Saison-al Session Quiz

Question 1

Multi-select: Which of the following were cited as compliance issues in the Solara Medical Supplies privacy case

Accepted Answer

PHising incident exposing ePHI, Failure to conduct security risk analysis

Question 2

Which of the following statements about qui tam (whistleblower) lawsuits is true?

Accepted Answer

The number of qui tam lawsuits is at an all-time high

Question 3

Why is repeat attendance by the same HCPs at a speaker program a concern?

Accepted Answer

IT may seem that the program lacks educational value

Question 4

True or False: The DOJ treats commission-based pay for independent sales reps as an automatic violation of AKS

Accepted Answer

False

Question 5

Which of the following would most likely be considered a deceptive practice under Section 5 of the FTC Act?

Accepted Answer

Describing data as “anonymized” when it can be re-identified

Question 6

What type of commercial speech cannot be compelled on labels?

Accepted Answer

Untrue or controversial speech

Question 7

What types of “product liability” cases require less proof and involve amassing many cases?

Accepted Answer

Non-injury Consumer Fraud Cases

Question 8

Which of the following enforcement trends has been most prominent in recent U.S. privacy and cybersecurity actions?

Accepted Answer

Enforcement actions targeting deceptive data collection & sharing practices

Question 9

What recent change has the FDA announced regarding inspections of foreign drug manufacturing facilities?

Accepted Answer

The FDA will expand the use of unannounced inspections abroad

Question 10

True or False: FDA never issues warning letters for HCP-facing presentations

Accepted Answer

False

Questions 10