I’m trying to line up today’s piece in The Age detailing the fretting “medical and fitness experts” are doing about mobile health apps actually being mobile health risks, with a post on The Next Web’s Insider lamenting the US Food and Drug Administration’s guidance documents, which it claims threatens to stifle innovation.
The Age trots out a medical negligence lawyer to opine that apps developers could be sued “if things go wrong” – while the heading is about liability, the first paragraph suggests the story is supposed to be about people being harmed, rather than people being sued – but I couldn’t see any convincing arguments to support the implication that users might develop umm, app-endicitis or whatever from relying on an app-le a day to keep the doctor away.
On the other hand, according to TNW, app developers are being confronted with the same regime that results in substantial delays and enormous costs: “bringing a medical product to market through the FDA requires an additional 72 months at an average cost of $75 million — approximately 77% of the cost” – this at a time when the demand for these products is surging.
According to Health IT Now, a coalition dedicated to the spread of healthcare IT, the App Store saw a 250% increase in available healthcare apps between 2010 and 2011. More significantly, by 2015, 500 million smartphone users are expected to have such apps on their phones. This is due, naturally, to the liberty harvested by the current technology landscape.
Nancy K. Stade, Deputy Director for Policy at the Centres for Devices and Radiological Health, seems to me to make an obvious point in a letter to the FDA quoted in that article: “For a mobile medical app that requires pre-market approval additional time and costs may require 72 months and 75 million additional dollars, these added costs will mean some applications that provide real benefits to patients may never be developed or used, negatively impacting consumer welfare and patient safety”
Now that, I think, is a much better story than the one The Age has come up with. These apps are likely to benefit many more patients than might be harmed, and we ought not be putting unreasonable barriers – or newspaper stories – in their path. Yes, developers need to take extreme care, but the mere fact that they know the lawyers are licking their chops surely makes that sort of negligence less likely.
See on www.ehealthcentral.com.au