Event Date: May 8, 2023
The National Health Council’s (NHC’s) Science of Patient Engagement Symposium was held in person on May 8, 2023, at the historic National Press Club in Washington, DC. This year’s Symposium brought together more than 150 leaders from patient advocacy organizations, non-profit groups, industry, academia, and government to discuss the impact of recent innovations in digital health on patient engagement and health equity.
While the Symposium sessions focused on different aspects of digital health – including telehealth and the digital divide, medical device development and technology design, and artificial intelligence – several common themes emerged:
Following are highlights from the day’s events.
WELCOME AND INTRODUCTIONS
In their welcoming remarks, Mr. Mendez, Mr. Rutta, and Dr. Escontrías welcomed attendees, thanked the event sponsors and panelists, and noted that this type of event exemplifies what the NHC does best; namely, bringing together patient groups to amplify the patient voice through discussions of the most important health care issues of the day. They emphasized that optimizing the impact of digital and artificial applications requires active engagement of patients at every step, and that we must listen and compassionately deploy new technology with consistent with equity, dignity, and privacy.
Dr. Califf began by noting patient engagement and digital health are priorities for the FDA, and that by pairing the two topics at the Symposium, the NHC underscores not only their individual importance, but also the potential for synergy as the digital world and understanding of how to engage people converges in many ways. At the same time, this convergence raises serious questions about our approach to clinical research, health, and health care.
The Commissioner emphasized that one of the most important aspects of the work of the FDA is to incorporate the perspectives and experiences of patients to make sure the evidence reflects what matters most to, and is most effective for, patients and their caregivers. As the FDA focuses on this issue, especially with improved digital technology, the agency should be able to design a more accurate, more complete benefit-risk framework that helps it to better evaluate the safety and effectiveness of a medical product across the vast expanse of patients and consumers. He cited the Patient Representative Program, which brings the patient voice to discussions about new and already approved drugs and devices, as well as to those that are currently being considered for approval, as an example.
He cautioned that the rapid advance of digital technology is likely to disrupt current methods. The ultimate goal of gathering all of this data and evidence is to better inform the FDA’s knowledge about the benefits and risks of health interventions and to assure that they can be used to improve health relative to the risk of harm. But as digital technology capabilities expand, the bright line between the individual product and the environment, both human and technological, only makes sense in the early phase of development and assessment. Ultimately, the benefits and risks of the use of a product depend on whether and how it is used, and the context in which it is used.
The Commissioner then identified several areas that raise questions and concerns he hoped the Symposium would shed light on:
The Commissioner concluded his remarks by stressing the need for all stakeholders to assemble the resources to put in place policies and tools and adaptively align digital health efforts to support public health and regulatory innovation in a world that is changing rapidly. The potential certainly exists, and there is good reason to hope that we will fulfill the enormous potential of digital health technologies and see more innovative solutions that can result in improved outcomes, but we better also preempt the risks.
SESSION 1 : BRIDGING THE DIGITAL DIVIDE: DISPARITIES AND DIAGNOSIS THROUGH TELEHEALTH
In her remarks, Dr. Turner Lee stressed that technologies like telehealth can be enablers, but the digital divide that exists – particularly for individuals with age, income, geographic, and health disparities – can bury certain perspectives and experiences of patients that are important to understanding their complete health care picture and can affect outcomes. There is a large segment of the American population that is “digitally invisible” who cannot get access to or take advantage of telehealth because they are not “digitally” connected.
As an example, Dr. Turner Lee noted that, according to research conducted by the Pew Research Center, Americans with lower incomes have lower levels of technology adoption. Smart phones are ubiquitous and help people stay connected; that trend expanded during the COVID-19 pandemic and helped cause the rise in telehealth use. But the percentage of Americans who have access to broadband and a laptop or home computer is significantly lower; those people could not take advantage of telehealth services during the pandemic, and they cannot now.
The impact of the digital divide on patient engagement and care is significant: it limits the use of technology for patient care and interventions; it causes persistent health and care inequities due to inconsistent communication with patients; it limits opportunities to create innovative care models; and it extends the “long road” to trust among medically impacted and vulnerable populations.
During the audience question and answer session Dr. Turner Lee offered perspectives on how policymakers and healthcare stakeholders can help address the digital disparities the digital divide has created:
Click below for the session video
SESSION 2: PANEL – ENHANCING PATIENT ENGAGEMENT IN MEDICAL DEVICE DEVELOPMENT
Ms. Capanna began the discussion by providing an overview of the Division’s work, which focuses on three areas: device development, digital health, and advancing health equity; and on the Division’s twin aims: advancing innovation and protecting patient safety.
The Division launched the Digital Health Center of Excellence in 2020, with the goal of empowering digital stakeholders to advance public health. The Center uses a collaborative approach to assess the safety and effectiveness of devices to foster transparency and manage bias in algorithms; to help bridge the digital divide and ensure that no person is left behind; and to make sure patient preference is included in all device benefit-risk guidance.
The Center’s 2020-2025 strategic priorities to advance health equity are: 1) empower informed decisions; 2) facilitate access for all populations; 3) reduce barriers and increase opportunities for participation by diverse populations; and 4) support innovations that address health equity by changing health care delivery to move care and wellness into the home.
She stressed that patient advocacy organizations play an essential role and can be partners in bringing key information into the evidence framework, particularly as they look at how to turn patient anecdotes into evidence, and how to identify more opportunities to access patient-centered information.
Ms. Shockley talked about her experience living with latent autoimmune diabetes, a form of diabetes not usually found in people of color, and the challenges associated with it. It was difficult for her to be properly diagnosed, which propelled her to find and join a diabetes community online. She was invited to participate in a diabetes summit and was the only black person there, and she started to wonder why more people of color weren’t represented in that patient space, and consequently, if this lack of representation was causing some of the specific challenges facing disadvantaged patients to not be adequately considered by medical researchers, doctors, providers, and other health care decision-makers.
She noted several specific examples: 1) a diabetic woman whose sight was failing and could not see the labels on her prescriptions well enough to take them, even though their cost was covered by insurance, and 2) diabetic patients who are hearing impaired and are forced to hack technologies to be able to hear doctors’ and pharmacists’ instructions.
She concluded by imploring health care decision-makers to include representatives from all disadvantaged and marginalized groups, to bring them in early in the process and to keep them engaged throughout, advocating “nothing about us, without us.”
Dr. Gibbons explained how his organization is focused on the challenge of ensuring digital innovations and devices address the social determinants of health. New technologies are exciting because they can do something differently and better than ever before and close gaps that no one has been able to close in the past, but those gaps will become bigger if not done well. Digital design is only as successful as its implementation. If it is designed well, it works properly all the time, for everyone – even for users without deep technological proficiency.
He cautioned, however, that the whole health care system is currently designed for experts, not for people – and that includes physicians. He warned that we cannot and should not layer new technologies onto a system that doesn’t work. The problem is not the patient.
When the panelists were asked about data use generated by new devices (who can use it and how, for both value-based care and reimbursement) and patient transparency, Ms. Capanna and Dr. Gibbons agreed that every member of the health care ecosystem must better understand the need for privacy and security, determine who really owns data, and created appropriate operating principles around that. Ms. Shockley added that patients should be given the tools they need to decide where their personal data is going.
Click below for the session video
SESSION 3: DIGITAL INNOVATION: THE ROLE OF GOOGLE AND YOUTUBE IN CONNECTING AND ENGAGING MENTAL HEALTH PATIENTS ON ONLINE PLATFORMS
Dr. Jones Bell began by explaining Google Health’s approach to mental health, which is a company-wide effort to help billions of people to be healthier. As she noted, Google Health is committed to “giving you tools to increase your knowledge, success, health, and happiness. “
Because three out of four US consumers turn to the internet first for information about their health, Google has a responsibility to make sure they get accurate, credible, and understandable information. The need to do so is particularly urgent when it comes to mental health; there has been an astronomical increase in searches to find mental health resources, with 25 billion global searches annually on You Tube in 2021.
The company recognizes that mental health exists in a complex continuum and changes over time. The dual continuum model Google Health has created supports mental health across people’s journeys, creates the space for the company to understand the road to recovery, and presents an opportunity to lean into prevention. Notable examples of Google Health’s efforts include:
The session concluded with Dr. Jones Bell offering her thoughts on both the opportunities and challenges of advancements in digital health.
Click below for the session video
SESSION 4: FIRESIDE CHAT: INTERSECTIONAL PERSPECTIVES IN MEDICAL TECHNOLOGY
The panel discussion centered on several topics: the impact of health technology on patients and caregivers; incorporating patient-centered perspectives in medical research; and how to use technology to support inclusion and increase health outcomes for patients. All the panelists agreed that in this era of consumerism, it is vitally important to give patients agency; they need to be armed with the skillsets to advocate for themselves.
The impact of health technology. Ms. Armstrong described her family’s health challenges – she lives with Myasthenia Gravis, her husband suffered from kidney disease, and her daughter was diagnosed with a thyroid tumor – and how, thanks to access to telehealth, they were each able to get the care they needed, particularly and most importantly throughout the COVID-19 pandemic. She stressed, however, that because her symptoms change and fluctuate (there are times, for instance, when it is difficult for her to read) technology must be adaptive.
Incorporating patient-centered perspectives in medical research. Mr. Crawford described how Howard University’s College of Medicine’s 1867 Project, which was founded in 2020 and which he leads, focuses on reaching medically underserved and vulnerable communities from a digital health perspective and is about centering the patient. The Project currently has active pilots in the diabetes space focusing on medication adherence and management of hemoglobin levels among people over 65, and they have identified a device that has natural language, telehealth, and facial recognitions capabilities which has led to positive outcomes among a digitally naïve patient population.
How to use technology to support inclusion and increase health outcomes. Dr. Rodriguez noted the most important thing medical research universities can do is listen. He described how his recent research, focused on Latino patients with Type 2 Diabetes, has uncovered the importance of designing patient portals with information in a language and tone that is most welcoming to the target patient group (in this case Spanish, supported by community stakeholders).
Mr. Crawford shared how Howard University has been having conversations with venture capital and private equity firms to encourage them to think about how to invest in different, addressable markets, and how to get technology entrepreneurs to think about building new platforms in multiple languages.
Click below for the session video.
SESSION 5: AI: INTERVENTION POINT FOR PATIENT-SHARED DECISION MAKING
Dr. Hall’s presentation focused on the potential of Artificial Intelligence to improve health care in several, specific areas: enabling providers to spend more time with patients by improving efficiency and reducing tasks; enabling a patient different opportunity to interact and better understand; how it can holistically make a difference by training providers, activating patients, and working with communities; and improving the standard of care of patients by decreasing time from diagnosis to treatment and improving accuracy.
She noted that health equity is fitting technology to and for the people who are using it, and this is key when thinking about algorithms to deploy Artificial Intelligence, because AI and machine learning are increasingly being used in diagnosis, treatment, drug development and patient monitoring. She added that we can think about it in every single state from the data that we put into the algorithm, from the algorithm itself, to the validation, and every other step along the way.
How AI improves time spent with patients. As an example, Dr. Hall cited Microsoft’s purchase of the AI company Nuance in 2021. Nuance captures, contextualizes, and documents every word between a health care worker and patient, which reduces the need for documentation, notetaking, and other administrative work, thus improving the time a health care worker can spend with patients. It also helps reduce burnout among health care workers.
How AI helps a patient. Dr. Hall described how guidelines can inform AI tools like CHAT GPT and thus help clinicians (to make sure all guidelines are followed); help patients, families, and caregivers become advocates (what do guidelines mean for treatment); and hospital administrators (what is the institution doing in terms of guidelines and how can we improve it). Dr. Hall then explained how the pillars of the American Heart Association’s work – changing policy, leading breakthroughs in science and technology, transforming health care, changing systems, and transforming communities – are designed to achieve maximum impact in equitable health and well-being. As an example of how that approach works in practice, she cited how the Association is addressing blood pressure control by developing guidelines for cardiovascular care with the American College of Cardiology.
Improving the standard of care. Dr. Hall noted that the gap between urban and rural death rates has expanded since the mid-1980s. People living in rural America typically have a 3-year shorter life expectancy and are more likely to have and die from cardiovascular disease. And yet an AI program developed by a company called VIZ AI was able to accelerate the detection of a stroke and subsequent treatment for a patient living in the rural United States. In this real-life story it saved a person’s life. Programs like this can also change the way hospitals are run in the future. She added that while AI doesn’t work by itself, it does work as a determinant for hospitals, providers, and others in the health care ecosystem.
During the question-and-answer session, Dr. Hall offered the following concluding thoughts:
Click below for the session video.
SESSION 6: PATIENT EXPERIENCE HEALTHCARE METRICS
Dr. Anderson began his presentation by referencing “The Digital Doctor: The Hope, The Hype, The Harm,” a book written in2014 by Dr. Bob Walker, which he believes is the seminal book on digital health. In the book, the author sets out the trajectory of ever-increasing digitization and use of one’s data in health care. Dr. Anderson sees this as the concept of inevitable futures. On one hand, more of what we do is going to be quantifiable and used for metrics and algorithms. On the other hand, how do we enable individuals to have greater agency and autonomy in how they make decisions.
Dr. Anderson then described his work at MITRE and shared his experience working closely with the White House COVID Task Force and Operation Warp Speed during the COVID-19 pandemic. One of the things the pandemic accelerated in a positive way is the concept of medical wellness at home and hospital at home. That has profound implications from an equity perspective, as well as improved clinical outcomes for otherwise unreachable populations. Another is the ability to capture additional kinds of data and to use that data for machine learning models.
One aspect of Dr. Anderson’s current work at MITRE is examining what real-world evidence generation “2.0” will look like, particularly regarding patient-generated data. The opportunity to collect new data now for good is tremendous. Individuals not only are becoming more empowered to own the data and have the agency to decide who they want to share that data with, they have the ability to interact directly with researchers, with physicians, and with clinicians in novel ways. He challenged the audience to help drive action – within government and the research institutions that fund this kind of research – to stand up the networks of Information Technology systems to allow researchers to reach a truly diverse cohort of people.
Dr. Anderson went on to describe several examples of promising new technology. He cited a Stanford University study that leveraged the Apple Watch and its EKG sensors, noting that tens of thousands of people participated in the study. The ability to directly reach out to and work with a diverse set of populations to get a better understanding of whether or not a therapy is working specifically for an individual or for an individual population is the promise of personalized medicine.
He highlighted decentralized clinical trials as a wonderful space for patients to participate with researchers that come from within their own communities and aren’t confined to brick-and-mortar health systems.
He also noted the development and use of smart health cards, which began with vaccination credentialing during the pandemic, empowering individuals to have access to and ownership over their own health data through the use of a provenance-enabled QR code that they can display on their mobile device. There are so many use cases beyond just vaccination credentials for a smart health card or smart health link or this QR code, from a patient’s complete health record to segments of that health record to insurance cards, for example.
Dr. Anderson highlighted the challenge of how to ensure that patients, patient advocates, and all organizations that represent patient advocates have a seat at that table to ensure that the right data that is being used to train these algorithms and being trained on our collective history is equitable, is mitigating unjustified biases, and is addressing the systemic racism in our society. He believes one way to address that challenge is through the Coalition for Health AI (CHAI), of which he is a founding member. CHAI published a blueprint that describes a set of core principles that it believes are critical for the development and implementation of models, and for the longitudinal governance of those models over time. What CHAI is trying to do is build a public, private, community partnership. It started with a set of academic institutions (the Mayo Clinic, Johns Hopkins, Emory University, Duke University, among others) each of which is strong in the AI learning space – and with technology companies (Microsoft and Google) that are at the forefront of innovation and development. Patient groups were not originally part of this effort, and he believes there is an urgent need to include them, now more than ever, as we enter this next state of innovation in digital health. The right people must be at the table to help build this consensus-driven set of best practices on how AI is governed, how to approach understanding and mitigation of unjustified bias, and how to build transparent testability so that AI can be monitored longitudinally. He asked the patient groups attending the Symposium to consider joining this effort.
The session ended with Dr. Anderson stressing that this is our opportunity as a society to lean in, and what a waste it will be if we do nothing.
In his brief closing remarks, Dr. Escontrías thanked the moderators, panelists, and attendees once again for participating and emphasized that the NHC is where all can come for support, conversation and idea sharing. He noted the Science of Patient Engagement Symposium has historically been a platform for scientific leaders and patient engagement experts to convene and build consensus on methodologies and strategies to advance the inclusion of the patient voice into research. The 2023 Symposium demonstrated the importance of being intentional in the inclusion of underrepresented voices and bringing in patient-centered innovation in digital health to move the needle forward in providing quality care for all.
Click below for the session video.