The U.S. Food and Drug Administration's approach to mHealth needs to be reworked, as the current strategy leaves innovators in limbo and is likely scaring off mobile health entrepreneurs, according to Scott Gottlieb, M.D.
For example, the agency's regulatory strategy of "we'll know when we see it," the former FDA official writes in a commentary at Forbes, is already having a big impact on the Apple Watch. That approach, he says, is one reason why the Watch has not delivered on digital health expectations.
Gottlieb, who currently works for the American Enterprise Institute, notes that the FDA listed out categories of products it is not interested in overseeing, but calls the FDA's exclusions "pedestrian."
"The scheme they reserved for the vast rest of the digital health tools wasn't well articulated," Gottlieb writes. "It means that those developing apps will have to come into FDA before they get too far, to see how the agency will treat them."
When it comes to Apple, in particular, he says, the company isn't building health capabilities right into the device because they fear too much FDA oversight. Instead, they rely on outside apps and add-ons, and because those still need some FDA review, updates to them will be limited.
Many industry experts, including healthcare consultant David Lee Scher, M.D., believe true adoption of mobile health apps won't take place until there is a validation and verification process to ensure safe use and eliminate any potential harm and risk.
For more information:
- read the commentary
David Lee Scher: Hurdling mHealth app challenges requires comprehensive strategy
Why regulatory action will play a key role in mHealth advancements
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Regulatory agencies' light touch on 'lower risk' mobile medical apps