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Episode: 1029
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Title: HPR1029: Karen Sandler on Medical Devices: OGG Camp Part Two
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Source: https://hub.hackerpublicradio.org/ccdn.php?filename=/eps/hpr1029/hpr1029.mp3
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Transcribed: 2025-10-17 17:39:59
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---
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The full circle podcast on hacker public radio in this episode, ArcCamp 11, Karen Sandler
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on medical devices.
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Hello World, and welcome to the full circle podcast on hacker public radio.
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This is the second of our highlights of ArcCamp 11, last summer's unconference, held
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at phantom maltings in the south of England.
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The full circle podcast is the companion to full circle magazine, the independent magazine
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for the Ubuntu community.
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Find us at fullcirclemagazine.org forward slash podcast.
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Next the presentation from Karen Sandler, legal eagle, formerly of the Software Freedom
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Law Centre and newly appointed executive director at the Nome Foundation.
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Karen wasn't due to speak on the scheduled track, but stepped into an unexpected gap to
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talk about something dare I say very close to her heart.
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You know talking about how all the things that we really like about open-source software
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of business come from software freedom that we have to tend to software freedom and we're
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going to expect to continue to have those freedom.
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So the first thing you need to know about me is that I'm your new cyborg overworked.
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So the story about how I've gotten involved in these issues is quite a personal one.
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I have a heart condition.
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It still feels really weird to say that in front of a whole group of people.
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I sort of feel like I've had some support group and sort of feeling like, hey everybody,
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I have a heart condition, but I do.
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I have a big heart.
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I have a huge heart.
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So my heart is actually three times the size of a moral person's heart.
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It's called hyper-trophic cardiomyopathy and it means that my heart is very big.
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But it's also very stiff and it's pretty clear.
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It's not just that my heart is scaled up, but it's much thicker.
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So the problem with it is that if I, you know, in certain circumstances,
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it might try to feed it really hard and then become it effective.
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And the technical term for that is sudden death.
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I have a very high risk of suddenly dying.
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And that's all the biggest part about my heart condition.
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Other than that, I don't mean symptoms.
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I'm not allowed to do things that I never wanted to do like run a marathon or go racing
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or realize that it's the greatest case.
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There is a chance that I could run across the street to try to catch the bus
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and not make it across the street.
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And there's a solution for it, which is to get a case-maker familiar and become cyborg.
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When I was told that I needed a heart device, you know,
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I think there were all sorts of normal kinds of reactions to that.
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Just first, there was dealing with my own mortality, the weirdness of it.
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The fact that, you know, I am now.
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But the longer I went on without getting it, the more I realized that I had to get it.
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And I could be a cyborg for good.
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But there was another problem that I don't think anybody who,
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I know who got a heart device before had thought about,
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which is that when the cardiologist slid the device,
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an example device that was, this is so terrifying,
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you could take out this little thing and say, look, it's really not scary at all.
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It's just this little thing.
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Doesn't it seem friendly?
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You can have it in your body, and it will stay your life.
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And you keep slitting over this to me, and I said, well, what is it run?
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And they had a mindset for me.
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And nobody there asked me that question before.
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He said, well, what do you mean? What is it run?
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And I said, well, it has software on it. That's how it operates.
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I actually already was a lawyer at the Software Freedom Law Center.
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So I was thinking about these issues.
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But I also was an engineer and a programmer.
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So I, you know, I said, surely, if you tell me what kind of software is running,
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and how runs and can I look at it?
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And he said, okay, well, we're going to pull out.
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There's actually a representative from the medical best manufacturer.
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You're going to pull him into the office and see if he can answer your questions.
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And he said, what are you talking about?
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There's software on this device.
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And you're going to put the device in my body connected to my heart.
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Can I see the source code?
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Can I see how it runs?
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And the answer was, whoa, that's a big problem.
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Yeah.
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I'm going to go talk to the company about that.
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And then nothing.
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So I called all three of the major medical device manufacturers in Aslam.
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You know, can I see the source code for the device?
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If I can, I'll go with your device.
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You know, I might have, I might put it in a call.
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I'm not sure.
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I'm going to work under a while.
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I don't know what I can find.
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But I ask my friends to look at it.
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And nothing, nothing.
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I offered them to sign a non-disclosure agreement saying, you know,
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I just feel so uncomfortable having this thing put in my body
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without being able to see it.
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Why don't I sign a non-disclosure agreement?
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Then I comment.
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I won't share it with anybody else, which is, you know,
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I took it belted, me being at the software Freedom Law Center.
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But I just felt so weird about having this thing that I was willing to do that.
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And they said, no.
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So I kept putting it up, putting it up.
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And my parents, you know, every time I didn't call my mother back for an hour,
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she would call all my friends and say, have you heard from Karen that she's still alive?
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It's a really important issue, but I, you know, I can't risk my life on it.
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So when Simon said, so I got on the device.
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And I decided that I was going to do all three research then.
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And I have really worked at the software Freedom Law Center
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and was able to launch an initiative there on this very issue.
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So I did a whole bunch of research.
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And I found out some things that probably won't surprise you like software has bugs.
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The software engineering institute published a study that they estimated
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that for every 100 lines of code, a bug is introduced, which is not very many lines of code.
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So even if you get most of the bugs, they're still going to be some bugs.
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And then I looked at all of these studies about the software of medical devices in particular.
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There's one study that systematically took all the recalls and other kinds of publications
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but the People Drug Administration in the United States approved these devices
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and they also put out, you know, warnings or whatever, something that's wrong.
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And these people studied all of the recalls.
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And so of all the recalls of the ones that they could determine were because of software,
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which wasn't all of them. And other ones that they could see what was a problem,
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many percent of them wouldn't have been detected if the company who had made the device
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had done all pairs testing.
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And so people who may not be a technical, it's basically testing where you test
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for multiple commissions happening at last.
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You're reading about the software, the bugs in the software was really sickening
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because there are all these examples of medical devices failing.
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And we're all aware that there are radiations that there's a lot of steps in them.
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There are insulin pops where was very unclear what field people were entering.
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And such clinicians thought they were entering hourly dosages for insulin delivery
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but they were actually entering minutes.
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A bunch of people died.
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But it really was telling me.
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And every time I would find one of these major medical device failures,
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it really made me physically ill.
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And I'm thinking, you know, what are the problems in my device?
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So I put it away and not work on it for a while back.
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So it took me like an over a year to work on this stuff.
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So I looked into what the Food and Drug Administration does.
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But what I really found out is what it doesn't.
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The Food and Drug Administration typically does not with you the source code of these devices.
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I couldn't believe it.
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They don't generally do so unless they already think there's some problem.
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Because of that, they actually don't even request the software in most instances.
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What they do is they ask the medical device manufacturers to come up with their own reports
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about what the software does and how it operates and they certify and contest it.
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But there's no clear set of guidelines as to what those companies have to do.
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And the idea behind that is, you know, pretty clear.
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The FDA basically doesn't want to have to be in a situation where they're saying,
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you know, your requirements are A, B, and C.
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And this new device should have been D.
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But because the FDA is a new device, the FDA didn't know it.
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So they say, the people who know the device is the best are these companies that are designing them.
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And so therefore, they know what kind of tests they should do.
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But basically, what this means is that because the NK is not working at the source code,
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and they're asking for it, and they don't have any clear guidelines, any clear requirements.
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They have some guidelines for requirements.
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You've tested, there's a lot of power being left at these companies.
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And because the FDA is not asking for the source code, they're never getting the source code,
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which means that there's no copy and there's no repository for the public.
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So in an instance that there's catastrophic failure at metronics, for example,
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you know, there may not be a copy of the software I went hard to buy.
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And my hard to buy is only as good as it works right now.
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So, you know, you can talk to these hard devices remotely, but you can update them.
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But if I don't have a source code, I can't patch it.
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And if there's no one on the tronic to help me, then I'm just out of the month.
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I talked to the head of cybersecurity and the FDA and said,
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I just want to say that people that really confused about what the FDA does.
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But we are not here to view every part of every device.
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We just couldn't do it.
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We don't have no resources.
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We can't really just sort of software.
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And I was like, that means, you know, this is for me, you know, time for me to tell them and say,
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well, actually, that's not what I'm asking for.
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What I'm asking for is for you to require them to be published so that everyone can review it.
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You know, this way, the FDA concerts the public.
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And he said, I thought, you know, I haven't actually thought that makes a lot of sense.
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Your name is that everybody has to ask that.
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Right.
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One of the things that also has found to me as a lawyer looking into this is that in the United States,
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because of the way that the FDA approval process works, it's a federal approval process.
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And therefore, patients are actually preempted from suing other state court law.
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So I can't just go into my state court and sue over my medical device because it's going to prove on a medical federal level.
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So it's like there's this whole list of remedies that I couldn't even go to court and take these medical device companies to task board
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because it was properly approved of the FDA.
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Which, you know, take a step further from what Simon was saying,
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how software freedom is critical of business.
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But this is my body.
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You're going to put something in my body.
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You're going to put a device and connect it literally screwed into my heart.
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And you won't let me see it.
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It's just madness.
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So we've got the worst of both worlds.
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We have no encryption.
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These devices are...
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Recently, someone was able to do the same thing with the implanted insulin pumps.
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Those are, like, the two biggest causes of implanted medical devices.
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There's the insulin pumps that are the case-maker to thirdulators.
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And there's also, like, a bunch of heat management steps and some implanted neuro simulation therapy.
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And then also, somebody wrote me that they're considering getting implanted hearing aids.
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So hearing implants that implanted into their skull.
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And they wanted to talk to me about, you know, the software freedom implications of this.
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And what's interesting to me is how well they get a whole bunch of work with hearing aids where they were able to turn.
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There could be privacy implications with hearing aids because, as they talk to each other,
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there's an opportunity to set that and actually be able to spy on people and get their whole conversation.
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So, like, just really many things.
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So we've got no security on these devices.
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And the reason they know that is because they say that it is to basically preserve battery power.
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But there's going to be a whole slew of proposals that would not run down the battery.
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And they still don't implement them.
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And on the other side, we've got plus code.
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So it's just like, who would need to leave us up?
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Right? Nobody can do the code so that, you know, to make sure that it's safe.
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And there's no requirement for privacy or to prevent people from tampering with them.
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All this led me to the conclusion that, admittedly, I was biased before as an employee of the software Freedom Law Center.
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But that these devices need to be free and open.
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It's so easy to see.
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You know, if it's free and open, anybody can...
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But no, you know, anyone can look at the system and find out if it has problems.
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They can assess the risks.
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If there is a problem, anybody can propose a patch.
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In the case of medical advice, software, you can see that being extremely important.
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But I guess in some ways, counterintuitive.
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But it goes the opposite way, which is, make our software open, but encrypted.
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So that I can choose what patch it's going to my software.
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And that's connected to my heart.
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And the most important thing about this is that all of these just will line up on my truck.
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Like, we've seen so many companies come in and out.
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We've seen their failures.
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We've seen the way that basic things that we expect companies to do don't get done.
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So I don't want to depend on a single party.
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A single, as a party, because I'm a large.
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But, you know, I always tend to rely on a single company.
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And so it's easy to go from there to say,
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our software must be safe.
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You know, and it's not just medical medicine.
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It's anything we rely on for our life and for our society.
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So our cars, we had a problem with one of the cars where, you know, I think there were,
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I think there was different examples in some countries, but where the software,
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cars were malfunctioning before it's crashing, which is public.
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The voting machines, you really need our voting machines.
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Because that's how we choose to govern our society, our financial markets,
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and again, our medical devices.
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But what's amazing to me right now is that what is science-sized critical is just completely
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learning.
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The way that we do our computing is changed.
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So like five years ago, my mother did not use computers for almost anything.
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She was terrified of them.
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She didn't want to do anything.
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It was completely not in her role.
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But in the last couple of years, she's literally taken to her mat.
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And she now uses a computer for everything.
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She was called to travel online.
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She, you know, she, and that's true across the board.
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Now, everybody is using their software for everything.
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And that means, you know, all of our grandparents using your software.
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Everybody is using software for everything.
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We're using it to see when our buses are coming.
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We're using it to keep track of, you know, what restaurants we should go to,
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and where our friends are from.
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We're using it to say what we have eaten, and what, you know,
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how to keep track of our diet, and how to keep track of our exercise.
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Now, there is already software for phones that can interact with those insulin pumps,
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so that you can interact, what you can track of your diet,
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and exercise with your function or something.
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So, this idea of what is life in society critical has completely blurred.
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And when people use computers, they expect them to be easily used to
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expect to use them to do this with something I was saying before.
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Even typing in a command to run a projector was too much effort.
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And if it was for assignment, he's technically minded.
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You know, my mother would never be able to do that.
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But, my mother expects to be able to use computers,
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and she expects to be able to use it for everything.
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So, our UI institutions have completely changed,
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which brings me to the desktop.
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So, about a month ago, I switched over from the software green and law center
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to be coming exactly for a perfect notebook.
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And, you know, I'm just released, you know, I'm free.
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It's so pretty.
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And I don't know if you guys have used it yet,
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but you should give it a try.
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It's still early days, there's been a lot of criticism about it,
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but there's been a lot of really positive feedback to you,
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especially for people like my mother,
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who are really reticent with computers.
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This is basically a complete redesign by, you know,
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for user experience.
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Basically, they solely went about trying to make a better experience
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for people ordinary people, not necessarily hackers,
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which I think, you know, it's kind of,
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it's just it's sleek and it's clean, and it's easy to use.
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And it dispenses with a lot of the things that we think,
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that we use to think people wanted to use better computers,
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but we've seen from, from Matthewsage and from other kinds of computers
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that this isn't really what we're going to need people want.
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I would just say that I would sign it.
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We need trends towards freedom.
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I love this thinking for a lot because it's just,
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it's so iconic and it's, you know, it's the,
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it's the crashing of the street, right?
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And we have no idea what our life and society critical
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functionality is going to be.
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We don't know what we're going to rely on.
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I mean, who thought that we would rely on our icon to interact
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with our, you know, our folks interact with our insulin pumps?
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We would never have thought that.
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And it's because it's coming out of the way we use everyday computing.
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We need to build on free open platforms as much as we can.
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It's so important.
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I sign in joke and say, think of the children,
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but think of the children.
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I mean, think about what kind of a world we're creating.
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And if we can all work together and focus on free open platforms,
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we're going to be much safer ultimately.
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And I think I am totally out of time as a candidate.
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The, you know, foundation and the software we don't care where I am.
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So being a pro bono work or both by the ones we've raised,
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become a friend of the known.
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We really need your help.
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Creating a great user interface is, it takes a lot of effort and a lot of volunteer
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and provide a lot of people.
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And having financial support is really important.
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Try out the goal.
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And I'm a CC biasing.
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So we should have freedom in content as well as if it's not work.
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Thank you very much.
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Thank you very much.
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So that was Karen Sandler of the Known Foundation on the subject of
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Close Source Medical Devices.
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Og Camp is a joint venture between those lovely podcasters for Linux Outlaws
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and the Ubuntu UK podcast.
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With more highlights of Og Camp coming up on the full circle podcast very soon,
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including Andy Piper on MQTT and the Og Camp panel discussion.
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I'm Robin Katling.
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Thank you for listening.
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And goodbye.
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Thank you for listening to Hack with OverGradio.
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HPR is sponsored by Carol.net.
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So head on over to CARO.NC for all of those meetings.
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Thank you very much.
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