The Extended Reality (XR) Ethics in Medicine is the next paper in the series of the IEEE Global Initiative on the Ethics of Extended Reality. This paper explores the applications of medical XR, trends of telemedicine, AI assistant bots, and some proposed next steps in generating an XR Ethical Framework.
The paper was co-authored by Jason Evans, Palak Patel, and Georgia Livieri. Evans and Patel are two of the three co-founders of Nurenyx.ai, which is a decentralized clinical trial software that leverages extended reality. Livieri is an ethicist, Ethics manager, Ethics Advisor, and getting her Ph.D. on bioethics in the digital era. Tune in to hear more about some of the latest explorations of ethics within the context of medicine.
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Here’s a slide from one of Walter Greenleaf’s presentations that shows the depth and breadth of the field of Medical XR.
🎉THREAD of an 8-part Voices of VR podcast series on XR Ethics covering the white papers produced by @IEEESA's Global Initiative on the Ethics of Extended Reality.
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Music: Fatality
Rough Transcript
[00:00:05.452] Kent Bye: The Voices of VR Podcast. Hello, my name is Kent Bye, and welcome to The Voices of VR Podcast. So continuing on my series of XR Ethics in collaboration with the IEEE Global Initiative on the Ethics of Extended Reality, today's episode is around XR Ethics in Medicine. Before we dive into this conversation, I want to paint the scene of how I think about medicine and the implications of medicine. There's the medical context, which I think is what we're going to be diving into in terms of practitioners and patients that are actually working within the context of medicine. I think there's going to be medical insights that are coming from everybody that's dealing with XR, meaning that if you have epilepsy and there's going to be certain experiential design considerations you need to understand, to be able to design that it's safe for people and what kind of trigger warnings you need and whatnot. I feel like seizures are the first part of that, but there's going to be lots of other different types of medical conditions that folks are going to be need-aware of. I think there's another aspect of the medical context, which has to do with training. We're not going to be talking about that. This conversation is with Jason Evans and Palak Patel. They're both co-founders at a company called Nirenix AI. It's a decentralized clinical trial software that's using XR technologies to do different aspects of telemedicine, but also using AI bots. I feel like there's a lot of this conversation that's dictated by their own personal use case and trying to suss out some of the different open questions in terms of the ethics of these different startups moving into the frontiers of medical technologies. They also collaborated with Georgia Olivieri, who's been involved with the executive committee member for the IEEE XR Ethics effort, but also is a bioethicist and has a strong philosophical background. She's really interested in looking at this bioethics in the digital era and collaborated with Jason Evans and Palak Patel. to put together this survey of all the different issues that are coming up when you start to think about everything from telecommunications and data and all the other ethical implications when you start to do medical application in the context of extended reality. So that's what we're coming on today's episode of the Wastes of VR podcast. So this interview with Jason Polak in Georgia happened on Thursday, April 7th, 2022. So with that, let's go ahead and dive right in.
[00:02:19.992] Jason Evans: My name is Jason Evans. I'm from Toronto, Ontario, Canada. Extended reality, I've been involved with since probably 2014, 2013, the early days with virtual reality, looking at some early augmented reality. It wasn't until 2015 when Microsoft announced the mixed reality HoloLens and So I submitted an application that was invited to apply. In October, they visited Toronto and set up a studio, invited select participants, come in and demo the Microsoft HoloLens. At that point, my mind was completely blown wide open. I understood the implications of technology, how it applies. Specifically to my background, my career has been in healthcare. I have approximately 15 years of industry experience. working in fields of specialty pharmacy. I've worked in virology research laboratories and more latter towards hospital automation systems for government, for the hospitals. Around the time I started developing on the Microsoft HoloLens in 2016, there was a small community of developers. We collaborated, we co-developed a holographic communications platform in the days called Mix3D. simple application where participants could remotely connect from anywhere on the globe, and they would be overlaid as digital avatars within each other's physical environments. Fast forward to about 2017, I went to Queen's University to do a Master's of Management Innovation and Entrepreneurship degree. And I specifically put through the Mixed Reality application to further understand it and really how to turn it from a cool idea, cool feature into a business. That's about the time when I met Plok and one of our other co-founders, John O'Kellough. And together, the three of us combined our technologies and co-created a company called Nirenix, which is a digital health organization. And what we're trying to do is we're creating decentralized clinical trial software that leverages extended reality and artificial intelligence, specifically because there's a high problem of clinical trial failure rates. And since the onset of the pandemic with COVID, it really stopped the majority of clinical trials right dead in their tracks. It impacted many project timelines. It was very costly to organizations and it left the organization scrambling trying to use tools like Microsoft Teams or Zoom to conduct these clinical trials. And so we saw an opportunity there, and that's where we're kind of at right now. We're currently enrolled in several incubator programs, one of them being with MIT, another one being with the University of Toronto, the health innovation sub here, and then through Queen's University, our startup runaway program. Plus we have sponsorship, we're part of the NVIDIA Inception program. and we have full support. So that's kind of where we're at today with developing our technology and our product. And we saw an opportunity with this medical XR ethics paper through the IEEE, where we saw it as a real opportunity to dig in and understand the ethics of this technology and how it could apply to our own kind of undertakings. So that's a little spiel about myself. Clock or Georgia, would you like to go next?
[00:05:45.083] Palak Patel: I can go next. So as Jason said, we've been working together since 2019. But just before that, my background is I got trained as a microbiologist. And then I moved on to cancer diagnosis and therapeutics field. This is where I did my PhD. I met John O'Kellough, one of the co-founders, who is not here at the moment. But my expertise are in cancer pathology, molecular pathology, as well as looking into ways how we can better diagnose or therapeutically introduce newer novel interventions, ideally a non-invasive way. So this is where like after 2019 is John, Jason and I, when we got together, I think we thought like, you know, there was quite synergy. We had ideas where we can actually further explore this whole thing. So as Jason mentioned that, you know, the clinical trial, the way currently it's been run, a lot of hands-on work. A lot of management, administrative tasks that are being done, follow-ups and so forth. But a lot of that could actually be automated, not just for that, but for patients that we don't want them to get left out and so forth. And so educational aspect as well as the inclusivity aspect with our software, I think we are including XR so that they can actually get a little bit more immersive experience with exactly what they're looking into, how can they better understand the disease, and how the clinical trial or the mental methodologies or the treatments that they're taught of, how can they actually improve their lifestyle. So what are these outcomes, essentially? So this is where, like, we kind of pull our different expertise. So my expertise comes from the academia, like the research and educational aspects. And John McKellar has a little bit of a business background as well. He's at MIT at the moment, and as a result, he wasn't able to join us today. But we are accounting for a diverse resource and skill sets to make sure that we can kind of put the XRM as a centerpiece so that people, everyone can get even without traveling, without like, you know, in a very convenient manner, they could do it. And the, some of the things that we're looking into right now, how to make sure that this is XR technology, whole thing is being used in a safe, but at the same time, innovative manner where we push the boundaries, but at the same time, we actually put the patients or participants of the clinical trials in the center of it. And this is where the IEEE chapter that we wrote kind of was the focus of it. Thank you.
[00:08:10.633] Georgia Livieri: Hello, Kent. Hello, everyone. Thank you very much for the honourable invitation. My name is Georgia Livieri. I'm coming from Athens, Greece. I'm an ethicist with a strong philosophical background. As a profession, I'm acting as an ethics consultant to European-funded projects in several positions, either as an ethics expert or ethics advisor. My main position is to act as an ethics manager to governmental projects I'm also acting as an ethics advisor to Frankfurt Big Data Lab Bioethics, in collaboration with Goethe University in Frankfurt, based on digital health technologies. I'm also a head of the executive committee of the Cyprus Unit of the International Chair in Bioethics, and I'm currently a PhD candidate specializing in bioethics and public health policy. The new role of bioethics in the digital era is my main motivation, it's up to my research interests and I want to introduce bioethics to governmental health policies, to computer science companies and to pharmaceutical industry. So my relationship to XR technologies is from my philosophical point of view. And I'm very happy for this interdisciplinary and multidisciplinary collaboration among scientists from another country, from Canada, and the company-oriented approach. I'm chairing the External Ethics Advisory Board in collaboration with the University College Dublin to direct a project in particular. And this was my actual engagement to XR technologies. Basically, it has to do with augmented reality in education. So this is my background. Thank you very much once again.
[00:10:08.840] Kent Bye: Yeah. Thanks everyone for joining me today to unpack this paper that you all worked on, which I understand came together kind of late in the process, but was able to give a really good overview of not only the field of medical XR, but some of the issues that I think come up when it comes to ethics and XR that maybe go above and beyond just the medical context, but are other issues of neuro rights and the implications of privacy and mental privacy. and other issues that we'll dive into. But before we do that, I just wanted to maybe set a little bit of the background context of this paper, because it's broken up into different sections, and I understand that some of you were addressing different aspects. So maybe Jason, we can start with you with the introduction, and then Pollack, we can get into some of the use cases and applications, and then Georgia, we'll start to dive into some of the ethical frameworks and aspects there. And yeah, and other recommendations and other aspects, I think we'll have a discussion about each of the different sections, but Jason, maybe you could kick us off setting the background context for this paper and who you're trying to address and the different stakeholders involved.
[00:11:09.307] Jason Evans: So this was a wonderful collaboration that came together last second, we formulated a team, we were able to leverage each other's time zones, you know, Plok and I were located in Toronto, Georgia is located in Greece. So it was kind of nice because Once we met and formed the team and did the intros and found our strengths and weaknesses, first thing we did was we just put together a quick skeleton framework of the paper and outlining the different chapters that we wanted to focus on. Then we looked at it from where we could apply our own strengths and interests. So I took on the introduction of looking at it. I looked at also some of the key ethical principles, some of the challenges, risks, medical extended reality. PLOC took on the section of the use cases and the laws and the policies and the principles, and then Georgia took on the ethical approach for building a medical extended reality framework and the conclusions and the recommendations that we put forth. What we were hoping to achieve out of this paper was to introduce it to readers who may be new to the field of extended reality technology, but They see opportunities within the medical field, as you can imagine. medicine, healthcare, it's probably within the top three of the fastest growing segmented market industries for uptake and adoption of XR technology. So the first thing we did was we just defined an executive summary that just more or less provides a reader with an overview of what the paper will be about. Through the introduction along the way, it was interesting because when I first started approaching this, We're developing some of our own language models in the back. And I trained one of the models on medical ethics, because as you can imagine, medical ethics isn't a new field. It's been around since the beginning of the field, really. And what I was interested in was I just wanted to get the AI's perspective. So it actually provided a quote where it said, we can't stop technological progress. So we have to be prepared for the consequences. And I thought that was quite interesting because having worked in the field of healthcare in Canada and also in the United States, I know that the adoption of technology in healthcare is very slow. It's very antiquated and newer technologies typically won't be adopted until they're really truly tested and safety is ensured and privacy is ensured. And so I found that this quote was really interesting because it's true. We can't stop the technological progress and we do have to be prepared for the consequences, especially when right now in the field of XR, it's kind of like the wild, wild West. You have everyone kind of off doing their own applications, And they may not be considering the safety, the privacy, and other risk opportunities that this new technology could introduce. So this is what we were hoping to achieve with this paper was more or less just defining an overall framework that could be built on through future iterations of this paper. And we're looking to evolve specific tools and checklists that could be used from anyone from a health care provider to maybe a program manager, maybe a developer, a wide range of different stakeholders that may find value in this technology for their specific use cases. So, yeah, that's just a quick introduction of the paper and what we were hoping to achieve out of it. And perhaps if, Vlach, would you like to go next?
[00:15:08.451] Palak Patel: Yeah, I can go next, actually. Talk about some of the use cases that we found. So one of the things I think, you know, there is a lot of XR work being done in the field of cardiology, neuroscience and the pharmacy fields. So we just had a few things actually that were not just being the very early research settings, but more in the product, which is already available in the market that people are actually trying to use it for like, you know, their own educational empowerment or even for, in some cases, clinical trials as well. So the first XR that we found out was It's been extensively getting more and more incorporated into cardiology for obvious reasons, like patient education, as well as not just the patient, but the newer personnel and the medical students, as well as the staff experts to simulate exactly what the patient is experiencing versus what are the other data that we do have available. If you have everything that's readily available right in front of you, it will be a lot more easier for people. whoever is going to get educated training or even for this simulation purposes, it's a lot more informative just before you do any of the things. So simplest scenario that I would draw out would be like, you know, for example, you know, if you are suffering from a very chronic disease, And then you can understand exactly what causes that disease, you know, having their environment, like, you know, just going through each motions and all of that, like a more realistic manner. It's extremely helpful for the patients to actually understand what is causing their symptoms and how can you actually better understand them and how is this treatment that they're part of, for example, can help them. Another scenario that we did look into was something called the body VR, which is like essentially looking at like all your radiological images and like a CT scan, MRI scans, or like a PAT scans, for example. Instead of like looking at individual images and flipping through them, the XR, because also like often it's actually also powered with AI, you can actually reconstruct exactly images, like a 3D image model for that particular patient. It's very personalized. And we all know personalized medicine is actually making a way through, which will be the future of how we deal with the healthcare going forward. And this XR actually makes it available at your fingertips. You can do a couple of clicks and you have the entire patients specifically models there. You can use those models to either simulate, let's say, imagine patients going through like an open heart surgery, for example. Before you just do that and just go through the whole surgery, you can actually simulate scenarios, things that you can encounter, things that you would hope to fix at the moment. So the more experience, the more kind of If you're already in the settings, the environment, then it's a lot more easier and it improves your success rates for the overall treatment and all of the surgery, for example. So it is quite powerful at this aspect. And this is where I think that the cardiology, especially like understanding what is causing, you know, let's say hypercardiopathy or any cardiology related diseases, I think just for education for me, it's just significant. But at the same time, we want to make sure that it is also being used actively as a part of the healthcare that's being utilized down the line. Like, so I got the diagnosis of therapeutics, ideally more like the example I give you, it's actually been used by the heart surgeons. So Another thing that we also looked into was neuroscience, just because XR has that wide variety of features that you can actually enable. One of the things that we actually particularly highlighted in here was reality exposure therapy. This is more to address patients who are suffering from some kind of a phobia, for example. A lot of the time, instead of actually coming face-to-face with the things you are most afraid of, like something that you are challenged to face, Instead of doing this, you can actually ease it into it, but at the same time also have a realistic environment that you can actually go through. It will be a very mild dose that gets into intermediate dose and a very high dose. That way you can have that transitional therapy approach. for the patients who will be suffering, you know, for something like this. So that's one of the ones that we looked into at the same time that, you know, XR quite often it's also coupled with other plugins or other add-ons where you can actually, by just tracking the right moment, your expressions and so forth, you can actually monitor your mood changes and your state of stress, your happiness state, for example, a lot of those things. So for research purpose, you can learn a lot of those things from patient perspective. At the same time, knowing all of those things will actually help you further refine the treatment regimen that the patient is getting. So again, this is kind of pushing the boundaries of what we call personalized medicine. The last example that we highlighted here was pharmacy. And one of the things here with the pharmacy is a similar concept, like an educational concept. But at the same time, I think this is where users, like the patient, for example, who is using the drug, even the pharmacy students, for example, or pharmacists, they actually can look into the environment. For example, a patient suffering from drug abuse, like if they are addicted to fentanyl or anything. how would you actually try the rehab? Instead of like actually going to the traditional one, but the research studies have shown that if you actually use anything that is actually remotely even more realistic, virtualized or augmented even, you would have a significant improvement over that. And there have been newer studies that have done virtual reality, mindful exposure therapy. This is where you can actually easily can do rehab. It doesn't have to be like another patient's who were actually using as a drug or those like patients, for example, or patients are actually recovering from let's say a recent car accident. But in order for the pharmacy aspect is that, you know, all the time the drug will only take you so far. Sometimes always that other exercise or some kind of like therapy in a combined manner actually takes you all the way through. And this is where that concept comes in. Like for example, patients who recently went through a significant trauma, they do have medication. So the XR can be used to actually educate them at the same time, understand them, the effects that this compound is going to take place in their body. like you know, immersive way, so that they actually make them more understandable of the situation, so they don't actually overdose on the medication. At the same time, they can also be coupled with, for a realistic manner, where they actually, once they're on the medication, you also have to do some kind of rehab, and then you can actually go through that environmental exposure, like you know, just some simulations that you go through a couple of times a day, for example, or if you have been in an accident and you're recovering from a broken leg, for example, you're still taking, let's say, Oxycodone, but then at the same time, you start to do the medication. So once you understand the facts of what Oxycodone is doing, and then you're also actually matching up with the exercise, for example, in this kind of a very realistic environment, for example, or And then you have much more higher empowerment when you go through this, because you better understand that you know exactly what they're going to expect. And it's just much easier for them to see. So this is kind of like paving the next stages of the healthcare. Like the COVID did one good thing was like healthcare got virtualized to some extent. But XR is just making it look physically going into the hospital or the clinic or anything like that. You can actually do the treatment diagnosis and lots more in addition to that. So I think this is one of the things that the XR has an upper edge on compared to everything else there is there. So these are the three main fields that we did look into and we realized it's been either developed or applied regarding XR to these three fields. But the more you use this, the more you run into the ethical issues, like the laws and policies and the principles that you should be following and so forth. And that's something that XR is still relatively a new field. So it's not as developed like, for example, the telemedicine. Even though telemedicine existed years ago, but it wasn't actually actively utilized in practice. So even though the policies and the laws there are still limited, They're not like how, when you go to a physical, let's say you're in a walking clinic or you're a family doctor, for example, all the laws that are applied there, they may or may not apply everywhere else. With some conditions, they may apply more harshly in some places, they may apply very liberally in other places. Well, the thing that we highlighted here, which is actually one of the most important aspects of it is, how do you ensure the safety and effectiveness of the XR? For example, you are using XR as a medication, as a treatment approach. How do you know that it actually is effective? And it's also very safe, because the more immersive environment you have, There is also risk. A patient can get a lot more information. They can feel things in real time, or they can actually experience things in real time, for example, that they would not be able to do otherwise. But then how do you ensure? Because it can also go on the other side. Like, for example, someone's experiencing epileptic seizures, for example. Putting something on, like an XR-related, very enriched environment in front of them, that they may have some adverse reaction to it, like mentally or emotionally, for example. So one of the recommendations that we did a thorough evaluation about how XR technology has been developed, how they were tested, and what they need to be doing before they actually make it into the market. One of the things that we did look into is that they were the things we recommended actually, where they need to go in through the similar clinical trial setting. You have two arms, three arms, for example, and then you actually have placebo group and other groups And then you literally run a clinical trial with XR because it will be roughly straightforward and a little bit simpler because it doesn't require patients to be trial and so forth. But it still needs to happen just to make sure that the safety and effectiveness of the XR. If you see an improvement, you need to quantify and show that it is safe for patients and they are getting a benefit out of it. And that is something that still needs to be addressed and further actually developed. We all know how hard it is for a drug to actually make it into the market. but XR is a roughly new thing. And the things that does follow, it's very comparable to drug development cycle. So it needs to be, all of those laws and policy needs to be expanded to XR as well, modification obviously, but it still needs to fall under that umbrella. But one of the things that we did see like that, so not us, but there was another recent research paper where they actually reviewed how people were using XR publications and studies and so forth, like even clinical trials, for example. So they looked into like, you know, I think over 60 or 70, like a published work. And they've identified that the issue with this whole approach is a lot of the time it kind of surrounds the consent, confidentiality. Like XR, you generate a lot more data than a typical clinical trial would do. Because any approaches, any like iMoment, anything that you click on, anything that you visit, it's very confidential. So that was another one of the bigger issues that was brought up. Privacy, obviously, you know, how do you secure the data? For example, doctor-patient relationship. XR essentially puts both doctor and patient in the same room, although it's not in a physical clinical setting, but then what are the laws? How do you actually protect that environment in a way? For example, data security. How do you store data? Who would get access to it? And you know, how is it for longer term? Who is responsible for the information that you're providing to participants, patients, even students, or even the experts in the field through XR? Who is responsible for that content, right? And how is it being used? Recordkeeping, for example, licensing, continuity of care. There is a big list that actually provided in the whole thing, but we just want to make sure that, you know, a lot of these things actually is a lot. Some of these things have been actually addressed by the telemedicine. And so reinventing the wheel, this should be extended to XR. And obviously, you don't want to have completely different policies, brand new review of the XR, because that would take a lot more time, a lot more effort, and it just would not be feasible for a lot of the technologies that are being developed right now. In a staged approach, one of the things that can be done is the telemedicine or virtual medicine kind of laws and policies that are existing can extend them to XR. And then you have further built up or amendments to that policy specific for XR. So that way, like a staged approach would be a better way of addressing that. And the purpose for the whole chapter was also to kind of propose a framework for it. So, for example, if you are using XR for educating participants or the patients, the medical information, for example, has to be provided by a 34 healthcare provider. So it has to be designed and assessed by them. And so once you get approval, then it goes live, for example, so at least you're not misleading because you don't want to provide misinformation to participants. So this is one of the things that needs to happen because it's concerning the immersive facts and the experience a patient will be getting. it is going to be a lot more persuading for participants or whoever actually uses XR to kind of believe more into this than something else that they will read over the internet. So that is a potential concern that needs to be addressed. Like, you know, how do you curate this information, accurate information, so that the users of XR, they don't get misled, especially in the healthcare. So one of the recommendations we did make was like, you know, healthcare professionals can actually make this possible. because they do do this for a living at the same time and they are providing this information either in a brochure format or a printout format. If it actually gets available as an excerpt, for example, it will be a panel or kind of a table of the healthcare provider experts that would actually certify or approve it before they can be used for medical purposes. All these things should be included ideally while the XR is being developed for one specific purpose. That way you're not going back forth. For example, if you are initiating something like an XR-based healthcare tool in a single clinical trial and during that clinical trial path, you would actually look into typical how you would actually assess a drug, if it's effective, the safety and all of that. At the same time, information and the security, data security and privacy and all of that needs to be addressed during that setting as well. So that's been, you know, it gets critic the same way that how the FDA has been using the template to kind of score or rank every single drug that goes through their template, for example, and same thing with the healthcare. So those are some of the guidelines. We initiated the framework, how it would lay out, but obviously in the next version of the chapter, we will be updating the more information because I know that there is a lot of things that have happened since we drafted this and since it's been published. So the XR is one of those fields where there's a lot of development going on and a lot of more and more pharmaceutical companies, biotech companies are actually trying to utilize this tool. to deprive the healthcare of innovation. So we expect significant changes to the proposed framework, but at the same time, we'll be in line with how we are doing clinical trials at the same time, how the telemedicine has been regulated during the COVID time. So there are a lot of things that we can learn from it, and we can adapt for XR. So that's something that we try to capture in those laws and policies, as well as the use cases. Use cases, we just try to highlight some of the famous ones that are the more common ones that people have been using, and something that you can actually even go out there and buy one of the devices, and you can actually test it out yourself as well. So we try to highlight something that were more and far advanced that can be developed, there are far more things coming up at the moment for not just like the three fields that we highlighted, but a lot more.
[00:31:57.600] Kent Bye: Great. Yeah. That's a great overview of a lot of that stuff. And I'm going to digest that a little bit and offer some reflections and then pass it over to Georgia. Because when I think about the medical XR field, I've talked a lot to Walter Greenleaf, who has been mapping out the landscape of all the different medical XR applications. One of the ways that he breaks it up is the stakeholders of the doctors and the patients and the health care providers. Well, the health care providers often need training. So there's certain uses of XR technologies to do training for medical professionals. But I think in this paper, you're mostly focusing a lot of the medical context specifically, meaning that it's either patients using it directly for care, getting medical treatment or rehabilitation, which I think covers a lot of what you were talking about in terms of pharmacy and virtual exposure therapy and virtual therapeutics is another whole area of using immersive technologies as like a digital drug. But then there's for the doctors to be able to use it within the context of doing different operations or whatnot. So there's the education of the doctors, there's a use for the patients, but there's also the education for the patients as well, helping them to become aware of different issues So I've seen that in terms of the medical context, which in terms of the ethical considerations, I don't think comes up as much in terms of those more educational or training contexts. But you do spell out here in terms of the stakeholders, the patients, doctors and nurses and other health care providers. And then there's a larger stakeholders of patient advocacy groups, governments, associated agencies, clinicians, scientists, researchers, regulatory bodies, insurance companies, social workers, and other support staff. So lots of other broader stakeholders that I think maybe eventually XR will get in there. But mostly I think we're really focusing on the patients, doctors and nurses and the different ethical considerations that come up. How those other start to come into play is when you start to talk about the data and how the data is being transferred between a lot of these entities. And I'd say the other thing I just wanted to mention before we start to move on to a more ethical frameworks is just how There's medical XR applications in terms of using what I would consider to be medical grade technologies to be able to get certain biometric and physiological information that is going to actually be used across the entire spectrum of XR technologies. So you start to get into different things like neuro rights and the different ethics of that data and whether or not it's used in a medical context and whether or not these should be classified as medical devices, or what happens that data when you're taking stuff that would only used to be in the context of a medical application and protected by HIPAA here in the United States and now this is all of a sudden a consumer application that has that same level of medical grade information. And what are the different implications of passing back and forth this medical information? So I think you get into that a little bit within the neuroscience section, but I just wanted to highlight and reflect, there are other aspects of, even with what you might consider medical conditions of epilepsy, as an example, where you might have flashing lights that people who have that medical condition, but that all the other contexts of developers independent of the medical context need to be aware of certain things in terms of trauma induction of PTSD depersonalization. So I think there's a whole other aspects of the risks and threats in terms of creating safe environments and cyber sickness, you mentioned a little bit, but some of those different aspects of creating experiences that are going to be comfortable for people on the one hand, but also not trigger medical conditions that people may have. So I think that's another aspect of the medical XR ethics that I think is probably more broadly generalizable to the rest of the community. And there's a paper by Metzger and Madry, The Ethics of Virtual Reality, where they start to dig into some of those medical conditions. And some of them are mentioned here, but I just wanted to give that a shout out as well, because I think that's another aspect. There is one passage here in the laws, and maybe that will be a good segue to Georgia that you're working on. There was a paper by Mars Morrison Scott around selfie telemedicine, what are the legal and regulatory issues? And you quote saying that there's concerns that are around consent, confidentiality, privacy, doctor patient relationships, data security, responsibility, record keeping licensure, continuity of care, quality of care, image quality, concordance, phone stewardship and patient satisfaction. were identified in some of the proposed guidelines. So I thought that was really quite interesting to see how there's already this movement towards telemedicine and how some of the different discussions around the ethics of telemedicine are actually mapping over pretty closely to some of the broader XR considerations when it comes to when you start to use XR technologies and do this kind of remote social VR or using those to be able to connect patients in certain ways that some of these other issues come up. Georgia, maybe I'll pass it over to you to be able to pick up on that thread, but also to expand on what you're focusing on on this paper.
[00:36:50.520] Georgia Livieri: Thank you, Kent. Despite the fact that I'm coming from the philosophy, my main priority is to be brief and targeted. So, on the other hand, we have advances in computing and displays, we have medical XR technologies, but the main problem is the evaluation of medical XR devices, which has significantly delayed, causing inefficiency and increased regulatory burden. ensuring the safety and effectiveness of medical XR technologies applications and in identifying acceptable claims due to the pace of the development. So it's of high priority to take into serious consideration that the extended reality world raises a host of ethical and philosophical questions about the collection, the control and exploitation of user data within these ecosystems. My main concern is around vulnerable persons. What happened in these cases? Well, medical XR technology offers intriguing therapeutic possibilities, but we should place all of our attention on the development and the use of these technologies, which should be guided by ethical priorities. And one other aspect is with regards to consent forms. What happens in this case? And finally, I want to highlight the need for training to health professionals and education based on philosophical and ethical values. I think it's now more than ever the need to train on ethical and moral principles. And now I need your contribution.
[00:38:46.513] Kent Bye: Yeah, well, Georgia, did you mention that you're also looking at the telemedicine? Is that something that's part of your background of looking at some? No, no. Okay.
[00:38:55.301] Jason Evans: Yeah, I can, I can pop in there. So yeah, I have experience with telemedicine fields. And one of the things I think Plok touched on was with the patient doctor relationship. I just wanted to also highlight is that we need to consider the patient bot relationship because. We're investigating and developing digital humans that can automate the delivery of a lot of this information, a lot of medical information, a lot of patient training, a lot of health care provider training, a lot of simulation scenarios. A bot serves 24-7 on demand for the patient. Those interactions are logged, they're recorded. It's all in the realm of medical information. The privacy, the legality, the regulatory requirements are on this technology. We're trying to steer clear of the hurdles that one would encounter when developing a medical device. When we first started our undertakings, we were looking at incorporating computer vision for anomaly detection of non-invasive biomarkers. And we started quickly realizing, yes, we're kind of venturing into the territory of medical device, where now there's country-specific regulatory requirements that have to be adhered to. So we decided for our purposes, we would remain more within the medical information side. And then we're looking more at the data ownership. Who owns that data? How long would our entity have to host that data, even though we're not the true owners of that data? The true owners of the data would be the pharmaceutical sponsors or the contract research organizations that are leveraging our services to conduct their clinical trials. We also realize that we have to work with existing ethical review boards for clinical studies and clinical design, and technology has to be clinically validated. before it's even permitted to be used in a clinical trial. In post-market surveillance of a drug that's already hit market approval and is being actively prescribed is working as a support program and developing these bot services. That's where we see the opportunity because currently in telemedicine, telemedicine is serving several different functions as a lot of government agencies will and those telemedicine services for their patient 1-800 numbers or patients call and connect with nurses. Same with sponsoring drug manufacturers. They'll host patient support programs for drug therapies with 1-800 numbers that are staffed with nurses. But in the sense of like a new technology where the patient is logging in into an XR environment and they may not be interacting with a human, they're going to be interacting with the bot service more likely. So there has to be some ethical considerations that goes into the design of those bots. And then for the type of data that's being collected, if it starts getting into the medical device territory, and if digital twins block had mentioned on with patient data, patient organs, patient body being recreated in an XR environment. There's companies that specialize and focus on the whole digital twin aspect of recreating patient organs. There's a company that has the Living Heart Project, which basically 3D models every patient's heart, and then that heart can be used through experimentation Similar to like how an auto manufacturer will design a new vehicle and then they put that new vehicle through computerized simulations of various accident scenarios with crash test dummies to cut down on the material costs. So it's happening today with the digital twin aspect of human hearts. What happens to that data? Who stores it? Who owns it? What are the ethical considerations around it? I was looking at training a neural voice network using my own voice. It got me thinking. am I giving up the rights to my own voice? Who owns my voice? Some company could acquire it and I don't own my voice from a commercial aspect. Even though we're borrowing on top of existing principles, we're encountering new scenarios where the law just hasn't been defined. I just wanted to point out those aspects of the whole bot digital twin, digital human, and the whole data ownership aspects and the consent to providing ownership to that data. Are you giving up your rights? I remember when I was doing my undergrad and I had a professor that was saying that he wouldn't even lick an envelope to send to the insurance company because technically he's providing them a free DNA sample that they could sequence So what are the privacy considerations there? And as Palak mentioned, yeah, the personal identifiable information such as biometric data, you know, and even in an XR environment, you're inviting a camera into your physical living space. That's 3D mapping the entire environment. Are all the other participants in that household providing consent to be part of that scenario? So it's, As cool as the technology is, we have to be very careful with the safety and the risks that can emerge from it. So I just wanted to throw that in.
[00:44:10.698] Kent Bye: Yeah, the privacy aspects, I think, go across all contextual domains of VR, especially when you look at the neurorights movement and the right to mental privacy. And so there's a sentence in here that says the freedom of thought and mental integrity is one of the most important ethical issue for XR and these emerging technologies that can exert behavioral modifications and change patients' attitudes through persuasion. So certainly within the medical XR, that could be an issue. I think it's probably even a bigger issue when it comes to that implications in the context of consumer VR and surveillance capitalism mixed up with that. But I think that's covered within the broader privacy discussions that we dive into. And so one of the things I just wanted to highlight was that, you know, when looking at different neurophilosophical approaches, the citations from Kelmeyer and his looking at the ethical aspects of virtual reality and therapy. And, you know, the thing that came up again and again, a theme was this aspect of accessibility and diversity and inclusion of making sure that the technologies that you're providing are not cutting out specific populations. It may not be accessible for them, whether that's just from the simple aspect of cyber sickness or if there's other aspects. And so, George, I'd love to hear if there's any other comments you wanted to make there in terms of accessibility and making sure that that's one of the key foundational ethical issues when it comes to the philosophical and ethical issues.
[00:45:31.325] Georgia Livieri: One more, we have equity and sustainability to the design process. With regards to design for inclusivity and accessibility, If people hope to ensure all these advances, inclusiveness and equity, they should pay attention to voices from vulnerable, marginalized or under-deserved individuals and communities which sometimes they are under-represented in the past discussions, both on policy and product development. We have a lot to do at this field, I guess.
[00:46:08.854] Kent Bye: Yeah, there's another citation in there from Matt Cutrell and et al. Back in 2019, IEEE, in terms of looking at accessibility, looking at both the accessibility of VR content, the accessibility of interaction techniques, device hardware accessibility, inclusive user representations within VR environments, and then accessibility focused application areas for VR. So laying out some of those. And so those are also, I think, probably broader accessibility issues that also come up, but particularly within XR, but yeah, the equity aspects as well. And the privacy, you know, specifically there's within the United States, there's laws that govern medical privacy. And so there's a whole section in here that also goes into the different dimensions of personal health information, personally identifiable information and medical privacy and confidentiality. And it's probably worth just mentioning that within the health context, at least here in the United States and probably elsewhere around the world, that the information that's handled in a medical context is trying to have the ownership over that into the hands of the user. At the same time, there's some applications that want to share some of that data back and forth, but also make sure that it doesn't get out into the wrong hands because there's a the judicial responsibility for the doctors to not sell that data to insurance companies that are then gonna deny you access to healthcare coverage because they have access to that. That's maybe unique here in the United States that doesn't have a universal healthcare system, but there's considerations there in terms of the data, what happens to that data, and just generally the medical privacy as a particularly unique thing when it comes to the medical field. So I'm not sure if you have any other comments of some of the other dynamics there, especially when it comes to sharing information across applications and ensuring that the privacy and the integrity of the privacy is maintained.
[00:47:54.197] Jason Evans: Yeah, I can hop in here, Kent. I just wanted to add to the design for inclusivity and accessibility. This is a real opportunity, especially in the clinical trial space, because clinical trial operators typically have a hard time recruiting clinical trial participants, especially from diverse backgrounds. So you consider the average time that it takes for a participant to travel to a clinical trial site in person is approximately two hours each way. Plus it accrues costs because the participant has to typically take off time from work You know, they're paying for transportation costs, fuel, mileage on the vehicle. They're paying for maybe hotel costs, parking costs. There's a lot of costs. So it basically limits the participants. And most studies, they're not inclusive enough to recruit a real broad representation of the population to their trials. So this is where we see it as an opportunity for the clinical trials design within an extended reality environment. especially if you consider end users have the ability to choose whatever avatar they wish to represent themselves with. So you have to provide that flexibility for the participant to represent themselves in such a way, which may be different than their physical form. And we have to be very careful with the design considerations to make our environments as inclusive and as safe and as diverse as possible. but we also see it as a real opportunity for this technology because it can be more inclusive in a way and you know you might have access issues with the hardware devices or if there's expensive compute requirements for the participants or there may be internet connectivity issues. So this is where we've kind of expanded our solutioning to help address those concerns by offering cross-platform solutions where it's not just limited to XR devices rather these same applications can be accessible from any device through a mobile phone if needed. It's just a different medium, the same type of data that gets transferred around. And then even designing for remote regions where they might have internet issues, we can still design local apps on their devices that don't necessarily need to be connected to the internet. So All these issues, we're trying to build our environments to be as inclusive and accessible as possible, even if issues with people that suffer colorblindness or maybe have mobility issues. We have to be very careful to be considerate to all those needs. Maybe people have a hard time reading text, so you have to provide audio transcription. services and it just goes on and on. But the point is we can design these environments any way we choose and we can make them more safe and more inclusive as we learn from our end users.
[00:50:49.331] Kent Bye: Yeah. And as we go through the key ethical principles for use of medical extended reality, we talked a little bit about equitable and sustainable medical XR technologies and the needs for inclusive and accessible technologies. The consent I think is an interesting one because Informed consent, when it comes to consumer context, usually is through the context of an adhesion contract where it's basically you have to agree to it, otherwise you can't use the technology at all. But in the medical context, informed consent, you define here as the process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention. So I think this is interesting just because many times within medical procedures, there's a range of options that people could take with different tradeoffs. And so valid informed consent, you say, requires that the patient has a full understanding of the proposed intervention, including the potential risks, benefits and alternatives. So it seems like it could possibly be choices that people have to make between getting an intervention that's using XR technology or not. And then them being fully aware of all of the risks and benefits of the XR technology, but also the potential harms that may come from this as an intervention, because There's always going to be various trade-offs between whatever you take, but when it comes to that informed consent, I think that's something that's distinctly different here within the medical context than what I see in, say, a consumer context, where there doesn't seem to be the clear of different trade-offs that are made available to make a choice as to what kind of care that they want to receive.
[00:52:23.898] Jason Evans: Yeah, absolutely. Consent is a big part of this process and we're borrowing on top of existing process for registration and consent into a variety of different medical programs, patient support programs that private industry uses or government agencies use. There has to be some type of consent process and some sort of sign off to capture the participants consent into the specific intervention that they're being part of. And then furthermore, also an understanding of the legality and it's nice that laws like GDPR exist. where you have to spell it to the user, the types of data that you're collecting, how you're using that data, where it's being shared, how long it's being stored for. Like in Canada, clinical trials typically have a shelf life data requirement of approximately 15 to 20 years. I think it's the same time span in the US. So like that data ownership, who's going to store those records? How do you get those records if need being? And so forth. And that's where a lot of the healthcare privacy laws intersect with these type of technologies, because the same standards have to be adopted into the design. And that's where almost you have to be compliant to the regulatory requirements. And they're there to safeguard individuals so that there's no harm being introduced to them, you know, not understanding the consent process and what they're getting into. So it has to be clearly spelled out to the participant. They have to understand it. There has to be some type of record. And then there has to be some type of maintenance of those records for a period of time as well. Plaka, Georgia, would you like to further add to anything there from your experiences?
[00:54:08.562] Georgia Livieri: Yes, I totally agree with you, Jason. And I also want to add that I think that the emphasis should play a pivotal role in this process to the design of informed consent, not only to the implementation, I think. We should place all our attention on that because they do have philosophical and humanistic approach and I think it's of crucial significance to add this parameter in the future.
[00:54:39.683] Palak Patel: Yeah, actually, I would agree. But the way we typically do the consent, consenting pretty much like the patients or any like participants, for example, will not be the same for XR. It has to be include multiple different aspects. Typical consent is like, you know, how, what are you going to experience? What are you going to, how your candidate is going to use, which is what we see in the hospital settings. But this goes way beyond because there's so many other aspects that whoever is going to be sending that consent will get affected by. So I think all of those concepts needs to be But at the same time, I think the hardest part for the consent would be to make sure that whoever's signing that understands what that is and how that actually affects them down the line, like in the near future, for example. So I think, yeah, I agree with Jason's points as well as George's points here.
[00:55:27.006] Jason Evans: I just wanted to add also like in conditions where there's no informed consent available, say it's an unconscious patient and they've assigned their power of authority over to a caregiver or a family member and now that same consent process would be bestowed onto that individual who would be more or less enrolling that participant into a study where XR at whatever point may be leveraged as part of the intervention. So yeah, there's going to be conditions where it's an informed consent, but there's also conditions where it may be a surrogate who will be providing that consent on behalf of a patient who just is unconscious perhaps, or some other limiting factor that preventing them from a proper informed consent, maybe some type of disability. I'm sure there could be a variety of different situations.
[00:56:19.890] Georgia Livieri: From my experience, if we want to ensure trust and enhance transparency, ethicists are of crucial significance to this point. I can see that from my experience, because people participate and we have a better quality, improvement in quality and the outcome, if they're aware that an ethicist is behind the implementation and the design process. And I want to share this information with you.
[00:56:49.179] Kent Bye: Yeah. And I think that informed consent as we're talking about it is laying out some of those trade-offs. And I just wanted to, in the time we have remaining, go through the last couple of sections here of some of the different ethical implications or the ethical frameworks, but also the recommendations that you have. And so in this section of the key ethical issues, challenges and risks of medical extended reality, there's a couple of citations here I just wanted to point out. One is from like 1995, which was a really interesting blast from the past that had a lot of really interesting, still really valid recommendations, but the ethical issues and the applications of virtual reality to medicine by Wally and computers and biology and medicine from 1995. So again, establishing different aspects of clinical safety, which I think is a theme that comes up again and again, but also making sure that there's issues of free will nature of interpersonal relationships and the consequences of our interpersonal behaviors and how that's understood. And there's another interesting, more recent citation from the FDA, which they have a whole medical extended reality program, research on medical extended reality based medical devices. And so some recommendations from the FDA in terms of, again, making sure that things are evaluated properly, and then looking at some of these consumer grade technologies and the sensors and accelerators, IMUs, cameras, and whether or not they need to be validated for the context of clinical use that needs to have like a medical grade. In other words, for some of these sensors to be able to really be used in medical context. And then again, back to tools to be able to evaluate the accessibility and including people into it. So again, some of the stuff that you laid out previously, but I'd love to hear any other thoughts and reflections on this section about the key ethical issues, challenges, and risks of medical extended reality.
[00:58:29.119] Jason Evans: Yes, we're looking at some of the ethical issues of medical XR and that includes both from the perspective of the device to the applications, the software applications. So it's involving both hardware, software, it's involving the design, it involves looking at from a private to a public lens of the ownership of that information, that data, whether it's a private company or a public agency, the data sharing around it. These are all some of the key issues around the use of MedicalXR. And then I think accessibility is a big factor though, just because it won't be widely accessible to everyone and it's going to be a new technology and it's going to be used in such a way that you know, as it tries to be inclusive and involve everyone, it may also limit everyone. So we have to identify what those pitfalls are and what are those groups that need to be captured and incorporated in part of the design. And yeah, in this chapter, we just kind of go through some of the key ethical issues that have been referenced And then we look at the regulatory kind of the gaps and the challenges of getting it into it. And I think this is where it's starting to get into classifying your application. Is it more a medical device or is it medical information? Because there's different regulatory requirements for both. The medical device is certainly more expensive. It requires more time and resources to meet all the requirements. It has to get approval, typically from in Canada, South Canada and the United States, it's also the FDA, but a lot of these agencies are only beginning to evolve these digital health rules. It's only in the last two years, Canada has been putting together a digital health advisory group. And they're the ones that are looking at these newer technologies that involve extended reality, artificial intelligence, internet of things, and these policies are evolving. So you have to really stay on top of them because they change from day to day as they evolve. And that goes for every country. I don't know what it would be like in a place like Greece, Georgia, maybe you can mention it with the regulatory landscape in Greece and the ethical considerations there.
[01:00:48.854] Georgia Livieri: We have a lot of work to do here in Greece with regards to the regulatory. There are many gaps here, but we have to address them. And of course, from an ethical point of view, I think health professionals and all people which are engaged to healthcare technology should be trained and deal with the future, the future challenges, which are not.
[01:01:14.538] Kent Bye: Yeah, well maybe when the last moments that we have here, we can go through quickly some of the different recommendations that you have and then start to wrap up.
[01:01:22.542] Jason Evans: Okay. So this final section, Georgia, you can speak to it. You led this one.
[01:01:30.185] Georgia Livieri: Oh, well, yes, actually we have here some recommendations. As I have said before, we need to develop a framework. This is of crucial significance since this framework should provide recommendations and guidelines based on designing, on testing and supporting the XR tools and models in healthcare settings. What is more, we need to have a comprehensive review of the landscape in healthcare. That means that An extensive review should be conducted with regards to the use of XR in healthcare setting and the organizations. If we want to have innovation in the field and better understand the size of market and the potential future growth sectors. Apart from that, we need to have a center of excellence to connect XR technologies with healthcare community. Of course, if we want to promote and encourage collaborations, about networking between the technology developers and the adopters, such as healthcare providers. We need, of course, partnerships between several fields such as academia, healthcare workers and XR device manufacturers. And we need to be critical on these emerging technologies. Furthermore, we need to promote guidelines and further equip, guarantee guidelines Testing and validation framework, which means we need the framework for testing and validating the XR-based medical tools. Transparency to the data collection, of course, we have mentioned that previously. And the medical XR ethics framework is necessary, which would be oriented on addressing the key concerns and providing questions for the exploration through an ethical point of view based on results and relationships and the reputation. And I think the final one is with regards to the decision-making model. We need to provide a decision roadmap for key collaborations including all stakeholders and other decision makers to input context into the design of technology that will go through an evaluation process including negotiation of course.
[01:04:01.020] Palak Patel: I think just the two things I would add like very quickly is, you know, that the recommendation need like the transparent data collection. I will also add usage, because the question would be like, you know, okay, you have the transparency and data collection, but how are you using it? Like, you know, we don't want to get this data in hands of insurance companies, for example, that can, you know, use it against you, for example, right, for any identity theft, for kind of an example. So I think that's one thing. And the other thing would be, now that I'm thinking, like, just because there were a couple of things that I've been noticing in, like, you know, the literature in the news conferences, where accessibility. So that, for example, like in Canada, for example, the normal general population is an aging population. So you essentially, they will be the one who will be utilizing healthcare resources the most. And the average age of that population is about 55 to 60 years. So you want to make sure that they have access, but at the same time, they are the ones using this. So obviously the millennia and all the younger age people will be very on board with this, but I think also I think that the gap needs to also be addressed, you know, not just like you know accessible that has to be throughout the diverse population, the communities across, you know, Canada or anywhere else in the world. I think that is one thing that would probably That's something that I'll probably think about doing some more research and adding that into it, because I think that's something that we need to actually keep track of exactly. You don't want to make sure that only the rich people or the very people who have easy access to these kind of technologies use it, but you want to make sure that it is something that's readily available, but at the same time, the focus on, let's say in Canada, for example, aging population, you know, they know exactly how to get access and how to use these devices, for example. I think that will be a key part as well. So accessibility and like a lot of these kind of intra-educational aspects.
[01:05:55.682] Jason Evans: And I just wanted to add to all those points that could roll up into effectively staging organizations against a maturity model for XR. Similar how you see it in like project management offices and other quality centers of excellence and organizations, typically they'll have a maturity model and And the maturity model can be an accumulation of all these factor inputs that more or less produce like how mature is that organization for delivering these types of services based on this ethical framework. So that's kind of where we see it evolving towards because it's certainly lacking right now. Like I mentioned, it's kind of like the wild, wild west. It's all these kind of loosely held standards.
[01:06:40.287] Kent Bye: Yeah, well, I think you guys did a really great job of giving a broad overview of the space and what is known and what is still yet to be done in terms of the work where this needs to go to the future. So it's a really good. Roadmap that helps to not only bring these insights into the medical context, but also the same types of things likely need to happen within other domains as well. So I'll be curious to kind of start to dig in and have similar conversations with the other paper authors to be able to. see the similarities across privacy and accessibility is one that I can already see is universal across all these contexts. But just as a final wrap-up question, I'd love to hear from each of you what you think the ultimate potential of virtual reality might be, and especially in the context of medicine, and what it might be able to enable.
[01:07:26.720] Jason Evans: Yeah, I can take this one then. So unless, Plok, you want to jump in. But yeah, the way I see this evolving is, yeah, it's very immature at this point in time. As the technology is evolving, so will the use cases and the breadth of those use cases and the scenarios that we'll discover along the way and account for and The whole goal to all this is to develop some type of standards, set of standards that can be adhered to by developers and organizations that are interested in healthcare and medicine, because the implications of XR technology are enormous for every single stakeholder involved. There can be improvements. in terms of how they conduct their business processes, how they collect information, how they connect remotely with their participants, how they can automate a lot of services using technologies like artificial intelligence. in XR to provide and deliver immersive and compelling end-user experiences for patient education and healthcare training. So the opportunities are endless, but at the start, we have to be able to define the set of standards effectively to make this technology more successful, more safe, and just overall more responsible to minimize harm. That's where I see it kind of evolving towards.
[01:08:48.391] Palak Patel: Yeah, and I think some of the things that I've noticed, since we've actually crafted this, we did the research and crafted this document, so when you capture like the top three fields where the use cases were, they're actually getting applied in much different ways to other fields, and that's something that we haven't captured. So the way, or probably random, you know, the use cases, even if it's not something that more heavily utilized, but if it's for a short case and it's conclusive, if they've done, you know, a good enough research to kind of back it up, I think I will probably do it in that kind of model where, you know, these are the successful use cases, not so much as how people have been trying to adapt and apply. Another thing that I would say, some of the papers actually, like as you mentioned here, like, you know, telemedicine laws and policies will be extended to XR, just to begin with, so that at least there's some initial phase that are being protected, but at the same time, the program review still needs to be done. But I think I would say within a year or so, I think we would see some of those negotiations and conversations coming up forward. And I think that's where I would say that, you know, how it starts being developed at the same time that this kind of technology is getting cheaper and cheaper by the day. So I think more and more people are actually inclined to use it or develop it. But I think that kind of a recognition, like the acknowledgement from the consumer side, for example, of who are the people who will be using this, it's not there yet. So I would also kind of have that kind of, you know, focus on that kind of education aspect, not just for like, you know, using this device, but about these devices, like, you know, how you can use this technology to further better empower your own health care. And so I think I would see a similar role, like, you know, like MSL, like the Medical Science Liaison, but like, you know, depending on like, for Microsoft, you know, XR, the HoloLens 2 or 3 device, for example, I think they will have a similar kind of approach, how pharmaceutical companies have been approaching this. Similar thing I would see from this developer, like a tech company, where they can actually reach out to healthcare professionals or practitioners to better adopt and recommend these devices or this technology to their users or the patients.
[01:11:02.374] Georgia Livieri: So last but not least, I think that medical XR technologies are very promising. So we have a lot to do, we have a lot to learn, and we should definitely develop frameworks standards, regulations, and definitely there is an urgent need for governmental policies with regards to medical XR technologies. Thank you very much, Ken, for this interview. Thank you.
[01:11:33.159] Kent Bye: Yeah. And Jason Pollock and Georgia, I very much appreciate the work that you did here. You know, I just wanted to cite one statistic that you had from a Perkins Coie survey from 2019 that said that the medical XR was like the second largest industry vertical. And so there is a lot of traction and there's a lot of movement in this space. And I think the type of stuff that you're laying out here provides a really good roadmap and framework. to close a lot of these regulatory gaps and gaps between what needs to happen in terms of the standard for validating these technologies. And there's a lot of potential promise, but still a lot of work to be done in navigating all these different issues that you lay out here, the privacy and accessibility, equity, all the other aspects that we talked about here. So, yeah, thanks again for writing this up and taking the time to chat about it today. So thank you.
[01:12:16.491] Palak Patel: And thank you, Ken. It's our pleasure. It is, yeah. Thanks so much.
[01:12:22.448] Jason Evans: Thank you very much, Kent. We appreciate the invitation. And yeah, it was a pleasure working with Georgia and Bloch on this paper. And we're just looking forward to future iterations and how we can expand on it. So thanks again.
[01:12:34.566] Georgia Livieri: Yes, looking forward to our next collaboration.
[01:12:37.844] Kent Bye: So that was Jason Evans and Palak Patel. They're both co-founders of Neurinix AI, which is a decentralized clinical trial software that is leveraging extended reality, as well as Georgia Oliveira. She's based out of Athens, Greece, and an ethicist with a strong philosophical background, working on her PhD, specifically focusing on bioethics in the digital era. So I have a number of takeaways about this interview is that, first of all, As they start to map out some of the different background and stakeholders and considerations and some use cases, I do actually think there's a lot more use cases that Walter Greenleaf has been documenting for a number of years. They pointed out cardiology, neuroscience and pharmacy. dozens of other things beyond just those three. I'm not sure why they chose just those three, but I think, from my sense, the field of medical XR is indeed, from Perkins Coie, one of the top three industries where XR is really thriving. Just because there is a lot of overlap between the types of sensor technologies, as they start to integrate that into XR technologies, it's enabling all sorts of new medical applications. Some of the different key principles for the medical extended reality that we talked about, some of the equitable and sustainable medical extended reality technologies, but also just design for inclusivity and accessibility, going back to the previous conversation of accessibility and all the different challenges there. Now, what was interesting to me was to hear how the different telemedicine applications that they were advocating for could also, on one hand, increase accessibility for a lot of people, but on the other hand, I think there's still a lot of challenges that need to be overcome in order to have an equal playing field for everybody to enjoy the same types of benefits for that type of telemedicine. I would hate to have everything move into a virtual telemedicine context, and there'd be no more physical hospitals, and then people wouldn't be able to actually get help if they couldn't use the virtually mediated technology. I don't think that's going to happen. I think there's always a need for physical help that you would get at a hospital. But it's just one of the things to point at, that in order to really move into that future of telemedicine, that inclusivity and accessibility has got to be at a foundational baseline to be able to get it working as good as other mediated technologies, or at least being able to bring more increased accessibility for people that actually provides an opportunity for them to have more accessibility than they didn't have before. Consent into medical extended reality apps is an interesting conversation because I think in the context of the medical consent it's a lot different than say adhesion contracts that are kind of a take it or leave it type of approach that when you have an informed consent when it comes to the consumer space and so the medical space has a lot more of just trying to lay out all the different variety of different options and all the different trade-offs and costs and benefits between all the different varieties of different approaches that you may be able to take in the future once you have more and more virtual therapeutics There's a whole other area of telecommunications and privacy, which, again, going back to privacy again and again, that's information that comes up. Here, there's personal health information and personally identifiable information, and then medical privacy and confidentiality. There's a lot of ways in which that COVID is bringing a new era of telemedicine, just because of COVIDSafe protocol. The technology was always there and possible, but I think it took a pandemic to start to have people start to actually create these alternatives than just going and having a face-to-face interaction. There's probably a lot of laws that were set up to prevent a lot of that type of telemedicine from a privacy perspective. Hopefully, a lot of these different gaps are starting to be closed, and we're moving into this new era to open up all sorts of new possibilities for having telemedicine through these immersive technologies. Just through the course of this conversation, there was a lot of specific things in terms of AI bots and being able to do this type of clinical trial that is very specific to their use case that I think is maybe not as generalizable to the entire field of medical XR. But I think they actually still managed to be able to do a great job of viewing all of the generalized aspects of medical XR. As it starts to expand out into other applications, I'm very curious to see if there's other papers that have been done with specific medical journals that are starting to explore some of these different ethical issues. It seems like telemedicine was probably the one area that was a lot of overlap between what has already been done in terms of the scholarship and pulling in different citations from the early 90s. Lots of different people that are thinking about that at a high-level, abstract level. Then the last sections of the different key ethical issues and challenges and risk of medical accident reality with the framework that was put forth by Georgia and starting to come up with what's needed as we move forward. It was, for me, a little bit more of a call to action of, this is the stuff that we need more as we move forward in terms of the need for an R&D and validation framework, a comprehensive review of the XR landscape in healthcare. established centers of excellence, connecting the XR health community and partnerships, adoption guidelines and testing and validation framework, transparent data collection, the medical XR framework, and the medical XR ethics decision-making model. A lot of things that are more aspirational for next steps. Some of this work may have already started to happen with the existing communities that are out there. The comprehensive review of the XR landscape in healthcare, I again point to the work that Walter Greenleaf has been doing. You can check out a lot of his slide shares, where he's been mapping that and really keeping track of it. He's been advising a lot of these different companies, but he's been at the heart of this community for well over 30 years now. There's a lot of folks that have been involved in this space and really helping to push it forward. Skip Rozo is another one. A lot of people that have been there for a long, long time. This is a good first draft in terms of starting to kickstart the conversation. Like I said, I'd like to see other folks come in and see if there's other stuff that's missing from here. There are other aspects, like I said at the very beginning, where I do think there's going to be certain things that every XR designer is going to need to know, not just people within the medical context. understanding things like depersonalization and the virtual body ownership illusion, or PTSD and trauma triggers, or things like epilepsy and seizures. So there's a whole list of that that, again, I refer to Michael Madry and Thomas Metzinger from 2016 in The Frontiers of Robotics and AI called Real Virtuality, a Code of Ethical Conduct, Recommendations for Good Scientific Practice and the Consumers of VR Technology. So that's a good piece. to go refer to to get some of those more universal aspects of the physiological implications of the technology. They're going to be universally applicable for everybody. I'm sure that's probably due for an update and just generally what are the different stuff that folks should be aware of. Just the other comment of how there's whole other areas of medical training. Are there other specific considerations about medical training, or does that fit into the education and training paper that we'll be diving into here? So, that's all that I have for today, and I just wanted to thank you for listening to the Voices of VR podcast. If you enjoyed the podcast, then please do spread the word, tell your friends, and consider becoming a member of the Patreon. This is a necessary part of the podcast, and I do rely upon donations from people like yourself in order to continue bringing this coverage. So you can become a member and donate today at patreon.com slash voicesofvr. Thanks for listening.
