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 a member of the Stakeholder Reference Group of the Accelerated Access Review, this editor was recently invited to write a blog to encourage contributions to the review, the purpose of which is to identify actions necessary to accelerate the uptake of innovation into the NHS. It seemed a shame for the blog also not to be shared with TelecareAware readers, so here it is:
The Digital Health & Care Alliance (DHACA), of which I am Managing Director, has a strong interest in the success of the Accelerated Access Review, both because the majority of our 550-odd members work in SMEs whose very existence depends on the responsiveness of the health & care organisations in the UK, and because all of our members have a strong interest in improving patient outcomes & treatment efficiency.
One thing I’m going to be very interested in seeing emerge from the Review is the consensus on how innovators gather and use evidence to develop their product to meet the demands of the NHS and needs of patients. In DHACA we think we have a fairly clear idea about how our members go about this, however we can only claim to represent the digital health stream in the Review, and then only for small organisations. Allied to this is the much tougher question for many, particularly our smaller and more innovative members, of how to sell to the NHS. (more…)