Regulatory Compliance & Legal Framework Flashcards
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Read the first 7 Regulatory Compliance & Legal Framework flashcards as text
Under the FDA's 510(k) premarket notification pathway, a cosmetic surgeon seeking to use a new energy-based device must demonstrate that the device is:
Answer: Substantially equivalent to a legally marketed predicate device
The 510(k) pathway requires the submitter to demonstrate substantial equivalence to a legally marketed predicate device in terms of intended use and technological characteristics.
A cosmetic surgeon performs a procedure on a patient who later claims they were not informed of a specific risk. Which legal doctrine is most directly implicated?
Answer: Failure to obtain informed consent
Failure to obtain informed consent is the doctrine most directly implicated when a patient claims they were not told about a material risk before a procedure.
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule requires that a Notice of Privacy Practices be provided to patients:
Answer: At the first service delivery and upon request thereafter
HIPAA requires covered entities to provide the Notice of Privacy Practices no later than the first date of service delivery and to make it available upon request at any time.
Which federal agency has primary regulatory authority over injectable dermal fillers used in cosmetic procedures?
Answer: Food and Drug Administration (FDA)
The FDA regulates dermal fillers as medical devices under the Federal Food, Drug, and Cosmetic Act, requiring premarket approval before they can be commercially distributed.
A cosmetic surgery practice that accepts Medicare or Medicaid reimbursement for any services must comply with which anti-kickback framework?
Answer: The Stark Law and Anti-Kickback Statute
Practices participating in federal healthcare programs must comply with both the Stark Law (physician self-referral prohibition) and the Anti-Kickback Statute, which prohibit remuneration intended to induce referrals.
A state medical board's primary mechanism for disciplining a cosmetic surgeon who performs procedures outside their scope of competence is:
Answer: Suspension or revocation of the state medical license
State medical boards hold the authority to suspend, revoke, or place conditions on a physician's medical license as the primary disciplinary mechanism for scope-of-practice violations.
Under the ABCS Code of Ethics, cosmetic surgeons must ensure that advertising materials are:
Answer: Truthful, not misleading, and not likely to deceive the public
The ABCS Code of Ethics requires that all advertising be truthful, not deceptive, and not misleading to the public, consistent with broader medical ethics standards.