Regulatory Compliance & Legal Framework Flashcards
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Read the first 7 Regulatory Compliance & Legal Framework flashcards as text
The Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard most directly requires cosmetic surgery offices to:
Answer: Implement an exposure control plan and provide hepatitis B vaccination to at-risk employees
OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) requires employers to develop an exposure control plan and offer hepatitis B vaccination to all employees with occupational exposure risk.
A cosmetic surgeon who delegates injectable procedures to an unlicensed medical assistant could face which legal consequence?
Answer: Disciplinary action for supervising unlicensed practice of medicine
Delegating medical procedures to unlicensed personnel constitutes aiding in the unlicensed practice of medicine, subjecting the supervising physician to state medical board disciplinary action.
When a cosmetic surgery complication results in patient death, the surgeon is legally required to:
Answer: File a MedWatch report with the FDA only if a device was involved
If a medical device was involved in or contributed to a death, the manufacturer and user facility must submit a MedWatch adverse event report to the FDA; independent practitioners in office settings also have voluntary reporting obligations.
The doctrine of respondeat superior holds that a cosmetic surgery employer is vicariously liable for an employee's negligent acts when:
Answer: The negligent act occurred within the scope of employment
Respondeat superior imposes vicarious liability on an employer for an employee's tortious acts committed within the scope of their employment.
Under HIPAA, a 'business associate agreement' (BAA) is required when a cosmetic surgery practice shares protected health information (PHI) with:
Answer: A third-party billing company that handles patient data
A BAA is required when PHI is disclosed to or used by a business associate—a third party that performs functions on behalf of the covered entity—such as a billing company.
Which of the following best describes the legal standard for informed consent in cosmetic surgery under most U.S. state laws?
Answer: The surgeon must disclose all risks that a reasonable patient would consider material in making their decision
Most states apply the 'patient-centered' or 'reasonable patient' standard, requiring disclosure of any risk that a reasonable patient would find material in deciding whether to undergo the procedure.
The False Claims Act (FCA) allows private citizens to file qui tam lawsuits against cosmetic surgery practices that:
Answer: Submit fraudulent claims for reimbursement to federal healthcare programs
The False Claims Act prohibits knowingly submitting false or fraudulent claims for payment to federal healthcare programs, and its qui tam provisions allow whistleblowers to file suits on the government's behalf.