I created one of the first medical apps for the iPhone - iStethoscope
- back in 2008,
and it's one of the few that still receives significant media attention and downloads each
month. But things are finally changing in North America as the FDA have released draft guidance on regulations for medical apps.
regulations look set to restrict many iPhone apps in the future. I've always tried to make it
clear that my app is intended as a demonstration of the technology and as a way to promote
awareness of healthy hearts for the general public. Just as functioning toy stethoscopes are
sold in USA without FDA approval, so I would hope my app could be sold in the same way. In
the meantime I am working with a medical device company to produce a new version of the
app designed specifically for use in medicine.
However, as we discussed in the recent nat
ure.com blog these new regulations may have a dramatic effect on the future of
medical iPhone apps. It's conceivable that my own app may be classed as a medical device
and I'll be forced to remove it from North American stores (I hope not all stores worldwide).
It's also conceivable that an over-strict interpretation of the regulations may stifle innovation
in the future. So while we welcome regulation of apps that are intended to be used for
diagnosis, treatment, or prevention of disease, I hope this will not restrict the diversity of
developers of medical apps, for their creativity now may lead to life-saving devices in the
What happens next? Only time will tell.