S&I+Steering+and+Consensus+Process



toc =1. Introduction= The Standards and Interoperability (S&I) Framework is a function of the Office of Interoperability and Standards in the Office of the National Coordinator for Health Information Technology (ONC) as part of the United States Department of Health and Human Services (HHS). Most Standards and Interoperability work revolves around standards and interoperability specifications related to health information technology. To accomplish this work, the S&I Framework process promotes the development of high-quality specifications, implementation guides, and other deliverables based on the consensus of the Community of Interest for an S&I Initiative.
 * The reader is advised to read the S&I Framework Introduction and S&I Initiative Overview, Phases and Outputs before reading the S&I Steering and Consensus Process. **

In order to satisfy the goals of openness, balance of interest, due process and appeals, and consensus, the S&I Steering and Consensus process defines how the S&I Framework works with the broader Community of Interest to address healthcare interoperability challenges.

As noted in IETF RFC 2026, a high quality process allows for:
 * technical excellence;
 * prior implementation and testing;
 * clear, concise and easily understood documentation;
 * openness and fairness; and
 * timeliness.

The procedures described in this document follow that RFC as well as the proven practices of the W3C, and are designed to be fair, open, and objective; to reflect existing (proven) practice; and to be flexible.
 * These procedures are intended to provide a fair, open, and objective basis for developing, evaluating, and adopting health interoperability specifications. They provide ample opportunity for participation and comment by all interested parties. At each stage of an S&I Initiative, a specification is repeatedly discussed and its merits debated in open meetings and/or public fora and it is made available for review via world-wide on-line wikis and other directories.
 * These procedures are explicitly aimed at recognizing and adopting generally accepted practices. A candidate specification must be implemented and tested for correct operation and interoperability by multiple independent parties and used in increasingly demanding environments, before it can be confidently adopted as part of the nationwide health information infrastructure.
 * These procedures provide a great deal of flexibility to adapt to the wide variety of circumstances that occur in the standardization process.

The goal of technical competence, the requirement for prior implementation and testing, and the need to allow all interested parties to comment all require significant time and effort. However, on the other hand the needs of Meaningful Use, ACA, VLER, and other national healthcare priorities require timely development of specifications. The S&I Framework is intended to balance these conflicting goals. The process is short and simple as possible without sacrificing technical excellence, thorough testing before adoption of a standard, or openness and fairness. =2. S&I Steering= The S&I Steering structures consist of two primary steering teams which provide the necessary strategic and tactical controls for executing S&I Initiatives.


 * S&I Steering Committee:** The S&I Steering Committee is responsible for S&I Initiative selection and prioritization, definition of value and outcomes and has accountability for value and outcomes. The S&I Steering Committee will track the progress of the Initiatives regularly and ensure alignment between activities and key measures and outcomes outlined for the Initiatives. The S&I Steering Committee is assigned by the ONC Deputy National Coordinator for Programs and Policies and consists of members from the ONC Office of Standards and Interoperability. The S&I Steering Team Members wiki page contains the current S&I Steering Committee membership.


 * Initiative Steering Team:** The Initiative Steering Team is responsible for detailed definition of goals and outcomes for the S&I Initiative, provides advice and prioritizes project goals, evaluates performance using the tactical plans for each of the Initiative Phases. The Initiative Steering Team will have a minimum of 4 members and a maximum of 7 members. Two members of the Initiative Steering Team are the Initiative Coordinator and the Director for ONC Office of Standards and Interoperability. Individuals can be nominated by other Initiative Members or themselves to be part of the Initiative Steering Team. The ONC Office of Standards and Interoperability Director must approve the individual's nomination before the individual is considered to be part of the Initiative Steering Team.

2.1 S&I Steering Process
The S&I Steering Process consist of the following:  =3. S&I Consensus Process= Consensus is a core value of the S&I Framework. To promote consensus, the S&I Consensus Process requires Initiative Coordinators to ensure that Initiative Members consider all legitimate views and objections, and endeavor to resolve them, whether these views and objections are expressed by the active participants of the Initiative or by others (e.g., Other Interested Parties). Decisions MAY be made during meetings (face-to-face or distributed) as well as through email. By default, the set of individuals eligible to vote in a decision are Initiative Members in Good Standing. Each Call for Consensus should start with a clean slate of votes and should not overwrite or edit previously recorded votes. A Call for Consensus can be issued for Initiative deliverables and decisions that are critical for ensuring progress.
 * In partnership with the key national Federal Advisory Committees (FACAs), the HIT Policy Committee (HITPC) and the HIT Standards Committee (HITSC), and based on feedback collected through public forums, ONC identifies current standards and interoperability challenges to national health priorities.
 * The S&I Steering Team prioritizes those challenges, and based on achievement of national health priorities and available resources (including direct funded resources, availability of participants, and other resource constraints), sponsors an S&I Initiative.
 * The S&I Steering Team assigns the Initiative Coordinator, allocates Staff, and issues a call for Initiative Members who, along with the public at large, form an Initiative Community of Interest. Alternatively, an Initiative Community of Interest forms without Staff allocation to address a self-selected Initiative Charter.
 * The Initiative Coordinator will assemble the S&I Initiative team after verifying public statements of commitment from potential participants.
 * The Initiative Coordinator will then execute the S&I Initiative through the Initiative Phases ensuring active community's participation and following the S&I Consensus Process outlined in the next section.
 * The Initiative Coordinator along with the Initiative Steering Team track the progress of the S&I Initiative, and ensure that the activities of the Initiative members are aligned with key outcomes.

The following terms are used in this document to describe the level of support for a decision among a set of eligible individuals:
 * 1) **Consensus**: A substantial number of individuals in the set support the decision and nobody in the set registers a Formal Objection. Individuals in the set may abstain. Abstention is either an explicit expression of no opinion or silence by an individual in the set. Unanimity is the particular case of consensus where all individuals in the set support the decision (i.e., no individual in the set abstains).
 * 2) **Dissent**: At least one individual in the set registers a Formal Objection.

The goal is unanimous consent, which is obtained by carefully considering and addressing significant input from the Community of Interest. Where unanimity is not possible, a group SHOULD strive to make consensus decisions where there is significant support and few abstentions. Any significant deliverable of the Initiative Charter will be approved through a formal Consensus process. Each Initiative Member will provide one of the following votes during the Consensus process:
 * Yes
 * Yes with comments
 * Formal Objection with comments indicating a path to address the objection in a way that meets the known concerns of other members of the Community of Interest. "Formal Objection" vote without such comments will be considered Abstain votes.
 * Abstain (decline to vote)

A Yes vote does not necessarily mean that the deliverable is the ideal one from the perspective of the Initiative Member, but that it is better to move forward than to block the deliverable. A Formal Objection means that the objector cannot proceed with the project unless the objections are met. It is acceptable and expected to use a Formal Objection in a first consensus round to communicate a point of view or process issue that has not been addressed in the drafting of the initial deliverable. If a Consensus Process attracts significant comments (through Yes with comment votes), it is expected that the comments be addressed in a future revision of the deliverable. Should a Consensus Process attract even one "Formal Objection" vote with comments from an Initiative Member, the deliverable must be revised to address the "Formal Objection" vote (unless an exceptional process is declared).

"Initiative Invited Experts" and "Other Interested Parties" may also supply comments and objections through the Consensus Process, and such comments and objections should be addressed by the Initiative Members.

If the Initiative Members do not address the comments and Formal Objections provided during the Consensus Process, Any individual who is an Initiative Member or is part of the broader Community of Interest can submit a written appeal to the S&I Steering Team questioning the validity of the Consensus decision.

3.1 Recording and Reporting Formal Objections
In the S&I Consensus process, any individual from the broader Community of Interest may register a Formal Objection to a decision. A Formal Objection to a decision is one that the individual requests that the Initiative Coordinator consider as part of evaluating the related decision. Note: In this document, the term "Formal Objection" is used to emphasize this process implication: Formal Objections receive Initiative Coordinator consideration. The word "objection" used alone has ordinary English connotations.

An individual who registers a Formal Objection MUST cite technical arguments and propose changes that would remove the Formal Objection; these proposals MAY be vague or incomplete. Formal Objections that do not provide substantive arguments or rationale are unlikely to receive serious consideration by the Initiative Coordinator. A record of each Formal Objection MUST be publicly available and permanently preserved. A Call for Consensus (of a document) to the Initiative Members MUST identify any Formal Objections.

3.1.1 Balance of Interest
The S&I Framework Call for Participation must be provided to a broad representation of organizations such as providers, vendors, system integrators, clinicians, SDO's, subject matter experts and government agencies in order to achieve Balance of Interest. Any Initiative Member can identify a potential Balance of Interest issue via a single written appeal to the Initiative Coordinator. The Initiative Coordinator needs to address such an issue promptly and ensure that the broader community's interest is represented appropriately by the Initiative Committed Members.

3.2 Formally Addressing an Issue
In the context of this document, Initiative Members have formally addressed an issue when they have sent a public, substantive response to the individual who raised the issue. A substantive response is expected to include rationale for decisions (e.g., a technical explanation, a pointer to charter scope, or a pointer to a requirements document). The adequacy of a response is measured against what an Initiative Member would generally consider to be technically sound. If Initiative Members believe that an individual's comments result from a misunderstanding, the Initiative Members SHOULD seek clarification before reaching a decision.

As a courtesy, both Initiative Coordinators and Initiative Members SHOULD set expectations for the schedule of responses and acknowledgments. The Initiative Members SHOULD reply to an individual's initial comments in a timely manner. The Initiative Members SHOULD set a time limit for acknowledgment by an individual of their substantive response; an individual cannot block the Initiative's progress. It is common for a individual to require a week or more to acknowledge and comment on a substantive response. The Initiative Members responsibility to respond to individuals does not end once a reasonable amount of time has elapsed. However, individuals SHOULD realize that their comments will carry less weight if not sent to the Initiative Members in a timely manner.

Substantive responses SHOULD be recorded. The Initiative Members SHOULD maintain an accurate summary of all substantive issues and responses provided.(e.g., in the form of an issues list).

3.3 Exception Process
In some rare cases, even after careful consideration of all points of view, Initiative Members might not reach consensus. The Initiative Coordinator MAY record a decision where there is dissent (i.e., there is at least one Formal Objection) so that the Initiative may make progress (for example, to produce a deliverable in a timely manner). Dissenters cannot stop the Initiative's work simply by saying that they cannot live with a decision. When the Initiative Coordinator believes that the Initiative Members have duly considered the legitimate concerns of dissenters as far as is possible and reasonable, the Initiative Members SHOULD move on. Initiative Members SHOULD favor proposals that create the weakest objections. This is preferred over proposals that are supported by a large majority but that cause strong objections from a few people.

Any individual who is an Initiative Member or is part of the broader Community of Interest can submit a written appeal to the S&I Steering Team questioning the validity of the Consensus decision, when they believe their comments and objections were not addressed to their satisfaction.

3.4 Reopening a Decision When Presented with New Information
The Initiative Coordinator MAY reopen a decision when presented with new information, including:
 * Additional technical information,
 * Comments by email from Initiative Members who were unable to attend a scheduled meeting,
 * Comments by email from meeting attendees who chose not to speak out during a meeting.

The Initiative Coordinator SHOULD record that a decision has been reopened, and MUST do so upon request from an Initiative Member. Any individual who is an Initiative Member or is part of the broader Community of Interest can submit a written appeal to the S&I Steering Team questioning the reopening of a Consensus decision, when they believe there is not enough justification to reopen the decision.

3.5 Appeal of an Initiative Coordinator's Decision
Initiative Members resolve issues through dialog. Individuals who disagree strongly with a decision SHOULD register with the Initiative Coordinator any Formal Objections (e.g., to a decision made as the result of a vote).

When an individual believes that their concerns is not being duly considered by the Initiative Members, they MAY ask the Initiative Coordinator to confirm or deny the decision. The individuals SHOULD also make their requests known to the Initiative Members. The Initiative Members MUST inform the Initiative Coordinator when an individual has raised concerns about process.

Any requests to the Initiative Coordinator to confirm a decision MUST include a summary of the issue (whether technical or procedural), decision, and rationale for the objection. All counter-arguments, rationales, and decisions MUST be recorded. =4. S&I Intellectual Property Rights Policy= Please find the Intellectual Property Rights (IPR) policies related to the S&I Initiatives here: Intellectual Property Rights (IPR) Policy =5. S&I Conflict of Interest Policy= Individuals participating materially in S&I Initiative work MUST disclose significant relationships when those relationships might reasonably be perceived as creating a conflict of interest with the individual's role in the S&I initiative. Each S&I participant MUST disclose their affiliating and sponsoring organization.