How Do You Regulate the Digital Health Revolution?

How Do You Regulate the Digital Health Revolution?

How Do You Regulate the Digital Health Revolution?
The ads, which played on the radio, in television commercials on channels from HGTV to CNN and in Google searches, were pervasive and seductive. The copy varied, but the message was always the same: brain games were the antidote for a range of cognitive issues, from garden-variety memory loss, to ADHD to Alzheimer’s.

“No matter why you want a better brain, Lumosity.com can help,” a man reassures, via voiceover, in one ad. “It’s like a personal trainer for your brain, improving your performance with the science of neuroplasticity, but in a way that just feels like games.”

Thirty-five million peoplebought into the fantasy, paying $14.95 for a monthly subscription for the company’sdesktop and mobilegames. But the Federal Trade Commission was unconvinced. In January, the agencysuedLumos Labs, the maker of Lumosity, fordeceptive advertising, claiming,its products’ effectiveness lacked valid scientific backing. Lumos Labs settled for $2 million, although it continues to make and market brain games.

“The settlement pertained to certain advertising language from past marketing campaigns,” Erica Perng, the company’s director of communications, said via email. “ It is important to note that this settlement does not speak to our recent marketing or the quality of our products.”

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It may be a rose-tinted interpretation — the FTC’s withering critique of the company’s lack of evidence reads very much like a judgement of quality — but fundamentally, she’s right. While the agency made passing references to the Federal and Drug Administration, the federal body tasked with protecting public health, the settlement centered on Lumosity’s deceptive advertorial language.

For an emerging industry unsure of when and how the regulatory shoe would drop, it was an illuminating detail.

Technology’s power can no longer be siloed; it’s tentacles are everywhere. The influence on health care and personal wellness is already obvious, but there’s a sense we’re on the brink of an impending sea change driven by personalization, one that’s already changing how physicians treat patients.

It’s easier than ever for consumers to directly tap into the trend.W earables are boomingand smartphones are now the rule, rather than the exception. Last year 64% of American adults had one, according to aPew survey, which means 64% of American adults owned a sophisticated health and fitness tool. By a recent count, there are more than 165,000 health apps,according to IMS Health; while the majority track simple data points, such as steps, heart rate and the number of calories burned, many go beyond this. There are apps that purport to turn a smartphone into a detection and monitoring tool for diabetes, heart conditions, depression and, yes, Alzheimer’s, among other conditions.

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As the industry has blossomed, pressure has grown for regulators to manage these claims. But if the entire digital health industry is new, the surrounding regulatory framework remains a work in progress.

The rules may still be coalescing, but23andMeprovides a cautionary tale on the danger of ignoring regulators. Citing concerns about the accuracy of the results, in 2013 theFood & Drug Administrationbanned the startup from selling its battery of saliva-based genetic tests to consumers, shutting down its core business.

The decision was a wakeup call for 23andMe, which, in the words of founder and CEO Anne Wojcicki, had been “behind schedule” in responding to the agencies demands. The startup went into immediate damage control mode — in a statement, it painted its relationship with the FDA as “extremely important” and emphasized that it was “fully engaging with them to address their concerns.”

Since then, it is has slowly worked its way back into the FDA’s good graces. In February 2015, the agency granted the company permission to sell its direct-to-consumer test for Bloom Syndrome, a rare genetic condition.

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