mobile medical apps


EU privacy requirements for (healthcare) apps – the Article 29 Working Party weighs in

The European Article 29 Working Party has just released its opinion 02-2013 on apps on smart devices. This detailed opinion provides very useful and detailed guidance for companies developing and distributing healthcare…


The new Commission eHealth Action Plan, and some thoughts on what it will mean for devices

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…


CE marking of apps: It Can Be Done and Here Is How

If there is one thing that I have learnt by now working with medical apps and medical device law is that physicians have little idea about rules for apps with medical functionality,…


Standalone software regulated as medical device: a look under the hood of the draft MEDDEV

Sometimes you have to go far away to learn a lot about thing close to home and that is what happened to me at the RAPS Regulatory Convergence Conference that I am…

Navigate through our knowledgebase