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jonnysods

macrumors G3
Sep 20, 2006
8,461
6,931
There & Back Again
Maybe one day Apple with create a magical chip that is surgically embedded in our bodies that will automatically log our excercise, food intake, general health, etc. Sounds like a pipe dream, but could be on our horizon if Apple's able to proliferate the healthcare industry.

It doesn't sound unlikely though! They will call it Apple Seed, and you swallow it and it tracks tour whole life.
 

Tech198

Cancelled
Mar 21, 2011
15,915
2,151
....yes and forget the rest of the world...

Apple has a nasty habit of touching "home-base" first with everything...


then rather rushing it out,, only slowly pushing it international.

Makes me sick.

But, that's Apple for ya... I hate green apple's too btw.
 

IJ Reilly

macrumors P6
Jul 16, 2002
17,909
1,496
Palookaville
In many cases it is ignorance of new regulations. The FDA regularly revises existing regulations and guidelines but many physicians and businesses in medicine lack the resources (i.e. regulatory authority knowledge and skills) to keep up to date with existing regulation and interpret them correctly. The issue is not so much reading and being aware of new regulation, but to communicate with the FDA about the interpretation thereof and gaining approval for changes in your product. Much of this can be done in bilateral agreements, but these are cumbersome in coordination and the FDA prefers to respond cryptically in order to not get into trouble themselves. Very annoying.

Or, I suspect, overly conservative interpretations by practitioners (perhaps as directed by their insurance companies). I recently had a doctor hit me with a hugely frustrating and I thought massively idiotic interpretation of HIPAA rules. That banner gets waived around quite a bit as a way for doctors to avoid talking to family members.
 

chimes

macrumors newbie
Aug 16, 2010
19
1
EHRs ripe for disruption

Considering the EMR/EHR world is a good 10-15 years behind on technology -- and the HITECH act only exacerbated that -- the industry is ripe for disruption. Epic, Cerner and others are cash cows and are not interested in innovating. Epic should be thanking its lucky stars that Apple is interested in working with them. If Judy Faulkner is smart, she'll do everything in her power to make this work.

----------

EMR systems like Epic are so horrible not only because of the system itself, but because of "meaningful use" and all the federal requirements for documentation.

Most doctors would agree with you.
 

peterdevries

macrumors 68040
Feb 22, 2008
3,146
1,135
Amsterdam, The Netherlands
i'm reading quite often the word 'revolutionize' but even tough many things, next to the ones you've been mentioning, could be made better I think to many people have this blind trust in Apple being able to revolutionize things in the health industry. that industry is all ready there, the pharmacy are extremely powerful, in many aspects way more powerful then Apple. It's the law, at least in Europe, that tries to keep these companies in line here. without these laws they would determine how the healthcare would operate with profit as the only guideline.

Sorry, but your understanding of how the pharmaceutical industry and regulation works is flawed. Regulation is not there to regulate profit intentions of companies, but to ensure the safety of patients and subjects. Pharmaceutical companies are among the companies that have the most relentless profit orientations. They wilfully ignore orphan diseases because these do not generate a profit and will abandon markets or diseases when competition increases and margins decrease (e.g. Roche and Johnson and Johnson have repeatedly indicated to abandon some of their markets in which competition is intensifying such as glucose monitoring).

There are already many (consumer) electronics companies active in medical devices. Examples are Panasonic, which is in the top 5 of largest blood monitoring companies. Another one is Philips, of which the healthcare division is the most profitable in the company. There is no reason why a consumer electronics company could not build a very good medical department capable of competing with established names. There are numerous examples of that.

Now, if you look at the market and understand how it works, you will realise that increased competition by new entrants is exactly what is needed. It is the reason why innovation and progress keeps happening. An example is the invention of glucose test-strips and the increase in accuracy that is currently being pushed mainly by small new companies.

This is also needed in medical software development. It is currently not a profitable field for most of the established companies, and therefore investments and progress are severely limited. Entry by Apple will be bound by regulatory requirements, which is a good thing. They will be held to the same standards as established companies. The thing that Apple can add to this market is incredible software development thrust and consumer behaviour knowledge. All fields that most established medical software companies are severely lacking.

The reason why many pharmaceutical- and medical fields are expensive and not sufficiently focused on the real user (the patient) is a lack of competition. The reasons are high entry barriers for new entrants due to the requirements on R&D, product development and regulatory, which in the case of medicines need an upfront investment of numerous years with associated capital. Apple can easily overcome these barriers on the software front. In that regard it is a mystery why they haven't already entered that market already.
 
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peterdevries

macrumors 68040
Feb 22, 2008
3,146
1,135
Amsterdam, The Netherlands
Or, I suspect, overly conservative interpretations by practitioners (perhaps as directed by their insurance companies). I recently had a doctor hit me with a hugely frustrating and I thought massively idiotic interpretation of HIPAA rules. That banner gets waived around quite a bit as a way for doctors to avoid talking to family members.

Totally agree. I'm sure there are lots of physicians that haven't looked at a regulatory publication since their graduation.
 

dragje

macrumors 6502a
May 16, 2012
874
681
Amsterdam, The Netherlands
Apple is becoming more and more a "lifestyle" company with their devices (wearable tech, etc). Unlike the old days where devices had more of a "utility" purpose to improve productivity in the office and other larger scale aims and goals. This being said, it's a natural progression of Apple to get into a field of which literally everyone on earth has a stake in some degree or another, namely, personal health.

As far as Apple monopolizing and controlling health data, that, I'd have to say, would be extremely unlikely to happen. Why? Because you have too many systems in place now and coming online soon with their own more or less proprietary means of storing data. What stops Allscripts or Epic or any other EHR/EMR system from developing their own apps? Especially, say, Epic with their already large deployment in the medical industry? Each passing day the medical community gets more fractured because of lacking standards. While Apple may bring some "order" to this fracturing, it's a very tall order for it outright control an industry with so many legacy systems, infinite platforms, and other players in the field.

You've a point here. Well, time will tell. Let's see how these plans of apple will turn out.
 

Moto G

macrumors 6502a
Jul 6, 2014
858
0
I got excited when I thought you wrote "Heathkit" :(

HR-10B-Heathkit-web.jpg
 

dragje

macrumors 6502a
May 16, 2012
874
681
Amsterdam, The Netherlands
Sorry, but your understanding of how the pharmaceutical industry and regulation works is flawed. Regulation is not there to regulate profit intentions of companies, but to ensure the safety of patients and subjects. Pharmaceutical companies are among the companies that have the most relentless profit orientations. They wilfully ignore orphan diseases because these do not generate a profit and will abandon markets or diseases when competition increases and margins decrease (e.g. Roche and Johnson and Johnson have repeatedly indicated to abandon some of their markets in which competition is intensifying such as glucose monitoring).

I'm the first to admit I'm no expert in the field, but what you call flawed understanding might as well be lack of understanding of the point I'm trying to make or just me not able to explain it to you. So let's skip the silly ego of who-knows-best competition and allow me to try to explain it differently: I agree what you're stating about the industry. ^^

There are already many (consumer) electronics companies active in medical devices. Examples are Panasonic, which is in the top 5 of largest blood monitoring companies. Another one is Philips, of which the healthcare division is the most profitable in the company. There is no reason why a consumer electronics company could not build a very good medical department capable of competing with established names. There are numerous examples of that.

.. :rolleyes: Everyone knows this I didn't object for Apple making gadgets, there is no comment out there where I object for companies in general for making gadgets. That's beside the point. The point I'm trying to make is that I'm a bit worried when "profit" comes with determining the course of "how" technology and the pharmacy industry will shift the health industry in a direction where making profit is more important then the quality of good healthcare. I might easily be wrong here and since nothing drastic had happened so far and everything, both you and me are stating here, about Apple's plans are highly speculative. It's impossible to say if my concerns are legitimate. In other words, time will tell. It might as well be nothing, that Apple will just comes up with a simple watch that gives a patient some extra information about his or her health and that's basically it...

Now, if you look at the market and understand how it works, you will realise that increased competition by new entrants is exactly what is needed. It is the reason why innovation and progress keeps happening. An example is the invention of glucose test-strips and the increase in accuracy that is currently being pushed mainly by small new companies.

Nothing wrong with competition and new inventions, true. But let's just see what happens. So far nothing is concrete, there are only gossips so far about an upcoming health-watch.

This is also needed in medical software development. It is currently not a profitable field for most of the established companies, and therefore investments and progress are severely limited. Entry by Apple will be bound by regulatory requirements, which is a good thing.

i agree.

They will be held to the same standards as established companies. The thing that Apple can add to this market is incredible software development thrust and consumer behaviour knowledge. All fields that most established medical software companies are severely lacking.

It seems to me you have some kind of blind faith in Apple's skills in producing good working GUI's and software packages. first of all, that's of course just speculative as for now, in the past even Apple made some real disaster products when it comes to deliver good working software products. and in this field my knowledge is not flawed, I work in the media industry for over 20 years and grew up with Apple both with their triumphs and failures. So, also here the saying goes: let's see what will become of Apple plans in this.

The reason why many pharmaceutical- and medical fields are expensive and not sufficiently focused on the real user (the patient) is a lack of competition. The reasons are high entry barriers for new entrants due to the requirements on R&D, product development and regulatory, which in the case of medicines need an upfront investment of numerous years with associated capital. Apple can easily overcome these barriers on the software front. In that regard it is a mystery why they haven't already entered that market already.

in this I agree, and again, nothing wrong with Apple to try to come up with new gadgets to release the burden a bit of the issues as described by you. I'm just a bit worried they, Apple, might swift the industry in a direction where it's becoming a fashion thing to record every bit of health data that people will blind-fully trust to large companies for which the philosophy is not about actually making people more healthy but is focused on making profit.

Bill Gates does invest millions as well in a new type of refrigerators that doesn't require much power in order for keeping specific medicine cool. The end goal? Fill these refrigerators with medicine and ship them to poor area's in Africa. What's in it for Gates? Nothing. He spends millions and millions of healthcare issue's like the millions he's spending to cure malaria. Where is he after? Nothing, he doesn't mind in making profit here.

Again, nothing wrong with making commercial gadgets (by apple) and make profit with whatever they come up with, but it seems to me that what Bill gates is doing for years is, so far, more pragmatic and more needed for sick patients world wide.

Again, time will tell. One thing is for certain, and I agree on this with you, there is much to be improved in the health industry. The only question that remains, is it truly in the interest for the end users?

----------

i got excited when i thought you wrote "heathkit" :(

image

:)
 
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peterdevries

macrumors 68040
Feb 22, 2008
3,146
1,135
Amsterdam, The Netherlands
I'm the first to admit I'm no expert in the field, but what you call flawed understanding might as well be lack of understanding of the point I'm trying to make or just me not able to explain it to you. So let's skip the silly ego of who-knows-best competition and allow me to try to explain it differently: I agree what you're stating about the industry. ^^

Sorry, wasn't trying to insult you, and I understood perfectly what you wrote. It was not my intention to start a male appendage measuring contest. But let me clarify myself. I'm a technology and innovation strategy consultant, currently revising processes for a pharmaceutical giant to make them more compliant to changed FDA regulations. My comments come from that background.

:rolleyes: Everyone knows this I didn't object for Apple making gadgets, there is no comment out there where I object for companies in general for making gadgets. That's beside the point. The point I'm trying to make is that I'm a bit worried when "profit" comes with determining the course of "how" technology and the pharmacy industry will shift the health industry in a direction where making profit is more important then the quality of good healthcare.

Your fear is unjustified. Like I said before this is what has been happening for the past 50 years in the medical industry, and the entry of Apple will not in any way change that or be outside of the normal pattern that happens. It will actually push others to step up their game.

Here is another example, quite related to rumors about the iWatch: one of the biggest cash cows in the history of pharmaceuticals and medical devices is glucose monitoring. Diabetics need to minor their glucose intake to adjust insulin dosage. In the 60s, 70s and 80s hundreds of millions (billions when inflation adjusted) were earned on an annual bases on urine sticks that cost a few cents to produce but were sold at incredible margins of over several hundreds of percents. Bayer at some point invented the now still used glucose blood teststrip which in the last 30 years has NOT CHANGED besides technology to protect white label test-strip producers to use their machines. Similar to Nespresso machines trying to protect against the use of white label supermarket cups. To this day these systems have changed only marginally in function and accuracy, although the regulators have pushed for changes for years. What happened is that still these manufacturers make about 3 billion a year on these systems, but R&D has virtually stopped to decrease costs and the manufacturing setups have been reduced and optimised to small units that churn out test-strips with very little human intervention needed. These giants still earn 90% margin while only maintaining the status quo. But now comes the interesting thing that proves that your fears are unjustified. Recently regulators and insurers alleviated regulation to allow the entry of smaller specialised companies that produce new technology to measure blood glucose. Suddenly prices for test-strips are falling by more than 20% per year AND accuracy is increasing because that is what the regulators have kept in place. Because of their high margin expectations the large manufacturers (Roche, Bayer, Abbot, Lifespan, Panasonic) have indicated to leave the market because they can't keep up anymore. Term and Arkray are now taking over, which is a good thing because they have better or similar systems at lower price points. This has enabled more diabetes 1 patients to use the systems and also more diabetes 2 patients to get it into their budget.

Nothing wrong with competition and new inventions, true. But let's just see what happens. So far nothing is concrete, there are only gossips so far about an upcoming health-watch.

No, Health and HealthKit are real (https://www.apple.com/ios/ios8/health/). And these have more potential than an iWatch in terms of medical support. Apple doesn't need to state exactly how their business model will look like to predict what they possibly will do. I agree that physicians can't require you to use an app, but the installed base of millions of iPhones will make physicians prepare for patients that demand to use it. Here the push wil come from the patients side rather than the physician.

It seems to me you have some kind of blind faith in Apple's skills in producing good working GUI's and software packages.

No I don't. I chose my words very carefully. Of course Health and HealthKit can be duds, but what Apple is doing looks from a strategic point of view exactly the right thing. This is about resources and capabilities. Let me explain. Even in dedicated medical devices and pharmaceutical companies the teams working on software development are very very small. Typically about 2-10 people per product. They usually have no supporting structure with other developers in other departments or clear and streamlined development processes such as a specialised software developer giant has. In addition they usually have a very physician oriented view in stead of a patient oriented view. What Apple can bring to the table is development capability for consumer products which they can use to more efficiently develop software. And now about the resources. We have heard several reports of people switching to Apple from small medical devices companies. These will certainly be used to bring together the needs of the patient and the physician and function as advisors to developers (we have also seen reports that Apple is hiring developers with a healthcare background). These are all things that established parties in the medical devices market have and are failing to do: large pharmaceuticals and medical devices manufacturers are constantly rerouting resources to the most profitable product. With the loss of resources also the capability drops and subsequently progress and innovation are stopped.


Again, nothing wrong with making commercial gadgets (by apple) and make profit with whatever they come up with, but it seems to me that what Bill gates is doing for years is, so far, more pragmatic and more needed for sick patients world wide.

It's a different business model. Gates is a private person and into charity. Apple is a business with shareholders and therefore focused on making a profit, the same as all large medical and pharmaceutical giants such as Novartis, Novo Nordisk, Bayer, Roche, Abbott etc. Apple's profit orientation alone will not make a difference in this market. It is their way of doing business that might.
 

Dave00

macrumors 6502a
Dec 2, 2003
883
106
Pittsburgh
Is this the literal regulatory requirement, or the interpretation? I've been told by institutions in other areas (banking) that the regulations require them to do diametrically opposed things with the same customer request, and they are all convinced that their interpretation is the only correct one.
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Oh, it's quite literal and specific. In order to electronically prescribe a controlled substance, I have to have two-factor identification, with options being a hard token, biometric screening, etc. Once I have these in place, both the EMR application and the intermediary (usually SureScripts) have to have a 3rd party verify me. It's insane. So what do most people do? Just fax it or call it in, which is obviously immensely less secure than even the most basic username/password electronic method.
Well, if so, see above. I've had pharmacists insist that by fax is the only way they can possibly renew my prescription. My MD uses a laptop in the examining room but he has never printed anything out for me, or even offered.

I can see how it's a huge hairball. Can Apple solve any or all of it? If so, a king's ransom awaits.
There's always an option to print the script - just ask. It creates a tiny little bit more work, because then you have to physically sign it, but not a big deal.

I just wish the IT departments would be more receptive to using Macs. It wouldn't be that hard, because often apps are run over the web and you can use Citrix to log on. As it is, I use a laptop that they consider to be "state-of-the-art", which weighs twice as much as a 13" macbook air, lasts about 3h on a charge, and because of all the security they put on it, takes 12-13 minutes to reboot after a blue screen of death, which happens around once a day. When I ask, I'm greeted with "we don't support Macs" - I wonder if they realize just how much easier it would be to actually support Macs than a Windows environment where some are on XP, some are on Vista, some are on 7.
 

Dave00

macrumors 6502a
Dec 2, 2003
883
106
Pittsburgh
Or, I suspect, overly conservative interpretations by practitioners (perhaps as directed by their insurance companies). I recently had a doctor hit me with a hugely frustrating and I thought massively idiotic interpretation of HIPAA rules. That banner gets waived around quite a bit as a way for doctors to avoid talking to family members.
It's waved around a lot because the rules are arcane and the penalties are enormous. I had someone threaten me with reporting a HIPAA violation when I left a message about a strep test on his home phone rather than cell phone. If he'd actually gone through with it, I could've gotten a fine for $50,000. The punishments are draconian and not necessarily in line with the violation.
 

IJ Reilly

macrumors P6
Jul 16, 2002
17,909
1,496
Palookaville
Oh, it's quite literal and specific. In order to electronically prescribe a controlled substance, I have to have two-factor identification, with options being a hard token, biometric screening, etc. Once I have these in place, both the EMR application and the intermediary (usually SureScripts) have to have a 3rd party verify me. It's insane. So what do most people do? Just fax it or call it in, which is obviously immensely less secure than even the most basic username/password electronic method.

There's always an option to print the script - just ask. It creates a tiny little bit more work, because then you have to physically sign it, but not a big deal.

I wasn't referring to controlled substances. If I run out of refills on anything, the pharmacy insists that they have to fax in the renewal request to my doctor. Welcome to the 1980s. I just changed pharmacies so I will see if they do the same.

Not sure what script you mean. Whenever I pick up a prescription I have to sign for them, decline counseling, and they stuff a sheet of disclosures in the bag.

----------

It's waved around a lot because the rules are arcane and the penalties are enormous. I had someone threaten me with reporting a HIPAA violation when I left a message about a strep test on his home phone rather than cell phone. If he'd actually gone through with it, I could've gotten a fine for $50,000. The punishments are draconian and not necessarily in line with the violation.

People can threaten all sorts of things, but what chance do they have of getting anywhere on a supposed violation of this kind? The stunt a doctor pulled on me last month was more likely to get him sued than prevent him from getting sued.
 

Dave00

macrumors 6502a
Dec 2, 2003
883
106
Pittsburgh
I wasn't referring to controlled substances. If I run out of refills on anything, the pharmacy insists that they have to fax in the renewal request to my doctor. Welcome to the 1980s. I just changed pharmacies so I will see if they do the same.
If the pharmacy and doctor are electronic (as most now are), there would never be a reason for the pharmacy to fax to the doctor. However, the doctor would have to fax to the pharmacy if it's a controlled substance, as described earlier.
People can threaten all sorts of things, but what chance do they have of getting anywhere on a supposed violation of this kind? The stunt a doctor pulled on me last month was more likely to get him sued than prevent him from getting sued.
Obviously, I can't speak to whatever happened between you and a physician. But if you don't have explicit written permission from a person, that person's physician does not have ability to even discuss with you whether or not they are a patient. This is even when it should be obvious that you are a person's representative, being their power of attorney or next of kin or whatever. It's ridiculous, but, as they say, "the law is an ass."

The law says you can be fined $50k even for a violation you not only didn't know about but wouldn't have had any ability to know about. HIPAA violations "due to reasonable cause and not due to willful neglect" have a MINIMUM fine of $1000. The incident I referenced caused involvement of a legal team and compliance officers for something that any reasonable person would determine is a benign mistake.
 

IJ Reilly

macrumors P6
Jul 16, 2002
17,909
1,496
Palookaville
Obviously, I can't speak to whatever happened between you and a physician. But if you don't have explicit written permission from a person, that person's physician does not have ability to even discuss with you whether or not they are a patient. This is even when it should be obvious that you are a person's representative, being their power of attorney or next of kin or whatever. It's ridiculous, but, as they say, "the law is an ass."

The law says you can be fined $50k even for a violation you not only didn't know about but wouldn't have had any ability to know about. HIPAA violations "due to reasonable cause and not due to willful neglect" have a MINIMUM fine of $1000. The incident I referenced caused involvement of a legal team and compliance officers for something that any reasonable person would determine is a benign mistake.

In this instance the doctor in question received verbal authorization from the ill family member in the hospital to talk to me, after which he called. But subsequently his office played "talk to the hand" with me even after being reminded that my family member had authorized me to be informed. Without going into too many details, it was clear that the patient was in no position whatsoever to charge him with a HIPAA violation and never would be, and if anyone was going to be ticked off it was going to be me. I have been through similar situations with family members before and had never been told by a doctor that they can't speak to me without written authorization. I think this doctor was hiding behind HIPAA because of the questions I was asking about my family member's diagnosis and treatment.
 
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