Clinical Data Extraction During Public Health Emergencies: A Blockchain Technology Assessment.

OBJECTIVE: We sought to explore the technical and legal readiness of healthcare institutions for novel data-sharing methods that allow clinical information to be extracted from electronic health records (EHRs) and submitted securely to the Food and Drug Administration's (FDA's) blockchain through a secure data broker (SDB). MATERIALS AND METHODS: This assessment was divided into four sections: an institutional EHR readiness assessment, legal consultation, institutional review board application submission, and a test of healthcare data transmission over a blockchain infrastructure. RESULTS: All participating institutions reported the ability to electronically extract data from EHRs for research. Formal legal agreements were deemed unnecessary to the project but would be needed in future tests of real patient data exchange. Data transmission to the FDA blockchain met the success criteria of data connection from within the four institutions' firewalls, externally to the FDA blockchain via a SDB. DISCUSSION: The readiness survey indicated advanced analytic capability in hospital institutions and highlighted inconsistency in Fast Healthcare Interoperability Resources format utilitzation across institutions, despite requirements of the 21st Century Cures Act. Further testing across more institutions and annual exercises leveraging the application of data exchange over a blockchain infrastructure are recommended actions for determining the feasibility of this approach during a public health emergency and broaden the understanding of technical requirements for multisite data extraction. CONCLUSION: The FDA's RAPID (Real-Time Application for Portable Interactive Devices) program, in collaboration with Discovery, the Critical Care Research Network's PREP (Program for Resilience and Emergency Preparedness), identified the technical and legal challenges and requirements for rapid data exchange to a government entity using the FDA blockchain infrastructure.

Do clinical practice guidelines improve processes or outcomes in primary care?

BACKGROUND: Clinical practice guidelines (CPGs) are common, but it is not clear whether they improve care. METHODS: Quality indicators for processes and outcomes of care were obtained from a computerized system-wide database by patient administration and utilization management personnel unaware of this study and without connection to or interests in guideline implementation. These indicators were compared before and after guideline implementation. RESULTS: After the asthma CPG, nebulizer treatments, emergency department visits, and admissions decreased significantly (p < 0.001 for all three) and education increased significantly (p < 0.001). Periodic measurements of lung function and controller medication prescriptions were unchanged. After the diabetes mellitus CPG, microalbumin screens and education increased significantly (p < 0.001). Angiotensin-converting enzyme inhibitor prescriptions and yearly foot examinations decreased significantly, along with the percentage of patients with blood pressure of < or = 130/85 mm Hg (p < 0.001). Mean hemoglobin A(1C) levels did not change significantly. After the tobacco cessation CPG, screening and education increased significantly (p < 0.001 and p = 0.04, respectively). CONCLUSIONS: The asthma CPG improved some processes and all outcomes. The diabetes CPG improved two of the eight measured processes but had no effect on outcomes. Education and screening, but not counseling, improved with the tobacco CPG. CPGs appear to improve diagnostic and educational processes more than provider-dependent treatment processes. Outcomes were improved after implementation of the asthma CPG but not after the diabetes CPG.