FDA says Apple feels a 'moral obligation' to improve health tracking data
Apple's new "Health" application in iOS 8 was apparently driven by what the company feels is a "moral obligation" to help its users live healthier lives, it disclosed in conversations with the U.S. Food and Drug Administration.
Prior to last week's unveiling of iOS 8 and the new Health app, executives from Apple had privately met with the FDA to discuss "mobile medical applications." Multiple meetings occurred between the two parties, most recently in December of 2013.
In an effort to find out what those meetings were about, Apple Toolbox filed a formal request with the FDA. The administration responded and revealed that Apple executives feel that mobile devices can do more to help people learn about themselves, and that they feel there "may be a moral obligation to do more."
Beyond Apple's philosophy regarding health tracking data, little else was revealed about the meeting between the company and the FDA. The administration simply said that Apple "wants to make sure they are on the side of the FDA" as they continue to innovate with future products.
"Apple will work closely with the FDA as they develop future products," the administration's disclosure reads. "The earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated."
Apple's first official foray into the so-called "quantified self" market will come with iOS 8 and its native Health application, which will serve as a central place for users to track and organize all of their health-related data. It also comes with a new digital Medial ID that could help first responders make life saving decisions in the event of a medical emergency.
Of course, Apple's interest in health-related applications -- and its talks with the FDA --?have only helped to further drive speculation that the company could be planning to launch a wrist-worn device later this year, frequently referred to as a so-called "iWatch." The latest rumors claim the device may sport a curved OLED touchscreen, and that Apple is apparently planning to hold an event to unveil the accessory this October.
Prior to last week's unveiling of iOS 8 and the new Health app, executives from Apple had privately met with the FDA to discuss "mobile medical applications." Multiple meetings occurred between the two parties, most recently in December of 2013.
In an effort to find out what those meetings were about, Apple Toolbox filed a formal request with the FDA. The administration responded and revealed that Apple executives feel that mobile devices can do more to help people learn about themselves, and that they feel there "may be a moral obligation to do more."
Beyond Apple's philosophy regarding health tracking data, little else was revealed about the meeting between the company and the FDA. The administration simply said that Apple "wants to make sure they are on the side of the FDA" as they continue to innovate with future products.
"Apple will work closely with the FDA as they develop future products," the administration's disclosure reads. "The earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated."
Apple's first official foray into the so-called "quantified self" market will come with iOS 8 and its native Health application, which will serve as a central place for users to track and organize all of their health-related data. It also comes with a new digital Medial ID that could help first responders make life saving decisions in the event of a medical emergency.
Of course, Apple's interest in health-related applications -- and its talks with the FDA --?have only helped to further drive speculation that the company could be planning to launch a wrist-worn device later this year, frequently referred to as a so-called "iWatch." The latest rumors claim the device may sport a curved OLED touchscreen, and that Apple is apparently planning to hold an event to unveil the accessory this October.
Comments
2) The longterm benefits of being able to collate around-the-clock data from hundreds of millions of people could have huge implications for the health of the human species.
I find it quite remarkable that I didn't wince when I read the words 'Apple' and 'moral obligation' in the same sentence.
Under normal circumstances, the association of the notion of 'morality' with a corporate entity would strike me as total bs.
I find it quite remarkable that I didn't wince when I read the words 'Apple' and 'moral obligation' in the same sentence.
Under normal circumstances, the association of the notion of 'morality' with a corporate entity would strike me as total bs.
Unfortunately, those kinds of statements can come back to bite a company when some tool decides it is Apple's "moral obligation" to hand them over a truckload of money for some bizarre lawsuit.
Here is where the leaked information came from
We all know the government can not keep a secret, unless they trying to spy on us. Even that they are not doing a very good job of.
Unfortunately, those kinds of statements can come back to bite a company when some tool decides it is Apple's "moral obligation" to hand them over a truckload of money for some bizarre lawsuit.
How true of a statement, and now that this is out in the wild you know some lawyer will subpoena information from those meetings with the FDA to back up their case.
Okay this is BS,
Anyone who works with any government agency will tell you this is no guaranty. FDA will tell you straight up, they can not advise you on how to do something, they can only tell you when you are wrong. The government does not want to be in a position where a company said they FDA or any government agency said to do it a certain way only to find out they were wrong. The FDA will hand you the rules and tell you to read it for yourself and decide for yourself how to do it. Then they will be the first one to come down on you hard if you got it wrong.
You're making something of nothing with your advice. Apple has not been in the health care business, so it makes sense to go directly to the agency to determine the process and criteria. FDA staff certainly advises companies on rules and regs and prior decisions, but staff only make recommendations, they are not the deciders. Aside from political pressure and agency capture by just those companies they are supposed to regulate (not a rare occurrence), such discussions are useful. I certainly would bet Apple did not openly discuss with the FDA the specs of their health devices, so it would have been impossible for FDA staff to give much in the way of specific advise or promises, even of they wanted to. When Apple has a specific product needing FDA approval, then and only then will FDA be able to take positions which Apple could rely on.
Your misstatements of how agencies work is quite misleading. They don't just sit in judgment hoping you'll screw up so they can pounce. You can rely on staff for good advice, with the caveat that staff are never the ultimate deciders.
Okay this is BS,
Anyone who works with any government agency will tell you this is no guaranty. FDA will tell you straight up, they can not advise you on how to do something, they can only tell you when you are wrong. The government does not want to be in a position where a company said they FDA or any government agency said to do it a certain way only to find out they were wrong. The FDA will hand you the rules and tell you to read it for yourself and decide for yourself how to do it. Then they will be the first one to come down on you hard if you got it wrong.
Actually by telling Apple when they are wrong they are in effect advising Apple. If they are in the wrong Apple changes direction to be in the right. The more "wrongs" they get the more focused they become.
It probably would be if it appeared in a corporate press release. But this was revealed by a government agency in response to an information request.
I find it quite remarkable that I didn't wince when I read the words 'Apple' and 'moral obligation' in the same sentence.
Under normal circumstances, the association of the notion of 'morality' with a corporate entity would strike me as total bs.
There is absolutely no doubt in my mind that, if Apple does manufacture and offer for sale health related software and hardware, the ambulance chasers will be rubbing their hands together in gleeful anticipation. Another deep pockets corporation to soak. The first time some bozo suffers a heart attack or stroke, or whatever they will claim Apple’s products failed to recognize and alert them to the danger. Sorry to be a pessimist but this is how the world works now in the U.S.
FDA says Apple feels a 'moral obligation' to improve health tracking data
This is the same FDA that just made it illegal to age cheese on wood, so take this with a grain of salt.
Oops, they just made salt illegal.
"Apple will work closely with the FDA as they develop future products,” assures that the health of nations will continue its spiral to the pits, thereby fully meeting the agenda of Big Pharma, Big Business, the Medical Mafia, (no insult meant to true, honest Mafia organisations), and of governments for all things deleterious to healthy. On this one, I am not so proud of Apple.
However, physical specs recording would be a possible value found in any such device; food, forget it!
?Food is politics so I won’t venture that insult in my rant but let it be said, a caveman and I could dine in any environment with or without access to fire. Rocks, clubs and stealth would be the order to our culinary delights. Gone would be the days of clean up, with that chore returned to vultures and wild wolves on standby kitchen duty.
Back at the ranch thrives the diseases from malnutrition, bulging tummies, pain and depression that plague the nation, thanks to the FDA.
Whene´er a diabolical deed is wrought
These times the FDA has sought
To while away the nations health;
?At leisure be the corporate sport,
To tame the reason in the minds of man
And spit the child to the devil’s hand.
On sickness, pain, to great distress,
Both brain and brawn, fail the test.
With sophistry its mindful aim
Its victims taught to nurture shame.
I have done away with a couple of apps since I installed iOS8 on my iPhone and have started entering my blood glucose levels and weight in the Health app.
The dashboard looks very nice.
I would love to have data entered automatically if it can be, so anything Apple makes in this respect will have my money.
Of course, I do wish there were some options, like changing the Units to the Metric System, but I know it will all come in time for the GM. Too much to expect on a 1st Beta!
Your misstatements of how agencies work is quite misleading. They don't just sit in judgment hoping you'll screw up so they can pounce. You can rely on staff for good advice, with the caveat that staff are never the ultimate deciders.
Actually that is exactly how they work. I personally have experience with the FCC and my wife with with the EEOC, and I have friends with the direct experience with the FDA, OSHA and Mine Safety. All of our direct experience is the same, yes they may answer questions but they will not tell you if you doing it right or wrong they tell you to read the regs and do it how you think your business should do. They will pounce on your if they feel you did it wrong, then you have to through the time and expense of defending yourself and proving why your solution met the rules or the spirit of the rules.
But they are bare from advise you on how to do it, they advise you on what the rules say, but if the rule is gray or unclear, they can not provide you an opinion on you should approach the rule and the possible solutions.
Actually by telling Apple when they are wrong they are in effect advising Apple. If they are in the wrong Apple changes direction to be in the right. The more "wrongs" they get the more focused they become.
To my above point, they will never tell you up front you may be wrong or in violations, they will tell you to figure it out or hire someone to help you figure it out.
Another example, call the IRS some time and ask them to help you do your taxes so you do not get audit, they will tell you what the rules say and will not interrupt it for you and tell you if you do not understand go hire someone who does.