The legal risks of prescribing the AliveCor ECG

The legal risks of prescribing the AliveCor ECG

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.

It is clear AliveCor wants to provide the device and its app, but will not be responsible for the interpretation of EKGs.  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 Fisher is a cardiologist who blogs at Dr. Wes.

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  • http://onhealthtech.blogspot.com Margalit Gur-Arie

    Why should you need a prescription for this gadget? People that want it should be able to buy it and use it without any legal ramifications to physicians. Or maybe they are hoping that insurance will be paying for this eventually?

    • Mengles

      It’s probably more for insurance coverage – as the app itself costs $199 + shipping.

      • http://onhealthtech.blogspot.com Margalit Gur-Arie

        In which case I would hope that some efficacy or medical necessity can be demonstrated for some condition (RCT?), before we are asked to pay for this and the many other cute gadgets that will surely follow.

    • faceless_man

      It looks like there are other handheld ECG devices which also require prescriptions. I think the two in this application were prescription rather than OTC, at least at application stage
      http: // www. accessdata. fda. gov/cdrh_docs/pdf8/K080933. pdf

  • http://www.facebook.com/ryan50jo John Ryan

    Don’t sign that prescription, Dr. Fisher! You are clearly stating that there is a medical need for the device. Isn’t that what “prescribing” implies? Common sense says that you are now responsible for its use & outcome, as with any prescribed drug or device.

  • rtpinfla

    I agree with the comments below but you definitely raise very good questions in an area that is likely going to continue to grow (health care apps). What looks innocuous may be fraught with legal or other pitfalls. What do we, as physicians, do when patients start requesting such apps that require a doctor’s order? Most of already have to deal with this in the form of requests for certain labs, meds, X-rays, etc.

    This strikes me as one of those things that the “worried well” will ask for so they can “check their heart”. Especially if/when it gets marketed directly to consumers -They will know that if you write for it the insurance will cover all or part of it. I would treat this like any other test or prescription because, after all, when you pull back the novelty of the product, that’s all it really is. I will ask myself, “What is the benefit of ordering X or prescribing Y?” If there is not a good reason then I don’t order it.

    • Trey

      “This strikes me as one of those things that the “worried well” will ask for so they can “check their heart”.”

      +1

      “Especially if/when it gets marketed directly to consumers -They will know that if you write for it the insurance will cover all or part of it.”

      +100

  • David Doherty

    I find myself in agreement with “Margalit Gur-Arie” in that it’s absurd that a citizen who would like to use tech like this needs permission from a Doctor when there is no permission needed for any of us to make a wide range of very unhealthy choices.

    Hi Dr Wes,

    Hesitation is a typical response to disruptive innovation and in Healthcare it’s really important as it can help ensure we maintain standards of safety for Patients.

    We hesitated for some time but have now been using the Alivecor ECG for nearly 2 years (which included use for making urgent clinical decisions) and have eventually managed to put together a private service to support the tech that we’ve included within the sale of price (in the UK and Ireland ONLY):

    http://mhealthinsight.com/2013/04/19/buy-an-alivecor-ecg-today-get-a-discount-your-first-read-for-free/

    Would be interested in your thoughts on this different approach…

    • rtpinfla

      While I agree that anyone that wants to pay for one of these should be able to get one, I don’t agree that it’s a very useful tool for the general public. An interpretation service would be rendered practically useless in the US due to liability concerns- they will almost certainly be over-read or come with the standard “Go to the ER or your doctor’s office if you are concerned”. Also, Americans being Americans, they will not want to wait 24 hours for a reading when they send in a strip when they feel “funny” and will likely end up in the ED or their doctors office with reading in hand demanding an interpretation.
      It probably has some merit as a tool to help monitor certain patients- but I as a physician would make that decision with the patient.

      • Paul

        There is already a product in existence called the heartcheck pen.

        The device itself comes with free software that allows you to send ekgs to a doctor (or even an ecg tech if you so desire) from anywhere with an internet connection.

        You get an analysis report within 30 minutes. The liability here is on the doctor reading the ekg.

        no prescription required (fda-cleared for consumer use)…

        • Guest

          “The device itself comes with free software that allows you to send ekgs to a doctor [...] You get an analysis report within 30 minutes.”

          Patients send this data off to “a” doctor (like, some random doctor who does this for a living, subcontracts to your company or something?) , or to THEIR doctor? If it’s to THEIR doctor, how can you guarantee that they’ll receive “an analysis report within 30 minutes”? And if it’s to some random doctor the patient has never seen before, but who just analyzes these things for your company, how can that doctor know enough about the patient to confidently analyze their self-performed ECG, and why would they be willing to take on that sort of liability risk?

          And as others have pointed out, “fda-cleared for consumer use” just means that you’re allowed to market it, it’s not like the FDA is endorsing it. It’s a marketing term, not a medical one. Most home breathalyzers are “FDA-cleared” as well, it doesn’t mean much quality-wise except it’s probably not going to hurt you when used as directed.

          • Paul

            Yes, the company has doctors hired to interpret ECGs for them through their ECG management system. This model has a 30 min turnaround

            It COULD be the patients actual doctor IF their doctor is set-up in the system to do so. (in this case, the 30 min turnaround would obviously not apply since the turnaround would be dependent on the doctor him/herself)

            This is not a replacement for visiting your own doctor in person and taking regular 12-leads…but the software does make the patient add in notes for each ECG reading they take giving the doctor somewhat of a clearer picture as to what the patient may have been doing or feeling at the time of the reading.

            Each user also registers themselves within the software (contact info, age, ect..) so they can be easily contacted should the doctor (or ecg tech) have any questions or concerns.

            I’m not a lawyer but the device/software does clearly warn patients about the dangers of self-diagnosis and the fact that this is not a replacement for visiting your doctor (and taking 12-leads). I would think the doctors that read ECGs for heartcheck take on the same liability as they do when they see their own patients. They do get paid to interpret these ECGs. It is a paid service.

            Nobody disagrees with the fact that the product is not FDA endorsed but is simply FDA cleared. Definitely a big difference but it’s very important to mention that this is the ONLY device of its kind that IS FDA Cleared for CONSUMER use. Any other similar product requires a prescription. This is important to consumers.

            For many patients being able to capture and transmit ECGs from anywhere can be very advantages and convenient. You don’t need to take off work days, wait hours in a waiting room, pay an arm and a leg for a 12-lead, holter or ELR….if you just want to know what your ECG might be showing at any given moment.

            Do you not see any advantage to being able to take an ECG from anywhere at anytime the moment symptoms are felt? Even if the person interpreting is not your actual doctor?

          • C.L.J. Murphy

            “Yes, the company has doctors hired to interpret ECGs for them through their ECG management system. This model has a 30 min turnaround”

            Suckers. Let’s wait till the first one gets sued.

    • Mengles

      Yes this innovation is indeed disruptive, esp. when it comes to liability and one’s wallet. Other than that it’s not a useful tool.

  • Close Call

    Margalit had it right. You shouldn’t need a prescription to buy one.

    Allow people free access to the device. Let them become experts on single-lead interpretation. But watch out when they have a non-ST elevation MI and just hang out at home, because AliveCor showed a normal reading.

    Here’s how to avoid the liability issues: don’t prescribe one.

    Demand well controlled studies showing efficacy, safety, and cost savings first. In the absence of such studies, the only manner in which AliveCor is disruptive is to the doctor’s day.

    • David Doherty

      Hi Close Call,

      I take it you haven’t seen the Alivecor used by a Doctor when they are punching info into the computer to screen Patients for AF?

      I take it you haven’t seen the Alivecor used by a Doctor to test the battery and leads on an implanted device?

      • Close Call

        Both tasks you mention are done by traditional EKG machines in the doctors office.

        There is absolutely no reason for a physician to have to write a prescription for Alivecor. It’s like a doctor having to write a script for a thermometer. It doesn’t make sense.

        I have no problem with people having and using Alivecor at home for whatever they want.

        I also have no problem with docs using something like Alivecor in clinc.

        But doctors shouldn’t be required to write a prescription for it, and most responsible doctors will wait until there are good data on how and when to use the readings.

        • Trey

          Exactly right.

        • David Doherty

          “Both tasks you mention are done by traditional EKG machines in the doctors office”

          I think this comment you make highlights very well the disruptive opportunity this device presents.

          With this device any healthcare professional can now do these tests on house visits, on emergency call outs, at the counter of the Pharmacy, during occupation health visits, inflight, etc, etc, and they don’t even need to remember to bring anything let alone an ECG Monitor (the protective casing of the device is also useful for the everyday protection of your mobile).

          In the future I think it will be conventional for this mobile based tech to be used by Patients to monitor their own implanted devices outside of the Doctors office. We will look back on today’s status quo (where most Patients don’t even know if their device is switched on/off, is working, has any remaining battery life, etc) as incredibly outdated and appreciate innovations like Alivecor for the technical contribution and Patient empowerment that will come with this modernisation.

          In the meantime there are lots of other weird and wonderful applications that are being discovered by users that might look superficial today but I think they will eventually provide some very useful lessons for the healthcare industry eg. I know a musician who uses the app to relax before very highly paid performances, I know a Clinician who finds the device helps them to wind down before they go to sleep so that they are better rested for the Patients they care for the next day, etc, etc.

          • Mengles

            You still haven’t answered the question you keep being asked – why does it require a doctor’s prescription?

          • David Doherty

            Hi Mengles,

            “You still haven’t answered the question you keep being asked – why does it require a doctor’s prescription?”

            I have already attempted to answer this but the way that this comments thread operates means you will need to scroll down to see a previous comment of mine. Here’s it repeated to make it very clear:

            “I find myself in agreement with “Margalit Gur-Arie” in that it’s absurd that a citizen who would like to use tech like this needs permission from a Doctor when there is no permission needed for any of us to make a wide range of very unhealthy choices”

          • Paul

            The FDA doesn’t want people to see the actual ECG waveform until they have interacted with a physician and put the ECG into some sort of context.

            They want to try and prevent people from trying to interpret their own ECGs…(atleast until they have communicated with their doctors in some way first)

          • Guest

            In the UK, are these given away free by the NHS, or do patients pay for them themselves? The issue of whether or not it’s a neat gizmo has to be separated from whether or not patients should expect their private insurance or the government (taxpayer) to buy it for them (which, like others, I suspect is the real reason for it being “prescription only” in the US).

  • Guest

    Who is behind the requirement for a prescription before purchase in the US, when no such thing is required for UK purchasers?

    I am just guessing, but perhaps AliveCor knows that in selling a medical device in the US, “someone” is going to be held liable for any stuff-ups that will inevitably occur. And given America’s litigious nature, they KNOW there are going to be lawsuits. So they’d rather have doctors holding the bag than them.

    • http://geoffclapp.blogspot.com/ Geoffrey Clapp

      This is part of the 510k Process, not “litigious America” – a 510k can be prescription required, based on the claims submitted and even the input of the company. You can find it marked on their 510k summary, which is public.

      • Guest

        Who was it that decided it would be prescription based though, the FDA, or the company (dodging potential litigation by shifting responsibility to doctors)?

  • Paul

    the HeartCheck PEN handheld ECG (a stand-alone device) is FDA cleared for consumer use (no prescription required) and comes with a service that allows you to transmit ECGs to a REAL doctor for analysis. (within 30 min)

    Everyone gets so excited over anything app….They fail to realize their is better technology available.

    • faceless man

      I have noticed that your marketing makes much of the fact that your device is “FDA Cleared”. It seems to be one of your main advertizing pitches, and unfortunately where I have seen that before is when sellers are trying to imply to unwary consumers that the FDA has tested the device in question and found that it has medical value. When in reality, it makes no judgment as to the quality of the device, or its medical effectiveness or safety.

      All it takes to declare a product “FDA Cleared” is to show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use. It is FDA _Approval_ which provides “a reasonable assurance of the device’s safety and effectiveness”.
      ————————————-
      From FDA-dot-gov:

      What does it mean when FDA “clears” or “approves” a medical device?

      When FDA review is needed prior to marketing a medical device, FDA will either

      –”clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or

      –”approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.

      Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.

      To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use.

      To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.

      • Paul

        Your correct that FDA-Approved is much more impressive than FDA-Cleared….But I’m sure you can appreciate why being able to buy a class 2 medical device like the heartcheck pen without a prescription would be important to consumers.

        In fact, both the device itself and the software that powers it have their own FDA-Clearances.

        HeartCheck’s parent company (Cardiocomm solutions, Inc) has been developing ECG management software for clinics and hospitals for years and this is the first time its available to consumers.

        A single-lead ECG is no replacement for a 12-lead. The true value is in the portability. Being able to take heart readings from the cottage, the gym, the office, ect… than send to a real doctor for analysis over the computer…You have to admit. Its pretty amazing. Many people could benefit from this.

        • Guest

          “They fail to realize their is better technology”

          Your correct that FDA-Approved is much more impressive”

          Its pretty amazing”
          =========================
          You apparently don’t know the difference between “their” and “there”, “your” and “you’re”, or “its” and “it’s”.

          Why should I buy a medical device marketed by retards?

          • C.L.J. Murphy

            Harsh, but fair.

          • Paul

            You shouldn’t buy one. The world needs less idiots like you anyway…

            What kind of reject spends the time pointing out grammatical errors in comments? Clearly you have nothing intelligent to add to this conversation so do the world a favor and go f*ck yourself.

          • Guest

            “The world needs less idiots like you anyway…”
            ===================
            “Fewer”, not “less”. You’re welcome.

  • faceless_man

    “With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4S…”

    The usual term would be “510(k) clearance“.
    “Approval” has its own meaning in FDA terms.

    See this FDA fact sheet on:
    What does it mean when FDA “clears” or “approves” a medical device?
    http: // www. fda. gov/AboutFDA/Transparency/Basics/ucm194460 .htm
    (remove the extra spaces)

  • Suzi Q 38

    I think it is great. Maybe my PCP will write an RX for me.
    I think it is the future, already here in the present.
    Doctors just have to get used to a little change.

    • Guest

      Is there an actual medical reason for this, or do you just want one (paid for by Someone Else, presumably) because you’re one of the growing ranks of the pathologically self-obsessed worried well who spends an inordinate number of their waking hours fixating on nonexistant “medical” problems?

      • Suzi Q 38

        “….do you just want one (paid for by Someone Else, presumably) because you’re one of the growing ranks of the pathologically self-obsessed worried well who spends an inordinate number of their waking hours fixating on nonexistant “medical” problems?”

        You make a good point.

        Why worry yourself over stuff that you should not be worrying about?

        Would this app also monitor BP 24/7? What else could it do?

        How much is an ECG at the doctor’s office, clinic, or hospital?

        I am a little self obsessed, but for a decent reason.

        On my mother’s side of the family, she had 4 brothers and 2 sisters. All dead. Let’s see:

        Her father died of a massive heart attack at 60.

        One brother died at work at the age of 38 (heart attack) another brother died at age 52 while riding his bicycle in Honolulu (heat attack). Two other brothers fared a little better, but diabetes took their toll. Those two ultimately died of heat attacks, too, but at least they were in their 70′s.

        Her two sisters died of heart attacks, but they endured the paralysis and after effects of strokes first. The two sisters had their strokes in their 40′s and 50′s. They were bedridden for years.

        My dad died of a heart attack at age 68 having endured high blood pressure for years and TWO heart bypasses.

        His brother died of a heart attack, but he had diabetes for years before he died.

        My mother is doing great. She is 89 and still walking and talking.

        I myself have had HBP since I was 27. My cholesterol was over 250 by the age of 40. My a1C was 7.1.
        I lost 40 pounds. The a1c and the BP went down, but my cholesterol barely improved. I think that my HDL is less than 40.

        My 3 brothers are in their 50′s and 60′s, and all have diabetes and HBP.

        Not having a medical background, I am wondering what this type of device would do for me.

        I have a friend that is 58, and has had 2 heart attacks already. His dad died at the age of 40 of a heart attack.
        He was supposed to have a stent put in the last time he was hospitalized, but he refused. He would rather take his chances with the heart attacks than live with the possible complications of the stent procedure. He walked out of the hospital against the doctor’s orders.
        He is a stubborn criminal lawyer with a stressful job.

        I am thinking that a device like this may set off an alarm and let him know that he is in danger of having a heart attack soon. That could be useful knowledge for him.

        I understand what you all are saying, but I think many of you have your heads in the sand.

        You are reticent to change. You are willing to eventually entertain the changes that medicine brings, but not the technology changes that can save lives, yet provide life-saving information in a timely and less expensive fashion.

        I don’t really want a doctor that wants to do things the old fashioned way. I want one that is open to some changes, even if it involves a little new technology.

        Don’t worry, there are plenty of older patients that will not be on board with this new technology that patients will have direct access to. They will be just fine with a doctor that doesn’t embrace it, either.

        I am at least going to check this app out.

        In the old days, how did we monitor blood sugars?
        Did we go to the doctors office or to the lab? Now they have our small, hand held monitors, or pumps that monitor a certain amount of insulin right to the patient.

        Medicine has “married” technology, and this “relationship” is constantly changing. Get used to it. These apps will be part of it. Personal at home monitoring will soon be the norm.

        The $200.00 will not be paid by my insurance company.
        I wouldn’t think to ask. I would probably pay for it on my own, but I would ask my doctor about it first. My doctor is in his mid to late 60′s. I am not sure that he would be interested in this technology. If not for me, but other patients that are more acute.

  • http://www.worldsbestsite.com/ Daniel Ginsberg

    I’m not a lawyer, but I don’t see the liability of prescribing the AliveCor as any different than prescribing a glucometer to a diabetic. I’m not liable if a patient has very high or low glucoses, though I may be if they tell me about it and I ignore it. I think it would be the same with the AliveCor. If they emailed a strip showing ventricular tachycardia then you’d know what to do. If they sent it a normal rhythm strip and said it was done while they felt like they were passing out, you could probably rule out an abnormal rhythm as the cause.

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