WEBVTT

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Hello, my name is Bill Daugherty.

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I'm the CISO of Omada Health.

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Joining me today is Patrick Curry, our Senior Director of Compliance.

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And today we're going to talk about threat modeling in digital health care.

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Patrick and I are the co-authors of the Includes No Dirt threat model, which we'll be discussing today.

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If you'd like to follow along with us, you can go to includesnodirt.com and download our white paper on that threat model.

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We've also got some specific exhibits that we've created just for this discussion.

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That's at includesnodirt.com slash defcon.pdf.

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And thank you for paying attention and watching our talk here today.

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Standard disclaimer, we have put together a discussion that is based on some real-world concepts, but this is not a real-world situation.

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So any information we share today should not be construed as being related to the products or services of our employer, Omada Health, or any of our partners or our customers.

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Now, if that's out of the way, we can dive into it.

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A little bit of background on us.

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Omada Health is a digital health care company.

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And what is digital health care really?

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It is the combination of technology and clinical expertise and humans to deliver better health outcomes.

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And we've been doing this for about nine years now, I think.

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And we really focus on digital care made human.

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So it's not just the machine that you're interacting with.

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We do it a little bit differently.

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We try to partner up devices, applications, with remote monitoring, and specialists who can provide assistance in our specific diseases to help improve health outcomes.

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And we do that through behavior change, remote monitoring with digital devices, care delivery, lab diagnostics, medication tracking, and a whole bunch of back-end systems that are necessities in health care, like outreach to patients, enrollment and eligibility,

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billing and reporting.

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That's all of the messy stuff behind the scenes.

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We have four diseases that have been kind of our core, which is type 2 diabetes prevention, type 2 diabetes treatment, hypertension.

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And last year, we added behavioral health, so treating anxiety and depression.

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Recently, we just bought a company called Physera that does digital physical therapy, so for muscular, skeletal, or pain treatment.

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So that's us.

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We're going to talk today a little bit about Sam.

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Sam is representative of a real participant in our program.

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She is not real.

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But Sam would be a participant who has type 2 diabetes and is using our program to try to better manage her disease state.

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And she does that through tracking her blood values.

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That information gets shared with her coach.

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Her coach is then giving her advice on meals and exercise and potentially talking about her insulin levels, things like that.

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And ultimately, what we're driving towards is behavior change.

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We're trying to give our participants lifestyle improvements that will help them better manage their chronic diseases.

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And we're going to come back to Sam and how she's managing her diseases in a little bit in the context of a threat model.

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But this is what OMADA does.

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We do whole person health care.

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And we do this with connected devices and lesson plans and coaching and all kinds of stuff.

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And we do a lot of it.

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We have, since our inception, served more than 350,000 participants.

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We have over 1,000 satisfied customers.

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And one of the largest data sets in behavioral health, as of last week, we had over 80 million weigh-ins from our digital connected scales.

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And our participants really seem to like our program.

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We have a 92% CSAT.

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So that's enough about OMADA.

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We shared that with you because we want you to understand who we are and why we came to do this.

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So why should we do threat models?

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Patrick and I started this about two years ago.

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In health care, we are required to do annual risk assessments.

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The problem with that is nobody ever tells you how.

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And we've been doing them for a couple of years.

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And we decided that we needed to up our game.

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And the reason we needed to up our game is because we were doing kind of a typical risk assessment process where we'd sit in a room and we'd just think about things that could go wrong and then we'd assess our risks.

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And the reality about all things in security and compliance is everybody's got to plan until they step into the ring and the first punch comes.

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And then your plans go to hell.

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And we knew we had blind spots.

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And we wanted to get rid of those blind spots.

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I love this cartoon, by the way.

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On the left side, this is typically how we would deal with things in health care.

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We're going to encrypt the laptop because HIPAA says that all the data has to be encrypted at rest.

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And then what would actually happen is somebody would force us to reveal our password anyway.

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Every time we give a talk on this, we update this slide.

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And sadly, I'm never out of companies that have had major breaches in the last six months to update.

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But these are examples of really bad things that have happened.

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Health care is by far the number one most breached industry, but everybody gets breached.

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And the underlying factor for all of these companies is they all had really, really good, smart security teams that were working really hard, that had lots of controls and lots of vendors and lots of stuff in place to try to protect their systems.

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And yet they still had problems.

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And the reason they had problems is because they had blind spots.

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So threat modeling is a way to try to eliminate some of those blind spots.

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And the fundamental truism in our business is nobody ever says thank you for the work you did to prevent the disaster that never happened.

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So there's no A for effort here.

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But doing threat modeling and doing them consistently will, over time, improve your security and your compliance and your privacy.

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And it is by far the right thing to do.

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So let's define it a little bit.

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In order to really talk about this, we have to have a taxonomy.

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We have to all be using the same language.

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Lots of people interchange the word threat with risk.

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We do that, too, accidentally.

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But we had to come to a common language.

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And when Patrick and I were working on this model, we were using the same word to mean different things.

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So we eventually wrote it down.

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This is our taxonomy.

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First thing is a system.

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And a system is anything you want to model.

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Lots of threat modeling focuses on applications, on software.

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And that is certainly a system that can be modeled, but so can a business process or a network or a vendor.

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And the defining characteristic of it is we want to protect it from specific threats.

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We just did our annual risk assessment and just completed it.

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And this time around, we modeled 26 business processes end-to-end.

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So systems typically have defined borders.

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You know what the entry point into the system is.

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You know what the exit is.

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And you can then model it for threats.

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Those borders are sometimes called trust boundaries, which are areas where principles can interact.

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Sometimes they're called attack surfaces.

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The key point is understanding all of the areas that an attack or a risk or a threat can come from.

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Vulnerability is a weakness in your system.

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Vulnerabilities are things that can be exploited.

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So if you have a weak password policy, that is a vulnerability.

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It can be exploited.

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If you leave your front door unlocked, that is a vulnerability.

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That doesn't actually mean that someone will breach your password or open your door, but it is vulnerable for exploitation.

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A threat is an actor.

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A threat can be a person.

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It can be an employee of a third party.

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It could be its own business process.

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It could be a piece of code.

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And threats exploit vulnerabilities.

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And we call that an attack vector in our taxonomy.

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Risk in this world, then, is the bad outcome that results when a threat exploits a vulnerability.

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And we can then measure risks by measuring the likelihood of it happening.

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That's the probability.

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And the impact, or the cost, if it does happen, that's the impact.

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And that's typically how people think about risks.

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You'll see this often.

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People trying to measure the impact by putting a dollar amount on it, a probability, and that gets you to an adjusted risk score.

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And then we talk about inherent risks and residual risks.

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And that's often how risk assessments are done.

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In our taxonomy, controls are things we do to reduce the probability or the impact of a risk.

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So, if your door is unlocked, that is a vulnerability.

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The key and lock is a control.

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And you can lock your door.

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That doesn't necessarily mean that nobody will open your front door.

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It just has lessened the probability of it.

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It might have increased the impact, by the way.

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So, controls have... there's no panacea to them.

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But we do need to model what are the risks and then what are the controls.

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And when we do that, we can then figure out what are the residual risks.

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Threat modeling is just an analysis.

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It's a way of systematically going through and looking at vulnerabilities and controls and threats against a defined list of risks.

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And defined list of risks is really important.

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Because we can sit around and talk about every bad outcome under the sun.

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A meteor may strike the planet, but that really isn't a risk we're going to try to go model as threat modelers.

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And then lastly, action items.

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This is the result.

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This is what we're trying to get out of a threat model.

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We've looked at all the bad things that could happen.

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We've measured the probability of impact.

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We've assessed the controls we have.

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And then now we've got a whole bunch of work that we want someone to go do to reduce the risk.

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And we're going to reduce the risk by creating new controls that either reduce the probability or the impact.

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So that's our taxonomy.

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If I can add to that while you change slides on that.

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One thing that was super critical for us is just exactly that taxonomy.

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Coming from different disciplines, from IT security and from healthcare compliance, we spoke very different languages when it came to risk and threats.

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And realizing that, reconciling that, and making sure that we had a consistent discussion was really important for us to be able to make breakthroughs on this.

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So if you decide to adopt this model and go forward with it, don't underestimate how important it is to create that taxonomy when you're speaking to your risk organization or your compliance team or your privacy office.

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Getting on the same page is really important.

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Absolutely.

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I could not agree more.

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And thank you for jumping in so I can take a drink.

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We would love to think that we were the inventors of all threat models and the geniuses who wrote this down.

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The truth is we're not.

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There are lots of very, very good threat models out there in the ether.

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And we borrowed heavily from them.

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And so we wanted to walk you through some of those traditional threat models so that you would have these resources available to you to go do your own research and hopefully take what we've done, take what these other people have done, and apply that into your own business,

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whether it's in healthcare or any other.

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So our starting point was this wonderful book here by Adam Shostak.

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I think he may be talking at BlackHat or DEF CON this week on threat modeling.

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It is fantastic.

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If you don't own it, I highly recommend it.

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He didn't pay me to say that.

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And we'll talk a little bit more about what's in that.

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But that's really on the software design standpoint.

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On the privacy design, there's this model called Linden.

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And again, it's excellent.

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So Adam's book largely focuses on the stride threat model.

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This is something that came out of Microsoft.

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And this was a way of getting software engineers to assess the major threats to applications.

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And they had narrowed down to really six areas.

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So spoofing, so somebody illegally accessing an application, tampering, somebody modifying the data, repudiation, somebody performing an act and we couldn't figure out who it was, elevation of privilege, somebody gaining credentials that they shouldn't have,

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denial of service, shutting it down, or information disclosure, which is what Patrick and I worry about a lot, which is breaching information.

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That's the stride model.

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It's excellent.

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Please go read about it.

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If you haven't already done so, get Adam's book.

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On the privacy side, the Linden model is also excellent.

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And when we started researching this, what became really apparent to us, and we'll talk more about this as well, is that sometimes privacy and security are polar opposites of each other.

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So in the stride model, we're worried about repudiation.

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Can somebody do something and then deny they did it?

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In privacy, we're worried about non-repudiation.

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Can I do something anonymously?

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And so we borrowed heavily from the Linden model as well.

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But there's some other models out there that are also good.

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Bruce Schneier wrote extensively about attack trees.

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Attack trees is one way of brainstorming where you start with an objective, like I want to open a safe, and then you walk down a tree of all the ways you would do that.

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So how could I open a safe?

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Well, I'd have to learn the combo.

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That would be one way.

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Or I could cut it open.

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And to learn the combo, how would I do that?

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And you walk down that, and then you start figuring out what is possible, what's not possible.

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And then once you've done that kind of a model, you can then insert controls in there to break up the attack tree.

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Kill chains came out of the military.

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And again, it's a way of modeling what needs to be done for somebody to execute an attack.

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And if you interrupt any step of the kill chain, you can impact or possibly prevent the attack.

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Both excellent models.

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Security scorecards.

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These came out of the University of Washington.

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This is a way of training threat modelers on how to do threat modeling.

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It's actually a deck of cards.

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And I have a deck that's at my office that's under lockdown from COVID.

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But it talks a lot about motivations and resources and methods.

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And it's really just a training mechanism, but they're worth checking out.

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And there are a ton of other models.

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I found this white paper from Carnegie Mellon on threat modeling.

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It's excellent.

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I highly recommend the POSTA model just because I like the name.

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But there's lots of models out there.

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But none of them really fit what Patrick and I wanted to do.

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Which was, we wanted a single approach that we could look at our software applications and our vendors and our business processes.

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And deal with all the intersections between compliance and security and privacy and ultimately reduce the risk of our organization.

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Lots of people do brainstorming.

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Brainstorming is the simplest form of threat modeling.

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It has its place.

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We do it too.

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But it also has its limitations.

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And we talked, I said earlier that we don't model everything.

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We model the things that are applicable to our system.

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And this is kind of a typical traditional threat model.

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We talked about SAM earlier.

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We're going to talk about SAM again later.

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But this is a situation, a diagram of how a continuous glucometer, a wearable glucometer might work, might interface with our company.

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And we draw this on a whiteboard and then say, okay, if we were going to attack this, how would we do it?

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And everybody starts drawing things and we say, well, I'd do a man in the middle of the application.

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Or I'd do a denial of service on the API.

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Or I'd do a breach of the partner.

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Or I'd figure out some way to hack the device to harm the participant.

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And that is one way of doing threat modeling, but it ignores lots of things.

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It ignores the motivations and capabilities of the attacker.

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It ignores the objectives of the system.

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It also ignores all of the controls we already have in place.

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Because we've already done things, like we've got TLS written up here.

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That's control that we encrypt the traffic.

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So we want something that doesn't ignore all that and is a little more structured than just a couple of smart people and a whiteboard.

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And threat models are done via brainstorming.

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They're limited by your imagination.

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And failures of imagination lead to blind spots.

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So this was the problem we were trying to solve.

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And now Patrick is going to talk about what we actually did.

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And specifically the includes-no-dirt model.

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Yeah, exactly.

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Thanks, Bill.

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So exactly that's what we were trying to solve for.

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There's a lot of dimensions to that.

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I think the one comment I would make on the brainstorming thing, and I think we've seen this before in prior practices.

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If your thoughts are limited or if you don't think of something, you don't actually expose that in your conversation.

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So what this process actually allows us to do is force us to think of things that may not be top of mind when we're actually doing the work.

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And that regimentation and that process actually drives us to that one.

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Okay, next slide.

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So what we were looking for in coming up with this process.

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Something that was easy for a non-SME to understand.

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Something that we could-and something that would be easy for someone to perform.

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So something that we could give to a non-expert, say someone on my team or on the privacy team, and have them not only understand what we were after and what we were trying to do, but actually something that they could deliver and run through in a fairly short amount of time.

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We wanted something that was flexible and repeatable.

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Something that we didn't have to shift every single time that we did the questions and something that we could do over and over and over again.

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We wanted something that was usable anywhere.

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We didn't want to have to design something that was great for business process, but really crappy for IT structures or vice versa on that.

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And of course, since we were putting a lot of effort into this, we wanted it to be memorable.

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Because why not when you're building it?

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And some creative uses of anagram generators actually got us where we are.

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So, next slide.

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So what we created with this process.

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It's a systematized approach to analyzing risks.

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That pays a couple of different dividends.

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One is it's systematized and it's easy to execute like we were just discussing.

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It's also interestingly started to be a key for us to explain how we think about risks.

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So it structures educational conversations when we have them with staff so they understand what we're trying to do.

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It's a repeatable process with objective scoring.

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So another huge win there.

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Something we can do over and over again, sometimes on the same system to see changes or see how things have evolved.

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And it gives us an objective score with some weights that we're going to see in the example we'll show you.

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That help us compare across risks or across even domains in what we're looking at.

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How we think about risks and what do we do first.

21:45.380 --> 21:49.160
There's never enough time, there's never enough resource, how do you focus your time?

21:49.380 --> 21:51.340
We wanted a system-centered approach.

21:51.340 --> 21:55.260
So something that isn't really focused on the thing that you're modeling.

21:55.260 --> 22:00.360
But something that actually is focused on the thing that you're modeling but not on the process itself.

22:01.700 --> 22:08.640
We tried to kind of bridge the gap between, say, having a Stride and a Linden for different things and create something consistent.

22:09.020 --> 22:13.220
Bill mentioned we focused on established controls and that's really important.

22:13.220 --> 22:19.460
If we've tested the control already and we're sure it works in our audit practice, we know it's actually running.

22:20.040 --> 22:22.400
Then we don't actually have to include it in the model.

22:22.400 --> 22:26.740
And in the example we'll show you, we've gone through a few things and eliminated it.

22:26.740 --> 22:29.060
Because they either don't apply or we know that it works.

22:29.060 --> 22:34.000
Lastly, we wanted to have a model that covers all of the domains we think are important.

22:34.000 --> 22:36.020
Privacy, security, and compliance.

22:36.020 --> 22:41.700
So not having three different models or three different versions and being able to include different regulatory regimens.

22:41.960 --> 22:42.880
Next slide.

22:44.760 --> 22:45.620
Alright.

22:46.000 --> 22:51.540
What we created with Includes No Dirt, the model that we have, your mileage may vary on this one.

22:51.540 --> 22:55.280
We designed it for our own uses at Omada Health.

22:55.280 --> 23:01.100
And if you're in the healthcare space, it may be directly applicable with the questions that we have.

23:01.100 --> 23:04.660
You may have to swap out some of the specific regulatory questions.

23:04.660 --> 23:08.740
If you're in an adjacent industry, it may need some questions adapted.

23:08.740 --> 23:14.600
Please, by all means, take the questions and modify them to your own use to target exactly what you're trying to get to.

23:14.880 --> 23:15.660
Next slide.

23:16.300 --> 23:16.720
Alright.

23:16.720 --> 23:17.980
And one last, the teaser.

23:17.980 --> 23:19.800
It is the Includes No Dirt model.

23:20.100 --> 23:23.740
And it has been arranged to actually be memorable.

23:23.740 --> 23:36.500
So identifiability, non-repudiation, clinical error, linkability, unlicensed activity, denial of service, elevation of privilege, spoofing, non-compliance to policy, overuse.

23:36.500 --> 23:42.720
Specifically, they were thinking of overuse of information and data as really pertains to the HIPAA space that we're in.

23:43.000 --> 23:48.720
Dirt, data error, information disclosure, repudiation, and tampering.

23:48.720 --> 23:51.860
So all those parts play together to make the model that we're using.

23:51.860 --> 23:52.580
Next slide.

23:53.740 --> 23:59.200
So for every risk, there's a property and a goal, and it comes from a specific place.

23:59.220 --> 24:00.680
So you skip down a couple.

24:00.680 --> 24:02.040
Clinical error.

24:02.420 --> 24:04.160
The risk is clinical error.

24:04.160 --> 24:07.340
A clinician making a mistake that may otherwise have been prevented.

24:07.520 --> 24:12.820
The property or the goal of that is the application of correct clinical standards.

24:12.820 --> 24:19.520
So making sure that the clinician both knows what they're doing and actually can do them at the moment in time where they actually need to do it.

24:19.520 --> 24:20.840
That's in the realm of compliance.

24:20.840 --> 24:27.120
And we've sorted on this slide the specific things as to what the goal of what we're trying to do is and where it comes from.

24:27.420 --> 24:28.360
Next slide.

24:32.000 --> 24:41.500
Now, you may have noticed that some of these things overlap, and that's where proper judgment by the risk assessors as you go through this is important.

24:41.640 --> 24:45.380
And I don't think I can say that enough strongly in the title slide.

24:45.580 --> 24:49.840
The risks that apply depend on the system being modeled.

24:49.840 --> 24:55.980
So some of these, you'll have to look at what you're trying to do and figure out, does this apply, does this not apply?

24:56.060 --> 24:57.580
How does it apply?

24:57.980 --> 25:00.680
And some things you may just factor out as you go through it.

25:00.700 --> 25:05.580
So these three in particular are complicated because they are very related.

25:05.580 --> 25:08.200
And Bill alluded to it at the beginning.

25:08.300 --> 25:13.940
Security and privacy sometimes are at opposite ends of what they're trying to do.

25:13.940 --> 25:16.060
And these tend to reflect it here.

25:16.060 --> 25:22.260
So identifiability, the property of a system that allows users to trace to a specific user.

25:22.300 --> 25:31.180
So there, the objective or the goal is anonymity, making sure that that's not actually possible.

25:31.360 --> 25:38.840
A risk of non-repudiation, non-repudiation, the process by which it's proven that a user took an action.

25:38.900 --> 25:41.460
The goal there is plausible deniability.

25:42.560 --> 25:45.800
It isn't clear if someone did something or not.

25:45.880 --> 25:48.020
The risk is repudiation.

25:48.640 --> 25:52.920
And here, what we're trying to get to is non-repudiation.

25:52.920 --> 25:58.420
So where someone can actually show that it actually hasn't happened yet.

25:58.420 --> 26:04.720
So these of note actually came from different parts, some from Stride, some from Lyndon.

26:04.720 --> 26:06.940
So privacy and security blended together.

26:07.120 --> 26:10.820
On the next slide and the next couple, we'll actually kind of unpack that a little bit.

26:10.820 --> 26:14.660
So de-conflicting these goals can be kind of complicated on this.

26:14.660 --> 26:18.380
Different stakeholders will have different needs for these things.

26:18.380 --> 26:27.800
So for example, with anonymity and identifiability, that risk goal, there are some times where you're building a system where that absolutely is required.

26:27.800 --> 26:30.780
We've got a whistle here for a whistleblower.

26:30.780 --> 26:43.660
If I'm designing, for example, a software application that holds anonymous reporting for whistleblowers, because that's required under healthcare compliance rules and other codes as well, anonymity is really important.

26:43.660 --> 26:49.660
But then for other goals and other people in the system, less important.

26:49.660 --> 27:01.380
So a hacker, for example, there in the middle, really relies on plausible deniability for what they're trying to do, either ethically or otherwise, making sure that there's that deniability as part of it.

27:01.460 --> 27:06.360
Repudiation and non-repudiation as well.

27:06.360 --> 27:09.700
Let's get into a little bit more of a specific example on the next slide, though.

27:09.700 --> 27:18.460
So let's say Human Resources wants to build or wants an employee complaint application that lets employees report sexual harassment.

27:19.280 --> 27:25.500
Lots of different goals, lots of different stakeholders, and figuring out how to balance between them gets really important.

27:25.500 --> 27:32.980
So employees want to be able to report and want, if they want to have anonymity, that their anonymity is protected.

27:32.980 --> 27:37.540
If they want to say something anonymous, they can't, and no one will know who it is.

27:37.960 --> 27:51.480
Well, HR wants to help ensure anonymity, but also wants to make sure that there's less of a possibility of abuse in the system, that you don't have one person anonymously reporting the same thing over and over again to drive a larger oppression.

27:52.020 --> 27:58.960
IT needs to provision and deprovision administrative access to this, but they have absolutely no need to see the complaints that are registered.

27:58.960 --> 28:03.900
Security runs DLP on every laptop, logs who has access to the application.

28:04.000 --> 28:18.040
Important from a security perspective, but then that becomes potentially challenging depending on the level of access and the fact that if they're provisioning it and they log who accesses, they have a proxy for who's actually reporting things.

28:18.180 --> 28:29.160
The legal department wants to be able to document complaints and collect evidence to take action, which is somewhat the opposite of anonymity.

28:29.160 --> 28:35.000
It's hard to take action and have a cause that comes out if we don't know actually who did something.

28:35.000 --> 28:44.720
So you have lots of different people running in the system with different needs, different roles, and those roles will conflict.

28:44.720 --> 28:50.620
So we can't completely make everything anonymous because then security and IT can't do their work.

28:51.200 --> 28:59.580
Legal will be able to document complaints and the harassment, if in fact it is actually occurring, will keep continuing because there's no way to investigate it.

28:59.580 --> 29:07.980
So all of these parts play together and need to be balanced in the work that you're doing when you do the modeling.

29:09.700 --> 29:11.260
All right, I think it's back to you.

29:11.340 --> 29:13.320
All right, so let's give it a try.

29:13.760 --> 29:15.420
Time to come back to Sam.

29:15.420 --> 29:34.620
So Sam is a typical patient with type 2 diabetes, and she's been using for years a blood glucometer, which means she's constantly pricking her finger, taking blood readings.

29:34.620 --> 29:50.900
We know that she would benefit from having a continuous glucometer, that she is a wearable, and that is automatically sending readings to her coach so that we get greater telemetry, so that we can respond quicker.

29:51.440 --> 29:59.300
So we want to introduce CGMs into our product set, but we want to do it safely.

29:59.300 --> 30:08.560
So what Patrick and I did is we filled out an Includes No Dirt threat model on the concept of a CGM to try to help us figure out where we need to pay attention.

30:09.120 --> 30:17.180
And again, you can download the one we've filled out at includesnodirt.com slash defcon.pdf.

30:17.180 --> 30:19.520
I highly encourage you to do so.

30:21.120 --> 30:23.260
We talked about brainstorming.

30:23.260 --> 30:39.320
The Includes No Dirt threat model, we've included a structured brainstorming worksheet that allows us to go through a system and kind of helps guide where we go.

30:39.320 --> 30:42.200
So again, I'm going to come back to this is our diagram.

30:42.200 --> 30:44.940
In our diagram, we have a wearable glucometer.

30:45.080 --> 30:54.420
That glucometer syncs to an application on the patient's cell phone, which then transmits the data to the partner.

30:54.420 --> 31:02.280
The partner then sends it to our endpoint, and it gets stored in our database.

31:02.280 --> 31:07.460
It then sends information back to our application.

31:07.460 --> 31:10.180
It also surfaces that information to the coach.

31:10.280 --> 31:15.720
And you'll see here that in addition to the CGM, the participant still has a BGM.

31:15.720 --> 31:24.260
So still does occasional finger sticks, and that information is also being sent to us.

31:24.260 --> 31:28.720
So we've got two sources now of blood sugar data.

31:28.720 --> 31:31.920
So this is the diagram we're going to be working off of.

31:32.280 --> 31:36.960
In our worksheet that we provided you, it's highly structured.

31:36.960 --> 31:40.980
One of the first things we do is we mark which threats we think apply.

31:40.980 --> 31:43.320
Who are the actors that are involved here?

31:44.000 --> 31:51.140
So certainly the participant is involved in this whole process, and the coach is involved, but we've got a vendor.

31:52.160 --> 31:55.120
We've got potentially other partners.

31:55.120 --> 31:58.320
We're going to be doing claims on this and billing.

31:58.320 --> 31:59.720
We're reporting.

31:59.760 --> 32:02.780
So there's business processes, there's people.

32:02.900 --> 32:05.580
For this one, we're not so worried about natural disasters.

32:05.580 --> 32:12.800
We're not so worried about geopolitical unrest, but other threat models, those might come into play.

32:13.980 --> 32:18.600
And we then do some brainstorming on vulnerabilities.

32:19.560 --> 32:22.800
So what are areas that could be vulnerable?

32:22.800 --> 32:29.500
They get an incorrect reading, or the service becomes unavailable, or the coach misinterprets the data.

32:29.500 --> 32:37.200
Now, up in the right-hand corner there, I've got a little diagram where I show the questionnaire and also the structured brainstorming.

32:37.200 --> 32:39.460
And this is an iterative process.

32:39.460 --> 32:44.480
We sometimes start with the questionnaire, and we sometimes start with the worksheet.

32:44.480 --> 32:50.920
But it's typical when we are doing one of these on a complex system, we are going back and forth.

32:50.920 --> 33:02.180
So we'll be going through the questionnaire, which is highly structured, and that will trigger us to go, Oh, wait, because we've said no on this question, we think that there's a vulnerability there.

33:02.180 --> 33:05.840
Let's go write that down on our worksheet on vulnerabilities.

33:05.840 --> 33:08.900
Let's go ask somebody to get more information.

33:08.900 --> 33:17.940
And we go through this process until we think we've got the questionnaire complete and the worksheet complete.

33:17.940 --> 33:19.980
And so we did that.

33:20.280 --> 33:26.680
And when we did that, we were able to take those vulnerabilities that I've listed here.

33:26.680 --> 33:28.920
There's five of them in our example.

33:28.920 --> 33:34.560
And we're mapping those to specific areas in the includes-no-dirt model.

33:35.620 --> 33:38.280
So you'll see, like, anonymity.

33:38.280 --> 33:39.380
We don't want anonymity.

33:39.380 --> 33:43.560
It doesn't apply in this one, but clinical error certainly does.

33:43.560 --> 33:47.190
And denial of service does, and spoofing does.

33:47.190 --> 34:02.770
So in the interest of time in our presentation, we're not going to go through all of our answers for every risk, but we're going to go through the answers we did for the risks that apply and talk about why they apply.

34:02.870 --> 34:07.050
And again, you can download our example and see our answers on all of them.

34:07.050 --> 34:18.770
So the factors that do apply are clinical error, unlicensed activity, denial of service, spoofing, noncompliance, data error, information disclosure, repudiation, and tampering.

34:18.890 --> 34:22.330
These are the things we're worried about in this particular threat model.

34:23.390 --> 34:26.050
So Patrick, let's start with clinical error.

34:26.170 --> 34:26.730
Sure.

34:26.730 --> 34:36.070
So what we did in this one, to make it a little clearer, is for the next few slides, on the left side of the slide is a snapshot of the answers.

34:36.070 --> 34:43.570
And all of these answers are in the materials that we put on the includes-no-dirt website under the DEFCON link.

34:43.570 --> 34:52.190
On the right side, we've clarified a little bit about what these actually mean in the context of the CGM work that we did for this specific example.

34:52.430 --> 34:57.370
It can be a little hard to read through those, so we've kind of pulled out what we think the important answers are.

34:57.490 --> 35:07.330
So here for clinical activities, what we're thinking about in the specific example of this continuous glucose monitor is, are we doing something that relates to the treatment of a patient?

35:07.330 --> 35:09.990
Well, of course we are in this particular example.

35:09.990 --> 35:26.650
So the specific question that we probe into here is, does this system or process, does this combination of things, have either inbuilt controls that prevent something from happening in the first place, or other review-based controls that can, if something does happen,

35:26.650 --> 35:29.290
we'd be able to find it and correct it as quickly as we can.

35:29.290 --> 35:31.230
So answer here, yes.

35:31.230 --> 35:42.430
And it's a little complicated because it's both CGM, it's both a device that is created by a partner of ours and software that we create for our coaches to be able to use that information.

35:42.850 --> 35:49.170
Each one of those has specific detective and preventive controls that operate in its own environment.

35:49.170 --> 35:54.830
And this is a great example of what Bill just said related to the iterative nature of this.

35:54.830 --> 36:00.630
When we hit this question, it's like, okay, wait, that's both the device and the software.

36:00.630 --> 36:01.450
How does that work?

36:01.450 --> 36:04.630
And we had to fork a little bit, came back, yep, that's exactly right.

36:05.150 --> 36:11.670
In questions 3.2 and 3.3, we delve down a little bit into some additional control work.

36:11.970 --> 36:16.390
And another thing I would say here is, not all controls are technical.

36:16.390 --> 36:24.990
In this particular case, with clinical error, part of preventing clinical errors is ensuring both the proper training of your clinicians.

36:24.990 --> 36:28.710
So being able to say, yeah, everybody that has access to this was properly trained.

36:28.810 --> 36:31.810
I almost said licensure, that's coming soon.

36:32.530 --> 36:40.170
And that the delivery and the quality of the deliveries is important and up to the standards we set in our clinical practice guidelines.

36:40.170 --> 36:49.510
So that becomes a review process and a quality check that our clinicians will do on the staff to make sure, by reviewing their output, that things are going the way we want it to.

36:49.550 --> 36:50.630
All right, next slide.

36:50.630 --> 37:01.430
So one thing I want to say before we move to the next slide, you'll see there on the left-hand side, on question 3.0, when we answered yes, it gets one point for that.

37:01.430 --> 37:08.390
If we'd answered no, we can skip the rest of the questions on clinical and move on to question 4.

37:08.730 --> 37:11.370
So those two things are really important.

37:11.370 --> 37:15.770
At the end of this, we're going to total up all the points, and that will drive a risk score.

37:15.770 --> 37:24.230
But being able to skip a whole bank of questions when they don't apply means you can go through the model much faster.

37:24.230 --> 37:36.270
So for simple systems that don't involve clinical, don't involve patient activities, we can maybe model them, as we said, very quickly, like 15 minutes.

37:36.270 --> 37:41.750
For something that's complicated, and this would be a fairly complicated one, it might take us several hours.

37:41.750 --> 37:48.850
But the model fits whichever size system, whichever level of complexity we're dealing with.

37:49.470 --> 37:51.630
Definitely, thanks for pointing that out.

37:51.990 --> 37:59.550
That weighting is really important because it helps to also create that apples-to-apples comparison that we talked about a little bit earlier.

37:59.550 --> 38:04.750
Second one, unlicensed activity, and I spilled it a little bit ago just talking about it.

38:04.750 --> 38:13.730
Does, in this case, the work that we do require licensure from either a site license or personnel licenses for the people that are delivering care?

38:13.970 --> 38:21.170
Just like the last question, yes, it does, and it's complicated because different parts of this thing require different licensure.

38:21.170 --> 38:39.480
The CGM manufacturer requires licensure by various federal and state authorities, and our clinicians internal to us require credentialing to make sure they're able to deliver the coaching that's appropriate for diabetes, so there are national standards for that.

38:40.760 --> 38:45.880
Also important here is the fact that we rely on other people in these things.

38:45.880 --> 38:52.800
Just like we talked about, if we've tested a control, we know it works, we don't have to bring that into the discussion here.

38:53.160 --> 39:03.820
We may, in diligence and checking, acknowledge that, yes, our business partners have the appropriate licensure, but we don't have to dig into that to make sure it's as robust as it is.

39:03.820 --> 39:13.580
Our contracting processes make sure that those exist, so we use that as effectively a control, and we focus on the things that are important to us, which is our own internal clinicians.

39:14.580 --> 39:15.960
I think you're next.

39:15.960 --> 39:17.060
Denial of service.

39:17.060 --> 39:22.640
So this is where we start looking about how mission critical the system is that we are modeling.

39:22.640 --> 39:45.140
For a connected glucometer, the availability of the entire system is very important, and if any piece of that system is having a problem, the connectivity between the device and the partner, the partner and us, us and the participant, isn't working, then it's going to have a significant impact on the effectiveness of getting that telemetry data to the coach,

39:45.140 --> 39:50.100
back to the participant, and being able to make decisions on that data.

39:50.100 --> 39:54.180
So when we go through our model, we ask, is it a mission critical system?

39:54.180 --> 39:57.260
If it is, that raises the point value.

39:57.400 --> 40:03.440
And then we look at, have we defined targets, and what are those targets, and how are they enforced?

40:03.760 --> 40:08.880
And again, Patrick said not all controls are technical.

40:08.900 --> 40:14.140
For the partner, they've got technical controls to ensure their availability.

40:14.140 --> 40:24.000
For us, we've got contractual controls, where we define an availability target with monitoring and penalties, and that's how we manage the risk on our side.

40:28.040 --> 40:38.400
Spoofing... we want to make sure that we are getting the right data, and we want to make sure that only the right people can access that data.

40:38.400 --> 40:52.740
And so spoofing as a threat is where we look and model in authentication, and this is a good example of where we can rely on existing controls.

40:52.740 --> 40:58.460
So we have defined authentication levels for our participants.

40:58.460 --> 41:06.380
We base it on NIST 800-63B, and they're defined as an AAL Level 1.

41:06.380 --> 41:13.120
Our coaches are defined as a Level 2, which means that they not only have to have a username and password, but a second factor.

41:13.120 --> 41:14.660
We test those.

41:14.660 --> 41:15.700
We know it works.

41:15.700 --> 41:23.880
So as long as the system is going to use those controls we've already defined, we can check those boxes and move on.

41:23.880 --> 41:35.940
We don't need to spend a lot of time detailing how authentication for this particular system is going to work, because it's a client of the greater system within our care delivery.

41:36.800 --> 41:38.340
All right.

41:38.820 --> 41:39.640
Noncompliance.

41:39.640 --> 41:51.680
So not surprisingly, when we have to address a particular business process or system, as a HIPAA covered entity, there's lots and lots of legal requirements that get attached to something.

41:51.680 --> 42:08.680
This is probably, let's call it the worst example of the complexity here, because for this combination of devices and software that we're building, it's everything from HIPAA, privacy policies, the terms of use both for the device and for our software application,

42:08.680 --> 42:11.060
there's a number of healthcare compliance issues.

42:11.060 --> 42:16.760
There would be FDA obligations for our business partners, the contracts that Bill just mentioned.

42:16.860 --> 42:21.240
So because this is clinical in nature, it relates to a device.

42:21.240 --> 42:22.820
There's patient data involved with it.

42:22.820 --> 42:24.840
This one's particularly complicated.

42:24.840 --> 42:38.240
As I mentioned kind of early on when we were talking about the problems that brainstorming can create, this question is specifically designed to bring up those non-obvious things that you may not have top of mind when you're actually doing it.

42:38.240 --> 42:55.000
If you have, if you're adapting this questionnaire, certain things that you want to target, definitely adding it to this list is important because, for example, here, terms of use may not have been something I would have thought about, but it has to include what we're trying to include in this specific example.

42:55.000 --> 42:58.060
So that was important to kind of drive through that.

42:58.060 --> 43:05.800
This also, you look down at the very bottom left of the screen, we can also check through the applicability of some of the credentials that we have.

43:05.800 --> 43:11.620
One of the things that I would stop to in a high trust certified organization is applying this particular case because of the nature of what we're trying to do.

43:11.760 --> 43:14.120
Okay, next one I think is mine as well.

43:14.140 --> 43:15.300
Data error.

43:15.300 --> 43:35.000
So here in this particular example, we're digging heavily into data integrity and for a medical process and a clinical record keeping process like this would create, so we're essentially creating a part of a medical record on glucose monitoring, glucose management for participants in the program.

43:35.000 --> 43:41.020
It's really important to make sure that this is ingested and maintained in an accurate and viable way.

43:41.660 --> 43:47.560
Again, here, in other includes no dirt models that we've actually done, we've tested some of that.

43:47.560 --> 43:51.580
We've tested, for example, the APIs that we do data ingestion with.

43:51.580 --> 44:00.380
So we can kind of check that off and go, yeah, it's acting as we intended it to and move on and focus the mitigation control work we're trying to do here for other things.

44:04.280 --> 44:06.600
So information disclosure.

44:06.820 --> 44:10.240
This is where we're worried about confidentiality of the system.

44:10.260 --> 44:23.360
We've got rules over within HIPAA, within our customer contracts on how we protect data to make sure that it isn't disclosed where it's not supposed to be.

44:23.360 --> 44:30.100
And again, here, we're largely consuming controls that we've already tested previously.

44:30.100 --> 44:35.740
So HIPAA requires us to encrypt PHI at rest and in transit.

44:35.740 --> 44:38.940
So we can ask, are we doing that?

44:38.940 --> 44:40.540
And if so, how?

44:40.620 --> 44:48.200
And since those are really well-known patterns for us, we can accept them and we can move on.

44:48.200 --> 44:51.520
It doesn't actually require a ton of discussion.

44:52.540 --> 44:55.360
Down at 12.6, data locality.

44:55.360 --> 44:57.240
This is a really good reminder for us.

44:57.360 --> 45:03.140
We have obligations to keep all of our data within the United States, processed, stored, and accessed.

45:03.320 --> 45:16.100
And so, especially when we're talking about a third-party vendor, this is a good reminder of, hey, let's make sure we know where their data centers are and where the data goes as it traverses its way to us.

45:18.360 --> 45:19.160
Repudiation.

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We've talked a lot about repudiation already.

45:22.860 --> 45:25.320
Does it require non-repudiation?

45:25.320 --> 45:25.740
Yes.

45:25.740 --> 45:27.500
What are those mechanisms?

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And again, in question 13.3, there's lots of mechanisms that we have in place, but we want to make sure we address them.

45:37.480 --> 45:39.780
How are user activities being logged?

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Do we have accurate timestamps?

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How long are logs retained?

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Things like that.

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That lets us know that this particular system is going to fit into our overall framework.

45:57.080 --> 45:58.180
And tampering.

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We don't want anyone to mess with the data.

46:01.380 --> 46:05.940
So, again, what are all the mechanisms in place to prevent tampering?

46:05.940 --> 46:21.160
Now, for this particular system, there's some interesting tampering things we need to deal with, like the chain of custody of the device between the manufacturer and the DME and the DME shipping it to the participant.

46:21.160 --> 46:32.460
And also, how do we make sure that the device that gets shipped gets assigned to the appropriate patient in our data model?

46:32.460 --> 46:41.380
And that's a fulfillment question, because we have to make sure that every device that gets shipped, that serial number comes to us assigned to the correct person.

46:41.380 --> 46:54.000
And if we don't, that then makes its way back up to not just tampering, but to data integrity and who has access to it.

46:54.000 --> 46:56.660
So, again, the model is iterative.

46:56.660 --> 46:58.000
It lets us go through it.

46:58.000 --> 47:03.180
And it reminds us to check, how are all these things being addressed for this?

47:03.180 --> 47:06.260
It is a very structured way of brainstorming.

47:07.020 --> 47:08.940
And we get to the end, we get a score.

47:10.240 --> 47:11.600
Patrick, you want to talk about this?

47:11.600 --> 47:12.280
Oh, sure.

47:12.360 --> 47:12.860
Yeah.

47:12.860 --> 47:15.240
So, as Bill said, we get to the end and we get a score.

47:15.240 --> 47:17.680
So, the product of all the numbers that you saw on the side.

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So, for example, when we've weighted the first element as one, when we're talking about clinical controls in place or not, all of those add up together.

47:28.460 --> 47:35.300
And in the particular governance risk and compliance system that we use, we can weight the scores, so some are stronger than others.

47:35.300 --> 47:39.400
But essentially, the product of that turns into a total score.

47:39.660 --> 47:50.180
We can rank that total score as a low, medium, or high, again, to be able to focus our efforts and make sure that we know, kind of, is this something we need to address immediately in the grand scheme of things?

47:50.180 --> 47:56.880
Is this something we can actually wait on for a while because it's not as critical as other things that we're looking at?

47:56.880 --> 48:00.000
On the right side, you actually see the list of action items.

48:00.000 --> 48:04.220
You saw that in a prior slide as far as how those work.

48:04.220 --> 48:06.400
Here's the specific action items for this one.

48:06.400 --> 48:08.880
So, for example, for this particular model.

48:08.880 --> 48:22.300
So, for example, creating clear instructions for participants on device calibration can help with data integrity issues because it's not clear if someone enters data incorrectly, the treatment would apply correctly.

48:22.300 --> 48:25.180
So, this addresses the clinical vulnerability issue.

48:25.340 --> 48:31.420
Backups to BGM and CGM also touches on some of the same issues.

48:31.460 --> 48:37.760
Sometimes that's required just because of the nature of the CGM and so forth with all of these.

48:37.760 --> 48:43.180
Each one of those action items is designed to address one or more vulnerabilities.

48:43.180 --> 48:51.380
And that's part of the process of this is everything that you've identified should have an action item at the end of it to make sure you're hitting everything you need to from a control perspective.

48:52.280 --> 48:54.760
And we've done a lot of these.

48:54.800 --> 48:59.260
I mentioned earlier that we launched a behavioral health application.

48:59.260 --> 49:02.540
And when we did that, Patrick and I did a threat model.

49:02.540 --> 49:05.520
And I think we came up with 19 action items.

49:05.520 --> 49:16.720
And those were specific things that we wanted to ingest into the system before we went live.

49:16.720 --> 49:35.060
So, we did that at the very early stages as we were just planning, which was six months before the launch, which meant that we had as risk assessors the ability to have a meaningful impact on the security and privacy and compliance of that application before it ever launched.

49:35.060 --> 49:41.360
And everybody involved also understood, because they went through the process with us, why.

49:41.360 --> 49:48.440
They knew why we had those action items, and what was the specific vulnerability we were trying to address.

49:48.780 --> 49:50.380
That latter is very important.

49:50.380 --> 50:00.220
You may have groups that, let's just say, are not necessarily as inclined to be helpful when working with the risk assessing organizations.

50:00.220 --> 50:10.600
We had, in this particular case, this behavioral health example, some of our developers come back to us and say, oh, we get it now, why this is important, after they've executed through the process.

50:10.600 --> 50:15.480
So, it becomes educational as well as helpful, just as a reminder as to why we're doing it.

50:17.040 --> 50:20.280
So, a couple of points to wrap this up.

50:20.380 --> 50:24.940
Vendor management, the threats you aren't seeing can also kill you.

50:25.640 --> 50:35.760
I use this example, this was a letter that Quest Diagnostics sent out about a year ago on a breach.

50:35.760 --> 50:45.040
And the important thing about this is not that Quest sent it out, but that they sent it out because one of their vendors had a problem.

50:45.060 --> 50:54.200
And that vendor was acting as Quest BAA, but Quest ultimately got sued for this breach.

50:55.200 --> 51:04.280
So, when you're doing threat modeling and risk assessments, it's important not only to look at your own systems, but your third parties as well.

51:04.280 --> 51:09.800
And we use the same methodology, the same checklist, to assess all of our vendors.

51:10.040 --> 51:15.060
Now, we have lots of vendors, we are a SaaS first company, we've got SaaS all over the place.

51:15.240 --> 51:23.740
And when somebody comes to us with a new vendor, and let's say it's a project management tool, we can go through this checklist pretty darn quickly, because it doesn't have clinical error.

51:23.740 --> 51:27.040
And it doesn't require licensure.

51:27.040 --> 51:35.360
But when somebody comes to us with a new device vendor, we're going to go through this same model very, very carefully.

51:35.980 --> 51:49.060
And so, when we use threat models to assess vendors, it's the same basic questionnaire, we're doing that checklist, we may or may not also do a brainstorming.

51:49.920 --> 51:54.660
But we then use that to influence our legal terms.

51:54.660 --> 52:06.420
So, if we define the vendor is going to be mission critical, well, that means we have to tell the legal department to make sure we have an SLA in the contract.

52:06.420 --> 52:19.400
And if we're worried about encryption of data at rest, then we have to include that term in the contract, and we have to assess that vendor to make sure that they are doing things we want.

52:19.400 --> 52:26.620
We put legal terms in to say they have to keep our data in the United States, but we then also verify where their data centers are.

52:26.620 --> 52:32.240
So, this model works for assessing vendors, and it works very, very well.

52:33.480 --> 52:36.240
All right, so when do you actually use this?

52:36.240 --> 52:41.900
We've talked a lot about different possibilities for it, and we've got a chart here that addresses a little bit of when to use it.

52:43.040 --> 52:46.680
As you can kind of tell from our examples, we use it all over the place.

52:47.580 --> 52:51.420
Initiations of significant projects, the behavioral health example that Bill just did.

52:51.420 --> 53:00.060
Vendor acquisition for the first time, and then annual assessments, both from a risk assessment perspective and from a vendor assessment perspective.

53:00.060 --> 53:07.620
Bill mentioned earlier that we did it for 26 material business processes on the risk assessment we just completed.

53:07.620 --> 53:19.880
I can't overstate how interesting and helpful that was this year, because traditionally from a compliance and a privacy perspective, risk assessments are really brainstorming in nature.

53:19.880 --> 53:26.020
This forced more rigor than I think we'd even seen last year when we did it a little bit closer to this way.

53:26.020 --> 53:35.140
And it took out the potential for missing things because you're not asking the questions in a regimented way, and that was a huge win.

53:35.680 --> 53:39.540
Resulted in a lot more action items for us to do, but that's a good thing in the grand scheme of things.

53:39.540 --> 53:42.700
There's a lot more because we're aware of it for us to look at.

53:43.020 --> 53:43.980
On demand, too.

53:43.980 --> 53:51.160
There are times when sometimes from an audit perspective, things just crop up and you think, maybe we should take a look at that more detail.

53:51.160 --> 53:53.640
There's the regimented way to actually look through it.

53:56.220 --> 53:56.860
All right.

53:57.160 --> 54:04.760
It does exist in a continuum of activity from a risk assessing perspective, and we've got a little bit of the dimensions that we think about it here.

54:04.760 --> 54:06.980
So threat model on the upper right.

54:06.980 --> 54:15.380
Really, its best practice seems to be when it's a new process or something that we're encountering for the first time, and we have no idea about the dimension of risk on it.

54:15.380 --> 54:17.460
So risk unknown in a new process.

54:17.780 --> 54:27.380
On the left side, there are things that we have an idea about, like processes that we're actually doing, and either how much we know about it or how much we don't know about it.

54:27.380 --> 54:34.580
So on an annual basis, the last few years, what our risks are as a company are pretty stable.

54:34.580 --> 54:37.300
We kind of know the general categories of risk.

54:37.620 --> 54:43.380
So we may not necessarily know with an existing product how it shifted over time.

54:43.380 --> 54:46.880
Take a look at that from an audit perspective, and these overlap.

54:46.880 --> 54:54.460
A threat model, in general, when you're talking about a threat model designs a control, you'll have to retest that control at some point.

54:54.460 --> 54:57.140
So that, in our world, still stays in my universe.

54:57.140 --> 55:01.480
That may get handed off to an internal audit group for them to be able to test that control eventually.

55:01.580 --> 55:02.920
But it's all related.

55:02.920 --> 55:09.200
It does create a completely virtuous circle, I guess you could say, from a control management perspective.

55:11.480 --> 55:15.280
So, final thoughts on all of this.

55:15.440 --> 55:22.860
When you are in security or compliance, your risk assessing organization, your job is actually to say yes.

55:22.940 --> 55:28.300
Security practitioners, we get a bad rap because people think we always say no.

55:28.300 --> 55:33.500
Our job is actually to figure out how to enable and empower the business.

55:33.580 --> 55:38.600
And so really, Patrick and I firmly believe that it's our job to say yes safely.

55:39.200 --> 55:51.140
And one of the ways we can say yes safely is to go through a regimented process of assessing risks and then coming up with action items and say, yes, it's fine to bring this new vendor on.

55:51.140 --> 55:53.400
It's fine to do this new process.

55:53.400 --> 56:03.440
But here are our recommendations for the ways to harden it, to improve the security and compliance and privacy of that system.

56:03.440 --> 56:07.100
And with that, thank you for listening to us.

56:07.100 --> 56:09.040
It's been our pleasure to talk to you.

56:09.040 --> 56:15.080
And we look forward to the Q&A portion here at DEF CON Biohacking Village.

