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Gepubliceerd op woensdag 19 december 2012
LS&R 405
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The new Commission eHealth Action Plan, and some thoughts on what it will mean for devices

Een bijdrage van Erik Vollebregt, Axon Lawyers.

Last week the Commission launched its new eHealth Plan (EHAP). It was announced under the header “Putting patients in the driving seat: A digital future for healthcare”. A nice rundown of the relevant documents is here and a good summary by MedTech Europe (Eucomed and EDMA) is here. Then there is the convenient overview and roadmap over here giving an overview of actions to be implemented in 2012 – 2020. You might want to take a look at this Commission presentation on eHealth of last month giving you the short and comprehensive version of what they then expected to be in EHAP.

These developments are important for the medical devices industry, for several reasons. First, more and more medical devices are standalone software and provides as service. Those are now explicitly regulated under the proposed Medical Devices Regulation and proposed In Vitro Diagnostic Devices Regulation. Secondly, more and more medical devices will connect to the internet as part of healthcare services in the internet of things. Thirdly, these devices, both software/service devices and physical ones, need degrees of interoperability to function together.

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