eHealth

Article

Digitalisering patiëntgegevens uitbesteden?

De Autoriteit Persoonsgegevens heeft recent onderzoek gedaan naar het digitaliseren van patiëntgegevens door ziekenhuizen. Het komt vaak voor dat externe bedrijven worden ingeschakeld voor dergelijke klussen. Dat mag ook, maar omdat het…

Article

eHealth meetlat: “Ik vraag de CT-scan mee op een DVD’tje”

De jaarlijkse eHealth-monitor van Nictiz en Nivel laat zien wat de stand van zaken is van digitale zorg in Nederland. Maar hoe eHealth-minded ben jij? Maak je gebruik van online consulten, gezondheidsapps,…

Article

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….

Article

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…

Article

FDA draft guidance on mobile medical applications

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…

Article

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…

Article

The MHRA's new guidance on standalone software as medical device and DIA Euromeeting update

A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between…

Article

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…

Navigate through our knowledgebase