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Section 1c: FHIR®
Section 3: Implementation Guides

HL7 FHIR® R4 Implementation Guide: At-Home In-Vitro Test Report, Release 1 - US Realm

DESCRIPTION

This implementation guide (IG) 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.

 

See the specification at http://hl7.org/fhir/us/home-lab-report/STU1

ALTERNATIVE NAMES

HL7 FHIR® R4 Implementation Guide: At-Home In-Vitro Test Report, Release 1 - US Realm may also go by the following names or acronyms:

"HL7 FHIR® IG: At-Home Test Report, Release 1 - US Realm", At-Home Testing

BENEFITS

  • Provides guidance to at-home test manufacturers, working in partnership with digital platforms on how to send test results.
  • Provides a unified strategy on data flow of test results from the at-home in-vitro test apps to downstream systems.
  • Provides a national data exchange standard 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.

IMPLEMENTATIONS/CASE STUDIES

  • https://www.nibib.nih.gov/covid-19/radx-tech-program/mars
  • https://careevolution.com/

DEVELOPMENT BACKGROUND

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. Test manufacturers, working in partnership with these digital platforms, are seeking 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.

RELATED DOCUMENTS

HL7 FHIR® R4 Implementation Guide: At-Home In-Vitro Test Report, Release 1 - US Realm

STU DOCUMENTS

HL7 FHIR® R4 Implementation Guide: At-Home In-Vitro Test Report, Release 1 - US Realm See the standard at http://hl7.org/fhir/us/home-lab-report/STU1/. (Submit Feedback on STU)

TOPICS

  • Laboratory
  • Public Health

BALLOT TYPE

  • STU

STATUS DATE

2023-03-25

RESPONSIBLE WORK GROUP

Public Health

PRODUCT TYPE

  • Implementation Guide

FAMILY

  • FHIR

CURRENT STATE

  • Active

REALM

  • US Realm