concerned about the risks of losing private keys, the resulting difficulty in accessing care, and the irrevocability of data access on blockchain. They did, however, favor a blockchain-based PHR that incorporates a private key recovery system and offers a health wallet hosted by government or other positively perceived organizations. They were more inclined to share data via blockchain if the third party used the data for collective good and offered participants nonmonetary forms of compensation and if the access could be revoked from the third party. CONCLUSIONS: Health care consumers were not strongly inclined to adopt blockchain-based PHRs and health data sharing. However, their intentions may increase when the concerns and recommendations demonstrated in this study are considered in application design.
Keehyuck Lee, Kahyun Lim, Se Young Jung, Hyerim Ji · 7 authors
BACKGROUND: Although the electronic health record system adoption rate has reached 96% in the United States, implementation and usage of health information exchange (HIE) is still lagging behind. Blockchain has come into the spotlight as a technology to solve this problem. However, there have been no studies assessing the perspectives of different stakeholders regarding blockchain-based patient-centered HIE. OBJECTIVE: The objective of this study was to analyze the awareness among patients, health care professionals, and information technology developers toward blockchain-based HIE, and compare their different perspectives related to the platform using a qualitative research methodology. METHODS: In this qualitative study, we applied grounded theory and the Promoting Action on Research Implementation in the Health Service (PARiHS) framework. We interviewed 7 patients, 7 physicians, and 7 developers, for a total of 21 interviewees. RESULTS: Regarding the leakage of health information, the patient group did not have concerns in contrast to the physician and developer groups. Physicians were particularly concerned about the fact that errors in the data cannot be easily fixed due to the nature of blockchain technology. Patients were not against the idea of providing information for clinical trials or research institutions. They wished to be provided with the results of clinical research rather than being compensated for providing data. The developers emphasized that blockchain must be technically mature before it can be applied to the health care scene, and standards of medical information to be exchanged must first be established. CONCLUSIONS: The three groups' perceptions of blockchain were generally positive about the idea of patients having the control of sharing their own health information. However, they were skeptical about the cooperation among various institutions and implementation for data standardization in the establishment process, in addition to how the service will be employed in practice. Taking these factors into consideration during planning, development, and operation of a platform will contribute to establishing practical treatment plans and tracking in a more convenient manner for both patients and physicians. Furthermore, it will help expand the related research and health management industry based on blockchain.
BACKGROUND: There are several challenges such as information silos and lack of interoperability with the current electronic medical record (EMR) infrastructure in the Canadian health care system. These challenges can be alleviated by implementing a blockchain-based health care data management solution. OBJECTIVE: This study aims to provide a detailed overview of the current health data management infrastructure in British Columbia for identifying some of the gaps and inefficiencies in the Canadian health care data management system. We explored whether blockchain is a viable option for bridging the existing gaps in EMR solutions in British Columbia's health care system. METHODS: We constructed the British Columbia health care data infrastructure and health information flow based on publicly available information and in partnership with an industry expert familiar with the health systems information technology network of British Columbia's Provincial Health Services Authorities. Information flow gaps, inconsistencies, and inefficiencies were the target of our analyses. RESULTS: We found that hospitals and clinics have several choices for managing electronic records of health care information, such as different EMR software or cloud-based data management, and that the system development, implementation, and operations for EMRs are carried out by the private sector. As of 2013, EMR adoption in British Columbia was at 80% across all hospitals and the process of entering medical information into EMR systems in British Columbia could have a lag of up to 1 month. During this lag period, disease progression updates are continually written on physical paper charts and not immediately updated in the system, creating a continuous lag period and increasing the probability of errors and disjointed notes. The current major stumbling block for health care data management is interoperability resulting from the use of a wide range of unique information systems by different health care facilities. CONCLUSIONS: Our analysis of British Columbia's health care data management revealed several challenges, including information silos, the potential for medical errors, the general unwillingness of parties within the health care system to trust and share data, and the potential for security breaches and operational issues in the current EMR infrastructure. A blockchain-based solution has the highest potential in solving most of the challenges in managing health care data in British Columbia and other Canadian provinces.
MinDong Sung, Sung-Jun Park, Sung-Jae Jung, Eunsol Lee · 6 authors
BACKGROUND: Although we are living in an era of transparency, medical documents are often still difficult to access. Blockchain technology allows records to be both immutable and transparent. OBJECTIVE: Using blockchain technology, the aim of this study was to develop a medical document monitoring system that informs patients of changes to their medical documents. We then examined whether patients can effectively verify the monitoring of their primary care clinical medical records in a system based on blockchain technology. METHODS: We enrolled participants who visited two primary care clinics in Korea. Three substudies were performed: (1) a survey of the recognition of blockchain medical records changes and the digital literacy of participants; (2) an observational study on participants using the blockchain-based mobile alert app; and (3) a usability survey study. The participants' medical documents were profiled with HL7 Fast Healthcare Interoperability Resources, hashed, and transacted to the blockchain. The app checked the changes in the documents by querying the blockchain. RESULTS: A total of 70 participants were enrolled in this study. Considering their recognition of changes to their medical records, participants tended to not allow these changes. Participants also generally expressed a desire for a medical record monitoring system. Concerning digital literacy, most questions were answered with "good," indicating fair digital literacy. In the second survey, only 44 participants-those who logged into the app more than once and used the app for more than 28 days-were included in the analysis to determine whether they exhibited usage patterns. The app was accessed a mean of 5.1 (SD 2.6) times for 33.6 (SD 10.0) days. The mean System Usability Scale score was 63.21 (SD 25.06), which indicated satisfactory usability. CONCLUSIONS: Patients showed great interest in a blockchain-based system to monitor changes in their medical records. The blockchain system is useful for informing patients of changes in their records via the app without uploading the medical record itself to the network. This ensures the transparency of medical records as well as patient empowerment.
Gracie Carter, Ben Chevellereau, Hossain Shahriar, Sweta Sneha
The healthcare system in the United States is unique. From payor to provider, patients have the freedom of choice. This creates a complicated and profitable paradigm of care. Legislation defines government expectations of data exchange; however, the methods are left to the discretion of the stakeholders. Today, devices and programs are not built to unified standards, thus they do not share data easily. This communication between software is known as interoperability. We address the health data interoperability by leveraging Fast Health Interoperable Resource (FHIR) standard, a viewer of FHIR called OpenPharma, and Blockchain technology. Our proof of concept, called "OpenPharma Blockchain on FHIR" (OBF), is interoperable by design and grants clinicians access to patient records using a combination of data standards, distributed applications, patient-driven identity management, and the Ethereum blockchain. OBF is a trustless, secure, decentralized, and vendor-independent method for information exchange. It is easy to implement and places the control of records with the patients.
BACKGROUND: The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. OBJECTIVE: The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. METHODS: We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. RESULTS: We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. CONCLUSIONS: We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.
BACKGROUND: Personal health record (PHR) security, correctness, and protection are essential for health and medical services. Blockchain architecture can provide efficient data retrieval and security requirements. Exchangeable PHRs and the self-management of patient health can offer many benefits to traditional medical services by allowing people to manage their own health records for disease prevention, prediction, and control while reducing resource burdens on the health care infrastructure and improving population health and quality of life. OBJECTIVE: This study aimed to build a blockchain-based architecture for an international health record exchange platform to ensure health record confidentiality, integrity, and availability for health management and used Health Level 7 Fast Healthcare Interoperability Resource international standards as the data format that could allow international, cross-institutional, and patient/doctor exchanges of PHRs. METHODS: The PHR architecture in this study comprised 2 main components. The first component was the PHR management platform, on which users could upload PHRs, view their record content, authorize PHR exchanges with doctors or other medical health care providers, and check their block information. When a PHR was uploaded, the hash value of the PHR would be calculated by the SHA-256 algorithm and the PHR would be encrypted by the Rivest-Shamir-Adleman encryption mechanism before being transferred to a secure database. The second component was the blockchain exchange architecture, which was based on Ethereum to create a private chain. Proof of authority, which delivers transactions through a consensus mechanism based on identity, was used for consensus. The hash value was calculated based on the previous hash value, block content, and timestamp by a hash function. RESULTS: The PHR blockchain architecture constructed in this study is an effective method for the management and utilization of PHRs. The platform has been deployed in Southeast Asian countries via the Asia eHealth Information Network (AeHIN) and has become the first PHR management platform for cross-region medical data exchange. CONCLUSIONS: Some systems have shown that blockchain technology has great potential for electronic health record applications. This study combined different types of data storage modes to effectively solve the problems of PHR data security, storage, and transmission and proposed a hybrid blockchain and data security approach to enable effective international PHR exchange. By partnering with the AeHIN and making use of the network's regional reach and expert pool, the platform could be deployed and promoted successfully. In the future, the PHR platform could be utilized for the purpose of precision and individual medicine in a cross-country manner because of the platform's provision of a secure and efficient PHR sharing and management architecture, making it a reasonable base for future data collection sources and the data analytics needed for precision medicine.
BACKGROUND: Health care professionals are required to maintain accurate health records of patients. Furthermore, these records should be shared across different health care organizations for professionals to have a complete review of medical history and avoid missing important information. Nowadays, health care providers use electronic health records (EHRs) as a key to the implementation of these goals and delivery of quality care. However, there are technical and legal hurdles that prevent the adoption of these systems, such as concerns about performance and privacy issues. OBJECTIVE: This study aimed to build and evaluate an experimental blockchain for EHRs, named HealthChain, which overcomes the disadvantages of traditional EHR systems. METHODS: HealthChain is built based on consortium blockchain technology. Specifically, three organizations, namely hospitals, insurance providers, and governmental agencies, form a consortium that operates under a governance model, which enforces the business logic agreed by all participants. Every peer node hosts an instance of the distributed ledger consisting of EHRs and an instance of chaincode regulating the permissions of participants. Designated orderers establish consensus on the order of EHRs and then disseminate blocks to peers. RESULTS: HealthChain achieves functional and nonfunctional requirements. It can store EHRs in a distributed ledger and share them among different participants. Moreover, it demonstrates superior features, such as privacy preservation, security, and high throughput. These are the main reasons why HealthChain is proposed. CONCLUSIONS: Consortium blockchain technology can help to build new EHR systems and solve the problems that prevent the adoption of traditional systems.
PURPOSE The healthcare system in the United States is unique. From payor to provider, patients have many choices but they lack in the ability to manage or share their health information. This complicated care paradigm places patients at a distinct disadvantage. Legislation clearly defines government expectations of data availability but not how to achieve exchange. Because methods of sharing are left to the discretion of care providers and software vendors, non-interoperability is the standard. METHODS The OpenPharma Blockchain on Fast Healthcare Interoperability Resources (FHIR) (OBF) solution is interoperable by design. OBF empowers patients with data access through biometric identity authentication, blockchain, and machine-–to-machine secure data access. OBF provides authenticated users read-only, real-time access to patient records using the healthcare interoperability standard HL7 FHIR. OBF is built around a modern, browser-based user interface, blockchain technologies (leveraging either Ethereum or the Hedera protocols) and modular, modern software exposed as Application Programming Interfaces (APIs). This allows OBF to meet the Office of National Coordinator for Health Information (ONC) metrics, which include sending, receiving, and finding information from outside sources and using that information to make informed clinical decisions without additional burden on clinicians or patients. RESULTS Building on the HL7 FHIR application community practices, OBF is a SMART-on-FHIR plug-in for Electronic Medical Record (EMR) systems. Using OBF, patients can identify themselves and gain access to their medical records using their voice. This unique feature is accomplished through the Saavha voice print biometrics technology. Saavha returns a unique member ID that is passed directly to the OBF blockchain smart contract for storage and interoperable patient record access (the ID does not contain public health information [PHI]). To ensure complete privacy, all information is passed through multiple layers of encryption where no keys are stored locally. Additionally, no PHI is shared to the blockchain. To ensure privacy, OBF creates a new encrypted address for the FHIR patient record object, using the Saavha generated member ID as the unique identifier. This encrypted address is then published on chain, making it available to participating providers. Providers must register their relationships to patients before OBF will permit online viewing of patient records. Patient record access is accomplished through voice verification and real-time surfacing of encrypted patient data through the OBF FHIR Viewer. CONCLUSIONS OBF is a lightweight, flexible, secure, and stable interoperable solution that places data stewardship with patients. Using industry-wide data standards, biometrics, Smart contracts, Ethereum, and OpenPharma’s data viewer for the first-time patients can authorize read-only record exchange using their voice.
BACKGROUND: Medical referral is the transfer of a patient's care from one physician to another upon request. This process involves multiple steps that require provider-to-provider and provider-to-patient communication. In Taiwan, the National Health Insurance Administration (NHIA) has implemented a national medical referral (NMR) system, which encourages physicians to refer their patients to different health care facilities to reduce unnecessary hospital visits and the financial stress on the national health insurance. However, the NHIA's NMR system is a government-based electronic medical referral service, and its referral data access and exchange are limited to authorized clinical professionals using their national health smart cards over the NHIA virtual private network. Therefore, this system lacks scalability and flexibility and cannot establish trusting relationships among patients, family doctors, and specialists. OBJECTIVE: To eliminate the existing restrictions of the NHIA's NMR system, this study developed a scalable, flexible, and blockchain-enabled framework that leverages the NHIA's NMR referral data to build an alliance-based medical referral service connecting health care facilities. METHODS: We developed a blockchain-enabled framework that can integrate patient referral data from the NHIA's NMR system with electronic medical record (EMR) and electronic health record (EHR) data of hospitals and community-based clinics to establish an alliance-based medical referral service serving patients, clinics, and hospitals and improve the trust in relationships and transaction security. We also developed a blockchain-enabled personal health record decentralized app (DApp) based on our blockchain-enabled framework for patients to acquire their EMR and EHR data; DApp access logs were collected to assess patients' behavior and investigate the acceptance of our personal authorization-controlled framework. RESULTS: The constructed iWellChain Framework was installed in an affiliated teaching hospital and four collaborative clinics. The framework renders all medical referral processes automatic and paperless and facilitates efficient NHIA reimbursements. In addition, the blockchain-enabled iWellChain DApp was distributed for patients to access and control their EMR and EHR data. Analysis of 3 months (September to December 2018) of access logs revealed that patients were highly interested in acquiring health data, especially those of laboratory test reports. CONCLUSIONS: This study is a pioneer of blockchain applications for medical referral services, and the constructed framework and DApp have been applied practically in clinical settings. The iWellChain Framework has the scalability to deploy a blockchain environment effectively for health care facilities; the iWellChain DApp has potential for use with more patient-centered applications to collaborate with the industry and facilitate its adoption.
Jan Heinrich Beinke, Christian Fitte, Frank Teuteberg
BACKGROUND: Data security issues still constitute the main reason for the sluggish dissemination of electronic health records (EHRs). Given that blockchain technology offers the possibility to verify transactions through a decentralized network, it may serve as a solution to secure health-related data. Therefore, we have identified stakeholder-specific requirements and propose a blockchain-based architecture for EHRs, while referring to the already existing scientific discussions on the potential of blockchain for use in EHRs. OBJECTIVE: This study aimed to introduce blockchain technology for EHRs, based on identifying stakeholders and systematically eliciting their requirements, and to discuss the key benefits (KBs) and key challenges (KCs) of blockchain technology in the context of EHRs. METHODS: The blockchain-based architecture was developed in the framework of the design science research paradigm. The requirements were identified using a structured literature review and interviews with nine health care experts. Subsequently, the proposed architecture was evaluated using 4 workshops with 15 participants. RESULTS: We identified three major EHR stakeholder groups and 34 respective requirements. On this basis, we developed a five-layer architecture. The subsequent evaluation of the artifact was followed by the discussion of 12 KBs and 12 KCs of a blockchain-based architecture for EHRs. To address the KCs, we derived five recommendations for action for science and practice. CONCLUSIONS: Our findings indicate that blockchain technology offers considerable potential to advance EHRs. Improvements to currently available EHR solutions are expected, for instance, in the areas of data security, traceability, and automation by smart contracts. Future research could examine the patient's acceptance of blockchain-based EHRs and cost-benefit analyses.
BACKGROUND: Nowadays, a number of mechanisms and tools are being used by health care organizations and physicians to electronically exchange the personal health information of patients. The main objectives of different methods of health information exchange (HIE) are to reduce health care costs, minimize medical errors, and improve the coordination of interorganizational information exchange across health care entities. The main challenges associated with the common HIE systems are privacy concerns, security risks, low visibility of system transparency, and lack of patient control. Blockchain technology is likely to disrupt the current information exchange models utilized in the health care industry. OBJECTIVE: Little is known about patients' perceptions and attitudes toward the implementation of blockchain-enabled HIE networks, and it is still not clear if patients (as one of the main HIE stakeholders) are likely to opt in to the applications of this technology in HIE initiatives. Thus, this study aimed at exploring the core value of blockchain technology in the health care industry from health care consumers' views. METHODS: To recognize the potential applications of blockchain technology in health care practices, we designed 16 information exchange scenarios for controlled Web-based experiments. Overall, 2013 respondents participated in 16 Web-based experiments. Each experiment described an information exchange condition characterized by 4 exchange mechanisms (ie, direct, lookup, patient-centered, and blockchain), 2 types of health information (ie, sensitive vs nonsensitive), and 2 types of privacy policy (weak vs strong). RESULTS: The findings show that there are significant differences in patients' perceptions of various exchange mechanisms with regard to patient privacy concern, trust in competency and integrity, opt-in intention, and willingness to share information. Interestingly, participants hold a favorable attitude toward the implementation of blockchain-based exchange mechanisms for privacy protection, coordination, and information exchange purposes. This study proposed the potentials and limitations of a blockchain-based attempt in the HIE context. CONCLUSIONS: The results of this research should be of interest to both academics and practitioners. The findings propose potential limitations of a blockchain-based HIE that should be addressed by health care organizations to exchange personal health information in a secure and private manner. This study can contribute to the research in the blockchain area and enrich the literature on the use of blockchain in HIE efforts. Practitioners can also identify how to leverage the benefit of blockchain to promote HIE initiatives nationwide.
In most regions of China, Electronic Medical Record (EMR) systems in hospitals are developed in an uncoordinated manner. Medical Insurance and Healthcare Administration are localised and organizations gather data from a functional management viewpoint without consideration of wider information sharing. Discontinuity of data resources is serious. Despite the government's repeated emphasis on EMR data integration, little progress has been made, causing inconvenience to patients, but also significantly hindering data mining.This exploratory investigation used a case study to identify bottlenecks of data integration and proposes countermeasures. Interviews were carried out with 27 practitioners from central and provincial governments, hospitals, and related enterprises in China. This research shows that EMR data collection without patients' authorization poses a major hazard to data integration. In addition, non-uniform information standards and hospitals' unwillingness to share data are also significant obstacles to integration. Moreover, friction caused by the administrative decentralization, as well as unsustainability of public finance investment, also hinders the integration of data resources.To solve these problems, first, a protocol should be adopted for multi-stakeholder participation in data collection. Administrative authorities should then co-establish information standards and a data audit mechanism. Finally, measures are proposed for expanding data integration for multiplying effectiveness and adopting the Public-Private Partnerships model.
Odhran O’Donoghue, Anuraag A Vazirani, David Brindley, Edward Meinert
BACKGROUND: A blockchain is a list of records that uses cryptography to make stored data immutable; their use has recently been proposed for electronic medical record (EMR) systems. This paper details a systematic review of trade-offs in blockchain technologies that are relevant to EMRs. Trade-offs are defined as "a compromise between two desirable but incompatible features." OBJECTIVE: This review's primary research question was: "What are the trade-offs involved in different blockchain designs that are relevant to the creation of blockchain-based electronic medical records systems?" METHODS: Seven databases were systematically searched for relevant articles using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Papers published from January 1, 2017 to June 15, 2018 were selected. Quality assessments of papers were performed using the Risk Of Bias In Non-randomized Studies-of Interventions (ROBINS-I) tool and the Critical Assessment Skills Programme (CASP) tool. Database searches identified 2885 articles, of which 15 were ultimately included for analysis. RESULTS: A total of 17 trade-offs were identified impacting the design, development, and implementation of blockchain systems; these trade-offs are organized into themes, including business, application, data, and technology architecture. CONCLUSIONS: The key findings concluded the following: (1) multiple trade-offs can be managed adaptively to improve EMR utility; (2) multiple trade-offs involve improving the security of blockchain systems at the cost of other features, meaning EMR efficacy highly depends on data protection standards; and (3) multiple trade-offs result in improved blockchain scalability. Consideration of these trade-offs will be important to the specific environment in which electronic medical records are being developed. This review also uses its findings to suggest useful design choices for a hypothetical National Health Service blockchain. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10994.
Eric Venner, Mullai Murugan, Walker Hale, Jordan M Jones · 7 authors
MOTIVATION: Clinical genome sequencing laboratories return reports containing clinical testing results, signed by a board-certified clinical geneticist, to the ordering physician. This report is often a PDF, but can also be a paper copy or a structured data file. The reports are frequently modified and reissued due to changes in variant interpretation or clinical attributes. MATERIALS AND METHODS: To precisely track report authenticity, we developed ARBoR (Authenticated Resources in a Hashed Block Registry), an application for tracking the authenticity and lineage of versioned clinical reports even when they are distributed as PDF or paper copies. ARBoR tracks clinical reports as cryptographically signed hash blocks in an electronic ledger file, which is then exactly replicated to many clients. RESULTS: ARBoR was implemented for clinical reporting in the Human Genome Sequencing Center Clinical Laboratory, initially as part of the National Institute of Health's Electronic Medical Record and Genomics (eMERGE) project. CONCLUSIONS: To date, we have issued 15 205 versioned clinical reports tracked by ARBoR. This system has provided us with a simple and tamper-proof mechanism for tracking clinical reports with a complicated update history.
Anuraag A Vazirani, Odhran O’Donoghue, David Brindley, Edward Meinert
BACKGROUND: The decentralized nature of sensitive health information can bring about situations where timely information is unavailable, worsening health outcomes. Furthermore, as patient involvement in health care increases, there is a growing need for patients to access and control their data. Blockchain is a secure, decentralized online ledger that could be used to manage electronic health records (EHRs) efficiently, therefore with the potential to improve health outcomes by creating a conduit for interoperability. OBJECTIVE: This study aimed to perform a systematic review to assess the feasibility of blockchain as a method of managing health care records efficiently. METHODS: Reviewers identified studies via systematic searches of databases including PubMed, MEDLINE, Scopus, EMBASE, ProQuest, and Cochrane Library. Suitability for inclusion of each was assessed independently. RESULTS: Of the 71 included studies, the majority discuss potential benefits and limitations without evaluation of their effectiveness, although some systems were tested on live data. CONCLUSIONS: Blockchain could create a mechanism to manage access to EHRs stored on the cloud. Using a blockchain can increase interoperability while maintaining privacy and security of data. It contains inherent integrity and conforms to strict legal regulations. Increased interoperability would be beneficial for health outcomes. Although this technology is currently unfamiliar to most, investments into creating a sufficiently user-friendly interface and educating users on how best to take advantage of it would lead to improved health outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10994.
Yu Rang Park, Eunsol Lee, Wonjun Na, Sung-Jun Park · 6 authors
BACKGROUND: There are many perspectives on the advantages of introducing blockchain in the medical field, but there are no published feasibility studies regarding the storage, propagation, and management of personal health records (PHRs) using blockchain technology. OBJECTIVE: The purpose of this study was to investigate the usefulness of blockchains in the medical field in relation to transactions with and propagation of PHRs in a private blockchain. METHODS: We constructed a private blockchain network using Ethereum version 1.8.4 and conducted verification using the de-identified PHRs of 300 patients. The private blockchain network consisted of one hospital node and 300 patient nodes. In order to verify the effectiveness of blockchain-based PHR management, PHRs at a time were loaded in a transaction between the hospital and patient nodes and propagated to the whole network. We obtained and analyzed the time and gas required for data transaction and propagation on the blockchain network. For reproducibility, these processes were repeated 100 times. RESULTS: Of 300 patient records, 74 (24.7%) were not loaded in the private blockchain due to the data block size of the transaction block. The remaining 226 individual health records were classified into groups A (80 patients with outpatient visit data less than 1 year old), B (84 patients with outpatient data from between 1 and 3 years before data collection), and C (62 patients with outpatient data 3 to 5 years old). With respect to mean transaction time in the blockchain, C (128.7 seconds) had the shortest time, followed by A (132.2 seconds) and then B (159.0 seconds). The mean propagation times for groups A, B, and C were 1494.2 seconds, 2138.9 seconds, and 4111.4 seconds, respectively; mean file sizes were 5.6 KB, 18.6 KB, and 45.38 KB, respectively. The mean gas consumption values were 1,900,767; 4,224,341; and 4,112,784 for groups A, B, and C, respectively. CONCLUSIONS: This study confirms that it is possible to exchange PHR data in a private blockchain network. However, to develop a blockchain-based PHR platform that can be used in practice, many improvements are required, including reductions in data size, improved personal information protection, and reduced operating costs.
David M. Maslove, Jacob Klein, M. Kathryn Brohman, Patrick Martin
BACKGROUND: Blockchain technology is emerging as an innovative tool in data and software security. OBJECTIVE: This study aims to explore the role of blockchain in supporting clinical trials data management and develop a proof-of-concept implementation of a patient-facing and researcher-facing system. METHODS: Blockchain-based Smart Contracts were built using the Ethereum platform. RESULTS: We described BlockTrial, a system that uses a Web-based interface to allow users to run trials-related Smart Contracts on an Ethereum network. Functions allow patients to grant researchers access to their data and allow researchers to submit queries for data that are stored off chain. As a type of distributed ledger, the system generates a durable and transparent log of these and other transactions. BlockTrial could be used to increase the trustworthiness of data collected during clinical research with benefits to researchers, regulators, and drug companies alike. In addition, the system could empower patients to become more active and fully informed partners in research. CONCLUSIONS: Blockchain technology presents an opportunity to address some of the common threats to the integrity of data collected in clinical trials and ensure that the analysis of these data comply with prespecified plans. Further technical work is needed to add additional functions. Policies must be developed to determine the optimal models for participation in the system by its various stakeholders.
Associating the health-related records and transactions of patients with their numerous “identities” as they interact with different healthcare providers, payers, pharmacy benefit managers and other entities is an expensive and complex problem. With many years of experience addressing this issue in different healthcare systems and Health Information Exchanges (HIEs), it is apparent that there is now a compelling and relatively straightforward technical solution for this problem. Presented here is a broadly feasible and technically compelling argument for a blockchain-based approach to addressing these issues. At the same time, challenges ahead and potential strategies to address them are discussed. Keywords: Blockchain; Master Patient Index; MPI; Distributed Ledger; Patient Identity; HIE; HealthInformation Exchange
Blockchain technology is often considered as the fourth industrial revolution that will change the world. The enthusiasm of the transformative nature of blockchain technology has infiltrated healthcare. Blockchain is often seen as the much needed and perfect technology for healthcare, addressing the difficult and complex issues of security and inter-operability. More importantly, the "value" and trust-based system can deliver automated action and response via its smart contract mechanism. Healthcare, however, is a complex system. Health information technology (HIT) so far, has not delivered its promise of transforming healthcare due to its complex socio-technical and context sensitive interaction. The introduction of blockchain technology will need to consider a whole range of socio-technical issues in order to improve the quality and safety of patient care. This paper presents a discussion on these socio-technical issues. More importantly, this paper argues that in order to achieve the best outcome from blockchain technology, there is a need to consider a clinical transformation from "information" to "value " and trust. This paper argues that urgent research is needed to address these socio-technical issues in order to facilitate best outcomes for blockchain in healthcare. These socio-technical issues must then be further evaluated by means of working prototypes in the medical domain in coming years.
Open access
Electronic Health Records Systems
Mobile Health and mHealth Applications
Artificial Intelligence in Healthcare and Education
Electronic Health Records (EHRs) are entirely controlled by hospitals instead of patients, which complicates seeking medical advices from different hospitals. Patients face a critical need to focus on the details of their own healthcare and restore management of their own medical data. The rapid development of blockchain technology promotes population healthcare, including medical records as well as patient-related data. This technology provides patients with comprehensive, immutable records, and access to EHRs free from service providers and treatment websites. In this paper, to guarantee the validity of EHRs encapsulated in blockchain, we present an attribute-based signature scheme with multiple authorities, in which a patient endorses a message according to the attribute while disclosing no information other than the evidence that he has attested to it. Furthermore, there are multiple authorities without a trusted single or central one to generate and distribute public/private keys of the patient, which avoids the escrow problem and conforms to the mode of distributed data storage in the blockchain. By sharing the secret pseudorandom function seeds among authorities, this protocol resists collusion attack out of N from N -1 corrupted authorities. Under the assumption of the computational bilinear Diffie-Hellman, we also formally demonstrate that, in terms of the unforgeability and perfect privacy of the attribute-signer, this attribute-based signature scheme is secure in the random oracle model. The comparison shows the efficiency and properties between the proposed method and methods proposed in other studies.