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“Apps” that harm patients will be hunted down, says regulator

BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h1579 (Published 23 March 2015) Cite this as: BMJ 2015;350:h1579
  1. Matthew Limb
  1. 1London

A UK health regulator has issued a warning to makers of mobile medical “apps” that may harm patients.

Neil McGuire, clinical director of devices at the Medicines and Healthcare Products Regulatory Agency (MHRA) said, “Be under no illusion—if you have a medical device and it’s software or an app and patients come to grief, we’re coming looking.”

McGuire spoke at a health technologies seminar in London on 18 March attended by NHS and private sector representatives including device developers and designers. He was asked whether the United Kingdom and Europe would follow the US Food and Drug Administration’s lead in taking a supposedly “softer” line on certain classes of devices in guidance issued last …

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