Blood Informatics: Negotiating the Regulation and Usership of Personal Devices for Medical Care and Recreational Self-monitoring
This chapter approaches PMDs firstly by outlining the uncertain environment of existing and emerging regulatory regimes, and secondly by examining actual and discursive local processes of adoption of exemplar devices both within and outside organised healthcare systems, given the regulatory context of the UK and the European Union. Two case studies are presented of portable devices that measure and/or monitor blood flow or blood pressure, one within medical jurisdiction, the other more or less ‘recreational’. The European Union regulatory frameworks are shown to be struggling with the challenge of ‘mHealth’ innovations. The concept of ‘technology identity’ is used to highlight key features of the devices in their regulatory context that shape the way in which potential users understand, evaluate, and might actually use these devices.
A version of parts of this chapter was presented at the Wellcome Trust/University of Cambridge Symposium ‘Theorising Personal Medical Devices: New Perspectives’, Cambridge, UK, 18–19 September 2014. I am grateful for comments from participants.
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