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The SHIELD Community was chartered in 2022 as a natural evolution of prior industry and government efforts to achieve interoperability of high-quality in-vitro diagnostic (IVD) test data. Most notably, the SHIELD Community is a successor from the SHIELD public/private partnership that operated in 2020 and 2021 between health care ecosystem stakeholders and the US Food and Drug Administration (FDA) to produce a Strategic Plan for achieving IVD test data interoperability. This itself emerged out of multi-agency workshops in 2015 and 2016 and subsequent work efforts. An urgency for action was created as a result of the challenges faced during the worldwide SARS-CoV-2/COVID-19 pandemic in sharing IVD test data.
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