Top Five Excuses ICD Manufacturers Use to Justify Not Releasing Data to Patients

I’ve been asked a few times to list the reasons why manufacturers of ICDs won’t release raw data to patients. (This data is collected via remote monitoring and shared with clinicians, but not with the patient who originates it.)

Here are their top five excuses:

Excuse #1: HIPAA.

“HIPAA prevents us from releasing data to patients.”
This is the most ridiculous of all excuses. HIPAA is the Health Insurance Portability and Accountability Act passed by the U.S. Congress in 1996. HIPAA is the single most significant legislation affecting the health care industry since the creation of Medicare and Medicaid back in 1965. One of the reasons HIPAA was created, was to give patients control over the use of their health information. NOT to prevent us from having it.

Excuse #2: Too complex.

“This information is too complex, patients wouldn’t understand it.”
You heard the ridiculous, now you heard the top patronizing excuse. To that I say: try us!

Excuse #3: Let us help you first.

“Sure, we’ll give patients their data. But first, let us figure out a way to put it into meaningful context for patients so they can understand it.”
Paternalism at its best. How about putting it into meaningful context WITH patients? Having manufacturers put our data in context means that they get to spin it for us. That is not what we want. Just give us our damn data and let us partner with whomever we want: doctors, family, statisticians, researchers, other patients, app developers or our electrical engineer friends to make it meaningful. Plus, different patients have different needs and different levels of understanding. We’re all in different phases of the same journey. It’s our job to make our health information meaningful, not theirs.

Excuse #4: It will overwhelm doctors with calls.

“If we give patients their data, doctors will be flooded with phone calls for no important reasons.”
Another patronizing excuse. I actually think that the exact opposite would happen. Instead of calling for every little thing, patients who are empowered with information and equipped with knowledge would only call their doctors for reasons that are important enough. Wouldn’t you?

Excuse #5: Doesn’t fit our business model.

“A pacemaker or defibrillator is put into a patient’s body for the therapy it delivers, not for the information it gathers. Making data available to patients does not fit our business model.” (Watch this on YouTube, here.)
In other words, “who’s going to pay for this?” or “why should we commit dollars to creating an infrastructure that provides data to patients when they don’t influence device purchase?” The doctor is the customer, in case you’re wondering. Not the patient.

The issue of giving patients access to our data will only be settled when doctors start talking about this and demanding that their patients be empowered with information.

Thankfully, this has already started to happen. Yay!

Read these related posts by Dr. David Lee Scher:

• Five Reasons Why Patients with Implantable Defibrillators Deserve Their Data, 
• Data from Implantable Defibrillators and Pacemaker: The World’s Best Kept Secret

I will get back to you.

I’ve been on a journey to unlock data from my implantable defibrillator for over two years now. While I’ve had quite a few successes, nothing compares with the overwhelmingly positive response received after a video of my talk at TEDxCambridge went live last week.

It was followed by an interview with Brooke Gladstone of NPR’s “On the Media” in which she asked: “Who owns the data from inside your body”?

These two developments caused my inbox to overflow with offers from hackers (listen to the interview) and emails from NPR listeners from the UK, Canada, and the entire U.S.

I was unprepared for such an overwhelming response. So, if you’re one of the people who wrote to me, please know what I will get back to you in time.

This has been a wild and unexpected ride, but I wouldn’t have it any other way.

Fighting for the right to access my heart’s data

Karen Sandler: a cyborg lawyer running on proprietary software

Should patients have the right to inspect and scrutinize the software that runs the implantable devices that keep them alive? Karen Sandler thinks so. Karen is a lawyer, executive director of the GNOME foundation, and Hypertrophic Cardiomyopathy patient who’s received an implantable defibrillator for primary prevention of sudden cardiac arrest.

In this talk, Karen explains how the FDA never reviews the source code that runs our ICDs and pacemakers and makes a case for free and open platforms for life-critical software.

“I don’t want to rely on one company for any part of my life. I don’t want to rely on Medtronic for my heart, and I don’t want to rely on any other company for any other thing. I want everybody to be able to see the source code. And I specially want to see the source code. We’re at a crossroads and it’s time to change.”

Watch:

Also, an interview with Karen Sandler:

VIDEO: A town hall meeting with the FDA

A town hall meeting with the FDA: democracy at work.

Dr. Jeff Shuren, Director,
FDA CDRH

Today, I had the exceptional opportunity to speak before Dr. Jeff Shuren director of the FDA’s Center for Devices and Radiological Health (CDRH). The CDRH is the center within the FDA that is responsible for pre- and post-market regulation of medical devices. Pacemakers and ICDs are under the center’s purview.

The town hall meeting was organized with the objective of having the FDA engage in discussions about issues of importance to the public. It was the third and last meeting being held this year.

It was a unique experience that filled my heart with patriotism, and an inspiring feeling of health activism and civic participation. I felt like a true patient advocate.

This is the message I delivered:

Good morning.


Thank you for the opportunity to be here.
 My name is Hugo Campos and I am a heart patient 
living with an implantable cardiac defibrillator.



Each year, hundreds of thousands of Americans are implanted with pacemakers, loop recorders and cardiac defibrillators like mine. However, not a single one of these patients has access to the wealth of personalized data that is continuously collected by their implantable devices.
 It is time for us to change this.

Pacemakers and ICDs are small, battery-powered, electrical impulse generators that are implanted in patients with slow heart beats or who are at risk of 
sudden cardiac arrest.

In addition to providing life-saving therapy, these medical devices collect and store advanced diagnostic information pertaining to their normal function and a patient’s clinical status. This information is transmitted to a secure and private network owned by the manufacturer of the device.

Some of the data collected is made available to clinicians through a secure Web site, enabling them the convenience of monitoring patients without the need for in-office visits.

However, this data is not made available to the patient who originates it.

Studies have shown that remotely monitored patients experience a significant reduction in time from 
clinical event to clinical decision and also benefit from shorter hospital stays and reduced costs per hospitalization.

This clearly makes the point that access to information saves lives and money.

Yet, even in light of such evidence, patients continue to be denied the right to access such useful and incredibly rich data about their bodies.

The main obstacle, in my view, has been the Cardiac Rhythm Management industry itself, which claims that a pacemaker or defibrillator is put into a patient’s body for the therapy it delivers, not for the information it gathers, and that making this data available to patients does not fit their business model.

The types of information collected by a modern ICD, for example, vary from trivial to potentially critical. Among other things, the device monitors its own battery voltage, the amount of time it takes to deliver a life-saving shock, collects and stores intracardiac electrograms, and monitors a patient’s heart rhythm, daily activity, arrhythmia episodes, and even the build-up of fluid in the lungs — which is critical to patients dealing with congestive heart failure.

In addition, patients who are at risk for atrial fibrillation and atrial flutter, have a higher propensity for stroke and heart failure. Atrial arrhythmias can also cause the ICD to deliver inappropriate shocks. So, rapid patient awareness of atrial fibrillation is crucial for those at risk.

Access to our data can do more than just help patients take control of our disease. It may also help with timely identification of device-related malfunctions, and ultimately, contribute to better patient engagement and improved health outcomes.

Knowledge is power. And a patient privy to his data is an empowered partner in his own health and healthcare. Access to my device’s data can help me track, understand and manage my condition better, become more active in my care, and work more effectively with my providers.

I rely on the FDA to protect me. And I need the FDA to stand with me in this quest for openness, access and transparency.

In the spirit of the new rules proposed last week by Health and Human Services Secretary, Kathleen Sebelius, that strengthen patients’ rights to access their own laboratory test results directly from labs, I would like to ask the FDA to follow suit and publicly declare that patients also have the right to the raw data collected and stored by the manufacturers of their implantable devices.

I have the right and the responsibility to care for myself, but cannot do so without information. It is time to fix this and put patients and our families at the center of our own care. And I call on the FDA to help us get there.

Thank you.

The highlight of the morning came at the end of the meeting when the audience was given the opportunity to ask questions. I asked Dr. Shuren who owns the data collected via remote monitoring by the manufacturer of my implantable device. He replied: “As a patient myself, I view the data on me...  it’s my data.”

Hoorah!

Attendees at the FDA CDRH town hall meeting of 9/22
in South San Francisco, during a break.

It isn’t nice, I want my data!

Each year, hundreds of thousands of pacemakers, ICDs and loop recorders are implanted in people all over the world. However, these patients have no access to the vast amount of critical data that is collected by their devices. I am one of those patients.

This song is inspired by the classic protest song “It isn’t nice” by Malvina Reynolds.

Follow along:

It isn’t nice to grab my data
from my implantable device.
Then to hog it, keep it from me.
That’s not right, I’ve told you twice.
It isn't nice, it isn't nice,
How can it be so hard to see
that I am the patient, it’s my data,
my heart, my ICD.

You ask me why I want these numbers
that you collect through my phone line
Then I give you all these reasons,
You still say no, that is not fine.
It isn't nice, it isn't nice.
It is my heart, my ICD
All I want is access, why on Earth...
won’t you give it to me?

Your excuse is: I'm unable
to make sense of the reports.
Will you please not patronize me.
Do I have to take this to the courts?
It isn't nice, it isn't nice.
How can it be so hard to see?
After all I am the patient
And the one with the ICD.

I think I know what your concerns are.
You want to keep me in the dark
I may learn who has the pacer
with longer life and bigger spark.
It isn't nice, it isn't nice,
How can it be so hard to see?
It’s time for you to unlock this,
I’m the one with the ICD.

I know it’s not nice to hack my pacer,
or intercept my Carelink call,
There are nicer ways to do it,
but you always seem to stall.
it isn’t nice, it isn’t nice,
but if my data is kept from me,
I just have no choice, I gotta have it

Why won’t you hear my plea?
One day you’ll go into retirement.
I hope still to be around,
with full access to my data.
Before they put me in the ground
It would be nice, it would be nice
If you are finally made to see
That the data is mine, just hear me out!
We have to set it free!

The battery life of my cardiac device

Sitting down with my interrogation reports is never fun. But it always makes me wonder what I’d be able to find if I had all of those numbers plugged into a database or spreadsheet. My clinic is unable to send me reports electronically, and so my only choice is to have them printed out on letter-sized or 110 mm thermal paper, which fades over time. But if I want to know how my device’s battery is performing, I have to spend a little time combing through all the pages of my reports and entering the numbers I find into Excel. I have all my printouts since the day after implant, 3 1/2 years ago, 44 months ago to be precise. In this amount of time, I’ve had 16 device interrogations, including two of them during a cardiac rhythm class I took at the Arrhythmia Technologies Institute (ATI) earlier this year. The above graphic shows the battery depletion curve of my ICD in comparison to an estimated Lithium/SVO battery discharge curve found in my school materials. I also took into account the estimated longevity published by the manufacturer for this model of ICD at 100% sensing and with semi-annual capacitor formations (as it is in my case).

It’s only an estimation, but it shows that my implant battery seems to be behaving according to plan. It’s an example of how access to our data can give patients some peace of mind. And aside from not getting a shock, that’s all I can hope for.

Hacking into my heart device’s data

All options have always been on the table regarding access to my implantable cardiac device’s data. But tapping my remote monitoring unit to get it has been among the options of last resort.

So, yesterday at the first Quantified Self conference, I announced my collaboration with Kyle Machulis, a software and hardware engineer who’s building open source libraries for whatever health equipment he can get his hands on. And that includes remote monitoring units used by pacemaker and implantable cardioverter-defibrillator (ICD) patients, eager to access their data.

Kyle Machulis, of OpenYou.org, presented at The Quantified Self Conference in Mountain View, CA. 

Above, a portion of the OpenYou table at the Quantified Self Conference. A commonly used remote monitoring is seen among a series of gadgets. In the Ziploc bag, an implantable defibrillator. 

A poster announced our collaboration and bold experiment.

The ICD

The implantable cardioverter-defibrillator is a small, battery-powered electrical impulse generator implanted in patients who are at risk of sudden cardiac death. The device is programmed to detect a life-threatening arrhythmia and correct it by delivering a jolt of electricity to the heart. It also has the ability to perform biventricular pacing in patients with congestive heart failure or bradycardia (slow heart rhythm).

In addition to providing life-saving therapy, the ICD also collects and stores comprehensive patient, device and physiological data that can indicate progression of the patient’s heart disease. Data collected by the ICD is automatically transmitted to a proprietary (and closed) network and made available to authorized physicians via the Internet, thus giving them efficient access to make informed decisions when and where needed.

No access for patients

The main problem with remote monitoring is the fact that it excludes patients from accessing this trove of personal medical data, thus giving them no opportunity to learn from it.

Only time will tell whether or not we will be successful in our experiment. But as Kyle says about the practice of keeping patients from their data: “[It] needs to stop, and we’re here to make that happen. It’s your data, it’s your right to have complete access to it.”

View the Quantified Self poster here (link downloads a PDF).

Online data access: at the bank and at the clinic

In addition to providing life-saving therapy, ICDs also collect and store comprehensive patient, device and physiological data that can indicate progression of the patient’s heart disease. Data collected by the ICD is automatically transmitted to a proprietary network and made available to physicians via the Internet, thus giving them efficient access to make informed decisions when and where needed.

However, ICD and pacemaker patients have no access to this trove of personal medical data.

Take a look at this conversation between a banker and her customer:

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Now, what makes it OK in the context of Health Care? Think about it.

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