Category Archives: News

Mobile medical apps: lobbying in the USA

The FDA is the responsible organisation for the regulation of medical devices in the USA. In a proactive move, the FDA published draft guidance (21 July 2011) for what it defined as “mobile medical applications”, and invited comments from industry … Continue reading

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City law firm opines on health app regulation

Simmons & Simmons, a respected law firm headquartered in the City of London, have published an article on their interpretation of the regulation of health apps currently in force in the UK, as well as where future EU regulation could … Continue reading

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Less haste, more speed: Robust risk-benefit analysis needed

Rapid response to BMJ letter Doctors taking a pulse using their mobile phone can spread MRSA by our CEO. The authors of a recent small study on the contamination risk associated with mobile phone usage in a clinical environment[1] should … Continue reading

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O2 privacy failure: is your mobile number being shared when browsing online?

An alarming story has emerged over the last 24 hours for mobile phone customers on the O2 network (potentially including MVNOs GiffGaff and Tesco Mobile that piggy back on O2): Your mobile phone number may be disclosed to internet servers … Continue reading

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App regulation one week on: MHRA, MDD and NHS in the spotlight

So it’s been a week since we published our document Regulation of health apps: a practical guide alongside the news that the Mersey Burns app has been released – the first app manufactured and CE marked as a Class I … Continue reading

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How safe is that app? Mersey Burns is the first app to be registered as a Class I medical device by the MHRA

EMBARGOED UNTIL 8AM GMT ON 10 JANUARY 2012 UK charity draws attention to the regulation of health apps and publishes guidance document to help health professionals, organisations, patients and industry 10 January 2012, London – A new app, Mersey Burns, … Continue reading

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Regulation of health apps: a practical guide

d4 have published a new guidance document today on the regulation of health apps (press release).  The document is available for download for free from our website. Download the guide for free: Regulation of health apps: a practical guide The … Continue reading

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A UK first: Mersey Burns app is registered with the MHRA as a Class I medical device

To mark this important milestone for UK health app regulation, d4 asked Rowan Pritchard-Jones MD FRCS(Plast), the clinician behind the app, to tell us more. Mersey Burns is a clinical tool for estimating burn area percentages, prescribing fluids using Parkland, … Continue reading

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Digital Healthcare 2012 – where’s your ID?

As we start the new year, there’s been no shortage of predictions across the tech press of themes to watch in 2012. TechCrunch’s 6 Big HealthTech Ideas That Will Change Medicine In 2012 is perhaps the most relevant for our readership, and … Continue reading

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What was hot at mHealth Summit 2011: #mhs11 twitter analysis

Did you miss the mHealth Summit 2011 in Washington, DC? Curious to know what was hot?  Here’s a frequency graph of Twitter traffic using the official #mhs11 hashtag.  Perhaps unsurprisingly the peaks co-incided with keynote speakers. You may also want … Continue reading

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