MHRA

Archive

Explainer: when is an app not an app (but a medical device)?

New guidance has been released on when an app becomes a ā€œmedical deviceā€ but attempts to control which apps creep
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QRisk2 in TPP “fixed” but up to 270,000 patients affected

Up to 270,000 patients have been affected by errors in a cardiovascular disease risk calculator, which is being blamed on
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RCP apps guidance attacked

Recent guidance from the Royal College of Physicians that says doctors should only use medical apps carrying a CE mark
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Appropriate regulation

The regulation of healthcare apps emerged as a hot topic at the end of last year; and will be the
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Patient safety reporting overhaul

The NHS is developing the National Reporting and Learning System to become an integrated reporting route for patient safety incidents.
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Addressing a burning issue

The Mersey Burns App was the overall winner of the EHI Awards 2013 in association with CGI; and will be
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Is there a regulation for that?

Richard Brady, a surgical registrar, is worried that too many medical apps have too little medical input – and may
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Datalink to support UK life sciences

The government has launched a ā€œworld-class e-health secure research serviceā€ that will provide life science researchers with greater access to
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Is there a regulation for that?

Apps are flooding into the healthcare market. But regulators are struggling to catch up – and many people in the
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Yellow cards built into SystmOne

Healthcare IT supplier TPP has announced that clinicians can now report adverse drug reactions direct from its SystmOne software. The
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