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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.
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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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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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Each Voting Representative on the Steering Committee shall hold a seat for a term of three (3) years and may serve up to two consecutive terms. Non-Voting RepresentativesSteering Committee members may be nominated again after at least a 1-year hiatus from service.
Non-Voting Representatives
Non-Voting Representatives shall be nominated by a government agency at the invitation of the Steering Committee. Such nominations shall then be confirmed by at least a two-thirds (2/3) vote of the Steering Committee’s Voting Representatives as is deemed beneficial to the SHIELD Community’s Vision and Mission for such terms as the Steering Committee prescribes.
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Industry Entity – 25%
Healthcare Provider – 25%30%
Standards Organization – 15%
Professional Organization – 15%Public / Private Partnership – 10%20%
Patient Advocacy - 10%
Notwithstanding the above, each Stakeholder Category listed shall be entitled to at least one Voting Representative on the Steering Committee.
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The proceedings of the Steering Committee shall be available to all Members. Steering Committee meeting summaries should be accessible for viewing on the organization's website within 14 days of convening regular or special meetings and within 30 days of convening an annual meeting. Notifications of meeting summaries should be communicated to audiences through the organization's electronic newsletter or other similar push delivery method.. Meetings will be recorded to support accuracy of decisions and detailed discussions in the minutes and not posted publicly.
Rule II. Steering Committee Meeting Agenda
Steering Committee meetings shall be structured to focus on critical decisions. The Chair or Vice Chair will distribute meeting agendas and related materials no less than 5 business days in advance.
Information on subjects that per the Charter do not require a vote will be provided in writing before meetings. These subjects will then appear in the meeting agenda within a consent agenda consisting of information that will be discussed only if a Steering Committee Voting Representative requests a discussion and will otherwise stand as pro forma acceptance by the governance body.
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Whenever an Organizational Member, Organizational Member Delegate, or Individual Member has a financial or personal interest in any matter coming before the Steering Committee or Workgroup, the affected person shall a.) fully disclose the nature of the interest and b.) withdraw from discussion, lobbying, and voting on the matterconflict of interest as part of a declaration for each Steering Committee member on file. Any transaction or vote involving a potential conflict of interest shall be approved only when a majority of disinterested Members determine that it is in the best interest of the organization to do so. The minutes of meetings at which such votes are taken shall record such disclosure, abstention and rationale for approval.
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Rule V. Representing SHIELD Community
Any SHIELD member should provide advance notice, as soon as possible to the Chair and Vice Chair of any public speeches, presentations, where it may be beneficial to represent SHIELD in an official capacity.Any member planning a presentation or talk about the work of the SHIELD Community should share presentation material in advance with the Steering Committee Chair to ensure it is up to date. Once such representations are made, the given member should report at minimum the title, speakers, and an audience characterization to the Vice-Chair for tracking purposes, but ideally share the slidesshall not speak or publish on behalf of the SHIELD community without approval of the Steering Committee Chair.
Rule VI. Intellectual Property
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 requires 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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· Each Steering Committee or Workgroup meeting should follow an order of business called an agenda. Everything on the agenda is reviewed in its order and disposed of before Members proceed to the next item.
· All Members have equal rights, privileges and obligations. Everyone has the right to be heard. No Member speaks twice about a motion until all Members have had the opportunity to speak.
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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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