Access to ICD data

All posts from Jan 1st 2011 to Dec, 31 2011

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Ed_H
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Access to ICD data

Post by Ed_H » December 13th, 2011, 10:37 pm

I ran across this on another forum. It is a short presentation to the FDA about providing patients with data collected by ICDs.



Ed
MI, Heart catheterization, 3 stents, 2010
Ventricular tachycardia, St Jude's ICD, 2011
Angina, 2 more stents, 2012
AFib, OK after meds change, 2016

My introduction: http://www.icdsupportgroup.org/board/vi ... 489#p81489

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mrag
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Re: Access to ICD data

Post by mrag » December 14th, 2011, 2:16 am

Interesting video from September 2011. The short version is if MY icd collects MY data, how come the icd manufacturer won't share MY data with ME when MY icd sends MY data to them. From a personal standpoint, I spoke relatedly with Boston Scientific a while ago and their view was they are sort of like the post office. They collect the data, but just pass it along to my EP's office. This makes some sense, why do they want to get involved and have any responsibility-they are not cardiologists. They're like Ford, they make a car, where you drive it and how is your business. And so far, my EP has been quite responsive in giving me copies of all my interrogations (although some of the copies are not that clear).

Now on the other side, if I was visiting a foreign country like Utah and ended up in a hospital, would they have 24/7 access to my interrogations? Would they possibly be of any value? And if I had a shock right now, I could send a "transmission" right now, but no one at my EP's would read it for 6 hours or more. That is a long time when you've had a shock. So for $30,000 or so, couldn't a manufacturer have a '911' line available all the time?

The last half of the video is basically a skilled political type hack blowing smoke.

Most importantly to me, how does one embed a YouTube video on this forum?
"The greatest enemy of knowledge is not ignorance, it is the illusion of knowledge" S Hawking

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freckles1880
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Re: Access to ICD data

Post by freckles1880 » December 14th, 2011, 9:22 am

mrag wrote:And if I had a shock right now, I could send a "transmission" right now, but no one at my EP's would read it for 6 hours or more. That is a long time when you've had a shock. So for $30,000 or so, couldn't a manufacturer have a '911' line available all the time?
My EP has directed me to call them and they will authorize a download thus will read it as soon as it has been completed. Granted it goes to Medtronics first then the the EP office. I understand that that only take a few minutes. Of course if I am having a problem I should have called 911 first. wavhi
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 54+ years and my daughters.

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Ed_H
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Re: Access to ICD data

Post by Ed_H » December 14th, 2011, 11:20 am

mrag wrote:...
Most importantly to me, how does one embed a YouTube video on this forum?
I copied the URL and pasted it into the message, selected it (highlighted it), then clicked on the youtube button (the last button in the edit area). That puts youtube html tags at the beginning and end of the URL.

Ed
MI, Heart catheterization, 3 stents, 2010
Ventricular tachycardia, St Jude's ICD, 2011
Angina, 2 more stents, 2012
AFib, OK after meds change, 2016

My introduction: http://www.icdsupportgroup.org/board/vi ... 489#p81489

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Eric
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Re: Access to ICD data

Post by Eric » December 14th, 2011, 1:11 pm

Wow -I just found out I live in a foriegn country. Man this board keeps educating me everyday :lol:

Just kiddin Al lmao4dx

Eric
Eric [bot]

Idiopathic CHF/ EF currently @ 53%, Low point 26%
St Jude ICD implanted 6/2008 Device changed 6/2009
1 Shock (innappropriate), ICD reprogramed 6/2010
Lead revision 3/2011 due to fractured lead
53 shock storm 4/21/2011 (Inappropriate)
ICD turned off May 20111 through 8/16/2011
Lead revision 8/16/2011
VT episodes starting in August 2012
ICD Changeout 2/25/2013 St. Jude Inspire Assura
Too many meds to count
Life is too short, live in the moment and make the best of it :)
Intro is here:http://www.icdsupportgroup.org/board/vi ... 271#p75271

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Kat
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Re: Access to ICD data

Post by Kat » December 14th, 2011, 1:43 pm

I hope everyone recognized Hugo. He was a member here early on but hasn't been back in a while, as you can see, aside from speaking out for data privacy, he is also involved in a Bay Area support group that meets in person. Good on him.
~Kat - Hypertrophic Cardiomyopathy
-That which does not kill us can really mess up our hair!
-Having one near life experience after another.

Intro post: http://www.icdsupportgroup.org/board/vi ... 5694#p5694

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TruckerRon
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Re: Access to ICD data

Post by TruckerRon » December 14th, 2011, 3:10 pm

trinity67 wrote:Wow -I just found out I live in a foriegn country. Man this board keeps educating me everyday :lol:

Just kiddin Al lmao4dx

Eric
Just don't let them know we all speak Yiddish here.
:mutt:
TruckerRon -- Received Minion I on 17 Sep 2009, Minion II on 26 Jan 2015

Non-ischemic cardiomyopathy
Medtronic Viva XT CRT-D
No shocks yet...
My intro is at: http://www.icdsupportgroup.org/board/vi ... 099#p57099

JoeNH

Re: Access to ICD data

Post by JoeNH » December 14th, 2011, 5:20 pm

<rolling eyes to the ceiling>

Well .... this is a topic that will create another firestorm of debate. We've had this debate on this board before, and it gets ugly. I remember it turned out to be a name-calling match, where some folks failed to find even a modicum of respect for individuals with an opposing view.

There are those folks like me, who agree with Hugo Campos 250%, and there are those who believe that the data belongs to the device manufacturers.

I see "Direct Patient Access" to the data is ONLY A COMPROMISE, in lieu of establishing "Patient Ownership," in my opinion. The notion that the data belongs to the manufacturers is absolutely ridiculous.

My blood pressure readings do not belong to the pharmaceutical company that manufactures the high blood pressure medication. My blood pressure readings do not belong to the company that manufactures the blood pressure cuff either. There is absolutely zero debate about who owns your blood pressure reading. THE PATIENT DOES !

My eyeglass prescription doesn't belong to the people who manufacture the eyeglass lenses, nor does the optician have the right to now what I look at and what I read when I'm wearing the glasses. There is absolutely zero debate about who owns your eye glass prescription. THE PATIENT DOES !

The manufacturer of my prosthetic knee doesn't have the right to know when I do or do not exercise, how extensively I exercise or were I walk with the artificial knee. There is absolutely zero debate about who owns the map of all the places you travel with your artificial knee. THE PATIENT DOES !

Everyone IMMEDIATELY recognizes all of those notions of the ownership of OUR medical data vesting in the manufacturer of the device that measures a condition or the pharmaceutical that treats a condition ..... as being complete silliness, completely ridiculous and impossible to regulate or police as any sort of a practical or moral matter.

An ICD etc., in terms of the information it generates [emphasis added] is absolutely no different than an eye chart on a wall, a blood pressure cuff or a glucose blood test, that millions and millions and millions of people self-administer on a regular basis. The fact that some folks don't know how to interpret a blood pressure reading or a glucose test, doesn't deny everyone else from self-administration.

On the other hand, the device manufacturers have set themselves up with a reporting mechanism (topology) where the device readings are sent ONLY to the manufacturer, and then THEY share what THEY believe is relevant with the EP/MD. They could have set up a system where the device reader reads the information into YOUR own computer, for YOU to share with your MD, and for YOU to share with the manufacturer .... if you so elected.

Me, I'm educated about my blood pressure readings. I don't bother my MD with the boring details of every lousy blood pressure reading I take. I take my blood pressure. I evaluate it. I make my MD aware of the exceptions to the norm. I hash out the problems with my MD. The pharmaceutical folks and the blood pressure cuff folks don't get involved.

Me, I'm educated about my eyesight. Most of the time I see just fine. I don't call the optometrist, daily, weekly, monthly or quarterly to say, "Hey ! I'm seeing just fine." I report the exceptions to the optometrist and together we evaluate whether I need new glasses. We don't get the folks who manufacture the frames or the lenses involved in the decision.

Can you imagine how outraged people would be if the manufacturer of the blood pressure cuff was the only one who could read your blood pressure and then THEY decided what information would be reported to your doctor ? People would FLIP THEIR WIGS !

I know .... I understand .... I appreciate .... that the manufacturers' claim THEY need the data to refine existing products and improve future products. I get it ! They can obtain that information in the same manner they obtained it during clinical trials .... get it from volunteers ! If they can't obtain enough volunteers, let them obtain their volunteers the old fashioned way. Let them get out their wallet.

I know .... I understand .... I appreciate .... that some assert that current ICD / CRT-D / Pacemaker users have a moral obligation to provide that information for it's research value and for the betterment of mankind. I get it ! But that is a decision which is between a patient and the Good Lord. The reality of the matter is that we live in the US of A where we do have a concept of privacy, and the logical extension of the "betterment of mankind" argument would be to negate all privacy interests in our bodies and our medical records because their might be some research value there.

In the United States, we are free to live a life which does not merit redemption. Indeed we are free in this country to withhold or to omit contributions to all sorts of research which might benefit mankind. We are not required to donate our bodies to science when we die. And are free to risk burning in hell because of it.

There is NOTHING NEW HERE except the stupidity of the reasoning of the device manufacturers.

I will caution everyone that the manufacturers are in business for the benefit of their shareholders. The shareholders' interests and their customers' interests MAY be aligned. They may not. And when they are not aligned, legally, the Boards of Directors of the manufacturers are legally obligated to serve the shareholder interests, NOT THE CUSTOMER interests.

There are a lot of folks who will call me cynical. Perhaps I am. But I am one of the folks who is a "fence case" as to whether I should or shouldn't have an ICD implanted. Yes, I'm CHF I with EF 30-35% .... right on the fence. "On the fence" is the point at which the "risks of implanting" are approximately equal to the "risks of not implanting." One risk that isn't considered is the risk that something unplanned will happen to your data. How will that be used ? Tell me what uses haven't yet been conceived ? Will the data be used to discriminate against me in the future ? Given that I am a Fence Case, this issue of information ownership and data utilization is singularly, the only reason I do not have an ICD today.

They once told the Wright Brothers "I'll never fly." And while the Wright Brothers turned out to be the more visionary, I reasonably suspect the Wright Brothers never imagined man would be landing on the moon in less than 70 years ! What will they be doing with your ICD data next week ? Next month ? Next year ? In 20 years ?

JoeNH

Re: Access to ICD data

Post by JoeNH » December 14th, 2011, 5:59 pm

mrag wrote:They're like Ford, they make a car, where you drive it and how is your business.

Al .....

You've hit the nail in the middle of the head.

If Ford wants to know how their car is going to perform in the event of an automobile accident, Ford doesn't get the right to repossess your car if your crash and they're not entitled to medical data from the driver. Ford tests their vehicles on test tracks and with crash dummies and in simulators BEFORE they let the public drive the car.

JoeNH

Re: Access to ICD data

Post by JoeNH » December 14th, 2011, 6:05 pm

mrag wrote:And so far, my EP has been quite responsive in giving me copies of all my interrogations

Geez Al ? How many times can you fit the words "me" and "my" in one sentence ?

I'll note that you do so very appropriately. IT IS YOUR DATA !

NOT providing you with the data would be as stupid as your MD refusing to tell you your total cholesterol, HDL or LDL. Sorry Al, you can't know what your blood pressure is. Oh no ! If you think you're going to find out your INR, your total blood glucose or any other important information, you can just forget about it. You are required to be ignorant and are only allowed to know what the MD feels like telling you.

Doesn't that sound just completely ridiculous to everyone's ear, immediately ? <shocked look>

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freckles1880
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Re: Access to ICD data

Post by freckles1880 » December 14th, 2011, 6:11 pm

Joe, I don't fully disagree about your feelings but I don't really want to make an issue out of it. I am very happy with the turnaround time from my downloads to a printable copy in my Email box. I also understand that my training does not give me enough judgement or understanding of the report to really identify some issues properly. I get copies of almost all of my reports from my multitude of tests, after the fact and the readings by the experts. Some things are easy to interpret others not so.
I don't always agree with what my doctors say and sometimes even get a second opinion. That's fine and they get the big bucks for their knowledge.

I will just say we disagree on some things and agree on others. That's OK with me. That's why I go on this board. I want to learn but not become the new doctor. If you don't want an ICD for your reasons that's also fine. I am very happy I have mine. wavhi
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 54+ years and my daughters.

JoeNH

Re: Access to ICD data

Post by JoeNH » December 14th, 2011, 6:27 pm

Bob,

You know better than most folks that I COMPLETELY AGREE that you should be able to do whatever you wish with your ICD data. Give it to the manufacturer. Publish it in the newspaper. Share it with friends. Upload it onto this website for everyone to read, enjoy and benefit.

But I find it impossible to distinguish the individualized data developed from your ICD as being any different than the data developed from ANY OTHER DIAGNOSTIC PROCEDURE PERFORMED ON YOUR BODY.

Your EKG results, your ECG results, your INR, your EEG, your TEE, your MRI, your blood pressure, your blood glucose, your height, your weight, even the size of the big toe on your left foot .... ARE ALL MATTERS which might benefit device manufacturers or benefit mankind, but WE ALL UNDERSTAND that the information belongs to you and even your MD cannot share it without your permission.

YOU ARE IN COMPLETE CONTROL OF ALL THAT DATA. YOU DO WITH IT WHAT YOU WANT (including sharing it and making public). What makes ICD data different ? Literally, what distinguishes ICD data from all other data about your body ? No kidding, I'm honestly stumped.

I'm further stumped as to why some folks believe we all have to make the same decision. That is, if one person decides to share their data with everyone, why do I have to share mine too ? <scratching head>

JoeNH

Re: Access to ICD data

Post by JoeNH » December 14th, 2011, 6:36 pm

freckles1880 wrote:I am very happy with the turnaround time from my downloads to a printable copy in my Email box. I also understand that my training does not give me enough judgement or understanding of the report to really identify some issues properly.

Bob,

That's terrific .... and I'm really glad to hear that. And you should be able to continue to do things that way. I REALLY DON'T want to change anything for the folks who are happy with the way things are. I REALLY DON'T want to force my way of doing things on other people.

I can't imagine you would support the notion that the "Joe Way" should be the routine everyone should be required to follow. Honestly, that would be a terrible idea. Some people might choose the "Joe Way" or the "Fred Way" or the "Medtronic Way" or the "Boston Scientific Way." That's what we're about in this country: choice, free will and stuff like that. We're not about forcing anyone to do anything.

So why do the manufacturers' continue to deny people who wish to do their own evaluation, more immediately, and privately [emphasis added] .... in EXACTLY THE SAME WAY as I take my own blood pressure and evaluate it immediately and privately ?

I didn't always have the knowledge required to take my own blood pressure and evaluate the results. I got educated. Same process would hold true with ICD data evaluation. I could get that education too. Nobody is forced to take and evaluate their own blood pressure, but those that wish to, are permitted. Those who wish to consult with a doctor are free to do that too.

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mrag
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Re: Access to ICD data

Post by mrag » December 14th, 2011, 6:51 pm

Lively discussion and here I am all prepared to call someone a "one dimensional, ignorant jerk," but I'm not sure where to direct it. I am a tad confused by all this.

Point 1: it is MY data coming out of MY icd so it is MINE. I think there should no argument on that and if so, please reread my first sentence. Now unfortunately, I have to go to the bathroom, but this may give Joe time to get fired up some more. Stay tuned.

Point 2: this data coming from MY icd may be pertinent to MY immediate health concerns and of possible benefit to MY continued well being. Like, did my icd fire, are there other things the icd might see? Example, if it did NOT actually fire, I would feel much better than if it did.

Point 3: In Pennsylvania, my EP closes at 5 PM. They do not return until 8 AM. If MY icd fires at 3 AM, there is NO one that will even read, let alone share with ME, MY 'interrogation' until maybe 8:01 AM at the earliest. Is there anyone here that would care to wait 5 hours before finding out they are having a heart attack?

Point 4: If I am in a foreign land with language differences like Utah and MY icd fires at 2:34 AM, would someone tell ME who and WHEN someone might review MY interrogation that I send from MY hotel room? Might such an interrogation be ultimately and immediately beneficial to MY health and welfare?
Geez Al ? How many times can you fit the words "me" and "my" in one sentence ?
Maybe eight if I try ;-)

Point 5: the lasix is kicking in, break time
"The greatest enemy of knowledge is not ignorance, it is the illusion of knowledge" S Hawking

JoeNH

Re: Access to ICD data

Post by JoeNH » December 14th, 2011, 7:15 pm

mrag wrote:Point 1: it is MY data coming out of MY icd so it is MINE. I think there should no argument on that and if so, please reread my first sentence.

Al,

I AGREE. That is EXACTLY the point that Hugo Campos was making the video. But the way it works, YOU can't have direct access to it AND you MUST share it with the manufacturer.

There may be good reasons to share it, but why should you be compelled to share it ?

And if you are in a sleazy "No Tell Motel" in the middle of "Nowhere, USA" at some "ungodly and unmentionable hour" .... why should you be required to wait until 8 o'clock tomorrow morning, Philadelphia time, Monday thru Friday, to get access to your data ?

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