Last Updated 04 Aug 2022

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:

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

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

3. 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

4. Understandable, reproducible, and useable results for both human and computerized systems

5. 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 this charter and its standing rules.

ARTICLE THREE: MEMBERSHIP

Section 1: Classes and Eligibility

There shall be two classes of membership in the organization:

• Any organization with mission-critical government, industry, clinical, academic, standards development, professional organization, or similar interests in promoting the cause of the organization as set forth in Article Two may apply for membership as an Organizational Member.

• Any individual who has interest in promoting the cause of the organization as set forth in Article Two may apply for membership as an Individual Member.  In such capacity, Individual Members shall represent only themselves in their personal capacity without regard to any organization with which they may be an employee or otherwise affiliated.

Section 2: Rights

All Members shall have the following rights in service of achieving and advancing the organization's mission:

• Nomination of organizations or individuals for Membership

• Vote on matters to which their class of Membership entitles them, as described subsequently in this charter

• Serve on the Steering Committee

• Serve on SHIELD Community Workgroups

• Access to the specifications and standards adopted and promoted by the organization (and its affiliated organizations), and license to the related IP and copyrights, to the extent that it is offered unrestricted in the public domain

In addition, all Organizational Members shall have the following additional rights:

• Selection of a primary representative to participate in SHIELD Community activities as speaking and voting on the Organizational Member’s behalf

• Selection of a secondary representative to participate in SHIELD Community activities as speaking and voting on the Organizational Member’s behalf when the primary representative is unable to participate

• Permit other personnel affiliated with the Organizational Member to participate in SHIELD Community activities

• Representation of the SHIELD Community in public forums (e.g., professional conferences or webinars)

Section 3: Voting

Any Member may abstain from participating in a vote.

Section 4: Responsibilities

All Members shall contribute time and expertise to SHIELD Community workgroups, honor their SHIELD Community commitments, solicit opinions from stakeholders, represent their broader field, be responsive to the organization's strategic goals, adhere to the organization’s charter and standing rules, and ensure their attendance and active participation in meetings and Workgroups.