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…)
As some readers will be aware, this editor is involved in organising a range of low-cost, and free, digital health events. Two that should be of interest to all commercially-minded readers are:
On Friday 22nd April DHACA is holding its eighth members’ day at the Conference Centre at 1 Victoria St., this time focusing on customer mapping: how do you identify and contact the right person in the NHS to sell your digital health product or service to? We will have Siobhan Jones, a Deputy Directory in the Department of Health, John Currie a senior procurement manager in NHS England, and Karen Livingstone, National Director of SBRI Healthcare, NHS England, and Director of Partnerships & Industry, Eastern AHSN to help us. However the most important part of the day will be attendees sharing what works & what doesn’t. Membership of DHACA is free (though we do need to make a small charge for refreshments). Do come along – book here.
Then on the evening of the 28th April the London Health Technology Forum is holding an event kindly sponsored by Baker Botts on the assessment & regulation of medical apps. Confirmed for the evening is Julian Hitchcock, a partner in Denoon Legal, who gave a masterful presentation recently at the RSM medical apps event – this is particularly important considering the EU GDPR finalisation and changes expected as the Medical Devices & In Vitro Devices Directives are converted to regulations. Book here – attendance is completely free.