Attitudes, Advertisements, and Access To Market: An Examination and Ethical Evaluation Of Digital Therapeutics

Abstract

As the United States confronts shortages of primary care and mental health professionals, the healthcare sector continues to turn towards digital health technologies to optimize workflows and deliver health services. A growing subset of these tools are powered by artificial intelligence (AI)—algorithms that can predict outcomes, track symptoms, monitor patients, and complete other complex tasks (e.g.diagnosis). Innovation in health AI has evolved to include the creation of tools that are medical interventions in and of themselves. Digital therapeutics (DTxs) are prescribable FDA-reviewed mobile or web applications that use clinical evidence and AI technology to treat and improve self-management for patients with a range of medical conditions. This dissertation explores factors impacting the uptake and regulation of DTxs through two empirical aims and one normative aim. The first empirical aim (Aim 1) is a cross-sectional vignette experiment survey of primary care providers to understand their attitudes towards digital therapeutics as effective interventions for patients with diabetes and depression. The second aim (Aim 2) is a comparative content analysis of DTx websites and FDA summaries that assess the readability, discussion of risks and benefits, and other details to determine the accessibility and transparency of these resources for patients and providers. For Aim 1, there were no statistically significant differences in provider selection of a DTx versus an in-person self-management program for patients of different demographics. However, when adjusting for all other variables, providers were less likely to believe that a digital therapeutic would an effective intervention for patients with depression (p<0.05). For Aim 2, most of the websites and all of the FDA summaries were above the reading level of the average American adult. Compared to the FDA summaries, websites less frequently communicated risks and adverse events to potential users. The normative paper (Aim 3) argues that the FDA should consider justice in its premarket safety and effectiveness review of AI-enabled medical devices. This paper articulates how inclusion, transparency, and epistemic justice can be used in the FDA guidance-making, premarket evaluations, and public communications to ensure all users are fairly considered in AI-enabled medical device development for safe use.

Attitudes, Advertisements, and Access To Market: An Examination and Ethical Evaluation Of Digital Therapeutics

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