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:

• Digital innovations are fueling hope, but optimizing the full value of their potential requires active engagement of patients at every step.
• The ability of Artificial Intelligence to mitigate inequities in health care is entirely dependent upon the data collected to support AI programming.
• 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.
• A collective dedication to patient centeredness and giving patients agency is more critical now than ever. 

Following are highlights from the day’s events.

WELCOME AND INTRODUCTIONS

• Kenneth Mendez, MBA, CEO & President, Asthma and Allergy Foundation of America (AAFA) and Chair, NHC Board of Directors
• Randall Rutta, MA, CEO, National Health Council
• Omar A. Escontrías, DrPH, MPH, Senior Vice President of Equity, Research, & Programs, National Health Council

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.

KEYNOTE REMARKS

• Robert M. Califf, MD, MACC, Commissioner of Food and Drugs, United States Food and Drug Administration

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: 

• Disparities – He noted the dramatic decline in life expectancy, only partially due to COVID-19, but also including gun violence, suicide, and opioid overdose, and that differences as a function of race, ethnicity, sex, education, wealth, and rural living status are stark. He quoted The Atlantic’s Ed Yong: “Technological solutions drift into society’s penthouses. Diseases seep into its cracks;” and he urged attendees to think beyond the hypothetical or artificial laboratory-based assessment of how new drugs, devices and foods will be used across our society.
• Representativeness – He pointed out the ability that now exists to interact with almost the entire spectrum of people with a disease or at risk, and that we will eventually need to address the diversity of values, preferences, beliefs, living circumstances, and economic factors by directly measuring them in broader populations.
• Algorithmic bias – He noted that algorithms evolve after they are put into practice, stressing that they will need adjustment and measurement of their operating characteristics continuously throughout the life cycle.
• Large language models – He acknowledged that the agency is not nimble in the use of large language models, and he sees their regulation models as critical to our collective future.
• Misinformation – He believes this new digital era can connect us, but technologies like large language models give almost everyone the potential to produce false narratives or even so-called deep fakes, which is why a key part of a successful transition to digital health is an effective regulatory scheme to guide digital technologies to improved human outcomes and interaction.

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

Moderator:

• Beth Matthews-Bradshaw, Vice President of Patient Engagement and Research, Alliance for Aging Research

Guest Speaker:

• Nicol Turner Lee, PhD, Senior Fellow of Governance Studies and Director for the Center of Technology Innovation, Brookings Institution

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:

• People not only don’t understand many existing technologies; they don’t understand that these technologies are used without their agency. We must demand that technologies are brought to patients in ways they can understand, and that impacted and marginalized communities’ needs and challenges are taken into account.
• There are aspects of the bipartisan infrastructure law that are worth highlighting and promoting, including the creation of a digital navigator program. The funds available in that program can be used for additional educational efforts to help build trust among vulnerable communities. Also available is the affordable connectivity program, which provides subsidies for broadband services for low-income households.
• We should be advocating for a digital equity fund that allows innovative projects.
• More non-anchor institutions – like churches, small businesses, and community health centers – are great resources and can provide wider and broader access to technology; they should have access to additional funding to do so.

Click below for the session video