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  • For the past century, health care measurement and delivery have been centered in hospitals and clinics. That is beginning to change as health measures and increasingly care delivery are migrating to homes and mobile devices. The COVID-19 pandemic has only accelerated this transition. While increasing access to care and improving convenience, this move toward platforms operated by for-profit firms raises concerns about privacy, equity, and duty that will have to be addressed. In addition, this change in measuring health and delivering health care will create opportunities for educators to expand the settings for training, researchers to conduct studies at enormous scale, payors to embrace lower-cost clinical settings, and patients to make their voices heard.

    • E. Ray Dorsey
    Comment Open Access
  • The COVID-19 pandemic has been a catalyst for the implementation of decentralized clinical trials (DCTs) enabled by digital health technologies (DHTs) in the field while curtailing in-person interactions and putting significant demands on health care resources. DHTs offer improvements in real-time data acquisition remotely while maintaining privacy and security. Here, we describe the implications of technologies, including edge computing, zero-trust environments, and federated computing in DCTs enabled by DHTs. Taken together, these technologies—in the setting of policy and regulation that enable their use while protecting the users—extend the scope and accelerate the pace of clinical research.

    • Walter De Brouwer
    • Chirag J. Patel
    • Nirav R. Shah
    Comment Open Access
  • Natural language computer applications are becoming increasingly sophisticated and, with the recent release of Generative Pre-trained Transformer 3, they could be deployed in healthcare-related contexts that have historically comprised human-to-human interaction. However, for GPT-3 and similar applications to be considered for use in health-related contexts, possibilities and pitfalls need thoughtful exploration. In this article, we briefly introduce some opportunities and cautions that would accompany advanced Natural Language Processing applications deployed in eHealth.

    • Diane M. Korngiebel
    • Sean D. Mooney
    Comment Open Access
  • Health applications for mobile and wearable devices continue to experience tremendous growth both in the commercial and research sectors, but their impact on healthcare has yet to be fully realized. This commentary introduces three articles in a special issue that provides guidance on how to successfully address translational barriers to bringing mobile health technologies into clinical research and care. We also discuss how the cross-organizational sharing of data, software, and other digital resources can lower such barriers and accelerate progress across mobile health.

    • Joy P. Ku
    • Ida Sim
    Comment Open Access
  • Competence and warmth are two essential dimensions of patient care. During the twentieth century, the industrial revolution in data collection, with the increasing use of machines and the division of labor that led to the development of many subspecialities, increased the overall competence of physicians at the expense of the warmth dimension. The spread of patient-centered care principles aimed to rebalance the two dimensions. In the twenty-first century, the industrial revolution in data processing with the emergence of algorithmic decision-making systems based on artificial intelligence is likely to disrupt further this balance. Competence will no longer be the prerogative of physicians, but a dimension to be shared between physicians and autonomous algorithmic decision-making systems, by contrast to warmth which should remain a human attribute. In this comment, we discuss the extent to which competence and warmth can remain the core dimensions of physician care in the era of artificial intelligence.

    • David Drummond
    Comment Open Access
  • From clinical trials to care delivery, advanced, digitally enabled technologies and analytics offer new approaches to how we think about medicine, health, and biology. The Covid-19 pandemic has accelerated this conversation, and forced a roadmap, once measured in years or decades, to unfold over days, weeks, and months. Yet the scaffolding for this roadmap had already emerged prior to the Covid-19 pandemic. In this perspective, we highlight a special collection of papers on “digital medicine,” which emerged from a symposium held in Boston in 2019 and were published in 2020 and 2021. The symposium was hosted by Harvard Business School and the Harvard MIT Center for Regulatory Science, and included a range of speakers and attendees from industry, government, and academics. We describe their ongoing relevance as we contemplate our early 2021 pandemic reality and the near future of digitally empowered health care.

    • William J. Gordon
    • Andrea R. Coravos
    • Ariel D. Stern
    Comment Open Access
  • The use of remote monitoring and virtual visits has accelerated to support socially-distanced patient care during the COVID-19 pandemic. Despite the necessity of this expansion, ambiguity in coding is hindering adoption and patient access, most notably for remote physiologic monitoring due to a lack of definition of the term “physiologic”. In this analysis, we describe the history of remote monitoring code development, present several examples in respiratory disease and other chronic conditions in which gaps and confusion remain and suggest ways to clarify and broaden coverage to ensure equitable access to remote monitoring.

    • Robert Jarrin
    • Meredith A. Barrett
    • Andrey Ostrovsky
    Comment Open Access
  • The COVID-19 pandemic has profoundly affected life worldwide. Governments have been faced with the formidable task of implementing public health measures, such as social distancing, quarantines, and lockdowns, while simultaneously supporting a sluggish economy and stimulating research and development (R&D) for the pandemic. Catalyzing bottom-up entrepreneurship is one method to achieve this. Home-grown efforts by citizens wishing to contribute their time and resources to help have sprouted organically, with ideas shared widely on the internet. We outline a framework for structured, crowdsourced innovation that facilitates collaboration to tackle real, contextualized problems. This is exemplified by a series of virtual hackathon events attracting over 9000 applicants from 142 countries and 49 states. A hackathon is an event that convenes diverse individuals to crowdsource solutions around a core set of predetermined challenges in a limited amount of time. A consortium of over 100 partners from across the healthcare spectrum and beyond defined challenges and supported teams after the event, resulting in the continuation of at least 25% of all teams post-event. Grassroots entrepreneurship can stimulate economic growth while contributing to broader R&D efforts to confront public health emergencies.

    • Khalil B. Ramadi
    • Freddy T. Nguyen
    Comment Open Access
  • Digital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital health innovation during the pandemic, such as guidance documents to expand the use of digital therapeutics for psychiatric disorders and medical devices for remote patient monitoring. In this article, we contextualize these policies to the agency’s existing regulatory framework for digital health, outline key considerations for patients and health care providers, and identify implications for the future of digital health innovation.

    • Kushal Kadakia
    • Bakul Patel
    • Anand Shah
    Comment Open Access
  • In this Comment, we characterize the current pipeline of digital therapeutics and offer a clinical perspective into the advantages, challenges, and barriers to implementation of this treatment modality for patient care, which we hope will inform future regulatory policy, prescribing decisions, and scope of real-world evidence collection.

    • Nisarg A. Patel
    • Atul J. Butte
    Comment Open Access
  • Digital health is a rapidly developing field which is positioned to transform the manner in which healthcare is delivered, especially amongst adolescents and young adults. In order to assess the efficacy of novel medical devices, clinicians and researchers often turn to the literature for guidance. Randomized control trials and the systematic reviews and meta-analyses that they inform are considered to be at the top of the evidence hierarchy. While they are excellent tools to identify and to summarize the best available evidence to answer a specific research question, they are poorly equipped to provide a more expansive understanding of the body of relevant literature in a timely manner. In this letter we discuss the utility of the scoping review, an underutilized style of academic writing designed to map key concepts in a body of literature. This method is ideal when reporting on the fast-paced field of digital medicine, as it allows for rapid synthesis of the available literature.

    • Katherine E. Lewinter
    • Sharon M. Hudson
    • Juan Espinoza
    Comment Open Access
  • Strategies to enable the reopening of businesses and schools in countries emerging from social-distancing measures revolve around knowledge of who has COVID-19 or is displaying recognized symptoms, the people with whom they have had physical contact, and which groups are most likely to experience adverse outcomes. Efforts to clarify these issues are drawing on the collection and use of large datasets about peoples’ movements and their health. In this Comment, we outline the importance of earning social license for public approval of big data initiatives, and specify principles of data law and data governance practices that can promote social license. We provide illustrative examples from the United States, Canada, and the United Kingdom.

    • James A. Shaw
    • Nayha Sethi
    • Christine K. Cassel
    Comment Open Access
  • In 2019, the World Health Organization (WHO) released the first-ever evidence-based guidelines for digital health. The guideline provides nine recommendations on select digital health interventions that involve the use of a mobile phone or device. It also provides information on implementation considerations, quality and certainty of extant evidence, factors related to acceptability and feasibility of the intervention, and gaps in the evidence that can inform future research. Given the pivotal role digital health can play in supporting health systems, seen especially in light of the COVID-19 pandemic, these guidelines can help provide a roadmap for governments and policymakers in introducing and scaling up digital health interventions to support population health outcomes.

    • Alain Labrique
    • Smisha Agarwal
    • Garrett Mehl
    Comment Open Access
  • To prevent the spread of COVID-19 and to continue responding to healthcare needs, hospitals are rapidly adopting telehealth and other digital health tools to deliver care remotely. Intelligent conversational agents and virtual assistants, such as chatbots and voice assistants, have been utilized to augment health service capacity to screen symptoms, deliver healthcare information, and reduce exposure. In this commentary, we examined the state of voice assistants (e.g., Google Assistant, Apple Siri, Amazon Alexa) as an emerging tool for remote healthcare delivery service and discussed the readiness of the health system and technology providers to adapt voice assistants as an alternative healthcare delivery modality during a health crisis and pandemic.

    • Emre Sezgin
    • Yungui Huang
    • Simon Lin
    Comment Open Access
  • The SARS-CoV-2 pandemic has challenged healthcare systems worldwide. Uncertainty of transmission, limitations of physical healthcare system infrastructure and supplies as well as workforce shortages require dynamic adaption of resource deployment to manage rapidly evolving care demands, ideally based on real time data for the entire population. Moreover, shut down of traditional face-to-face care infrastructure requires rapid deployment of virtual health care options to avoid collapse of health organizations. The Alberta Electronic Health Record Information System is one of the largest population based comprehensive electronic medical record (EMR) installations. Alberta’s long standing solid telehealth hardware-, training-, provider remuneration- and legislation infrastructure has enabled quick transition to virtual healthcare. Virtual health services including asynchronous secure clinical communications, real-time virtual care via messaging, telephony or video conferencing (telehealth) and ancillary functions like triage, scheduling, documentation and reporting, the previously established virtual hospital program with home monitoring, virtual health assessments, medication review, education and support for patients and families and coordination between family doctors, specialists and other health team members help to control viral transmission, protect healthcare personnel and save supplies. Moreover, rapid launch of online screening and triage tools to guide testing and isolation, online result sharing, infected patient and contact tracing including a smartphone exposure tracking application (ABTraceTogether), electronic best practice alerts and decision support tools, test and treatment order sets for standardized COVID-19 management, continuous access to population level real-time data to inform healthcare provider, public health and government decisions have become key factors in the management of a global crisis in Alberta.

    • Daniel C. Baumgart
    Comment Open Access
  • Artificial Intelligence (AI) has generated a large amount of excitement in healthcare, mostly driven by the emergence of increasingly accurate machine learning models. However, the promise of AI delivering scalable and sustained value for patient care in the real world setting has yet to be realized. In order to safely and effectively bring AI into use in healthcare, there needs to be a concerted effort around not just the creation, but also the delivery of AI. This AI “delivery science” will require a broader set of tools, such as design thinking, process improvement, and implementation science, as well as a broader definition of what AI will look like in practice, which includes not just machine learning models and their predictions, but also the new systems for care delivery that they enable. The careful design, implementation, and evaluation of these AI enabled systems will be important in the effort to understand how AI can improve healthcare.

    • Ron C. Li
    • Steven M. Asch
    • Nigam H. Shah
    Comment Open Access
  • It has been proposed that telehealth may help to combat the epidemic of diabetes and other chronic diseases in the US. As a result of rapid technological advancement over the past decade, there has been an explosion in virtual diabetes management program offerings rooted in smartphone technology, connected devices for blood glucose monitoring, and remote coaching or support. Such offerings take many forms with unique features. We provide a care team-based classification system for connected diabetes care programs and highlight their strengths and limitations. We also include a framework for how the different classes of connected diabetes care may be deployed in a health system to promote improved population health.

    • Brian J. Levine
    • Kelly L. Close
    • Robert A. Gabbay
    Comment Open Access
  • Digital health technology tools (DHTT) are technologies such as apps, smartphones, and wearables that remotely acquire health-related information from individuals. They have the potential advantages of objectivity and sensitivity of measurement, richness of high-frequency sensor data, and opportunity for passive collection of health-related data. Thus, DHTTs promise to provide patient phenotyping at an order of granularity several times greater than is possible with traditional clinical research tools. While the conceptual development of novel DHTTs is keeping pace with technological and analytical advancements, an as yet unaddressed gap is how to develop robust and meaningful outcome measures based on sensor data. Here, we describe two roadmaps which were developed to generate outcome measures based on DHTT data: one using a data-centric approach and the second a patient-centric approach. The data-centric approach to develop digital outcome measures summarizes those sensor features maximally sensitive to the concept of interest, exemplified with the quantification of disease progression. The patient-centric approach summarizes those sensor features that are optimally relevant to patients’ functioning in everyday life. Both roadmaps are exemplified for use in tracking disease progression in observational and clinical interventional studies, and with a DHTT designed to evaluate motor symptom severity and symptom experience in Parkinson’s disease. Use cases other than disease progression (e.g., case-finding) are considered summarily. DHTT research requires methods to summarize sensor data into meaningful outcome measures. It is hoped that the concepts outlined here will encourage a scientific discourse and eventual consensus on the creation of novel digital outcome measures for both basic clinical research and clinical drug development.

    • Kirsten I. Taylor
    • Hannah Staunton
    • Michael Lindemann
    Comment Open Access
  • It has been 30 years since the passage of the Americans with Disabilities Act and technological development has drastically changed the future for those with disabilities. As healthcare evolves toward promoting telehealth and patient-centered care, leaders must embrace persons with disabilities and caregivers as valued partners in design and implementation, not as passive “end-users”. We call for a new era of inclusive innovation, a term proposed in this publication to describe accessible technological design for all. The next 30 years of the ADA leading to year 2050, should reflect a new era of access, whereby digital health surmounts geographic, social, and economic barriers toward an inclusive virtual society.

    • Kimberly Noel
    • Brooke Ellison
    Comment Open Access