The Journal of mHealth Vol 1 Issue 1 (Feb 2014) | Page 19

FDA Issues Final Guidance on Mobile Medical Apps
liably and it would take a long time
to do the job manually. Play to Cure:
Genes in Space will help us find
ways to diagnose and treat cancer
more precisely – sooner.”
Dr Harpal Kumar, Cancer Research
UK’s chief executive, said: “We’re
enormously proud to launch our
first mobile phone game which
we believe will build on the great

progress we’re making to discover
and develop the most effective new
treatments for all cancers.
“This is ambitious – it’s no mean
feat combining the most advanced
genetic data with cutting-edge gaming technology. But Cancer Research
UK will go to whatever lengths possible to pursue the most innovative approaches to increase survival

from cancer.
“And now we’re calling on our supporters to join in by asking everyone
to give up five minutes to play this
fantastic game and help us discover
cures for cancer sooner.”
For more information and to download the game visit: www.genes-inspace.org. 

FDA Issues Final Guidance
on Mobile Medical Apps

USA

“Our [FDA] mobile medical app policy provides app developers with
the clarity needed to support the continued development of these
important products”
September 2013 saw the U.S. Food and Drug Administration issue their long-awaited final guidance for developers of mobile medical applications.
The agency intends to exercise enforcement discretion
(meaning it will not enforce requirements under the
Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The
FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to
patients if they do not work as intended.
Mobile apps have the potential to transform health care
by allowing doctors to diagnose patients with potentially
life-threatening conditions outside of traditional health
care settings, help consumers manage their own health
and wellness, and also gain access to useful information
whenever and wherever they need it.
Mobile medical apps currently on the market can, for
example, diagnose abnormal heart rhythms, transform
smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used
by a person with insulin-dependent diabetes.

“Some mobile apps carry minimal risks to consumer or
patients, but others can carry significant risks if they
do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Centre for
Devices and Radiological Health.
The FDA is focusing its oversight on mobile medical
apps that are intended to be used as an accessory to a
regulated medical device – for example, an application
that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a
smartphone or a mobile tablet; or transform a mobile
platform into a regulated medical device – for example,
an appl