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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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ARTICLE ONE: ORGANIZATION NAME, TYPE AND HISTORY
Section 1: Name
The name of this organization shall be the "Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) Community."
Section 2: Type
The organization shall be a voluntary Membership organization that serves only such purposes and functions and shall engage in such activities as are consonant with the purposes set forth in Article Two.
Section 3: History
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/COVID-19 pandemic in sharing IVD test data.
ARTICLE TWO: PURPOSES AND GOVERNING INSTRUMENTS
Section 1: Purpose
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 test data 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”.
Section 3: Mission
To achieve its vision, the SHIELD Community’s mission consists of the following key components:
Consistent, standards-based identification and description of IVD laboratory 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
Section 4: Guiding Principles
In its operation and deliverables, the SHIELD Community adheres to the following guiding principles:
Committed to Patient Safety
Dedicated to Improving Patient Outcomes
Collaborative in Approach
Integrative in Methodology
Transparent in Activities
Open in Deliverables and Results
Feasible in Recommendations
Focused in Scope
Section 5: Governing Instruments
The organization shall be governed by these bylaws and its standing rules.
Work on Article 3 (Membership) will continue at the next SHIELD Re-Organization Committee meeting on .
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