Blood informatics: negotiating the regulation and usership of personal devices for medical care and recreational self-monitoring

This chapter approaches personal medical devices 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 delivery systems, given the regulatory context of the UK and 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’. European Union regulatory frameworks are shown to be struggling with the challenge of ‘mHealth’ innovations, and the concept of ‘technology identity’ is used to highlight key features of the devices in their uncertain regulatory context that shape the way in which the range of stakeholders and potential users understand, evaluate, and might actually use these devices.