1 00:00:00,000 --> 00:00:02,360 I just dropped it in the private chat. 2 00:00:17,780 --> 00:00:20,080 And we're not streaming. 3 00:00:20,080 --> 00:00:23,400 We host DEF CON music and it takes a hot second to switch away from it. 4 00:00:33,060 --> 00:00:34,900 There we go. 5 00:00:35,540 --> 00:00:37,420 And you guys are live. 6 00:00:39,660 --> 00:00:42,360 Welcome DEF CON safe mode. 7 00:00:42,360 --> 00:00:46,560 We're here at the DEF CON 28 safe mode. 8 00:00:46,560 --> 00:00:52,180 Do no harm, a healthcare security conversation Q&A. 9 00:00:52,660 --> 00:00:57,780 If you haven't had an opportunity to check out our pre-recorded video, it's on the media server and it's also on YouTube. 10 00:00:57,780 --> 00:01:03,440 We go for about an hour talking about some various topics that we'll probably touch on again tonight. 11 00:01:03,440 --> 00:01:10,040 Your opportunity here is to ask us questions in the Discord text channel and then see us live on Twitch. 12 00:01:10,040 --> 00:01:15,760 If you have any questions or anything, go ahead and feel free to put them in there and we'll get them in no particular order. 13 00:01:15,760 --> 00:01:19,040 All right, I'm going to kick it off and let everyone introduce themselves briefly. 14 00:01:19,040 --> 00:01:21,300 And then we're going to go ahead and get to the first question. 15 00:01:21,300 --> 00:01:22,420 I'll start with myself. 16 00:01:22,420 --> 00:01:23,440 Hey, I'm Quadi. 17 00:01:25,180 --> 00:01:25,820 Replicant here. 18 00:01:25,820 --> 00:01:27,400 Hope everyone is safe and healthy. 19 00:01:29,440 --> 00:01:30,980 Hi, my name is Ash Luft. 20 00:01:30,980 --> 00:01:35,780 I'm an embedded software developer from Starfish Medical. 21 00:01:40,920 --> 00:01:42,440 I have no idea what order we're going in. 22 00:01:42,440 --> 00:01:43,460 So I'm Jessica Wilkerson. 23 00:01:43,460 --> 00:01:46,120 I'm from the FDA and I'm a cyber policy advisor. 24 00:01:51,920 --> 00:01:53,100 Hey, I'm Vidya. 25 00:01:53,100 --> 00:01:55,560 I am from MedCorp. 26 00:01:55,560 --> 00:01:58,640 We are a cybersecurity solution targeting medical devices. 27 00:01:58,640 --> 00:02:00,280 And V, I'll turn it to you. 28 00:02:01,160 --> 00:02:02,280 It's Ivy. 29 00:02:02,440 --> 00:02:03,740 I'm a goon. 30 00:02:03,740 --> 00:02:06,440 I am a patient, a hacker, and a researcher. 31 00:02:06,600 --> 00:02:08,400 And that's about all about me. 32 00:02:08,400 --> 00:02:09,620 Back to you, Quadi. 33 00:02:10,200 --> 00:02:10,880 Awesome. 34 00:02:10,880 --> 00:02:13,620 So I'm accepting some fantastic questions tonight. 35 00:02:13,620 --> 00:02:22,060 We're going to go ahead and kick off the first one with a user called Raziz, which has a multi-part question, but I think the heart of it is at the end here. 36 00:02:22,060 --> 00:02:24,900 And it's a question to everybody. 37 00:02:24,900 --> 00:02:27,020 Please don't be shy. 38 00:02:27,100 --> 00:02:35,160 Do we have the resources to adequately detect and respond to attacks against internet-connected medical devices? 39 00:02:35,160 --> 00:02:41,910 So right now, in the status quo, can we even detect these attacks as they're happening, specifically on the devices? 40 00:02:43,360 --> 00:02:45,440 Who wants to take it first? 41 00:02:45,500 --> 00:02:46,800 So I'll take a first pass. 42 00:02:46,800 --> 00:03:00,660 I think while there are several solutions that exist in the IoT space, their application to healthcare is what creates this problematic scenario where we're relatively inadequately equipped to sufficiently respond right now. 43 00:03:00,660 --> 00:03:10,620 I think we think about what's the worst thing that could happen when you put security on a thermostat, and we don't really think about, well, what's the worst that can happen when something happens to a medical device that's attached to a patient? 44 00:03:10,720 --> 00:03:21,940 And so being cognizant that while there is a potential to detect this from a technical perspective, there are ramifications for implementing that for real patient safety and actual patient care. 45 00:03:24,800 --> 00:03:30,420 I totally have to agree there, and it becomes even more complicated when we talk about implant tools. 46 00:03:30,420 --> 00:03:38,300 So to do any detection on those devices is very hard and not very robust at the moment. 47 00:03:38,700 --> 00:03:51,740 But the problem is, as well as Lydia said, the implementation of traditional cybersecurity tools in the healthcare space is problematic due to the fact that this is not your traditional cybersecurity space. 48 00:03:52,300 --> 00:03:56,440 Each hospital or healthcare institution faces their own challenges. 49 00:03:57,280 --> 00:04:04,520 So it's almost about having something that caters to your hospital and your healthcare institution. 50 00:04:09,900 --> 00:04:24,020 Yeah, I just want to chime in here for a second and say, yeah, I don't think many hospitals, under-resourced hospitals, have robust detection methods. 51 00:04:24,020 --> 00:04:30,180 You'll be surprised how many of them lack intrusion detection systems or have good endpoint security. 52 00:04:30,180 --> 00:04:35,020 You'd be surprised how many of them get regularly penetration tested or go through that entire process. 53 00:04:35,020 --> 00:04:48,960 And just to plug again, HHS and the FDA, the 2017 Health and Human Services Task Force report estimated that a good majority of hospitals in the United States lack a single full-time security professional on staff. 54 00:04:48,960 --> 00:04:56,280 So that's like a perfect storm to have a lot of attacks probably go undetected. 55 00:04:56,420 --> 00:04:59,860 The other little part of that, and I just want to just reflect on what Vee said, I completely agree. 56 00:04:59,860 --> 00:05:04,180 The home space is this complete black box. 57 00:05:04,180 --> 00:05:13,760 A lot of people who get medical devices, especially in the era of COVID, are given home monitoring equipment or they get an implantable and it has an accompanying base station. 58 00:05:13,760 --> 00:05:17,540 And when they're discharged from the hospital, they say, go plug this into your router at home. 59 00:05:17,820 --> 00:05:21,520 And there's really not a lot of work done to secure their home environments. 60 00:05:21,520 --> 00:05:23,440 And we don't know much about that space. 61 00:05:23,440 --> 00:05:25,860 It could be fine, or it could be a nightmare. 62 00:05:25,860 --> 00:05:32,160 I think what we lack is the ability to collect that information and then share it with people. 63 00:05:33,120 --> 00:05:35,960 I think that's a perfect point to raise around ownership, right? 64 00:05:35,960 --> 00:05:38,060 Like who is actually responsible for securing this? 65 00:05:38,060 --> 00:05:47,240 Is it really reasonable to ask someone to go home and secure their home network, not knowing their technical skillset or whether that's really part of getting care, right? 66 00:05:47,240 --> 00:05:52,400 And then you think about hospitals, is their core competency really going to become cybersecurity? 67 00:05:52,580 --> 00:06:02,380 And to the point of not even having resources, we have to really think about how we can think about where the ownership really needs to originate and what is most efficient and effective. 68 00:06:05,810 --> 00:06:25,430 One thing that I would say on this, I think is like the token government person on this panel, is I do have to plug all of the work that is happening at some of the national level policy issues, because I promise we are aware that these things are issues and they are being worked on. 69 00:06:25,550 --> 00:06:36,290 And so there are a lot of industry bodies, industry bodies, government bodies, and then bodies where the two come together, that have documented and just general conversations about this on a recurring basis. 70 00:06:36,290 --> 00:06:47,750 So I know as little respect as everybody can have for the myriad best practices guides and other things that, you know, white papers that the government puts out that sometimes just sit on shelves and never get used. 71 00:06:48,130 --> 00:06:57,630 But these are things that have been looked at and things like the medical device sectors, joint security plan, they've been looked at for healthcare delivery organizations, something called the HICUP. 72 00:06:57,630 --> 00:07:02,050 And if you paid me money right now, I could not actually tell you what that acronym stands for. 73 00:07:02,050 --> 00:07:06,550 But it's like the healthcare version, the hospital version of their best practices guide. 74 00:07:07,650 --> 00:07:19,330 And in the HICUP in particular, I want to say it is, or maybe it's the JSP, one of the two, they actually have like, it's separated out into what large organizations can do, and then what small and medium sized organizations can do. 75 00:07:19,330 --> 00:07:22,830 And they do different things for both or recommend different things for both. 76 00:07:22,910 --> 00:07:27,170 So this is an ongoing conversation that is happening at that national level. 77 00:07:27,610 --> 00:07:31,230 But we certainly don't claim to have all of those answers. 78 00:07:34,940 --> 00:07:40,700 Another thing that I think is important is we're moving into a thing where we want to do early detection and monitoring. 79 00:07:40,700 --> 00:07:45,860 But most of the instances where there has been hospital breaches, we've been left on the back foot, right? 80 00:07:46,380 --> 00:07:50,720 We needed to become aware of the breach before we could actually act on the breach. 81 00:07:50,900 --> 00:07:56,000 So I don't think there is that early... within healthcare at the moment. 82 00:07:56,160 --> 00:08:03,720 I can use an example of a healthcare attack in South Africa itself, they only became aware of it once the systems were encrypted. 83 00:08:03,720 --> 00:08:05,860 And once you know, the damage has been done. 84 00:08:06,460 --> 00:08:13,780 So often, we have to rely on the cyber criminals to make us aware of their presence in our networks. 85 00:08:14,920 --> 00:08:17,700 It would be awesome if we could detect it early and stop it. 86 00:08:17,700 --> 00:08:19,060 I mean, that is the golden standard. 87 00:08:19,060 --> 00:08:20,180 That is the dream. 88 00:08:20,180 --> 00:08:21,880 But I don't think we're there yet. 89 00:08:22,880 --> 00:08:31,860 I think the real dream is being proactive about this, and getting the security on the device so it doesn't even get to the point of there being a vulnerability that has to be detected. 90 00:08:31,860 --> 00:08:38,400 If we can just reduce the end of things that need to be detected, there's a better probability of actually coming up with it. 91 00:08:39,160 --> 00:08:43,260 But is that going to actually be something that we're going to get? 92 00:08:43,260 --> 00:08:45,060 Because I mean, these devices last for long. 93 00:08:45,060 --> 00:08:48,040 So inevitably, there is going to be vulnerabilities always. 94 00:08:48,940 --> 00:08:57,220 It's going to be there because as time progresses, research is done, and libraries become vulnerable, or hardware becomes vulnerable. 95 00:08:57,440 --> 00:09:00,740 Also, it's about the threat landscape, right? 96 00:09:00,860 --> 00:09:02,380 We're talking about risk here. 97 00:09:02,380 --> 00:09:05,560 And just like everything in life, there's nothing, there's no such thing as risk-free. 98 00:09:05,560 --> 00:09:08,800 We can't just have a device that has security or doesn't. 99 00:09:08,940 --> 00:09:10,240 There's always pros and cons. 100 00:09:10,240 --> 00:09:12,480 We can't think of every possible thing. 101 00:09:13,000 --> 00:09:22,060 So it's always, it's this combination, right, of, you know, building the devices and making them as secure as we can in a reasonable amount of time with the resources we have. 102 00:09:22,060 --> 00:09:34,800 And then once they're out into, you know, the healthcare ecosystem or the consumer ecosystem, in the case of, you know, medical devices that maybe have to be on a home network, there's so many pieces to that threat landscape, right? 103 00:09:34,800 --> 00:09:40,560 I don't, like, I'm not sure how we can fully secure it. 104 00:09:40,560 --> 00:09:45,720 Like, there's no, there's no perfectly secure network, right? 105 00:09:47,320 --> 00:09:57,160 I also want to throw one other wrinkle into this, which is that there's actually some systemic, systematic issues when it comes to healthcare. 106 00:09:57,380 --> 00:10:09,360 Usually in hospitals, what's traditionally been the paradigm is that the network's owned by IT, and that's where all the security folks live, and they're able to detect kind of the attacks that they're used to, and they can control some of that. 107 00:10:09,360 --> 00:10:19,840 But as soon as it comes to the medical device side of it, they kind of wash their hands or are told, don't go there, that's bioengineering, and they handle all the medical devices. 108 00:10:19,880 --> 00:10:26,220 And so what you often have is a dearth of cybersecurity knowledge in the bioengineering space. 109 00:10:26,340 --> 00:10:40,460 By no fault of their own, they have a lot of other things, they're fantastic people, but what we have as a result of that is this something we call the discovery dilemma, where if you don't have people thinking about these issues, and you have malfunctioning medical devices, 110 00:10:40,460 --> 00:10:49,840 you are unlikely to find a problem, even if there was some random malware that spread over your network, it affected some of your medical devices, and as a consequence they stopped working. 111 00:10:49,840 --> 00:11:00,860 Unless you are thinking about that as a potential etiology of your problem, you're not going to go and look the one and two steps further to figure out if that was the issue. 112 00:11:01,000 --> 00:11:05,060 So we talked a little bit before this panel started about the discipline of forensics. 113 00:11:05,060 --> 00:11:19,420 I've asked many bioengineering organizations and groups and hospitals across the country and asked how many of them do that type of forensic work on malfunctioning devices that are just really out of the ordinary, and none of them said that they did. 114 00:11:19,420 --> 00:11:20,920 It's something we have to change. 115 00:11:20,920 --> 00:11:35,820 So it's because the structure of these healthcare systems in such a way where there's a bright line between who handles medical devices and who handles the network, and because those two groups don't co-mingle and have equitable cybersecurity knowledge where we might have this problem, 116 00:11:35,820 --> 00:11:39,660 where this might be a very common thing, but just we're not detecting it. 117 00:11:40,120 --> 00:11:55,900 So I don't know if you want to, if we're like looking to move on to the next question here, but one thing that I would point out on that, that I've certainly experienced, especially over the last couple of months, is we're, we have experienced, I would say, 118 00:11:55,900 --> 00:12:03,060 less and less medical device specific vulnerabilities where it's like the pacemaker has a vulnerability or the MRI has a vulnerability. 119 00:12:03,220 --> 00:12:06,940 What we're now seeing are like higher level protocol vulnerabilities. 120 00:12:08,300 --> 00:12:09,920 Swintooth was a great example. 121 00:12:09,920 --> 00:12:13,580 There was the, all of the, the whole run of Bluetooth vulnerabilities. 122 00:12:14,060 --> 00:12:15,580 There was the Ripple 20. 123 00:12:15,580 --> 00:12:22,940 There was the Trek, which I think was, was the one part or Trek TCP IP was one part of Ripple 20 or whatever it was. 124 00:12:23,020 --> 00:12:25,680 But anyway, these are things that are not medical device specific. 125 00:12:26,520 --> 00:12:30,400 But what we're starting to see, and it goes to the detection point. 126 00:12:30,400 --> 00:12:32,840 And then I wanted to hit on something that Vidya had said. 127 00:12:34,560 --> 00:12:46,800 The, the, almost the nice thing that's happening about the fact that we have general IT vulnerabilities that are now making their way into the medical device space or becoming relevant to the medical device space is other sectors are detecting them for us. 128 00:12:46,800 --> 00:12:56,840 So even though there's maybe a little bit of a lag in detection and in, I don't know, identification capability within the sector itself, because that expertise may exist in other sectors. 129 00:12:56,840 --> 00:13:02,520 And because we're all relying on the same software, the software that's in a medical device is the same that's in a consumer product. 130 00:13:02,520 --> 00:13:09,540 We're ending up still being notified and still being able to notify others because it's happening in other sectors. 131 00:13:09,780 --> 00:13:14,500 But the other thing, you know, Vidya had a good point about like, we need to, we need to lessen essentially the attack space. 132 00:13:14,800 --> 00:13:20,340 And certainly acknowledging the fact that V and Ash are both right, like things are always going to be vulnerable. 133 00:13:20,600 --> 00:13:27,480 Another thing that we've noticed is that we have an increasing number of manufacturers who will tell them about vulnerabilities. 134 00:13:27,780 --> 00:13:38,460 And especially with the Bluetooth ones, we have certain manufacturers who are like, oh yeah, but like the way we architected our system, like our device doesn't trust the Bluetooth that's built into the device. 135 00:13:38,460 --> 00:13:42,300 So all of these Bluetooth vulnerabilities don't impact us. 136 00:13:42,500 --> 00:13:50,320 And I think that that's sort of what Vidya was getting at is like, we can build systems that are not impacted by certain types of vulnerabilities. 137 00:13:50,320 --> 00:13:53,160 We just have to actually put in the work to do that. 138 00:13:55,060 --> 00:14:02,120 And I think, sorry, Ash and I had this conversation, right? 139 00:14:02,160 --> 00:14:13,420 Security, the way that you change security and manufacturing Ash was, right, we said it needs to be cheap and it needs to be easy and it needs to be accessible and it should be the easiest thing to do. 140 00:14:13,420 --> 00:14:17,040 It shouldn't be the hardest thing to do and it shouldn't be the most expensive thing to do. 141 00:14:17,040 --> 00:14:30,940 And when I refer to expensive, I don't necessarily mean in terms of cost, it could be time, it could be design, it could be research, it could be CPU, it could be battery life, right? 142 00:14:30,960 --> 00:14:46,280 But the thing is at this point, I don't think, you know, at that end of the pipeline, that is very easily accessible for the smaller companies, I'm not talking about your big companies, but your smaller ones that are doing some innovative work. 143 00:14:49,930 --> 00:14:53,450 All right, we have a new question from Judo. 144 00:14:53,450 --> 00:14:56,790 And I think that this is going to be one we can all kind of chime in on. 145 00:14:56,990 --> 00:15:08,630 It's, I think, boiled down to what are the steps that industry and I'm going to add regulators in the space are taking to formalize stricter risk and controls around device development that we use in patients. 146 00:15:08,790 --> 00:15:17,290 They assume that a larger device manufacturer formalized basic security features, just like the payment brands have done, and set standards for the rest of the industry. 147 00:15:17,290 --> 00:15:19,470 So I think there's a lot that's already been done. 148 00:15:19,470 --> 00:15:25,990 I just want to quickly reflect on that to say, you know, the conversations that we were having 10 years in this space, we're asking for this. 149 00:15:25,990 --> 00:15:31,130 And I feel like so much has changed between now and then where we, we do have a lot more standards. 150 00:15:31,270 --> 00:15:34,570 And I think that the industry is moving forward in a lot of ways. 151 00:15:34,570 --> 00:15:36,910 And we can still talk about some of the criticisms. 152 00:15:36,910 --> 00:15:43,870 But what I really think is a lot of people that have been paying close attention will say, yes, we saw the problem of legacy devices. 153 00:15:43,870 --> 00:16:00,050 But we, you know, I said it in the video, we don't have this year, to my knowledge, and there's still some time left, a story of a device manufacturer threatening to sue a security researcher, for example, or something like that, like WannaCry happened in 2017. 154 00:16:00,050 --> 00:16:03,870 So can everyone reflect on kind of what the industry has been doing ? 155 00:16:03,870 --> 00:16:12,350 And we can take it back a few years and give examples of some of the landmark documents and guidance that has come from the industry as well as the regulation space. 156 00:16:21,120 --> 00:16:23,820 Well, I can kick us off as the regulator. 157 00:16:24,980 --> 00:16:44,080 So I, you know, I think I was not at FDA, let me preface this by saying, when some of these documents came out, but the two in 2014, I want to say, there was, you know, one of the first drafts of a cybersecurity guidance, particularly cybersecurity guidance came out at FDA. 158 00:16:44,540 --> 00:16:47,960 A few years later, there was the postmarket cybersecurity guidance. 159 00:16:47,960 --> 00:16:55,400 And then in 2018, the most recent one, you know, there was the new postmarket draft. 160 00:16:55,400 --> 00:17:09,440 And this was the one that talked about coordinated disclosure, talked about cybersecurity bill of materials, it talked about a lot of the advancements that had been made in the sector over the past couple of years from the time that the guidance had been most recently updated. 161 00:17:09,700 --> 00:17:21,460 And actually, let me just really quickly, for those of you who don't know, is essentially how FDA tells industry, the best way to meet the regulations, because if you try and read FDA's regulations, they're pretty bare bones. 162 00:17:21,460 --> 00:17:23,900 It's pretty much like you must do risk assessments. 163 00:17:23,900 --> 00:17:27,780 But then like that, that's the end of the sentence, and it doesn't have any other detail. 164 00:17:27,780 --> 00:17:33,960 So the guidance allows FDA to elaborate a little bit more on what precisely that means in given contexts. 165 00:17:34,220 --> 00:17:37,740 And so, you know, credit to to Suzanne Schwartz and Dr. 166 00:17:37,740 --> 00:17:42,880 Seth Harmony, who was worked on a lot of this when he was still with the agency. 167 00:17:43,360 --> 00:17:50,680 You know, they actually like fought the good fight and got cybersecurity specific guidance out from the FDA to industry. 168 00:17:50,680 --> 00:18:00,680 And I think, you know, obviously, I'm biased here, but that was just a huge leap forward, I think, in many ways for, for not only us, but for the industry. 169 00:18:05,660 --> 00:18:23,940 Yeah, I think, to that point, I think there, the the conversation that's come from all of that initiative, right, you you have, you have this relationship that I think didn't exist before, even if we go back four or five years, like there wasn't such a collaboration or willingness to have manufacturers work with security researchers work with security vendors, 170 00:18:23,940 --> 00:18:24,180 right? 171 00:18:24,180 --> 00:18:26,760 It was more of Okay, who can get what off of eBay? 172 00:18:26,920 --> 00:18:31,400 What can we prove doesn't work and then try to try to get the best headline that we can get out of it. 173 00:18:31,400 --> 00:18:43,960 And I think the if you listen to the recorded version of this, there's a lot of hope that we all have for where this conversation is going, and that there are going to be solutions coming out of this, I think on on all sides that are actually sustainable and efficient. 174 00:18:45,920 --> 00:18:47,860 So I can add a positive story. 175 00:18:47,860 --> 00:18:57,020 So three years ago, I had my first DEF CON, came as a patient, had some concerns about my own device, it was, as I would say, beautifully broken and wonderfully flawed. 176 00:18:57,760 --> 00:19:00,440 And I made Suzanne Schwartz at that one. 177 00:19:00,440 --> 00:19:09,040 But except for that, before coming to DEF CON, I actually reached out to my manufacturer and had a discussion with him and I was met with legal. 178 00:19:09,760 --> 00:19:12,020 You know, it was like running into a wall. 179 00:19:12,060 --> 00:19:15,580 It was a cold, unloving situation. 180 00:19:16,300 --> 00:19:22,760 Three years later, I'm working with that same manufacturer on things that I bought to them three years ago. 181 00:19:23,420 --> 00:19:29,080 It took us since December to find a footing where, you know, the discussion is not incriminating. 182 00:19:29,080 --> 00:19:30,440 It's not me pointing a finger. 183 00:19:30,440 --> 00:19:31,640 It's not them pointing a finger. 184 00:19:31,640 --> 00:19:38,320 It's finding a unison and what they bring to the table, what I bring to the table and working together. 185 00:19:38,320 --> 00:19:41,400 But except for that, I mean, we had conversations. 186 00:19:41,400 --> 00:19:42,920 I've been on the patient. 187 00:19:44,360 --> 00:19:55,480 I don't know what the word is that you guys, that Jessica, that gave patients the opportunity to give their experiences, right? 188 00:19:56,660 --> 00:20:01,140 So generally in three years that I've been involved in this, we've made leaps and bounds. 189 00:20:01,700 --> 00:20:04,460 Is that necessarily enough yet? 190 00:20:04,460 --> 00:20:06,420 No, I don't think we should lose momentum. 191 00:20:06,420 --> 00:20:08,480 I think we should kick ass and keep going. 192 00:20:08,480 --> 00:20:10,140 I think we should push the envelope. 193 00:20:10,140 --> 00:20:12,420 I think we should have the hard conversations. 194 00:20:12,640 --> 00:20:14,660 And I don't think we should stop now. 195 00:20:19,200 --> 00:20:21,140 Yeah, I would agree. 196 00:20:21,140 --> 00:20:25,620 I think that the landscape is shifting really quickly. 197 00:20:25,940 --> 00:20:34,840 When I started working on medical devices, which was over five years ago, already the technology has changed so much. 198 00:20:34,840 --> 00:20:46,520 Even in the last 15 years, if you think about, you know, smartphones and, you know, 20 years ago, I don't think most of us would have predicted that ubiquitousness of it and the impact that it would have on our daily lives. 199 00:20:46,520 --> 00:21:01,760 And so, you know, historically medical devices were electromechanical and, you know, as medical device manufacturers, we come, we have a system about approaching things from a risk and from a safety perspective, like how do we make sure that people are safe? 200 00:21:01,900 --> 00:21:04,820 And a lot of medical devices didn't have software in them. 201 00:21:04,820 --> 00:21:10,080 And then we started putting software in and then we started connecting that software to the internet. 202 00:21:10,080 --> 00:21:21,340 And then all of a sudden the risk just blew open because now we can, we have , we have IOT devices, we have clinical IOT devices, we have medical IOT devices, we have implantable IOT devices. 203 00:21:21,600 --> 00:21:23,600 And so everything has been changing so fast. 204 00:21:23,600 --> 00:21:30,340 And I think, you know, getting regulatory and getting standards in place takes time. 205 00:21:30,540 --> 00:21:34,540 And, you know, especially from a software perspective, how many standards exist? 206 00:21:34,540 --> 00:21:39,000 Like we have so many standards in software that are competing standards. 207 00:21:39,000 --> 00:21:42,340 If everyone would just follow my standard, it would all be fine. 208 00:21:42,340 --> 00:21:47,160 But then there's 20 other people who also have a standard that they want everyone to follow. 209 00:21:47,160 --> 00:21:48,300 And so it's, you know, it's tough. 210 00:21:48,300 --> 00:21:51,180 It's like the wild, wild west for software, right? 211 00:21:51,260 --> 00:22:04,640 And so I've seen like a lot of these different groups coming together, you know, obviously FDA is a part of it, but, you know, you know, most of our customers are, they want to serve American markets. 212 00:22:04,640 --> 00:22:07,320 So we actually talk about FDA a lot every single day. 213 00:22:07,900 --> 00:22:10,700 But there is the rest of the world that isn't governed by the FDA. 214 00:22:11,480 --> 00:22:14,700 And so there's a lot of different bodies working together. 215 00:22:14,700 --> 00:22:16,660 And yeah, I see it as hopeful. 216 00:22:17,680 --> 00:22:24,760 I know IEEE is working on international standards for clinical IOT and medical devices and interoperability. 217 00:22:25,460 --> 00:22:30,300 And yeah, I think people are working on it, but I don't think we're there yet. 218 00:22:30,940 --> 00:22:31,740 Certainly. 219 00:22:32,380 --> 00:22:39,500 I actually have to jump on that because I think if I don't, one of my bosses is going to find me at home. 220 00:22:39,620 --> 00:22:46,800 But to the point about international regulation, there is a body called the International Medical Device Regulators Forum. 221 00:22:47,000 --> 00:22:51,300 And speaking of, you can never get government to do anything in any reasonable amount of time. 222 00:22:51,300 --> 00:22:54,180 That's just sort of a default law of the universe. 223 00:22:54,300 --> 00:22:58,500 But that group, which is a group of, it's like a nested group of regulators. 224 00:22:58,500 --> 00:23:01,980 So you would have thought that this would have taken significantly longer than it did. 225 00:23:02,040 --> 00:23:06,980 But they actually just came out with a cybersecurity guidance document. 226 00:23:07,360 --> 00:23:11,440 And so that's another thing that's been really valuable for us. 227 00:23:11,720 --> 00:23:14,040 And I would actually encourage everybody to go look at it. 228 00:23:14,040 --> 00:23:18,180 It's got a really fun definition of legacy that you all might have thoughts on. 229 00:23:18,180 --> 00:23:20,760 So anyway, IMDRF guidance. 230 00:23:25,220 --> 00:23:28,420 The only thing I can add is that we're never going to be done, right? 231 00:23:28,420 --> 00:23:40,080 So as much as we've progressed, and absolutely take a moment to recognize the accomplishments here, there's certainly a path that we need to continue pursuing in order to even maintain a baseline of security across the board. 232 00:23:41,280 --> 00:23:56,860 I think what I want to see, and this would make me like as a patient super happy, is if we had in the manufacturing, we had security standards for secure manufacturing, because it's one thing having a cybersecurity framework, right? 233 00:23:56,860 --> 00:23:58,700 Or a guidance in terms of that. 234 00:23:58,700 --> 00:24:09,280 But it's a different thing and having a standard for, you know, how we are going to securely manufacture these devices, because often than not, you know, hardware is the constraint. 235 00:24:09,300 --> 00:24:15,000 Because when we talk medical devices, we are designing, you know, firmware to run on hardware. 236 00:24:15,720 --> 00:24:26,020 So I think we need to, you know, completely start at the beginning, when they conceptualize the requirements is that we need to build security in there, right? 237 00:24:26,020 --> 00:24:33,660 It shouldn't be this, you know, after the fact, kind of like, let's put it on the end and, you know, hope for the best. 238 00:24:33,860 --> 00:24:42,880 And that's, you know, normally done, because we didn't consider it in the beginning, and it hasn't been in that, you know, that practice. 239 00:24:42,880 --> 00:24:46,300 But there are companies doing that, and that is changing. 240 00:24:46,920 --> 00:24:51,980 But you know, it's also been an industry that's been around for a very, very long time. 241 00:24:51,980 --> 00:24:56,340 And it's got some bad behavior and bad things that it's been doing. 242 00:24:56,340 --> 00:24:58,040 It's also got good things, right? 243 00:24:58,060 --> 00:25:01,140 I mean, how many lives have medical devices saved? 244 00:25:01,140 --> 00:25:02,940 I mean, you're always focusing on the negative. 245 00:25:02,940 --> 00:25:04,700 I mean, I wouldn't be here. 246 00:25:04,960 --> 00:25:06,680 I would have died at 19. 247 00:25:07,300 --> 00:25:14,680 I'm not much older, I'm not going to tell you my age, but you know, so I mean, So Vi, are you saying, are you saying push left? 248 00:25:14,680 --> 00:25:15,980 Is that the summary of what you're saying? 249 00:25:15,980 --> 00:25:19,580 Yes, I think you and I said that, let's push all the way left, right? 250 00:25:19,580 --> 00:25:21,480 Let's not do this at the end. 251 00:25:22,000 --> 00:25:25,380 I've worked with the developers and the engineers, right? 252 00:25:25,380 --> 00:25:27,980 You know, everyone thinks like security is the answer. 253 00:25:27,980 --> 00:25:30,260 You want to change this shit? 254 00:25:30,400 --> 00:25:35,720 Get them to start doing with security in mind, and you know, you're not going to deal with future problems. 255 00:25:35,740 --> 00:25:45,160 I literally have found that security and forensics forms part of hardware engineering and forms part of software development and firmware design. 256 00:25:45,160 --> 00:25:53,380 You know, it just, there's this synergy when we start working as a team and as a collective instead of, you know, silos. 257 00:25:53,460 --> 00:25:59,180 And I know there's people that are going to argue the silos are good because everyone needs to focus on the independent thing. 258 00:25:59,240 --> 00:26:06,820 But when we bring different minds together, that's when we start seeing things come together in a different way. 259 00:26:06,820 --> 00:26:11,620 And I think that's going to be the answer, is working together instead of against each other. 260 00:26:11,820 --> 00:26:14,420 And, you know, that multidisciplinary approach. 261 00:26:14,420 --> 00:26:15,620 Because we're not all experts. 262 00:26:15,620 --> 00:26:19,540 I mean, I shouldn't be doing any hardware design. 263 00:26:19,640 --> 00:26:21,240 It will break. 264 00:26:21,360 --> 00:26:23,140 You know, that's not my speciality. 265 00:26:23,140 --> 00:26:29,520 But I can tell you from a security and a logging perspective or forensics perspective what would work. 266 00:26:30,400 --> 00:26:34,140 So I think we need to get that multidisciplinary approach. 267 00:26:35,040 --> 00:26:36,420 All right. 268 00:26:36,880 --> 00:26:42,880 Iona, go ahead and get our next question kicked off by Ken in the DEF CON Discord. 269 00:26:42,880 --> 00:26:44,660 He says there's been a lot of progress in the last five years. 270 00:26:44,660 --> 00:26:48,700 I think we've all talked about the optimism that we've had, you know, guarded optimism. 271 00:26:48,920 --> 00:26:51,720 But there's still problems with smaller device manufacturers. 272 00:26:51,720 --> 00:26:53,040 There's problems with smaller hospitals. 273 00:26:53,040 --> 00:26:54,360 How do we motivate them? 274 00:26:54,580 --> 00:26:56,180 How do we get them to do the right thing? 275 00:26:56,480 --> 00:27:06,620 And I think, Ash, on the recorded talk, you had, you know, talked about how that's a big part of medical device development are kind of these smaller boutique consultant shops like your own. 276 00:27:08,020 --> 00:27:10,600 Yeah, I wish I had a I think that's a fantastic question. 277 00:27:10,600 --> 00:27:12,220 I have that question every day. 278 00:27:12,360 --> 00:27:14,800 How do we how do we motivate them? 279 00:27:14,800 --> 00:27:18,020 How do we make the how do we get there, right? 280 00:27:18,020 --> 00:27:21,300 Because we've got constraints on lots of sides. 281 00:27:21,340 --> 00:27:34,160 And, you know, at the end of the day, you know, most of the people who are working on this, we are really passionate about the end patients, especially, you know, some of the smaller shops, like everyone that I work with actually cares about the patients. 282 00:27:34,500 --> 00:27:43,340 And a lot of our clients are doctors who have an idea for some medical device that they think will save lives, and they only have so much budget. 283 00:27:43,340 --> 00:27:44,940 So, yeah, how do we motivate them? 284 00:27:44,940 --> 00:27:47,160 I think I think everyone is motivated. 285 00:27:47,780 --> 00:27:51,260 Or at least for some of the smaller ones. 286 00:27:51,620 --> 00:28:10,520 We are motivated how to actually get there, how to implement how to how to communicate to clients, and even to other engineers about what the risks are with software, because sometimes, again, we're so used to see thinking about things as, you know, electromechanical device, 287 00:28:10,520 --> 00:28:22,040 you know, we think about safety is like, the lock on the door, you know, people who aren't in software all the time, people who don't come from a security background, they don't think about all the creative ways, they just kind of think, well, this is secure, 288 00:28:22,040 --> 00:28:23,300 we put a lock on it. 289 00:28:24,380 --> 00:28:29,440 You know, it's like, I put my phone into a little like box, and then I put a lock on it, how could it not be secure? 290 00:28:29,440 --> 00:28:34,940 Well, because I can connect to your phone through Wi Fi, and then exploit it somehow, right? 291 00:28:34,940 --> 00:28:37,700 Like, so it's not actually immediately obvious to a lot of people. 292 00:28:37,700 --> 00:28:49,020 So then, when you're trying to, you know, trying to set up a project and talking about budget, and how much time we allocate, and, you know, what, what sort of security things do care about? 293 00:28:49,040 --> 00:28:51,460 And, you know, everything is pulled in all these directions. 294 00:28:51,460 --> 00:28:56,160 So I, I don't have an answer for how to balance all of those perfectly. 295 00:28:56,160 --> 00:28:58,240 I think we're trying to do that every single day. 296 00:28:58,400 --> 00:29:00,400 But I think it's a really great question. 297 00:29:00,520 --> 00:29:02,460 And I think we should keep asking it. 298 00:29:04,280 --> 00:29:06,460 Yeah, that's what I have to say. 299 00:29:12,330 --> 00:29:14,350 I think the phone's a great analogy. 300 00:29:14,350 --> 00:29:15,950 Sorry, just two seconds here, right? 301 00:29:15,950 --> 00:29:23,270 I think that the fact that you bring up this notion of, okay, people understand security on a phone, and they say, I'm comfortable that my iPhone is going to do this. 302 00:29:23,270 --> 00:29:25,170 And I know Bea and I had this conversation. 303 00:29:25,170 --> 00:29:34,770 But how do we translate that into the expectation that a medical device will be secure in and of itself, independent of how it's going to connect to whatever the clinical care is? 304 00:29:34,770 --> 00:29:48,190 And I think part of it is, we have to be fair to all these clinical innovations that are really trying to bring something to the patient experience and change it for the better, and not try to force them to become cybersecurity experts. 305 00:29:48,190 --> 00:29:54,730 There has to be a way for us to enable them to get there without having to become pros at cybersecurity. 306 00:29:55,330 --> 00:29:57,830 I will say, though, and I have to say it. 307 00:29:57,830 --> 00:29:58,650 Sorry, everyone. 308 00:29:58,650 --> 00:30:00,170 I think I disappeared for a moment. 309 00:30:00,170 --> 00:30:03,130 My computer decided it didn't want to be part of this panel anymore. 310 00:30:05,090 --> 00:30:07,650 So there is pre-market guidance. 311 00:30:07,690 --> 00:30:14,930 And the current version is not nearly as detailed as I think some of the things that we're working on now. 312 00:30:15,210 --> 00:30:21,690 But to get on the market, medical devices have to go through the FDA in most cases. 313 00:30:21,690 --> 00:30:23,510 I'm not going into the class system. 314 00:30:23,510 --> 00:30:24,770 None of us need that. 315 00:30:25,010 --> 00:30:31,190 But if they're going to have software and other things like that, chances are they have to get pre-market approval to even go on the market. 316 00:30:31,190 --> 00:30:42,750 And so to a certain extent, they have to demonstrate through FDA, whatever the device is, however small the manufacturer is, that they have provided reasonable assurance of safety and effectiveness. 317 00:30:42,750 --> 00:30:46,230 And we check for cybersecurity concerns. 318 00:30:46,230 --> 00:30:50,130 I think I made some clever comment about Matt being my elementary school best friend. 319 00:30:50,130 --> 00:30:54,930 But Matt is the lead for a lot of the cybersecurity reviewers at FDA. 320 00:30:54,930 --> 00:30:59,530 And like I said in the recording, we're getting better at that every day. 321 00:30:59,530 --> 00:31:08,830 But this is something where FDA is rightfully by statute, by law, the gatekeeper of what can and can't be put on the market. 322 00:31:08,830 --> 00:31:15,470 And so I think, you know, for better or worse, you can argue whether or not it's good or bad that we're doing what we're doing. 323 00:31:16,730 --> 00:31:19,590 The smaller manufacturers still have to go through us. 324 00:31:19,870 --> 00:31:22,090 So there is still going to be that part of it. 325 00:31:23,930 --> 00:31:31,110 I also just want to say, we had talked multiple times about how you have to make security the easy thing to do. 326 00:31:31,270 --> 00:31:38,890 And for some of these rural access hospitals, smaller organizations, they're just not going to be able to do the job right. 327 00:31:39,070 --> 00:31:47,930 And so I think collaboration, I've said this a couple times, there shouldn't be a competitive advantage in cybersecurity when it comes to hospitals, right? 328 00:31:47,930 --> 00:31:57,490 So you shouldn't see a billboard as you drive down the street that says, you know, when you have your heart attack, come to hospital A because we didn't get hacked last year like hospital B did, right? 329 00:31:57,490 --> 00:31:59,530 So that shouldn't be like that. 330 00:31:59,530 --> 00:32:09,270 And I think, luckily, there's been a lot of momentum towards collaboration, information sharing, through a lot of these organizations and bodies we've already talked about. 331 00:32:09,270 --> 00:32:20,990 But, you know, what was an alien concept to hospitals five years ago is probably not that crazy now, which is, hey, if we get hit with ransomware, you know, we're going to go through our protocol of incident response. 332 00:32:20,990 --> 00:32:21,590 And guess what? 333 00:32:21,590 --> 00:32:27,910 I'm going to call the CISO at competitor hospital B and let them know this happened to us. 334 00:32:27,910 --> 00:32:29,170 And did you see anything? 335 00:32:29,230 --> 00:32:30,030 Collaborate. 336 00:32:30,150 --> 00:32:39,950 What normally was a very, we're not going to share, we're not going to talk, we're not going to collaborate in the space, has clearly gone out the window for some of the more forward thinking organizations. 337 00:32:39,950 --> 00:32:41,590 Now, let's take that information. 338 00:32:41,670 --> 00:32:54,790 For example, all the great work that larger organizations have done, like Mayo, looking at particularly secure devices compared to others, share that information with other rural hospitals, so they don't have to go and reproduce all that work from scratch, 339 00:32:54,790 --> 00:32:56,030 they're doing that. 340 00:32:56,290 --> 00:32:58,810 Being able to share in that space is so, so key. 341 00:32:58,810 --> 00:33:01,710 So let's not reinvent the wheel at every single hospital. 342 00:33:01,710 --> 00:33:09,870 Let's not try to build gigantic teams that do vulnerability testing, penetration testing on every medical device and reproduce that work time and time again. 343 00:33:09,870 --> 00:33:11,390 Instead, it's a community. 344 00:33:11,390 --> 00:33:16,450 We got to recognize that it doesn't follow the same competition that you normally would where you're not sharing. 345 00:33:16,450 --> 00:33:17,390 This is a different world. 346 00:33:17,390 --> 00:33:19,010 This is about patient safety, though. 347 00:33:19,030 --> 00:33:20,650 We all have to be on the same page. 348 00:33:22,210 --> 00:33:26,310 Yeah, but I mean, I'm going to say something that's going to be very unpopular, right? 349 00:33:26,310 --> 00:33:30,510 If you take a medical device, functional requirement is not security. 350 00:33:30,510 --> 00:33:35,150 Functional requirement is keeping someone alive or healthcare, right? 351 00:33:35,150 --> 00:33:41,910 We need to understand that because we are superimposing security onto these devices when that's not their main functionality. 352 00:33:42,250 --> 00:33:46,730 Yes, as they advance, they are connected and they need to be secure. 353 00:33:46,730 --> 00:33:53,590 But I don't think we should solely focus on having such secure devices that might just never see the, market. 354 00:33:53,590 --> 00:33:56,010 They might never save their life. 355 00:33:56,010 --> 00:33:58,610 That one patient's life that they can change. 356 00:33:58,610 --> 00:34:08,950 I think we should never lose sight of what the purpose of these devices are when we try and attempt the security implementations onto them. 357 00:34:14,390 --> 00:34:15,130 Awesome. 358 00:34:15,130 --> 00:34:15,510 All right. 359 00:34:15,510 --> 00:34:19,830 We're going to go to the next question here. 360 00:34:19,830 --> 00:34:23,370 This is from Synapsys. 361 00:34:24,230 --> 00:34:41,510 Questions about where the industry is going insofar as what are the new, and perhaps we can even talk about the pre-market guidance in this regard, like what types of requirements are we going to be putting into some of these new devices as they go for approval to push that forward? 362 00:34:41,510 --> 00:34:48,050 To perhaps, of course, always respect that these devices are security, or sorry, that was not a slip, I promise. 363 00:34:48,090 --> 00:34:51,850 They're medical devices meant to help patients, but they have to be secure. 364 00:34:51,950 --> 00:35:01,190 Are we going to be deploying things like stack protection, ASLR, DEP, and other things like modern, like language changes that have better security kind of baked in from the start? 365 00:35:01,190 --> 00:35:12,270 Are we seeing trends in this space towards utilizing more secure tools and development of these medical devices so that they are less prone to some of the scary vulnerabilities we've seen in legacy devices? 366 00:35:13,250 --> 00:35:18,090 So I think you called me out there a little bit with the cybersecurity guidance. 367 00:35:18,090 --> 00:35:29,270 So yes, you know, I think I had made the comment earlier that the FDA, the actual regulation parts of FDA's regulations are pretty high level. 368 00:35:29,270 --> 00:35:36,890 I really would be amused if any of you were like that motivated to go look at literally the code for federal regulations and go look at our regulations. 369 00:35:36,890 --> 00:35:38,450 They're very dry. 370 00:35:38,830 --> 00:35:45,530 And then you have guidance, and then you have what companies are actually doing to meet the guidance or to meet regulations. 371 00:35:45,890 --> 00:35:56,190 And I think from the FDA standpoint, it would help no one if we picked like the one way of doing security to rule them all and then told all the manufacturers that they have to do that one thing. 372 00:35:56,550 --> 00:36:07,930 So instead, essentially, what we've we have been communicating to them, and we continue to work with manufacturers on and continue to work with our own internal processes on is essentially saying like, you need to have a secure architecture. 373 00:36:08,090 --> 00:36:10,450 We're not going to tell you what the architecture looks like. 374 00:36:10,510 --> 00:36:12,510 But you need to, it needs to be secure. 375 00:36:12,510 --> 00:36:17,150 And you need to be able to produce the documentation to us that proves and validates that it's secure. 376 00:36:17,510 --> 00:36:19,790 You need to have security controls that are the same thing. 377 00:36:19,790 --> 00:36:23,290 You need to be able to not only have them, you need to prove that they work. 378 00:36:24,030 --> 00:36:33,490 And so and then but but then at that point, it's sort of like and it's now the ball is in your courts, manufacturers, you tell us what your security controls are, you tell us what your secure architecture is. 379 00:36:34,890 --> 00:36:51,650 Because I think like going down into the the ASLR level and things like that, to V's and Asher's and videos and some of the other points that have been raised, each individual medical device is very unique, you know, the things that you're going to do to secure drug infusion pump are not going to be the things that you're going to do to secure an MRI. 380 00:36:52,230 --> 00:37:07,670 And so we do need to have that flexibility built into the regulations built into the guidance, so that, you know, we can we can allow the manufacturers to figure out, you know, what is the best, most efficient way to secure the device to V's point that we don't, 381 00:37:07,670 --> 00:37:17,250 you know, impose such rigid constraints on it that certain devices just can never meet them, you know, maybe they can do something else. 382 00:37:17,250 --> 00:37:18,710 So that's what I would say. 383 00:37:23,440 --> 00:37:25,020 Didn't mean to call you out. 384 00:37:25,020 --> 00:37:27,260 I just think it's such a great segue. 385 00:37:27,740 --> 00:37:29,560 All right, who's up on that question? 386 00:37:29,560 --> 00:37:33,420 So I mean, you had mentioned Ash, like how much things are changing? 387 00:37:33,420 --> 00:37:38,760 And do you see trends towards more kind of baking in these controls from the start? 388 00:37:38,760 --> 00:37:40,960 And do you see exciting trends emerging? 389 00:37:42,980 --> 00:37:46,480 I mean, I think I agree with what Jessica said, I think. 390 00:37:48,540 --> 00:37:55,600 I'm not sure, you know, I come from software and engineering development background, and I'm learning more and more about security. 391 00:37:55,600 --> 00:38:00,000 But so traditional security controls, I don't have a huge history with that. 392 00:38:00,000 --> 00:38:02,520 But I think every device is really different. 393 00:38:02,520 --> 00:38:17,700 And from security perspective, or from a safety perspective, we make sure that the device is secure, so that it provides safety, so that patient outcomes are, are successful or positive, right? 394 00:38:17,700 --> 00:38:19,340 Every device is different. 395 00:38:19,340 --> 00:38:26,560 I think that more people are learning more people are like me, there's more engineers who care about the security part. 396 00:38:26,560 --> 00:38:32,180 And, you know, obviously, with FDA and guidances, and with regulatory, we have to meet standards. 397 00:38:32,700 --> 00:38:34,060 That's absolutely correct. 398 00:38:34,060 --> 00:38:38,160 How we choose to meet those standards is up to each manufacturer. 399 00:38:38,160 --> 00:38:41,860 So we have an internal process of how we approach that. 400 00:38:41,860 --> 00:38:47,160 At the end of the day, you know, it's, it's literally different every time we make a device. 401 00:38:47,160 --> 00:38:50,840 So we're different too, because we are a consulting firm. 402 00:38:50,840 --> 00:38:58,300 So we make a lot of different devices, we have no, we have none of our own in house products that we are continually sort of like, building. 403 00:38:59,300 --> 00:39:04,540 So every, every device is unique, and it has a unique solution has unique architecture. 404 00:39:04,820 --> 00:39:12,700 And as technology is changing as Wi Fi's in everything now, more and more and more. 405 00:39:12,800 --> 00:39:14,840 Yeah, I mean, we're using different approaches. 406 00:39:14,840 --> 00:39:20,100 Yes, we have to make more, we have to have a bigger focus on security because of that. 407 00:39:20,100 --> 00:39:27,800 But, but I think it's just we're just following the trends with technology itself. 408 00:39:33,830 --> 00:39:39,850 Yeah, the only thing I'd add there is I think there are there are a variety of ways to approach it. 409 00:39:39,850 --> 00:39:46,750 And we have to absolutely keep patient care at the center of it to make sure we don't introduce new problems by trying to solve the security problem. 410 00:39:47,890 --> 00:40:00,030 But I think there's there's a fundamental expectation now that there is security built into this, it's not something that can be bolted on afterwards, where we're seeing the narrative more and more that it has to be part of the initial requirements discussion, 411 00:40:00,030 --> 00:40:03,210 it has to be part of how the device is going to connect how it's going to be patched. 412 00:40:03,230 --> 00:40:17,110 If we don't think about it from the onset of these fundamental architecture decisions, I think we'll we'll continue to have this problem of trying to solve the quick regulation question that came back and try to get it through so it so it can get to the hospitals. 413 00:40:19,130 --> 00:40:20,270 No, definitely. 414 00:40:20,270 --> 00:40:31,410 I don't think we can get to a granular level that we can start dictating architecture, because again, those things depend on the type of device and the requirements that you need the device to fulfill. 415 00:40:32,010 --> 00:40:35,350 But I am looking forward to better guidances. 416 00:40:35,350 --> 00:40:41,790 And yes, I was that boring person that went and read that because I wanted to understand our pre-market post-market book. 417 00:40:41,790 --> 00:40:56,390 But after some discussions with Jessica and Suzanne, I'm excited to see the new ones coming out and the more robust nature of them because we are moving towards a place where we are going to be enforcing better manufacturing. 418 00:40:59,020 --> 00:41:05,740 So let's transition to our next question into a little bit outside the medical device space and more into the hospital. 419 00:41:05,740 --> 00:41:12,340 Ken brings up another question about who's keeping the hospitals in line? 420 00:41:12,340 --> 00:41:19,720 Meaning the Joint Commission is, and there's a couple other bodies, are the ones that accredit hospitals. 421 00:41:19,720 --> 00:41:27,880 So when you go by a hospital, and they can be a hospital, some type of regulatory body has to make sure that they are to meet certain standards. 422 00:41:27,880 --> 00:41:30,460 The Joint Commission is probably the most famous one of those. 423 00:41:30,460 --> 00:41:36,640 And so a lot of what we talk about on the hospital side actually would never be FDA jurisdiction. 424 00:41:36,640 --> 00:41:38,780 Those are medical devices in their approval. 425 00:41:38,980 --> 00:41:44,700 This is the Joint Commission's probably space or other organizations that accredit hospitals. 426 00:41:44,700 --> 00:41:50,100 So the question that Ken poses is, you know, has the Joint Commission jumped in here? 427 00:41:50,100 --> 00:41:55,980 And how do we make sure that hospitals do what they're supposed to do? 428 00:41:55,980 --> 00:42:07,900 We've talked at length about how we can do better with medical devices, but I think we need to start moving also into the space of, like, hospitals need to be held accountable in some cases, and in accordance to what they're able to do. 429 00:42:07,900 --> 00:42:22,380 But we need to move that needle as well, because we've all heard stories of devices with certain security controls from the manufacturers that get turned off, or aren't deployed appropriately, or deployed on horribly secured networks at hospitals. 430 00:42:22,380 --> 00:42:26,820 And so part of the responsibility has to be this multiple people, right? 431 00:42:26,820 --> 00:42:29,960 How do we get hospitals to do the right thing? 432 00:42:30,020 --> 00:42:36,200 Knowing that, especially in times like COVID, it's not going to be the place they're going to be putting their resources in, right? 433 00:42:36,200 --> 00:42:38,440 They're worried about their ventilators in the ICU. 434 00:42:38,440 --> 00:42:42,440 They're not necessarily worried about this problem right now. 435 00:42:42,440 --> 00:42:47,280 Is there a way that we can move forward and make sure hospitals do the right thing? 436 00:42:51,400 --> 00:42:52,960 To be flippant, but like, do we? 437 00:42:52,960 --> 00:43:00,860 I feel like there's such a burden here that we're trying to historically pass on to hospitals that maybe was unfair, right? 438 00:43:00,860 --> 00:43:08,340 Like, yes, hospitals, if they're told in a user guide that they need to have certain controls in place, and they didn't, sure, there's something there. 439 00:43:08,340 --> 00:43:09,840 There's a flaw there in the plan. 440 00:43:09,840 --> 00:43:19,900 But at the same time, is it a fair expectation for a device vendor to say, okay, we want you to have these 32 different controls in place, times a hospital having a bunch of different vendors? 441 00:43:19,900 --> 00:43:22,380 Like, I think there's a balance there. 442 00:43:22,380 --> 00:43:30,380 So I think, yes, you have to enable hospitals to be more successful in having some of the basic security in place. 443 00:43:30,380 --> 00:43:34,220 But I think it's also somewhat unfair to place the onus on them so much. 444 00:43:36,660 --> 00:43:39,680 Yeah, I mean, I think I could just share something. 445 00:43:39,740 --> 00:43:42,460 You know, we talk all the time about shared responsibility. 446 00:43:42,460 --> 00:43:47,780 And actually, Christian, thank you so much for pointing out that FDA does not actually regulate hospitals. 447 00:43:48,100 --> 00:43:54,320 Because I think sometimes people forget that we actually have a very small slice of the pie. 448 00:43:54,320 --> 00:43:59,820 And we like to think we're very effective, whether or not we are, as I suppose, for debate from others. 449 00:43:59,820 --> 00:44:03,100 But, you know, that's not something we have any control over. 450 00:44:03,360 --> 00:44:09,000 But, you know, there are multiple federal agencies and state-level agencies. 451 00:44:09,000 --> 00:44:19,320 And actually, that's part of the problem, is the sheer number of regulators who are active in this space, who may or may not have harmonized regulatory requirements that hospitals are expected to meet. 452 00:44:19,700 --> 00:44:22,080 You know, that's challenging enough as it is. 453 00:44:22,080 --> 00:44:26,140 But something that Vidya said I wanted to hit on, because we were... 454 00:44:26,940 --> 00:44:43,440 one of these, you know, public-private partnership bodies that I'm a part of, we were recently talking, and one of the core CISOs was like, I have a spreadsheet of 400 different websites that I have to continually check to figure out what updates I need to make to all of the different devices that I have. 455 00:44:44,100 --> 00:44:51,340 And it's not something where, you know, they're not always getting active notification from the vendors as, like, you should go check one of these 400 websites. 456 00:44:51,420 --> 00:45:03,300 And there's just, it seems, you know, almost an infinite variety of procedures that each individual manufacturer can try and impose on a given hospital, and that just can add up so fast. 457 00:45:04,380 --> 00:45:08,480 So, you know, in that sense, like, there are certainly things that we can do better. 458 00:45:10,420 --> 00:45:16,120 I don't know necessarily that punishment is always the way to go with that. 459 00:45:16,120 --> 00:45:28,160 You know, I don't know how many of you know about the Office of Civil Rights wall of shame, but literally if you have a breach of more than 500 people, or at least this was the way that it was a couple of years ago, you go up on a portion of HHS's website with, 460 00:45:28,160 --> 00:45:32,480 like, your name, and how many records were breached, and how you got breached, and etc. 461 00:45:32,480 --> 00:45:33,020 etc. 462 00:45:33,900 --> 00:45:48,620 And it's not exactly the most helpful way to do it, because you also get fined in that case, which is then, that's resources that you have now lost, that you then cannot put towards your security, because you just had to pay it, you know, to somebody else. 463 00:45:48,620 --> 00:46:06,260 And so, you know, there's, I think, and this is, these are conversations that happen at the federal government level all the time, is like, how do we, how do we regulate, holistically, how do we regulate in such a way that, you know, we are, we are helping the industry move forward, 464 00:46:06,260 --> 00:46:11,460 rather than, you know, continuing to perpetuate some of the problems that we see? 465 00:46:13,280 --> 00:46:20,800 I want to touch on that, because this is something that is really near and dear to my heart, is hospitals. 466 00:46:21,180 --> 00:46:28,600 And the one thing that I've realized is we've created this, this shameful thing of finger-pointing when a hospital gets breached, right? 467 00:46:29,500 --> 00:46:35,300 Where we make it this negative connotation that they don't want to come out and say, hey, we've been breached, we need help. 468 00:46:35,320 --> 00:46:44,420 We've made it impossible for them to turn to the security industry and ask for help, because we shame them when they have been breached, right? 469 00:46:44,420 --> 00:46:50,560 When they are having to deal with medical care and then sophisticated attacks from cybercriminals. 470 00:46:50,560 --> 00:46:59,900 You know, and on top of that, implementing different patches and different software updates, different systems, and now how they're going to connect all these things up. 471 00:47:00,060 --> 00:47:06,500 I think we are expecting them to take ownership and accountability for things that aren't theirs to do. 472 00:47:07,000 --> 00:47:11,180 And then still, we punish them for not being able to do it. 473 00:47:11,240 --> 00:47:17,700 It's a very negative connotation to, you know, we need help. 474 00:47:19,960 --> 00:47:21,180 I agree. 475 00:47:21,180 --> 00:47:26,540 I don't think punishment is necessarily the right way, but I think that they're not being punished. 476 00:47:26,540 --> 00:47:34,420 The only hammer that really they pay attention to is HIPAA, because it's tied to a fine and an embarrassment on a wall. 477 00:47:35,080 --> 00:47:42,960 There isn't really, for example, rural hospitals, AIDS gets owned and there isn't a HIPAA breach. 478 00:47:42,960 --> 00:47:44,440 No one knows about that. 479 00:47:44,440 --> 00:47:51,780 And there is likely going to be little remediation efforts, probably because they've been owned for years and they don't even know. 480 00:47:51,780 --> 00:48:06,600 What I'm trying to say is that I don't think we should shame hospitals, but the status quo is likely untenable for a long term, because there is an increasing attack surface. 481 00:48:06,600 --> 00:48:09,360 There's less resources being put into this. 482 00:48:09,360 --> 00:48:27,980 And then on top of it, there's just, it's going to have to be looked at in some way, because we can't have the most secure medical devices on the planet with phenomenal protections, and then put on networks that no one cares about, or that no one's doing a good job at securing because there isn't that pressure. 483 00:48:27,980 --> 00:48:30,000 So how do you incentivize the hospitals? 484 00:48:30,000 --> 00:48:38,240 Do you say, for example, we're going to give you 0.25% more on your Medicaid reimbursement if you meet these cybersecurity requirements, right? 485 00:48:38,240 --> 00:48:45,240 Are you going to say we're going to cut your reimbursement from insurance claims on this if you don't meet these requirements? 486 00:48:45,240 --> 00:48:51,060 Is the joint commission going to say, hey, we're not going to credit your hospital unless you meet these requirements? 487 00:48:51,180 --> 00:48:56,260 These are the questions we should be talking about, whether or not it's a carrot or a stick. 488 00:48:56,260 --> 00:48:57,620 This is how we're going to have to figure it out. 489 00:48:57,620 --> 00:49:08,660 But what I do know is, you can look at many different healthcare organizations across the globe, and know that that's just, we can't keep going in that realm, because the patient information is just too valuable. 490 00:49:08,660 --> 00:49:13,620 And the risks of compromises to these networks are just too great for patient safety. 491 00:49:13,700 --> 00:49:16,740 And so we have to have that conversation sometime. 492 00:49:17,560 --> 00:49:26,320 Again, I don't want to shame anybody, but we have to do better on all fronts of this, because if you just secure one side, our patients are still vulnerable on the other side. 493 00:49:26,320 --> 00:49:28,060 It's really got to circle the wagons. 494 00:49:28,060 --> 00:49:29,440 Everyone's got to get on board. 495 00:49:30,700 --> 00:49:32,080 I think to your point, right? 496 00:49:32,080 --> 00:49:38,640 I think cybersecurity in healthcare was defined as HIPAA for the longest period of time, and nobody ever connected it to patient safety. 497 00:49:38,640 --> 00:49:48,580 So I think that's why there is disincentive, but in absence of an incentive for a hospital to really build security beyond just what the UCR is going to find them for. 498 00:49:50,860 --> 00:49:55,860 It's a change of how they perceive security, right? 499 00:49:56,200 --> 00:50:00,120 Cybersecurity is always the stick that's beating you, that's saying you need to do X, Y, and Z. 500 00:50:00,160 --> 00:50:05,740 It's never the thing, well, if you don't do this, this is what's going to happen, and it's going to impact your patients. 501 00:50:05,920 --> 00:50:08,080 I think we need to change the narrative. 502 00:50:08,640 --> 00:50:17,180 And the way that we approach this is by getting the hospitals to believe that this is the best for their patients. 503 00:50:17,980 --> 00:50:24,060 This is not just something that needs to be done because HIPAA says so, or any other organization says so. 504 00:50:24,060 --> 00:50:30,280 I don't know the Joint Commission, and I'm going to be honest with you, I don't follow that because I'm not from the US. 505 00:50:31,040 --> 00:50:44,940 But I do feel that if you change the way security is perceived within a hospital, and you make it more patient safety, you will see people change the way that they approach the problem. 506 00:50:48,890 --> 00:50:49,570 You're absolutely right. 507 00:50:49,570 --> 00:50:50,950 And I think there's a balance there, right? 508 00:50:50,950 --> 00:50:55,770 We don't want people declining clinical care because they now understand the potential risk. 509 00:50:55,770 --> 00:50:57,610 But I absolutely think you're right. 510 00:50:57,750 --> 00:51:01,990 The focus here should always be about the patient safety that we're trying to ensure collectively. 511 00:51:04,250 --> 00:51:07,090 I mean, COVID's kind of broken the perimeter, right? 512 00:51:07,730 --> 00:51:11,290 It's, I mean, they are sending home monitors. 513 00:51:11,290 --> 00:51:14,170 I mean, which angle do you defend from? 514 00:51:14,250 --> 00:51:16,250 Where is our perimeter at the moment? 515 00:51:16,250 --> 00:51:23,110 I think it's just, we're going to have to rebuild healthcare, I think, after COVID globally. 516 00:51:23,350 --> 00:51:26,750 And that's an opportunity to do things different, right? 517 00:51:26,750 --> 00:51:36,390 We now have a way to move forward positively without having to reinvent the wheel because the wheel's kind of broken down now. 518 00:51:37,510 --> 00:51:40,030 So I see the positive in that as well. 519 00:51:40,990 --> 00:51:43,510 And I'm excited for it, personally. 520 00:51:44,630 --> 00:51:46,730 All right, everybody, we're going to have to wrap up here soon. 521 00:51:46,730 --> 00:51:51,990 But I want to give everyone an opportunity to just say where they're going to go party after this Q&A. 522 00:51:51,990 --> 00:51:53,730 So I'm going to start off with Jeff. 523 00:51:54,130 --> 00:51:55,290 Where are you going to party? 524 00:51:56,110 --> 00:51:58,230 His internet is having a seizure, he told me. 525 00:51:58,230 --> 00:51:59,910 So I'm not sure if he'll be able to respond. 526 00:51:59,910 --> 00:52:01,230 He's going to go party with me, I bet. 527 00:52:01,230 --> 00:52:02,670 Yeah, somewhere with better... 528 00:52:04,590 --> 00:52:07,130 He's going to go to Starbucks and steal some internet. 529 00:52:07,130 --> 00:52:09,510 Ash, where are you going to go party after this Q&A? 530 00:52:10,750 --> 00:52:19,410 I'm going to open the new record player that I got that arrived in the mail today and set it up and probably party here. 531 00:52:19,550 --> 00:52:21,530 V, where are you going to go party after this? 532 00:52:22,170 --> 00:52:25,870 It is 6am, so I am going to go party at Club Duvet. 533 00:52:25,870 --> 00:52:29,050 It is a very, very, very warm, toasty club. 534 00:52:29,050 --> 00:52:31,210 And that's where I'm going to be spending the rest of my morning. 535 00:52:31,970 --> 00:52:32,690 Nice. 536 00:52:32,690 --> 00:52:34,170 Vidya, where are you going to go party? 537 00:52:34,430 --> 00:52:36,970 Going to hit up the beach, all day, every day. 538 00:52:37,110 --> 00:52:38,630 All day, every day. 539 00:52:38,630 --> 00:52:41,370 And Jessica, take us home. 540 00:52:41,610 --> 00:52:46,830 I was going to say I was going to Club BED with DJ Pillow, because that's exactly what I'm going to do. 541 00:52:48,250 --> 00:52:59,810 Well, on that note, we want to say thank you to DEF CON, the CFP board for giving us another shot at this, and everyone out there watching us on Twitch to say thank you for attending our Do No Harm panel. 542 00:52:59,810 --> 00:53:01,810 Again, stay connected with this. 543 00:53:01,810 --> 00:53:02,830 This is really important work. 544 00:53:02,830 --> 00:53:04,330 Let's keep our patients safe. 545 00:53:04,330 --> 00:53:05,410 And everyone, take care.