mhealth

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EU Commission’s mHealth Code Nears Completion – But Will It Be A Success?

DG Connect, the European Commission’s department of communications networks, content and technology, has been working on an mHealth code, with the view to completing it  by the end of 2016. Amanda Maxwell…

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The devices have landed – and some promotion

So, it took a while but the devices have finally landed. During the EPSCO council of 1 December it was confirmed that the medical devices policy has indeed moved to DG ENTR….

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In, on and near body networks EU regulation

I had the pleasure of being invited to speak at the Health IT forum at the MEDICA conference last week on regulation of in, on and near body networks. Most of my…

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Mobile medical apps update from the HIMSS

On Thursday 8 May I presented about EU regulation of mobile medical apps at the HIMSS Mobile Medical Apps roadshow in Berlin. The European Commisison’s Green Paper on mHealth has been hotly anticipated…

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EU mHealth regulatory requirements and update: why the NO in innovation?

mHealth is one of the big promises worldwide to reduce costs of healthcare and empower patients. The challenges in mHealth are roughly the same in the EU and US: watch Rock Health’s…

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IMDRF Software as Medical Device definition document completes

In relative quiet the IMDRF has delivered its first deliverable in the series of documents relating to Software as a Medical Device (SaMD) on 18 December last year, together with a number…

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Happy Holidays, and an exciting and innovative New Year to you – and a correction

You have a lot to look forward to next year unannounced notified body inspections will start (I hope you, your subcontracts and suppliers are prepared – if not, take a look at…

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Healthcare software enforcement alert

If you are active in the medical software field in the Netherlands you may probably be aware already that the the Dutch healthcare Inspectorate IGZ has announced that it will rigorously enforce…

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eHealth and mHealth at the DIA Euromeeting

I had the privilege to preside a session about eHealth and mHealth at the DIA Euromeeting in Amsterdam last week, joined by Mr Tapani Piha, Head of Unit for eHealth, Health Technology…

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