Wearing Many Hats: Stakeholder Collaboration in the Formation of Digital Therapeutics

• In Event: The Interpretive, Affective, and Ethical Work of Big Data in Health Care and Medicine - I

Abstract

Pursuant to the 2016 passage of the United States’ 21st Century Cures Act, the primary burden of low-risk medical technology evaluation is shifting from pre-market safety and efficacy tests to post-market “real world” assessment in an attempt to expedite novel devices to patients and consumers. Policies to appropriately regulate digital health products are in development. The U.S. Food and Drug Administration (FDA) is working with industry to create a new framework for evaluating digital health technologies, intended to address the iterative nature of software product development cycles. While the newly envisioned regulatory pathway lifts barriers to market for digital health products—serving as an incentive for innovation—the method for categorizing low-risk digital health products leaves significant grey area among products, including many classified as “digital therapeutics,” which do not fit neatly within a specific risk category as determined by the FDA. These loopholes create considerable space for companies developing novel products to shape the regulatory environment overseeing them.

In keeping with this panel’s interrogation of new labor forms emerging from the “datafication of health,” this paper will draw on ethnographic research to investigate the practices of stakeholder collaboration in the formation of digital therapeutics, as well as its regulatory framework. Drawing on 1) multi-sited field observations of worksites, industry conferences, and an FDA public workshop; 2) in-depth interviews with stakeholders; and 3) relevant document analysis, this paper addresses private sector digital therapeutics production practices, regulatory development practices, and the ways in which these activities are connected.

Author

• Meg Martin, University of California, San Francisco