A federal agency settlement with a computer software maker regarding deceptive claims tied to a game's ability to help boost children's mental acumen illustrates the complex and overlapping aspect in government oversight regarding healthcare technology and devices.
The Federal Trade Commission (FTC) last week settled charges against Texas-based vendor Focus Education for allegedly making unsubstantiated claims that its game Jungle Rangers improved children's memory, behavior and focus, and helped those with attention deficit hyperactivity disorder.
"This case is the most recent example of the FTC's efforts to ensure that advertisements for cognitive products, especially those marketed for children, are true and supported by evidence," Jessica Rich, director of the Bureau of Consumer Protection, said in an announcement on the settlement.
The FTC settlement comes on the heels of a Food and Drug Administration (FDA) ruling not to regulate wellness software. The actions serve as a reminder to developers the FDA is not the lone agency involved in healthcare app and device oversight, health attorney Brad Thompson of Epstein Becker Green, told FierceMobileHealthcare.
"This is big for mhealth app developers making performance claims. The FDA is backing away from low risk apps, but FTC is reminding us FDA is not the only sheriff in town," said Thompson, noting that even when an app is low risk, the company promoting it must still have adequate evidence on hand to support any performance claims.
"Claims a product can be used to help treat diseases and conditions such as ADHD would suggest the product meets the definition of a medical device," Thompson said. "But the FDA let FTC handle this one."
The regulatory actions illustrate an unclear area in medical product oversight, which is tied to overlapping jurisdiction, Thompson said. For example, while both agencies regulate, the FDA takes the lead in labeling and approval of a product or technology, while it's up to the FTC to take the lead regarding product advertising.
"I think FDA and FTC have at least a tactic understanding that for these software products that fall into the grey area of FDA jurisdiction, FTC will take the lead if the issue is over-promotion," Thompson said. "So when no one is being hurt, but the claims go well beyond the evidence, I think you will see FTC step in."
For more information:
- read the FTC announcement
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