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Regulatory Compliance & Legal Framework Flashcards

7 cards from real CMC practice questions. Tap to flip, then mark Knew It or Still Learning โ€” missed cards come back until you master them.

Read the first 7 Regulatory Compliance & Legal Framework flashcards as text
  1. Under HIPAA's Minimum Necessary Standard, a cardiac nurse accessing a patient's full medical history to schedule a stress test is:

    Answer: Non-compliant, only information necessary for scheduling should be accessed

    The Minimum Necessary Standard requires accessing only the PHI needed for the specific task, not the entire record.

  2. A hospital's cardiac catheterization lab wants to participate in a multi-site clinical trial. Which federal regulation governs the protection of human research subjects?

    Answer: The Common Rule (45 CFR 46)

    The Common Rule (45 CFR Part 46) establishes federal standards for protecting human subjects in research, including IRB oversight.

  3. A physician refers a cardiac patient to a diagnostic imaging center in which the physician holds a financial interest. This arrangement may violate:

    Answer: The Stark Law

    The Stark Law prohibits physician self-referrals for designated health services, including imaging, when a financial relationship exists.

  4. Which accrediting body sets standards for cardiac catheterization laboratory quality and safety in the United States?

    Answer: The Joint Commission (TJC)

    The Joint Commission accredits and certifies healthcare organizations including cardiac cath labs, setting safety and quality standards.

  5. When a patient with chest pain arrives at an emergency department, EMTALA requires the hospital to:

    Answer: Provide a medical screening examination regardless of ability to pay

    EMTALA mandates a medical screening examination for all individuals presenting to an ED regardless of payment ability.

  6. A cardiac care unit implements a new protocol using an AI-based arrhythmia detection device. This device must receive clearance from:

    Answer: The FDA's Center for Devices and Radiological Health (CDRH)

    The FDA's CDRH regulates medical devices including AI-based diagnostic tools through the 510(k) or PMA pathway.

  7. A cardiologist documents a procedure with a higher complexity code than was actually performed to increase reimbursement. This is an example of:

    Answer: Upcoding

    Upcoding is billing for a higher-level service than was provided, constituting Medicare/Medicaid fraud.