Apple In Talks to Roll Out HealthKit to Medical Professionals Across U.S.

[peterdevries]

I am somewhat concerned that data collection devices will be approved in any reasonable time frame. Two years ago LifeScan announced the OneTouch Vario Sync glucose meter, which is used to measure glucose using already available strips. This meter uses Bluetooth to connect to an iPhone or iPad using a free app to do so. It took LifeScan over a year to get this concept approved for use. Moveover, although it was reasonably priced at $20, Medicare would not approve it since there were other devices available that were as accurate but did not use Bluetooth, and cost about three times as much. I bought one myself with a prescription which was hard to come by, since the device was not yet listed on the medical device list that is given to physicians. The device is wonderful and has had some recent software upgrades to make it more useful.

Good luck, Apple.

The reason why this took so long is that at that time Apple had not implemented functionality to compartmentalise apps. The concern is that updates for other apps or viruses might affect the Glucose Monitoring app, making it vulnerable to changes that might affect insulin dosage decisions.

There are now (apparently) functionalities within iOS that enable this compartmentalisation. In addition Apple might decide to store the app and information in a sectioned off part of the logic board (separate chip or whatever). The FDA indicated that such solutions would be satisfactory.

 

[Dave00]

It has enormous potential but it seems like they're focusing entirely on the wrong things. As a physician I care only minimally about things like caffeine consumption, but if the app would have their med list, health history, and copies of labs or other diagnostics, that would be huge, especially if a person were traveling and not seeing their regular doctor. I could see the med list tying in with a pharmacy app that could remind people to pick up their refills. Or a protocol-driven reminder system for health maintenance and routine follow-up. A list of how many steps were taken per day is kind of the last thing I'd want a person wanting to show me in the office.

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. Thus, the potential for Apple to improve it is limited. But, we'll see where things go.

 

[Pete1945]

I keep seeing HeathKit

And wondering why Appile is selling do it yourself stereo kits.

 

[winston1236]

That is incorrect. Regulatory approval is straightforward for devices where measurement is "outsourced" to peripherals. The average approval period is about 6 months (well within Apple product cycles) and costs only a few hundred dollars (well within Apple's budget).

I think you missed this. All of this tracking is stirring up a ton of privacy concerns.

 

[IJ Reilly]

I love how everyone predicts something as a failure before it's even been announced. I guess that's par for the course with Apple.

You should know by now that you don't have to know what it is to know that it will never work.

----------

I'm afraid you have little to fear. Regulatory requirements will make it uneconomic for Apple to commercialize the level of integration discussed in this article.

And you know that how, exactly? The fact is, medical information is already being digitally collected and shared, but in an inefficient way. If anyone can rethink this problem and implement a solution, it is Apple.

----------

I think you missed this. All of this tracking is stirring up a ton of privacy concerns.

So what one Senator said about one product translates into "a ton" of privacy concerns?

Protecting the privacy of health data is not hugely difficult. Doctors and hospitals are handling this data day in and day out, and it does not seem to be raising "a ton" of concerns.

 

[newyorksole]

You all are so worried about the "security of your health", yet you have passwords with Apple, fingerprints on your device, credit card info, iCloud data ... But NOW you're worried about security ?

I don't get it ...

 

[peterdevries]

I think you missed this. All of this tracking is stirring up a ton of privacy concerns.

This has nothing to do with the FDA and regulation of medicines and medical devices. The article you reference is just a (IMO justified) opinion from a Senator.

 

[GFLPraxis]

I work in the medical field and it needs a company like apple to revolutionize some aspects of health care. Most systems are cumbersome and get in the way of health care professionals.

Let's hope apple can make a big difference and encourage others to do the same

I do as well and want to second this. I work in Medical IT and am constantly appalled at the quality of software that hospitals choose to implement and then ask for help running.

A ton of healthcare applications are ancient and poorly supported. They conform to very very strict requirements as far as how data is transmitted and stored...and that's about it. They have terrible GUIs, cost way, way too much compared to their quality, never get updates, and have support lines that take forever to get back to you. Oftentimes new software purchased was clearly originally meant to run on Windows 95.

Ever notice how rarely hospitals are on the newest version of Windows? Generally, vendors take a couple years to catch their software up, so hospitals are afraid to upgrade their PCs because some software across the hospital will break when they do.



There's a huge golden opportunity to revolutionize this industry. And Apple can tie things in to the hardware people already have.

But meeting their regulatory requirements is going to be tough.

 

[topmounter]

And wondering why Appile is selling do it yourself stereo kits.

They're not just for radio now... DIY pacemaker, insulin pump, etc.

 

[IJ Reilly]

I do as well and want to second this. I work in Medical IT and am constantly appalled at the quality of software that hospitals choose to implement and then ask for help running.

A ton of healthcare applications are ancient and poorly supported. They conform to very very strict requirements as far as how data is transmitted and stored...and that's about it. They have terrible GUIs, cost way, way too much compared to their quality, never get updates, and have support lines that take forever to get back to you. Oftentimes new software purchased was clearly originally meant to run on Windows 95.

Ever notice how rarely hospitals are on the newest version of Windows? Generally, vendors take a couple years to catch their software up, so hospitals are afraid to upgrade their PCs because some software across the hospital will break when they do.



There's a huge golden opportunity to revolutionize this industry. And Apple can tie things in to the hardware people already have.

But meeting their regulatory requirements is going to be tough.

I agree with most of this, but I wonder why you think Apple meeting the regulatory requirements would be so difficult. It should not be a problem for Apple to at least equal the level of security already used for protecting medical data. The privacy standards don't seem that complicated, at least from a patient's point of view. We are constantly being asked by doctors and hospitals to sign HIPAA releases, which are mostly badly photocopied forms that presumably get entered into a database.

 

[peterdevries]

I agree with most of this, but I wonder why you think Apple meeting the regulatory requirements would be so difficult. It should not be a problem for Apple to at least equal the level of security already used for protecting medical data. The privacy standards don't seem that complicated, at least from a patient's point of view. We are constantly being asked by doctors and hospitals to sign HIPAA releases, which are mostly badly photocopied forms that presumably get entered into a database.

Indeed, I have been working with the FDA for the past 6 months on safety data collection and their guidance is actually not very well defined, which means we have quite a bit of freedom. In addition approval processes for software are relatively fast compared to medicines and medical devices.

In many cases it is not the regulatory framework that is the problem, but a lack of innovation, focus on the user and lack of imagination that is the cause of bad medical software.

 

[IJ Reilly]

Indeed, I have been working with the FDA for the past 6 months on safety data collection and their guidance is actually not very well defined, which means we have quite a bit of freedom. In addition approval processes for software are relatively fast compared to medicines and medical devices.

In many cases it is not the regulatory framework that is the problem, but a lack of innovation, focus on the user and lack of imagination that is the cause of bad medical software.

I don't know how any of this works in Europe (also a market for Apple of course) but in the U.S. (and speaking entirely as a patient) the medical data system seems to be about as sophisticated as banging two rocks together. Only recently have doctors started using laptops in examining rooms and some can even send a prescription directly to you pharmacy now. But the pharmacies I've used, if they need a renewal from your doctor, they send the request by fax. Astonishing.

 

[Dave00]

I agree with most of this, but I wonder why you think Apple meeting the regulatory requirements would be so difficult. It should not be a problem for Apple to at least equal the level of security already used for protecting medical data. The privacy standards don't seem that complicated, at least from a patient's point of view. We are constantly being asked by doctors and hospitals to sign HIPAA releases, which are mostly badly photocopied forms that presumably get entered into a database.

Ah, but you confuse what makes sense with what actually happens. There are many security-related policies that make zero sense. For instance, I cannot prescribe a controlled substance electronically, even though this requires an ID, password, and encription. But I can fax or even call it in, which is obviously much more susceptible to fraud. So, what matters (from a practical standpoint) is not whether Apple can provide better security, but whether they can prescribe security which meets the letter of regulatory requirements. Welcome to my world.

 

[Dave00]

I don't know how any of this works in Europe (also a market for Apple of course) but in the U.S. (and speaking entirely as a patient) the medical data system seems to be about as sophisticated as banging two rocks together. Only recently have doctors started using laptops in examining rooms and some can even send a prescription directly to you pharmacy now. But the pharmacies I've used, if they need a renewal from your doctor, they send the request by fax. Astonishing.

They actually shouldn't send by fax, unless they're totally behind. Requests come electronically from the pharmacy, but again in a bizarre twist, I might have to send a reply as a fax if it is for a controlled substance.
You are right about the stone-age technology in medicine. I frequently get errors like "bad memory pointer." You know what would have happened to me if in one of my coding classes my final product produced bad memory pointers? Much of this comes from two stupid words - "meaningful use." The law says that you can't just have a computer, it has to be "meaningfully used" - and there's all sorts of regulation about what those two words mean. To be a meaningful user, I *have* to print out a 3-page clinical visit summary for every patient that comes in. Ostensibly, the patient is supposed to read it, but they generally don't want it, and it goes into the shredder. I don't have the option to offer and have it refused; it MUST be printed out or I actually run the risk of having my pay lowered. But important things like interoperability were delayed until later stages, so now you have a situation where hundreds of different electronic health records are supposed to be able to talk to each other. You thought it was bad converting a Word document to an iWork file? Imagine if instead of two operating systems there were hundreds. So instead records are printed out and faxed.

 

[Robin4]

I do as well and want to second this. I work in Medical IT and am constantly appalled at the quality of software that hospitals choose to implement and then ask for help running.


There's a huge golden opportunity to revolutionize this industry. And Apple can tie things in to the hardware people already have.

But meeting their regulatory requirements is going to be tough.

I am astounded about the changes happening recently in my own provider's office. I have signed on to their site and I am in constant contact with them. Yesterday my doctor emailed me with the test results of the day before, sent a new prescription to my pharmacy. The pharmacy had it ready. Today she emailed again, any reaction? Wow, I didn't know one could really have such intimate contact. That is just great. I'm sure they will be all too happy to adopt a successful method that makes life easier for all involved.

 

[IJ Reilly]

Ah, but you confuse what makes sense with what actually happens. There are many security-related policies that make zero sense. For instance, I cannot prescribe a controlled substance electronically, even though this requires an ID, password, and encription. But I can fax or even call it in, which is obviously much more susceptible to fraud. So, what matters (from a practical standpoint) is not whether Apple can provide better security, but whether they can prescribe security which meets the letter of regulatory requirements. Welcome to my world.

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.

----------

They actually shouldn't send by fax, unless they're totally behind. Requests come electronically from the pharmacy, but again in a bizarre twist, I might have to send a reply as a fax if it is for a controlled substance.
You are right about the stone-age technology in medicine. I frequently get errors like "bad memory pointer." You know what would have happened to me if in one of my coding classes my final product produced bad memory pointers? Much of this comes from two stupid words - "meaningful use." The law says that you can't just have a computer, it has to be "meaningfully used" - and there's all sorts of regulation about what those two words mean. To be a meaningful user, I *have* to print out a 3-page clinical visit summary for every patient that comes in. Ostensibly, the patient is supposed to read it, but they generally don't want it, and it goes into the shredder. I don't have the option to offer and have it refused; it MUST be printed out or I actually run the risk of having my pay lowered. But important things like interoperability were delayed until later stages, so now you have a situation where hundreds of different electronic health records are supposed to be able to talk to each other. You thought it was bad converting a Word document to an iWork file? Imagine if instead of two operating systems there were hundreds. So instead records are printed out and faxed.

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.

 

[Col4bin]

Seems like I'm going to have to input a lot of data for this to be effective.

Every coffee, every snack etc. Can't be bothered.

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.

 

[msbdude]

It has enormous potential but it seems like they're focusing entirely on the wrong things. As a physician I care only minimally about things like caffeine consumption, but if the app would have their med list, health history, and copies of labs or other diagnostics, that would be huge, especially if a person were traveling and not seeing their regular doctor. I could see the med list tying in with a pharmacy app that could remind people to pick up their refills. Or a protocol-driven reminder system for health maintenance and routine follow-up. A list of how many steps were taken per day is kind of the last thing I'd want a person wanting to show me in the office.

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. Thus, the potential for Apple to improve it is limited. But, we'll see where things go.

if they could somehow manage to integrate a PACS/Ris app like Osirix into this. then we would have something compelling

 

[wongo]

I am astounded about the changes happening recently in my own provider's office. I have signed on to their site and I am in constant contact with them. Yesterday my doctor emailed me with the test results of the day before, sent a new prescription to my pharmacy. The pharmacy had it ready. Today she emailed again, any reaction? Wow, I didn't know one could really have such intimate contact. That is just great. I'm sure they will be all too happy to adopt a successful method that makes life easier for all involved.

What system and/or software does your provider use for all that you describe, if you happen to know?

 

[dragje]

I'm afraid you have little to fear. Regulatory requirements will make it uneconomic for Apple to commercialize the level of integration discussed in this article.

Actually, I regard that as good news ^^

It's a principal thing for me, entertainment is something Apple can commercialize to any level they want,I don't mind that at all. But as for healthcare, well, I think that it would be unhealthy to commercialize that field of business. That patients getting dependend on special medication from a specific firm is controversial enough, to get dependent on gadgets from an electronic company (any) on top of that is getting out of control.

In short, healthcare should be all about taking care of patients where the patient doesn't need to care about having an Apple product or some product from an other electronic company in order to get the specified treatment he or she needs that comes along with it.

I've no objections for Apple making things like iWatch which consumers can buy on their own free will to improve their sporting activities. But at the docter I want to hear questions relevant to my illness and not about if I own an Apple devise in order to undergo some treathment.

----------

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.

That sounds more like Orwell's 1984 nightmare, the uncut version.....
It's just silly to trust any company with all of the data your body would generate on such an implanted chip in the hands of a company.

 

[peterdevries]

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.

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.

----------

It's a principal thing for me, entertainment is something Apple can commercialize to any level they want,I don't mind that at all. But as for healthcare, well, I think that it would be unhealthy to commercialize that field of business. That patients getting dependend on special medication from a specific firm is controversial enough, to get dependent on gadgets from an electronic company (any) on top of that is getting out of control.

I'm sorry to be the bearer of bad news, but this is already happening all over the world, and not by Apple. Pharmacists and physicians push products to you as a patient that they have agreed with pharmaceutical and medical devices companies to prescribe in exchange for conference visits and medical materials.

e.g. if you are a diabetic and go to your local pharmacy in Amsterdam, there is a big chance that they wil sell you only Bayer glucose monitors because their sales headquarters is only 25 km away. Regardless of the fact that Lifescan currently builds the best meter.

 

[dragje]

There's a huge golden opportunity to revolutionize this industry. And Apple can tie things in to the hardware people already have.

But meeting their regulatory requirements is going to be tough.

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. Apple is, like these pharmacy companies, first and foremost interested in making profit NOT in the health of one individual. Stating differently is just PR talk. And this is not wrong, that is, as long the law makes sure patients will have choices and will not be depended on buying Apple products I'm ok with everything Apple does, but it starts getting creepy when any company where profit is their guideline would be able to monopolize the healthcare industry.

To many people simply romanticize the whole idea of Apple making things better for the sick / ill patient while in fact their first priority would be: how to get lot's of money from this and profit is the last thing that comes in my mind when thinking how a patient could get healthy once again.

As long it stays with gadget and the scenario remains that the patient have a choice in making his or her live more healthy using an apple product it's fine with me, but I never would like to see that a doctor would write an subscription for me that doesn't contains medicine but some Apple devise.

Of course, it will not go that far, it better not, and I'm confident that the laws engaged in Europe will limit any commercial company to uphold their strategy stating that this would be beneficial for the patients and that making profit is not an issue here, we all know this is not the case, so yes, these law restrictions that some describe as a downside are for me the best laws where patients benefit from.

 

[wongo]

In many cases it is ignorance of new regulations ... 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.

As per legalese of Obamacare, isn't this picture now more complicated by requiring approval of HHS.gov (Dept of Health & Human Services) on top of the FDA?!? If so, what a nightmare in negotiating.

I have no specific knowledge of what HHS now mandates, however after seeing how much that department has been tasked (and enormously so at that) by this new law I wouldn't be surprised the complexities of designing anything have become more difficult.

 

[dragje]

In many cases it is ignorance of new regulations.

I've no doubt it is. But as you said, in many cases, not all.

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.

----------

Yes, and there is much that should be improved. I'm not conservative, I welcome more convenient ways to tackle these issues as described above, but I have reasons to believe that it should go along with regulations provide with safety in mind and where making profit isn't that relevant. If anyone would take that aspect away then new regulations will be made by companies with profit as their main goal, Apple is no Zen company with one single aim to make people's health better just out of sincere care.

I'm sorry to be the bearer of bad news, but this is already happening all over the world, and not by Apple. Pharmacists and physicians push products to you as a patient that they have agreed with pharmaceutical and medical devices companies to prescribe in exchange for conference visits and medical materials.

With all do respect, everyone knows this and that's exactly the reason why regulations are still so important, not regulations provide by the companies but by law. This explains the huge amount of money company's provide to lobbyist to enable politicians to pass a law that would favor the launch of a new product or provide a company with more rights to state what medicine should be used. Regulations makes sure it's the doctor that is in control in determining what is good for a patient and what's not.

That this situation is shrinking, as you stated correctly, is the very reason why regulations are the only means to restrict this for going down to fast. Europe is going in the direction of where America is now, which is just a plain nightmare as for healthcare matters while America is struggling to fight with the pharmacy companies and give choices back to the people where it is all about, the doctors and the patients. I thank god i'm living in the Netherlands and not in America in this aspect that is, because healthcare in America is almost as bad as living in the middle ages.

so, regulations, godthanks we still have those. But of course, this doesn't mean that changes are not welcome here but even better is to keep an good eye on it and make sure that patients and doctors are the ones that decide what device they would like to use and with the right treatment that comes along with it. If Apple is aiming for making changes only in the background, update computers and machinery then I'm ok with that.

e.g. if you are a diabetic and go to your local pharmacy in Amsterdam, there is a big chance that they wil sell you only Bayer glucose monitors because their sales headquarters is only 25 km away. Regardless of the fact that Lifescan currently builds the best meter.

true, and this is what concerns me greatly. but I don't see how Apple will be able to tackle this.

 

[wongo]

...But as for healthcare, well, I think that it would be unhealthy to commercialize that field of business. That patients getting dependend on special medication from a specific firm is controversial enough, to get dependent on gadgets from an electronic company (any) on top of that is getting out of control.

In short, healthcare should be all about taking care of patients where the patient doesn't need to care about having an Apple product or some product from an other electronic company in order to get the specified treatment he or she needs that comes along with it.

I'm sorry to be the bearer of bad news, but this is already happening all over the world, and not by Apple. Pharmacists and physicians push products to you as a patient that they have agreed with pharmaceutical and medical devices companies to prescribe in exchange for conference visits and medical materials.

This is very true! As one who grew up in a medical family and had managed both doctor's offices and medical buildings, this is somewhat of an open secret among the medical community. It's flat out another form of bribery. Does it lead to questioning of a doctor's integrity and bias in their medical advice towards patients? Of course it does. Ethics be damned.

I would also add medical diagnoses and processes are no longer determined purely from a physician's expertise. Unfortunately insurance companies have become so involved with healthcare decisions that any advice you receive in the office now includes an invisible 3rd party (e.g. cost-cutting mandates/"incentives" of managed-care organizations). It's sad to see doctors cannot truly be doctors today; in essence you are not getting what is truly the best advice for the patients today compared to the old days. This is a HUGE reason why so many doctors in my family's generation are retiring in droves. They just don't like the red-tape now involved. Plus what's scary too is how Obamacare will now enroll some 35+ million new patients into the healthcare system without any mandate or incentives to boost the total number of MDs in medical schools to fill in for the retiring doctors! But I digress.

... Apple is, like these pharmacy companies, first and foremost interested in making profit NOT in the health of one individual. Stating differently is just PR talk. And this is not wrong, that is, as long the law makes sure patients will have choices and will not be depended on buying Apple products I'm ok with everything Apple does, but it starts getting creepy when any company where profit is their guideline would be able to monopolize the healthcare industry ...

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.