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Lawyer Demands Pacemaker Vendor Supply Source Code
oztiks writes "Lawyer Karen Sandler's heart condition means she needs a pacemaker to ward off sudden death. Instead of trusting that the vendor will create a flawless platform for the device to operate, Sandler has demanded to see the device's source code. Sandler's reasoning brings into question the device's reliably, stability, and oddly enough, security."
She could just let her heart regulate itself naturally.
A related story on NPR today points out that as a patient you don't have access to the data collected in and about your own body. The story focuses on one man's attempt to see his own data. He's looking for someone with technical skills to help him get at the data. Seems to me that somebody on /. should be able to help. http://www.onthemedia.org/2012/jan/20/who-owns-data-inside-your-body/
Did you just seriously say that there are no more software bugs in their code?
You're the reason lawyers exist.
There are two types of people in the world: Those who crave closure
Yet I don't demand to audit their code.
Well, if you don't demand that somebody audits their code you are pretty stupid. Unaudited code and code which is proprietary and never shared with outside bodies (this doesn't have to mean the public; just at least someone external) just doesn't have a place in any critical parts of our infrastructure. It is as irresponsible as it would be if Boeing didn't have to hand over the mechanical specifications of their planes, which of course they do. However, If you had read the article you would have seen this quote:
I think you will find that aircraft software, whilst it isn't open source and available to everyone, gets a bit more review than that.
Apart from that, the plane code isn't part of you and is, as a passenger, something you just visit for a short time. I think people have a right to understand fully, to the level of their own ability, things that are made part of their body.
=~ s,(.*),<sarcasm>$1</sarcasm>,g if any_point_you_wish();
It's called software validation and it's a pain in the ass. It's such a pain for medical devices that everyone avoids it unless absolutely needed. Which is why medicine is 10 years behind when it comes to electronics.
For a "quick" overview, here's a start: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126954.htm
The world is made by those who show up for the job.
10 thump
20 thump
30 sleep 1s
40 go to 10
Oh, come on. The source code is not going to tell you a whole lot, it would be only comprehensible to experts and it says nothing about the little hardware bits.
Experst are for hire.
I'm not an architect. The blueprints of my house are useless to me, but I can hire an architect to read them for me. That architect can than tell me if the house I'm living in is well designed or not. He won't be able to tell if the building-materials are of sufficient quality, but if the design is not sound the materials used don't even matter.
I'm dissappointed in Slashdot. One would expect that over here people would see the value of having access to the source of the software that keeps you alive.
There are many assumptions here that should be questioned.
Source code reviews are highly imperfect ways to ensure stable and accurate software, and good ones are extremely hard on the developers involved. Techniques like test driven development and paired programming offer a much better solution at lower cost.
New medical devices are released all the time and they have new code operating them, even if that general type of device has been in use for decades. New models with new or modified code have new bugs.
Perhaps owners of electronic devices that have caught fire or misbehaved in other physical ways have learned to start inquiring about manufacturing, mean time between failure and other manufacturing and quality issues.
I have worked in the medical software industry for thirty years as a developer, and was at one time an employee of Medtronic. I have a Medtronic pacemaker/defibrillator embedded in my chest which can be remotely accessed and controlled. I am professionally qualified to study and understand my device's software, development and testing methodology, and security issues - but Medtronic declined to share with me their source code when asked. The technical manuals for my devices which appear to provide all necessary information for hacking my pacemaker/defibrillator are available online.
I think that more can and should be done with oversight of medical device manufacturers and their software than the FDA currently requires, but this is true of all mission critical software like military and aerospace systems as well. The problem is neither uppity lawyers nor uncaring medical device manufacturers but instead the way we build software. Anyone with personal experience in the software industry who relies on a programmable medical device but who is not concerned over the accuracy and stability of the software running it is not thinking clearly.
If you read the article or ones on the same topic from last year, you'll find that the reason she is making the request is that not even the FDA has audited the code. It's just there.
Other embedded hardware has been found to be easily crackable and able to deliver fatal doses of medication. Someone has to audit the code, since the FDA is not doing it, Karen is making an issue of it. In these cases, there is no excuse for the code not being 100% open. People's lives hang in the balance.
Beta is broken and the link to classic doesn't work. Stop wasting our time or there won't be anybody left here.
I thought they had their hearts removed when they passed the bar at the same place that performs MBA lobotomies.
I love Jesus, except for his foreign policy.
The summary is pretty bad, but one of the more salient points is that modern pacemaker/debrillators have Wi-Fi in them. Yes, WiFi. According the the recording, someone at defcon has already managed to hack into an insulin pump equipped with WiFi and been abe to manipulate the delivery rate (which could kill the patient). So the security concerns aren't completely unwarranted.
Demanding the source code is a bit silly. How many people are really going to be able to review the source code for a pacemaker/debriliator? Very very few. Even if they do, there's a hell of a lot more to a pacemaer/debrillator than the software, so why is it just the software that's her concern?
A more sane approach would be demanding the software follow basic security rules like not allowing the wi-fi connection to ever change anything in the medical device. (It's supposed to be a reporting mechanism so the doctor can follow the progress of the patient). I can't believe she has anylegal grounds to demand source code, so this is a fight for the minds of the public rather than a legal one. Demanding source code is a bit silly since most of the public doesn't even understand that there is such a thing as source code. The public is by now very aware of security problems and hackers, so ensuring that the wi-fi is read-only would be an easier battle to win.
AccountKiller
The MBA lobotomy is a very precise operation, they only remove the parts of the brain that remember to pay taxes and how to truthfully report corp. earnings.
You forgot empathy.
If you had measurable empathy in the first place, they wouldn't have let you in.
If Slashdot were chemistry it would look like this:Cadaverine
Last year at OSCON. Sadly the line was too long for me to shake her hand and say thanks for starting this.
There's a few points I'd like to add, many already covered.
1) She's qualified to do this. Not to review the software. But she has plenty of good colleagues for that.
She's a director of GNOME (I know, I know...), former GC of the SFLC, an attorney... and ... from listening to her talk, she either genuinely gets software -- or someone that did wrote her whole speech for her.
2) This is a real, not a hypothetical problem.
People commenting without RTFA need to understand--These devices are 802.11 enabled. Remote exploits /have/ been demonstrated.
This is not a wholly uncommon situation -- one of my coworkers has a daughter with a computerized glucose pump that has also had remote compromise demonstrated.
And even a trivial interest in breathatlizers reveals there has been...myriad incidences of these devices not just being a total failure of design, but having rollover and similar bugs in their implementations.
3) People may be correct that it would be hard to get people to understand the code. That is wholly irrelevant and a false front of an argument. I don't care what your medical experience is in your industry or company. What your experience with regulators or lawsuits are. There's companies that commit fraud, lie, cheat, steal. They exist. This is indisputable. There's places where MBA's and biologists that can barely write a hello world by themselves compose pointer arithmetic, hit compile, hit test, and go home at the end of the day. I've worked at places like that on applications that could kill if they failed. It is why I do not as of two years ago.
I presently work with a woman that could not compose a CSV in a basic ETL from another filetype without help. She has the language being used using on her resume. Her workflow involved copy/paste off of the internet, and then changing one line at a time, saving it as file.### and trying to run it. If it didn't crash, she'd examine the output and try to put in what she thought would fix it. If it did, she'd try to find the error. When I offered a hand, she was currently at over her 500th revision.
So let me be damend clear -- even an unqualified person can do a basic code review just by running a fucking linter on it and looking at the warnings. Because if it generates one or a million -- that says something about the quality right there.
Why? Because unless you're in a business whose core business *IS* software, my personal experience is that 80% plus of the developers have never heard of one, and 95% don't know how to use it if they have. And that is why my code has less bugs than my colleagues.
Now -- even if my experiences are anecdotal, and "invalid" -- I've just proven the existence of the problem.
This is her life we're talking about. Her life entrusted to a piece of cybernetics that has had a demonstrated remote exploit.
Please /., have a little bit of humanity for once. This isn't about corporate profits, NDAs, lawsuits. This is about someone asking to read something to make an informed choice about their continued existence.