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