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This page was LOCKED for editing AFTER the ALL SHIELD call on February 28th, 2023 - the text content will be copied into 2 pages, one for the charter and one for the Standing Rules prior to Steering Committee Vote on March 7th, 2023.

Info

This page consists of the Articles that have already been reviewed at least once in a Re-Organization Committee meeting. As each successive Article is reviewed in Committee meetings, it will be added here for further comment.

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The SHIELD Community is an organization of industry, clinical, academic, patient advocacy, standards development, public/private partnership, and professional organization stakeholders working in partnership with government entities with a singular focus on improving the quality, interoperability, and utility of IVD (In Vitro-Diagnostic) test related data and its adoption across the health care ecosystem.

Section 2: Vision

The vision of the SHIELD Community is to enable consistent and uniform communication of high-quality laboratory IVD test data that are computer and human actionable to promote safe, high quality and equitable patient outcomes.  In simple words: “Describe the SAME TEST the SAME WAY EVERYWHERE in the health care ecosystem”.

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  • Consistent, standards-based identification and description of IVD laboratory test related data and their attributes which contributes to its semantic harmonization

  • Secure, standards-based description of patient information in a manner that allows effective utilization while protecting patient privacy

  • Consistent, standards-based interoperability across all applicable information technology systems from the point of order through all downstream uses, both within and between entities in the health care ecosystem

  • Understandable, reproducible, and useable results for both human and computerized systems

  • Support universal implementation of the above across all entities within the US health care ecosystem

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Consistent with its Purpose as stated in Article One Section 1 and the Guiding Principle “Open in Its Deliverables and Results” in Article Two Section 4, the SHIELD Community seeks to freely distribute the results of its work to all interested parties within the health care ecosystem.  In order to achieve this, all SHIELD Community Members must agree that their contributions may be used by any and all ecosystem entities without restriction.  Further, SHIELD Community Members must agree not to disclose any information in the course of their SHIELD Community participation for which they, or anyone else they may be aware of, has or may seek to claim an intellectual property interest.Notwithstanding the foregoing, if in the course of its activities a SHIELD Member seeks to disclose information for which they, or anyone else they may be aware of, has or may seek to claim an intellectual property interest, it is the responsibility of that participant to identify such intellectual property interest and seek prior written approval from the SHIELD Community Chair or Vice Chair prior to making any such disclosurerequires that all contributions to the SHIELD community and all distributions from the SHIELD Community must be compatible with the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ or send a letter to Creative Commons, PO Box 1866, Mountain View, CA 94042, USA.

Rule VII: Antitrust

Although a collaborative organization such as the SHIELD Community is recognized as a valuable forum for advancing the goals of the health care ecosystem, one of the potential dangers which participants of any organization face is compliance with federal and state antitrust laws.  Such laws generally forbid any combination, contract or conspiracy that restrains trade. Since by its nature SHIELD Community Members may be competitors in the course of their normal business, all SHIELD Community Members must ensure that their activities do not violate applicable law.

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After debate and discussion have been had and no one else has risen to take the floor, the chair will call the question will be asked and the voting process can begin.

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