Informally Regulated Innovation Systems: Challenges for Responsible Innovation in Diagnostics (original) (raw)

Emerging Technologies for Diagnosing Alzheimer's Disease, 2016

Abstract

High expectations accompany developments in genomics, but responsible diagnostic innovation faces many impediments. Drawing on observations of a feasibility study of personalized cancer care, the authors highlight the informally regulated nature of diagnostic innovation systems, where translational imperatives blur clinical and research aims, key regulatory institutions are bypassed, and other cognitive, normative, and regulative institutions encourage attention to test performance, rather than patient outcomes. In these socio-technical systems of limited accountability, intentions to help patients and act ethically are not subject to test; instead, presumptions of benefit and duty are stabilized within material and organizational routines to produce diagnostic innovations of questionable value. Wider patient and public engagement, together with robust, legitimate, and accountable regulatory regimes will be required to truly ‘innovate with care’.

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