I want to inspect the blueprints of every building I walk into and know the sourcing and composition of all the structural components as well. For my life depends on these things to be true and properly constructed.
“I Want to Know What Code Is Running Inside My Body”
81–90 of 217 posts
Re: “I Want to Know What Code Is Running Inside My Body”
#82How about when I'm flying an airplane; I'm also putting my life in the hands of people that wrote the code that controls it and I have to trust that the plane won't shut itself down mid-flight because of faulty code. Should a similar argument be made here?
Re: “I Want to Know What Code Is Running Inside My Body”
#83Does anyone know if at least the FDA is allowed to review the source code for pacemakers? Or is it a complete blackbox? Personally I would be appalled if even the FDA is not allowed to.
I used to work at a diagnostic medical equipment company. Rules were slightly different for us (diagnostic rather than therapeutic = lower bar) and we had FDA audits. They were basically making sure we had written down our processes to an adequate degree, and checking that we actually followed what we wrote down. They most definitely were not doing code audits (which isn't their job or area of expertise).
> and checking that we actually followed what we wrote down
We never got that. For the most part, checking that we followed what we wrote down involved reading more documents that said that we did what we wrote down. The auditors weren't even allowed to walk around freely in our office, nor even be left alone without supervision, and we were all carefully coached on how to answer interviews with non-compromising responses. "I do what the SOP says. I cannot quite recall at the moment, but if you let me refresh my memory by reading the SOP, I will gladly clear it up for you."
It's just smoke and mirrors to pretend like important testing took place. Probably also to make sure whom to blame when things go bad. Some testing does frequently happen, between the document writing about the testing.
Re: “I Want to Know What Code Is Running Inside My Body”
#84By extension should every device I own require me to have access to the source code and output data? Not a rhetorical question.
Y'know, back in the early 2000's and the days of Slashdot, it was quite common to find people who advocated for free software everywhere. Now we find people who like yourself have to specify that the radical position that all software should be free is something worthy of serious consideration. That they're not joking or trying to be deliberately provocative. What happened to us? Why did we go from boasting about ins…
The fear is then others can rip it .
It's an interesting proposition.
Re: “I Want to Know What Code Is Running Inside My Body”
#85Earlier quoted context omitted.
Do you want to control the device, or do you want someone else to control your devices? If you're OK with someone else (who probably doesn't have your well-being anywhere in their list of priorities) controlling all of your devices, then the answer is no, you are not required to have access to the source code and output data. EDIT: I didn't realize this was such a controversial statement. I stand by it, though; even…
In theory, open sourcing pacemaker software make sense, but in practice, the pool of people qualified to review and edit that software may not be very large. Most people would still be depending on someone else to control their devices in any case.
There are probably very few parts of the code of a pacemaker that requires knowledge about medical devices or pacemakers specifically - probably the drivers that connect to the sensors and the algorithms that determine what the pacemaker should do based on the result of the sensors.
The majority of the code, especially if as said in the article it has wifi and listens to external requests, is code that requires only expertise in more general software, of which there are many many people who are qualified to review such software (or write it).
Re: “I Want to Know What Code Is Running Inside My Body”
#86I want to inspect the blueprints of every building I walk into and know the sourcing and composition of all the structural components as well. For my life depends on these things to be true and properly constructed.
Not necessary because this is realised to a certain extent through safety standards. Certified earthquake proof. Done.
Now, in this case, FDA approval should include software standards that prevent this scenario. Done*.
Re: “I Want to Know What Code Is Running Inside My Body”
#87I want to inspect the blueprints of every building I walk into and know the sourcing and composition of all the structural components as well. For my life depends on these things to be true and properly constructed.
I'd like to read commments here without total strawmen derailing the conversation to nonsense. Do you have anything constructive to add?
Re: “I Want to Know What Code Is Running Inside My Body”
#88How about when I'm flying an airplane; I'm also putting my life in the hands of people that wrote the code that controls it and I have to trust that the plane won't shut itself down mid-flight because of faulty code. Should a similar argument be made here?
Perhaps you are being sarcastic, but I shall attempt to answer the question earnestly anyway.
I've been reading up on aviation regs due to a recent interest in getting a pilot's license. By my understanding, airplanes certified by the FAA as airworthy undergo some fairly heavy testing to exactly determine and prove what their capabilities and limits are. Given that getting your prototype wrong can cause the plane to crash and kill your test pilot, there's incentive to get this stuff right. Furthermore, once a plane is type certified, it can't be modified from that configuration without further testing to prove the modified configuration. Thus you'd better be damned certain that your engine control computers are correct, lest the FAA revoke the plane's airworthiness certificate, making that model unsellable, nevermind the lawsuits of the survivors of deceased passengers or insurance companies recouping their losses.
Additionally, from what I've seen, most general aviation airplanes are stuck in the 60s as far as engine tech goes, in part because of the strict FAA regs. We're talking air-cooled engines with carburettors here, no engine computer to speak of, or if you're running a fancy modern engine, mechanical fuel injection. Unless you're flying a brand new Cirrus SR22 or Diamond DA20, there's no code to inspect. Even if there was, it'd be in the avionics. You don't need a nav beaon, radio, or transponder to land an airplane safely -- though they can make it much easier, and the FAA is going to want to know what happened once you're back on the ground.
As far is large passenger jets? I'd say as a passenger, no, you don't have access to the code. It's not your airplane; it belongs to the carrier.
Personally, if I were to own a plane and fly it, I very much would want access to any and all code that makes the plane go. Though if I'm going to be hacking on said code, I suppose that's what the FAA's Experimental category is for.
Re: “I Want to Know What Code Is Running Inside My Body”
#89By extension should every device I own require me to have access to the source code and output data? Not a rhetorical question.
By what extension? There's a very real criteria here, it literally controls the rhythm of a persons heartbeat. This isn't a trivial device that runs on a wall outlet. "By extension" is doing a significant amount of work in this comment.
Re: “I Want to Know What Code Is Running Inside My Body”
#90Does anyone know if at least the FDA is allowed to review the source code for pacemakers? Or is it a complete blackbox? Personally I would be appalled if even the FDA is not allowed to.
I know. Nope. The FDA probably doesn't even know what source code is. They have vague regulations on how medical devices should be tested, which by tradition has been interpreted in a particular way to mean certain kinds of documents have to be prepared. There are auditors that check that those documents are written. Nobody checks that what the documents say about the software is in fact true because neither those wr…
As someone who has been on the receiving end of several FDA audits, I would really like to know on what basis you're saying all of this, because everything in my 10 years of experience of doing this is contrary to what you've said.