UCSF

Purpose: This critical ethnographic study explores regulatory, social, and commercial spheres of behavioral health innovation in the United States through the lens of a burgeoning employment sector: digital therapeutics. By examining ways that digital therapeutics are being defined and operationalized in connection with shifting policies to evaluate digital health, this study draws on collected data to examine evolving conceptions of evidence, access, and public benefit happening in the name of health innovation.

Background: Pursuant to the 2016 passage of the 21st Century Cures Act, The U.S. Food and Drug Administration is actively revamping its evaluation frameworks for digital health products. Policies to appropriately regulate software as a medical device (SaMD) are in development to review whole company characteristics rather than individual product efficacy, address the iterative nature of software product development cycles, and empower commercial actors to provide their own effectiveness analytics for post-market assessment purposes.

Methods: A qualitative approach was used drawing on multiple data sources for this project. These sources included: collected documents (n=25), in-depth individual interviews with stakeholders working on or with knowledge of digital therapeutic products across professional areas including engineering, clinical science, regulatory science, executive leadership, academia, and financial services (n=41), and ethnographic observations (n=75 hours) taking place at two digital therapeutic conferences, technology sector worksites, interview locations, and an FDA workshop. Data were transcribed, thematically coded, and analyzed using a qualitative software program, Dedoose.

Results: Digital therapeutics are being defined and operationalized in connection with the digitization of behavioral health. This shift entails a connected commercialization of behavioral science interventions. In an environment where standards to guide product development are unclear, regulatory expertise is heightened as an asset for which companies compete. The FDA’s evolving regulatory schema advantages commercial actors with more resources, which may impact the types of organizations from which innovative and FDA approved digital health products originate.

Digital therapeutics advance conceptions of health that center the optimization of individual selfhood through processes that seek to “purify” interventions. These “purified” interventions, often digitized therapeutic encounters, eliminate interference and variation by human actors in the name of improving biomedical intervention standards. Commercial promises to increase digital access to care ignore varying ways that access is invoked through product creation, including the possibility that digital therapeutics may hinder in-person access to therapeutic relationships and contribute to stratifying occupational dynamics with implications for health equity.

Conclusion: This study highlights ways that scientific evidence is being reshaped in the commercialization of behavioral health, in addition to the co-production of digitization and commercialization as stratifying processes. Findings shed light on the need to assess evidence production within emergent health technology production more closely. Ethical guidelines to define and center equity should be incorporated into digital health implementation strategies and are of considerable importance to the domains of regulatory and translational science.