Category: Digital Health

The FDA, Patient Empowerment, and the Type 1 Diabetes Communities in the Era of Digital Health

The day-long September 2018 workshop, “Medical Devices-Patient Engagement in Real World Evidence: Lessons Learned and Best Practices,” sponsored by the Food and Drug Administration (FDA) and University of Maryland (UM), met on the Baltimore campus, the city where I spent my graduate school years. In contrast to Baltimore’s palpable desperation, UMB’s health campus gleamed with newness, its brick walkways and tastefully planted vegetation viewable through floor-to-ceiling windows. In the well-appointed auditorium, Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH, pronounced ‘cedar’), closed his introduction to the conference with the pronouncement that as the FDA moved toward real world evidence (RWE), “patient engagement” and the data patients may collect are invaluable for RWE. (read more...)

The Dawn of Digital Therapeutics

A techno-optimistic attitude tells us we’re living at an inflexion point where care practices are being transformed by technology. Monitoring and attending to health and well-being are no longer activities bound within physical spaces like hospitals and clinics; these activities have extended to the basic functions of smart phones. A new labor force has emerged for this digitized health transformation utilizing open source engineering platforms, structuring work into two-week Agile design sprints, and leveraging professionals from traditional healthcare settings. In many ways, the practices of these workers appear synonymous to those of other start-up companies across industry spaces. Throughout ethnographic fieldwork over the last year, I have explored the evolution of this phenomenon within an emergent area of the digital health sphere: Digital therapeutics. (read more...)