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Regulatory risks and mHealth

mhealth regulatory riskThis week’s blog concerns the topic of regulation in mHealth.  Before you all fall asleep (OK, regulation can be a little dull) let me explain why.  This week I was astonished to learn how few mHealth software applications have been approved as medical devices 

Regulatory approvals – a rare beast

I learnt this at a very good Health 2.0 talk in Manchester this week by Chris Seaton, who developed the “Mersey Burns” app on behalf of St Helens and Knowsley NHS Trust.  This clever app turns a complex manual calculation for fluid replacement into a quick and easy interactive tool for busy doctors in Emergency Departments, and has wide applicability.  Chris realised the inherent risks of harm if there were any inaccuracies in his software, so applied for Medical Device approval in early 2012.  He was amazed to hear that this was the first approval of standalone mHealth software requested in Europe!  This made me dig a little further.  On the MHRA website, there are only a handful of standalone software manufacturers listed in their database, yet I know there are hundreds of companies producing mHealth, telehealth and telecare software in the UK alone.  I tried to look at the EU-wide picture and it was impossible to determine if other countries had more in the way of registrations – the EUDAMED database is not public access.  The FDA in the US is a little more helpful, with a list of over 70 mobile medical applications approved (one even as far back as 1997).  

Now, consider this – according to Research2Guidance there are more than 97,000 apps available on the app stores globally, and others that are only distributed away from the app stores, yet only a hundred or so have medical device approval?  OK, a lot of those apps will fall into the non-regulated fitness/wellness/diet category, but a short glance just at the Google Play app store showed me 100 or so dosage calculators.  It’s barely credible that some of these shouldn’t be seeking some sort of registration or approval, even in a low-risk category.  Indeed in a piece of work we did at Vodafone, one of the experts we consulted (Bradley Thompson of the mHealth Regulatory Coalition) suggested that up to a third of apps may require regulatory clearance.  

So what can we do about it?

My advice – always do a risk assessment and review the guidance from the national authorities if you’re developing any health-related software (app, web-based or whatever). If you’re in any doubt, consult a regulatory expert. Also, if you’re operating under FDA jurisdiction, there’s a helpful process known as 513(g) which allows you to ask the FDA directly for advice on device classification – though there is a fee. The alternative is to ignore all this and one day you may get a firm letter forcing you to withdraw from the market.  

I hope you managed to stick with this short discussion on regulatory matters – and why they really do matter.  As usual, please feel free to agree or disagree, and of course contact me.

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