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Open challenges in developing digital therapeutics in the United States

['Brenda Y. Miao', 'Bakar Computational Health Sciences Institute', 'University Of California', 'San Francisco', 'Douglas Arneson', 'Michelle Wang', 'Atul J. Butte', 'Center For Data-Driven Insights', 'Innovation', 'University Of California Health']

Date: 2022-02 

Competing interests: Atul Butte is a co-founder and consultant to Personalis and NuMedii; consultant to Samsung, Mango Tree Corporation, and in the recent past, 10x Genomics, Helix, Pathway Genomics, and Verinata (Illumina); has served on paid advisory panels or boards for Geisinger Health, Regenstrief Institute, Gerson Lehman Group, AlphaSights, Covance, Novartis, Genentech, and Merck, and Roche; is a shareholder in Personalis and NuMedii; is a minor shareholder in Apple, Facebook, Alphabet (Google), Microsoft, Amazon, Snap, 10x Genomics, Illumina, CVS, Nuna Health, Assay Depot, Vet24seven, Regeneron, Sanofi, Royalty Pharma, AstraZeneca, Moderna, Biogen, Paraxel, and Sutro, and several other non-health related companies and mutual funds; and has received honoraria and travel reimbursement for invited talks from Johnson and Johnson, Roche, Genentech, Pfizer, Merck, Lilly, Takeda, Varian, Mars, Siemens, Optum, Abbott, Celgene, AstraZeneca, AbbVie, Westat, and many academic institutions, medical or disease specific foundations and associations, and health systems. Atul Butte receives royalty payments through Stanford University, for several patents and other disclosures licensed to NuMedii and Personalis. Atul Butte’s research has been funded by NIH, Peraton (as the prime on an NIH contract), Genentech, Johnson and Johnson, FDA, Robert Wood Johnson Foundation, Leon Lowenstein Foundation, Intervalien Foundation, Priscilla Chan and Mark Zuckerberg, the Barbara and Gerson Bakar Foundation, and in the recent past, the March of Dimes, Juvenile Diabetes Research Foundation, California Governor’s Office of Planning and Research, California Institute for Regenerative Medicine, L’Oreal, and Progenity. None of these organizations played a role in the authoring of this manuscript.

Funding: BM was supported by grants from the National Institutes of Health, USA (NIH grant 5T32GM67547-18). AJB and MW were funded and supported by the FDA UCSF-Stanford Center of Excellence in Regulatory Science and Innovation funding program. Additional support was provided by the Bakar Computational Health Sciences Institute and University of California Health, and the Sling Health UCSF group. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration.

Introduction

Digital therapeutics (DTx) are a rapidly emerging therapeutic modality that use evidence-based software to prevent, manage, or treat disease. In the United States, these new digital health tools fall under the FDA’s software-as-a-medical-device (SaMD) category and are subject to regulatory approval, much like conventional medical devices or therapeutic drugs [1]. The ability of DTx to deliver continuous and personalized care make them an attractive approach for chronic disease management, and they can be either used as standalone therapies or in combination with other treatments. Because DTx are typically administered through consumer devices, such as smartphones or tablets, they also have the potential to bridge significant care gaps created by shortages of specialized health providers and geographic barriers in accessing physical healthcare systems [2], but could also face other obstacles, such as the digital divide [3].

The COVID-19 pandemic accelerated the adoption of these digital solutions, especially with relaxed FDA guidelines allowing temporary approval of DTx offering psychiatric treatment for the duration of this public health emergency [4]. At least 63 approved DTx are now documented in the openFDA device databases, with 30 of these SaMDs approved after 2017 [5] (Table 1). The majority of these DTx (54/63) were approved through the 510(K) pathway with demonstrated substantial equivalence, three were approved as de novo applicants, and six SaMDs required premarket approval (PMA). Breaking down these devices by medical specialty, the most common categories for approved products were cardiovascular and anesthesiology, with 24 and 11 SaMDs respectively [5].

Funding for digital health companies, including the development of DTx, has grown exponentially in the past year, totaling $14.7 billion in just the first quarter of 2021 and already surpassing annual investments in 2020 ($14.6B) and 2019 ($7.7B) [6]. Both Hinge Health and MindMaze, which focus on chronic musculoskeletal conditions and substance abuse disorder, respectively, have raised over $100 million each in 2021 [7]. Although the financial backing for DTx supports their potential in providing healthcare at scale, many regulatory, commercial, and technical barriers remain in the adoption of these interventions into routine clinical care.

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[1] Url: https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000008

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