While health tech has to be approved by the Food and Drug Administration, the agency will be taking “an almost hands-off approach” to fitness-oriented wearables like the Apple Watch, says policy advisor Bakul Patel in an interview in Bloomberg.
“We are taking a very light touch, an almost hands-off approach,” Patel, the FDA’s associate director for digital health, said in an interview. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”
Patel said the FDA would be drawing a distinction between products whose health claims focused on fitness rather than diagnosis …
The FTC is fining the creators of two different smartphone apps, both of which were previously available as paid apps on the App Store, for falsely claiming to detect symptoms of melanoma. The two apps, MelApp and Mole Detective, have long been removed from the App Store (although a version of Mole Detective remains on Google Play for $4.99), and Apple appears to have cracked down on similar apps that were available on the store as recently as early 2014.
The Federal Trade Commission has challenged marketers for deceptively claiming their mobile apps could detect symptoms of melanoma, even in its early stages. In two separate cases, marketers of MelApp and Mole Detective have agreed to settlements that bar them from continuing to make such unsupported claims. The agency is pursuing charges against two additional marketers of Mole Detective who did not agree to settle.
It’s not the first and it likely won’t be the last time app makers face scrutiny from government officials over health care claims as fitness becomes more of a focus on mobile devices and companion wearables. As recently as November, the FTC was said to be pressing Apple on how it plans to use sensitive health related data collected from its upcoming Apple Watch launching in April.
Before the Apple and Beats marriage can really be official, the two companies must first gain regulatory approval from various governing bodies where the companies conduct business. Apple included the following expectation in its official press release announcing the deal: Subject to regulatory approvals, Apple expects the transaction to close in fiscal Q4.
For Apple, having regulatory approval and closing the transaction by the end of fiscal Q4 means it expects everything to be in order by the end of September. According to a Reuters report, regulators in the European Union will announce their decision on the deal by July 30th next month.