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 …
Claims which centered on diagnosis of health conditions would face greater scrutiny. The FDA’s primary role there would be to ensure that companies weren’t claiming more than they delivered.
“A lot depends on how the device is marketed, Patel said. If a company is promoting a product to assist doctors in making medical decisions, it will require more oversight, he said.”
If devices like the Apple Watch do prove capable of diagnosing disease, the FDA doesn’t have an issue with that, said Patel: it simply wants to be sure that any claims made are accurate.
We have to be confident in what we are getting. The trajectory is there and all signals are headed that way, but by the same token the research and science should get us that confidence. It boils down to will it work or not.
The FDA wants Apple to play a role in screening health-related claims made by apps, and the company has already held discussions with the agency, he said.
Apple has been talking-up the health and fitness capabilities of the watch and iPhone, providing a look inside its gym-style testing-lab and discussing the potential of ResearchKit to help find cures for diseases. Stanford University recently shared that ResearchKit allowed it to sign-up 11,000 participants in a medical study in just 24 hours–something that would normally take 50 medical centers a year. It has also been suggested that ResearchKit could provide a massive open-source database of anonymized medical data which could be made available to medical researchers all around the world.
We learned quite a few new things yesterday about Apple’s plans for selling the Apple Watch including business pricing/financing details, with Mark Gurman providing a run-through of the complete customer experience when visiting a store to try out the watch, perks for Apple Watch Edition customers, and virtual online try-ons and setups for gold and steel Apple Watch customers.
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