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