Tag Archives: regulation

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 In a proactive move, the FDA published draft guidance (21 July 2011) for what it defined as “mobile medical applications”, and invited comments from industry … Continue reading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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Insufficient clinical involvement in health app development

A new paper accepted for publication in the British Journal of Dermatology calls for greater clinical involvement in the production of health apps. The authors of the paper, titled “Medical Professional Involvement in Smartphone Apps in Dermatology“, analyse the descriptions … 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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