Re-Think Health Podcast Season 1

Season 1: Pain Points of Integrating New Technologies into an Existing Healthcare Ecosystem

In the premier season, we explore the explosive growth of internet-based communication protocols and mobile health devices/apps in clinical research and consumer therapeutics. Season 1’s five-part series features technologists, researchers, and ethicists sharing insights into opportunities and challenges of these latest technology applications, vet stakeholders’ unresolved concerns, and highlight the need for trusted and validated solutions including global adoption of consensus-driven open source standards.

Episode 1

BioCompute - Open and Connected Gene Communication

Maria Palombini, Director of Emerging Communities & Opportunities Development and Healthcare and Life Sciences (HLS) Practice Lead at IEEE Standards Association (IEEE SA), interviews Raja Mazumder and Jonathon Keeney to shine a spotlight on the many different use cases from submissions for FDA regulatory review, to potential COVID-19 antibody research and other vaccine and infectious disease development applications.

Speakers
Raja Mazumder

As a Biochemistry and Molecular Medicine professor and co-director of The McCormick Genomic & Proteomic Center at The George Washington University (GW) and while working at National Center for Biotechnology Information (NCBI) at NIH, and UniProt Dr. Mazumder has worked closely with national and international colleagues in developing international molecular biology resources and using these resources to identify therapeutics, diagnostics and vaccines targets. His research focus is on developing novel methods for data-to-knowledge discovery through national and international initiatives in biomedical sciences such as GlyGen and OncoMX, and community driven bioinformatics projects such as the BioCompute initiative. He has experience in scientific coordination, bioinformatics infrastructure building, and through NCI, NSF, NIGMS, NIAD, pharmaceutical, non-profit and FDA funding he has been involved in genomic and bioinformatics research associated with cancer biology, glycobiology, and metagenomics. Dr. Mazumder is also the co-developer of High Performance Integrated Virtual Environment (HIVE) which is approved for use in a regulatory environment at US FDA. In addition to his research activities he mentors faculty, graduate students, and directs the Bioinformatics M.S. graduate program track and co-directs the Ph.D. Bioinformatics and Genomics program at GW.

Follow Raja Mazumder on Twitter. Learn more at https://orcid.org/0000-0001-8823-9945.

Raja Mazumder Headshot
Jonathon Keeney

Jonathon Keeney is a Research Assistant Professor, Managing Director for the Executive Steering Committee for the BioCompute Public Private Partnership, and lead for the High-performance Integrated Virtual Environment (HIVE) bioinformatics platform. He was Secretary for IEEE 2791-2020, the BioCompute standard, which is now a published standard adopted by the FDA and others. His work develops novel approaches to research questions that comprise both strategy and bioinformatic framework, and which have included neuroscience, microbiome, and virus research. He has contributed heavily to the development of the BioCompute standard for the communication of computational analyses, genomic copy number variation in the developing human brain, and strategies for adventitious virus detection.

Follow Jonathon Keeney on LinkedIn.

Jonothon Keeney headshot
Full Transcript

Maria Palombini:
Hello everyone. I’m Maria Palombini with the IEEE Standards Association. I lead the Healthcare and Life Sciences practice. So much is changing in the world of health. We have new technologies, tools, and applications, all of which should make us think: how can we rethink the approach to health, so that we as patients, you and me, end up with better health.

I’m very excited to have with me the chairs of IEEE 2791 Raja Mazumder and Jonathon Keeney. Just for all of you who don’t know what P2791 is, we just actually released that standard last month, very fresh off the presses. And it is the IEEE standard for bioinformatics analysis generated by high throughput sequencing to facilitate communication. Yes, it is quite a mouthful, but very important, very cutting edge application of this technology.

And you will see, it is important today even in the middle of this global pandemic. Just to let you know, Raja is a professor of biochemistry and molecular medicine and co-director of the McCormick Genomic & Proteomic Center at the George Washington University. And Jonathon is an assistant research professor in bioinformatics department of biochemistry and molecular medicine also at the George Washington University. And he’s a member of the executive steering committee for biocompute. Let’s get to the great stuff, Raja. We hear genome sequencing seems to be talk within the science community about solving the position medicine puzzle. We know genomes generate great insight, but a lot of it in many different places, therefore, what exactly is biocompute and how will it help address this growing challenge?

Raja Mazumder:
Thank you Maria, and that’s a great question. Genome sequencing, in my mind, has revolutionized the way we do biomedical research. We do biomedical research worldwide. When sequencing started happening, it became really easy to generate a lot of data and analyze it. Now, the problem that happened was that the data, but it was not being well documented. So biocompute helps organize this information in a way that is human and machine readable.

Jonathon Keeney:
I would add to that. I think you’re right, that genome research can really generate really great insights, but exactly how sometimes may not be clear. For example, the degree of variation in some sort of certain spot in the genome and whether or not these contribute to disease or just normal variance is sort of an ongoing question. For example, in genome research is still fairly new. So there’s still thousands of questions like this. And the way that genome data gets turned into useful information depends on the question that’s being asked and the way that the researcher is asking that question and the way that they’re trying to answer it. And so, because of all that variability, it can be very hard to follow what someone did. And so there’s, there’s been a real need for some way of communicating that information in a clear and articulate way.

And some labs have tried to standardize the way that they report that sort of information on their own. And that’s really great, but it’s often specific to the way that they do things and not widely adopted. And so biocompute has been great because it’s, it really abstracts away the process of a computational analysis from any specific way of doing things. It doesn’t matter which software you use or which platform or which strategy and so on. You keep doing things exactly the way that you have been. And because there’s been such a big community investment in building the standard that will help meet the needs of the most number of people. So different groups will know exactly what to expect when communicating their work to each other.

Maria Palombini:
Fascinating. I know I’ve talked to your colleague Dr. Vahan Simonyan many times, and he tells me, we’re just starting to scratch the surface of the amount of data we can get from human genomes alone. And he said that a year ago and it really holds true. This is fascinating work. So, Jonathon you know, we know that biocompute is a public private partnership and we kind of would like to know how it came about with the FDA and, you know, besides university and the FDA who are some other partners involved and more or less like, what are the motivating factors to join forces? I’m sure this was not born overnight.

Jonathon Keeney:
No, it wasn’t. Well, there’s a big difference in a standard in the application of that standard. Maybe you could standardize a cigarette later for your car and they have the same dimensions and the same power and the same safety, et cetera. And then people go and start using it to charge their electronic devices. So, you know, there’s a big difference between the way that something is standardized and the application of that standard. And so the public private partnership is meant to tackle issues like that. It’s a great vehicle for a federal agency that’s considering using the standard as a means to communicate next generation sequencing information to them.

So they say, you know, this is what we’re considering doing as a means to apply that standard. And the partnership will facilitate development evolution and use of the standard. For example, that could be in terms of joint projects with a common goal or formal integration of the standard into institutions or building extension domains that have their own consensus. One of the cool things about biocompute is that it’s got this, this user defined extension domain. So biocompute will work for probably 99% of all use cases because it was built on this consensus, but there’s going to be some specific applications where it may not. And so in order to deal with that, there’s this extension domain built in so that different groups can kind of modify it in their own way. The partnership can kind of help my building, some of those and things like that. The partnership is actually brand new, as you mentioned, the standard just published. And we’re recruiting for it right now.

Raja Mazumder:
In addition to that the partners that we have been working with for now several years will contribute it to the development of the standard, our industry partners pharmaceutical companies, bioinformatics platform companies, and so on, and also academic institutions. So a standard is only useful when different groups use it to communicate with each other also. For example, academic institution may develop this really amazing protocol for detecting viruses or detecting Rapids mutation and viruses. And then industrial partner can then take it to the next level and make the product a diagnostic product. And then they submit the product it’s a whole ecosystem. And at every step, there could be dozens, maybe sometimes more than that, people involved in developing this product. And it’s critical that when something like this is being developed, that every step of the process is correctly recorded and also standardized and biocompute helps achieve that. So it’s the whole process from all the way from the bench all the way until it reaches the bedside biocompute actually has a very important role to play. Last year we did publish a paper in plus biology with several of our collaborators on how biocompute helps precision medicine.

Maria Palombini:
I can totally see that Raja. I mean, I’m so glad that you highlighted the point because there are not many standards out there that I’m aware of that can really give you the gamut from bench to bedside. And this is one of the unique applications of the biocompute standard, you know and the other interesting about this Jonathon, was that I noticed you guys had a heavy focus on making it an open source standard. Do you want to maybe just explain a little bit why there was such a commitment or dedication to that concept?

Jonathon Keeney:
Yeah, sure. I think there’s a couple of answers to that. One is that we’ve taken great pains to make the entire process adhere to what’s called the fair standards. Findable, accessible, interoperable and reusable. And so this is a big part of that effort. And that’s a very big effort in academia right now. And in research generally to try and make research that conforms to that fair standard. The other thing is, you know, like I said, individual labs have standardized the way that they’ve done things and it’s great, but the real power of language of communication, like this is when lots and lots of people use it.

And we really needed to go through a formal standardization process. It’s well recognized and has a far reach, but we wanted to do it in a way that still empowers the individual researchers who are very independent minded. And having an open, open source repository allows different groups to build off of it in their own ways that might be integrated into their own systems. You know, so for example, if there’s a private company that has some sort of proprietary process that they don’t want to expose, and they there’s something about it, they want to keep to themselves, but they still want to build an internal way of handling that that is compatible with biocompute, we’ve made it very easy to do that, so they can fork off a branch of the repository and kind of build off of it in their own way.

Maria Palombini:
Excellent. P2791 is actually one of the first projects of the IEEE SA open source program. Everything just fell into the right place. Speaking of that Raja. So we’re focusing on the standard, the publishing of the standard, but there’s a little bit more to biocompute in the full suite of opportunities and services that it can provide just beyond the actual standard. Maybe we could talk a little bit about them and how they actually all work together and help in the entire process.

Raja Mazumder:
Yes. So using the biocompute, creating a biocompute, reading a biocompute and so on to get there. We do realize that sometimes it makes sense to have demos in our training. Right now, for example, we are providing treaty to FDA regulatory scientists on how to evaluate and use biocompute and these types of framings, you know, we are also recording and we are going to make them available through biocomputeobject.org and other places, really at a level where people can look at the reporting YouTube video kind of things. But on top of that, there is another thing that we have already started doing, which is registering the domain space for biocompute. For example, if you are a pharmaceutical company and you’re a big company and you have multiple products, multiple groups working on many, many projects, and you want to register a particular space for the view, which means, let’s say you are company X, Y, Z. All your biocompute starts with XYZ. So we have a mechanism in place which allows institutes companies, whatever have you to register their succession space within our compute object registry.

So this will allow them to be, to have unique identifiers for their biocompute objects as they go along so that they can refer to it when they’re submitting something or submitting some research work to a journal or, or even for their own in house lab note. This is really important. You also have ways where our mechanisms for people who do not have the resources to create their own biocompute object database, and their own interfaces to create a biocompute. So there are links which will take you to some tutorials to create a vital object that gets stored within the within the biking.org gaming space. Those are some of the things that we are working with. There, there are a few others that are going to come out within the next six months to a year. And we are really looking forward to it. Actually we are already working on some of the COVID-19 and the SARS related issues that is all on everybody’s mind. So biocompute is also playing, or at least we are trying to go to create right computer objects, which might help in that direction.

Maria Palombini:
You took the words right out of my mouth for, with regards to COVID-19, because we know this omnipresent pandemic may consume all of us. We know that the race is on right to find the vaccine hundreds of companies are getting into it. So my question to you is how, how can really biocompute help the researcher right now and beyond just COVID-19 what are some, what would you in your mind say, this is a great use case to use the biocompute standard, whether it’s in vaccine or some other sort of application within the healthcare ecosystem.

Raja Mazumder:
You know, that’s something, I mean, I’m wondering use the, the, the COVID-19 as an example, then I can talk about a little bit about a few other things. Right now there are thousands off genomic sequences for the SARS strains that are being generated. Many of them are getting deposited at NCBI or GIS aid or other places. And many of these genomes people are calling variations. They say these genomes of SARS strains, which were isolated from let’s say, Germany is different than what has been isolated from Australia. There’s a big bioinformatics application that has to happen for you to make those kinds of statements, right? You first, the next generation sequencing, you assemble all of the reads, and then you identify what are the new stations based on the restaurant strain that they’re using.

If I use the Wuhan reference string, for example, and you use a different reference strain or mutation profile a little bit different, and trying to dig in who is using what it’s time consuming and actually makes it very hard to figure out how to compare and contrast results from different groups from around the world, if people are losing biocompute objects. So when you tell me these are the mutations, and this is the biocompute object that defines exactly how I found it. Then when I analyze it, then I can know easily what exactly you did. And this is going to be important. And not only in identifying what are the different mutations circulating mutations right now in the human population, it’s going to help people who are working on vaccines or working on antivirals. We’re working on drugs to see how the mutations are happening.

Let’s say in the spike protein, which is one of the most important vaccine targets, the spike protein, which is a glycoprotein. So this is important. Now it has been important in the past. It has, it will be important in the future talking about the past. So several years ago, there was an outbreak of food pathogen in Germany, and next generation sequencing data was used to identify the pathogen fast forward several years. There was another outbreak of a similar pathogen over, in all care in the U S. Now, if we had the biocompute objects on the Germany study, then we could apply it and see, okay, so we are using the exact same methods to see if we are able to detect the pathogen that was detected in in, in Germany. So it saves a lot of time. It just saves a lot of effort, but on top of that, it helps us also see how by informatics methods and other technologies are evolving over time.

So, for example, what if the current methods are more sensitive? So you use the old biocompute object to then improve upon it, to say, hey, now we can detect at a much lower level, our faculty at it using this biocompute because you’re using a much more sensitive software and the name of the software and the portion of the software, then wouldn’t biocompute. So all of these things are not only important to save time and money, but also helps us understand, are we actually getting better at doing some of these things over the years, or are we just at standstill? And the algorithms are not getting better? So this is an easy and a quick way to evaluate these and the things because my computer objects also has a computer also has the input files, the output files, and also what are the possible errors that one can generate. And the validation that is associated with the, biocompute in together, all of this can help a user to run analysis what the original authors of the biocompute object had used an envision of what the sparkle should be.

Jonathon Keeney:
Yeah. That was a really great answer. The one quick thing I would add to that is that there has actually been a similar use case that I’ll mention really quickly which was something called the RE TB pipeline. And that’s a pipeline that the world health organization adapted for the detection of tuberculosis. And so one of the researchers who was funded by the Bill and Melinda Gates foundation actually came and presented at one of our workshop, the ways that they’re using biocompute for that pipeline for, for ways similar to what Raja was talking about. And so I think that’s a great example because it’s a situation where you have lots and lots of researchers that are all very geographically distributed around the world, and they all need to be on the same page fast, and they don’t have time for these big errors in communication and things need to be very clear.

And so biocompute is perfect for that. And it lets researchers as we said earlier, keep doing what they’re doing without needing to change anything about their workflows. It just gets everyone on the same page as far as how that communication happens back and forth, and it sets expectations for what data is in the document and where it exists and so on. And since there is so many similarities with, with COVID-19 research, I think that’s, that’s a really good use case example to kind of pattern some of this work after and it also kind of helps demonstrate the utility, you know, it sort of sets the precedence for using bio-computer in that kind of a way.

Maria Palombini:
Excellent. I mean, I automatically could see right away once I read the full standards deck about it. So, so Jonathon, this is not something you can maybe so easily just pick up and go with. I imagine there may be some training, obviously in today’s situation. It might be virtual. Do you guys have anything going on? How can people find out about if there’s any kind of training or a virtual training?

Jonathon Keeney:
Yeah, it can’t, I mean, we made it tried to make it as easy to understand as possible. You know, that’s sort of the fundamental idea is grouping all of the information into these conceptually meaningful categories. If you want to know the parameters, you go to the perimeter parametric domain, if you want to know the IO files, you go to the input output domain. So, you know, at a very basic, yeah, I get it kind of level. Hopefully it will be relatively easy to understand, but you’re right. It’s, it’s got a lot of depth to it and a lot of advanced things that you can do. And so as Raja mentioned, we are building training modules for the FDA right now to explain how to read a BCO, what information is in it, what to do in certain circumstances and so on.

And we can certainly build training modules for other groups based on our experiences, too. I think at this point, it’s safe to say we’re sort of subject matter experts in this space. And I think the best way to do that is just to reach out and to contact Raja. And I we are putting together a lot of different training modules and materials. We have a BCO editor that can help people. It’s a, a web based a form-based way to build BCS that’s on the web and it kind of walks you through building it. But as I mentioned, there’s more advanced things that you can do with it. I talked a little bit about the extension domain. There’s a lot of things that you can do in that kind of a case. If your, your project is very specific, you wanted to build a bibliography domain or a supplemental domain or something like that. There’s a lot of really cool things that you can do with it. And we can, we can most definitely help out with that and the best way to do that. It’s just to directly contact Raja. And I great.

Maria Palombini:
So we’re up on our time. I want to thank Raja and Jonathon for joining me today. I feel like we could have maybe made this interview for like two hours, cause there’s so much great stuff in there. We didn’t even start to scratch the surface of the opportunity for 2791, but also I want to share with all of you out there that 2791 is actually part of a new pilot we’re doing in the healthcare life science practice called the rapid activator program. And it’s exactly how it sounds. The idea is a recently published standard that we want to put to work and try to get some feedback on how it’s performing its environment. So if it’s a form of biotech company or a research organization using it and that way we can actually help educate on how to use the standard and what outcomes to look for and that kind of thing.

So if you’re a researcher out there or, you know, in a pharma or a biopharmaceutical company, or within a government research organization who feels that this would be a great opportunity for them, please do not hesitate to reach out to me. It’s [email protected] Also, as Jonathon mentioned, the training and all the suite of opportunities, if you’re interested in learning more, you can visit www.biocomputeobject.org. There’s a whole bunch of great information there even how the, the whole biocomputer object came to happen. So I think that’d be a great resource and to learn more about the actual standard and other IEEE standards. And also P2791 is featured in our contributions and work we’re doing for COVID-19. You can visit standards that standards.ieee.org.

Episode 2

Decentralizing Clinical Trials – Removing the Pain in Enhancing Patient Care

Maria Palombini, Director of Emerging Communities & Opportunities Development and Healthcare & Life Sciences (HLS) Practice Lead at the IEEE Standards Association (IEEE SA), interviews Walter De Brouwer, CEO & Founder of Doc.ai and Chair of the IEEE SA Technology and Data Harmonization for Enabling Decentralized Clinical Trials Industry Connections (IC) Program to discuss decentralizing clinical trials, addressing remote health challenges during COVID-19, and how to engage in the IC program.

Speaker
Walter De Brouwer

Walter De Brouwer is the founder and CEO of the Palo-Alto based deep learning company Doc.ai. which is building AI-powered pipelines for the pharma and healthcare industry. He is an adjunct professor at Stanford University School of Medicine (CERC) and the executive Chairman of xy.ai, a Harvard spin-off that uses satellite data to map the impact of the exposome on human health. Additionally, Walter is Chair of the IEEE SA’s IC19-004-01; a member of RDSC (the ROCHE Data Science Coalition); a member of Anthem’s Digital Leadership; and a member of TED and of the American Mathematical Society. He holds a master’s degree in Formal Linguistics from the University of Ghent, Belgium, and a Ph.D. in Computational Semantics from the Catholic University of Tilburg, the Netherlands. His current interests include 5G Cognitive Radio, tinyML, Quantum Computing, Federated Edge Learning, and Information Theory.

Follow Walter De Brouwer on Twitter.

Walter De Brouwer Headshot
Full Transcript

Maria Palombini:
Hello everyone, welcome to Re-Think Health, a podcast series powered by, IEEE SA Health Care and Life Sciences Practice. I’m Maria Palombini. And I’m your host and I’m delighted that you’ve joined us today.

Maria Palombini:
It’s a really exciting discussion on digitalizing clinical trials, what I like to call removing the pain and enhancing patient care, and I’m honored to have with me Walter De Brouwer, founder and CEO of Doc.ai and the volunteer chair of the IEEE SA Technology and Data Harmonization for Enabling Remote [now entitled Decentralized] Clinical Trials Industry Connections Program. As you all know, for those of you who are actually members, we put a lot of words into a lot of our programs. So just a little bit about Walter. He is an adjunct professor at Stanford University School of Medicine and a visiting professor at the School of Management. He runs the Harvard Medical School spinoff XY.AI, which actually pioneered the digital twin algorithm in medical research and created the geo-intelligence system to study the cosmic burden on genomes. That just a sentence alone just makes me think how amazing and grand that work is. He also participates in various other programs, including the Growth Data Science Coalition and other organizations. So and he has many interesting interests and interests. He’s looking at five key cognitive radio, quantum computing and everything in between. So, Walter, thank you for joining me today. It’s a pleasure to have you.

Walter De Brouwer:
Thank you for having me.

Maria Palombini:
So we know whoever’s in the pharmaceutical health care domain that there are some systemic challenges in clinical trials. So let’s start with who clinical trials are supposed to help patients? Why do patients feel so out of the loop when it comes to the ability to make decisions about their health in their care? And what are some of the trends impacting drug development, cheering and ownership of this health data?

Walter De Brouwer:
Well, first of all, I think it’s common for too many people that we have a delivery problem for health care in the United States. And delivery problems always arise when it’s just some of the scaling per square kilometer and the inhabitants of scale kilometers. And it’s also a symptom of the complexity of industrialized civilizations, of course. But in the states, really to get an appointment with the doctor or specialist, it’s really painful. And also the costs associated to that are horrendous because we are in a situation where medical bills are the first cause of bankruptcy in the United States. And then if the results were great, perhaps we could understand that a little bit. But the results are abysmal because we have the lowest life span, the lowest life expectancy. We have the highest mortality of babies. So we have the highest rates of suicide.

So there is something between the collection of price and value that is completely wrong. And also our health care is linked to our job. So you mostly get sick when you’re not having a job because you have too much time. Time is also a bit of like a medication. You know, you can overdose if you have too much time. But just when you don’t have a job and then you’re also your health care falls away. And then there are all these layers, like I call them the five piece, like the patient is one.

But there is the provider, the physician of pharma, the politics, the regulator. And all these create actually and the pay are of course, all these create an enormous layer of bureaucracy where the patient has to find its way.

And for the moment they don’t find their way in and they just do the best they can. So Americans aren’t a society of whiners, so they just make to make the best of it. But being out of that digging, that side loop is, of course, of course, one of the reasons our mental health problems also go off.

Maria Palombini:
Absolutely. There’s just the whole complexity of problems. Speaking of an interesting problem, we are all in the midst of our fourth or fifth month of this covid-19 pandemic, which has been which has opened the Pandora’s box for the idea of telehealth, remote health and care. And we also know that many clinical trials, unfortunately, had to be paused or canceled as a result of the pandemic. So when the clinical trials IC program was born at the end over a year ago at the IEEE Standards Association, we had not envisioned covid-19 pandemic. At the time, we were trying to address some of the challenges we saw in the clinical trials industry and low and behold, the future became today.

Maria Palombini:
So my question to you is, how do you think the group can impact the continuation of trials in the future even? With covid-19 and beyond to whatever the next potential challenge might be, how and what do you foresee happening as a result of it?

Walter De Brouwer:
Well, first of all, there’s a lot of new things that have happened in technology that still have to go into drug development, which will dramatically reduce the costs of medical research. You know, why have all these clinical trials forced now? Well, first of all, there’s this paranoia set in. Patients don’t want to see doctors because they think they’re infectious and doctors don’t want to see patients because they think they’re infectious. So and so they find each other on the screen and that they now know that it’s a lot easier. And they can also do it digitally, which is we have evolved towards a synchronous communication society. We’d rather actually do things writing or chatting than ever having actually voice calls, which you can never interrupt because there’s a guy, you know, sitting in his living room talking about this life for an hour. So all these things are actually very good for people to realize, hey, you know, there’s a new kind of delivery there and it works very well for doctors and for patients. And why have these trials now paused not only because of that, but because people start to realize I don’t want to go to a site where there are doctors, where I’m actually handled in an unfriendly way, almost like patronizing way. And there is another way for us to do it. If I want to be in a trial, I don’t want to do it for eight dollars a day and risk my health and go through all this hassle.

So people who organize clinical trials have to rethink this relationship today because, of course, nobody likes change. You know, my wife always says that I only change to avoid change, which is probably true, but probably work for everyone. But, there’s something worse than change and that is an irrelevance. And this is the time to change now. And of course, if your bread and butter and if you make a great income, it’s very hard to persuade people who make a lot of money that they have to change, you know, but it has to be.

So let’s look at the drug development. How can the technologies of today, how can we make this a lot cheaper and a lot better? First of all, there is a big wave coming and now it’s covid-19. This has brought momentum and acceleration. So patients and they are realizing it. Patients are becoming the buyer’s market. So the seller’s market is over more and more. They will be in charge. They want a Yelp industry of doctors and providers so that decentralization from a central point of hospitals where people have to go and to a doctor. And so they want to do it, you know, like what they are experiencing now. They want to keep it going.

And this also translates in our technology because we now have we build up the cloud, you know, like where every enterprise is using the cloud and every user is using the cloud. But now everyone has a smartphone. So if you think of it. And so, first of all, if you have a smartphone, you are basically a researcher. And that’s a new concept that we have to tell people, as is the story that we have to tell people now, and that we have to actually admit to people that medicine we don’t know everything.

Basically in medical research, we use a lot of statistics to basically hide our temporary ignorance of facts. So we should also share that with people that they are researchers, the participants are researchers, and they can do that on their smartphone and in that smartphone. We will use from the technology side every component in that smartphone to extract medical information. And that smartphone itself will be a remote device where a hub where we can connect to all the other devices around us and extract medical data. And then the technology is now there to both ensure the privacy on the edge of the device, because now if you have a smartphone, you don’t need to go to the cloud anymore, you know, as an individual, because I can store more on my smartphone than on my laptop. I can compute on my smartphone. But until recently I could not train a model. I could not make my smartphone learn.

Now, at Federated Learning, we can do everything on a smartphone. So that means in the future. Now, how does it work? Like we have a lot of daytime companies have a lot of data. They put it in the cloud, which is a sort of a public toilet, you know, like because you never know who goes before, who comes off to you and you just want to wash your hands and get out. Now, we can do it on our smartphone and we don’t have to go back to the cloud and process some information that is there. It is on our smartphone and what where it is created, it will be continuously computer. And so we are going for health care as a discrete function. And with the discrete function, I mean, like your bank account, you know, something goes in, goes out. It’s a bit like a patient, you know, like you false that put them in a hospital. A week later, they will come out and that’s where the protocol ends. And then, you know, you see people crawling to a cup and there again in the world, in the real world, and they don’t actually know what happened to them.

So that’s because health care is a discrete function. We only need, you know, engineers who are once also discrete. We only corrected bugs in the system, but now we don’t do that anymore. Well, we’re still correctable bugs, but I mean, we are looking at what we are doing as a marathon. We are continuously looking for security and looking for mistakes. And health care will be a continuous function, just like a plant that grows that is only to singularities.

You are born and you die. And everything that comes between is a superposition of you are healthy and you are not healthy. But by getting a lot of data on that, we will you know, patients will learn to know themselves and they will if they have a disease, they will even become expert patients after that, you know, to tell other patients, because if they give me the opportunity, if I have a disease to talk to an expert doctor or an expert patient who went through it, I first want to talk to the patient. So all these things are happening now that decentralization and another big thing is happening that is real world data. And I want to explain that a little bit, because this is going to be so important for the future.

Up to now, our medical research worked in controlled studies with the placebo control group and another group, some group got the real bill. The other group got the placebo. You know, people always have placebo for you. You know, like, you know, I have the placebo pill that basically – you come to a situation where they come to people like us, you know, mathematicians, and they make us a model because it has to go through the FDA. And these are the standard deviations that the FDA will follow. So for us, so that we white boards, because we know the success of getting through the FDA is basically how you calculate error.

So we are making a model of a world and we stipulate what this world is. And in this world, the model works and the drug works. But please don’t go out of this world because it’s a world. It is not the world. So then afterwards you go into the world and there you have something like pharmacovigilance, which the FDA does, and then you see how a drug performs in the market.

Now, why do we do that? It cost a lot of money. It’s basically mathematically controlled into an ideal world while we could do real world data and real world evidence. And where is that? Well, for instance, it’s in claims that its claims are payers, insurers, and they have already actually paid out for a disease. And we sure, if they pay out, you really have had that disease, you know, because they check every step of it so that that’s the placebo. So you can give people a bill and then you take, you know, like a big amount of data where you make digital twins. Basically, you say like we want the same people, the same BMI, the same age, the same gender, the same condition, and that is the placebo. This will speed up medical research enormously. And so out of that comes real world evidence.

Then another thing, that’s why I mentioned this, everything on extra computing and the learning for the first time in the world, probably we have found a way which is non zero sum up to that. You know, for data up to now, everything was a zero sum. If I get something, I have to take it from somewhere else. So that’s why people don’t want to give their data because, you know, everyone keeps their data in silos because if they give it, they don’t no longer have what we have done.

And basically on earlier research of Google in 2015, we were the first actually that worked on that for medical research because what does it mean? Well, in Federated Learning, you give a model to people who have data and you say, you know, populate that model and give us the encrypted answers, which is mathematical formula. And that is actually the essence of the learning. You don’t know any of the data. You haven’t touched the data. You don’t even know the structure of the data. You certainly don’t know who is behind that data or, you know, you don’t have to identify it, but then you can exchange the answers and both win. It’s a win-win. It’s not a zero sum. So this will help medical research enormously because in academia, we always have to beg for data. Now, with that new situation where A.I. has come on through learning, we can even do it on smartphones. People can collect their data on their smartphones. And then what we do is we put all these smartphones together and then everyone because of a smartphone. I know how I am doing, but I don’t know how the others are doing. So I have no point of view. But if I then have how I’m doing and all the learning of all the others, I not only learn, but I also know where I am in the perspective to the.

So also we have recently you know, there is a big problem with privacy and with learning privacy won’t go away. People think that, you know, at one point we’ll give up our privacy. I don’t believe that because our DNA is unique. If I give my DNA to someone, I expose my germline. Perhaps my grandchild someday will be brought up because his DNA is mixed up with other DNA and he gets in through Jalabi by some, you know, like because I didn’t check my sources when I did that the privacy will not go away. But you also have to learn. So how can you how can our models learn with privacy data? And of course, we have all sorts of we can use hashes and cryptography, but there’s another way we can just leave it to the user, to the patient, and we can tell them, because how does privacy work? We are adding randomization. So we are adding a lot of random noise to something. If you take a picture and you want it completely private, you won’t recognize yourself in that picture anymore and nobody will be able to decrypt. But then that picture cannot learn anymore. When you tell people you can you yourself, you can actually Parise that if you want 50 percent privacy and 50 percent learning, that’s what we will give you.

If you want 80 percent privacy, 20 percent learning, because you see that is the equilibrium. What do you want? You want to learn or do you want to be completely private? And I think that’s the best way to leave it to the people. This creates markets. You know, perhaps medical research wants people who are complete. They want to know everything so they will have to pay more because this is going to be a gig economy, just like doctors are basically now already in the gig economy. If you do telehealth, you find them on several systems, the same doctor. It’s a bit like you drive for people, you drive for Lyft and then concierge doctors, they drive the limos the same thing. And now patients will also go into that gig economy because in their downtime on their phone, they will add some, you know, medical information for which they will be paid because in micropayment, every time they do that, so they will make you know, they will make a bit of money. And so, for instance, one of our sisters, we have integrated Amazon or no cryptocurrency or just Amazon. Amazon goes. So what does that mean? Well, people make points on Amazon and they can buy everything on Amazon. Basically, it’s really become the world’s store.

You can buy everything. And people like it because that’s the new way of going to research, I think. I believe all these new technologies will dramatically reduce the cost of medical research. It will give Thayer’s, for instance, who have a lot of data, which is real world data, the ability to sell that data and reduce their premiums. It will give people like Walmart or Verizon enormous ability of getting that data and also sell it and therefore reduce their prices. So everything is reduced. The bias market comes up, services go up. People are friendly. And it may be an idealistic world, but it’s one that I want to believe in and as a scientist, we are ready to make this happen, but we need leaders who go behind this. You know, we need leaders of large corporations to say this is what we’re going to do, a little bit of channeling and consensus. But in the end, this is the vision. And we also need this to be accepted by clinical research. We need publishing. We need to publish about this is how we did it with placebo as well, how we did it. We’re not placebo. This works. This doesn’t work. So if we get these two things together, so then we are in a completely different world.

Maria Palombini:
And so, well, that was very fascinating, your vision, I mean, you have set out quite a task for your team on this industry connections program. For those of you not a part of our legal system, maybe in the connections program, you can understand as an incubator program. And it’s to take a team of 12 groups working with Walter to sort of test and make this sort of vision happen. Right. And what does that look like from workflows to changing the process? I think it’s just unbelievable. One point that I think is really you covered so many great points on benefits to patients and benefits to sponsors of clinical trials. I guess you touched on this. This is a very I don’t like to use the term disruptive in medicine because it makes people feel uneasy. But this is really revolutionizing how we think about trials in the process. And what do you what will you do you believe is going to be the element that’s going to get all these stakeholders to sort of change and accept this new approach? This is the way we have to go. What do you fundamentally believe will drive home? That is a policy like FDA writes it in. Is it through the development of standards? Is it your consensus of the system? Like what do you feel will be the turning point? Well, I have to say I have to be part of this. I have to engage this.

Walter De Brouwer:
Well, I think the industry, as it now is, is a bit like the post office. And we basically bungled the post office. The physical aspect is now Amazon and the digital aspect is email. And we’re all happy with the delivery. So when we see US Postal or coming to our door, say, I was only able to even think about this anymore, I think that we are going for and now everyone is aligned. We are going for what I call the de-carbonization of health care. And with de-carbonization, I mean fewer and fewer humans, you know, carbon based units, the highest form of carbonization is hospitals. It’s, you know, because you need more than one human and then you need more than 10 humans through a project and to bureaucratize these other humans. So it’s the number-one line item of cost. A lot of people go to hospitals and they shouldn’t go there. That’s why we have you know, we have a delivery problem there. So people should just stay in there. You know, I think there are a couple of startups now already working on the strip at the hospital rooms up at home where you just if you just need an ultrasound, you can now buy one for two thousand dollars. You can rent them at a hundred dollars a month. And since you have a virtual health care on your screen, you know, a doctor can say, oh, that looks like this, or you can even do this now. Or, you know, like there are companies like seven cents. You can just put it on your arm. There’s so many things available now. And you know what? The number one, that item that people go to hospitals for is an I.V. drip. You know, like say like, you know, you can really do that at home. You know, like a nurse can do that or, you know, they can show you once and in training you have to do it through each other. The next level of carbonization is the physical checkup.

Now, before you have a telehealth, you first have to meet this doctor who sits on the other part of the room. You are both masked. No, actually, it’s not necessary. You can even do it immediately. Telehealth is the third line, you know, like hospitals, doctors, telehealth, telehealth is a little digital. But there’s still like a doctor that on the other side before it’s de-carbonization is digital. And that is you can chat, you can go email, you can look at the response group, you can text your doctor. And you really love it because, you know, I prefer to text my doctor about medication and my medication arrives at home then really to go there and talk about it. It’s no use. Of course, I’m a declarative person. I do not seek a regulation. And then the last part is mobile, we have an agent’s identity for mental health that we are getting ready now. We put all the clinical protocols in there because there’s a lot of anxiety around now, because the more you give data to people, the more anxious they become before actually providing in the human being. So serenity is so great. People love it. Why? Because it all stays on your phone.

If you want to talk about mental health issues and anxiety, I don’t want to be on a corporate server somewhere. I want to give it to Google, you know, like before you know, it ends up somewhere you don’t want to. I want to be on my phone own device, not going to the cops. And this is possible. So this is the funnel. Hospital’s physical doctor, then virtual health, digital health, mobile health, because we will never be comfortable with getting the human out of the loop. You know, we thought so 20 years ago, 30 years ago. We thought so with banking. We optimize the hell out of banking. And in the beginning, every banker thought they were going to lose their jobs. But guess what? There are more bankers now than ever. And also there are more computer scientists working in banks every time we introduce technology. It doesn’t reduce jobs. It creates, of course, probably not with the same people. But that’s the learning thing that you have to actively work on, not becoming irrelevant. And also and it’s fun working alone. Just learning brings you adrenaline. It gives me a little probably. Well, I think it gives everyone that you just have to learn them how to learn, you know, and yeah, that’s how I see that funnel going from hospital to doctor to virtual to digital to robot. And this will scale doctors because no way we will create 10 times more doctors than we have now in the next five years. That’s not possible.

Maria Palombini:
Well, there’s so many great pieces of information and insight you share with us today. Walter, we’ve come up on time just if anybody’s interested in joining the clinical.

And Walter and his cohorts have been leading this incubator program, please visit standards that are too big. This is a great participation. If you are a pharma company or a technologist, a chain company, if you want to see clinical trials really revolutionized, this is the opportunity to be a part of something that will definitely put a football front in the ground. Walter, thank you so much for your time today. I will be sure to invite you again to see how the team is progressing and definitely get a little more insight into how you’re seeing the future of trials going and how we’re starting to make that change for everyone else. Thank you so much for joining us. Until next time. Stay safe and be well.

Episode 3

Taking a Stand – Moving Medical Wearables Beyond Monitoring

In an effort to enhance clinical research, Maria Palombini, Director of Emerging Communities & Opportunities Development and Healthcare & Life Sciences (HLS) Practice Lead at the IEEE Standards Association (IEEE SA), interviews Jennifer Goldsack, Executive Director of Digital Medicine Society (DiME) to explore the need for bringing together pharmaceutical clinical researchers and technologists to compel device makers to embrace and develop open source and compatible technologies.

Speaker
Jennifer Goldsack

Jennifer C. Goldsack co-founded and serves as the Executive Director of the Digital Medicine Society (DiMe), a 501(c)(3) non-profit organization dedicated to advancing digital medicine to optimize human health. Jen’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine.

Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA. There, she led development and implementation of several projects within CTTI’s Digital Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System.

Jen spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware.

Jen earned her master’s degree in chemistry from the University of Oxford, England, her master’s in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Jen is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.

Follow Jennifer Goldsack on Twitter.

Jennifer Goldsack Headshot
Full Transcript

Maria Palombini:
Welcome to the Re-Think Health podcast series. I am your host, Maria Palombini, leader of the IEEE Standards Association Healthcare and Life Sciences Practice. You may wonder why this podcast series so much is changing in the world of health, new technology tools, applications, all of which should make us think, how can we rethink their approach to health care so that patients like you and me will end up with better health. We are bringing you experts, advocates, researchers who are looking at how we need to rethink the process anywhere in the healthcare ecosystem. So we’re talking from the bench to bedside and all with the goal to get us where we need to be healthier today. I’m delighted to bring you one of these experts, Jennifer Goldsack, executive director of the Digital Medicine Society. Our episode today is entitled taking a stand moving health wearables to the necessary next level. And by the end of this short broadcast, you will understand why and how to get involved. So Jennifer, welcome to the podcast.

Jennifer Goldsack:
Thanks, Maria. I appreciate you inviting me today.

Maria Palombini:
So tell us a little bit about yourself and your work as a digital medicine society.

Jennifer Goldsack:
Yeah. So if you said I’m the executive director here at the digital medicine society or dying Maria, we’re a 501c3 nonprofit. We are a member organization and we are committed to advancing the safe, effective, ethical, and equitable use of digital medicine products to improve lives.

Maria Palombini:
Excellent. So this is how I came to know Jennifer because we have a lot of alignments here. We were talking about ethical, responsible use of technologies. How do we advance medicine? How do we save lives? So you want to give us some examples, some of the great work that Digital Medicine Society has done.

Jennifer Goldsack:
Yeah. So it was still quite humorous. So we were founded in May 2019. At the time of this recording, we are at sort of 16 months old, we held us to a high standard, like if Maria is doing clinical quality wise on a text timeline, we recognize that there’s huge opportunity to use new digital technologies, whether that’s access to new dataset or whether it’s on a face, but it’s computing power to improve lives. We also recognize that the pace of innovation and health technology is moving a little bit faster than all of the stakeholders find it easy to understand, and certainly at faster than our pay to regulate and control it. So we are very focused on making sure that these technologies are really deployed in the service of health and that we don’t miss that. A critically important part of that. We believe it’s bringing all of the different experts to the table for citizen scientists and bioethicists through every flavor that is clinical and engineering. It’s basically scientists to regulators and payers. If everyone isn’t at the table, we are not going to have the success and improving outcomes and improving lives that we should. And we may also submit step along the way. So our role here at DiMe is to try and coordinate expertise and collaboration and unifying frameworks and languages using digital technologies.

Maria Palombini:
Absolutely agreed and well said. Before we get to the core of what our conversations about, you know, we’re in a very digital world. So I would like to ask you, what is one little fun fact about you that would really humanize your voice, your expertise with our audience?

Jennifer Goldsack:
So I tell you this, it makes me feel older than I can shake. You may notice that my accent is British. I found myself in the US in 2007. My mother’s actually American. So I always had dual citizenship. And, um, I also graduating from grad school at a university about outputs. I actually spent a few years as a professional athlete. So when I came to the States, I’ve been on the British rowing team for a few years and they changed to the States, use my American passport and actually competed on the U S seven 15, um, in Beijing in 2008. And Maria, I intended to go straight into your mouth today calling back to London, but I really loved the safety. So having sort of retired from my athletic career, um, I got into, uh, sort of health research here in the States. Um, and I’ve been here ever since. So that’s probably my contacts. And we’ll say here in the US.

Maria Palombini:
That is fascinating. So we have an Olympian on our podcast. Very exciting today.

Jennifer Goldsack:
Yes, that’s right. Very stubborn. I feel like doing the right way.

Maria Palombini:
That’s exciting. We’re getting into our next segment. The core of the whole podcast is what are we trying to rethink here? Therefore, big tech in healthcare, we’re hearing more about digital therapeutics. We know there’s a growing use of wearables. There is reports all over from all kinds of the big consultancies to the big research writers saying anywhere from 120 million health wearables to be utilized by 2023 sensors in the body, on the body, around the body, wearable, ECG, monitors, wearable, blood pressures, fitness trackers, excellent. Every 75% of the population wants to use them to go towards better health. But here’s the core question. What are we doing with these wearables? What are we not pushing the bounds on? So, Jennifer, my question to you is in your words, what do you think is being issue with health wearables as it relates to clinical research?

Jennifer Goldsack:
Picking just one issue is a bit of a challenge. And I used to be that not to be negative about weather, but because I think it’s moving really quickly. I would say these two things I’d want to highlight Maria. I think we’re at a moment where people have taken their eye off the ball, not everyone, but I think that there’s a misnomer right now, even in some of the statistics that you just quoted, that more digital, more health tech is better. Um, and I think, um, I think that’s the wrong way to look at it. And there are persistent challenges that we faced in health tech and in clinical research is lack of access, unaffordable, affordable cost. We still have crushing conditions like Alzheimer’s that we have no disease modifying treatment for. In the US in particular, we have particularly poor outcomes despite spending 14. These are the problems that we should be focusing on. And I think that digital and wearables and technology are a very important tool that can help us address these problems. I see huge bias in. But I think that, one of the challenges right now is just rubbing digital as a problem. Thinking more about the digital solutions rather than its unique applicability to today’s patients or clinical or business problem we’re trying to solve for.

Maria Palombini:
Excellent. What do you perceive your road’s perception of wearables? We hear a lot that they can’t trust them. They’re concerned about patient adherence. There’s some corruption in the communication or security vulnerabilities and transport of data. I mean, there’s a whole list of things we’ve heard. But do you find that the trucks of these technologies for validating efficient use for research would really push pharma to do more comfortable with the use of these, of these tools? Or what do you think is all the challenges?

Jennifer Goldsack:
I really liked that you used the word trust because I think that’s what it all boils down to is. And, you know, we were chatting at the beginning of the podcast about how this is probably one of the most interdisciplinary fields that we can think of. And I think that that is at the core, the challenge with trust that isn’t yet a unifying the language or the field. If I say validation to a data scientist, to a hardware engineering, to a regulator, they all mean different things. So we, it’s not easy to communicate. It’s not easy to collaborate. We also don’t yet have shared framework for evaluating what good even looks like. Whether it’s from a measurement point of view, whether it’s from a security or a data rights point of view, whether it can be used the better at the end. You tell it to the point. That is, I think until, until we can overcome the silos of expertise with vendors sitting at arm’s length outside of pharma and CRM wave out a common unifying language without common framework, we are always going to have a trust problem because people they understand what’s going on. That sort of list of problems is really at the core of what we try and address paradigm. We’re getting everyone together, making that comment, unifying language, creating those common frameworks. I know that we share those goals with your team, Maria, at IEEE Standards Association.

Maria Palombini:
Excellent, agreed. We’re very aligned on some of the challenges that we’re seeing. So we talk a lot about challenges in medical devices. We’ve seen challenges all along normal point of view of interoperability, compatibility, and portability. We see all these big devices coming into play from diagnostics and therapeutics. What’s going to you think is going to be the catalyst when it comes to wearables, like who do you think is going to be the true big entities or big players to catalyze this change that needs to be done with it comes to portability, interoperability and compatibility and the use of wearables?

Jennifer Goldsack:
I think ultimately it comes down to recognizing that this is what patients want. If we talk to patients, if we talk to research participants, they want to be able to take their data. They want to be able to go to the provider or participate in the trial that they want to. They also recognize that it is their right to access their data. And so I think increasingly as patients and participants are exposed to technology and how that allows them to transport information in other areas of their lives, they’re going to expect that when they come into contact with the healthcare system. I also recognize that I think we often burden patients to be the catalyst to change. And I think on the industry side, we need to step up, recognize their needs and realize it, um, something that we’ve been thinking about a lot recently at dying. And in fact, on the clinical research side in particular I think that by the pharma industry, standing shoulder to shoulder and demanding bare minimum standards around compatibility interoperability portability from vendors coming into this space. I think that essentially that buying power could be a very powerful letter and effecting change in compatibility and interoperability on you. You mentioned we’ve seen him in the medical device world for decades. However, with wearables, we are at an exciting time, um, all of this new sort of stuff, the old, and I think we do have the opportunity to bring everyone to the table if we are strategic.

Maria Palombini:
Definitely a great thing. Strategic is the key term there. We’re coming up on our final segment. You know, the podcast is called Rethink, which means we want everybody to take an action. Therefore, when we think about all these use of the rise in the use of digital therapeutics, wearables, what kind of challenges are we really thinking about? Like what keeps you up at night about the use of these devices that really give you that fear that we can’t yet trust them?

Jennifer Goldsack:
So it’s really interesting. I don’t think that there are any gaps in our knowledge or our capabilities to deploy these tools in a way that is ethical is safe, effective, and ethical. It’s equitable. I think the challenge is that we’re not quite well enough aligned yet. We haven’t quite assembled the jigsaw puzzle pieces well enough to ensure that always the case. Maria, I can have a bit of a flare for the dramatic sometimes, but you know, the way I think about these things is this is a critically important juncture in the evolution of the field of sort of digital health and digital medicine. I think we have this opportunity to develop and deploy digital products as powerful, powerful tools in the service of improving health, equity, health outcomes in reducing healthcare costs and improving access. So on and so forth. I also think that we’re in the precipice of some pretty big risks that, you know, that there’s a risk of instead of developing precision therapy kits and precision approaches to help test and to reset. We actually just doubled down on the surveillance economy that instead of, um, using these tools to try and immediate right health disparities, we actually make them worse. So what picks me up at night is are we moving quickly enough to make sure that that ethical and that lens of equity that ends up that, that lens of safety, um, is sort of keeping pace with the promise of these technologies? Are we really using them as a tool and not well.

Maria Palombini:
Very well said. I mentioned a little earlier that you and I came to class cause we’ve had very common alignment on the use of technologies in clinical research. So how do you envision the digital medicine society and triple collaborating to figure out how it was a great solution to really leverage these wearables beyond monitoring?

Jennifer Goldsack:
Yeah. So I’m going to go back to your question earlier, Maria, that to honed in on issues of sort of interoperability and compatibility. I think that is an opportunity for us to work together and to bring all communities together. And I think the timing is right, and I think we both have sort of the energy and the expertise to actually move the needle on that early enough, that it, if it comes to sort of a permanent and an impactful change on this rapidly developing industry, I honestly think standing shoulder to shoulder and what we define as that common unifying language, helping folks understand what sets the purpose really means to each and every use case. I think if we can put those forward, we’ve done a lot of that work already at dime. I know that you guys have some initiatives on the way. I think if we can continue to sort of collaborate to support the field rather than sort of fracturing, um, and coming up with competing frameworks, I think that’s something that I’m very proud of and as I’m sort of standing together and making a commitment to the field that we will share and combine our knowledge and our best practice to best the industry. That’s something I’m really proud of. Um, and in particular, I think that, you mentioned going to scale, I think a lot of that is going to come down to the interoperability and compatibility pieces. I think in less particularly pharma companies can be confident in that compatibility, for example, over time or that, um, something as simple as continuous hot right, is actually defined as the same thing, measured and recorded at the same thing across technologies, across studies across populations, with always going to be hamstrung in trying to take these technologies.

Maria Palombini:
Exactly. And for patients out there, you might think this is a wearable and this is a wearable, and when it comes to clinical research, there’s always a difference. And this is the heart of what we want to get to the point where we can make these things work in a way so that the patient experience is seamless for them as well as for the clinical research process. That’s exactly what we want. We want it to make it seamless, but we want to make it work.

Jennifer Goldsack:
I think that’s really important. I also think it necessary, for example, for the patient has to be bud instead of in the weeds and I’ll use the continuous thought right. Example, right. There are some smartwatches that might report that as sort of average hall, right. Across 10 seconds, but reported per minutes, others might do it sort of average pub beat. Others might do it over 60 seconds. Um, and so until that’s sort of standardized, it’s always impossible to make sure that the patient or the participant can actually get the technology that they want to use that works best for them because we’re going to be constrained by reporting it and in a particular way. So, yeah, I really liked how you framed that, keeping the patient right at the front of mind.

Maria Palombini:
Absolutely Jennifer, you call it there an opinion piece, which I enjoyed reading called the wild West, the data. And I actually liked the title more. And how can some of the listeners read on what you guys wrote?

Jennifer Goldsack:
So Maria, what about you? You gave us some really good support. As we put that piece together, you read a draft and I’m very grateful for you. So, with Jordan Bryanov of the Data Sciences Institute of Takeda, and Bill Byrom from Signant Health, we did recently publish news, but it’s opinions when it is in these called the wild West of data. And now we were talking about this challenge that we’ve spent some time on this morning. You were talking about the challenge of the pharmaceutical industry in particular has spent many years now completing many successful proof of concept studies using technology. Patients is telling them that they’re comfortable using them, that they want to use them. And their COVID-19 crisis has made us realize that we have to get better quickly at becoming less dependent on data collected in the clinic. And that we can not only keep patients safe by keeping them out of the clinic, but we can also capture much more complete information about their experience with and without therapy using these cities sense, the technology. The problem is it goes back to what we were just talking about with our example, the part, right? With our example of continuous heart rate monitoring, we’re not comparing apples and apples, even when there’s some of the language suggests we off and until we can get off on the teachable call, each sufficiency, that technologies are going to be back compatible over time that they can select the technologies that work best for their participants, that data is reported in a way that it can be synthesized to be more than the sum of the parts we aren’t going to make for progress. And I think that tremendous work has been done. And I’m proud of Don’s role in doing some of the work around identifying what good looks like in terms of measurement and performance. For example, we propose the B3 framework, verification, validation, clinical validation. But you know, until we can take that to scale, we aren’t going to see technologies making the impact on speeding the development of new medical products patients until we can guarantee some bare minimum level of interoperability. And so, yes, we get into that in much more detail. And I can send you the names if you’d like to face it with the podcast. And within that, there’s also a link for folks to sign up if they are keen to join us, we will be working together to advance that notion of bare minimum standards that if trying to send the whole industry.

Maria Palombini:
Yes, for sure. And we’ll include a link to it. We’re going to write a little blog about this podcast on the Beyond Standards blog, and we’ll include the link to the op-ed piece. For sure. Jennifer, you’ve given us so many great insights today and so much to think about. And I want to thank you for joining me and being a part of this podcast series.

Jennifer Goldsack:
Thank you for having me. And it’s always a pleasure. I think that I’m very proud of us, your organizations and communities being so committed to lessons together. So it was a pleasure to be your guest this morning. And I look forward to continuing to work together.

Maria Palombini:
Absolutely same here. And I want to thank all of you for listening. And if you’re interested in taking a stand and joining Jennifer and the digital medicine society and IEEE SA to tackle the challenge of moving wearables beyond monitoring, or to help address any other challenges, solutions in the clinical trials research process and the healthcare ecosystem, and just end at the end of the day, to make sure that we have a better chance for all patients to have access to better health, please visit our website at ieeesa.io/hls, and you can look us up and find more information and how to get engaged, want to wish all of you to continue to stay safe and well. And hopefully you’ll join us on our next episode where we’re going to tackle the quality challenges around digital therapeutics until then enjoy the rest of your day. Thank you.

Episode 4

Establishing a Standard of Quality in Digital Therapeutics

Maria Palombini, Director of Emerging Communities & Opportunities Development and Healthcare Life Sciences (HLS) Practice Lead at IEEE Standards Association (IEEE SA), Michael Ambrose, Director of Product Quality and Analytical Process at USP about establishing standards in digital therapeutics to assure quality and build trust with patients — the core of the healthcare ecosystem.

Speaker
Michael Ambrose

Michael Ambrose, PhD., is the Director of Product Quality & Analytical Methods Incubation, Digital and Innovation Division at the United States Pharmacopeia. Dr. Ambrose has been with the USP for over 14 years, serving as the Director of the Biologics and Biotechnology Laboratory for over 10 years before moving to the Digital and Innovation Division. The mission of Division is to explore and incubate emerging technologies and trends that may impact USP, the way we work or in the way our standards are used or produced. This includes advancing digital fluency and applications of digital technologies and solutions throughout the organization and to our stakeholders. In the Division, Dr. Ambrose has been involved in various technologies including qNMR, Digital Therapeutics and DNA Methods for the Identification of Botanicals.

Follow Michael Ambrose on LinkedIn or get in touch.

Michael Ambrose Headshot
Full Transcript

Maria Palombini:
Welcome to the Rethink Health Podcast Series. I’m your host, Maria Palombini, leader of the IEEE Standards Association Healthcare and Life Science Practice. You may wonder why we’re doing this podcast series. So much is changing in the world of health. We have new technologies, tools, applications, all of which should make us think, how can we rethink the approach to health so that we have patients, like you and me, end up with better health. We bring you experts, advocates, researchers looking at rethink the process anywhere in the healthcare ecosystem from bench to bedside to get to where we need to be healthy. So I’m delighted to bring you one of these experts. Michael Ambrose, director at USP is an exciting organization. You know, when we think of quality, we think of USP in the scientific standards world. So Michael, why can’t you tell us a little bit about what USP does and the great work you’re doing there with them.

Michael Ambrose:
Thank you very much for this opportunity and good afternoon, everybody. I am the director of product quality and analytical methods within the digital innovation division. Our group explores and evaluates emerging technologies and trends that impact public health, especially in terms of medicine and therapies. We begin to really work together with the intersection of therapies and technology. USP is a global leader in building trust in medicines like patients and healthcare providers, industry, regulators, and such. We do this by setting standards, that ensure the quality, safety and promote public trust in these medicines, USP, is that doing this for just over 200 years? We started in 1820. Today we are in use in over 150 different countries throughout the world.

Maria Palombini:
Excellent. A fascinating organization. Now we’re in the world of COVID and everybody’s in a virtual environment and I’d like to humanize the experience. So for our audience, let’s hear a little fun fact about you, something that you do in your downtime or nice, interesting place you’ve traveled before, something that you would like to impart with our audience.

Michael Ambrose:
Besides science and technology, I actually have a number of different hobbies. One of the ones, the longest ones I’ve had so far is I am a guitarist. I’ve been playing guitar and blues for about 40 years now. I’ve also recently got a 3d printer and I’ve been having a lot of fun printing things and designing my own jewelry and such. So we also have fun outside of work as well.

Maria Palombini:
So we have a little garage biotech type of situation going on now. All right. So why don’t we get to the core, what do we really need to rethink with digital therapeutics? People talk about them, or people don’t even understand when I say people – patients, doctors, clinicians, we hear anything from an app to be a digital therapeutic or some other application of a technology, which gives us a bit of concern. From your point of view, how would you define a digital therapeutic?

Michael Ambrose:
Digital therapeutics and digital health in general is, as you just stated is a multifaceted area. Uh, we do concentrate on digital therapeutics and we’ve kind of defined it as a modality that uses high quality software programs that provide an evidence-based therapeutic intervention. This is to prevent, manage or treat a medical disorder or disease. These digital therapeutics can actually be the therapy in and of itself, or it can be in conjunction with other therapies as well.

Maria Palombini:
It’s a fascinating area that seems to be growing very rapidly. You know, what are some of the trends in the use of digital therapeutics? You know, we’ve seen the new norm, a lot of conversation about using them for mental wellness due to a lot of emotional distress, but also in pain management. So we’re seeing quite a different use cases for them from your side. What do you see them as a growing trend?

Michael Ambrose:
I see the trend as continuing where it is now to some degree in that the different types of applications for these digital therapy, therapeutic products continue to grow. This is both in areas where the digital product itself is the therapy. And I think that’s one of the weak aspects of it, where the software is therapy. We also continue to see the growth in digital therapeutics in conjunction with not only the therapeutic itself, but in areas where patient and doctor actually develop a different type of relationship outside of just the office visit with the change we’ve had with the COVID-19 the areas of mental health and such is an area where the ability to use digital therapeutic products is really starting to emerge the ability for the patient and the doctor to interact again, outside of the office. Some of the other areas that we’re starting to see is, is in areas of augmented reality and virtual reality applications as well. I think that is one of the larger areas that of study starting to actually trend down.

Maria Palombini:
We’re seeing something very similar as well obviously through the, IEEE standards association, the rise in augmented realities of Fidessa applications. So do you think the best use cases, just from a point of view of industry and patients and doctors and consumers is the best use cases for a digital therapeutic on the commercial side, or maybe from an FDA regulated application kind of thing?

Michael Ambrose:
That’s a tough question to ask because we’re really not in a position to say one way or the other newest. USP is for the quality of medicine that public trust and such. The applications, I think it’s between the patients, the doctor, the healthcare provider, the regulatory agencies, and such. I think there are a couple of different examples, where we can talk about the different types of digital therapeutics companies, such as well doc, there we star products for diabetes, intervention, and interactive. They just got their digital therapeutic endeavor cleared for the treatment of ADHD in children. And that’s an example where the therapy itself is the software or the others such as care therapeutics. They recently had reset, all clear. And that’s an example where the digital therapeutic is used in conjunction with an ongoing outpatient treatment of opioid addiction. Again, that’s where we’ve actually combined both the counseling aspects, as well as traditional therapy with this new digital therapeutic product as well.

Maria Palombini:
Definitely. I think it’s, it is a hard question, but we have to ask. We’re getting to the good part. Now the call to action, right? There’s a great new opportunity in the market for health digital therapeutics mischief makes us rethink a therapy. But now with the rise of something new, we always have to ask questions. There’s always a challenge. So what are you finding with the rise of these therapeutics to be some of the more concerning issues then perhaps need to be a little viewed closer or need a little more attention?

Michael Ambrose:
Sure. I’m not sure one would call it an issue, but it’s something that is extremely important that I think we all have to keep in mind in this new modality, digital therapeutics, these products treat people. We need to keep in mind that in the end, the patients is coming to a healthcare provider or a medical condition. And the provider is trying to treat that patient, that patient can be treated in the number of different modalities. The newest one will be emerging. One we’re talking today, digital therapeutics, it’s still treating patients. And so we have to keep in mind that these are there to alleviate discomfort they’re there to treat the patient. I think that’s one of the things we have to continue keep in mind. Sometimes when you talk about all of the different aspects, it doesn’t always come through, but I think it’s back of everybody’s mind, but the agencies, the FDA, the doctors, the manufacturers, that is the key aspect. I think we also need to make sure we keep that in mind.

Maria Palombini:
I’m so glad you mentioned that because in the world of new technologies applications, we’re so focused on the tool working. Sometimes we forget who the tool is for, and the patient is definitely the center of the healthcare ecosystem. So we must never lose sight of that. And I’m so glad you brought that up. So I think maybe the question, like what adjustments or what really needs to be considered when you think meaning a practitioner or someone who says you should be using this digital therapeutic needs to evaluate and assess it for its patients, what are maybe some considerations you all feel that that would be there?

Michael Ambrose:
Sure. I think if we go back to the premise that we’re treating patients, we start looking at it from the point of view of a patient where again, the patient has to have this trust. So it does have this trust in that this therapy either prescribed or recommended by that healthcare provider is going to have a positive effect on whatever condition they are being treated for the patient, just as in any other therapy has no way of knowing the quality or whether or not that product is going to do anything or do anything positive. And therefore, I think what we need to do is continually to evolve the ability to assess and evaluate the quality of that therapeutic product from the manufacturing, make sure that they have their quality management systems in place that they do the proper testing and evaluation. The regulatory agencies evaluate that product, not only from a software point of view, but this, but from the actual point of view of it being a therapeutic, there are a number of different quality management systems and quality standards out there for a software. But I don’t see many of them talking about the quality needed for actual therapeutics. I think that’s one of the areas that, that, that continues to be addressed. When we talk about software, we talk about security, data management, privacy ownership, we build into the hat and such. So I think all of those areas need to really to be considered even more importantly again, because these are treating patients first.

Maria Palombini:
So speaking of quality, how does USP see its role in helping to establish some sort of standard quote unquote equality for digital therapeutics?

Michael Ambrose:
Really good question. And I’m going to address that by going back a little bit of time, USP’s again, been around for 200 years. Through those 200 years, USP has evolved along with all the different modalities to continue to work with those industries to create the standards needed to assess quality. So we’ve gone from recipes and tinctures back in the 1820s and such to advance chemical medicines and the use of analytical technologies to evaluate quality to today with a complex biologics and such. USP is our ability to convene the appropriate stakeholders, industry leaders, thought leaders, academia, regulatory agencies, and such to convene and work together to try to understand what the quality measurements are for these different modalities and working together to create what those standards are and how to assess them. So I see USP, looking at this, not as a revolution of therapy, but just as the next evolution. Again, as we move from botanicals to typical medicines to biologics now to digital therapy, it is the evolution of the therapeutics and USP has, is continuing to want to do a history of addressing those in bridging technologies, working with the industries to actually create them.

Maria Palombini:
I think that’s really important and a fun fact for our audience out there. IEEE is a little over a 100 years old. And as Michael said, USP is 200 years old. So we are talking to a company who’s a hundred years older than us right now. So that’s awesome that we have some sustainability going on. Okay. So how did I come to learn about USP’s involvement in digital therapeutics is when one of Michael’s colleagues showed me this great paper that they’ve developed. So, Michael, do you want to talk a little bit about the paper you did and how maybe people can find out about it?

Michael Ambrose:
Sure. We just recently published a white paper on digital therapeutics where we go into a lot more detail about, our approach not just to digital therapeutics, but are the USP for appeal approach to reference standards and to the use of quality standards overall, and the value. We do this by first addressing the typical quality parameters that we have in more traditional therapies, such as identity, strength, purity, performance. And also, the question is, are these the correct terms? Do we need to adapt the definition? How do we determine identity and the software or the string, or do we to get, do we need to have a different set of terms that measure the quality of the software? Again, not just as a software, but as a therapeutic software. The paper can be found at http://www.usp.org/dtx . And in that paper, we actually address what your comments, comments, and the industry comments. Everybody’s reading the paper as well. Anybody listening to this podcast, maybe we’ve set up a special dedicated email just for that site, just so that you can submit your comments and thoughts. And that is at [email protected] We look forward to hearing your comments and thoughts.

Maria Palombini:
And we will be sure to put both links. We’re going to write a blog about this podcast, and we’ll put both links on the blog post as well. So people can find it from there as well off the IEE SA beyond standards blog site, we make sure people have access to that. For sure. So everyone out there listening digital therapeutics are here. They’ve been here, they’re growing. I definitely think you should check them out, read this white paper, do a little research. We they’re helping us rethink the healthcare system. So if you want to get involved in some of the work we’re doing, um, at the IEEE SA, we’re doing, we’re talking digital therapeutics and clinical research. We’re looking at it from a point of view of wearables in our, you know, whammy certification program, many different applications and areas. Michael, I want to thank you for being a part of this podcast for sharing your insight and time with me.

Michael Ambrose:
Thank you very much. Appreciate that.

Maria Palombini:
And you know, it’s been a great collaboration. We’ve been collaborating with USP on some of these unique applications, such as smart pills, and now we’re talking together on digital therapeutics, and I think it’s a great collaboration between science and tech.

Michael Ambrose:
Thank you very much. And just one last statement for those that want to learn more about you to learn more about USP and standards setting such. So you please visit us at www.usp.org. You can see what we do with food and dietary supplements, biologics medicines, global public health, and such, and learn how you can, you can work with us as well.

Maria Palombini:
Yes, definitely. Uh, if you’re into this area of quality, definitely you want to talk to USP and for everyone out there, thank you again for joining us. We look forward. We have our next podcast next week coming up on artificial intelligence and blockchain in the world of epidemiology, which is another application of how we really need to rethink epidemiological research. But for now, thank you again for listening and we look forward to your participation and engagement in helping us to bring new solutions to drive adoption in the market.

Michael Ambrose:
Thank you very much. Bye bye.

Episode 5

Contact Tracing Applications and Technologies Beyond COVID-19

Maria Palombini, Director of Emerging Communities & Opportunities Development and Healthcare Life Sciences (HLS) Practice Lead at IEEE Standards Association (IEEE SA), interviews Ali Hessami, Innovation Director at Vegas Global Systems LTD and Chair and Technical Editor for IEEE P7000 Standards, about ethical considerations on contact tracing technologies and applications in order to mitigate the spread of the pandemic and protect personal privacy and public.

Speaker
Ali Hessami

Ali is a physics and electronics engineer with a track record in risk assessment and management, knowledge and talent/competence management, and design of mission critical systems. He has experience in safety, security, and sustainability assurance in complex products and projects, developing European and Global safety/security standards and technology ethics certification including COVID-related Contact Tracing Technologies. General interests include Photography, cosmology, mysticism and culture.

Follow Ali Hessami on Linkedin.

Ali Hessami Headshot
Full Transcript

Maria Palombini:
Welcome, everyone, to the next edition of IEEE SA’s Rethink Health podcast, today. We’re gonna be talking about the great debate in contact tracing technologies and applications ethical considerations and protecting personal privacy and public health. I’m your host Maria Palombini. I’m the leader of the IEEE Standards Association Healthcare and Life Sciences practice.

You may want to why are we doing this podcast series. There’s so many new technologies applications, scientific breakthroughs and more frequently. Recurrence of unexpected, natural disasters such as pandemic. That makes us really have to think, how are we going to rethink the healthcare system, so that we can deliver better care for you me, and anyone it was a patient we’re all patients? So we all should have the right to better care. This series will feature guests for technology, ethicist, clinical, medical researchers, advocates, and any other committed or passionate stakeholder who is pushing the boundaries in our approach to better healthcare.

We’re not just talking about bedside practice or therapy development. We’re looking at any aspect that impacts our care. And how do we make it better? And how do we make it universal for everyone? So, with that today, I would like to welcome, Ali Hessami, to our discussion. He’s going to talk about this contact tracing technology. An application that is a very hot topic, thanks to COVID-19. They’ve been around for a while, but now they’ve come to a center stage and it’s something we’re all debating public health versus private, a private personal data privacy.

So, with that, I want to first, thank you Ali for joining us and welcome to the series. Tell us a little bit about the work you do as innovation director of biggest system, but I know you’re heavily involved in a lot of the work and IEEE SA’s ethics programs. So, perhaps you can give us a little information about that.

Ali Hessami:
Of course, my role and regular systems has been really largely focused on tackling critical problems through innovative, technical technology, and solutions basically. So that borders with many aspects, such as system systems engineering, that’s my general background as a physicist as well as knowledge and risk management practices that I’ve been doing over many decades in industry, largely at the top involvement in the academic research publication and teaching. I got involved roughly four years ago being an arguably member for over thirty-five years. But with SA, I got involved with P7000 technology, ethics standard initially, as a working group member and ultimately honored to accept leading work as a chair to basically process manage and architect and approach to ethics certification. For SA, I was given a very brief free made and since then I’ve been largely involved in the ethics certification program for autonomous, and intelligence systems. For short. We have been exploring what kind of qualifications are needed for technology embedded products and services, largely autonomous and a category to make them ethically acceptable societally and make them successful. And one latest initiative has been the application of similar approach on thinking towards contact tracing and proximity tracing, risk mitigation technologies

Maria Palombini:
So, when it comes to everything being virtual, and we have great experts speaking on our podcast. But I always like to humanize the person behind the expertise. Perhaps you can share with us. You’re very passionate about this topic. And I know this, because I see all the different people involved the P7000 series and the ethics programs. Maybe you could share a little bit about what personally drives you.

Ali Hessami:
If I may indulge – I’m a follower of mysticism of the Eastern nature, a couple of people I revere in my life had private life. These people are really focused on paths to fostering harmony into society and spirituality. I can just quote from my favorite work from Rumi. He says this world is the deep trouble from top to bottom, but it can be swiftly healed by the palm of love. And that frankly translates into what can build bridges for good will and understanding the barriers being encountered in life. To me, ethics, respecting other people’s differences is an excellent bridge building environment. That’s what enthused me to get involved in P7000 series of standards and a number of them indeed. I’m later greatly honored and embraced the responsibility of developing ethical certification criteria, again with the same aim to promote a faster ethical value in technologies that’s ultimately device for the benefit of humanity.

Maria Palombini:
Great, thank you. And for our audience who may not be familiar, IEEE has a globally renowned initiative on autonomous systems. You can definitely find it on our website at https://standards.ieee.org [or a link in the resources section of this blog post], if you’re interested and just as passionate as Ali and the rest of the hundreds of other individuals who are participating in those projects.

Right now, I want to get to the core of what we’re here for – contact tracing technology. So we know they’re in the news. Everybody’s talking about it thanks to COVID, but they’ve been around for a while. It’s just not so widespread. Most people don’t know that, but in your research, what does it actually mean when we say a contact tracing technology and applications, regardless whether we’re using for an infectious disease, such as COVID or some other public health matter?

Ali Hessami:
Going back to the story around how human societies effectively and globally have responded to the threat and the major scourge of this pandemic, we have really not been very successful. We haven’t been prepared adequately. We haven’t responded with sufficient insights and effectiveness. It gave us the impression that as IEEE’s tag line implies we are really trying to contribute to the advancement of technology for the benefit of humanity. Since there was already an ongoing project on ethically qualification of products and services, in consultation with the Managing Director of SA and we managed to agree that the line of work on how to make contact tracing more successful globally, as the current only technological solution that we have available to us to mitigate the risks of the pandemic would have been in line with our strapline and our philosophy in IEEE.

So, contact tracing is basically using any form of technology or proximity tracings sometimes, to identify how close we have been to other contacts in any context, family, social, general public contacts. In the event that one of those people who have been in proximity with ourselves have tested positive regarding possibility of having caught the virus, then it informs others to take protective measures and stop this spread. So any technology, whether it’s an application that you download on your mobile device to any valuable technology is subject to the study that started some eleven weeks ago and in a fairly fast track project, we managed to get to the bottom of essential ethical that captures any such technology and not just a particular application of it that is necessary to the public trust in these technology, so that they will become more effective and ultimately end up saving lives.

Maria Palombini:
For sure. It’s definitely something. I think people still grasping, from a common citizen to technologist to everybody. In the last six to eight months since contact tracing technology started to surface, we’ve seen various challenges with them, whether it be some sort of central repository information, or we find that they’re using a Bluetooth proximity tool, so that you could see somebody within fifty feet, your app would dictate that that person has it. All of these as with anything they come with deficits. So what are some of the deficits that you’re seeing in these tracing technologies or applications that you really feel that the technical community, ethicist, scientists, or whoever has to come together to ensure that we have citizen consent to participating them but as well as that we can safeguard confidentiality.

Ali Hessami:
Indeed. If you look at the history, and this is only the last few months of successes and lack of successes of rolling out these technologies as the short term solution, while we’re still waiting for vaccines against the virus. To imagine the global community, technologically, this is one of the very few promising solutions that we have. But as any technology, this has been a quickly put together as a means to an end in the sense that the end is to try and reduce contamination, reduce the spread. And this is one very simple and technically a feasible solution that we don’t need to do a lot of R&D on.

Of course, on the downside, there are many dimensions, but those mentions are often to do with ethical properties in terms of: How transparent is the way technologies operate? Who are behind these developments? What is the mindset? Is there a clear concept of operation? Is there a reasonable attempt of ethically architecting such solutions, so that our data are not kept on central servers and hacked and abused? Is there any form of confidence in the ecosystem behavior? It’s not just the technology, it’s the other players. And all of these, including how do we operate and how do we keep vigilance during the operation. And eventually the demise and retirement of such technology, whether it’s a downloadable app or electronic product.

Technologies have got some shortcomings such as lack of precision in proximity measurement, what does exposure mean, how long is long enough to be considered to be at risk. Because it uses Bluetooth low energy that’s embedded in most mobile devices for other purposes as means of proximity detection with other people. On the ethical side, matters of transparency in communicating with the society citizens you’re trying to protect, how is the device architected? How is the overall operation? What are our stakeholders? Who would have access to our data? Would it be shared with other government agencies, et cetera? There’s significant lack of transparency in such matters. Governments, rushed by desperate necessity to come up with a solution to get out of lockdown and go back to some form of normal economic activities are rushing these technologies from private enterprises without sufficient clarity or transparency.

The second part is lack of sufficient accountability in the sense that we want to know who are the key decision makers, where our grievances go, when things go wrong, who are the responsible people or bodies or entities especially since we are talking about massive, large scale adoption and implementation of such solutions in such a hasty manner. The formal aspect is matters of privacy. We know that in Europe, we have protection of privacy by legislation called GDPR. But we’re talking about ethical privacy: in what manner our personal data is respected and regarded as private to us, rather than become some entities’ property, whether it’s a public entity, government entity. etc.

So these are three matters where the focus of the fast track study that we started sometime in late June, and they managed to put a fast interim report on what kind of actions, behaviors and practices on policies can safeguard against abuses in accountability, transparency and privacy. Hence a report was issued in July as the interim report, and the team and myself, have been working hard to complete this study. I’m pleased to announce that the studies being completed. Now we are in the final stages of putting a more comprehensive set of criteria on a report that’s going to be shared by SA as a Creative Commons global attribution, as a non-commercial product, where the whole international community with the focus of helping governments – city and states, public and private duty holders – to actually declare how they have gone about preserving these attributes of privacy, transparency and accountability in the architecture and the solutions that they’re rolling out, providing trust and confidence in the public and more effectiveness of technology to save lives.

Maria Palombini:
I can very much sense your passion and your advocacy for this work. I mean, you already answered two of my next questions on transparency and accountability, because I was having the same concerns of wondering how you all were addressing them. Now we’re coming to our final segment, which is an action. We need to take an action, right? The idea of Re-Think Health is that we want to actually do something to make it better. In this case, I know you’ve already sort of previewed the paper and we’ll leave that to the end to tell the audience how they can get to it. But there’s a lot of stake because I believe that contact tracing technologies, thanks to COVID, maybe sustainable and used in other applications. So I think we need to understand what will allow it to be sustainable, but in a way that people feel like it’s responsibly used and we can establish trust in the use of it. Where do you and the team feel like it’s needed there?

Ali Hessami:
Well, when we started this work, we were all passionate about how quickly we can generate a workable, comprehensive solution for supporting governments’ and private and public enterprises’ efforts towards rolling out such mitigation technologies against the pandemic. We actually decided that the most insufficient time and huge urgency with sensible parameters in terms of ethical assurance. We tapped into the work, the ethics certification program that we have developed prior to COVID. Last year we developed three sets of ethical criteria for certification of autonomous and intelligence systems on ethical transparency, accountability, and freedom from unethical bias. And we decided that the best solution was to adopt one of those and configure, adapt, modify and tailor that to the needs of contact tracing.

Fundamentally, it was around accountability and transparency models that we had already developed and these models have a huge body of criteria for ethical assurance. We basically decided that, because of the urgency, we couldn’t afford the luxury of a comprehensive ground-up sort of green field site study. We could build on some of the criteria that we already had and that’s exactly what we have done. That’s why we have two phases. Within roughly ten weeks we have reached a stage where we can share some of the findings to an interim report, which we have already published, and the work continued to completion. We’re hoping that before end of October and in November, a final report will be shared under this Creative Commons attribution for global access and benefits. Basically any entity who’s got these solutions is aware of aspects that are highly conducive to generating public trust. For example, don’t cover up any aspect of technology behavior; do not cater for any feature that can lend it open to abuse; and on the plus side make sure there are sufficient competences into design and understanding and governance of the institutions who generate such technologies, declare their intent and concept of operation with everyone transparently architected in such a way that it doesn’t lend itself to hacking, abuse, and loss of data; make the users aware of how they are interacting with the systems. Generally, make human supervision and oversight a feature of such systems rather than total and autonomous systems based on AI. And ultimately manage the operational risk.

So these were the concerns that are all factored in our fast track study. Our first report covers part of these issues, and our final report covers all of these issues to a fair amount of detail. Just to give you a feed, our first report has roughly fifty-five parameters for ethical transparency, accountability and bias in contact tracing. Our second report is likely to be doubling that.

Maria Palombini:
I’m sure there’s going to be a lot more. So on this paper on pandemic and ethics and contact tracing application, are you still open for comments and feedback? Is there a timeline for that or what’s the process there for that?

Ali Hessami:
The report was published late July and is available for free download from the IEEE SA site. It’s called The IEEE Use Case Criteria for Addressing Ethical Challenges in Transparency, Accountability, and Privacy of CTA/CTT, which stands for contact tracing application, which is contact tracing technology. Our focus is a global call for consultation.

We’re sharing our insides and criteria with the global community. We believe these are a comprehensive and reasonably broad set of ethical promises that can be accepted across many cultures. The deadline for commenting was also announced to be the first of September, but recognizing that August was a holiday season we have extended it to eighteenth of September. So people are still welcome from any institution or as an individual to send comments. This was an interim report and we are in the final stage of creating a very comprehensive set of ethical criteria by end of October. We are also planning a webinar to explain this to the global community to explain our intent, approach and value proposition from this non-commercial sharing of insights for the benefit of humanity on the tenth of October, ten o’clock, Eastern time. The experts and myself as the chair and vice chair of the ethics certification would be present to explain both the way we have worked together and benefits for others, and also rationalize why do we need to invest energy and time in making technology trusted before we rolled it out for the benefits of the society.

Maria Palombini:
And we will feature both the links to sign up for the webinar and for the paper on the IEEE SA site. You can find the information and we will be posting the webinars. I believe it’s already open for registration and we’ll have a link there as well. So we’re actually coming to our close. There’s been so much great information and we could do this for two hours. Is there any final thought that you would like impart to our audience? Something for them to think about because it’s something on our mind that’s very current in front of us.

Ali Hessami:
It actually pains us to have medicine solutions but no trust. If you look at the lack of takeoff of these technologies, which are currently the only medicine we have, if you like, against the virus that the majority of global community are suffering from. This is one technology that could be successfully rolled out, as problematic as it is in some aspects in terms of lack of precision. Nevertheless, we have a solution and the only failing on behalf of the global community has been the mannerism of explaining and respecting public opinion.

So the final thought I would suggest is that, as a global responsibility, it is upon all of us, especially decision makers, to actually not just think technologically for quick fixes, but also why should the public trust such quick fixes? Look at the process it takes to generate a vaccine. And why do people trust the vaccine? Because it goes through an enormous amount of verification and validation. We haven’t done that successfully for contact tracing. Our attempt is to get into what makes it transparent, accountable, and respectful of people’s privacy, to try and support understanding and trust in these technologies. Then if the majority adopt, adapt and apply it, we are going to hopefully maximize protection for the society and much faster return to normal social and economic life.

So it is really amazingly indicative of the necessity for humanizing technology to care for the society by explaining what happens to people’s data, who owns it, how it’s shared, what is the sunset criteria for technologies, etc. None of those have been done virtually anywhere that I know, with a catastrophic consequence that in most societies you ended up with countries that suffered most where the general public face only single solution on the horizon that could protect them automatically with the use of commercial kits, such as a mobile phone, and decided that they were not entrusting data to such technology because they didn’t understand how it was going to operate it, in what way they could be victimized or used for surveillance. In some countries, statistics show that less than 3 percent of the population, even though they are suffering from the pandemic, trusted and downloaded the application. This is desperately poor in time of crisis. We need to do much better than this. Our attempt is just one gesture on how to do better.

Maria Palombini:
I think that’s very well said. The statistics that you pointed out – something that we really need but yet we don’t trust so we don’t engage. Thank you Ali for this really insightful, interesting conversation. I’m so delighted that you joined me today. And I want to thank our audience for listening in and I hope you will check out the rest of our episodes on the podcast series. We’re covering everything from clinical research, wearables, decentralized health technology – everything that we can to make it better for all of us.

And if you want to get involved in any of our activities like incubator programs for decentralized health technologies and toolkits to drive adoption of decentralized clinical trials, establishing privacy and security in the use of wireless connected, medical devices, our newest program coming up will be telehealth, privacy, security, connectivity for all in a world of pandemics. Please visit our website at https://ieeesa.io/hls. Thank you everyone again and I look forward to joining us on our next episode. Bye.

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About the Host

Maria Palombini Headshot

Maria Palombini

Director, IEEE SA Healthcare & Life Sciences

As the leader of IEEE SA Healthcare & Life Sciences, Maria works with a global community of multi-disciplinary stakeholder volunteers who are committed to establishing trust and validation in tools and technologies that will change the approach from supply-driven to patient-driven quality of care for all. Her work advocates for a patient-centered healthcare system focused on targeted research, accurate diagnosis, and efficacious delivery of care to realize the promise of precision medicine.

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