Many health apps will be banned
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A few weeks ago I was invited to the EU Commission to give a speach for a workgroup in mHealth. Many interesting things were discussed, such as privacy, ownership of data and ethics.
But the most important issue, that many app-developers seem not to be aware of within the Lifestyle and Health arena, that it can be classified as a medical device. If so, it needs to be CE marked and to get that clinical trials etc is required. I quote from the summary of the workshop;
Software itself can be classified as a medical device. This is something that the producers of many mobile phone applications appear to be unaware of. Reform of the Medical Device Directive will have to work out methods that will allow adequate regulation of such innovations. This will include where such software is intended to be operated in conjunction with other devices not traditionally considered medical devices such as mobile phones.
I see clear parallells with when IT was introduced to hospitals. All os a sudden developers became health experts and doctors developers.
Dangerous and important for all app-developers! FDA is even considering banning all apps within theese sectors as a result of the total chaos on the app-market. Just because “apps” are in and cool, mHealth services need not be developed as software’s – nor should they as they may be considered medical devices – textmessaging works equally well, is cheaper and more accessible to the patients.
I urge everobody to have a clear focus of why mHealth services are developed! They should be in the best interest of the patient and enhance the care of the patients. Nothing else!
Services and Apps
This was enlightening Sophie, thamnks.
Two reflections:
1. text messaging wouldn’t be exempt because the software for the application sits on a server somewhere? ie if I am getting stock inventory levels relayed to my phone at my clinic via SMS … it becomes a medical device. Or?
2. For it top be a medical device, it would have to be used by a medical professional where medicine is practiced (Is my understanding ok here pls). So if I have a ‘wellness’ app that I use at home and on the road that gives me dietary advice, it would not be classed as a medical device.
I remember discussing business cases in the health/wellness area with a vendor last year, my uinderstanding then was that the m-wellness market was large and easier for developers to target because they were less likely to get bogged down in the legals you describe.
Hi Mark,
Textmessaging does not install any software on the mobilephone, like an app.Therefore if you get a textmessage, it is not considered a medical device. Then the mobile is only used for communication, not to measure anything health related. It is when you develop a software, download it into your mobile phone and use the information (puls, heart rate, even the distans you just run)to make anykind of decision that concerns your health or wellbeing, then it is considered a medical device. No, incorrect. It can be considered a medical device even if you as a non-health person measure something with an app on the phone and use it as decision support for wellbeing or health. As an example, if you have an app that measures how many calories you used during training and you use that to take a decision of how much you can eat that day, it is considered a medical device.
So, as a summary, it has to measure something that you use use as decision support.
Unfortunately the vendor you spoked to last year and many with him who has invested in the mHealth arena, are going to be chocked…….
2.