Julian Hitchcock, ably assisted by Zac Fargher, has kindly agreed to spend an evening updating people on the regulation of medical and in vitro devices at a joint DHACA/Heath Technology Forum London meeting on Wednesday 17th July.
This comes at a time of huge uncertainty so Julian and Zac’s advice will be especially important for members: in addition to Brexit, the Notified Body capacity crisis is imperiling the implementation dates of both the MDR in 2020, and the IVDR after that.
Anyone following this editor’s recommendations will already be aware of Julian’s presentational clarity and depth, and his very humourous style.
Booking is here. Please try to arrive at 6.15 pm on 17th July so we can get started promptly at 6.30 pm. Julian and Zac will speak until 8pm, after which there will be time for networking drinks, kindly sponsored by Bristows, who are also generously hosting us for the evening.
Do come and join us!
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…)
Following on from our piece on the action taken by the FTC against two melanoma apps, it has been drawn to this editor’s attention that Mole Detective is still available, for £3.14/download, on the Google Play Store.
The relevant section of the FTC press release says:
Mole Detective Settlement and Lawsuit. Kristi Kimball and her company, New Consumer Solutions LLC, developed and first marketed Mole Detective in January 2012. U.K.-based Avrom “Avi” Lasarow and his company, L Health Ltd., took over marketing the app in August 2012. The marketers advertised the app primarily online, where it has sold in the Apple and Google app stores for as much as $4.99.
The settlement with Kimball and her company prohibits them from claiming that a device, such as an app, can detect or diagnose melanoma, unless the representation is truthful, not misleading, and supported by competent and reliable scientific evidence in the form of human clinical testing of the device. It also prohibits them from making any other misleading or unsubstantiated health claims about a product or service, and requires them to disgorge $3,930.
The agency will pursue a litigated judgment against non-settling defendants Lasarow and his company.
Especially as the organisation marketing the app is UK-based, (more…)
This is a brief summary of the main points made at an event on medical apps held at the Royal Society of Medicine on 10th April 2014.
First up was Prof Mike Kelly, Director of the Centre of Public Health at NICE who spoke about how apps could change behaviour. He described what he called “system 1”, the rational reflective system that he associated with Apollo, and “system” 2 the impulsive automatic system that he associated with Dionysus. System 1 is most often targeted by behaviour change, however most people find thinking hard so spend most of their time in system 2 mode, so it is much more effective to “nudge” the automatic system 2, if you can.
Humans are relational creatures, not billiard balls, so (more…)