TTC #216 Is an App a Medical Device or Software that Needs to be Certified?

Published: Dec. 12, 2015, 2:47 p.m.

Brian O\u2019Connor, Chair ECHAlliance\nCatherine Chronaki, Secretary General at HL7 International Foundation\nGeorge Crooks, Medical Director for NHS24\nAlexander Berler, HL7 Chair for Greece\n\nA recent Imperial College of London study showed that a number of NHS approved apps, while sending out data to associated services, 33% of them were doing so without encrypting their data. This is a security threat invoking identity theft plus privacy issues. Does the EU need a medical software certification strategy and if so, who should implement & enforce it?