Tags: FDA | health | apps | phones

Experts: FDA Rules Limit Health Apps on Cellphones

By    |   Friday, 08 August 2014 09:49 AM

Overregulation by the Food and Drug Administration needlessly restricts the mobile phone industry's ability to include medical applications, two FDA experts say.

Apple and other smartphone makers are working to include health-information platforms as a major part of their operating systems, Dr. Scott Gottlieb, resident fellow at the American Enterprise Institute and a former deputy commissioner at the FDA, and Coleen Klasmeier, head of the FDA regulatory practice at Sidley Austin law firm, write in The Wall Street Journal.

"But these smartphones will be purposely dumbed down, according to early reports on their features, in order to manage the uncertain risk of unwieldy FDA regulation," they note.

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So what's the problem?

The FDA has said that software that uses a medical sensor technically makes the phone a medical device, thereby falling under its jurisdiction. In addition, software that measures health-related conditions, such as glucose meters for people with diabetes, is considered a diagnostic device, again making the phone fall under its regulations.

"The FDA's regulatory dysfunction is driven by its 30-year failure to establish a coherent approach to regulating medically related software," Gottlieb and Klasmeier say.

"Only about 100 mobile medical apps have been reviewed and approved by the FDA. That's a fraction of what's possible. The problem isn't merely a regulatory regime ill-suited for reviewing these innovations. It's the products that are never created because mobile-tech entrepreneurs choose to direct their talents elsewhere."

"Many consumer-focused apps that support health are not 'devices' — for example, apps that help patients self-manage a health condition. This is clear from the language of the relevant statute and case law," the duo argues.

"But the FDA's guidance says that they are medical devices but that the agency chooses, at this time, not to actively regulate them. What is an app developer supposed to do with that internally contradictory position?"

The pair notes that the ambiguity "forces innovators to seek the FDA's nod for every new launch and every small advance."

To be sure, some in the medical profession see unchecked expansion of medical apps as a dangerous thing.

"This is not only because [they think] apps and smartphones have the potential to marginalize expertise, making it harder for doctors to cash in on their medical training," Mark Honigsbaum, a Wellcome Trust Research Fellow at Queen Mary University of London, writes in The Guardian

"Giving people the ability to monitor their vital signs, it is argued, also risks generating needless anxiety."

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Overregulation by the Food and Drug Administration needlessly restricts the mobile phone industry's ability to include medical applications, two FDA experts say.
FDA, health, apps, phones
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2014-49-08
Friday, 08 August 2014 09:49 AM
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