MediLinker: a blockchain-based decentralized health information management platform for patient-centric healthcare.

Patients' control over how their health information is stored has been an ongoing issue in health informatics. Currently, most patients' health information is stored in centralized but siloed health information systems of healthcare institutions, rarely connected to or interoperable with other institutions outside of their specific health system. This centralized approach to the storage of health information is susceptible to breaches, though it can be mitigated using technology that allows for decentralized access. One promising technology that offers the possibility of decentralization, data protection, and interoperability is blockchain. In 2019, our interdisciplinary team from the University of Texas at Austin's Dell Medical School, School of Information, Department of Electrical and Computer Engineering, and Information Technology Services developed MediLinker-a blockchain-based decentralized health information management platform for patient-centric healthcare. This paper provides an overview of MediLinker and outlines its ongoing and future development and implementation. Overall, this paper contributes insights into the opportunities and challenges in developing and implementing blockchain-based technologies in healthcare.

Clinical, Organizational and Regulatory, and Ethical and Social (CORES) Issues and Recommendations on Blockchain Deployment for Healthcare: Evidence from Experts.

Objective: While existing research by our team has demonstrated the feasibility of building a decentralized identity management application ("MediLinker") for health information, there are implementation issues related to testing such blockchain-based health applications in real-world clinical settings. In this study, we identified clinical, organizational and regulatory, and ethical and social (CORES) issues, including recommendations, associated with deploying MediLinker, and blockchain in general, for clinical testing. Methods: CORES issues and recommendations were identified through a focus group with 11 academic, industry, and government experts on March 26, 2021. They were grouped according to their expertise: clinical care (n = 4), organizational and regulatory concerns (n = 4), and ethical and social issues (n = 3). The focus group was conducted via Zoom in which experts were briefed about the study aims, formed into breakout groups to identify key issues based on their group's expertise, and reconvened to share identified issues with other groups and to discuss potential recommendations to address such issues. The focus group was video recorded and transcribed. The resulting transcriptions and meeting notes were imported to MAXQDA 2018 for thematic analysis. Results: Clinical experts identified issues that concern the clinical system, clinical administrators, clinicians, and patients. Organizational and regulatory experts emphasized issues on accountability, compliance, and legal safeguards. Ethics and social-context experts raised issues on trust, transparency, digital divide, and health-related digital autonomy. Accordingly, experts proposed six recommendations that could address most of the identified issues: (1) design interfaces based on patient preferences, (2) ensure testing with diverse populations, (3) ensure compliance with existing policies, (4) present potential positive outcomes to top management, (5) maintain clinical workflow, and (6) increase the public's awareness of blockchain. Conclusions: This study identified a myriad of CORES issues associated with deploying MediLinker in clinical settings. Moreover, the study also uncovered several recommendations that could address such issues. The findings raise awareness on CORES issues that should be considered when designing, developing, and deploying blockchain for healthcare. Further, the findings provide additional insights into the development of MediLinker from a prototype to a minimum viable product for clinical testing. Future studies can use CORES as a socio-technical model to identify issues and recommendations associated with deploying health information technologies in clinical settings.

Improving Transitions of Care: Designing a Blockchain Application for Patient Identity Management.

Background: The current healthcare ecosystem in the United States is plagued by inefficiencies in transitions of patient care between healthcare providers due in large part to a lack of interoperability among the many electronic medical record (EMR) systems that exist today. Both providers and patients experience significant frustration due to the negative effects of increased costs, unnecessary administrative burden, and duplication of services that occur because of data fragmentation in the system. Blockchain technology provides a potential solution to mitigate or eliminate these gaps by allowing for exchange of healthcare information that is distributed, auditable, immutable, and respectful of patient autonomy. Our multidisciplinary team identified key tasks required for a transition of care to design and develop a blockchain application, MediLinker, which served as a patient-centric identity management system to address issues of data fragmentation ultimately aiding in the delivery of high-value care services. Methods: The MediLinker application was evaluated for its ability to accomplish various key tasks needed for a successful transition of patient care in an outpatient setting. Our team created 20 unique patient use cases covering a diversity of medical needs and social circumstances that were played out by participants who were asked to perform various tasks as they received case across a simulated healthcare ecosystem composed of four clinics, a research institution, and other ancillary public services. Tasks included, but were not limited to, clinic enrollment, verification of identity, medication reconciliation, sharing insurance and billing information, and updating demographic information. With this iteration of MediLinker, we specifically focused on the functionality of digital guardianship and patient revocation of healthcare information. In addition, throughout the simulation, we surveyed participant perceptions regarding the use of MediLinker and blockchain technology to better ascertain comfortability and usability of the application. Results: Quantitative evaluation of simulation results revealed that MediLinker was able to successfully accomplish all seven clinical scenarios tested across the 20 patient use cases. MediLinker successfully achieved its goal of patient-centered interoperability as participants transitioned their simulated healthcare data, including COVID-19 vaccination status and current medications, across the four clinic sites and research institution. In addition to completing all key tasks designated, all eligible participants were able to enroll with and subsequently revoke data access with our simulated research site. MediLinker had a low data-entry error rate, with most errors occurring due to work-flow vulnerabilities. Our qualitative analysis of user perceptions indicated that comfortability and trust with blockchain technology, such as MediLinker, grew with increased education and exposure to such technology. Conclusions: The ubiquitous problem of data fragmentation in our current healthcare ecosystem has placed considerable strain on providers and patients alike. Blockchain applications for health identity management, such as MediLinker, provide a viable solution to stem the inefficiencies that exist today. The interoperability that MediLinker provided across our simulated healthcare system has the potential to improve transitions of care by sharing key aspects of healthcare information in a timely, secure, and patent-centric fashion allowing for the delivery of consistent and personalized high value care. Blockchain technologies appear to face similar challenges to widespread adoption as other novel interventions, namely recognition, trust, and usability. Further development and scaling are required for such technology to realize its full potential in the real world and transform the practice of modern health care.

Technical Design and Development of A Self-Sovereign Identity Management Platform for Patient-Centric Health Care Using Blockchain Technology.

Objective: Clinical data in the United States are highly fragmented, stored in numerous different databases, and are defined by service providers or clinical specialties rather than by individuals or their families. As a result, linking or aggregating a complete record for a patient is a major technological, legal, and operational challenge. One of the factors that has made clinical data integration so difficult to achieve is the lack of a universal ID for everyone. This leads to other related problems of having to prove identity at each interaction with the health system and repeatedly providing basic information on demographics, insurance, payment, and medical conditions. Traditional solutions that require complex governance, expensive technology, and risks to privacy and security of the data have failed adequately to solve this interoperability problem. We describe the technical design decisions of a patient-centric decentralized health identity management system using the blockchain technology, called MediLinker, to address some of these challenges. Design: Our multidisciplinary research group developed and implemented an identity wallet, which uses the blockchain technology to manage verifiable credentials issued by healthcare clinics, banks, and insurance companies. To manage patient's self-sovereign identity, we leveraged the Hyperledger Indy blockchain framework to store patient's decentralized identifiers (DIDs) and the schemas or format for each credential type. In contrast, the credentials containing patient data are stored 'off-ledger' in each person's wallet and accessible via a computer or smartphone. We used Hyperledger Aries as a middleware layer (API: Application Programming Interface) to connect Hyperledger Indy with the front-end, which was developed using a JavaScript framework, ReactJS (Web Application) and React Native (iOS Application). Results: MediLinker allows users to store their personal data on digital wallets, which they control. It uses a decentralized trusted identity using Hyperledger Indy and Hyperledger Aries. Patients use MediLinker to register and share their information securely and in a trusted system with healthcare and other service providers. Each MediLinker wallet can have six credential types: health ID with patient demographics, insurance, medication list including COVID-19 vaccination status, credit card, medical power of attorney (MPOA) for guardians of pediatric or geriatric patients, and research consent. The system allows for in-person and remote granting and revoking of such permissions for care, research, or other purposes without repeatedly requiring physical identity documents or enrollment information. Conclusion: We successfully developed and tested a blockchain-based technical architecture, described in this article, as an identity management system that may be operationalized and scaled for future implementation to improve patient experience and control over their personal information.

Designing and testing a blockchain application for patient identity management in healthcare.

OBJECTIVE: Healthcare systems suffer from a lack of interoperability that creates "data silos," causing patient linkage and data sharing problems. Blockchain technology's unique architecture provides individuals greater control over their information and may help address some of the problems related to health data. A multidisciplinary team designed and tested a blockchain application, MediLinker, as a patient-centric identity management system. METHODS: The study used simulated data of "avatars" representing different types of patients. Thirty study participants were enrolled to visit simulated clinics, and perform various activities using MediLinker. Evaluation was based on Bouras' criteria for patient-centric identity management and on the number of errors in entry and sharing of data by participants. RESULTS: Twenty-nine of the 30 participants completed all study activities. MediLinker fulfilled all of Bouras' criteria except for one which was not testable. A majority of data errors were due to user error, such as wrong formatting and misspellings. Generally, the number of errors decreased with time. Due to COVID-19, sprint 2 was completed using "virtual" clinic visits. The number of user errors were less in virtual visits than in personal visits. DISCUSSION: The evaluation of MediLinker provides some evidence of the potential of a patient-centric identity management system using blockchain technology. The results showed a working system where patients have greater control over their information and can also easily provide consent for use of their data. CONCLUSION: Blockchain applications for identity management hold great promise for use in healthcare but further research is needed before real-world adoption.

Barriers to the Digitization of Health Information: A Qualitative and Quantitative Study in Kenya and Lao PDR Using a Cloud-Based Maternal and Child Registration System.

Digitalization of health information can assist patient information management and improve health services even in low middle-income countries. We have implemented a mother and child health registration system in the study areas of Kenya and Lao PDR to evaluate barriers to digitalization. We conducted in-depth interviews with 20 healthcare workers (HCWs) who used the system and analyzed it qualitatively with thematic framework analysis. Quantitatively, we analyzed the quality of recorded data according to missing information by the logistic regression analysis. The qualitative analysis identified six themes related to digitalization: satisfaction with the system, mothers' resistance, need for training, double work, working environment, and other resources. The quantitative analysis showed that data entry errors improved around 10% to 80% based on odds ratios in subsequent quarters compared to first quarter periods. The number of registration numbers was not significantly related to the data quality, but the motivation, including financial incentives among HCWs, was related to the registration behavior. Considering both analysis results, workload and motivation to maintain high performance were significant obstacles to implementing a digital health system. We recommend enhancing the scope and focus on human needs and satisfaction as a significant factor for digital system durability and sustainability.

The Phenotypic Spectrum of a Mutation Hotspot Responsible for the Short QT Syndrome.

OBJECTIVES: This study sought to evaluate the phenotypic and functional expression of an apparent hotspot mutation associated with short QT syndrome (SQTS). BACKGROUND: SQTS is a rare channelopathy associated with a high risk of life-threatening arrhythmias and sudden cardiac death (SCD). METHODS: Probands diagnosed with SQTS and their family members were evaluated clinically and genetically. KCNH2 wild-type (WT) and mutant genes were transiently expressed in HEK293 cells, and currents were recorded using whole-cell patch clamp and action potential (AP) clamp techniques. RESULTS: KCNH2-T618I was identified in 18 members of 7 unrelated families (10 men; median age: 24.0 years). All carriers showed 100% penetrance with variable expressivity. Eighteen members in 7 families had SCD. The average QTc intervals of probands and all carriers was 294.1 ± 23.8 ms and 313.2 ± 23.8 ms, respectively. Seven carriers received an implantable cardioverter-defibrillator. Quinidine with adequate plasma levels was effective in prolonging QTc intervals among 5 cases, but 3 cases still had premature ventricular contraction or nonsustained ventricular tachycardia. Bepridil successfully prevented drug-refractory ventricular fibrillation in 1 case with 19-ms prolongation of the QTc interval. Functional studies with KCNE2 revealed a significant increase of IKr (rapidly activating delayed rectifier potassium channel) tail-current density in homozygous (119.0%) and heterozygous (74.6%) expression compared with WT. AP clamp recordings showed IKr was larger, and peak repolarizing current occurred earlier in mutant versus WT channels. CONCLUSIONS: We reported the clinical characteristics and biophysical properties of the highly frequent mutation that contributes to genetically identified SQTS probands. These findings extend our understanding of the spectrum of KCNH2 channel defects in SQTS.

Genotype-dependent differences in age of manifestation and arrhythmia complications in short QT syndrome.

BACKGROUND: Short QT syndrome (SQTS) is a rare inheritable arrhythmia, associated with atrial and ventricular fibrillations, caused by mutations in six cardiac ion channel genes with high penetrance. However, genotype-specific clinical differences between SQTS patients remain to be elucidated. METHODS AND RESULTS: We screened five unrelated Japanese SQTS families, and identified three mutations in KCNH2 and KCNQ1. A novel mutation KCNH2-I560T, when expressed in COS-7 cells, showed a 2.5-fold increase in peak current density, and a positive shift (+14 mV) of the inactivation curve compared with wild type. Computer simulations recapitulated the action potential shortening and created an arrhythmogenic substrate for ventricular fibrillation. In another family carrying the mutation KCNQ1-V141M, affected members showed earlier onset of manifestation and frequent complications of bradyarrhythmia. To determine genotype-specific phenotypes in SQT1 (KCNH2), SQT2 (KCNQ1), and other subtypes SQT3-6, we analyzed clinical variables in 65 mutation-positive patients among all the 132 SQTS cases previously reported. The age of manifestation was significantly later in SQT1 (SQT1: 35 ± 19 years, n = 30; SQT2: 17 ± 25 years, n = 8, SQT3-6: 19 ± 15 years, n = 15; p = 0.011). SQT2 exhibited a higher prevalence of bradyarrhythmia (SQT2: 6/8, 75%; non-SQT2: 5/57, 9%; p < 0.001) and atrial fibrillation (SQT2: 5/8, 63%; non-SQT2: 12/57, 21%; p = 0.012). Of 51 mutation-positive individuals from 16 SQTS families, nine did not manifest short QT, but exhibited other ECG abnormalities such as atrial fibrillation. The resulting penetrance, 82%, was lower than previously recognized. CONCLUSION: We propose that SQTS patients may exhibit different clinical manifestations depending upon their genotype.

Low-cost remote patient monitoring system based on reduced platform computer technology.

Telemedicine is a well-accepted method providing healthcare benefits to people over long distances. However, in normal telemedicine practices, dedicated complex hardware and network backbones for data collection and communication make the system unintelligible to the common man. Centralization of telemedicine units also makes it accessible only to the immediate surrounding community. In an attempt to address these issues, a study aimed at developing a low-cost remote patient monitoring (RPM) system based on reduced platform computer technology has been carried out. The main focus of the work was to develop a real-time, universal serial bus plug-in module for a portable RPM system, specifically the XO Laptop. In addition, this system is also intended to serve as an educational tool especially for the One Laptop per Child target community. This article discusses data collection, preprocessing, and constraints such as network bandwidth and power availability prior to data transmission over a user datagram protocol (UDP)-based network.