When is an app not an app? (When it’s a conundrum)

It all started so simply. In DHACA under the leadership of Rob Turpin (BSI) we produced the definitive guide to app regulation in the UK. Sure it was 44 pages long (and will shortly need updating) however we all knew that an app was standalone software and that none other than MEDDEV 2.1/6, the ultimate definitive guide to when an app is a medical device defined software as:

…a set of instructions that processes input data and creates output data.

However doubts began to creep into this editor’s mind when he heard that app developers in the US were avoiding (US/FDA) medical device classification as that would rule them out as service providers, which can reduce future  reimbursement benefits – as we quoted Ralph-Gordon Jahns of research2guidance in 2014 “profitable developers… rely on service sales as their primary source of revenue.”

Things got more complicated when it emerged at the UK Health Show this autumn that PHE was considering listing digital GP services as (more…)

A few observations from September’s Health Technology Forum London

On Wednesday 17th September, Health Technology Forum members gathered at Baker Botts’ office in London for a couple of key presentations on legal aspects of medical software.

The first, by Joe Hagan-Brown, Regulatory Affairs Specialist at the MHRA, covered the EU’s medical device-specific regulation. The second, by Alex Denoon of Lawford Davies Denoon, was a presentation on the EU’s data protection regulation.

Readers with long memories will recall that I summarised medical device-specific regulation a while back; much of what Joe said added colour to that summary. A few comments he made are perhaps worthy of repetition (more…)