FDA ‘taking a very light touch’ on regulating the Apple Watch

“With Apple Inc. and fellow Silicon Valley companies edging further into health care, the U.S. agency in charge of oversight says it will give the technology industry leeway to develop new products without aggressive regulation,” Adam Satariano reports for Bloomberg News. “”

“Bakul Patel, who oversees the new wave of consumer-focused health products at the Food and Drug Administration, said most wearable gadgets such as the soon-to-be-released Apple Watch and health-focused applications for smartphones have a way to go before warranting close scrutiny from the agency,” Satariano reports. “‘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 Apple and Google Inc. and other corporations should play a role in screening applications to be sure health-software developers aren’t over-promising the benefits of their products,” Satariano reports. “Both companies have visited FDA headquarters in Maryland to discuss their health initiatives, he said.”

Read more in the full article here.

MacDailyNews Take: This sounds good. Let the fitness devices and apps bloom. The ones that need regulation should, of course, receive it. Apple et al. could identify items (apps, new sensors/features) for the FDA to inspect further and they should keep up a continuous dialog with the FDA, although the risk of trade secrets leaking to competitors or even to the press is concerning.


  1. The apple watch is not a food. It is also not a drug.
    It does not go in the body, nor does it treat or diagnose disease.?why under heaven is the FDA involved ?

    1. I can see that if the sensors are used in a study (research kit) that the possibility of careful scrutiny would be resonable, given the choices doctors would be making based on the sensors information

    2. The FDA also regulates medical devices, things like radiation emitting devices (like x-ray machines) and devices that pose a serious risk of injury if not funtioning properly (like surgery robots).

  2. I wonder if the DOJ said to the FDA to back away from the Infinite Loop ’cause the Watch might be a back door to your private data that could be exploited in the name of the Homelands.

    Imagine being able to send your private medical metrics instantly to your doctor via Watch. Now, just after or maybe during the transmit, a profligate HIPAA regulation requiring some unessential authentication of the data, ends up doing a reach-around and grabbing your non-healthcare ‘lifestyle’ data, all the while data transmits to your physician.

    It could happen.

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