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…)
What follows is a brief summary of the presentations given at the Royal Society of Medicine’s third “Appday”, held on 9th April 2015. All three events have been sell-outs.
Anne Hayes, Head of Market Development at BSI, opened the event with an excellent presentation on the then shortly-to-be-finalised PAS 277 on mHealth apps (now available, free, here). She particularly welcomed the opportunity to present to clinicians, as too often her audience was primarily technologists. The presentation was especially impressive because Anne had only agreed to do the presentation the previous Friday, following realisation by both MHRA & NICE that proximity to the election meant neither could present. Anne explained that PAS 277, as a Publicly Available Specification, is not mandatory – it is essentially a checklist for developers and purchasers of medical apps to consider.
Julie Bretland, CEO of OurMobileHealth, then presented on the preliminary conclusions of the NIB Workstream 1.2 on how best to approve medical apps. (more…)
After some six months of consultation and hard work, the BSI has produced PAS 277, which can be downloaded free, here. The purpose of the code, which is not mandatory, is to provide guidance to app developers on the key issues to be aware of when developing and delivering medical apps. This editor, as Managing Director of DHACA, was a member of the team developing the code.
PAS stands for Publicly Available Standard – to quote Wikipedia, the objective of a Publicly Available Specification is to speed up standardization. PASs are often produced in response to an urgent market need.
Again representing DHACA, this editor is now also a member of the drafting committee of the EU’s voluntary code focusing (more…)