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
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.
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.
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.
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.
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.
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.
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.