Category - mhealth

medicaldeviceslegal

Software MEDDEV updated

The Commission issued an updated version of the MEDDEV 2.1/6 regarding standalone software on 15 July. After all the rumors around the difficult discussions surrounding the revision process I was very curious about the changes finally implemented. Unfortunately these changes turned out to be very limited and in my view do not change the scope […]

medicaldeviceslegal

Wearables – a seminar about legal and regulatory aspects

Wearables are getting more and more popular and start to move more into the healthcare field by tracking all kinds of data concerning physiological processes and performance. Some companies explicitly want their wearables to be medical devices, others prefer their wearables to stay out of that.  Some companies plan their data protection compliance for personal data […]

medicaldeviceslegal

End of year bonanza

Normally one looks back at the end of the year, but I also like to look ahead because there are a lot of developments in EU law that will affect the medical devices industry next year: new rules on cybersecurity, data protection, mHealth and business compliance will put their mark on 2016, additional to the never-ending […]

medicaldeviceslegal

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. I have also heard Commission officials tasked with medical devices at DG SANCO say they are in transition now. It also became clear […]

medicaldeviceslegal

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 day at the MEDICA I spent in the health IT hall, catching up on developments, particularly in the interesting Wearable Technology Pavillion with […]

medicaldeviceslegal

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 for quite a long time (at least by me!), so expectations were high. So high actually that I have not heard exultantly positive […]

medicaldeviceslegal

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 Halle Tecco’s speech in the Stanford Technology Ventures Program identifies systemic challenges facing healthcare in America and shares examples of companies working to address these […]

medicaldeviceslegal

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 of other documents, after it was adopted at the meeting n Brussels 12-14 November 2013. People that commented on the document will remember that  the […]

medicaldeviceslegal

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 medical devices law against medical software that they consider a medical device as of 1 January 2014. They have said so pretty clearly […]