Background:

The IVD and Clinical Information System (CIS) industries strive to meet the needs of customers and promote public health through the provision of safe and effective products. One barrier to laboratory interoperability is the lack of standardization.  Addressing this through semantic harmonization and standardization will have a significant positive impact on clinical laboratory operations, as it will significantly reduce the time and cost involved with deploying, connecting, and updating instruments in the laboratory. Such standardization will reduce the need for vendor-customized connectivity implementations and serve as a catalyst and common incentive for stakeholders across the ecosystem to promote interoperability of laboratory data. In this context, SHIELD aims to promote the use of high-quality data for secondary use purposes. A practical application of this goal is the establishment of a tool or data system that serves as an IVD Data Hub to facilitate the use of RWD. An IVD Data hub provides incentive for all stakeholders for the for the purposes of supporting regulatory decision making, improving public health reporting, and developing and effectively implementing future innovation.

Vision

Landscape outside of SHIELD

A review of other initiatives outside of SHIELD which are seeking to establish a publicly avaialble data platform empowering use of quality real world data for secondary use purposes (e.g. public health reporting, regulatory reviews, etc)

https://www.iderha.org/about/work-packages/infrastructure-and-tools-integration-data-wp1

https://seer.cancer.gov/data-software/crwdi/

Baseline Requirements & Use Cases:

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