We are delighted to be one of the first companies in the world to be CE approved and we are strong advocates of the regulation of the mobile health industry. Our app ONCOassist is now classified as a “medical device” meaning it can be used to make clinical decisions in a hospital. In our mind there is no doubt that mobile apps that fall under the definition of a medical device need to be regulated.
Cell phones today have more computational power than the computers that controlled the first trip into outer space. We are only scratching the surface of what these devices are capable of, from a healthcare perspective; smartphones employed to make clinical decisions and without proper regulation could be very dangerous. However, as with all industries, regulators need to apply a degree of common sense, they should only regulate when the patient is at risk.
Since we have got our CE mark, I will be first to admit that we haven’t been shy in telling people. This includes our customers; we believe it’s a one of a number of valid arguments as to why a doctor should choose ONCOassist over other apps. However, we have found the vast majority of our customers are completely unaware of the meaning of CE approval. Whilst this is understandable considering how the traditional hospital procurement system works e.g. the hospital procurement department check that all devices used are compliant (correct me if I am wrong here) not the clinicians.
So, this leaves us with an interesting question. What are the future distribution channels for clinical decision support apps? At the moment clinical decision support app distribution is very much direct to user, but can this continue? Will new distribution channels and controls emerge?
These are some of the possible routes of the future:
The hospital route
Is it possible that hospitals will procure medical device apps just like they buy traditional medical devices? iPads and other tablet devices are being issued as standard in hospitals around the world. Safe validated decision support software to sit on these devices is crucial to the maximizing the utility of these devices.
Self contained and managed AppStores
Regulated AppStores set up by third parties or by known institutions is also a possibility. The NHS recently set up their own AppStore, which is now in Alpha phase, however this is only for consumer apps. The Happtique AppStore in the USA offers a certification programme and vets apps on behalf of medics and consumers.
Direct sales to doctors
In time doctors may become more discerning about which type of app they choose to use. In order for this to happen the regulator or hospital administrators may have to get involved in the education of doctors and tell them how to identify a safe app from an unsafe app.
Appstore and Google play store
As for Apple and the Google play store, Apple recently set up a medical app section, however there was no mention of CE or FDA approval. Maybe they should consider allowing a special badge for those that are CE or FDA approved or special medical device section of the AppStore.
The new regulated clinical decision support app market is only in its infancy. Therefore, new business models are set to emerge in the coming months and years.
Exciting times ahead……
Try out our first app ONCOassist.