@Article{info:doi/10.2196/70463, author="Sanchez, William and Dewan, Ananya and Budd, Eve and Eifler, M. and Miller, C. Robert and Kahn, Jeffery and Macis, Mario and Gross, Marielle", title="Decentralized Biobanking Apps for Patient Tracking of Biospecimen Research: Real-World Usability and Feasibility Study", journal="JMIR Bioinform Biotech", year="2025", month="Apr", day="10", volume="6", pages="e70463", keywords="patient empowerment", keywords="biobanking", keywords="biospecimens", keywords="transparency", keywords="community engagement", keywords="nonfungible tokens", keywords="NFTs", keywords="blockchain technology", keywords="decentralized biobanking", keywords="pilot studies", keywords="technical feasibility", keywords="biowallet", abstract="Background: Biobank privacy policies strip patient identifiers from donated specimens, undermining transparency, utility, and value for patients, scientists, and society. We are advancing decentralized biobanking apps that reconnect patients with biospecimens and facilitate engagement through a privacy-preserving nonfungible token (NFT) digital twin framework. The decentralized biobanking platform was first piloted for breast cancer biobank members. Objective: This study aimed to demonstrate the technical feasibility of (1) patient-friendly biobanking apps, (2) integration with institutional biobanks, and (3) establishing the foundation of an NFT digital twin framework for decentralized biobanking. Methods: We designed, developed, and deployed a decentralized biobanking mobile app for a feasibility pilot from 2021 to 2023 in the setting of a breast cancer biobank at a National Cancer Institute comprehensive cancer center. The Flutter app was integrated with the biobank's laboratory information management systems via an institutional review board--approved mechanism leveraging authorized, secure devices and anonymous ID codes and complemented with a nontransferable ERC-721 NFT representing the soul-bound connection between an individual and their specimens. Biowallet NFTs were held within a custodial wallet, whereas the user experiences simulated token-gated access to personalized feedback about collection and use of individual and collective deidentified specimens. Quantified app user journeys and NFT deployment data demonstrate technical feasibility complemented with design workshop feedback. Results: The decentralized biobanking app incorporated key features: ``biobank'' (learn about biobanking), ``biowallet'' (track personal biospecimens), ``labs'' (follow research), and ``profile'' (share data and preferences). In total, 405 pilot participants downloaded the app, including 361 (89.1\%) biobank members. A total of 4 central user journeys were captured. First, all app users were oriented to the ?60,000-biospecimen collection, and 37.8\% (153/405) completed research profiles, collectively enhancing annotations for 760 unused specimens. NFTs were minted for 94.6\% (140/148) of app users with specimens at an average cost of US \$4.51 (SD US \$2.54; range US \$1.84-\$11.23) per token, projected to US \$17,769.40 (SD US \$159.52; range US \$7265.62-\$44,229.27) for the biobank population. In total, 89.3\% (125/140) of the users successfully claimed NFTs during the pilot, thereby tracking 1812 personal specimens, including 202 (11.2\%) distributed under 42 unique research protocols. Participants embraced the opportunity for direct feedback, community engagement, and potential health benefits, although user onboarding requires further refinement. Conclusions: Decentralized biobanking apps demonstrate technical feasibility for empowering patients to track donated biospecimens via integration with institutional biobank infrastructure. Our pilot reveals potential to accelerate biomedical research through patient engagement; however, further development is needed to optimize the accessibility, efficiency, and scalability of platform design and blockchain elements, as well as a robust incentive and governance structure for decentralized biobanking. ", doi="10.2196/70463", url="https://bioinform.jmir.org/2025/1/e70463", url="http://www.ncbi.nlm.nih.gov/pubmed/40208659" } @Article{info:doi/10.2196/64634, author="Zheng, Yuanyuan and Chen, Yizhen and Chen, Yan and Lin, Liang and Xue, Ting and Chen, Chuhui and Wen, Junping and Lin, Wei and Chen, Gang", title="Metaverse Clinic for Pregnant Women With Subclinical Hypothyroidism: Prospective Randomized Study", journal="J Med Internet Res", year="2025", month="Feb", day="5", volume="27", pages="e64634", keywords="metaverse", keywords="subclinical hypothyroidism", keywords="adverse pregnancy outcomes", keywords="psychological health", keywords="neurobehavioral development", abstract="Background: Health care is experiencing new opportunities in the emerging digital landscape. The metaverse, a shared virtual space, integrates technologies such as augmented reality, virtual reality, blockchain, and artificial intelligence. It allows users to interact with immersive digital worlds, connect with others, and explore unknowns. While the metaverse is gaining traction across various medical disciplines, its application in thyroid diseases remains unexplored. Subclinical hypothyroidism (SCH) is the most common thyroid disorder during pregnancy and is frequently associated with adverse pregnancy outcomes. Objective: This study aims to evaluate the safety and effectiveness of a metaverse platform in managing SCH during pregnancy. Methods: A randomized controlled trial was conducted at Fujian Provincial Hospital, China, from July 2022 to December 2023. A total of 60 pregnant women diagnosed with SCH were randomly assigned into two groups: the standard group (n=30) and the metaverse group (n=30). Both groups received levothyroxine sodium tablets. Additionally, participants in the metaverse group had access to the metaverse virtual medical consultations and metaverse-based medical games. The primary outcomes were adverse maternal and offspring outcomes, and the secondary outcomes included the neurobehavioral development of offspring and maternal psychological assessments. Results: Of the 30 participants in each group, adverse maternal outcomes were observed in 43\% (n=13) of the standard group and 37\% (n=11) of the metaverse group (P=.60). The incidence of adverse offspring outcomes was 33\% (n=10) in the standard group, compared to 7\% (n=2) in the metaverse group (P=.01). The Gesell Development Scale did not show significant differences between the two groups. Notably, the metaverse group demonstrated significantly improved scores on the Self-Rating Depression Scale and the Self-Rating Anxiety Scale scores compared to the standard group (P<.001 and P=.001, respectively). Conclusions: The use of metaverse technology significantly reduced the incidence of adverse offspring outcomes and positively impacted maternal mental health. Maternal adverse outcomes and offspring neurobehavioral development were comparable between the two groups. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300076803; https://www.chictr.org.cn/showproj.html?proj=205905 ", doi="10.2196/64634", url="https://www.jmir.org/2025/1/e64634" } @Article{info:doi/10.2196/58575, author="Marino, Antonio Carlos and Diaz Paz, Claudia", title="Smart Contracts and Shared Platforms in Sustainable Health Care: Systematic Review", journal="JMIR Med Inform", year="2025", month="Jan", day="31", volume="13", pages="e58575", keywords="health care", keywords="smart contracts", keywords="blockchain", keywords="security", keywords="privacy", keywords="supply chain", keywords="patient centricity", keywords="system trust", keywords="stakeholders", abstract="Background: The benefits of smart contracts (SCs) for sustainable health care are a relatively recent topic that has gathered attention given its relationship with trust and the advantages of decentralization, immutability, and traceability introduced in health care. Nevertheless, more studies need to explore the role of SCs in this sector based on the frameworks propounded in the literature that reflect business logic that has been customized, automatized, and prioritized, as well as system trust. This study addressed this lacuna. Objective: This study aimed to provide a comprehensive understanding of SCs in health care based on reviewing the frameworks propounded in the literature. Methods: A structured literature review was performed based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) principles. One database---Web of Science (WoS)---was selected to avoid bias generated by database differences and data wrangling. A quantitative assessment of the studies based on machine learning and data reduction methodologies was complemented with a qualitative, in-depth, detailed review of the frameworks propounded in the literature. Results: A total of 70 studies, which constituted 18.7\% (70/374) of the studies on this subject, met the selection criteria and were analyzed. A multiple correspondence analysis---with 74.44\% of the inertia---produced 3 factors describing the advances in the topic. Two of them referred to the leading roles of SCs: (1) health care process enhancement and (2) assurance of patients' privacy protection. The first role included 6 themes, and the second one included 3 themes. The third factor encompassed the technical features that improve system efficiency. The in-depth review of these 3 factors and the identification of stakeholders allowed us to characterize the system trust in health care SCs. We assessed the risk of coverage bias, and good percentages of overlap were obtained---66\% (49/74) of PubMed articles were also in WoS, and 88.3\% (181/205) of WoS articles also appeared in Scopus. Conclusions: This comprehensive review allows us to understand the relevance of SCs and the potentiality of their use in patient-centric health care that considers more than technical aspects. It also provides insights for further research based on specific stakeholders, locations, and behaviors. ", doi="10.2196/58575", url="https://medinform.jmir.org/2025/1/e58575" } @Article{info:doi/10.2196/57754, author="Liu, Shuimei and Guo, Raymond L.", title="Data Ownership in the AI-Powered Integrative Health Care Landscape", journal="JMIR Med Inform", year="2024", month="Nov", day="19", volume="12", pages="e57754", keywords="data ownership", keywords="integrative healthcare", keywords="artificial intelligence", keywords="AI", keywords="ownership", keywords="data science", keywords="governance", keywords="consent", keywords="privacy", keywords="security", keywords="access", keywords="model", keywords="framework", keywords="transparency", doi="10.2196/57754", url="https://medinform.jmir.org/2024/1/e57754" } @Article{info:doi/10.2196/50730, author="Kaafarani, Rima and Ismail, Leila and Zahwe, Oussama", title="Automatic Recommender System of Development Platforms for Smart Contract--Based Health Care Insurance Fraud Detection Solutions: Taxonomy and Performance Evaluation", journal="J Med Internet Res", year="2024", month="Oct", day="18", volume="26", pages="e50730", keywords="blockchain", keywords="blockchain development platform", keywords="eHealth", keywords="fraud detection", keywords="fraud scenarios", keywords="health care", keywords="health care insurance", keywords="health insurance", keywords="machine learning", keywords="medical informatics", keywords="recommender system", keywords="smart contract", keywords="taxonomy", abstract="Background: Health care insurance fraud is on the rise in many ways, such as falsifying information and hiding third-party liability. This can result in significant losses for the medical health insurance industry. Consequently, fraud detection is crucial. Currently, companies employ auditors who manually evaluate records and pinpoint fraud. However, an automated and effective method is needed to detect fraud with the continually increasing number of patients seeking health insurance. Blockchain is an emerging technology and is constantly evolving to meet business needs. With its characteristics of immutability, transparency, traceability, and smart contracts, it demonstrates its potential in the health care domain. In particular, self-executable smart contracts are essential to reduce the costs associated with traditional paradigms, which are mostly manual, while preserving privacy and building trust among health care stakeholders, including the patient and the health insurance networks. However, with the proliferation of blockchain development platform options, selecting the right one for health care insurance can be difficult. This study addressed this void and developed an automated decision map recommender system to select the most effective blockchain platform for insurance fraud detection. Objective: This study aims to develop smart contracts for detecting health care insurance fraud efficiently. Therefore, we provided a taxonomy of fraud scenarios and implemented their detection using a blockchain platform that was suitable for health care insurance fraud detection. To automatically and efficiently select the best platform, we proposed and implemented a decision map--based recommender system. For developing the decision-map, we proposed a taxonomy of 102 blockchain platforms. Methods: We developed smart contracts for 12 fraud scenarios that we identified in the literature. We used the top 2 blockchain platforms selected by our proposed decision-making map--based recommender system, which is tailored for health care insurance fraud. The map used our taxonomy of 102 blockchain platforms classified according to their application domains. Results: The recommender system demonstrated that Hyperledger Fabric was the best blockchain platform for identifying health care insurance fraud. We validated our recommender system by comparing the performance of the top 2 platforms selected by our system. The blockchain platform taxonomy that we created revealed that 59 blockchain platforms are suitable for all application domains, 25 are suitable for financial services, and 18 are suitable for various application domains. We implemented fraud detection based on smart contracts. Conclusions: Our decision map recommender system, which was based on our proposed taxonomy of 102 platforms, automatically selected the top 2 platforms, which were Hyperledger Fabric and Neo, for the implementation of health care insurance fraud detection. Our performance evaluation of the 2 platforms indicated that Fabric surpassed Neo in all performance metrics, as depicted by our recommender system. We provided an implementation of fraud detection based on smart contracts. ", doi="10.2196/50730", url="https://www.jmir.org/2024/1/e50730", url="http://www.ncbi.nlm.nih.gov/pubmed/39423005" } @Article{info:doi/10.2196/46556, author="Liang, Xueping and Alam, Nabid and Sultana, Tahmina and Bandara, Eranga and Shetty, Sachin", title="Designing A Blockchain-Empowered Telehealth Artifact for Decentralized Identity Management and Trustworthy Communication: Interdisciplinary Approach", journal="J Med Internet Res", year="2024", month="Sep", day="25", volume="26", pages="e46556", keywords="telehealth", keywords="blockchain", keywords="security", keywords="software", keywords="proof of concept", keywords="implementation", keywords="privacy", abstract="Background: Telehealth played a critical role during the COVID-19 pandemic and continues to function as an essential component of health care. Existing platforms cannot ensure privacy and prevent cyberattacks. Objective: The main objectives of this study are to understand existing cybersecurity issues in identity management and trustworthy communication processes in telehealth platforms and to design a software architecture integrated with blockchain to improve security and trustworthiness with acceptable performance. Methods: We improved personal information security in existing telehealth platforms by adopting an innovative interdisciplinary approach combining design science, social science, and computer science in the health care domain, with prototype implementation. We used the design science research methodology to implement our overall design. We innovated over existing telehealth platforms with blockchain integration that improves health care delivery services in terms of security, privacy, and efficiency. We adopted a user-centric design approach and started with user requirement collection, followed by system functionality development. Overall system implementation facilitates user requirements, thus promoting user behavior for the adoption of the telehealth platform with decentralized identity management and an access control mechanism. Results: Our investigation identified key challenges to identity management and trustworthy communication processes in telehealth platforms used in the current health care domain. By adopting distributed ledger technology, we proposed a decentralized telehealth platform to support identity management and a trustworthy communication process. Our design and prototype implementation using a smart contract--driven telehealth platform to provide decentralized identity management and trustworthy communication with token-based access control addressed several security challenges. This was substantiated by testing with 10,000 simulated transactions across 5 peers in the Rahasak blockchain network. The proposed design provides resistance to common attacks while maintaining a linear time overhead, demonstrating improved security and efficiency in telehealth services. We evaluated the performance in terms of transaction throughput, smart contract execution time, and block generation time. To create a block with 10,000 transactions, it takes 8 seconds on average, which is an acceptable overhead for blockchain-based applications. Conclusions: We identified technical limitations in current telehealth platforms. We presented several design innovations using blockchain to prototype a system. We also presented the implementation details of a unique distributed architecture for a trustworthy communication system. We illustrated how this design can overcome privacy, security, and scalability limitations. Moreover, we illustrated how improving these factors sets the stage for improving and standardizing the application and for the wide adoption of blockchain-enabled telehealth platforms. ", doi="10.2196/46556", url="https://www.jmir.org/2024/1/e46556", url="http://www.ncbi.nlm.nih.gov/pubmed/39320943" } @Article{info:doi/10.2196/46160, author="Wang, Guanyi and Chen, Chen and Jiang, Ziyu and Li, Gang and Wu, Can and Li, Sheng", title="Efficient Use of Biological Data in the Web 3.0 Era by Applying Nonfungible Token Technology", journal="J Med Internet Res", year="2024", month="May", day="28", volume="26", pages="e46160", keywords="NFTs", keywords="biobanks", keywords="blockchains", keywords="health care", keywords="medical big data", keywords="sustainability", keywords="blockchain platform", keywords="platform", keywords="tracing", keywords="virtual", keywords="biomedical data", keywords="transformation", keywords="development", keywords="promoted", doi="10.2196/46160", url="https://www.jmir.org/2024/1/e46160", url="http://www.ncbi.nlm.nih.gov/pubmed/38805706" } @Article{info:doi/10.2196/52740, author="Narayan, Aditya and Weng, Kydo and Shah, Nirav", title="Decentralizing Health Care: History and Opportunities of Web3", journal="JMIR Form Res", year="2024", month="Mar", day="27", volume="8", pages="e52740", keywords="Web3", keywords="health care", keywords="patient-centric", keywords="data ownership", keywords="decentralization", keywords="interoperability", keywords="electronic health record (EHR)", keywords="privacy", keywords="blockchain", keywords="digital transformation", keywords="digital health care", keywords="digital health", keywords="patient", keywords="patients", keywords="technological framework", keywords="security and privacy", keywords="security", doi="10.2196/52740", url="https://formative.jmir.org/2024/1/e52740", url="http://www.ncbi.nlm.nih.gov/pubmed/38536235" } @Article{info:doi/10.2196/50339, author="Charles, M. Wendy and van der Waal, B. Mark and Flach, Joost and Bisschop, Arno and van der Waal, X. Raymond and Es-Sbai, Hadil and McLeod, J. Christopher", title="Blockchain-Based Dynamic Consent and its Applications for Patient-Centric Research and Health Information Sharing: Protocol for an Integrative Review", journal="JMIR Res Protoc", year="2024", month="Feb", day="5", volume="13", pages="e50339", keywords="best practices", keywords="blockchain", keywords="clinical trial", keywords="data reuse", keywords="data sharing", keywords="dynamic consent", keywords="health care data", keywords="integrative research review", keywords="scientific rigor", keywords="technology implementation", abstract="Background: Blockchain has been proposed as a critical technology to facilitate more patient-centric research and health information sharing. For instance, it can be applied to coordinate and document dynamic informed consent, a procedure that allows individuals to continuously review and renew their consent to the collection, use, or sharing of their private health information. Such has been suggested to facilitate ethical, compliant longitudinal research, and patient engagement. However, blockchain-based dynamic consent is a relatively new concept, and it is not yet clear how well the suggested implementations will work in practice. Efforts to critically evaluate implementations in health research contexts are limited. Objective: The objective of this protocol is to guide the identification and critical appraisal of implementations of blockchain-based dynamic consent in health research contexts, thereby facilitating the development of best practices for future research, innovation, and implementation. Methods: The protocol describes methods for an integrative review to allow evaluation of a broad range of quantitative and qualitative research designs. The PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) framework guided the review's structure and nature of reporting findings. We developed search strategies and syntax with the help of an academic librarian. Multiple databases were selected to identify pertinent academic literature (CINAHL, Embase, Ovid MEDLINE, PubMed, Scopus, and Web of Science) and gray literature (Electronic Theses Online Service, ProQuest Dissertations and Theses, Open Access Theses and Dissertations, and Google Scholar) for a comprehensive picture of the field's progress. Eligibility criteria were defined based on PROSPERO (International Prospective Register of Systematic Reviews) requirements and a criteria framework for technology readiness. A total of 2 reviewers will independently review and extract data, while a third reviewer will adjudicate discrepancies. Quality appraisal of articles and discussed implementations will proceed based on the validated Mixed Method Appraisal Tool, and themes will be identified through thematic data synthesis. Results: Literature searches were conducted, and after duplicates were removed, 492 articles were eligible for screening. Title and abstract screening allowed the removal of 312 articles, leaving 180 eligible articles for full-text review against inclusion criteria and confirming a sufficient body of literature for project feasibility. Results will synthesize the quality of evidence on blockchain-based dynamic consent for patient-centric research and health information sharing, covering effectiveness, efficiency, satisfaction, regulatory compliance, and methods of managing identity. Conclusions: The review will provide a comprehensive picture of the progress of emerging blockchain-based dynamic consent technologies and the rigor with which implementations are approached. Resulting insights are expected to inform best practices for future research, innovation, and implementation to benefit patient-centric research and health information sharing. Trial Registration: PROSPERO CRD42023396983; http://tinyurl.com/cn8a5x7t International Registered Report Identifier (IRRID): DERR1-10.2196/50339 ", doi="10.2196/50339", url="https://www.researchprotocols.org/2024/1/e50339", url="http://www.ncbi.nlm.nih.gov/pubmed/38315514" } @Article{info:doi/10.2196/46547, author="Liang, Xueping and Zhao, Juan and Chen, Yan and Bandara, Eranga and Shetty, Sachin", title="Architectural Design of a Blockchain-Enabled, Federated Learning Platform for Algorithmic Fairness in Predictive Health Care: Design Science Study", journal="J Med Internet Res", year="2023", month="Oct", day="30", volume="25", pages="e46547", keywords="fairness", keywords="federated learning", keywords="bias", keywords="health care", keywords="blockchain", keywords="software", keywords="proof of concept", keywords="implementation", keywords="privacy", abstract="Background: Developing effective and generalizable predictive models is critical for disease prediction and clinical decision-making, often requiring diverse samples to mitigate population bias and address algorithmic fairness. However, a major challenge is to retrieve learning models across multiple institutions without bringing in local biases and inequity, while preserving individual patients' privacy at each site. Objective: This study aims to understand the issues of bias and fairness in the machine learning process used in the predictive health care domain. We proposed a software architecture that integrates federated learning and blockchain to improve fairness, while maintaining acceptable prediction accuracy and minimizing overhead costs. Methods: We improved existing federated learning platforms by integrating blockchain through an iterative design approach. We used the design science research method, which involves 2 design cycles (federated learning for bias mitigation and decentralized architecture). The design involves a bias-mitigation process within the blockchain-empowered federated learning framework based on a novel architecture. Under this architecture, multiple medical institutions can jointly train predictive models using their privacy-protected data effectively and efficiently and ultimately achieve fairness in decision-making in the health care domain. Results: We designed and implemented our solution using the Aplos smart contract, microservices, Rahasak blockchain, and Apache Cassandra--based distributed storage. By conducting 20,000 local model training iterations and 1000 federated model training iterations across 5 simulated medical centers as peers in the Rahasak blockchain network, we demonstrated how our solution with an improved fairness mechanism can enhance the accuracy of predictive diagnosis. Conclusions: Our study identified the technical challenges of prediction biases faced by existing predictive models in the health care domain. To overcome these challenges, we presented an innovative design solution using federated learning and blockchain, along with the adoption of a unique distributed architecture for a fairness-aware system. We have illustrated how this design can address privacy, security, prediction accuracy, and scalability challenges, ultimately improving fairness and equity in the predictive health care domain. ", doi="10.2196/46547", url="https://www.jmir.org/2023/1/e46547", url="http://www.ncbi.nlm.nih.gov/pubmed/37902833" } @Article{info:doi/10.2196/44578, author="Liang, Huan-Wei and Chu, Yuan-Chia and Han, Tsung-Hsien", title="Fortifying Health Care Intellectual Property Transactions With Blockchain", journal="J Med Internet Res", year="2023", month="Aug", day="18", volume="25", pages="e44578", keywords="intellectual property", keywords="open innovation", keywords="blockchain", keywords="appropriability regime", keywords="health care", keywords="mobile phone", abstract="Background: Intellectual property (IP) is a substantial competitive advantage in the health care industry. However, the COVID-19 pandemic highlighted the need for open innovation and collaboration for the greater good. Despite this, the industry faces challenges with innovation owing to organizational and departmental barriers. A secure platform is necessary to facilitate IP sharing without compromising the rights of IP owners. Objective: This study proposes a blockchain-based framework to secure IP transactions in health care and bring social impact. Methods: This study reviews existing researches, publications, practical cases, firm and organization websites, and conferences related to blockchain technology, blockchain in health care, blockchain in IP management, IP pledge research, and practice of IP management blockchain. The platform architecture has 7 components: pledgers, advanced research technology (ART), IP pledge platforms, IP databases, health care research, seeking ART, and transaction condition setting. These components work together seamlessly to support the sharing and pledging of ART and knowledge, while ensuring the platform's transparency, security, and trust. Results: The open IP pledge framework can promote technology dissemination and use, reduce research and development costs, foster collaboration, and serve the public interest. Medical organizations' leadership and support and active participation from stakeholders are necessary for success. By leveraging blockchain technology, the platform ensures tamper-proof and transparent transactions and protects the rights of IP owners. In addition, the platform offers incentive mechanisms through pledge tokens that encourage stakeholders to share their ART and contribute to the platform. Conclusions: Overall, the proposed framework can facilitate technological innovation, tackle various challenges, and secure IP transactions. It provides a secure platform for stakeholders to share their IP without compromising their rights, promoting collaboration and progress in the health care industry. The implementation of the framework has the potential to revolutionize the industry's approach to innovation, allowing a more open and collaborative environment driven by the greater good. ", doi="10.2196/44578", url="https://www.jmir.org/2023/1/e44578", url="http://www.ncbi.nlm.nih.gov/pubmed/37594787" } @Article{info:doi/10.2196/41805, author="Esmaeilzadeh, Pouyan and Mirzaei, Tala", title="Role of Incentives in the Use of Blockchain-Based Platforms for Sharing Sensitive Health Data: Experimental Study", journal="J Med Internet Res", year="2023", month="Aug", day="18", volume="25", pages="e41805", keywords="blockchain technology", keywords="data sharing", keywords="health data", keywords="clinical research", keywords="incentive mechanisms", abstract="Background: Blockchain is an emerging technology that enables secure and decentralized approaches to reduce technical risks and governance challenges associated with sharing data. Although blockchain-based solutions have been suggested for sharing health information, it is still unclear whether a suitable incentive mechanism (intrinsic or extrinsic) can be identified to encourage individuals to share their sensitive data for research purposes. Objective: This study aimed to investigate how important extrinsic incentives are and what type of incentive is the best option in blockchain-based platforms designed for sharing sensitive health information. Methods: In this study, we conducted 3 experiments with 493 individuals to investigate the role of extrinsic incentives (ie, cryptocurrency, money, and recognition) in data sharing with research organizations. Results: The findings highlight that offering different incentives is insufficient to encourage individuals to use blockchain technology or to change their perceptions about the technology's premise for sharing sensitive health data. The results demonstrate that individuals still attribute serious risks to blockchain-based platforms. Privacy and security concerns, trust issues, lack of knowledge about the technology, lack of public acceptance, and lack of regulations are reported as top risks. In terms of attracting people to use blockchain-based platforms for data sharing in health care, we show that the effects of extrinsic motivations (cryptoincentives, money, and status) are significantly overshadowed by inhibitors to technology use. Conclusions: We suggest that before emphasizing the use of various types of extrinsic incentives, the users must be educated about the capabilities and benefits offered by this technology. Thus, an essential first step for shifting from an institution-based data exchange to a patient-centric data exchange (using blockchain) is addressing technology inhibitors to promote patient-driven data access control. This study shows that extrinsic incentives alone are inadequate to change users' perceptions, increase their trust, or encourage them to use technology for sharing health data. ", doi="10.2196/41805", url="https://www.jmir.org/2023/1/e41805", url="http://www.ncbi.nlm.nih.gov/pubmed/37594783" } @Article{info:doi/10.2196/44135, author="Lopez-Barreiro, Juan and Alvarez-Sabucedo, Luis and Garcia-Soidan, Jose-Luis and Santos-Gago, M. Juan", title="Creation of a Holistic Platform for Health Boosting Using a Blockchain-Based Approach: Development Study", journal="Interact J Med Res", year="2023", month="Apr", day="19", volume="12", pages="e44135", keywords="blockchain", keywords="exercise", keywords="gamification", keywords="habits", keywords="healthy lifestyle", keywords="physical fitness", abstract="Background: Low adherence to healthy habits, which is associated with a higher risk of disease and death, among citizens of Organization for Economic Co-operation and Development countries is a serious concern. The World Health Organization (WHO) and the physical activity (PA) guidelines for Americans provide recommendations on PA and healthy diets. To promote these habits, we suggest using a blockchain-based platform, using the PA Messaging Framework to deliver messages and rewards to users. Blockchain is a decentralized secure platform for data management, which can be used for value-added controls and services such as smart contracts (SCs), oracles, and decentralized applications (dApps). Of note, there is a substantial penetration of blockchain technologies in the field of PA, but there is a need for more implementations of dApps to take advantage of features such as nonfungible tokens. Objective: This study aimed to create a comprehensive platform for promoting healthy habits, using scientific evidence and blockchain technology. The platform will use gamification to encourage healthy PA and eating habits; in addition, it will monitor the activities through noninvasive means, evaluate them using open-source software, and follow up through blockchain messages. Methods: A literature search was conducted on the use of blockchain technology in the field of PA and healthy eating. On the basis of the results of this search, it is possible to define an innovative platform for promoting and monitoring healthy habits through health-related challenges on a dApp. Contact with the user will be maintained through messages following a proposed model in the literature to improve adherence to the challenges. Results: The proposed strategy is based on a dApp that relies on blockchain technology. The challenges include PA and healthy eating habits based on the recommendations of the WHO and the Food and Agriculture Organization. The system is constituted of a blockchain network where challenge-related achievements are stored and verified using SCs. The user interacts with the system through a dApp that runs on their local device, monitors the challenge, and self-authenticates by providing their public and private keys. The SC verifies challenge fulfillment and generates messages, and the information stored in the network can be used to encourage competition among participants. The ultimate goal is to create a habit of healthy activities through rewards and peer competition. Conclusions: The use of blockchain technology has the potential to improve people's quality of life through the development of relevant services. In this work, strategies using gamification and blockchain are proposed for monitoring healthy activities, with a focus on transparency and reward allocation. The results are promising, but compliance with the General Data Protection Regulation is still a concern. Personal data are stored on personal devices, whereas challenge data are recorded on the blockchain. ", doi="10.2196/44135", url="https://www.i-jmr.org/2023/1/e44135", url="http://www.ncbi.nlm.nih.gov/pubmed/37074766" } @Article{info:doi/10.2196/42685, author="Esmaeilzadeh, Pouyan", title="Evolution of Health Information Sharing Between Health Care Organizations: Potential of Nonfungible Tokens", journal="Interact J Med Res", year="2023", month="Apr", day="12", volume="12", pages="e42685", keywords="health information exchange", keywords="HIE", keywords="personal health information", keywords="PHI", keywords="blockchain", keywords="nonfungible token", keywords="NFT", keywords="evolution of technology", doi="10.2196/42685", url="https://www.i-jmr.org/2023/1/e42685", url="http://www.ncbi.nlm.nih.gov/pubmed/37043269" } @Article{info:doi/10.2196/42743, author="Subramanian, Hemang", title="A Decentralized Marketplace for Patient-Generated Health Data: Design Science Approach", journal="J Med Internet Res", year="2023", month="Feb", day="27", volume="25", pages="e42743", keywords="decentralized marketplace", keywords="smart contracts", keywords="nonfungible tokens", keywords="patient-generated health data", abstract="Background: Wearable devices have limited ability to store and process such data. Currently, individual users or data aggregators are unable to monetize or contribute such data to wider analytics use cases. When combined with clinical health data, such data can improve the predictive power of data-driven analytics and can proffer many benefits to improve the quality of care. We propose and provide a marketplace mechanism to make these data available while benefiting data providers. Objective: We aimed to propose the concept of a decentralized marketplace for patient-generated health data that can improve provenance, data accuracy, security, and privacy. Using a proof-of-concept prototype with an interplanetary file system (IPFS) and Ethereum smart contracts, we aimed to demonstrate decentralized marketplace functionality with the blockchain. We also aimed to illustrate and demonstrate the benefits of such a marketplace. Methods: We used a design science research methodology to define and prototype our decentralized marketplace and used the Ethereum blockchain, solidity smart-contract programming language, the web3.js library, and node.js with the MetaMask application to prototype our system. Results: We designed and implemented a prototype of a decentralized health care marketplace catering to health data. We used an IPFS to store data, provide an encryption scheme for the data, and provide smart contracts to communicate with users on the Ethereum blockchain. We met the design goals we set out to accomplish in this study. Conclusions: A decentralized marketplace for trading patient-generated health data can be created using smart-contract technology and IPFS-based data storage. Such a marketplace can improve quality, availability, and provenance and satisfy data privacy, access, auditability, and security needs for such data when compared with centralized systems. ", doi="10.2196/42743", url="https://www.jmir.org/2023/1/e42743", url="http://www.ncbi.nlm.nih.gov/pubmed/36848185" } @Article{info:doi/10.2196/37978, author="Kang, Giluk and Kim, Young-Gab", title="Secure Collaborative Platform for Health Care Research in an Open Environment: Perspective on Accountability in Access Control", journal="J Med Internet Res", year="2022", month="Oct", day="14", volume="24", number="10", pages="e37978", keywords="blockchain", keywords="attribute-based encryption", keywords="eHealth data", keywords="security", keywords="privacy", keywords="cloud computing", keywords="research platform for health care", keywords="accountability", keywords="Internet of Things", keywords="interoperability", keywords="mobile phone", abstract="Background: With the recent use of IT in health care, a variety of eHealth data are increasingly being collected and stored by national health agencies. As these eHealth data can advance the modern health care system and make it smarter, many researchers want to use these data in their studies. However, using eHealth data brings about privacy and security concerns. The analytical environment that supports health care research must also consider many requirements. For these reasons, countries generally provide research platforms for health care, but some data providers (eg, patients) are still concerned about the security and privacy of their eHealth data. Thus, a more secure platform for health care research that guarantees the utility of eHealth data while focusing on its security and privacy is needed. Objective: This study aims to implement a research platform for health care called the health care big data platform (HBDP), which is more secure than previous health care research platforms. The HBDP uses attribute-based encryption to achieve fine-grained access control and encryption of stored eHealth data in an open environment. Moreover, in the HBDP, platform administrators can perform the appropriate follow-up (eg, block illegal users) and monitoring through a private blockchain. In other words, the HBDP supports accountability in access control. Methods: We first identified potential security threats in the health care domain. We then defined the security requirements to minimize the identified threats. In particular, the requirements were defined based on the security solutions used in existing health care research platforms. We then proposed the HBDP, which meets defined security requirements (ie, access control, encryption of stored eHealth data, and accountability). Finally, we implemented the HBDP to prove its feasibility. Results: This study carried out case studies for illegal user detection via the implemented HBDP based on specific scenarios related to the threats. As a result, the platform detected illegal users appropriately via the security agent. Furthermore, in the empirical evaluation of massive data encryption (eg, 100,000 rows with 3 sensitive columns within 46 columns) for column-level encryption, full encryption after column-level encryption, and full decryption including column-level decryption, our approach achieved approximately 3 minutes, 1 minute, and 9 minutes, respectively. In the blockchain, average latencies and throughputs in 1Org with 2Peers reached approximately 18 seconds and 49 transactions per second (TPS) in read mode and approximately 4 seconds and 120 TPS in write mode in 300 TPS. Conclusions: The HBDP enables fine-grained access control and secure storage of eHealth data via attribute-based encryption cryptography. It also provides nonrepudiation and accountability through the blockchain. Therefore, we consider that our proposal provides a sufficiently secure environment for the use of eHealth data in health care research. ", doi="10.2196/37978", url="https://www.jmir.org/2022/10/e37978", url="http://www.ncbi.nlm.nih.gov/pubmed/36240003" } @Article{info:doi/10.2196/36774, author="Zhuang, Yan and Zhang, Luxia and Gao, Xiyuan and Shae, Zon-Yin and Tsai, P. Jeffrey J. and Li, Pengfei and Shyu, Chi-Ren", title="Re-engineering a Clinical Trial Management System Using Blockchain Technology: System Design, Development, and Case Studies", journal="J Med Internet Res", year="2022", month="Jun", day="27", volume="24", number="6", pages="e36774", keywords="blockchain", keywords="clinical trials", keywords="clinical trial management system", keywords="electronic data capture", keywords="smart contract", abstract="Background: A clinical trial management system (CTMS) is a suite of specialized productivity tools that manage clinical trial processes from study planning to closeout. Using CTMSs has shown remarkable benefits in delivering efficient, auditable, and visualizable clinical trials. However, the current CTMS market is fragmented, and most CTMSs fail to meet expectations because of their inability to support key functions, such as inconsistencies in data captured across multiple sites. Blockchain technology, an emerging distributed ledger technology, is considered to potentially provide a holistic solution to current CTMS challenges by using its unique features, such as transparency, traceability, immutability, and security. Objective: This study aimed to re-engineer the traditional CTMS by leveraging the unique properties of blockchain technology to create a secure, auditable, efficient, and generalizable CTMS. Methods: A comprehensive, blockchain-based CTMS that spans all stages of clinical trials, including a sharable trial master file system; a fast recruitment and simplified enrollment system; a timely, secure, and consistent electronic data capture system; a reproducible data analytics system; and an efficient, traceable payment and reimbursement system, was designed and implemented using the Quorum blockchain. Compared with traditional blockchain technologies, such as Ethereum, Quorum blockchain offers higher transaction throughput and lowers transaction latency. Case studies on each application of the CTMS were conducted to assess the feasibility, scalability, stability, and efficiency of the proposed blockchain-based CTMS. Results: A total of 21.6 million electronic data capture transactions were generated and successfully processed through blockchain, with an average of 335.4 transactions per second. Of the 6000 patients, 1145 were matched in 1.39 seconds using 10 recruitment criteria with an automated matching mechanism implemented by the smart contract. Key features, such as immutability, traceability, and stability, were also tested and empirically proven through case studies. Conclusions: This study proposed a comprehensive blockchain-based CTMS that covers all stages of the clinical trial process. Compared with our previous research, the proposed system showed an overall better performance. Our system design, implementation, and case studies demonstrated the potential of blockchain technology as a potential solution to CTMS challenges and its ability to perform more health care tasks. ", doi="10.2196/36774", url="https://www.jmir.org/2022/6/e36774", url="http://www.ncbi.nlm.nih.gov/pubmed/35759315" } @Article{info:doi/10.2196/37133, author="Liu, Jia", title="HIV Digital Vaccine Strategy: Proposal for Applying Blockchain in Preventing the Spread of HIV", journal="JMIR Res Protoc", year="2022", month="Jun", day="13", volume="11", number="6", pages="e37133", keywords="HIV", keywords="blockchain", keywords="digital vaccine", keywords="decentralized surveillance", abstract="Background: The HIV epidemic imposes a heavy burden on societal development. Protection of susceptible populations is the most feasible method for eliminating the spread of HIV. In the absence of a biological vaccine, the definitive solution is enabling susceptible populations to recognize and avoid high-risk sexual behavior. Objective: The objective of this study is to use specific technologies and strategies to establish a system by which high-HIV-risk individuals can determine the HIV infection status of one another anonymously, conveniently, and credibly. Methods: This study proposes an HIV digital vaccine (HDV) strategy, a decentralized application (Dapp) based on blockchain for use by individuals with a high risk of HIV and accredited testing agencies (ATAs). Following testing, only the HIV-negative results (or linked information) are uploaded to the blockchain, which results in high-risk individuals being able to determine the HIV-negative status of each other anonymously, conveniently, and credibly. Results: Future work includes the following: (1) a survey of the willingness to use Dapps among high-HIV-risk populations, (2) a larger framework containing both HDV and people living with HIV (PLH) and discussing the influence of HDV on PLH and its possible solutions, and (3) coordinating with the blockchain development team, ATAs, community-based organizations, and third-party organizations to raise funds, develop the Dapp, formulate detailed plans, and publicize and promote it. The exact timeline for achieving these objectives cannot be determined at present. Conclusions: The HDV strategy may reduce the occurrence of high-risk sexual behavior and effectively protect susceptible populations; combined with current strategies, it is a promising solution to prevent the spread of HIV. The included concepts of decentralized surveillance and surveillance as intervention may spark a change in current infectious disease prevention and control modes to introduce beneficial innovations in public health systems globally. International Registered Report Identifier (IRRID): PRR1-10.2196/37133 ", doi="10.2196/37133", url="https://www.researchprotocols.org/2022/6/e37133", url="http://www.ncbi.nlm.nih.gov/pubmed/35700007" } @Article{info:doi/10.2196/34276, author="Gambril, John and Boyd, Carter and Egbaria, Jamal", title="Application of Nonfungible Tokens to Health Care. Comment on ``Blockchain Technology Projects to Provide Telemedical Services: Systematic Review''", journal="J Med Internet Res", year="2022", month="May", day="30", volume="24", number="5", pages="e34276", keywords="telemedicine", keywords="distributed ledger", keywords="health information exchange", keywords="blockchain", keywords="cryptocurrency", keywords="nonfungible token", keywords="non-fungible token", keywords="medical education", keywords="internet", keywords="finance", doi="10.2196/34276", url="https://www.jmir.org/2022/5/e34276", url="http://www.ncbi.nlm.nih.gov/pubmed/35635749" } @Article{info:doi/10.2196/34207, author="Subramanian, Hemang and Subramanian, Susmitha", title="Improving Diagnosis Through Digital Pathology: Proof-of-Concept Implementation Using Smart Contracts and Decentralized File Storage", journal="J Med Internet Res", year="2022", month="Mar", day="28", volume="24", number="3", pages="e34207", keywords="digital pathology", keywords="nonfungible token standard", keywords="decentralized storage", keywords="security and patient data confidentiality using design", keywords="pathology", keywords="storage", keywords="security", keywords="confidentiality", keywords="data", keywords="design", keywords="diagnosis", keywords="proof of concept", keywords="implementation", keywords="software", keywords="blockchain", keywords="limitation", keywords="privacy", abstract="Background: Recent advancements in digital pathology resulting from advances in imaging and digitization have increased the convenience and usability of pathology for disease diagnosis, especially in oncology, urology, and gastroenteric diagnosis. However, despite the possibilities to include low-cost diagnosis and viable telemedicine, digital pathology is not yet accessible owing to expensive storage, data security requirements, and network bandwidth limitations to transfer high-resolution images and associated data. The increase in storage, transmission, and security complexity concerning data collection and diagnosis makes it even more challenging to use artificial intelligence algorithms for machine-assisted disease diagnosis. We designed and prototyped a digital pathology system that uses blockchain-based smart contracts using the nonfungible token (NFT) standard and the Interplanetary File System for data storage. Our design remediates shortcomings in the existing digital pathology systems infrastructure, which is centralized. The proposed design is extendable to other fields of medicine that require high-fidelity image and data storage. Our solution is implemented in data systems that can improve access quality of care and reduce the cost of access to specialized pathological diagnosis, reducing cycle times for diagnosis. Objective: The main objectives of this study are to highlight the issues in digital pathology and suggest that a software architecture--based blockchain and the Interplanetary File System create a low-cost data storage and transmission technology. Methods: We used the design science research method consisting of 6 stages to inform our design overall. We innovated over existing public-private designs for blockchains but using a 2-layered approach that separates actual file storage from metadata and data persistence. Results: Here, we identified key challenges to adopting digital pathology, including challenges concerning long-term storage and the transmission of information. Next, using accepted frameworks in NFT-based intelligent contracts and recent innovations in distributed secure storage, we proposed a decentralized, secure, and privacy-preserving digital pathology system. Our design and prototype implementation using Solidity, web3.js, Ethereum, and node.js helped us address several challenges facing digital pathology. We demonstrated how our solution, which combines NFT smart contract standard with persistent decentralized file storage, solves most of the challenges of digital pathology and sets the stage for reducing costs and improving patient care and speed of diagnosis. Conclusions: We identified technical limitations that increase costs and reduce the mass adoption of digital pathology. We presented several design innovations using NFT decentralized storage standards to prototype a system. We also presented the implementation details of a unique security architecture for a digital pathology system. We illustrated how this design can overcome privacy, security, network-based storage, and data transmission limitations. We illustrated how improving these factors sets the stage for improving data quality and standardized application of machine learning and artificial intelligence to such data. ", doi="10.2196/34207", url="https://www.jmir.org/2022/3/e34207", url="http://www.ncbi.nlm.nih.gov/pubmed/35343905" } @Article{info:doi/10.2196/29108, author="?Lee, Sejong and Kim, Jaehyeon and Kwon, Yongseok and Kim, Teasung and Cho, Sunghyun", title="Privacy Preservation in Patient Information Exchange Systems Based on Blockchain: System Design Study", journal="J Med Internet Res", year="2022", month="Mar", day="22", volume="24", number="3", pages="e29108", keywords="electronic medical records", keywords="consortium blockchain", keywords="data security", keywords="medical data management", keywords="privacy preservation", keywords="smart contract", keywords="proxy re-encryption", keywords="patient-centered medical system", keywords="InterPlanetary File System", abstract="Background: With the increasing sophistication of the medical industry, various advanced medical services such as medical artificial intelligence, telemedicine, and personalized health care services have emerged. The demand for medical data is also rapidly increasing today because advanced medical services use medical data such as user data and electronic medical records (EMRs) to provide services. As a result, health care institutions and medical practitioners are researching various mechanisms and tools to feed medical data into their systems seamlessly. However, medical data contain sensitive personal information of patients. Therefore, ensuring security while meeting the demand for medical data is a very important problem in the information age for which a solution is required. Objective: Our goal is to design a blockchain-based decentralized patient information exchange (PIE) system that can safely and efficiently share EMRs. The proposed system preserves patients' privacy in the EMRs through a medical information exchange process that includes data encryption and access control. Methods: We propose a blockchain-based EMR-sharing system that allows patients to manage their EMRs scattered across multiple hospitals and share them with other users. Our PIE system protects the patient's EMR from security threats such as counterfeiting and privacy attacks during data sharing. In addition, it provides scalability by using distributed data-sharing methods to quickly share an EMR, regardless of its size or type. We implemented simulation models using Hyperledger Fabric, an open source blockchain framework. Results: We performed a simulation of the EMR-sharing process and compared it with previous works on blockchain-based medical systems to check the proposed system's performance. During the simulation, we found that it takes an average of 0.01014 (SD 0.0028) seconds to download 1 MB of EMR in our proposed PIE system. Moreover, it has been confirmed that data can be freely shared with other users regardless of the size or format of the data to be transmitted through the distributed data-sharing technique using the InterPlanetary File System. We conducted a security analysis to check whether the proposed security mechanism can effectively protect users of the EMR-sharing system from security threats such as data forgery or unauthorized access, and we found that the distributed ledger structure and re-encryption--based data encryption method can effectively protect users' EMRs from forgery and privacy leak threats and provide data integrity. Conclusions: Blockchain is a distributed ledger technology that provides data integrity to enable patient-centered health information exchange and access control. PIE systems integrate and manage fragmented patient EMRs through blockchain and protect users from security threats during the data exchange process among users. To increase safety and efficiency in the EMR-sharing process, we used access control using security levels, data encryption based on re-encryption, and a distributed data-sharing scheme. ", doi="10.2196/29108", url="https://www.jmir.org/2022/3/e29108", url="http://www.ncbi.nlm.nih.gov/pubmed/35315778" } @Article{info:doi/10.2196/17278, author="Elangovan, Deepa and Long, Soon Chiau and Bakrin, Safina Faizah and Tan, Siang Ching and Goh, Wen Khang and Yeoh, Fei Siang and Loy, Jun Mei and Hussain, Zahid and Lee, Seng Kah and Idris, Che Azam and Ming, Chiau Long", title="The Use of Blockchain Technology in the Health Care Sector: Systematic Review", journal="JMIR Med Inform", year="2022", month="Jan", day="20", volume="10", number="1", pages="e17278", keywords="blockchain", keywords="health care", keywords="hospital information system", keywords="data integrity", keywords="access control", keywords="data logging", keywords="health informatics", abstract="Background: Blockchain technology is a part of Industry 4.0's new Internet of Things applications: decentralized systems, distributed ledgers, and immutable and cryptographically secure technology. This technology entails a series of transaction lists with identical copies shared and retained by different groups or parties. One field where blockchain technology has tremendous potential is health care, due to the more patient-centric approach to the health care system as well as blockchain's ability to connect disparate systems and increase the accuracy of electronic health records. Objective: The aim of this study was to systematically review studies on the use of blockchain technology in health care and to analyze the characteristics of the studies that have implemented blockchain technology. Methods: This study used a systematic review methodology to find literature related to the implementation aspect of blockchain technology in health care. Relevant papers were searched for using PubMed, SpringerLink, IEEE Xplore, Embase, Scopus, and EBSCOhost. A quality assessment of literature was performed on the 22 selected papers by assessing their trustworthiness and relevance. Results: After full screening, 22 papers were included. A table of evidence was constructed, and the results of the selected papers were interpreted. The results of scoring for measuring the quality of the publications were obtained and interpreted. Out of 22 papers, a total of 3 (14\%) high-quality papers, 9 (41\%) moderate-quality papers, and 10 (45\%) low-quality papers were identified. Conclusions: Blockchain technology was found to be useful in real health care environments, including for the management of electronic medical records, biomedical research and education, remote patient monitoring, pharmaceutical supply chains, health insurance claims, health data analytics, and other potential areas. The main reasons for the implementation of blockchain technology in the health care sector were identified as data integrity, access control, data logging, data versioning, and nonrepudiation. The findings could help the scientific community to understand the implementation aspect of blockchain technology. The results from this study help in recognizing the accessibility and use of blockchain technology in the health care sector. ", doi="10.2196/17278", url="https://medinform.jmir.org/2022/1/e17278", url="http://www.ncbi.nlm.nih.gov/pubmed/35049516" } @Article{info:doi/10.2196/32104, author="Sengupta, Arijit and Subramanian, Hemang", title="User Control of Personal mHealth Data Using a Mobile Blockchain App: Design Science Perspective", journal="JMIR Mhealth Uhealth", year="2022", month="Jan", day="20", volume="10", number="1", pages="e32104", keywords="blockchain", keywords="mobile apps", keywords="mining", keywords="HIPAA", keywords="personal health data", keywords="data privacy preservation", keywords="security", keywords="accuracy", keywords="transaction safety", abstract="Background: Integrating pervasive computing with blockchain's ability to store privacy-protected mobile health (mHealth) data while providing Health Insurance Portability and Accountability Act (HIPAA) compliance is a challenge. Patients use a multitude of devices, apps, and services to collect and store mHealth data. We present the design of an internet of things (IoT)--based configurable blockchain with different mHealth apps on iOS and Android, which collect the same user's data. We discuss the advantages of using such a blockchain architecture and demonstrate 2 things: the ease with which users can retain full control of their pervasive mHealth data and the ease with which HIPAA compliance can be accomplished by providers who choose to access user data. Objective: The purpose of this paper is to design, evaluate, and test IoT-based mHealth data using wearable devices and an efficient, configurable blockchain, which has been designed and implemented from the first principles to store such data. The purpose of this paper is also to demonstrate the privacy-preserving and HIPAA-compliant nature of pervasive computing-based personalized health care systems that provide users with total control of their own data. Methods: This paper followed the methodical design science approach adapted in information systems, wherein we evaluated prior designs, proposed enhancements with a blockchain design pattern published by the same authors, and used the design to support IoT transactions. We prototyped both the blockchain and IoT-based mHealth apps in different devices and tested all use cases that formed the design goals for such a system. Specifically, we validated the design goals for our system using the HIPAA checklist for businesses and proved the compliance of our architecture for mHealth data on pervasive computing devices. Results: Blockchain-based personalized health care systems provide several advantages over traditional systems. They provide and support extreme privacy protection, provide the ability to share personalized data and delete data upon request, and support the ability to analyze such data. Conclusions: We conclude that blockchains, specifically the consensus, hasher, storer, miner architecture presented in this paper, with configurable modules and software as a service model, provide many advantages for patients using pervasive devices that store mHealth data on the blockchain. Among them is the ability to store, retrieve, and modify ones generated health care data with a single private key across devices. These data are transparent, stored perennially, and provide patients with privacy and pseudoanonymity, in addition to very strong encryption for data access. Firms and device manufacturers would benefit from such an approach wherein they relinquish user data control while giving users the ability to select and offer their own mHealth data on data marketplaces. We show that such an architecture complies with the stringent requirements of HIPAA for patient data access. ", doi="10.2196/32104", url="https://mhealth.jmir.org/2022/1/e32104", url="http://www.ncbi.nlm.nih.gov/pubmed/35049504" } @Article{info:doi/10.2196/33399, author="Tseng, Henry Chinyang and Chen, Ray-Jade and Tsai, Shang-Yu and Wu, Tsung-Ren and Tsaur, Woei-Jiunn and Chiu, Hung-Wen and Yang, Cheng-Yi and Lo, Yu-Sheng", title="Exploring the COVID-19 Pandemic as a Catalyst for Behavior Change Among Patient Health Record App Users in Taiwan: Development and Usability Study", journal="J Med Internet Res", year="2022", month="Jan", day="6", volume="24", number="1", pages="e33399", keywords="personal health records", keywords="COVID-19", keywords="My Health Bank", keywords="blockchain", keywords="public health", abstract="Background: During the COVID-19 pandemic, personal health records (PHRs) have enabled patients to monitor and manage their medical data without visiting hospitals and, consequently, minimize their infection risk. Taiwan's National Health Insurance Administration (NHIA) launched the My Health Bank (MHB) service, a national PHR system through which insured individuals to access their cross-hospital medical data. Furthermore, in 2019, the NHIA released the MHB software development kit (SDK), which enables development of mobile apps with which insured individuals can retrieve their MHB data. However, the NHIA MHB service has its limitations, and the participation rate among insured individuals is low. Objective: We aimed to integrate the MHB SDK with our developed blockchain-enabled PHR mobile app, which enables patients to access, store, and manage their cross-hospital PHR data. We also collected and analyzed the app's log data to examine patients' MHB use during the COVID-19 pandemic. Methods: We integrated our existing blockchain-enabled mobile app with the MHB SDK to enable NHIA MHB data retrieval. The app utilizes blockchain technology to encrypt the downloaded NHIA MHB data. Existing and new indexes can be synchronized between the app and blockchain nodes, and high security can be achieved for PHR management. Finally, we analyzed the app's access logs to compare patients' activities during high and low COVID-19 infection periods. Results: We successfully integrated the MHB SDK into our mobile app, thereby enabling patients to retrieve their cross-hospital medical data, particularly those related to COVID-19 rapid and polymerase chain reaction testing and vaccination information and progress. We retrospectively collected the app's log data for the period of July 2019 to June 2021. From January 2020, the preliminary results revealed a steady increase in the number of people who applied to create a blockchain account for access to their medical data and the number of app subscribers among patients who visited the outpatient department (OPD) and emergency department (ED). Notably, for patients who visited the OPD and ED, the peak proportions with respect to the use of the app for OPD and ED notes and laboratory test results also increased year by year. The highest proportions were 52.40\% for ED notes in June 2021, 88.10\% for ED laboratory test reports in May 2021, 34.61\% for OPD notes in June 2021, and 41.87\% for OPD laboratory test reports in June 2021. These peaks coincided with Taiwan's local COVID-19 outbreak lasting from May to June 2021. Conclusions: This study developed a blockchain-enabled mobile app, which can periodically retrieve and integrate PHRs from the NHIA MHB's cross-hospital data and the investigated hospital's self-pay medical data. Analysis of users' access logs revealed that the COVID-19 pandemic substantially increased individuals' use of PHRs and their health awareness with respect to COVID-19 prevention. ", doi="10.2196/33399", url="https://www.jmir.org/2022/1/e33399", url="http://www.ncbi.nlm.nih.gov/pubmed/34951863" } @Article{info:doi/10.2196/28770, author="Cabrera, Daniel and Nickson, P. Christopher and Roland, Damian and Hall, Elissa and Ankel, Felix", title="Distributed Autonomous Organization of Learning: Future Structure for Health Professions Education Institutions", journal="JMIR Med Educ", year="2022", month="Jan", day="4", volume="8", number="1", pages="e28770", keywords="blockchain", keywords="multidisciplinary", keywords="credentialing", keywords="medical education", keywords="health professionals", keywords="education", keywords="decentralization", keywords="training", keywords="curriculum", keywords="instruction", doi="10.2196/28770", url="https://mededu.jmir.org/2022/1/e28770", url="http://www.ncbi.nlm.nih.gov/pubmed/34982722" } @Article{info:doi/10.2196/24109, author="Yeung, Karen", title="The Health Care Sector's Experience of Blockchain: A Cross-disciplinary Investigation of Its Real Transformative Potential", journal="J Med Internet Res", year="2021", month="Dec", day="20", volume="23", number="12", pages="e24109", keywords="blockchain", keywords="health information management", keywords="health information systems", keywords="electronic health record", keywords="data sharing", keywords="health services administration", keywords="privacy of patient data", keywords="computer security", keywords="mobile phone", abstract="Background: Academic literature highlights blockchain's potential to transform health care, particularly by seamlessly and securely integrating existing data silos while enabling patients to exercise automated, fine-grained control over access to their electronic health records. However, no serious scholarly attempt has been made to assess how these technologies have in fact been applied to real-world health care contexts. Objective: The primary aim of this paper is to assess whether blockchain's theoretical potential to deliver transformative benefits to health care is likely to become a reality by undertaking a critical investigation of the health care sector's actual experience of blockchain technologies to date. Methods: This mixed methods study entailed a series of iterative, in-depth, theoretically oriented, desk-based investigations and 2 focus group investigations. It builds on the findings of a companion research study documenting real-world engagement with blockchain technologies in health care. Data were sourced from academic and gray literature from multiple disciplinary perspectives concerned with the configuration, design, and functionality of blockchain technologies. The analysis proceeded in 3 stages. First, it undertook a qualitative investigation of observed patterns of blockchain for health care engagement to identify the application domains, data-sharing problems, and the challenges encountered to date. Second, it critically compared these experiences with claims about blockchain's potential benefits in health care. Third, it developed a theoretical account of challenges that arise in implementing blockchain in health care contexts, thus providing a firmer foundation for appraising its future prospects in health care. Results: Health care organizations have actively experimented with blockchain technologies since 2016 and have demonstrated proof of concept for several applications (use cases) primarily concerned with administrative data and to facilitate medical research by enabling algorithmic models to be trained on multiple disparately located sets of patient data in a secure, privacy-preserving manner. However, blockchain technology is yet to be implemented at scale in health care, remaining largely in its infancy. These early experiences have demonstrated blockchain's potential to generate meaningful value to health care by facilitating data sharing between organizations in circumstances where computational trust can overcome a lack of social trust that might otherwise prevent valuable cooperation. Although there are genuine prospects of using blockchain to bring about positive transformations in health care, the successful development of blockchain for health care applications faces a number of very significant, multidimensional, and highly complex challenges. Early experience suggests that blockchain is unlikely to rapidly and radically revolutionize health care. Conclusions: The successful development of blockchain for health care applications faces numerous significant, multidimensional, and complex challenges that will not be easily overcome, suggesting that blockchain technologies are unlikely to revolutionize health care in the near future. ", doi="10.2196/24109", url="https://www.jmir.org/2021/12/e24109", url="http://www.ncbi.nlm.nih.gov/pubmed/34932009" } @Article{info:doi/10.2196/27816, author="Albalwy, Faisal and Brass, Andrew and Davies, Angela", title="A Blockchain-Based Dynamic Consent Architecture to Support Clinical Genomic Data Sharing (ConsentChain): Proof-of-Concept Study", journal="JMIR Med Inform", year="2021", month="Nov", day="3", volume="9", number="11", pages="e27816", keywords="blockchain", keywords="smart contracts", keywords="dynamic consent", keywords="clinical genomics", keywords="data sharing", abstract="Background: In clinical genomics, sharing of rare genetic disease information between genetic databases and laboratories is essential to determine the pathogenic significance of variants to enable the diagnosis of rare genetic diseases. Significant concerns regarding data governance and security have reduced this sharing in practice. Blockchain could provide a secure method for sharing genomic data between involved parties and thus help overcome some of these issues. Objective: This study aims to contribute to the growing knowledge of the potential role of blockchain technology in supporting the sharing of clinical genomic data by describing blockchain-based dynamic consent architecture to support clinical genomic data sharing and provide a proof-of-concept implementation, called ConsentChain, for the architecture to explore its performance. Methods: The ConsentChain requirements were captured from a patient forum to identify security and consent concerns. The ConsentChain was developed on the Ethereum platform, in which smart contracts were used to model the actions of patients, who may provide or withdraw consent to share their data; the data creator, who collects and stores patient data; and the data requester, who needs to query and access the patient data. A detailed analysis was undertaken of the ConsentChain performance as a function of the number of transactions processed by the system. Results: We describe ConsentChain, a blockchain-based system that provides a web portal interface to support clinical genomic sharing. ConsentChain allows patients to grant or withdraw data requester access and allows data requesters to query and submit access to data stored in a secure off-chain database. We also developed an ontology model to represent patient consent elements into machine-readable codes to automate the consent and data access processes. Conclusions: Blockchains and smart contracts can provide an efficient and scalable mechanism to support dynamic consent functionality and address some of the barriers that inhibit genomic data sharing. However, they are not a complete answer, and a number of issues still need to be addressed before such systems can be deployed in practice, particularly in relation to verifying user credentials. ", doi="10.2196/27816", url="https://medinform.jmir.org/2021/11/e27816", url="http://www.ncbi.nlm.nih.gov/pubmed/34730538" } @Article{info:doi/10.2196/19846, author="Fatoum, Hanaa and Hanna, Sam and Halamka, D. John and Sicker, C. Douglas and Spangenberg, Peter and Hashmi, K. Shahrukh", title="Blockchain Integration With Digital Technology and the Future of Health Care Ecosystems: Systematic Review", journal="J Med Internet Res", year="2021", month="Nov", day="2", volume="23", number="11", pages="e19846", keywords="blockchain, Internet of Things", keywords="digital", keywords="artificial intelligence", keywords="machine learning", keywords="eHealth", keywords="ledger", keywords="distributed ledger technology", abstract="Background: In the era of big data, artificial intelligence (AI), and the Internet of Things (IoT), digital data have become essential for our everyday functioning and in health care services. The sensitive nature of health care data presents several crucial issues such as privacy, security, interoperability, and reliability that must be addressed in any health care data management system. However, most of the current health care systems are still facing major obstacles and are lacking in some of these areas. This is where decentralized, secure, and scalable databases, most notably blockchains, play critical roles in addressing these requirements without compromising security, thereby attracting considerable interest within the health care community. A blockchain can be maintained and widely distributed using a large network of nodes, mostly computers, each of which stores a full replica of the data. A blockchain protocol is a set of predefined rules or procedures that govern how the nodes interact with the network, view, verify, and add data to the ledger. Objective: In this article, we aim to explore blockchain technology, its framework, current applications, and integration with other innovations, as well as opportunities in diverse areas of health care and clinical research, in addition to clarifying its future impact on the health care ecosystem. We also elucidate 2 case studies to instantiate the potential role of blockchains in health care. Methods: To identify related existing work, terms based on Medical Subject Headings were used. We included studies focusing mainly on health care and clinical research and developed a functional framework for implementation and testing with data. The literature sources for this systematic review were PubMed, Medline, and the Cochrane library, in addition to a preliminary search of IEEE Xplore. Results: The included studies demonstrated multiple framework designs and various implementations in health care including chronic disease diagnosis, management, monitoring, and evaluation. We found that blockchains exhibit many promising applications in clinical trial management such as smart-contract application, participant-controlled data access, trustless protocols, and data validity. Electronic health records (EHRs), patient-centered interoperability, remote patient monitoring, and clinical trial data management were found to be major areas for blockchain usage, which can become a key catalyst for health care innovations. Conclusions: The potential benefits of blockchains are limitless; however, concrete data on long-term clinical outcomes based on blockchains powered and supplemented by AI and IoT are yet to be obtained. Nonetheless, implementing blockchains as a novel way to integrate EHRs nationwide and manage common clinical problems in an algorithmic fashion has the potential for improving patient outcomes, health care experiences, as well as the overall health and well-being of individuals. ", doi="10.2196/19846", url="https://www.jmir.org/2021/11/e19846", url="http://www.ncbi.nlm.nih.gov/pubmed/34726603" } @Article{info:doi/10.2196/28613, author="Xie, Yi and Zhang, Jiayao and Wang, Honglin and Liu, Pengran and Liu, Songxiang and Huo, Tongtong and Duan, Yu-Yu and Dong, Zhe and Lu, Lin and Ye, Zhewei", title="Applications of Blockchain in the Medical Field: Narrative Review", journal="J Med Internet Res", year="2021", month="Oct", day="28", volume="23", number="10", pages="e28613", keywords="blockchain", keywords="smart health care", keywords="health care", keywords="health data", keywords="review", keywords="COVID-19", keywords="electronic health records", abstract="Background: As a distributed technology, blockchain has attracted increasing attention from stakeholders in the medical industry. Although previous studies have analyzed blockchain applications from the perspectives of technology, business, or patient care, few studies have focused on actual use-case scenarios of blockchain in health care. In particular, the outbreak of COVID-19 has led to some new ideas for the application of blockchain in medical practice. Objective: This paper aims to provide a systematic review of the current and projected uses of blockchain technology in health care, as well as directions for future research. In addition to the framework structure of blockchain and application scenarios, its integration with other emerging technologies in health care is discussed. Methods: We searched databases such as PubMed, EMBASE, Scopus, IEEE, and Springer using a combination of terms related to blockchain and health care. Potentially relevant papers were then compared to determine their relevance and reviewed independently for inclusion. Through a literature review, we summarize the key medical scenarios using blockchain technology. Results: We found a total of 1647 relevant studies, 60 of which were unique studies that were included in this review. These studies report a variety of uses for blockchain and their emphasis differs. According to the different technical characteristics and application scenarios of blockchain, we summarize some medical scenarios closely related to blockchain from the perspective of technical classification. Moreover, potential challenges are mentioned, including the confidentiality of privacy, the efficiency of the system, security issues, and regulatory policy. Conclusions: Blockchain technology can improve health care services in a decentralized, tamper-proof, transparent, and secure manner. With the development of this technology and its integration with other emerging technologies, blockchain has the potential to offer long-term benefits. Not only can it be a mechanism to secure electronic health records, but blockchain also provides a powerful tool that can empower users to control their own health data, enabling a foolproof health data history and establishing medical responsibility. ", doi="10.2196/28613", url="https://www.jmir.org/2021/10/e28613", url="http://www.ncbi.nlm.nih.gov/pubmed/34533470" } @Article{info:doi/10.2196/29905, author="Gross, S. Marielle and Hood, J. Amelia and Miller Jr, C. Robert", title="Nonfungible Tokens as a Blockchain Solution to Ethical Challenges for the Secondary Use of Biospecimens: Viewpoint", journal="JMIR Bioinform Biotech", year="2021", month="Oct", day="22", volume="2", number="1", pages="e29905", keywords="blockchain", keywords="biospecimens", keywords="research ethics", keywords="nonfungible tokens", keywords="health platforms", keywords="HeLa cells", keywords="patient data", keywords="deidentification", keywords="eHealth", keywords="data security", keywords="integrity", doi="10.2196/29905", url="https://bioinform.jmir.org/2021/1/e29905" } @Article{info:doi/10.2196/33113, author="Hasselgren, Anton and Kralevska, Katina and Gligoroski, Danilo and Faxvaag, Arild", title="Medical Students' Perceptions of a Blockchain-Based Decentralized Work History and Credentials Portfolio: Qualitative Feasibility Study", journal="JMIR Form Res", year="2021", month="Oct", day="22", volume="5", number="10", pages="e33113", keywords="blockchain", keywords="eHealth", keywords="qualitative research", keywords="VerifyMed", abstract="Background: Increased digitization of health care might challenge some of the trust functions that are established in a traditional health care system. We have, with the concept of VerifyMed, developed a decentralized service for work history and competence verification, as a means to increase trust in the virtual interaction between a patient and a caregiver, mitigate administrative burden, and provide patient-reported outcomes seamlessly for health professionals. Objective: This research aimed to validate the use case of a decentralized credentials service for health care professionals in Norway. We also aimed to evaluate the proof-of-concept of VerifyMed, a blockchain-based credential service for health care professionals. Methods: A qualitative approach was applied with data collection through 9 semistructured interviews and 2 focus groups (one with 4 participants and the other with 5 participants). The System Usability Scale (SUS) was used as a part of the interviews. Data were analyzed through the principles of systematic text condensation. The recruitment of participants ended when it was concluded that the data had reached saturation. Results: The following 5 themes were identified from the interviews and focus groups: (1) the need for aggregated storage of work- and study-related verification, (2) trust in a virtual health care environment, (3) the potential use of patient feedback, (4) trust in blockchain technology, and (5) improvements of the VerifyMed concept. The SUS questionnaire gave a score of 69.7. Conclusions: This study has validated the need for a decentralized system where health care professionals can control their credentials and, potentially, their reputation. Future work should update the VerifyMed system according to this input. We concluded that a decentralized system for the storage of work-related verifiable credentials could increase trust in a virtualized health care system. ", doi="10.2196/33113", url="https://formative.jmir.org/2021/10/e33113", url="http://www.ncbi.nlm.nih.gov/pubmed/34677137" } @Article{info:doi/10.2196/26802, author="Jung, Young Se and Kim, Taehyun and Hwang, Ju Hyung and Hong, Kyungpyo", title="Mechanism Design of Health Care Blockchain System Token Economy: Development Study Based on Simulated Real-World Scenarios", journal="J Med Internet Res", year="2021", month="Sep", day="13", volume="23", number="9", pages="e26802", keywords="mechanism design", keywords="optimization", keywords="blockchain", keywords="token economy", keywords="eHealth", keywords="electronic health records", keywords="healthcare", keywords="economy", keywords="health records", abstract="Background: Despite the fact that the adoption rate of electronic health records has increased dramatically among high-income nations, it is still difficult to properly disseminate personal health records. Token economy, through blockchain smart contracts, can better distribute personal health records by providing incentives to patients. However, there have been very few studies regarding the particular factors that should be considered when designing incentive mechanisms in blockchain. Objective: The aim of this paper is to provide 2 new mathematical models of token economy in real-world scenarios on health care blockchain platforms. Methods: First, roles were set for the health care blockchain platform and its token flow. Second, 2 scenarios were introduced: collecting life-log data for an incentive program at a life insurance company to motivate customers to exercise more and recruiting participants for clinical trials of anticancer drugs. In our 2 scenarios, we assumed that there were 3 stakeholders: participants, data recipients (companies), and data providers (health care organizations). We also assumed that the incentives are initially paid out to participants by data recipients, who are focused on minimizing economic and time costs by adapting mechanism design. This concept can be seen as a part of game theory, since the willingness-to-pay of data recipients is important in maintaining the blockchain token economy. In both scenarios, the recruiting company can change the expected recruitment time and number of participants. Suppose a company considers the recruitment time to be more important than the number of participants and rewards. In that case, the company can increase the time weight and adjust cost. When the reward parameter is fixed, the corresponding expected recruitment time can be obtained. Among the reward and time pairs, the pair that minimizes the company's cost was chosen. Finally, the optimized results were compared with the simulations and analyzed accordingly. Results: To minimize the company's costs, reward--time pairs were first collected. It was observed that the expected recruitment time decreased as rewards grew, while the rewards decreased as time cost grew. Therefore, the cost was represented by a convex curve, which made it possible to obtain a minimum---an optimal point---for both scenarios. Through sensitivity analysis, we observed that, as the time weight increased, the optimized reward increased, while the optimized time decreased. Moreover, as the number of participants increased, the optimization reward and time also increased. Conclusions: In this study, we were able to model the incentive mechanism of blockchain based on a mechanism design that recruits participants through a health care blockchain platform. This study presents a basic approach to incentive modeling in personal health records, demonstrating how health care organizations and funding companies can motivate one another to join the platform. ", doi="10.2196/26802", url="https://www.jmir.org/2021/9/e26802", url="http://www.ncbi.nlm.nih.gov/pubmed/34515640" } @Article{info:doi/10.2196/16293, author="Gonzales, Aldren and Smith, R. Scott and Dullabh, Prashila and Hovey, Lauren and Heaney-Huls, Krysta and Robichaud, Meagan and Boodoo, Roger", title="Potential Uses of Blockchain Technology for Outcomes Research on Opioids", journal="JMIR Med Inform", year="2021", month="Aug", day="27", volume="9", number="8", pages="e16293", keywords="blockchain", keywords="distributed ledger", keywords="opioid crisis", keywords="outcomes research", keywords="patient-centered outcomes research", keywords="mobile phone", doi="10.2196/16293", url="https://medinform.jmir.org/2021/8/e16293", url="http://www.ncbi.nlm.nih.gov/pubmed/34448721" } @Article{info:doi/10.2196/17475, author="Koshechkin, Konstantin and Lebedev, Georgy and Radzievsky, George and Seepold, Ralf and Martinez, Madrid Natividad", title="Blockchain Technology Projects to Provide Telemedical Services: Systematic Review", journal="J Med Internet Res", year="2021", month="Aug", day="18", volume="23", number="8", pages="e17475", keywords="telemedicine", keywords="distributed ledger", keywords="health information exchange", keywords="blockchain", abstract="Background: One of the most promising health care development areas is introducing telemedicine services and creating solutions based on blockchain technology. The study of systems combining both these domains indicates the ongoing expansion of digital technologies in this market segment. Objective: This paper aims to review the feasibility of blockchain technology for telemedicine. Methods: The authors identified relevant studies via systematic searches of databases including PubMed, Scopus, Web of Science, IEEE Xplore, and Google Scholar. The suitability of each for inclusion in this review was assessed independently. Owing to the lack of publications, available blockchain-based tokens were discovered via conventional web search engines (Google, Yahoo, and Yandex). Results: Of the 40 discovered projects, only 18 met the selection criteria. The 5 most prevalent features of the available solutions (N=18) were medical data access (14/18, 78\%), medical service processing (14/18, 78\%), diagnostic support (10/18, 56\%), payment transactions (10/18, 56\%), and fundraising for telemedical instrument development (5/18, 28\%). Conclusions: These different features (eg, medical data access, medical service processing, epidemiology reporting, diagnostic support, and treatment support) allow us to discuss the possibilities for integration of blockchain technology into telemedicine and health care on different levels. In this area, a wide range of tasks can be identified that could be accomplished based on digital technologies using blockchains. ", doi="10.2196/17475", url="https://www.jmir.org/2021/8/e17475", url="http://www.ncbi.nlm.nih.gov/pubmed/34407924" } @Article{info:doi/10.2196/28496, author="Hasselgren, Anton and Hanssen Rensaa, Jens-Andreas and Kralevska, Katina and Gligoroski, Danilo and Faxvaag, Arild", title="Blockchain for Increased Trust in Virtual Health Care: Proof-of-Concept Study", journal="J Med Internet Res", year="2021", month="Jul", day="30", volume="23", number="7", pages="e28496", keywords="blockchain", keywords="ethereum", keywords="decentralization", keywords="Healthcare 4.0", keywords="virtualization", keywords="trust", abstract="Background: Health care systems are currently undergoing a digital transformation that has been primarily triggered by emerging technologies, such as artificial intelligence, the Internet of Things, 5G, blockchain, and the digital representation of patients using (mobile) sensor devices. One of the results of this transformation is the gradual virtualization of care. Irrespective of the care environment, trust between caregivers and patients is essential for achieving favorable health outcomes. Given the many breaches of information security and patient safety, today's health information system portfolios do not suffice as infrastructure for establishing and maintaining trust in virtual care environments. Objective: This study aims to establish a theoretical foundation for a complex health care system intervention that aims to exploit a cryptographically secured infrastructure for establishing and maintaining trust in virtualized care environments and, based on this theoretical foundation, present a proof of concept that fulfills the necessary requirements. Methods: This work applies the following framework for the design and evaluation of complex intervention research within health care: a review of the literature and expert consultation for technology forecasting. A proof of concept was developed by following the principles of design science and requirements engineering. Results: This study determined and defined the crucial functional and nonfunctional requirements and principles for enhancing trust between caregivers and patients within a virtualized health care environment. The cornerstone of our architecture is an approach that uses blockchain technology. The proposed decentralized system offers an innovative governance structure for a novel trust model. The presented theoretical design principles are supported by a concrete implementation of an Ethereum-based platform called VerifyMed. Conclusions: A service for enhancing trust in a virtualized health care environment that is built on a public blockchain has a high fit for purpose in Healthcare 4.0. ", doi="10.2196/28496", url="https://www.jmir.org/2021/7/e28496", url="http://www.ncbi.nlm.nih.gov/pubmed/34328437" } @Article{info:doi/10.2196/25946, author="Wang, Zhengfei and Wang, Lai and Xiao, Fu'an and Chen, Qingsong and Lu, Liming and Hong, Jiaming", title="A Traditional Chinese Medicine Traceability System Based on Lightweight Blockchain", journal="J Med Internet Res", year="2021", month="Jun", day="21", volume="23", number="6", pages="e25946", keywords="blockchain", keywords="traditional Chinese medicine", keywords="TCM", keywords="traceability system", keywords="fake drugs", keywords="IPFS", keywords="fraud", keywords="traceability", abstract="Background: Recently, the problem of traditional Chinese medicine (TCM) safety has attracted attention worldwide. To prevent the spread of counterfeit drugs, it is necessary to establish a drug traceability system. A traditional drug traceability system can record the whole circulation process of drugs, from planting, production, processing, and warehousing to use by hospitals and patients. Once counterfeit drugs are found, they can be traced back to the source. However, traditional drug traceability systems have some drawbacks, such as failure to prevent tampering and facilitation of sensitive disclosure. Blockchain (including Bitcoin and Ethernet Square) is an effective technology to address the problems of traditional drug traceability systems. However, some risks impact the reliability of blockchain, such as information explosion, sensitive information leakage, and poor scalability. Objective: To avoid the risks associated with the application of blockchain, we propose a lightweight block chain framework. Methods: In this framework, both horizontal and vertical segmentations are performed when designing the blocks, and effective strategies are provided for both segmentations. For horizontal segmentation operations, the header and body of the blockchain are separated and stored in the blockchain, and the body is stored in the InterPlanetary File System. For vertical segmentation operations, the blockchain is cut off according to time or size. For the addition of new blocks, miners only need to copy the latest part of the blockchain and append the tail and vertical segmentation of the block through the consensus mechanism. Results: Our framework could greatly reduce the size of the blockchain and improve the verification efficiency. Conclusions: Experimental results have shown that the efficiency improves compared with ethernet when a new block is added to the blockchain and a search is conducted. ", doi="10.2196/25946", url="https://www.jmir.org/2021/6/e25946", url="http://www.ncbi.nlm.nih.gov/pubmed/34152279" } @Article{info:doi/10.2196/28616, author="Milne-Ives, Madison and Lam, Ching and Rehman, Najib and Sharif, Raja and Meinert, Edward", title="Distributed Ledger Infrastructure to Verify Adverse Event Reporting (DeLIVER): Proposal for a Proof-of-Concept Study", journal="JMIR Res Protoc", year="2021", month="Jun", day="10", volume="10", number="6", pages="e28616", keywords="adverse drug reaction reporting systems", keywords="drug-related side effects and adverse reactions", keywords="blockchain", keywords="mobile applications", keywords="distributed ledger technology", abstract="Background: Adverse drug event reporting is critical for ensuring patient safety; however, numbers of reports have been declining. There is a need for a more user-friendly reporting system and for a means of verifying reports that have been filed. Objective: This project has 2 main objectives: (1) to identify the perceived benefits and barriers in the current reporting of adverse events by patients and health care providers and (2) to develop a distributed ledger infrastructure and user interface to collect and collate adverse event reports to create a comprehensive and interoperable database. Methods: A review of the literature will be conducted to identify the strengths and limitations of the current UK adverse event reporting system (the Yellow Card System). If insufficient information is found in this review, a survey will be created to collect data from system users. The results of these investigations will be incorporated into the development of a mobile and web app for adverse event reporting. A digital infrastructure will be built using distributed ledger technology to provide a means of linking reports with existing pharmaceutical tracking systems. Results: The key outputs of this project will be the development of a digital infrastructure, including a backend distributed ledger system and an app-based user interface. Conclusions: This infrastructure is expected to improve the accuracy and efficiency of adverse event reporting systems by enabling the monitoring of specific medicines or medical devices over their life course while protecting patients' personal health data. International Registered Report Identifier (IRRID): PRR1-10.2196/28616 ", doi="10.2196/28616", url="https://www.researchprotocols.org/2021/6/e28616", url="http://www.ncbi.nlm.nih.gov/pubmed/34110292" } @Article{info:doi/10.2196/20713, author="Velmovitsky, Elkind Pedro and Bublitz, Moreira Frederico and Fadrique, Xavier Laura and Morita, Pelegrini Plinio", title="Blockchain Applications in Health Care and Public Health: Increased Transparency", journal="JMIR Med Inform", year="2021", month="Jun", day="8", volume="9", number="6", pages="e20713", keywords="health care", keywords="blockchain", keywords="EHR", keywords="health insurance", keywords="drug supply chain", keywords="genomics", keywords="consent", keywords="digital ledger", keywords="food supply chain", abstract="Background: Although big data and smart technologies allow for the development of precision medicine and predictive models in health care, there are still several challenges that need to be addressed before the full potential of these data can be realized (eg, data sharing and interoperability issues, lack of massive genomic data sets, data ownership, and security and privacy of health data). Health companies are exploring the use of blockchain, a tamperproof and distributed digital ledger, to address some of these challenges. Objective: In this viewpoint, we aim to obtain an overview of blockchain solutions that aim to solve challenges in health care from an industry perspective, focusing on solutions developed by health and technology companies. Methods: We conducted a literature review following the protocol defined by Levac et al to analyze the findings in a systematic manner. In addition to traditional databases such as IEEE and PubMed, we included search and news outlets such as CoinDesk, CoinTelegraph, and Medium. Results: Health care companies are using blockchain to improve challenges in five key areas. For electronic health records, blockchain can help to mitigate interoperability and data sharing in the industry by creating an overarching mechanism to link disparate personal records and can stimulate data sharing by connecting owners and buyers directly. For the drug (and food) supply chain, blockchain can provide an auditable log of a product's provenance and transportation (including information on the conditions in which the product was transported), increasing transparency and eliminating counterfeit products in the supply chain. For health insurance, blockchain can facilitate the claims management process and help users to calculate medical and pharmaceutical benefits. For genomics, by connecting data buyers and owners directly, blockchain can offer a secure and auditable way of sharing genomic data, increasing their availability. For consent management, as all participants in a blockchain network view an immutable version of the truth, blockchain can provide an immutable and timestamped log of consent, increasing transparency in the consent management process. Conclusions: Blockchain technology can improve several challenges faced by the health care industry. However, companies must evaluate how the features of blockchain can affect their systems (eg, the append-only nature of blockchain limits the deletion of data stored in the network, and distributed systems, although more secure, are less efficient). Although these trade-offs need to be considered when viewing blockchain solutions, the technology has the potential to optimize processes, minimize inefficiencies, and increase trust in all contexts covered in this viewpoint. ", doi="10.2196/20713", url="https://medinform.jmir.org/2021/6/e20713", url="http://www.ncbi.nlm.nih.gov/pubmed/34100768" } @Article{info:doi/10.2196/26230, author="Kim, Hyeong-Joon and Kim, Hyeon Hye and Ku, Hosuk and Yoo, Don Kyung and Lee, Suehyun and Park, In Ji and Kim, Jin Hyo and Kim, Kyeongmin and Chung, Kyung Moon and Lee, Hwa Kye and Kim, Han Ju", title="Smart Decentralization of Personal Health Records with Physician Apps and Helper Agents on Blockchain: Platform Design and Implementation Study", journal="JMIR Med Inform", year="2021", month="Jun", day="7", volume="9", number="6", pages="e26230", keywords="personal health records", keywords="blockchain", keywords="mobile health", keywords="semantic interoperatbility", keywords="decentralized system", keywords="patient-centered system", abstract="Background: The Health Avatar Platform provides a mobile health environment with interconnected patient Avatars, physician apps, and intelligent agents (termed IoA3) for data privacy and participatory medicine; however, its fully decentralized architecture has come at the expense of decentralized data management and data provenance. Objective: The introduction of blockchain and smart contract technologies to the legacy Health Avatar Platform with a clinical metadata registry remarkably strengthens decentralized health data integrity and immutable transaction traceability at the corresponding data-element level in a privacy-preserving fashion. A crypto-economy ecosystem was built to facilitate secure and traceable exchanges of sensitive health data. Methods: The Health Avatar Platform decentralizes patient data in appropriate locations (ie, on patients' smartphones and on physicians' smart devices). We implemented an Ethereum-based hash chain for all transactions and smart contract--based processes to guarantee decentralized data integrity and to generate block data containing transaction metadata on-chain. Parameters of all types of data communications were enumerated and incorporated into 3 smart contracts, in this case, a health data transaction manager, a transaction status manager, and an application programming interface transaction manager. The actual decentralized health data are managed in an off-chain manner on appropriate smart devices and authenticated by hashed metadata on-chain. Results: Metadata of each data transaction are captured in a Health Avatar Platform blockchain node by the smart contracts. We provide workflow diagrams each of the 3 use cases of data push (from a physician app or an intelligent agents to a patient Avatar), data pull (request to a patient Avatar by other entities), and data backup transactions. Each transaction can be finely managed at the corresponding data-element level rather than at the resource or document levels. Hash-chained metadata support data element--level verification of data integrity in subsequent transactions. Smart contracts can incentivize transactions for data sharing and intelligent digital health care services. Conclusions: Health Avatar Platform and interconnected patient Avatars, physician apps, and intelligent agents provide a decentralized blockchain ecosystem for health data that enables trusted and finely tuned data sharing and facilitates health value-creating transactions with smart contracts. ", doi="10.2196/26230", url="https://medinform.jmir.org/2021/6/e26230", url="http://www.ncbi.nlm.nih.gov/pubmed/34096877" } @Article{info:doi/10.2196/25094, author="Fang, Andrew Hao Sen and Tan, Hwee Teng and Tan, Cheryl Yan Fang and Tan, Marcus Chun Jin", title="Blockchain Personal Health Records: Systematic Review", journal="J Med Internet Res", year="2021", month="Apr", day="13", volume="23", number="4", pages="e25094", keywords="blockchain", keywords="personal health records", keywords="electronic health records", keywords="distributed ledger", keywords="systematic review", abstract="Background: Blockchain technology has the potential to enable more secure, transparent, and equitable data management. In the health care domain, it has been applied most frequently to electronic health records. In addition to securely managing data, blockchain has significant advantages in distributing data access, control, and ownership to end users. Due to this attribute, among others, the use of blockchain to power personal health records (PHRs) is especially appealing. Objective: This review aims to examine the current landscape, design choices, limitations, and future directions of blockchain-based PHRs. Methods: Adopting the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, a cross-disciplinary systematic review was performed in July 2020 on all eligible articles, including gray literature, from the following 8 databases: ACM, IEEE Xplore, MEDLINE, ScienceDirect, Scopus, SpringerLink, Web of Science, and Google Scholar. Three reviewers independently performed a full-text review and data abstraction using a standardized data collection form. Results: A total of 58 articles met the inclusion criteria. In the review, we found that the blockchain PHR space has matured over the past 5 years, from purely conceptual ideas initially to an increasing trend of publications describing prototypes and even implementations. Although the eventual application of blockchain in PHRs is intended for the health care industry, the majority of the articles were found in engineering or computer science publications. Among the blockchain PHRs described, permissioned blockchains and off-chain storage were the most common design choices. Although 18 articles described a tethered blockchain PHR, all of them were at the conceptual stage. Conclusions: This review revealed that although research interest in blockchain PHRs is increasing and that the space is maturing, this technology is still largely in the conceptual stage. Being the first systematic review on blockchain PHRs, this review should serve as a basis for future reviews to track the development of the space. ", doi="10.2196/25094", url="https://www.jmir.org/2021/4/e25094", url="http://www.ncbi.nlm.nih.gov/pubmed/33847591" } @Article{info:doi/10.2196/26460, author="Platt, Moritz and Hasselgren, Anton and Rom{\'a}n-Belmonte, Manuel Juan and Tuler de Oliveira, Marcela and De la Corte-Rodr{\'i}guez, Hortensia and Delgado Olabarriaga, S{\'i}lvia and Rodr{\'i}guez-Merch{\'a}n, Carlos E. and Mackey, Ken Tim", title="Test, Trace, and Put on the Blockchain?: A Viewpoint Evaluating the Use of Decentralized Systems for Algorithmic Contact Tracing to Combat a Global Pandemic", journal="JMIR Public Health Surveill", year="2021", month="Apr", day="6", volume="7", number="4", pages="e26460", keywords="COVID-19", keywords="public health", keywords="blockchain", keywords="distributed ledger technology", keywords="mobile apps", keywords="pandemic mitigation", keywords="contact tracing", keywords="epidemiological monitoring", doi="10.2196/26460", url="https://publichealth.jmir.org/2021/4/e26460", url="http://www.ncbi.nlm.nih.gov/pubmed/33727212" } @Article{info:doi/10.2196/25245, author="Idrees, Mohammad Sheikh and Nowostawski, Mariusz and Jameel, Roshan", title="Blockchain-Based Digital Contact Tracing Apps for COVID-19 Pandemic Management: Issues, Challenges, Solutions, and Future Directions", journal="JMIR Med Inform", year="2021", month="Feb", day="9", volume="9", number="2", pages="e25245", keywords="COVID-19", keywords="digital contact tracing", keywords="privacy preservation", keywords="security", keywords="blockchain technology", keywords="blockchain", keywords="privacy", keywords="contact tracing", keywords="app", keywords="surveillance", doi="10.2196/25245", url="https://medinform.jmir.org/2021/2/e25245", url="http://www.ncbi.nlm.nih.gov/pubmed/33400677" } @Article{info:doi/10.2196/13556, author="Xiao, Yonggang and Xu, Bin and Jiang, Wenhao and Wu, Yunjun", title="The HealthChain Blockchain for Electronic Health Records: Development Study", journal="J Med Internet Res", year="2021", month="Jan", day="22", volume="23", number="1", pages="e13556", keywords="electronic health record", keywords="distributed ledger", keywords="privacy preservation", keywords="proof of authority", keywords="chaincode application programming interface", abstract="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. ", doi="10.2196/13556", url="http://www.jmir.org/2021/1/e13556/", url="http://www.ncbi.nlm.nih.gov/pubmed/33480851" } @Article{info:doi/10.2196/20567, author="Lee, Hsiu-An and Kung, Hsin-Hua and Lee, Yuarn-Jang and Chao, C-J Jane and Udayasankaran, Ganesh Jai and Fan, Hueng-Chuen and Ng, Kwok-Keung and Chang, Yu-Kang and Kijsanayotin, Boonchai and Marcelo, B. Alvin and Hsu, Chien-Yeh", title="Global Infectious Disease Surveillance and Case Tracking System for COVID-19: Development Study", journal="JMIR Med Inform", year="2020", month="Dec", day="22", volume="8", number="12", pages="e20567", keywords="blockchain", keywords="infectious disease surveillance", keywords="international collaboration", keywords="HL7 FHIR", keywords="COVID-19 defense", keywords="COVID-19", abstract="Background: COVID-19 has affected more than 180 countries and is the first known pandemic to be caused by a new virus. COVID-19's emergence and rapid spread is a global public health and economic crisis. However, investigations into the disease, patient-tracking mechanisms, and case report transmissions are both labor-intensive and slow. Objective: The pandemic has overwhelmed health care systems, forcing hospitals and medical facilities to find effective ways to share data. This study aims to design a global infectious disease surveillance and case tracking system that can facilitate the detection and control of COVID-19. Methods: The International Patient Summary (IPS; an electronic health record that contains essential health care information about a patient) was used. The IPS was designed to support the used case scenario for unplanned cross-border care. The design, scope, utility, and potential for reuse of the IPS for unplanned cross-border care make it suitable for situations like COVID-19. The Fast Healthcare Interoperability Resources confirmed that IPS data, which includes symptoms, therapies, medications, and laboratory data, can be efficiently transferred and exchanged on the system for easy access by physicians. To protect privacy, patient data are deidentified. All systems are protected by blockchain architecture, including data encryption, validation, and exchange of records. Results: To achieve worldwide COVID-19 surveillance, a global infectious disease information exchange must be enacted. The COVID-19 surveillance system was designed based on blockchain architecture. The IPS was used to exchange case study information among physicians. After being verified, physicians can upload IPS files and receive IPS data from other global cases. The system includes a daily IPS uploading and enhancement plan, which covers real-time uploading through the interoperation of the clinic system, with the module based on the Open Application Programming Interface architecture. Through the treatment of different cases, drug treatments, and the exchange of treatment results, the disease spread can be controlled, and treatment methods can be funded. In the Infectious Disease Case Tracking module, we can track the moving paths of infectious disease cases. The location information recorded in the blockchain is used to check the locations of different cases. The Case Tracking module was established for the Centers for Disease Control and Prevention to track cases and prevent disease spread. Conclusions: We created the IPS of infectious diseases for physicians treating patients with COVID-19. Our system can help health authorities respond quickly to the transmission and spread of unknown diseases, and provides a system for information retrieval on disease transmission. In addition, this system can help researchers form trials and analyze data from different countries. A common forum to facilitate the mutual sharing of experiences, best practices, therapies, useful medications, and clinical intervention outcomes from research in various countries could help control an unknown virus. This system could be an effective tool for global collaboration in evidence-based efforts to fight COVID-19. ", doi="10.2196/20567", url="http://medinform.jmir.org/2020/12/e20567/", url="http://www.ncbi.nlm.nih.gov/pubmed/33320826" } @Article{info:doi/10.2196/17005, author="Lam, Ching and van Velthoven, Helena Michelle and Meinert, Edward", title="Developing a Blockchain-Based Supply Chain System for Advanced Therapies: Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2020", month="Dec", day="14", volume="9", number="12", pages="e17005", keywords="blockchain", keywords="digital health", keywords="IOT", keywords="internet of things", keywords="regenerative medicine", abstract="Background: Advanced therapies, including cell and gene therapies, have shown therapeutic promise in curing life-threatening diseases, such as leukemia and lymphoma. However, these therapies can be complicated and expensive to deliver due to their sensitivity to environment; troublesome tissue, cell, or genetic material sourcing; and complicated regulatory requirements. Objective: This study aims to create a novel connected supply chain logistics and manufacturing management platform based on blockchain, with cell and gene therapy as a use case. Objectives are to define the requirements and perform feasibility evaluations on the use of blockchain for standardized manufacturing and establishment of a chain of custody for the needle-to-needle delivery of autologous cell and gene therapies. A way of lowering overall regulatory compliance costs for running a network of facilities operating similar or parallel processes will be evaluated by lowering the monitoring costs through publishing zero-knowledge proofs and product release by exception. Methods: The study will use blockchain technologies to digitally connect and integrate supply chain with manufacturing to address the security, scheduling, and communication issues between advanced therapy treatment centers and manufacturing facilities in order to realize a transparent, secure, automated, and cost-effective solution to the delivery of these life-saving therapies. An agile software development methodology will be used to develop, implement, and evaluate the system. The system will adhere to the EU and US good manufacturing practices and regulatory requirements. Results: This is a proposed study protocol, and upon acceptance, grant funding will be pursued for its execution in 2021. Conclusions: The successful implementation of the integrated blockchain solution to supply chain and manufacturing of advanced therapies can push the industry standards toward a safer and more secure therapy delivery process. International Registered Report Identifier (IRRID): PRR1-10.2196/17005 ", doi="10.2196/17005", url="http://www.researchprotocols.org/2020/12/e17005/", url="http://www.ncbi.nlm.nih.gov/pubmed/33315020" } @Article{info:doi/10.2196/20832, author="Velmovitsky, Elkind Pedro and Miranda, Souza Pedro Augusto Da Silva E. and Vaillancourt, H{\'e}l{\`e}ne and Donovska, Tania and Teague, Jennifer and Morita, Pelegrini Plinio", title="A Blockchain-Based Consent Platform for Active Assisted Living: Modeling Study and Conceptual Framework", journal="J Med Internet Res", year="2020", month="Dec", day="4", volume="22", number="12", pages="e20832", keywords="health care", keywords="blockchain", keywords="Internet of Things", keywords="aging", keywords="informed consent", keywords="mobile phone", keywords="computing methodologies", keywords="computer security", abstract="Background: Recent advancements in active assisted living (AAL) technologies allow older adults to age well in place. However, sensing technologies increase the complexity of data collection points, making it difficult for users to consent to data collection. One possible solution for improving transparency in the consent management process is the use of blockchain, an immutable and timestamped ledger. Objective: This study aims to provide a conceptual framework based on technology aimed at mitigating trust issues in the consent management process. Methods: The consent management process was modeled using established methodologies to obtain a mapping of trust issues. This mapping was then used to develop a conceptual framework based on previous monitoring and surveillance architectures for connected devices. Results: In this paper, we present a model that maps trust issues in the informed consent process; a conceptual framework capable of providing all the necessary underlining technologies, components, and functionalities required to develop applications capable of managing the process of informed consent for AAL, powered by blockchain technology to ensure transparency; and a diagram showing an instantiation of the framework with entities comprising the participants in the blockchain network, suggesting possible technologies that can be used. Conclusions: Our conceptual framework provides all the components and technologies that are required to enhance the informed consent process. Blockchain technology can help overcome several privacy challenges and mitigate trust issues that are currently present in the consent management process of data collection involving AAL technologies. ", doi="10.2196/20832", url="https://www.jmir.org/2020/12/e20832", url="http://www.ncbi.nlm.nih.gov/pubmed/33275111" } @Article{info:doi/10.2196/18582, author="Lee, Keehyuck and Lim, Kahyun and Jung, Young Se and Ji, Hyerim and Hong, Kyungpyo and Hwang, Hee and Lee, Ho-Young", title="Perspectives of Patients, Health Care Professionals, and Developers Toward Blockchain-Based Health Information Exchange: Qualitative Study", journal="J Med Internet Res", year="2020", month="Nov", day="13", volume="22", number="11", pages="e18582", keywords="blockchain", keywords="health information exchange", keywords="qualitative study", abstract="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. ", doi="10.2196/18582", url="http://www.jmir.org/2020/11/e18582/", url="http://www.ncbi.nlm.nih.gov/pubmed/33185553" } @Article{info:doi/10.2196/21995, author="Lu, Chang and Batista, Danielle and Hamouda, Hoda and Lemieux, Victoria", title="Consumers' Intentions to Adopt Blockchain-Based Personal Health Records and Data Sharing: Focus Group Study", journal="JMIR Form Res", year="2020", month="Nov", day="5", volume="4", number="11", pages="e21995", keywords="blockchain", keywords="personal health record", keywords="health data sharing", keywords="consumers' intentions to adopt", keywords="focus group study", keywords="microinterlocutor analysis", abstract="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. ", doi="10.2196/21995", url="http://formative.jmir.org/2020/11/e21995/", url="http://www.ncbi.nlm.nih.gov/pubmed/33151149" } @Article{info:doi/10.2196/22013, author="Wan, Kengfai Paul and Satybaldy, Abylay and Huang, Lizhen and Holtskog, Halvor and Nowostawski, Mariusz", title="Reducing Alert Fatigue by Sharing Low-Level Alerts With Patients and Enhancing Collaborative Decision Making Using Blockchain Technology: Scoping Review and Proposed Framework (MedAlert)", journal="J Med Internet Res", year="2020", month="Oct", day="28", volume="22", number="10", pages="e22013", keywords="blockchain", keywords="health care", keywords="alert fatigue", keywords="clinical decision support", keywords="smart contracts", keywords="information sharing", abstract="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. ", doi="10.2196/22013", url="http://www.jmir.org/2020/10/e22013/", url="http://www.ncbi.nlm.nih.gov/pubmed/33112253" } @Article{info:doi/10.2196/20897, author="Cadoret, Danielle and Kailas, Tamara and Velmovitsky, Pedro and Morita, Plinio and Igboeli, Okechukwu", title="Proposed Implementation of Blockchain in British Columbia's Health Care Data Management", journal="J Med Internet Res", year="2020", month="Oct", day="23", volume="22", number="10", pages="e20897", keywords="blockchain", keywords="electronic medical records", keywords="health data management", keywords="patient centric", abstract="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. ", doi="10.2196/20897", url="http://www.jmir.org/2020/10/e20897/", url="http://www.ncbi.nlm.nih.gov/pubmed/33095183" } @Article{info:doi/10.2196/20477, author="Khurshid, Anjum", title="Applying Blockchain Technology to Address the Crisis of Trust During the COVID-19 Pandemic", journal="JMIR Med Inform", year="2020", month="Sep", day="22", volume="8", number="9", pages="e20477", keywords="blockchain", keywords="privacy", keywords="trust", keywords="contact tracing", keywords="COVID-19", keywords="coronavirus", abstract="Background: The widespread death and disruption caused by the COVID-19 pandemic has revealed deficiencies of existing institutions regarding the protection of human health and well-being. Both a lack of accurate and timely data and pervasive misinformation are causing increasing harm and growing tension between data privacy and public health concerns. Objective: This aim of this paper is to describe how blockchain, with its distributed trust networks and cryptography-based security, can provide solutions to data-related trust problems. Methods: Blockchain is being applied in innovative ways that are relevant to the current COVID-19 crisis. We describe examples of the challenges faced by existing technologies to track medical supplies and infected patients and how blockchain technology applications may help in these situations. Results: This exploration of existing and potential applications of blockchain technology for medical care shows how the distributed governance structure and privacy-preserving features of blockchain can be used to create ``trustless'' systems that can help resolve the tension between maintaining privacy and addressing public health needs in the fight against COVID-19. Conclusions: Blockchain relies on a distributed, robust, secure, privacy-preserving, and immutable record framework that can positively transform the nature of trust, value sharing, and transactions. A nationally coordinated effort to explore blockchain to address the deficiencies of existing systems and a partnership of academia, researchers, business, and industry are suggested to expedite the adoption of blockchain in health care. ", doi="10.2196/20477", url="http://medinform.jmir.org/2020/9/e20477/", url="http://www.ncbi.nlm.nih.gov/pubmed/32903197" } @Article{info:doi/10.2196/17423, author="Gaynor, Mark and Tuttle-Newhall, Janet and Parker, Jessica and Patel, Arti and Tang, Clare", title="Adoption of Blockchain in Health Care", journal="J Med Internet Res", year="2020", month="Sep", day="17", volume="22", number="9", pages="e17423", keywords="blockchain adoption", keywords="blockchain technology in health care", keywords="supply chain", keywords="data management", doi="10.2196/17423", url="https://www.jmir.org/2020/9/e17423", url="http://www.ncbi.nlm.nih.gov/pubmed/32940618" } @Article{info:doi/10.2196/18623, author="Mackey, Ken Tim and Miyachi, Ken and Fung, Danny and Qian, Samson and Short, James", title="Combating Health Care Fraud and Abuse: Conceptualization and Prototyping Study of a Blockchain Antifraud Framework", journal="J Med Internet Res", year="2020", month="Sep", day="10", volume="22", number="9", pages="e18623", keywords="fraud", keywords="blockchain", keywords="medical informatics", keywords="delivery of healthcare", keywords="Medicare", keywords="information science", abstract="Background: An estimated US \$2.6 billion loss is attributed to health care fraud and abuse. With traditional health care claims verification and reimbursement, the health care provider submits a claim after rendering services to a patient, which is then verified and reimbursed by the payer. However, this process leaves out a critical stakeholder: the patient for whom the services are actually rendered. This lack of patient participation introduces a risk of fraud and abuse. Blockchain technology enables secure data management with transparency, which could mitigate this risk of health care fraud and abuse. Objective: The aim of this study is to develop a framework using blockchain to record claims data and transactions in an immutable format and to enable the patient to act as a validating node to help detect and prevent health care fraud and abuse. Methods: We developed a health care fraud and abuse blockchain technical framework and prototype using key blockchain tools and application layers including consensus algorithms, smart contracts, tokens, and governance based on digital identity on the Ethereum platform (Ethereum Foundation). Results: Our technical framework maps to the claims adjudication process and focuses on Medicare claims, with the US Centers for Medicare and Medicaid Services (CMS) as the central authority. A prototype of the framework system was developed using the blockchain platform Ethereum (Ethereum Foundation), with its design features, workflow, smart contract functions, system architecture, and software implementation outlined. The software stack used to build the system consisted of a front-end user interface framework, a back-end processing server, and a blockchain network. React was used for the user interface framework, and NodeJS and an Express server were used for the back-end processing server; Solidity was the smart contract language used to interact with a local Ethereum blockchain network. Conclusions: The proposed framework and the initial prototype have the potential to improve the health care claims process by using blockchain technology for secure data storage and consensus mechanisms, which make the claims adjudication process more patient-centric for the purposes of identifying and preventing health care fraud and abuse. Future work will focus on the use of synthetic or historic CMS claims data to assess the real-world viability of the framework. ", doi="10.2196/18623", url="http://www.jmir.org/2020/9/e18623/", url="http://www.ncbi.nlm.nih.gov/pubmed/32909952" } @Article{info:doi/10.2196/19480, author="Chang, Ernest Shuchih and Chen, YiChian", title="Blockchain in Health Care Innovation: Literature Review and Case Study From a Business Ecosystem Perspective", journal="J Med Internet Res", year="2020", month="Aug", day="31", volume="22", number="8", pages="e19480", keywords="blockchain", keywords="health care industry", keywords="business ecosystem", keywords="smart contract", keywords="paradigm shift", abstract="Background: Blockchain technology is leveraging its innovative potential in various sectors and its transformation of business-related processes has drawn much attention. Topics of research interest have focused on medical and health care applications, while research implications have generally concluded in system design, literature reviews, and case studies. However, a general overview and knowledge about the impact on the health care ecosystem is limited. Objective: This paper explores a potential paradigm shift and ecosystem evolution in health care utilizing blockchain technology. Methods: A literature review with a case study on a pioneering initiative was conducted. With a systematic life cycle analysis, this study sheds light on the evolutionary development of blockchain in health care scenarios and its interactive relationship among stakeholders. Results: Four stages---birth, expansion, leadership, and self-renewal or death---in the life cycle of the business ecosystem were explored to elucidate the evolving trajectories of blockchain-based health care implementation. Focused impacts on the traditional health care industry are highlighted within each stage to further support the potential health care paradigm shift in the future. Conclusions: This paper enriches the existing body of literature in this field by illustrating the potential of blockchain in fulfilling stakeholders' needs and elucidating the phenomenon of coevolution within the health care ecosystem. Blockchain not only catalyzes the interactions among players but also facilitates the formation of the ecosystem life cycle. The collaborative network linked by blockchain may play a critical role on value creation, transfer, and sharing among the health care community. Future efforts may focus on empirical or case studies to validate the proposed evolution of the health care ecosystem. ", doi="10.2196/19480", url="http://www.jmir.org/2020/8/e19480/", url="http://www.ncbi.nlm.nih.gov/pubmed/32865501" } @Article{info:doi/10.2196/19657, author="Sung, MinDong and Park, SungJun and Jung, Sungjae and Lee, Eunsol and Lee, Jaehoon and Park, Rang Yu", title="Developing a Mobile App for Monitoring Medical Record Changes Using Blockchain: Development and Usability Study", journal="J Med Internet Res", year="2020", month="Aug", day="14", volume="22", number="8", pages="e19657", keywords="blockchain", keywords="monitoring app", keywords="clinical documents", abstract="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. ", doi="10.2196/19657", url="http://www.jmir.org/2020/8/e19657/", url="http://www.ncbi.nlm.nih.gov/pubmed/32795988" } @Article{info:doi/10.2196/15472, author="Chang, Ernest Shuchih and Chen, YiChian and Lu, MingFang and Luo, Louis Hueimin", title="Development and Evaluation of a Smart Contract--Enabled Blockchain System for Home Care Service Innovation: Mixed Methods Study", journal="JMIR Med Inform", year="2020", month="Jul", day="28", volume="8", number="7", pages="e15472", keywords="home care service", keywords="trust", keywords="innovation", keywords="blockchain", keywords="smart contract", keywords="automation", abstract="Background: In the home care industry, the assignment and tracking of care services are controlled by care centers that are centralized in nature and prone to inefficient information transmission. A lack of trust among the involved parties, information opaqueness, and large manual manipulation result in lower process efficiency. Objective: This study aimed to explore and demonstrate the application of blockchain and smart contract technologies to innovate/renovate home care services for harvesting the desired blockchain benefits of process transparency, traceability, and interoperability. Methods: An object-oriented analysis/design combined with a unified modeling language tool was used to construct the architecture of the proposed home care service system. System feasibility was evaluated via an implementation test, and a questionnaire survey was performed to collect opinions from home care service respondents knowledgeable about blockchain and smart contracts. Results: According to the comparative analysis results, the proposed design outperformed the existing system in terms of traceability, system efficiency, and process automation. Moreover, for the questionnaire survey, the quantitative analysis results showed that the proposed blockchain-based system had significantly (P<.001) higher mean scores (when compared with the existing system) in terms of important factors, including timeliness, workflow efficiency, automatic notifications, insurance functionality, and auditable traceability. In summary, blockchain-based home care service participants will be able to enjoy improved efficiency, better transparency, and higher levels of process automation. Conclusions: Blockchain and smart contracts can provide valuable benefits to the home care service industry via distributed data management and process automation. The proposed system enhances user experiences by mitigating human intervention and improving service interoperability, transparency/traceability, and real-time response to home care service events. Efforts in exploring and integrating blockchain-based home care services with emerging technologies, such as the internet of things and artificial intelligence, are expected to provide further benefits and therefore are subject to future research. ", doi="10.2196/15472", url="https://medinform.jmir.org/2020/7/e15472", url="http://www.ncbi.nlm.nih.gov/pubmed/32720903" } @Article{info:doi/10.2196/19029, author="Zhuang, Yan and Chen, Yin-Wu and Shae, Zon-Yin and Shyu, Chi-Ren", title="Generalizable Layered Blockchain Architecture for Health Care Applications: Development, Case Studies, and Evaluation", journal="J Med Internet Res", year="2020", month="Jul", day="27", volume="22", number="7", pages="e19029", keywords="blockchain", keywords="smart contract", keywords="health information exchange", keywords="electronic health records", keywords="health care application", abstract="Background: Data coordination across multiple health care facilities has become increasingly important for many emerging health care applications. Distrust has been recognized as a key barrier to the success of such applications. Leveraging blockchain technology could provide potential solutions tobuild trust between data providers and receivers by taking advantage of blockchain properties such as security, immutability, anonymity, decentralization, and smart contracts. Many health technologies have empirically proven that blockchain designs fit well with the needs of health care applications with certain degrees of success. However, there is a lack of robust architecture to provide a practical framework for developers to implement applications and test the performance of stability, efficiency, and scalability using standard blockchain designs. A generalized blockchain model is needed for the health care community to adopt blockchain technology and develop applications in a timely fashion. Objective: This study aimed at building a generalized blockchain architecture that provides data coordination functions, including data requests, permission granting, data exchange, and usage tracking, for a wide spectrum of health care application developments. Methods: An augmented, 3-layered blockchain architecture was built on a private blockchain network. The 3 layers, from bottom to top, are as follows: (1) incorporation of fundamental blockchain settings and smart contract design for data collection; (2) interactions between the blockchain and health care application development environment using Node.js and web3.js; and (3) a flexible development platform that supports web technologies such as HTML, https, and various programing languages. Two example applications, health information exchange (HIE) and clinical trial recruitment, were developed in our design to demonstrate the feasibility of the layered architecture. Case studies were conducted to test the performance in terms of stability, efficiency, and scalability of the blockchain system. Results: A total of 331,142 simulated HIE requests from accounts of 40,000 patients were successfully validated through this layered blockchain architecture with an average exchange time of 11.271 (SD 2.208) seconds. We also simulated a clinical trial recruitment scenario with the same set of patients and various recruitment criteria to match potential subjects using the same architecture. Potential subjects successfully received the clinical trial recruitment information and granted permission to the trial sponsors to access their health records with an average time of 3.07 seconds. Conclusions: This study proposes a generalized layered blockchain architecture that offers health technology community blockchain features for application development without requiring developers to have extensive experience with blockchain technology. The case studies tested the performance of our design and empirically proved the feasibility of the architecture in 2 relevant health application domains. ", doi="10.2196/19029", url="https://www.jmir.org/2020/7/e19029", url="http://www.ncbi.nlm.nih.gov/pubmed/32716300" } @Article{info:doi/10.2196/18619, author="Durneva, Polina and Cousins, Karlene and Chen, Min", title="The Current State of Research, Challenges, and Future Research Directions of Blockchain Technology in Patient Care: Systematic Review", journal="J Med Internet Res", year="2020", month="Jul", day="20", volume="22", number="7", pages="e18619", keywords="blockchain", keywords="health information technology", keywords="systematic review", keywords="security", keywords="privacy", keywords="interoperability", keywords="health outcomes", abstract="Background: Blockchain offers a promising new distributed technology to address the challenges of data standardization, system interoperability, security, privacy, and accessibility of medical records. Objective: The purpose of this review is to assess the research on the use of blockchain technology for patient care and the associated challenges and to provide a research agenda for future research. Methods: This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. We queried the Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, Excerpta Medica dataBASE (EMBASE), and Web of Science databases for peer-reviewed research articles published up to December 2019 that examined the implementation of blockchain technology in health care settings. We identified 800 articles from which we selected 70 empirical research articles for a detailed review. Results: Blockchain-based patient care applications include medical information systems, personal health records, mobile health and telemedicine, data preservation systems and social networks, health information exchanges and remote monitoring systems, and medical research systems. These blockchain-based health care applications may improve patient engagement and empowerment, improve health care provider access to information, and enhance the use of health care information for medical research. Conclusions: Blockchain health information technology (HIT) provides benefits such as ensuring data privacy and security of health data, facilitating interoperability of heterogeneous HIT systems, and improving the quality of health care outcomes. However, barriers to using blockchain technology to build HIT include security and privacy vulnerabilities, user resistance, high computing power requirements and implementation costs, inefficient consensus algorithms, and challenges of integrating blockchain with existing HIT. With 51\% of the research focused on medical information systems such as electronic health record and electronic medical record, and 53\% of the research focused on data security and privacy issues, this review shows that HIT research is primarily focused on the use of blockchain technologies to address the current challenges HIT faces. Although Blockchain presents significant potential for disrupting health care, most ideas are in their infancy. ", doi="10.2196/18619", url="http://www.jmir.org/2020/7/e18619/", url="http://www.ncbi.nlm.nih.gov/pubmed/32706668" } @Article{info:doi/10.2196/17199, author="El-Gazzar, Rania and Stendal, Karen", title="Blockchain in Health Care: Hope or Hype?", journal="J Med Internet Res", year="2020", month="Jul", day="10", volume="22", number="7", pages="e17199", keywords="blockchain", keywords="health care", keywords="innovation", keywords="security", keywords="implications", doi="10.2196/17199", url="http://www.jmir.org/2020/7/e17199/", url="http://www.ncbi.nlm.nih.gov/pubmed/32673219" } @Article{info:doi/10.2196/17508, author="Ismail, Leila and Materwala, Huned and Karduck, P. Achim and Adem, Abdu", title="Requirements of Health Data Management Systems for Biomedical Care and Research: Scoping Review", journal="J Med Internet Res", year="2020", month="Jul", day="7", volume="22", number="7", pages="e17508", keywords="big data", keywords="blockchain", keywords="data analytics", keywords="eHealth", keywords="electronic medical records", keywords="health care", keywords="health information management", keywords="Internet of Things", keywords="medical research", keywords="mHealth", abstract="Background: Over the last century, disruptive incidents in the fields of clinical and biomedical research have yielded a tremendous change in health data management systems. This is due to a number of breakthroughs in the medical field and the need for big data analytics and the Internet of Things (IoT) to be incorporated in a real-time smart health information management system. In addition, the requirements of patient care have evolved over time, allowing for more accurate prognoses and diagnoses. In this paper, we discuss the temporal evolution of health data management systems and capture the requirements that led to the development of a given system over a certain period of time. Consequently, we provide insights into those systems and give suggestions and research directions on how they can be improved for a better health care system. Objective: This study aimed to show that there is a need for a secure and efficient health data management system that will allow physicians and patients to update decentralized medical records and to analyze the medical data for supporting more precise diagnoses, prognoses, and public insights. Limitations of existing health data management systems were analyzed. Methods: To study the evolution and requirements of health data management systems over the years, a search was conducted to obtain research articles and information on medical lawsuits, health regulations, and acts. These materials were obtained from the Institute of Electrical and Electronics Engineers, the Association for Computing Machinery, Elsevier, MEDLINE, PubMed, Scopus, and Web of Science databases. Results: Health data management systems have undergone a disruptive transformation over the years from paper to computer, web, cloud, IoT, big data analytics, and finally to blockchain. The requirements of a health data management system revealed from the evolving definitions of medical records and their management are (1) medical record data, (2) real-time data access, (3) patient participation, (4) data sharing, (5) data security, (6) patient identity privacy, and (7) public insights. This paper reviewed health data management systems based on these 7 requirements across studies conducted over the years. To our knowledge, this is the first analysis of the temporal evolution of health data management systems giving insights into the system requirements for better health care. Conclusions: There is a need for a comprehensive real-time health data management system that allows physicians, patients, and external users to input their medical and lifestyle data into the system. The incorporation of big data analytics will aid in better prognosis or diagnosis of the diseases and the prediction of diseases. The prediction results will help in the development of an effective prevention plan. ", doi="10.2196/17508", url="https://www.jmir.org/2020/7/e17508", url="http://www.ncbi.nlm.nih.gov/pubmed/32348265" } @Article{info:doi/10.2196/16748, author="Lee, Hsiu-An and Kung, Hsin-Hua and Udayasankaran, Ganesh Jai and Kijsanayotin, Boonchai and B Marcelo, Alvin and Chao, R. Louis and Hsu, Chien-Yeh", title="An Architecture and Management Platform for Blockchain-Based Personal Health Record Exchange: Development and Usability Study", journal="J Med Internet Res", year="2020", month="Jun", day="9", volume="22", number="6", pages="e16748", keywords="blockchain", keywords="personal health records", keywords="health information interoperability", keywords="precision health care", keywords="health information management", abstract="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. ", doi="10.2196/16748", url="https://www.jmir.org/2020/6/e16748", url="http://www.ncbi.nlm.nih.gov/pubmed/32515743" } @Article{info:doi/10.2196/16887, author="Khurshid, Anjum and Rajeswaren, Vivian and Andrews, Steven", title="Using Blockchain Technology to Mitigate Challenges in Service Access for the Homeless and Data Exchange Between Providers: Qualitative Study", journal="J Med Internet Res", year="2020", month="Jun", day="4", volume="22", number="6", pages="e16887", keywords="blockchain", keywords="distributed ledger technology", keywords="health care", keywords="data sharing", keywords="homeless", keywords="data autonomy", abstract="Background: In the homeless population, barriers to housing and supportive services include a lack of control or access to data. Disparate data formats and storage across multiple organizations hinder up-to-date intersystem access to records and a unified view of an individual's health and documentation history. The utility of blockchain to solve interoperability in health care is supported in recent literature, but the technology has yet to be tested in real-life conditions encompassing the complex regulatory standards in the health sector. Objective: This study aimed to test the feasibility and performance of a blockchain system in a homeless community to securely store and share data across a system of providers in the health care ecosystem. Methods: We performed a series of platform demonstrations and open-ended qualitative feedback interviews to determine the key needs and barriers to user and stakeholder adoption. Account creation and data transactions promoting organizational efficiency and improved health outcomes in this population were tested with homeless users and service providers. Results: Persons experiencing homelessness and care organizations could successfully create accounts, grant and revoke data sharing permissions, and transmit documents across a distributed network of providers. However, there were issues regarding the security of shared data, user experience and adoption, and organizational preparedness for service providers as end users. We tested a set of assumptions related to these problems within the project time frame and contractual obligations with an existing blockchain-based platform. Conclusions: Blockchain technology provides decentralized data sharing, validation, immutability, traceability, and integration. These core features enable a secure system for the management and distribution of sensitive information. This study presents a concrete evaluation of the effectiveness of blockchain through an existing platform while revealing limitations from the perspectives of user adoption, cost-effectiveness, scalability, and regulatory frameworks. ", doi="10.2196/16887", url="https://www.jmir.org/2020/6/e16887", url="http://www.ncbi.nlm.nih.gov/pubmed/32348278" } @Article{info:doi/10.2196/18938, author="Hirano, Tomonobu and Motohashi, Tomomitsu and Okumura, Kosuke and Takajo, Kentaro and Kuroki, Taiyo and Ichikawa, Daisuke and Matsuoka, Yutaka and Ochi, Eisuke and Ueno, Taro", title="Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox", journal="J Med Internet Res", year="2020", month="Jun", day="2", volume="22", number="6", pages="e18938", keywords="blockchain", keywords="clinical trial", keywords="data management", keywords="validation", keywords="breast cancer", keywords="regulatory sandbox", abstract="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. ", doi="10.2196/18938", url="https://www.jmir.org/2020/6/e18938", url="http://www.ncbi.nlm.nih.gov/pubmed/32340974" } @Article{info:doi/10.2196/16810, author="Glicksberg, Scott Benjamin and Burns, Shohei and Currie, Rob and Griffin, Ann and Wang, Jane Zhen and Haussler, David and Goldstein, Theodore and Collisson, Eric", title="Blockchain-Authenticated Sharing of Genomic and Clinical Outcomes Data of Patients With Cancer: A Prospective Cohort Study", journal="J Med Internet Res", year="2020", month="Mar", day="20", volume="22", number="3", pages="e16810", keywords="data sharing", keywords="electronic health records", keywords="genomics", keywords="medicine", keywords="blockchain", keywords="neoplasms", abstract="Background: Efficiently sharing health data produced during standard care could dramatically accelerate progress in cancer treatments, but various barriers make this difficult. Not sharing these data to ensure patient privacy is at the cost of little to no learning from real-world data produced during cancer care. Furthermore, recent research has demonstrated a willingness of patients with cancer to share their treatment experiences to fuel research, despite potential risks to privacy. Objective: The objective of this study was to design, pilot, and release a decentralized, scalable, efficient, economical, and secure strategy for the dissemination of deidentified clinical and genomic data with a focus on late-stage cancer. Methods: We created and piloted a blockchain-authenticated system to enable secure sharing of deidentified patient data derived from standard of care imaging, genomic testing, and electronic health records (EHRs), called the Cancer Gene Trust (CGT). We prospectively consented and collected data for a pilot cohort (N=18), which we uploaded to the CGT. EHR data were extracted from both a hospital cancer registry and a common data model (CDM) format to identify optimal data extraction and dissemination practices. Specifically, we scored and compared the level of completeness between two EHR data extraction formats against the gold standard source documentation for patients with available data (n=17). Results: Although the total completeness scores were greater for the registry reports than those for the CDM, this difference was not statistically significant. We did find that some specific data fields, such as histology site, were better captured using the registry reports, which can be used to improve the continually adapting CDM. In terms of the overall pilot study, we found that CGT enables rapid integration of real-world data of patients with cancer in a more clinically useful time frame. We also developed an open-source Web application to allow users to seamlessly search, browse, explore, and download CGT data. Conclusions: Our pilot demonstrates the willingness of patients with cancer to participate in data sharing and how blockchain-enabled structures can maintain relationships between individual data elements while preserving patient privacy, empowering findings by third-party researchers and clinicians. We demonstrate the feasibility of CGT as a framework to share health data trapped in silos to further cancer research. Further studies to optimize data representation, stream, and integrity are required. ", doi="10.2196/16810", url="http://www.jmir.org/2020/3/e16810/", url="http://www.ncbi.nlm.nih.gov/pubmed/32196460" } @Article{info:doi/10.2196/13649, author="Mackey, Tim and Bekki, Hirofumi and Matsuzaki, Tokio and Mizushima, Hiroshi", title="Examining the Potential of Blockchain Technology to Meet the Needs of 21st-Century Japanese Health Care: Viewpoint on Use Cases and Policy", journal="J Med Internet Res", year="2020", month="Jan", day="9", volume="22", number="1", pages="e13649", keywords="information storage and retrieval", keywords="blockchain", keywords="Japan", keywords="aging", keywords="health informatics", keywords="health policy", keywords="global health", doi="10.2196/13649", url="https://www.jmir.org/2020/1/e13649", url="http://www.ncbi.nlm.nih.gov/pubmed/31917371" } @Article{info:doi/10.2196/15870, author="Hau, Sauk Yong and Lee, Min Jae and Park, Jaechan and Chang, Cheol Min", title="Attitudes Toward Blockchain Technology in Managing Medical Information: Survey Study", journal="J Med Internet Res", year="2019", month="Dec", day="9", volume="21", number="12", pages="e15870", keywords="electronic health records", keywords="attitude", keywords="medical staff", keywords="patient", keywords="surveys and questionnaires", abstract="Background: The recently developed blockchain technology uses a peer-to-peer network to distribute data to all participants for storage. This method enhances data safety, reliability, integrity, and transparency. To successfully introduce blockchain technology to medical data management, it is essential to obtain consent from medical doctors and patients. Objective: The aim of this study was to examine medical doctors' and patients' attitudes toward the use of blockchain technology and interpret the findings within the framework of expectancy theory. Methods: In this questionnaire survey, we examined medical doctors' (n=90) and patients' (n=90) attitudes toward the use of blockchain technology in the management and distribution of medical information. The questionnaire comprised 8 questions that assessed attitudes toward new means of managing and distributing medical information using blockchain technology. Responses were rated on a scale that ranged from 1 (very negative) to 7 (very positive). Results: Medical doctors (mean 3.7-5.0) reported significantly more negative attitudes than patients (mean 6.3-6.8). Furthermore, self-employed doctors reported more negative attitudes than employed doctors and university professors. Conclusions: To successfully introduce blockchain technology to medical data management, it is necessary to promote positive attitudes toward this technology among medical doctors, especially self-employed doctors. ", doi="10.2196/15870", url="https://www.jmir.org/2019/12/e15870", url="http://www.ncbi.nlm.nih.gov/pubmed/31815676" } @Article{info:doi/10.2196/13563, author="Lo, Yu-Sheng and Yang, Cheng-Yi and Chien, Hsiung-Fei and Chang, Shy-Shin and Lu, Chung-Ying and Chen, Ray-Jade", title="Blockchain-Enabled iWellChain Framework Integration With the National Medical Referral System: Development and Usability Study", journal="J Med Internet Res", year="2019", month="Dec", day="4", volume="21", number="12", pages="e13563", keywords="medical referral", keywords="electronic referral system", keywords="blockchain", keywords="decentralized application", keywords="electronic medical records", keywords="electronic health records", keywords="interoperability", abstract="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. ", doi="10.2196/13563", url="https://www.jmir.org/2019/12/e13563", url="http://www.ncbi.nlm.nih.gov/pubmed/31799935" } @Article{info:doi/10.2196/13601, author="Johnson, Matthew and Jones, Michael and Shervey, Mark and Dudley, T. Joel and Zimmerman, Noah", title="Building a Secure Biomedical Data Sharing Decentralized App (DApp): Tutorial", journal="J Med Internet Res", year="2019", month="Oct", day="23", volume="21", number="10", pages="e13601", keywords="blockchain", keywords="geolocation", keywords="tutorial", keywords="mobile health", keywords="privacy", keywords="DApp", keywords="iOS", keywords="biomedical research", keywords="decentralized application", keywords="smart contract", doi="10.2196/13601", url="https://www.jmir.org/2019/10/e13601", url="http://www.ncbi.nlm.nih.gov/pubmed/31647475" } @Article{info:doi/10.2196/13585, author="Beinke, Heinrich Jan and Fitte, Christian and Teuteberg, Frank", title="Towards a Stakeholder-Oriented Blockchain-Based Architecture for Electronic Health Records: Design Science Research Study", journal="J Med Internet Res", year="2019", month="Oct", day="7", volume="21", number="10", pages="e13585", keywords="blockchain", keywords="electronic health records", keywords="data security", keywords="information storage and retrieval", abstract="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. ", doi="10.2196/13585", url="https://www.jmir.org/2019/10/e13585", url="http://www.ncbi.nlm.nih.gov/pubmed/31593548" } @Article{info:doi/10.2196/13587, author="Jin, Xiao-Ling and Zhang, Miao and Zhou, Zhongyun and Yu, Xiaoyu", title="Application of a Blockchain Platform to Manage and Secure Personal Genomic Data: A Case Study of LifeCODE.ai in China", journal="J Med Internet Res", year="2019", month="Sep", day="10", volume="21", number="9", pages="e13587", keywords="genomics big data platform", keywords="blockchain", keywords="data ownership", keywords="data sharing", keywords="data security", keywords="digital health", abstract="Background: The rapid development of genetic and genomic technologies, such as next-generation sequencing and genome editing, has made disease treatment much more precise and effective. The technologies' value can only be realized by the aggregation and analysis of people's genomic and health data. However, the collection and sharing of genomic data has many obstacles, including low data quality, information islands, tampering distortions, missing records, leaking of private data, and gray data transactions. Objective: This study aimed to prove that emerging blockchain technology provides a solution for the protection and management of sensitive personal genomic data because of its decentralization, traceability, encryption algorithms, and antitampering features. Methods: This paper describes the case of a blockchain-based genomic big data platform, LifeCODE.ai, to illustrate the means by which blockchain enables the storage and management of genomic data from the perspectives of data ownership, data sharing, and data security. Results: Blockchain opens up new avenues for dealing with data ownership, data sharing, and data security issues in genomic big data platforms and realizes the psychological empowerment of individuals in the platform. Conclusions: The blockchain platform provides new possibilities for the management and security of genetic data and can help realize the psychological empowerment of individuals in the process, and consequently, the effects of data self-governance, incentive-sharing, and security improvement can be achieved. However, there are still some problems in the blockchain that have not been solved, and which require continuous in-depth research and innovation in the future. ", doi="10.2196/13587", url="http://www.jmir.org/2019/9/e13587/", url="http://www.ncbi.nlm.nih.gov/pubmed/31507268" } @Article{info:doi/10.2196/13592, author="Hylock, Hales Ray and Zeng, Xiaoming", title="A Blockchain Framework for Patient-Centered Health Records and Exchange (HealthChain): Evaluation and Proof-of-Concept Study", journal="J Med Internet Res", year="2019", month="Aug", day="31", volume="21", number="8", pages="e13592", keywords="blockchain", keywords="chameleon hashing", keywords="health information exchange", keywords="health information management", keywords="HL7 FHIR", keywords="patient-centered health", keywords="medical records", keywords="proxy re-encryption", keywords="redactable blockchain", keywords="smart contracts", keywords="digital health", keywords="electronic health records", abstract="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. ", doi="10.2196/13592", url="http://www.jmir.org/2019/8/e13592/", url="http://www.ncbi.nlm.nih.gov/pubmed/31471959" } @Article{info:doi/10.2196/13600, author="Jones, Michael and Johnson, Matthew and Shervey, Mark and Dudley, T. Joel and Zimmerman, Noah", title="Privacy-Preserving Methods for Feature Engineering Using Blockchain: Review, Evaluation, and Proof of Concept", journal="J Med Internet Res", year="2019", month="Aug", day="14", volume="21", number="8", pages="e13600", keywords="privacy", keywords="machine learning", keywords="confidentiality", keywords="data collection", keywords="mobile health", keywords="feature engineering", keywords="geolocation", keywords="blockchain", keywords="smart contract", keywords="cryptography", keywords="trusted execution environment", abstract="Background: The protection of private data is a key responsibility for research studies that collect identifiable information from study participants. Limiting the scope of data collection and preventing secondary use of the data are effective strategies for managing these risks. An ideal framework for data collection would incorporate feature engineering, a process where secondary features are derived from sensitive raw data in a secure environment without a trusted third party. Objective: This study aimed to compare current approaches based on how they maintain data privacy and the practicality of their implementations. These approaches include traditional approaches that rely on trusted third parties, and cryptographic, secure hardware, and blockchain-based techniques. Methods: A set of properties were defined for evaluating each approach. A qualitative comparison was presented based on these properties. The evaluation of each approach was framed with a use case of sharing geolocation data for biomedical research. Results: We found that approaches that rely on a trusted third party for preserving participant privacy do not provide sufficiently strong guarantees that sensitive data will not be exposed in modern data ecosystems. Cryptographic techniques incorporate strong privacy-preserving paradigms but are appropriate only for select use cases or are currently limited because of computational complexity. Blockchain smart contracts alone are insufficient to provide data privacy because transactional data are public. Trusted execution environments (TEEs) may have hardware vulnerabilities and lack visibility into how data are processed. Hybrid approaches combining blockchain and cryptographic techniques or blockchain and TEEs provide promising frameworks for privacy preservation. For reference, we provide a software implementation where users can privately share features of their geolocation data using the hybrid approach combining blockchain with TEEs as a supplement. Conclusions: Blockchain technology and smart contracts enable the development of new privacy-preserving feature engineering methods by obviating dependence on trusted parties and providing immutable, auditable data processing workflows. The overlap between blockchain and cryptographic techniques or blockchain and secure hardware technologies are promising fields for addressing important data privacy needs. Hybrid blockchain and TEE frameworks currently provide practical tools for implementing experimental privacy-preserving applications. ", doi="10.2196/13600", url="http://www.jmir.org/2019/8/e13600/", url="http://www.ncbi.nlm.nih.gov/pubmed/31414666" } @Article{info:doi/10.2196/13767, author="Zhu, Xiaobao and Shi, Jing and Lu, Cuiyuan", title="Cloud Health Resource Sharing Based on Consensus-Oriented Blockchain Technology: Case Study on a Breast Tumor Diagnosis Service", journal="J Med Internet Res", year="2019", month="Jul", day="23", volume="21", number="7", pages="e13767", keywords="blockchain", keywords="cloud health", keywords="breast tumor diagnosis", keywords="k-nearest neighbors (KNN)", keywords="Proof of Authority (PoA)", keywords="consensus-oriented", abstract="Background: In recent years, researchers have made significant efforts in advancing blockchain technology. This technology, with distinct features of decentralization and security, can be applied to many fields. In areas of health data and resource sharing, applications of blockchain technology are also emerging. Objective: In this study, we propose a cloud health resource-sharing model based on consensus-oriented blockchain technology and have developed a simulation study on breast tumor diagnosis. Methods: The proposed platform is built on a consortium or federated blockchain that possesses features of both centralization and decentralization. The consensus mechanisms generate operating standards for the proposed model. Open source Ethereum code is employed to provide the blockchain environment. Proof of Authority is selected as the consensus algorithm of block generation. Results: Based on the proposed model, a simulation case study for breast tumor classification is constructed. The simulation includes 9893 service requests from 100 users; 22 service providers are equipped with 22 different classification methods. Each request is fulfilled by a service provider recommended by the weighted k-nearest neighbors (KNN) algorithm. The majority of service requests are handled by 9 providers, and provider service evaluation scores tend to stabilize. Also, user priority on KNN weights significantly affects the system operation outcome. Conclusions: The proposed model is feasible based on the simulation case study for the cloud service of breast tumor diagnosis and has the potential to be applied to other applications. ", doi="10.2196/13767", url="http://www.jmir.org/2019/7/e13767/", url="http://www.ncbi.nlm.nih.gov/pubmed/31339106" } @Article{info:doi/10.2196/14184, author="Esmaeilzadeh, Pouyan and Mirzaei, Tala", title="The Potential of Blockchain Technology for Health Information Exchange: Experimental Study From Patients' Perspectives", journal="J Med Internet Res", year="2019", month="Jun", day="20", volume="21", number="6", pages="e14184", keywords="health information exchange", keywords="patients", keywords="privacy", keywords="trust", keywords="risk", keywords="perception", abstract="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. ", doi="10.2196/14184", url="http://www.jmir.org/2019/6/e14184/", url="http://www.ncbi.nlm.nih.gov/pubmed/31223119" } @Article{info:doi/10.2196/13665, author="Hawig, David and Zhou, Chao and Fuhrhop, Sebastian and Fialho, S. Andre and Ramachandran, Navin", title="Designing a Distributed Ledger Technology System for Interoperable and General Data Protection Regulation--Compliant Health Data Exchange: A Use Case in Blood Glucose Data", journal="J Med Internet Res", year="2019", month="Jun", day="14", volume="21", number="6", pages="e13665", keywords="distributed ledger technology", keywords="directed acyclic graph", keywords="IOTA", keywords="IPFS", keywords="blockchain", keywords="Masked Authenticated Messaging, MAM", keywords="mobile health", keywords="blood glucose", keywords="diabetes", keywords="FHIR", abstract="Background: Distributed ledger technology (DLT) holds great potential to improve health information exchange. However, the immutable and transparent character of this technology may conflict with data privacy regulations and data processing best practices. Objective: The aim of this paper is to develop a proof-of-concept system for immutable, interoperable, and General Data Protection Regulation (GDPR)--compliant exchange of blood glucose data. Methods: Given that there is no ideal design for a DLT-based patient-provider data exchange solution, we proposed two different variations for our proof-of-concept system. One design was based purely on the public IOTA distributed ledger (a directed acyclic graph-based DLT) and the second used the same public IOTA ledger in combination with a private InterPlanetary File System (IPFS) cluster. Both designs were assessed according to (1) data reversal risk, (2) data linkability risks, (3) processing time, (4) file size compatibility, and (5) overall system complexity. Results: The public IOTA design slightly increased the risk of personal data linkability, had an overall low processing time (requiring mean 6.1, SD 1.9 seconds to upload one blood glucose data sample into the DLT), and was relatively simple to implement. The combination of the public IOTA with a private IPFS cluster minimized both reversal and linkability risks, allowed for the exchange of large files (3 months of blood glucose data were uploaded into the DLT in mean 38.1, SD 13.4 seconds), but involved a relatively higher setup complexity. Conclusions: For the specific use case of blood glucose explored in this study, both designs presented a suitable performance in enabling the interoperable exchange of data between patients and providers. Additionally, both systems were designed considering the latest guidelines on personal data processing, thereby maximizing the alignment with recent GDPR requirements. For future works, these results suggest that the conflict between DLT and data privacy regulations can be addressed if careful considerations are made regarding the use case and the design of the data exchange system. ", doi="10.2196/13665", url="http://www.jmir.org/2019/6/e13665/", url="http://www.ncbi.nlm.nih.gov/pubmed/31199293" } @Article{info:doi/10.2196/13583, author="Zheng, Xiaochen and Sun, Shengjing and Mukkamala, Rao Raghava and Vatrapu, Ravi and Ordieres-Mer{\'e}, Joaqu{\'i}n", title="Accelerating Health Data Sharing: A Solution Based on the Internet of Things and Distributed Ledger Technologies", journal="J Med Internet Res", year="2019", month="Jun", day="06", volume="21", number="6", pages="e13583", keywords="Internet of Things", keywords="distributed ledger technologies", keywords="data sharing", keywords="health information interoperability", keywords="IOTA Tangle", keywords="masked authenticated messaging", keywords="blockchain", keywords="intelligent healthcare", abstract="Background: Huge amounts of health-related data are generated every moment with the rapid development of Internet of Things (IoT) and wearable technologies. These big health data contain great value and can bring benefit to all stakeholders in the health care ecosystem. Currently, most of these data are siloed and fragmented in different health care systems or public and private databases. It prevents the fulfillment of intelligent health care inspired by these big data. Security and privacy concerns and the lack of ensured authenticity trails of data bring even more obstacles to health data sharing. With a decentralized and consensus-driven nature, distributed ledger technologies (DLTs) provide reliable solutions such as blockchain, Ethereum, and IOTA Tangle to facilitate the health care data sharing. Objective: This study aimed to develop a health-related data sharing system by integrating IoT and DLT to enable secure, fee-less, tamper-resistant, highly-scalable, and granularly-controllable health data exchange, as well as build a prototype and conduct experiments to verify the feasibility of the proposed solution. Methods: The health-related data are generated by 2 types of IoT devices: wearable devices and stationary air quality sensors. The data sharing mechanism is enabled by IOTA's distributed ledger, the Tangle, which is a directed acyclic graph. Masked Authenticated Messaging (MAM) is adopted to facilitate data communications among different parties. Merkle Hash Tree is used for data encryption and verification. Results: A prototype system was built according to the proposed solution. It uses a smartwatch and multiple air sensors as the sensing layer; a smartphone and a single-board computer (Raspberry Pi) as the gateway; and a local server for data publishing. The prototype was applied to the remote diagnosis of tremor disease. The results proved that the solution could enable costless data integrity and flexible access management during data sharing. Conclusions: DLT integrated with IoT technologies could greatly improve the health-related data sharing. The proposed solution based on IOTA Tangle and MAM could overcome many challenges faced by other traditional blockchain-based solutions in terms of cost, efficiency, scalability, and flexibility in data access management. This study also showed the possibility of fully decentralized health data sharing by replacing the local server with edge computing devices. ", doi="10.2196/13583", url="https://www.jmir.org/2019/6/e13583/", url="http://www.ncbi.nlm.nih.gov/pubmed/31172963" } @Article{info:doi/10.2196/13385, author="Motohashi, Tomomitsu and Hirano, Tomonobu and Okumura, Kosuke and Kashiyama, Makiko and Ichikawa, Daisuke and Ueno, Taro", title="Secure and Scalable mHealth Data Management Using Blockchain Combined With Client Hashchain: System Design and Validation", journal="J Med Internet Res", year="2019", month="May", day="16", volume="21", number="5", pages="e13385", keywords="mobile health", keywords="electronic health records", keywords="blockchain", keywords="client hashchain", keywords="clinical trial", abstract="Background: Blockchain is emerging as an innovative technology for secure data management in many areas, including medical practice. A distributed blockchain network is tolerant against network fault, and the registered data are resistant to tampering and revision. The technology has a high affinity with digital medicine like mobile health (mHealth) and provides reliability to the medical data without labor-intensive third-party contributions. On the other hand, the reliability of the medical data is not insured before registration to the blockchain network. Furthermore, there are issues with regard to how the clients' mobile devices should be dealt with and authenticated in the blockchain network in order to avoid impersonation. Objective: The aim of the study was to design and validate an mHealth system that enables the compatibility of the security and scalability of the medical data using blockchain technology. Methods: We designed an mHealth system that sends medical data to the blockchain network via relay servers. The architecture provides scalability and convenience of operation of the system. In order to ensure the reliability of the data from clients' mobile devices, hash values with chain structure (client hashchain) were calculated in the clients' devices and the results were registered on the blockchain network. Results: The system was applied and deployed in mHealth for insomnia treatment. Clinical trials for mHealth were conducted with insomnia patients. Medical data of the recruited patients were successfully registered with the blockchain network via relay servers along with the hashchain calculated on the clients' mobile devices. The correctness of the data was validated by identifying illegal data, which were made by simulating fraudulent access. Conclusions: Our proposed mHealth system, blockchain combined with client hashchain, ensures compatibility of security and scalability in the data management of mHealth medical practice. Trial Registration: UMIN Clinical Trials Registry UMIN000032951; https://upload.umin.ac.jp/cgi-open- bin/ctr\_e/ctr\_view.cgi?recptno=R000037564 (Archived by WebCite at http://www.webcitation.org/78HP5iFIw) ", doi="10.2196/13385", url="http://www.jmir.org/2019/5/e13385/", url="http://www.ncbi.nlm.nih.gov/pubmed/31099337" } @Article{info:doi/10.2196/12426, author="O'Donoghue, Odhran and Vazirani, A. Anuraag and Brindley, David and Meinert, Edward", title="Design Choices and Trade-Offs in Health Care Blockchain Implementations: Systematic Review", journal="J Med Internet Res", year="2019", month="May", day="10", volume="21", number="5", pages="e12426", keywords="blockchain", keywords="interoperability", keywords="distributed ledger technology", keywords="scalability", keywords="health information exchange", abstract="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 ", doi="10.2196/12426", url="https://www.jmir.org/2019/5/e12426/", url="http://www.ncbi.nlm.nih.gov/pubmed/31094344" } @Article{info:doi/10.2196/10654, author="Khurshid, Anjum and Gadnis, Ashish", title="Using Blockchain to Create Transaction Identity for Persons Experiencing Homelessness in America: Policy Proposal", journal="JMIR Res Protoc", year="2019", month="Mar", day="06", volume="8", number="3", pages="e10654", keywords="affordable housing", keywords="Austin", keywords="blockchain", keywords="distributed ledger", keywords="emergency medical services", keywords="health information", keywords="homelessness", keywords="interoperability", keywords="transaction identity", doi="10.2196/10654", url="http://www.researchprotocols.org/2019/3/e10654/", url="http://www.ncbi.nlm.nih.gov/pubmed/30839279" } @Article{info:doi/10.2196/12439, author="Vazirani, A. Anuraag and O'Donoghue, Odhran and Brindley, David and Meinert, Edward", title="Implementing Blockchains for Efficient Health Care: Systematic Review", journal="J Med Internet Res", year="2019", month="Feb", day="12", volume="21", number="2", pages="e12439", keywords="blockchain", keywords="electronic health records", keywords="efficiency", keywords="interoperability", keywords="health", keywords="information science", keywords="computers", abstract="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 ", doi="10.2196/12439", url="http://www.jmir.org/2019/2/e12439/", url="http://www.ncbi.nlm.nih.gov/pubmed/30747714" } @Article{info:doi/10.2196/12533, author="Park, Rang Yu and Lee, Eunsol and Na, Wonjun and Park, Sungjun and Lee, Yura and Lee, Jae-Ho", title="Is Blockchain Technology Suitable for Managing Personal Health Records? Mixed-Methods Study to Test Feasibility", journal="J Med Internet Res", year="2019", month="Feb", day="08", volume="21", number="2", pages="e12533", keywords="personal health record", keywords="mobile health", keywords="blockchain", keywords="Ethereum", abstract="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. ", doi="10.2196/12533", url="http://www.jmir.org/2019/2/e12533/", url="http://www.ncbi.nlm.nih.gov/pubmed/30735142" } @Article{info:doi/10.2196/10994, author="Meinert, Edward and Alturkistani, Abrar and Foley, A. Kimberley and Osama, Tasnime and Car, Josip and Majeed, Azeem and Van Velthoven, Michelle and Wells, Glenn and Brindley, David", title="Blockchain Implementation in Health Care: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2019", month="Feb", day="08", volume="8", number="2", pages="e10994", keywords="blockchain", keywords="electronic health records", keywords="efficiency", keywords="interoperability", keywords="health", keywords="information science", keywords="computers", abstract="Background: A blockchain is a digitized, decentralized, distributed public ledger that acts as a shared and synchronized database that records cryptocurrency transactions. Despite the shift toward digital platforms enabled by electronic medical records, demonstrating a will to reform the health care sector, health systems face issues including security, interoperability, data fragmentation, timely access to patient data, and silos. The application of health care blockchains could enable data interoperability, enhancement of precision medicine, and reduction in prescription frauds through implementing novel methods in access and patient consent. Objective: To summarize the evidence on the strategies and frameworks utilized to implement blockchains for patient data in health care to ensure privacy and improve interoperability and scalability. It is anticipated this review will assist in the development of recommendations that will assist key stakeholders in health care blockchain implementation, and we predict that the evidence generated will challenge the health care status quo, moving away from more traditional approaches and facilitating decision making of patients, health care providers, and researchers. Methods: A systematic search of MEDLINE/PubMed, Embase, Scopus, ProQuest Technology Collection and Engineering Index will be conducted. Two experienced independent reviewers will conduct titles and abstract screening followed by full-text reading to determine study eligibility. Data will then be extracted onto data extraction forms before using the Cochrane Collaboration Risk of Bias Tool to appraise the quality of included randomized studies and the Risk of Bias in nonrandomized studies of Interventions to assess the quality of nonrandomized studies. Data will then be analyzed and synthesized. Results: Database searches will be initiated in September 2018. We expect to complete the review in January 2019. Conclusions: This review will summarize the strategies and frameworks used to implement blockchains in health care to increase data privacy, interoperability, and scalability. This review will also help clarify if the strategies and frameworks required for the operationalization of blockchains in health care ensure the privacy of patient data while enabling efficiency, interoperability, and scalability. International Registered Report Identifier (IRRID): PRR1-10.2196/10994 ", doi="10.2196/10994", url="http://www.researchprotocols.org/2019/2/e10994/", url="http://www.ncbi.nlm.nih.gov/pubmed/30735146" } @Article{info:doi/10.2196/11949, author="Maslove, M. David and Klein, Jacob and Brohman, Kathryn and Martin, Patrick", title="Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study", journal="JMIR Med Inform", year="2018", month="Dec", day="21", volume="6", number="4", pages="e11949", keywords="blockchain", keywords="clinical trial", keywords="informatics", keywords="data accuracy", keywords="data collection", abstract="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. ", doi="10.2196/11949", url="http://medinform.jmir.org/2018/4/e11949/", url="http://www.ncbi.nlm.nih.gov/pubmed/30578196" } @Article{info:doi/10.2196/10163, author="Sylim, Patrick and Liu, Fang and Marcelo, Alvin and Fontelo, Paul", title="Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention", journal="JMIR Res Protoc", year="2018", month="Sep", day="13", volume="7", number="9", pages="e10163", keywords="supply and distribution", keywords="information systems", keywords="counterfeit drugs", keywords="blockchain", abstract="Background: Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30\% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network. Objective: This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network. Methods: We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal. Results: Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type--specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history. Conclusions: Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability. Registered Report Identifier: RR1-10.2196/10163 ", doi="10.2196/10163", url="http://www.researchprotocols.org/2018/9/e10163/", url="http://www.ncbi.nlm.nih.gov/pubmed/30213780" } @Article{info:doi/10.2196/10725, author="Balsari, Satchit and Fortenko, Alexander and Blaya, A. Joaqu{\'i}n and Gropper, Adrian and Jayaram, Malavika and Matthan, Rahul and Sahasranam, Ram and Shankar, Mark and Sarbadhikari, N. Suptendra and Bierer, E. Barbara and Mandl, D. Kenneth and Mehendale, Sanjay and Khanna, Tarun", title="Reimagining Health Data Exchange: An Application Programming Interface--Enabled Roadmap for India", journal="J Med Internet Res", year="2018", month="Jul", day="13", volume="20", number="7", pages="e10725", keywords="health information exchange", keywords="India", keywords="health APIs", doi="10.2196/10725", url="http://www.jmir.org/2018/7/e10725/", url="http://www.ncbi.nlm.nih.gov/pubmed/30006325" } @Article{info:doi/10.2196/mhealth.7938, author="Ichikawa, Daisuke and Kashiyama, Makiko and Ueno, Taro", title="Tamper-Resistant Mobile Health Using Blockchain Technology", journal="JMIR Mhealth Uhealth", year="2017", month="Jul", day="26", volume="5", number="7", pages="e111", keywords="telemedicine", keywords="electronic health records", keywords="sleep", keywords="cognitive therapy", keywords="computer security", abstract="Background: Digital health technologies, including telemedicine, mobile health (mHealth), and remote monitoring, are playing a greater role in medical practice. Safe and accurate management of medical information leads to the advancement of digital health, which in turn results in a number of beneficial effects. Furthermore, mHealth can help lower costs by facilitating the delivery of care and connecting people to their health care providers. Mobile apps help empower patients and health care providers to proactively address medical conditions through near real-time monitoring and treatment, regardless of the location of the patient or the health care provider. Additionally, mHealth data are stored in servers, and consequently, data management that prevents all forms of manipulation is crucial for both medical practice and clinical trials. Objective: The aim of this study was to develop and evaluate a tamper-resistant mHealth system using blockchain technology, which enables trusted and auditable computing using a decentralized network. Methods: We developed an mHealth system for cognitive behavioral therapy for insomnia using a smartphone app. The volunteer data collected with the app were stored in JavaScript Object Notation format and sent to the blockchain network. Thereafter, we evaluated the tamper resistance of the data against the inconsistencies caused by artificial faults. Results: Electronic medical records collected using smartphones were successfully sent to a private Hyperledger Fabric blockchain network. We verified the data update process under conditions where all the validating peers were running normally. The mHealth data were successfully updated under network faults. We further ensured that any electronic health record registered to the blockchain network was resistant to tampering and revision. The mHealth data update was compatible with tamper resistance in the blockchain network. Conclusions: Blockchain serves as a tamperproof system for mHealth. Combining mHealth with blockchain technology may provide a novel solution that enables both accessibility and data transparency without a third party such as a contract research organization. ", doi="10.2196/mhealth.7938", url="http://mhealth.jmir.org/2017/7/e111/", url="http://www.ncbi.nlm.nih.gov/pubmed/28747296" } @Article{info:doi/10.2196/jmir.6686, author="Rouleau, Genevi{\`e}ve and Gagnon, Marie-Pierre and C{\^o}t{\'e}, Jos{\'e} and Payne-Gagnon, Julie and Hudson, Emilie and Dubois, Carl-Ardy", title="Impact of Information and Communication Technologies on Nursing Care: Results of an Overview of Systematic Reviews", journal="J Med Internet Res", year="2017", month="Apr", day="25", volume="19", number="4", pages="e122", keywords="information and communication technology", keywords="eHealth", keywords="telehealth", keywords="nursing care", keywords="review, overview of systematic review", abstract="Background: Information and communication technologies (ICTs) are becoming an impetus for quality health care delivery by nurses. The use of ICTs by nurses can impact their practice, modifying the ways in which they plan, provide, document, and review clinical care. Objective: An overview of systematic reviews was conducted to develop a broad picture of the dimensions and indicators of nursing care that have the potential to be influenced by the use of ICTs. Methods: Quantitative, mixed-method, and qualitative reviews that aimed to evaluate the influence of four eHealth domains (eg, management, computerized decision support systems [CDSSs], communication, and information systems) on nursing care were included. We used the nursing care performance framework (NCPF) as an extraction grid and analytical tool. This model illustrates how the interplay between nursing resources and the nursing services can produce changes in patient conditions. The primary outcomes included nurses' practice environment, nursing processes, professional satisfaction, and nursing-sensitive outcomes. The secondary outcomes included satisfaction or dissatisfaction with ICTs according to nurses' and patients' perspectives. Reviews published in English, French, or Spanish from January 1, 1995 to January 15, 2015, were considered. Results: A total of 5515 titles or abstracts were assessed for eligibility and full-text papers of 72 articles were retrieved for detailed evaluation. It was found that 22 reviews published between 2002 and 2015 met the eligibility criteria. Many nursing care themes (ie, indicators) were influenced by the use of ICTs, including time management; time spent on patient care; documentation time; information quality and access; quality of documentation; knowledge updating and utilization; nurse autonomy; intra and interprofessional collaboration; nurses' competencies and skills; nurse-patient relationship; assessment, care planning, and evaluation; teaching of patients and families; communication and care coordination; perspectives of the quality of care provided; nurses and patients satisfaction or dissatisfaction with ICTs; patient comfort and quality of life related to care; empowerment; and functional status. Conclusions: The findings led to the identification of 19 indicators related to nursing care that are impacted by the use of ICTs. To the best of our knowledge, this was the first attempt to apply NCPF in the ICTs' context. This broad representation could be kept in mind when it will be the time to plan and to implement emerging ICTs in health care settings. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews: CRD42014014762; http://www.crd.york.ac.uk/PROSPERO/display\_record.asp?ID=CRD42014014762 (Archived by WebCite at http://www.webcitation.org/6pIhMLBZh) ", doi="10.2196/jmir.6686", url="http://www.jmir.org/2017/4/e122/", url="http://www.ncbi.nlm.nih.gov/pubmed/28442454" }