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.
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About This Episode’s Guest
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.
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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.
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