From: FierceMobileGovernment
By Zach Rausnitz
Smartphones, tablets, app stores, and mobile networks won’t be subject to Food and Drug Administration regulation just because they can be used as platforms for mobile health apps, said Christy Foreman, director of the FDA’s Office of Device Evaluation, at a House hearing March 21.
The FDA regulates some mobile health apps, but only those that pose a high risk to consumers, Foreman told the House Energy and Commerce subcommittee on oversight and investigations. Apps that help users with diets or count their steps, for example, don’t require FDA approval.
Other health apps can be regulated, such as one that a nurse can use to measure a patient’s heart rate or one that can produce an ultrasound image. An app that claims to diagnose skin cancer but is inaccurate can pose dangers to users, Foreman noted. The FDA has so far reviewed about 100 mobile health apps.
Smartphones, tablets, app stores, and mobile networks won’t be subject to Food and Drug Administration regulation just because they can be used as platforms for mobile health apps, said Christy Foreman, director of the FDA’s Office of Device Evaluation, at a House hearing March 21.
The FDA regulates some mobile health apps, but only those that pose a high risk to consumers, Foreman told the House Energy and Commerce subcommittee on oversight and investigations. Apps that help users with diets or count their steps, for example, don’t require FDA approval.
Other health apps can be regulated, such as one that a nurse can use to measure a patient’s heart rate or one that can produce an ultrasound image. An app that claims to diagnose skin cancer but is inaccurate can pose dangers to users, Foreman noted. The FDA has so far reviewed about 100 mobile health apps.
“We regulate based on intended use, not based on platform, so just because a device moves to a mobile platform, it would not be the agency’s intention that that would make it deregulated,” she said.
By the end of the fiscal year, the FDA plans to finalize its guidance for mobile health apps, and Foreman said that should remove the uncertainty some developers have about whether their products will be subject to regulation.
The guidance won’t require app developers to receive renewed approval for minor updates, she said.
Regulation of health apps isn’t new territory for the FDA. The agency approved its first mobile app in 1997, Foreman said, and it has overseen medical device software for decades.
Several Republicans on the subcommittee expressed concern that smartphones and tablets might be subject to the medical device tax enacted as part of the Affordable Care Act, as health apps can turn them into medical devices. Foreman deferred questions about taxes to the Internal Revenue Service, but she pointed out that the tax contains an exemption for retail products.
The IRS says the tax won’t apply to “devices that are of a type generally purchased by the general public at retail for individual use.”
For more: – visit the hearing webpage (prepared testimonies and webcast available)
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