Skip to comments.Man with defibrillator demands access to his own heart's information
Posted on 02/10/2012 4:39:08 AM PST by expat1000
SAN JOSE, Calf. (MCT) Hugo Campos has a small computer buried in his chest to help keep him alive. But he has no idea what it says about his faulty heart.
All the raw data it collects, especially any erratic rhythms it controls with shocks, goes directly to the manufacturer. And some of it later gets sent to his doctor.
But Campos had to step onto a national stage in his fight to see the data his body produces.
His David-and-Goliath campaign puts him on the leading edge of what's called the "e-patient movement" "engaged, equipped and enabled" that seeks to harness data so patients can learn more about their bodies.
"It's mine. I paid for it. It's in my body," asserts the tech-savvy 45-year-old, who since his sudden collapse at the Fruitvale, Calif., BART station four years ago has devoted himself to studying cardiology textbooks, attending device symposiums and scheming how to access the electronics of his tiny defibrillator.
"I have a right to my own damn data," he said.
(Excerpt) Read more at jewishworldreview.com ...
"I will not be monitored remotely unless I'm part of the loop," he asserts.
But new allies have rallied to him: hackers.
More than a dozen engineers have volunteered to help him tap into the wireless system and unlock the data.
"I'll get it," he said, "one way or another.
It is literally his data. He has the right under privacy laws to control who has access to it.
"You can't handle the data!"
If this is part of his doctors records then by law he is already allowed to see it. The official records are part of the doctors practice and required to be maintained by the doctor, but the patient is legally required to be provided a copy.
Even the Navy has to provide a copy of their medical records to the service member upon request. yes he may have to pay for the cost of generating the copy, but he has a right to the information.
The problem is that he wants real-time access to raw data from the device. The manufacturer records data about his heart and proprietary data about how the device is functioning. Very interesting dilema from a software development standpoint. The manufacturer needs to develop a solution for patients, but that will increase production costs.
In my experience in the healthcare field, this guy is an exception to the rule. You don't have to go this far, but it's amazing how little time and effort people put into understanding their own medical conditions.
I don't know how many times I've seen people come to the pharmacy and ask for a refill of their "heart pill." Which one of the dozens on the market? They don't know.
At the very least, you should know the name(s) of the drug you're taking. Wouldn't hurt to know the effects and interactions, as well. If your health is that important, there's no excuse for not knowing.....unless you're taking something for Alzheimer's.
Having worked med devices the last 12 years I can definitively state that it will cost a minor amount of investment to provide a limited access hook to allow his data without the proprietary device info as both are currently already hooked. Say one engineer for 2 weeks at most (and he/she would spend most time on other projects anyway).
Production cost would not be impacted since it would be a matter of the firmware version being uploaded being swapped out.
Bigger issue would be for those already implanted where firmware can’t be “swapped”. In that case they fall back on - sorry real time access isn’t currently available, but here is the access for your data once it has been downloaded and interpreted. Doctor’s notes aren’t required to be provided with a patients records as I understand so the mfgrs info would not be covered either and can be removed, and patient records aren’t required to be provided real time - only ‘within a reasonably alloted time’. So.... While he has a right to the data he doesn’t have a right to real time data if it wasn’t a feature originally in the device. He doesn’t get MRI pics, blood results, or othe r such items same day so,,,
When my wife went through her breast cancer, both she and the doc got frustrated with me. Her because I was buying medical texts to learn more and the doc because I was reading papers that he hadn’t had a chance to yet so wasn’t able to answer my questions readily and he said it made him feel kinda useless. I kept doing what I was doing, but just kept it to myself after he finally threw up his hands. We got along fine after that. Wife is going on 7 years post-op with no signs of remission...so it all worked out.
But I know what you mean about some people just being sheep. There were a number of those in the waiting room all the time, similar to the way some people expect to be taken care of financially, etc.
I have one of these devices and have never had a problem getting my data after download to the collection server.
I can go to my provider and ask to see what's happening in real time and they'll be happy to show me.
I've only been shocked twice in five years and I can assure you, I've been over-analyzed immediately after it happened and viewed the screens with the medical folks as they went through the process.
The device manufacturer is trying to avoid getting sued for any software/hardware glitches. Selling in the American healthcare market is a legal mine field and most executives at pharma and medical device manufactures are lawyers, not doctors. That’s because most of their job entails dealing with legal attacks, not solving medical problems.
Having developed software for 20+ years, I can definitively state that “adding features” costs money short and long term. Software is never having to say “we’re done.” There is always maintenance. It’s never once and done. The data must be interpeted and presented to the patient in an understandable format. Then there are storage retention concerns and the management of those records.
A few weeks ago, I went to the doctor downstairs for a check-up thinking I could at least score some Viagra. But before it ever got that she was telling me to keep my clothes on and was referring me to a specialist because of some answers I gave her about my colon/intestines/guts/whatever.
Then I went to the specialist. They took blood and I almost fainted, because I really really don’t do medical. It just makes me sick. Anything medical on TV and I stop watching instantly.
Then a doctor was pushing really hard on my stomach area, trying to get me to say it hurts, but it actually kind of tickled so I laughed and said OUCH just to get her to stop. The doctor said she couldn’t feel anything so it might be cancer because there is a history of that in my family.
I was sent to the next room where eventually another doctor came in and did a sound test on my stomach area. He was pushing really hard with a devise that was connected to a monitor and he kept wanting me to look at the picture. But I don’t do medical so I resisted looking, thinking this guy is really weird.
Then he told me to take a deep breath and push my stomach out as much as possible. He got excited and said - there you have a rupture. He insisted I look at it go in and out while I kept pushing and relaxing my stomach and all I could think was I need to escape this Freak, so I finally sat up.
They referred me to another specialist. And now it gets worse. That doctor had me drinking stuff that makes all the poo leave the body. Then the next day he put me to sleep and sent a camera up my butt to look around. However I woke up near the end and sure enough he was trying to show me on his monitor. And I was thinking - this guy has the largest eyebrows I ever saw in my life and focused on that because I don’t do medical and I Don’t want to see inside my gut.
The doctor was done and I got dressed and sat in his office. He came in with printed pictures of my colon (or gut or whatever) but really wasn’t looking at them. He gave me copies and I sealed them in an envelope and passed them off to the next specialist at the hospital.
At the hospital I went through the same camera treatment again except this time I did not wake-up and they had no pictures to show me. They said I have two problems. One problem is a muscle tear they will fix with surgery. The other is a large polyp (or something) that has to be removed Tuesday because the larger it is the more likely it can turn to cancer.
This morning my wife was looking at my blood result that was printed out for me. She googled my blood sugar level and said I was one point below diabetes. She gave me the phone to the doctor but the doctor said I don’t have to worry because that is the extreme low end of diabetes.
I finally asked about Viagra and she told me to finish with the hospital and then make an appointment.
That’s the only medical I want to know about!
well aware of both the part 11 software issues/regs with the FDA and the engineers who can’t say “when”, but I’ve worked manufacturing, quality, and New products with lots of change management (including software) and while there is always “room for improvement” there are plenty of release revisions/version cutoffs since it has to get to market some time - and updates are already in the plan for the version already out when it is released the first time...
One of the ‘great’ things of regulated industries is that you are never done as continual improvement is actually required and lack of resources is not an acceptable excuse, though risk assessment/categorization is. In this case it would not be a mandated update due to risk, but a feature upgrade/nice to have that could be incorporated in the next scheduled upgrade/mandatory safety upate.
just wait until people find out how much their DNA is being used without compensation to the DNA owner.
Seriouly, you need to submit this to the Reader’s Digest. This is one of the funniest things I’ve read in a long time.
That’s my medical history!