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HHS and FDA launch COVID-19 At-Anywhere Diagnostics Design-A-Thon


The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) launch the “COVID-19 At-Anywhere Diagnostics Design-A-Thon”, an initiative to help develop technical innovations to help fight COVID-19.

Capturing diagnostic data from COVID-19 tests is of paramount importance to guide an evidence-based pandemic response at the local, state, and national levels. The primary goal of this event is to spur technological innovation by aligning software developers, designers, and engineers with diagnostic device developers and COVID-19 subject matter experts to build digital tools that are directly integrated with COVID-19 tests (e.g. in vitro diagnostic devices) and testing workflows, both in clinical and non-clinical settings. These digital tools will automate data capture directly from tests, improve harmonization, enhance security, and expedite direct reporting for greater speed, quality, comprehensiveness, and utility of diagnostic data. Timely access to core data elements from both lab-based and non-lab-based tests by public health authorities, healthcare providers, patients, and the public is essential to support real-time, data-driven COVID-19 response efforts. During the event, we will also be building U.S. government-developed tool will be named “Wireless Automated Transmission for Electronic Reporting Systems” (WATERS). The reporting systems could be IVDs (devices- hardware/software), apps, Laboratory Information Management Systems (LIMS), or any other entity that is transmitting/reporting diagnostic data.