Apple's December FDA Meeting Addressed 'Moral Obligation' for Health, Sensor Innovation, and Regulation

[yankinwaoz]

Will Apple Disrupt Big Pharma and Health Insurance

I suspect this will not go well for Apple. Here is my reason.

Apple has a reputation as an industry disrupter. When Apple decides to enter a market, the establish players in that market find that the ground shifts below their feet. The old cartels are threatened.

Big Pharma and the health care industry are one of the most entrenched cartels out there. They have Congress in their pocket. The FDA in effect works for them. The FDA's job is not to improve the health of the US citizens. It is to protect established big phara players from competitors. It is there to stifle innovation that might lower prices, or god forbid, eliminate a profitable disease.

The only way Apple will find the FDA helpful is if they make apps and hardware that help hypochondriacs seek more medical care and medicine. If your iPhone starts nagging you to buy some blood pressure medication, instead of getting you healthy enough to not need medication, then they will find approval with the FDA.

I'm sorry that I seem to pessimistic. But the evidence of the last 20 years shows that our government was sold to corporate America. Corporate crimes are simply no longer punished. Instead, Congress just continues to give them legal protection and tax breaks. The financial regulators have completely sold out. Why would the health care industry be any different?

 

[IJ Reilly]

The FDA seems fundamentally broken under this administration. This week, the FDA ruled that cheese can no longer be aged in wood. Where exactly is the problem they are trying to solve?

Also note: many beers, wines, meads, and liquors are aged in wooden containers. How long until the FDA addresses this "risk"?

Exaggerate much?

----------

I wonder, will data on the iPhone will be regulated under HIPA?

Perhaps, but HIPAA doesn't so much regulate as prevent the sharing of health care information in non-medical situations without the individual's consent. Assuring the privacy of medical data is no more difficult than protecting other personal information, like your credit card numbers. Nothing that can't be readily addressed. None of this will ever be bullet-proof, given that someone will always be trying to steal valuable information, but the principles are the same.

 

[FloatingBones]

Exaggerate much?

No. Please tell us what you think the exaggeration is.

 

[kdarling]

If they want Apple to take steps to comply with federal mandates for "health safety" reasons that's fine, but I have a difficult time taking the FDA seriously when they claim to be an authority on "moral standards" of any kind.

It was Apple that said "there may be a moral obligation to do more" with devices, not the FDA.

Just a smart thing to do. Apple doesn't want to make something and get it pulled out by the FDA later. Ignorance is NOT bliss!

This. The last thing Apple wants is someone else regulating their code and devices.

 

[MacSince1990]

*eyeroll*

Yes, the moral imperative to monitor the health of those of us who can afford an iPhone and a monthly plan of $130+/month.

The FDA seems fundamentally broken under this administration. This week, the FDA ruled that cheese can no longer be aged in wood. Where exactly is the problem they are trying to solve?

Also note: many beers, wines, meads, and liquors are aged in wooden containers. How long until the FDA addresses this "risk"?

To be fair, your analogy sucks; fementation vs. mold, and cheese doesn't kill bacteria... alcohol does.

 

[JohnStrass]

Pen and Paper would solve 80% of my problems

I suspect this will not go well for Apple. Here is my reason.

Apple has a reputation as an industry disrupter. .....
Big Pharma and the health care industry are one of the most entrenched cartels out there........The financial regulators have completely sold out. Why would the health care industry be any different?

If patients showed up in my office with (1) a medication list (2) telephones of their other doctors and (3) a list of medical procedures, then we would be a long way forward. Gadgetry is just that. Do yo think that a person who can't bring a med list to their doctor can do an iMed app/device?

 

[IJ Reilly]

No. Please tell us what you think the exaggeration is.

One bureaucratic ruling that might well be silly on its face, but hasn't even been enforced, being spun into a hysterical prediction of the destruction of food as we know it by those bad, bad people in the Obama administration, followed by a reductio ad absurdum argument of its other imagined implications. Other than that?

The bureaucrats at the FDA (as at other federal agencies) have little choice but to implement the laws as they are written. If the problem is the law, which it appears to be, then the fix rests with Congress. We will see if Congress has any enthusiasm for addressing this, or whether it will instead be treated as an opportunity for another political finger-pointing game. Recent history makes forecasting the outcome a relatively trivial matter.

 

[NT1440]

I don't think it's technically possible.

Non invasive glucose sensors have never been shown to work well and I don't see how apple's solution could be better.

My guess is that it will not include glucose sensor.

I don't think that it will make the first round. That said, noninvasive glucose monitoring has been a massive center of intention and R&D in the medical field for quite some time now, with many breakthroughs happening in the last few years.

Seeing as 1/3 Americans will have diabetes by 2050 (and projected to climb further) I see this as an imperative for the medical field, so you can bet that it will make it in the next few years.

 

[IJ Reilly]

I don't think that it will make the first round. That said, noninvasive glucose monitoring has been a massive center of intention and R&D in the medical field for quite some time now, with many breakthroughs happening in the last few years.

Seeing as 1/3 Americans will have diabetes by 2050 (and projected to climb further) I see this as an imperative for the medical field, so you can bet that it will make it in the next few years.

And that's only in the US. As industrializing countries eat more like we do and take on more sedentary lives like ours, diabetes will become possibly the world's single-most serious health issue.

 

[SHNXX]

I don't understand where all this pessimism about the big pharma and FDA comes from.
As a biomedical phd, I find it mildly amusing lol.

 

[bawbac]

Wonder if they also told Apple that they need to backup user iHealth data to the iNSA cloud.

Why?
I'm sure Apple wants to keep all this personal information to themselves... until a company requests it at the right price/agreement.

 

[edk99]

Why?
I'm sure Apple wants to keep all this personal information to themselves... until a company requests it at the right price/agreement.

Sorry my comment was being sarcastic and I should of included a few . I thought saying iNSA would of tipped that off.

 

[FloatingBones]

One bureaucratic ruling that might well be silly on its face, but hasn't even been enforced, being spun into a hysterical prediction of the destruction of food as we know it by those bad, bad people in the Obama administration, followed by a reductio ad absurdum argument of its other imagined implications. Other than that?

Exactly. You do indeed have a bunch of speculation there.

What facts do you have that the Forbes story is false? So far, all you've given us is conjecture.

What facts do you have that there is some actual risk from using wood? It's been done that way for hundreds if not thousands of years.

The bureaucrats at the FDA (as at other federal agencies) have little choice but to implement the laws as they are written.

You are confused. This is an order from the executive branch. If you think there is some new law they are now enforcing, you need to provide a reference.

If the problem is the law, which it appears to be, then the fix rests with Congress.

Again, you are confused. If you think there is some new law, you should tell us what law you're talking about.

We will see if Congress has any enthusiasm for addressing this

The Constitutional remedy that Congress has to address this overzealous activity is impeachment.

whether it will instead be treated as an opportunity for another political finger-pointing game.

That's exactly what you have done.

One more time: if you think there is some new law that the FDA is enforcing, you should have no problem telling us what law you're talking about.

To be fair, your analogy sucks; fementation vs. mold, and cheese doesn't kill bacteria... alcohol does.

Actually, you are misinformed. Both the creation of cheese and beer/wine/etc. are fermentation. You can read this piece to get educated from one of the world's experts on fermentation. If you read closely Katz's comments on cheese, you'll also learn why the risk is ludicrous.

To both of you: why doesn't France have a problem with aging cheese in wooden forms? Why doesn't Switzerland? WTF do these pencil pushers think they know that nobody else does?

 

[IJ Reilly]

Exactly. You do indeed have a bunch of speculation there.

What facts do you have that the Forbes story is false? So far, all you've given us is conjecture?

I looked it up. I read beyond the Forbes story and all the right-wing web sites ranting about the story and found a whole lot of "it could" instead of "it will."

I think in complete thoughts. I will not respond to anyone who breaks my thoughts into tiny fragments.

 

[FloatingBones]

I looked it up. I read beyond the Forbes story and all the right-wing web sites ranting about the story and found a whole lot of "it could" instead of "it will."

What you COULD NOT FIND is any reference to any law that has changed. This is purely an executive action.

What actual facts about a risk did you find in your search? Do you find any explanation for this proposed ad hoc rule change by the Executive branch? Other than pencil-pushers wanting to add a regulation, do you have any evidence that this proposed rule change is actually needed?

I think in complete thoughts.

No. You have made a series of conjectures that you cannot defend. You told us

The bureaucrats at the FDA (as at other federal agencies) have little choice but to implement the laws as they are written.

but there has been NO CHANGE IN THE LAW. You made up stuff, and you have no response when called on your conjecture.

I don't mind when people make mistakes in a discussion. I do mind when they make claims and then run away when called on their stuff. Don't do that.

 

[r3m1]

I don't understand where all this pessimism about the big pharma and FDA comes from.
As a biomedical phd, I find it mildly amusing lol.

Ignorance is bliss

 

[SHNXX]

Ignorance is bliss

Ignorance?
Please do explain.
Are you a big pharma executive?