Testing the At-Home In-Vitro Test Report Implementation Guide, which provides resources for use in transmitting At-Home In-Vitro Test results to local, state, territorial and federal health agencies.
Point-of-care (POC) and At-Home In-Vitro Tests offer increased accessibility to needed diagnostic solutions during a pandemic. Test results provide value to both the individual taking the tests and also to public health authorities responsible for coordinating a regional and national response. Digital platforms are being developed that allow individual test results, with permission of the individual, to be captured, organized, and transmitted to public health systems. This IG gives test manufacturers, working in partnership with these digital platforms, guidance on how to send test results. With multiple tests already entering the market, there is a need for a unified strategy on data flow of test results from the apps to downstream systems. A national data exchange standard should be supported that guides data exchange from test results residing on individual users’ digital test applications to public health authorities, at both the federal and regional levels.
This implementation guide is for use in transmitting At-Home In-Vitro Test results to local, state, territorial and federal health agencies. It was developed as part of a collaborative project with the NIH/NIBIB, ONC, a vendor manufacturer of diagnostic healthcare products that makes one of the FDA approved At-Home In-Vitro Test kits, and an app developer who is a leading provider of secure interoperability solutions. The intention of this guide is to assist developers in producing and sending standardized FHIR test result data from tests performed at home. FHIR eases app development and the FHIR US Core IG is in a rapid adoption curve. This guide points to already existing US Core Guidance and other guidance with respect to FHIR Parameters, FHIR operations, and RESTful and SMART on FHIR information.
Track Kick off Call
2-3pm ET Wednesday, 19 April, 2023
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Recording: May 2023 Connectathon Track Kick Off - At Home In-Vitro Test Results FHIR IG