introduction
Eight Elements
Design can be used as a tool to prevent, find, and correct noncompliance and unethical behavior in concrete, actionable steps. Simplicity of design can make complex laws and regulations easier to understand and learn. This course applies design within the Office of Inspector General’s seven elements of an effective compliance program (OIG Guidance), plus an element from the US Federal Sentencing Guidelines. The Department of Justice has provided a more detailed document on these elements in 2020 in its Evaluation of Corporate Compliance Programs. The Department of Justice document provides a much more explicit description of the use of design in an effective compliance program. The OIG Guidance uses six variations of the word “design” to explain the role of a compliance officer in various contexts.
Variations of Design
In addition to emphasizing that compliance professionals should be independent, OIG Guidance uses six variations of the word “design” to explain the role of a compliance officer in various contexts, including within the context of designing audits, compliance programs, and interactive training. In one example, the OIG Guidance uses the word “design” in describing the compliance officer’s role, stating that part of the compliance officer’s role includes “… the flexibility to design and coordinate internal investigations (e.g., responding to reports of problems or suspected violations) and any resulting corrective action with all hospital departments, providers, and sub-providers, agents, and, if appropriate, independent contractors.”
USER EXPERIENCE
Inferring from the textual use of the word in the OIG Guidance, the meaning of the word “design” and its variations in 63 CFR 8987 (1998) likely means a plan, which can include something tangible that is written, something abstract such as culture, or something that is a habit or repetitive activity such as a process, developed with the intent to create an outcome. Given the OIG’s repeated emphasis on clarity, ease of use, and providing accessible, inclusive education to a wide range of individuals, the experience of the user also matters to the OIG. Therefore, it seems that the guidance is suggesting a combination of design that incorporates both the required regulations and laws and an empathetic approach to the user.