Wednesday, February 13, 2013

When Patients Can Obtain Their Own EKG

With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to "licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms."

While this sounds nice, how, exactly, does one become a "prescribed patient?"  Once a doctor "prescribes" such a device, what are his responsibilities?  Does this obligate the physician to 24/7/365 availability for EKG interpretations?  How are HIPAA-compliant tracings sent between doctor and patient?  How are the tracings and medical care documented in the (electronic) medical record?  What are the legal risks to the doctor if the patient transmits OTHER patient's EKG's to OTHER people, non-securely?

At this point, no one knows.  We are entering into new, uncharted medicolegal territory.

But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, "live" medical device.  But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.

This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them.  So I sent AliveCor's Dr. Dave Alpert a tweet and later received this "how to" e-mail response from their support team:
Dear Dr. Fisher,


Thank you for your interest in the AliveCor Heart Monitor. I'm writing in response to your tweet to Dr. Dave (Alpert) yesterday. Below are the instructions; in addition these instructions can be found at www.alivecor.com (click on the “Buy Now” link in the upper right corner).

To obtain a monitor for your patients, please follow these steps:

1. Write a prescription for the “AliveCor Heart Monitor for iPhone 4/4S”

2. Ask your patient to go to here and submit the following:

a. The prescriber’s information - your name, address, phone number, license number and license state or NPI (National Provider Identifier)

b. A copy of the prescription (attach a scanned copy or photo)

3. Go to www.alivecor.com and click on the “Buy Now” link in the upper right to purchase the monitor

a. In the “NPI/State Medical Lic #” enter “Prescription”

NOTE: The patient's credit card will be charged once they place their order, however we can’t process their order unless we have received their prescription.

Please know that at this time AliveCor does not provide any ECG interpretation, diagnosis or analysis of the data obtained with the monitor. Patients will be instructed to contact you, their physician, regarding any questions they may have regarding their recordings.

Please let me know if you have any questions.

Regards,
It is clear AliveCor wants to provide the device and its app, but will not be responsible for the interpretation of EKG's.  That is up to the doctor and their patient how to manage the clinical expectations of this technology.  While some patients could probably perform EKG interpretation basics, I would guess most don't really understand what that wavy line means.  Hence, this is where a discussion should be held with a patient BEFORE prescribing this device and the expectations defined before its use.

For me, I am happy to provide interpretations free of charge when needed as long as it is convenient and non-disruptive to my clinical responsibilities and personal life.  There are only so many hours of the day and since I must value that time, cannot bill for this EKG-reading service, and have no quality control over the caliber of the recordings submitted, I consider my interpretations of tracings sent to me to be provided to the patient as a "good Samaritan" in every legal sense of the term.  Patients who have clinically worrisome symptoms and need emergent analysis of their heart rhythm should seek help in an emergency department or call 911 and not expect a doctor to provide an immediate interpretation of their tracing, unless such an arrangement is defined clearly between doctor and patient before issuing the device.  Expecting a doctor to make urgent clinical decisions based on this single-lead EKG app is of limited utility, in many (and maybe most) instances in my view, so patients should look at this device as a convenient adjunct to more conventional medical care.  While it might come one day, the AliveCor iPhone EKG has simply has never been tested for emergency use as of the time of this writing.

So I may do a test run to see how it goes on a test basis but I can already see some legal concerns for doctors who prescribe this device.  Until a clear interpretation workflow is established that can provide comprehensive coverage of interpretations paired with a well-defined and easy-to-use interface with a medical record system, patients should understand doctors' possible hesitation to prescribing this device to a multitude of patients for personal use.

-Wes

39 comments:

Bryan Vartabedian said...

If I'm not mistaken, Wes,you once wrote of time creep. One of the key issues inherent in self quantification, who's gonna assess what's been measured?

Like many of these new devices, we have to define precisely how we intend to use it. Expectations with patients must be clear as well.

Anonymous said...

It will be a shame if the opportunity for a patient empowering tool like this gets mucked up by the 'system'.

I've had a holter, I've had a few event monitors - all were a waste of time because my problems are infrequent. I've learned the triggers and practice avoidance. (It hurts when I do X...don't do X).

I finally bought a $200 personal ECG machine on ebay. I record the events and print the tracings. Once a year, I bring the printouts to appointments. Now the problem is crystal clear. Amazing what a little data will do.....

betsy said...

A ridiculous device. Things are truly 'in the saddle and riding Mankind". Americans accept no limits. They think death is optional, and if they throw enough money and technology at it it will go away. No wonder we cannot control health care costs. (I have been a critical care RN for forty years).

Lisa said...

Even with an infrequent arrhythmia I can't see the benefit of personal use of that device. I appreciate it when my EP shows me my EKG and explains it to me. But all that device would do for me is make me obsess about my heart rhythym. For an Md or a paramedic it might have a benefit, but even that seems slight. In the end a regular strip is going to be run.

Rajesh Gupta said...

This is an absurd rant: since when getting a more knowledge to the individual became a problem. Think of yourself as a teacher, not as a lawyer worried about billable hours.

Re time creep: have you looked at the rest of the workforce and how productivity increases have driven the society, not necessarily individual benefits. Physicians as a group must hide behind a massively complex reimbursement system to limit availability. I am amazed to see physicians talk about and discuss endlessly giving email access to their patients.

DrWes said...

Rajesh Gupta -

In my view, this post is not absurd nor a rant, but rather a real-life observation of the challenges that confront doctors who prescribe this device. We are legally responsible for the use of such a device once we write a prescription. I agree with you that 99.9% of patients will use this device responsibly and understand its limitations, but we must consider the small but real risks of how life-threatening rhythms that could be transmitted to a doctor's email will be handled.

Doctor means "teacher" and through this post, I am teaching the world the real legal, financial and time challenges that doctors face in our new electronic era.

This thread could take several angles. For instance, should our expertise and training be provided for free? Is there another professional you know that offers their services with no expectation of compensation?

Doctors have to "hide" behind lack of liability reform and HIPAA regulations. That's our reality. We communicate via SECURED e-mail daily, but NOT via gmail. Those are the rules. Our "massively complex reimbursement system" is a pain in the butt, and many doctors have left it for more conventional concierge practices. Payment for professional services that we provide must route through our byzantine billing and medical documentation system whether we like it or not, because our legal system requires this documentation.

So please, don't shoot the messenger. These are the challenges every mobile health (device) company must face and provide solutions for.

Anonymous said...

Leave the Doctors prescription out. It just makes things complicated and adds costs.

Curious interested patients will find the device on their own and then approach their Doc about it. I bet the demand will be staggering.

A person can already buy a cholesterol meter, blood glucose meters, any number of heart rate monitors, modified 1-lead ECG's (in the same price range as this device), and even a 12-lead without a prescription.

In most states a person can walk into a lab location and get hundreds of blood tests (many requiring knowledge to interpret) without a prescription.

The prescription is just a tool to get someone else to pay for the device. $200 isn't really much if you're already getting bills from any cardiology office.

Alivecor is making this much more convoluted than it should be.

This model is scaring people away.

Focus on building useful tools. Stop trying to control every step of the use process. The result will be better than you ever imagined.



DrWes said...

Dear Anony 11:08:00 AM -

Please send your comment to the FDA, okay?

Anonymous said...

I'd not be involved in any part of it, Wes.

-SCRN

Will said...
This comment has been removed by the author.
Will said...

How is this different from any other holter monitoring device on the market? For example PocketECG or TTM holter monitors. I see this as a possible leap forward. I would be more interested in where the data goes. Does it stay on the device or go to a monitoring center where the data is interpreted? Or even to the physician themselves? With anything there are pros and cons. Self diagnosing is always of concern, but that requires them to learn how to read the ekg. The ones that will benefit least are medical pros that CAN interpret their own ekg.

Hugo Campos said...

The problem here is exactly the requirement that all patients obtain a prescription from a physician before ordering the AliveCor heart monitor. Get rid of the prescription prerequisite and you get rid of the problem altogether.

Thankfully, the AliveCor ECG heart monitor is set to sell in Europe WITHOUT a doctor's prescription. Yay!

Also, it saddens me to read comments such as Betsy's (above), whom after 40 years as a critical care RN (and despite overwhelming evidence), still fails to see how empowering patients with knowledge has the potential to change healthcare for the better. Sad indeed. It's clearly time for her to retire, if she would be so kind.

Healthcare is changing, whether you like it or not. Sorry if you are the type who has a bit of trouble adapting to change.

And consider this: the true disruptive power of the AliveCor iPhone ECG has yet to be unleashed. It will be, when the device is finally sold as an over-the-counter consumer product at Apple stores and Best Buys. And I can't wait for that day to arrive.

Hugo Campos
(e-Patient and member of the Society for Participatory Medicine)

PS: I'll bet folks who share Betsy's opinion that the AliveCor ECG is a "ridiculous device" are just jealous they didn't come up with this simple and brilliant idea.

Will said...

Hugo,

It has been my experience that a little knowledge can be a bad thing. For example, I work in a EKG monitoring center. So how can a untrained person, who knows nothing about the hearts anatomy/physiology, pathophysiology, electrophysiology especially in a pathologic state be empowered and given all the knowledge needed? Holter monitors are given based on a chief complaint, and as an investigational study with physician oversight. So with a broad window of a smorgasbord of possibilities revolving around a single chief complaint it is not possible to go over each and every avenue. Thats why in the U.S. you need a prescription so the doctor can be a doctor and diagnose accordingly based upon clinical experience and training.

If you get the device in the UK, great. Tell me if you can differentiate A-fib with RVR > 180 BPM vs. SVT, or A-fib with LBBB and RVR > 150 bpm vs. V-Tach using just this monitor. Without training, this will succeed in scaring the user.

And lastly lets say we let everyone use this device w/o oversight and lets even say you recognize a critical rhythm correctly. For example a "sine wave". How are YOU the common lay person going to fix this? You going to hopefully see a doctor. However how much better would it be if the doctor that knows you, and treating you being alerted, and meeting you at the hospital receiving transmission of a critical event. Think about it.

Anonymous said...

Hugo,

If your house needs re-wiring and you want to do it yourself instead of calling in an electrician - go for it. You know that if you mess up, you'd just have to deal with that yourself.

I assure you nobody is trying to keep you from going it alone with your healthcare. It's always your decision.

Sounds like you the type of guy who understands this.

-SCRN

Christopher said...

Not sure how this would be any different than the advent of home blood pressure, SpO2, or EtCO2 availability.

If anything companies could make some big money, have a bunch of MD's/CRT's on staff: "You send your tracings to our service, we'll read them, and send you back an interp and some key tracings to bring to your doctor for $X."

Hugo Campos said...

Will,

Ah... the excuse that patients can't handle information always creeps up sooner or later.

I suppose you're making two points: (1) That sometimes it's best to know absolutely nothing about something rather than knowing a little about it; and (2) That it's pointless to be aware of a problem you can't fix. Neither are valid arguments, and I'll tell you why.

First, it is nonsense to argue that knowledge is ever a bad thing. Plus, it's nobody's business whether or not a patient can understand his medical data or not. He still should have full access to it. Doctors hardly have time (or bother to) explain anything anyway. So, if you're not going to educate me, for goodness sake, don't stand in my way of learning for myself.

Also, I believe we are more likely to make poor decisions when we have NO information at all about something than when we have little information about it. Try controlling a high blood pressure you don't measure. Won't work too well, will it?

In addition, how much can anyone (trained or not) really tell from a single-lead ECG anyway? If people can at least recognize they're in a-fib (it's not that hard) and take a couple of aspirins before calling his doctor, he may have saved himself from the serious consequences of having a stroke. Other obvious benefits would be to help activate patients, improve public awareness of cardiac arrhythmias, and raise overall health literacy.

But what really excites me is shifting control to the hands of patients. It's now possible to record our ECG rhythm whenever we want and share it with whomever we want (doctor or not). We might even find it more useful (dare I say it) to crowdsource the diagnosis of an ECGs somewhere online. A medical student in India may hold the key to a difficult interpretation.

Your second point is also fallacious because it assumes patients have no control over their health. This is obviously untrue, since there are many things patients can do to improve their health, or in this case, take steps to reduce the incidence of cardiac arrhythmias. I am a living example of that.

Technology is enabling medical knowledge to be transferred to the masses, and I can see how this may be uncomfortable for so many who, like you, make their living reading ECGs.

To quote Dave deBronkart (e-patient Dave) “when Gutenberg printed his Bible in 1455, it gave ordinary people access to knowledge that had previously belonged to the priesthood: instead of relying on another’s interpretation, they could read it themselves. Within a lifetime (1517), Martin Luther wrote his 95 Theses and the Reformation began.

The healthcare reformation has begun. What many can't stand is the very real possibility that they may be cut out of the care circle, and miss an opportunity to bill. Money's really what's at stake here.

But as an uninsured and chronically ill patient looking to gain control over a condition that could claim my life, I have little sympathy for that.

Hugo

Anonymous said...

How dare you not give away your services for free! You are not a lawyer. Being a doctor is a calling. Physicians demanding payment is an outrage. Real physicians would not accept payment knowing that the gratification of caring for their patients is payment enough.

Who cares that neutering a dog pays a veterinarian more than a cardiologist earns with a cardiac cath.

All services to me should be free and I should be the only one allowed to charge for my services.

BTW, if you screw up, expect a million dollar lawsuit.

Anonymous said...

Hugo,

The point I am making is 1. How is a untrained person who cannot make an informed decision based on lack of clinical training or experience going to benefit from looking at their own EKG?

2. How are you going to treat a rhythm you know nothing about? For example. Most people who have a new onset of a-fib have a-fib with rvr. What is more concerning the decrease in cardiac output from the RV or the possibility of stroke? How can the lay person differentiate lone a-fib vs. Paroxysmal a-fib vs. A-fib caused by a heart valve defect? Treatment for each is different. What about a-fib vs. Sinus rhythm with artifact?

You need actual training to read and understand what you are looking at. Oh and by the way there is a lot of information you can gather from just a 3-lead. (NSR, *WPW,A-fib, a-flutter, 1st degree, 2nd degree and 3rd degree heart blocks, ventricular arrhythmias (v-tach, v-fib, AIVR, IVR,) functional rhythms, atrial arrhythmias etc.

From what your suggesting we should all have 12-lead monitors in our home so you can diagnose a heart attack. While on that, do you know the mimics of a heart attack on a ekg? Brugada syndrome, Wellens syndrome? What about LAFB, LPFB, hemiblocks, bifasicular / trifasicular blocks. Right and left bundle branch blocks.

I can tell you from experience that most patients do not want to be taught how to read ekgs. It can get complicated very quickly. If you can teach yourself, Great!. And I do believe in informing patients of their diagnosis and allowing them to explore the vast knowledge base that's on the web, but after the diagnosis has been made by a physician who is qualified to make that call, and set up treatment plans. You give the wrong OTC Med to the wrong patient and bad things can happen.

For example if you give someone potassium for cramps and lack of deep tendon reflexes, and their serum potassium is already high, when all they need is calcium. You can cause that patient to go into a ventricular dysrhythmia which can lead to death. All because someone "heard" that all muscle cramps are due to low potassium.

If you want to be cavalier with your health go right ahead. I think it has the possibility to be dangerous and easily misconstrued to someone who is not trained.

peggyzuckerman said...

The underlying issue here is not how difficult it might be correctly interpret an EKG, but that the information derived from the patient belongs to the patient. The patient can then decide how to utilize that information, requesting help from his cardiologist, or the neighbor lady. The reality is that the consumer/patient can truly access his radiology images, get those reports, which are interpreted usually NOT by his doctor, but a third party. A patient can get a wide variety of blood labs or genetic tests, and request an interpretation of that information by a doctor or geneticist or not.

This is a simple matter of rights and access to one's own data, not a discussion of how hard it might be interpret data, or how one's insurance may or may not help pay for the service.

Peggy Zuckerman

HRCFS said...

Wes,

I think the trickiest part of this is the broad scope of any patient population. No doubt there is a tremendous range of health literacy levels who you see in your practice - some of whom you might be perfectly comfortable prescribing the device for.

The separation between the tele-reader and the person with no healthcare literacy is simply education.

The question becomes, to my way of thinking - - where would you like to see the whole thing end up and what steps can you take individually to get there?

Adrian Gropper said...

Prescriptions should be reserved for some therapeutics. I can't think of any examples where restricting access to diagnostics has proved to be reasonable in the long-term. It took some years but home HIV testing is now available.

When it comes to diagnostics, I would argue that the default is open access unless one can _prove_ that harm has occurred.

The Internet will make subspecialization a community project. It's only a matter of time.

Anonymous said...

@6:29 - all I can offer is an example in my own case.

In my case, the arrhythmia was infrequent and short-lived. It wasn't possible to get a diagnosis via traditional channels.

I tried - multiple times. $5,000 out of pocket later, I've had event monitors, holters, shown up at both the ER and an urgent clinic with an arrhythmia and had it convert while they tried to figure out if I really should get the ECG I was asking for (20min-90min later).

It was a waste of everyone's time and lots of my money :)

Along the way I did see an EP and had many bad things ruled out. He made an eventually correct guess of avnrt based on history. Still, he wanted to see some evidence - not unreasonable.

Fed up from fighting the system, I buy a $200 machine from ebay. Works like a charm. I had clear tracings from the next episode (6 months later) and now we have a very good idea of what's going on.

I really don't understand why some are treating an ECG tracing like it's one step removed from the nuclear launch codes. It's age old technology. You can build a crude machine in your kitchen with $5 in parts and a laptop (check youtube). It's not invasive. No residual effects.

As an aside, I'm sure my pitiful ECG interpretation skills are considerably better than a few of the front line Docs I saw during my quest to get an ECG that would id the problem. They told me as much. Sad as it is, that's a reality us patients have to deal with sometimes.

Here's the truth.

There aren't enough skilled EP's to hold the hand of every patient with an arrhythmia. This will be even more true as boomers age and insurance coverage is expanded.

You can encourage patients to take control of some things, or continue to be overly paternalistic AND overwhelmed.

How's the current model working for you?

Anonymous said...

Dear paternalistic doctors and other medical personnel who believe that giving me access to my data is dangerous,

You want all the control? Then be prepared to take every. single. ounce. of blame.

Signed,

A Heart Patient who learned to read ECGs after her cardiologist repeatedly and erroneously insisted her ECG was "normal."



Jay said...

I agree Dr. Wes's blog is neither absurd nor a rant; it's simply reality that physicians have to face up to.

At the same time, there are two contexts in which one might view a device like this (and others, like Scanadu).

Firstly, it represents low cost care that has to be instituted into the mainstream of medicine. For too long have we been given this innovation theory of extremely expensive, questionable, devices and pharmaceuticals coming from the large manufacturing world. These companies have huge pockets, vested interests, and able to lobby regulatory authorities with minimal - even inconclusive - data demonstrating efficacy. Dr. Topol refers to many of these approved on the basis of meeting "surrogate" end points that have no real therapeutic value. In this scenario, AliveCor represents a new generation of devices from small innovative ventures that are upturning how value could be delivered in healthcare. It's remarkable that it even got approved.

Second, the true value - if we are to benefit from its embedded low cost - of such devices are not explicit to the end-patient. It is, even in this emerging "quantified self" world, foolhardy to expect patients to fully understand and undertake self-care when it comes to serious ailments (even if that means consulting with his or her physician on the latest data). The real value actually lies in integrating such devices into a modified practice of care in a physician office or via well trained nurse practitioners and enable real time collaboration that is missing in today's highly specialized practices. In doing so - and evolving mechanisms for workflow, remote or online consultations and cross-referrals, and permanent record in a patient's EHR - there is possibility that healthcare costs could be continuously lowered through a mix of lower transaction costs, paperwork, slicing the huge layers of reimbursement, obviating the need for very expensive equipment whose only value lies in integrating with a vendor's other very expensive hospital equipment, etc.

Dr. Wes is right in voicing concern but I think the medical world should also embrace these innovations and explore how they could begin substituting for more expensive ways of delivering care (of course, after due comparisons with standard equipment of the accuracy, stability, etc of such devices).

Best,

Jay

Brenda said...

A doctor has to write a prescription for many medical items and certainly not in this country are they then responsible for say that of a PEG tube, the incorrect use, any obstruction etc etc.so I cant see why for an ECG/EKG monitor. same as the diabetics BGL meter!
What I do know is that if a patient is able to see, doesnt have to understand, what electrical blips are occurring, and they are having clinical symptoms, then being able to cope with an arrhythmia, ectopic, and able to record it,then better control/reaction/response can occur. Like all things, there will be the OTT personality, but for that 2% why should those then capable of having a better QOL as that jumping heart can then be identified and hopefully the correct treatment or not required be suitably prescribed.
I have spent many hours explaining why drinking coffee and other stimulants is not good for someone who is prone to tachycardias. And often find out I am the first to explain the cardiac electrical pathway, after years of cardiology visits [I was in a rural ED] And then had them return weeks later to thank me for the information, and in most cases report a far better QOL. so YES give the patient THEIR data, and their personal culture can decide on the response.

pheski said...

If patients need permission from a doctor to record data from their heart, it seems a small step to needing a prescription to record one's blood sugars, peak flows, daily calorie intake. Perhaps one should need a prescription to have a scale or thermometer at home? After all, the patient might not know how to interpret the results or might get upset.

The idea that it is acceptable to limit a patient's access to information about themselves is absurd on its face.

Peter Elias, MD (family physician)

Eric Topol said...

Wes
You really got things stirred up, which is good
I could not agree more with and applaud the comments of Hugo Campos and Peggy Zuckerman above

David Albert said...

Dr. Dave Albert:

First, thanks Wes for a great post that brought out real issues to consider. A prescribing physician will be responsible for the results so that is a real concern and being overwhelmed is also a concern.

This is a first generation solution and I can assure everyone that it will evolve and improve but you have to start somewhere. We have conducted many clinical studies and published them at the AHA, HRS and ACC so the quality of the data is excellent. "Consumers" have used the device and I have interpreted thousands of recordings including detecting VTach, WPW, lots of AF, AVNRT in congenital heart disease, etc, etc.

Now, to address a number of the comments:

(1) Bravo to my friend Hugo who is a pioneer for allowing patients to have access to their long-protected data. We physicians have been paternalistic and that era (like Fee for Service) will be coming to and end and it will be painful.

(2) Dr. V -- we will find out how useful and how burdensome this may be by trying. Without question, it will be interesting. One of my rants is that the combination of 3rd-party medical payment and fee for service has created our out of control cost problem in the US. I have a son in med school and my wife and I are physicians and we tell our son that everything in medicine is going to change but it will still be an incredibly rewarding career.

(3) Anonymous: there will be automatic analysis and human over-read services available and we are confident that they will be excellent. Our auto AF detection algorithm we presented at AHA had 100% sn and 96% sp in 313 patients.

(4) Betsy: people have to buy the case and will have to pay for the reads-- that will make them think about using it appropriately. Personal financial feedback has been missing in medicine but it is in every other part of our life. Open loop anything is bad for controlling costs and medicine is a prime example of that.

(5) Rajesh: WE have had a system not of evidence based medicine but of reimbursement based medicine. It is a business and you want to maximize revenue. This will change with capitated care.

(6) Dr. Wes-- thanks again for starting a great discussion my friend. CHange is coming and I hope it is for the best.

(7) anaon: An OTC version is coming as soon as the FDA clears it-- I think it will be in the summer.

(8) Will:

the data is auto-uploaded to a HIPAA compliant server but can also be emailed to a caregiver. BTW, if you have a HR of 180 at rest- you need to see Dr. Wes!

(9) Christopher: A human over-read with a very reasonable cost per read will be available in the near future. You can pick cardiac tech, CCU nurse or doc and how quickly you want the answer depending on how much you want to pay. Financial feedback and personal control.

(10) Adrian: As I said, OTC will be coming.

(11) Eric-- thanks for all your support-- disruption is never painless.

Dave Albert, MD
Inventor, ALiveCor ECG

Anonymous said...

The real world and how patients are already using tools like this. It is no different than a BP cuff, thermometer or diabetics who test at home. (I know please don't tell the FDA we aren't dogs and can figure out tools like this)

I bought the Vet version of this last summer for a friends dog at the fire dept. Although it isn't approved for humans I of course tried it out on myself and many of my friends (including Hugo at a conference in CA last fall)

I was able to use it very easily while on vacation in Florida this December to capture a pattern that no one could ever capture on a holter (x3) before since it was so infrequent but symptomatic.

I looked up the pattern, frequency etc online and wasn't too concerned but I emailed (via regular email since my patient portal doesn't accept PDF's or images yet) a copy to my primary care doc (medical home model $50/month so they are accessible and affordable) and had a response within an hour. They didn't diagnose me over email but reassured me that it was essentially benign and didn't require me to go to an ER but apparently family reunions and talking politics in Florida can case up to 10 PVC's a minute)

Feeling "heard" was the most valuable outcome - finally I could show my health care team what up until then I had only "felt" (and got my brother-in-law to stop arguing with me - I showed him he literally was breaking my heart);-).

Since then I have only used it once or twice but now I know that if anything were to ever happen to me or a family member while backpacking, sailing or up in the San Juan Islands that I can have near real time access to health care at very low cost.

It fit into MY workflow and met my needs and saved everyone in the system money (no ER visit). It also saved my family from worrying, and BOTH me and my doctor time (a two minute phone call vs a 20 minute visit or a hours long trip to an ER).

(I am only anonymous because I don't want to publicly disclose a medical condition or upset Alivcor or the FDA). SR

Alliance4Health said...

Wes

It sounds like Alivecor's disruptive EKG(like much of technology in health care) real value might be to highlight flaws and opportunities in the existing medical system.

For example

1) PAYMENT MODELS FLAWED - A need to move to a medical home model (vs fee for service) so yes the team would be expected to respond to a patient's need for information in almost real time.


2) NEW ROLES _ PATIENTS ARE PART OF CARE TEAM - Most patients are in fact able to understand how to use this (the same argument used to be used with people who were diabetic or had cancer)

3) PROVIDERS AND PATIENTS WORKFLOWS COST - A patients time, cost and inconvenience are just as important as a providers.

4) AN AMAZING BUSINESS OPPORTUNITY (which clearly David has already recognized)Outsource the reading of these tracings could become the razor blade to razor financial model. (ie almost free tech but pay to interpret)

5) DISRUPTIVE INNOVATION - is always laughed at or attacked. As others have noted perhaps the real benefit of this device will be simply peace of mind.

6) MARKET SIZE - heart disease is the number one killer of women

beverly said...

Anon is missing the point that a patient doesn't have to be able to recognize ALL abnormal rhythms in order to help himself - only his OWN rhythm. In addition to his bad attitude already described by others. As a doc who has had episodes of abnormal heart rhythm since my 20's (like others, never captured on EKG), I can assure anon that those of us with the problem - NOT the entire patient population - will be interested in this technology. So wake up, will you.
In addition, I agree with Dr. Wes that the legal issues would worry a doc. Make this thing available without prescription, already.

Gilles Frydman said...

Dr. Wes,

The fact is, not all patients, far from it, have the ability to read & understand an EKG. But, so what?

We had the same argument 17 years ago (!) when the NCI decided to make the PDQ statements for health professionals Open Access to all, including patients & caregivers. For years after that, I heard MDs complaining this was very dangerous or even that it was illegal to provide the URLs for these PDQ statements, because untrained patients could never understand their content. But this is exactly what allowed me & my ex-wife to start making an informed decision regarding her treatment for breast cancer and what allowed her to avoid multiple unnecessary treatments that were going to be administered by an breast surgeon that believed she was an oncologist (she was not!). The PDQ statement written for patient was just insufficient.

The same methodology should be used for health data today. Open access to all. It's nobody's business to decide if the end user can make a positive use of that data. And that's the end of it. Nothing about me without me!

I want to remind you that Gunther Eisenbach, MD, researched how many people died due to bad information collected on the internet. He couldn't find a single case. On the other hand, how many people die every year from errors by doctors, who are supposed to be the experts?

In the age of networked knowledge it is absurd to see that some licensed professionals still cling to their belief that their license makes them the only people able to analyze a data set.

Anonymous said...

Dr. Dave Albert,

No prescription for your device. No tie to any healthcare provider to allow you to secure automatic medicare or insurance cash-ola.

Don't want to see your ads on TV about how "At little or no cost to you the patient, you too can monitor your heart at home, on vacation, anywhere! Our representatives will speak with your doctor and help insure that you can have one of our monitors sent to your door. We'll do all the paper work for you!"

-SCRN

Bob Fenton said...

As a patient, I appreciate this blog. Dr. Wes highlights many of the problems wrecking havoc in the current state of our healthcare system. To cover costs, doctors must be able to bill for time spent, however, I think this will be changed in the near future, whether doctors or patients like it.

This article explains what is happening and some of the whys. http://www.medscape.com/viewarticle/779399?src=rss

Yes, we all need more government oversight and interference – NOT! But for now our concerns need to be on remote patient monitoring (RPM). Doctors and hospitals will receive payments based on it or penalties based on the lack of monitoring.

The one disagreement I have with Dr. Wes comes from the lack of testing the piece of equipment he is concerned about. Until he can show that the results are unreliable and cannot be used, then we must assume that the FDA for now is correct in their approval. Equipment for patient use always has a much more variable specification since trained medical personnel will not be using the equipment in a lab setting.

As a patient, I know doctors are not likely to want to acknowledge devices for patient uses, but with the coming tsunami of RPM requirements, doctors and hospitals had better educate themselves about the monitoring devices being approved by the FDA as they will be required to use many of them in the next few years, or face penalties for not using them.

Ethan Weiss said...

I have several patients for whom this would be very useful. They have paroxysmal a fib but often can't tell if they are in fib and want confirmation. We sometimes try to figure it out using techniques like walking up and down stairs or other things, but mostly they come into the office. This little device will save them and me a lot of time and trouble. For select patients, it will be wonderful. For others, not so much. I look forward to learning how to incorporate this device into my practice and do not worry about the potential issues. They will get sorted out...

Anonymous said...

I am in no way a heart patient or do I profess to have much knowledge of EKG's but as someone who has been in the healthcare field, I believe that this could be a highly beneficial product for alot of people who have abnormal rhythms. I personally think that if properly trained there are many people that would be able to tell when something is "out of whack." Of course every doctor involved in this would probably have the patient sign some kind of a waiver giving up the right to hold the doctor responsible in the event an abnormal rhythm caused a serious heart problem.if I were a doctor that is what I would do unless that patient is specifically under my care and we have an agreement that I will be monitoring this device - Just a regular citizen putting their two cents in.

Anonymous said...

Is it going to help establish a diagnosis every now and then? probably

Is there a risk in the way the information will be used? maybe, maybe not...

If a patient wants to know what their rhythm is by all means... but if they call me about it... I may set an appointment to go over the data set or require compensation for my time and liability when providing a diagnosis and professional advice...

At the end of the day you can get expert advice (from say a Cardiologist or an EP) or have a tech read the tracing, in 99% of cases it won't make much of a difference... in the remaining 1% you can bet it will...

Anonymous said...

in my experience, the patients who would buy this device are the same ones that could learn to palpate their pulse and determine whether they are in atrial fibrillation or NSR. If those are the only things on the differential list, this is an expensive tool.

However, there seem to be potential uses for as yet unidentified rhythms that are extremely sporadic in nature.

Patients might buy this and then tell me they can't afford their metoprolol, even at $4 a month. This would cover a lot of months.

Anonymous said...

I use a medical device every day that records data and has a modem that a Dr can dial into to get the data. It also stores the information to an SD card which gives me and others access to the information. This device is used not only by me, but by millions of others with the same medical problem... Sleep Apnea. To me, this EKG device is no different from my CPAP... it's just used for something different and runs on a different platform. There hasn't been a problem with safety, efficacy, privacy, or anything else... I have control of my own health information and can get 2nd, 3rd... opinions.

In my opinion, there is a fear of these mobile devices in the healthcare industry because some of them will make Drs more accountable due to the ease of sharing real-time data with multiple physicians... hence putting the patient in control of their health rather than the physician.