Regulatory Frameworks and Legal Compliance Flashcards

Under the False Claims Act (FCA), the 'reverse false claim' provision imposes liability on a party that:

Answer: Knowingly conceals or improperly avoids an obligation to pay money to the government

The reverse false claim provision (31 U.S.C. § 3729(a)(1)(G)) covers situations where a party knowingly avoids or decreases an obligation to transmit money owed to the federal government.

The 'compliance triangle' concept in regulatory risk management refers to the relationship between:

Answer: Risk assessment, control design, and monitoring

The compliance triangle — risk assessment, control design, and monitoring — represents the three interdependent activities that form an effective compliance control cycle.

A company receives a Civil Investigative Demand (CID) from the Department of Justice. This instrument is most analogous to:

Answer: A pre-litigation subpoena requiring production of documents, interrogatory responses, or testimony

A CID is a pre-litigation discovery tool used by the DOJ (and FTC) under statutory authority to compel document production, written answers, and oral testimony before any lawsuit is filed.

Under HIPAA's Security Rule, what is the standard for determining which specific security safeguards a covered entity must implement?

Answer: Required safeguards must always be implemented; addressable safeguards must be implemented if reasonable and appropriate given the entity's circumstances

The HIPAA Security Rule distinguishes 'required' specifications (always mandatory) from 'addressable' specifications (must be implemented if reasonable and appropriate, or an equivalent alternative documented).

In international trade compliance, an Export Control Classification Number (ECCN) is used to:

Answer: Classify items on the Commerce Control List that may require an export license

An ECCN is an alphanumeric classification on the Bureau of Industry and Security's Commerce Control List (CCL) that determines whether an export license is required based on destination, end-use, or end-user.

The 'due diligence defense' available under some anti-corruption statutes, such as the UK Bribery Act Section 7, requires an organization to demonstrate:

Answer: That it had adequate procedures in place designed to prevent bribery by associated persons

Under UK Bribery Act Section 7, an organization's only defense to the corporate offense of failing to prevent bribery is demonstrating it had 'adequate procedures' to prevent associated persons from committing bribery.

A compliance officer is reviewing whether a new employee training program satisfies regulatory expectations. Under the Federal Sentencing Guidelines for Organizations, which element of an effective compliance program specifically addresses training?

Answer: Element 5 — training and communication to all levels of the organization

FSGO Element 5 requires organizations to communicate and train all levels of the workforce on the compliance program's standards and procedures to create genuine awareness.