Development and Pilot-Test of Blockchain-Based MyHealthData Platform

The concept of MyData emerged as a paradigm shift in personal data management and the process of seeking to transform the current organization-centered system. MyData enables the utilization of one’s own personal information that is scattered among various institutions as a system for data subjects to exercise rights of self-determination. We aimed to develop and demonstrate a MyData platform (MyHealthData) that allows data subjects to download and manage health-related personal data stored in various medical institutions. The platform consists of a mobile app for users, API (application–program interface) for data conversion and exchange installed in the hospital information system (HIS), and a relay server connected to the blockchain to ensure data integrity. User surveys were conducted to explore perceived usefulness, perceived ease of use, and satisfaction. We provided four services to users through the platform developed in this study: inquiring about medical and health checkup records, health coaching, checking conditions of participation in clinical research, and claims, all by using an app. A total of 1228 participants signed up for the service and the overall user satisfaction was high, especially with ‘inquire about medical and health checkup records’. MyData brings a user-centered paradigm in which data subjects can directly participate in the use of their own data. MyData will improve healthcare data interoperability, allowing it to be used not only in research areas but also in other areas by sharing and integrating various healthcare data

Safety and Immunogenicity of the ID93 + GLA-SE Tuberculosis Vaccine in BCG-Vaccinated Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

Abstract Introduction This randomized, double-blind, placebo-controlled, phase 2a trial was conducted to evaluate the safety and immunogenicity of the ID93 + glucopyranosyl lipid adjuvant (GLA)-stable emulsion (SE) vaccine in human immunodeficiency virus (HIV)-negative, previously Bacillus Calmette–Guérin (BCG)-vaccinated, and QuantiFERON-TB-negative healthy adults in South Korea. Methods Adults (n = 107) with no signs or symptoms of tuberculosis were randomly assigned to receive three intramuscular injections of 2 μg ID93 + 5 μg GLA-SE, 10 μg ID93 + 5 μg GLA-SE, or 0.9% normal saline placebo on days 0, 28, and 56. For safety assessment, data on solicited adverse events (AEs), unsolicited AEs, serious AEs (SAEs), and special interest AEs were collected. Antigen-specific antibody responses were measured using serum enzyme-linked immunosorbent assay. T-cell immune responses were measured using enzyme-linked immunospot and intracellular cytokine staining. Results No SAEs, deaths, or AEs leading to treatment discontinuation were found. The solicited local and systemic AEs observed were consistent with those previously reported. Compared with adults administered with the placebo, those administered with three intramuscular vaccine injections exhibited significantly higher antigen-specific antibody levels and Type 1 T-helper cellular immune responses. Conclusion The ID93 + GLA-SE vaccine induced antigen-specific cellular and humoral immune responses, with an acceptable safety profile in previously healthy, BCG-vaccinated, Mycobacterium tuberculosis-uninfected adult healthcare workers. Trial Registration This clinical trial was retrospectively registered on 16 January 2019 at Clinicaltrials.gov (NCT03806686)