Apple

Apple Just Announced ResearchKit: iOS Software For Collecting Medical Information That'll Be Severely Limited Because of the FDA

How the FDA will limit the usefulness of Apple's latest innovation.

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Apple CEO Tim Cook just announced ResearchKit, a new suite of open source apps for the iPhone that will allow medical researchers to gather data from users on conditions like asthma and Parkinson's disease.

Tim Cook |||

The presentation by Apple's Senior Vice President of Operations Jeff Williams at Apple's "spring forward" event today left many unanswered questions about how ResearchKit will work, but it seems like it's designed primarily as a conduit for sending medical information to doctors at research institutions to help them conduct clinical trials.

This is certainly a valuable service, but ResearchKit seemingly won't take advantage of the true potential of iPhones and wearable devices: Allowing software to analyze survey and biometric data, so that users can interpret their own medical information without a human doctor. Doing so this would require getting approval for each function from the U.S. Food and Drug Administration (FDA), which is a slow and expensive process. In f

Research Kit |||

act, the coming Apple Watch was stripped of many biometric collection features in part to avoid running afoul of the agency.

In January, the FDA released draft rules for devices like the iPhone, limiting their use to only making "general wellness claims." Otherwise, they need approval from the agency.

Last September, I wrote about how wearable devices like the Apple Watch could revolutionize health care, if only the FDA would get out of the way.

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  1. And as a protest against the FDA you gave us an article that was also of severely limited utility to show us how it felt before posting this. Well played sir.

  2. my friend’s sister-in-law makes $63 /hour on the internet . She has been fired from work for 6 months but last month her payment was $16955 just working on the internet for a few hours. go to the website…….

    ????? http://www.netjob70.com

  3. Tangerines.

  4. In protest to the FDA, I will not buy an Apple product.

  5. No.

    There is no limit to them collecting information in anything linked in this article.

    What is limited is them selling the device as having any specific health benefits other than the aforementioned “general wellness”.

    (This is the same thing Reason kept getting wrong, over and over, about 23AndMe – they were nailed not for ‘giving you the information’ but for ‘offering diagnoses and health advice they hadn’t backed up to the FDA’.

    Apple could easily give you every bit of health information any sensor it could sell you generated … it can’t just give you health advice or make product claims about health based on it, without FDA approval.

    That is naturally not a libertarian outcome either, but we should be accurate about what’s being prohibited by a paternalistic and overreaching state.

    Also, on the WSJ link? Gruber doesn’t buy that it was ever going to have 10 sensors and they just gave up on some.

    And Gruber has a very, very good track record on things Apple.)

    1. ” Apple could easily give you every bit of health information any sensor it could sell you generated …”

      Ha! Have you ever worked in an FDA regulated industry?

      The FDA can, any time it so desires, classify any bodily *measurement* as a regulated medical test.

      1. They can, but the issue here is did they? Apparently not.

  6. “so that users can interpret their own medical information without a human doctor.”

    Ha! That’s what they’ll never allow – citizens being able to circumvent the medical mafia and make their own health care decisions. Holding our *health* hostage to their power is simply too profitable.

    ” I wrote about how wearable devices like the Apple Watch could revolutionize health care, if only the FDA would get out of the way.”

    *Freedom* could revolutionize our health care system, but that would cut into the profits of the medical mafia, and the power of the FDA.

    1. No, actually people at FDA are very enthusiastic about self-care. It’s just that their enthusiasm is channeled paternalistically, into hoping the industry comes up with devices that satisfy their desiderata. Unfortunately since one of their desiderata is making sure patients diagnosing themselves don’t miss anything that might’ve been caught by a professional, the devices would have to be smart enough to practically replace human beings even in worst case scenarios.

  7. Apple would not want users to keep their own data and analyze it
    themselves. Apple wants to collect that data and profit from it.

    If the devices ran on free software, users would be free to do what
    they wish. This illustrates the injustice of nonfree software.
    See http://gnu.org/philosophy/free…..tant.html.

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